Ivermectin Injection

IVERMECTIN

IVERMECTIN

ANADA 200-429,Approved by FDA

Injection for Cattle and Swine

1% Sterile Solution

A Parasiticide for the Treatment and Control of Internal and External Parasites of Cattle and Swine

Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

Introduction

Ivermectin is an injectable parasiticide for cattle and swine. One low-volume dose effectively treats and controls the following internal and external parasites that may impair the health of cattle and swine: gastrointestinal roundworms (including inhibited Ostertagia ostertagi in cattle), lungworms, grubs, sucking lice, and mange mites of cattle; and gastrointestinal roundworms, lungworms, lice, and mange mites in swine.


Product Descripton


Ivermectin is derived from the avermectins, a family of potent, broad-spectrum antiparasitic agents isolated from fermentation of Streptomyces avermitilis.

Ivermectin Injection is a clear, ready-to-use, sterile solution containing 1% ivermectin, 40% glycerol formal, and propylene glycol, q.s. ad 100%. Ivermectin Injection is formulated to deliver the recommended dose level of 200 mcg ivermectin/kilogram of body weight in cattle when given subcutaneously at the rate of 1 mL/110 lb (50 kg). In Swine, Ivermectin Injection is formulated to deliver the recommended dose level of 300 mcg ivermectin/kilogram body weight when given subcutaneously in the neck at the rate of 1 mL/75 lbs (33 kg).

Mode of Action

Ivermectin is a member of the macrocyclic lactone class of endectocides which have a unique mode of action. Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA)

The margin of safety for compounds of this clas sis attributable to the fact that mammals do not have glutamate-gated chloride channels, the macrcyclic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier.

Indications

Cattle:  Ivermectin Injection is indicated for the effective treatment and control of the following harmful species of gastrointestinal roundworms, oungworms, grubs, sucking lice and mange mites in cattle:

Gastrointestinal Roundworms

(adults and fourth-stage larvae):

Ostertagia ostertagi

    (Including inhibitedO. ostertagi)

O. lyrata

Haemonchus placei

Trichostrongylus axei

T. colubriformis

Cooperia oncophora

C. punctata

C. pectinata

Oesophagostomum radiatum

Bunostomum phlebotomum

Nematodirus helvetianus

    (adults only)

N. spathiger (adults only)


Lungworms

(adults and fourth-stage larvae):

Dictyocaulus viviparus

Cattle Grubs(parasitic stages):

Hypoderma bovis

H. lineatum

Sucking Lice:

Linognathus vituli

Haematopinus eurysternus

Solenopotes capillatus

Mites Iscabies:

Psoroptes ovis

    (Syn.P. communisvar.bovis)

Sarcoptes scabieivar. bovis

Persistent Activity

Ivermectin Injection has been proved to effectively control infections and to protect cattle from reinfection withDictyocaulus viviparus and Oesophagostomum radiatum for 28 days after treatment;Ostertagia ostertagi, Trichostrongylus axei and Cooperia punctata for 21 days after treatment;Haemonchus placei and Cooperia oncophorafor 14 days after treatment.

Swine:  Ivermectin Injection is indicated for the effective treatment and control of the follwoing harmful species of gastrointestinal roundworms, lungworms, lice and mange mites in swine:

Gastrointestinal roundworms

Large roundworm,Ascaris suum

(adults and fourth-stage larvae)

Red stomach worm,Hyostrongylus rubidus

(adults and fourth-stage larvae)

Nodular worm,Oesophagostomum spp.

(adults and fourth-stage larvae)

Threadworm,Strongyloides ransomi (adults)

Somatic Roundworm Larvae:

Threadworm, Strongyloides ransomi (somtic larvae)

Sows must be treated at least seven days before farrowing to prevent infection in piglets.

Lungworm:

Metastrongylus spp. (adults)

Lice:

Haematopinus suis

Mange Mites:

Sarcoptes scabiei  var. suis

Dosage

Cattle:  IVERMECTIN should be given only by subcutaneous injection under the loose skin in front of or behind the shoulder at the recommended dose level of 200 mcg ivermectin per kilogram of body weight. Each mL of IVERMECTIN contains 10 mg of ivermectin, sufficient to treat 110 lb (50 kg) of body weight (maximum 10 mL per injection site.).

Swine: IVERMECTIN should be given only by subcutaneous injection in the neck of swine at the reocmmended dose level of 300 mcg ivermectin per kilogram (2.2 lb) of body weight. Each mL of IVERMECTIN contains 10 mg of ivermectin, sufficient to treat 75 lb of body weight.

Administration

Cattle: Ivermectin Injection is to be given subcutaneously only, to reduce risk of potentially fatal clostridial infection of the injection site.

Animals should be appropriately restrained to achieve the proper route of administration. Use of a 16-gauge, 1/2 to 3/4" needle is suggested. Inject under the loose skin in front of or behind the shoulder (see illustration). When using the 200 mL, 500 mL size, use only automatic syringe equipment. Use sterile equipment and sanitize the injection site by applying a suitable disinfectant. Clean, properly disinfected needles should be used to reduce the potential for injection site infections. No special handling or protective clothing is necessary.

Swine:  Ivermectin Injection is to be given subcutaneously in the neck. Animals should be appropriately restrained to achieve the proper route of administration. Use of a 16- or 18-gauge needle is suggested for sows and boars, while an 18- or 20-gauge needle may be appropriate for young animals. Inject under the skin, immediately behind the ear (see illustration). When using teh 200 mL, 500 mL size, use only automatic syringe equipment. As with any injection, sterile equipment should be used. The injection site should be cleaned and disinfected with alcohol before injection. The rubber stopper should also be disinfected with alcohol to prevent contamination of the contents. Mild and transient pain reactions may be seen in some swine following subcutaneous administration.

Recommended Treatment Program

SWINE: At the time of initiating any parasite control program, it is important to treat all breeding animals in the herd. After the initial treatment, use Ivermectin Injection regularly as follows:

BREEDING ANIMALS:

Sows:  Treatment prior to farrowing, preferably 7 - 14 days before, to minimize infection of piglets.

Gilts:   Treat 7 - 14 days prior to breeding.

            Treat 7 - 14 days prior to farrowing.

Boars: Frequency and need for treatment are dependent upon exposure.  Treat at least two times a year.

FEEDER PIGS

(Weaners/Growers/Fininshers)

All weaner/feeder pigs should be treated before placement in clean quarters.

Pigs exposed to contaminated soil or pasture may need retreatment if reinfection occurs.

NOTE:

(1) Ivermectin Injection has a persistent drug level sufficient to control mite infestations throughout the egg to adult life cycle. However, since the ivermectin effect is not immediate, care must be taken to prevent reinfestation from exposure to untreated animals or contaminated facilities. Generally, pigs should not be moved to clean quarters or exposed to uninfested pigs for approximately one week quarters or exposed to uninfested pigs for approximately one week after treatment. Sows should be treated at least one week before farrowing to minimize transfer of mites to newborn baby pigs.

(2) Louse eggs are unaffected by Ivermectin Injection and may require up to three weeks to hatch. Louse infestations developing from hatching eggs may require retreatment.

(3) Consult a veterinarian for aid in teh diagnosis and control of internal and external parasites of swine.

Special Minor Use

Reindeer: For the treatment and control of warbles (Oedemagena tarandi) in reindeer, inject 200 micrograms ivermectin per kilogram of body weight, subcutaneously. Follow use directions for cattle as described in ADMINISTRATION.

American Bison: For the treatment and control of grubs (Hypoderma bovis) in American bison, inject 200 micrograms ivermectin per kilogram of body weight, subcutaneously. Follow use directions for cattle as described under ADMINISTRATION.

RESIDUE WARNING: Do not treat reindeer or American bison within 8 weeks (56 days) of slaughter. 

WARNING

Not for use in humans.

Keep this and all drugs our to reach of children.

The Material Safety Data Sheet (MSDS) contains more detailed occurpational safety information. To report adverse effects, obtain a MSDS or for asstance, contact Sparhawk Laboratories, Inc. at 1-800-255-6368.

  RESIDUE WARNING: Do not treat cattle within 35 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. 

  A withdrawal period has not been established for this product n pre-ruminating calves. Do not use in calves to be processed for veal.

  Do not treat swine within 18 days of slaughter.

Precautions

Transitory discomfort has been observed in some cattle following subcutaneous administration. A low incidence of soft tissue swelling at the injection site has been observed. These reactions have disappeared without treatment. For cattle, divide doses greater than 10 mL between two injection sites to reduce occasional discomfort or site reaction.

Use sterile equipment and sanitize the injection site by applying a suitable disinfectant. Clean, properly disinfected needles should be used to reduce the potential for injection site infection.

Observe cattle for injection site reactions. Reactions may be due to clostridial infection and should be aggressively treated with appropriate antibiotics. If injection site infections are suspected, consult your veterinarian.

This product is not for intravenous or intramuscular use.

Protect product from light.

Ivermectin Injection for Cattle and Swine has been developed specifically for use in cattle, swine, reindeer and American bison only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs may result.

When to Treat Cattle with Grubs

IVERMECTIN effectively controls all stages of cattle grubs. However, proper timing of treatment is important. For most effective results, cattle should be treated as soon as possible after the end of the heel fly (warble fly) season. Destruction of Hypoderma larvae (cattle grubs) at the period when these grubs are in vital areas may cause undesirable host-parasite reactions including the possibility of fatalities. Killing Hypoderma lineatum when it is in the tissue surrounding the esophagus (gullet) may cause salivation and bloat.: Killing H. bovis when it is in the vertebral canal may cause staggering or paralysis. These reactions are not specific to treatment with a IVERMECTIN, but can occur with any successful treatment of grubs. Cattle should be treated either before or after these stages of grub development. Consult your veterinarian concerning the proper time for treatment. Cattle treated with IVERMECTIN after the end of the heel fly season may be retreated with IVERMECTIN during the winter for internal parasites, mange mites, or sucking lice without danger of grub-related reactions. A planned parasite control program is recommended.

Environmental Safety

Studies indicate that when ivermectin comes in contact with the soil, it readily and tightly binds to the soil and becomes inactive over time. Free ivermectin may adversely affect fish and certain water born organisms on which they feed. Do not permit water runoff from feedlots or production sites to enter lakes, streams, or ponds. Do not contaminate water by direct application or by the improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration.

As with other avermectins, ivermectin is excreted in the dung of treated animals and can inhibit the reproduction and growth of pest and beneficial insets that use dung as a source of food and for reproduction. The magnitude and duration of such effects are species and lifestyle specific. When used according to label directions, the product is not expected to have an adverse impact on populations of dung-dependent insects.

How Supplied

50 mL, 200 mL, 500 mL

Store at 20-25oC.

Restricted Drug (California) - use only as directed.

IVERMECTIN  ivermectin  injection

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 58005-346 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IVERMECTIN (IVERMECTIN) IVERMECTIN 10 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 58005-346-02 50 mL In 1 VIAL None 2 58005-346-07 200 mL In 1 VIAL None 3 58005-346-06 500 mL In 1 VIAL None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200-429	07/05/2010

Labeler - Sparhawk Laboratories, Inc. (958829558)

Revised: 06/2010Sparhawk Laboratories, Inc.

Gildess FE 1/0.2

Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)

Brand Names: Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Estrostep Fe, Femcon FE, Generess Fe, Gildess FE 1.5/0.03, Gildess FE 1/0.2, Junel 1.5/30, Junel 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Lo Loestrin Fe, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin 1/20, Microgestin FE 1.5/30, Microgestin FE 1/20, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 35 Fe, Ovcon 50, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent Fe, Zeosa

What is Gildess FE 1/0.2 (ethinyl estradiol and norethindrone)?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.

Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.

Ethinyl estradiol and norethindrone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Gildess FE 1/0.2 (ethinyl estradiol and norethindrone)?

Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

What should I discuss with my healthcare provider before taking Gildess FE 1/0.2 (ethinyl estradiol and norethindrone)?

This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). You should not take birth control pills if you have:

• 
  

  coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;

  
  


• 
  

  a history of a stroke, blood clot, or circulation problems;

  
  


• 
  

  a hormone-related cancer such as breast or uterine cancer;

  
  


• 
  

  unusual vaginal bleeding that has not been checked by a doctor;

  
  


• 
  

  liver disease or liver cancer;

  
  


• 
  

  severe migraine headaches; or

  
  


• 
  

  a history of jaundice caused by pregnancy or birth control pills.

  
  

To make sure you can safely take this medication, tell your doctor if you have any of these other conditions:

• 
  

  high blood pressure or a history of heart disease;

  
  


• 
  

  high cholesterol, gallbladder disease, or diabetes;

  
  


• 
  

  migraine headaches or a history of depression; or

  
  


• 
  

  a history of breast cancer or an abnormal mammogram.

  
  

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take Gildess FE 1/0.2 (ethinyl estradiol and norethindrone)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.

The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.

The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Missing a pill increases your risk of becoming pregnant. If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.

If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while taking Gildess FE 1/0.2 (ethinyl estradiol and norethindrone)?

Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Gildess FE 1/0.2 (ethinyl estradiol and norethindrone) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  sudden numbness or weakness, especially on one side of the body;

  
  


• 
  

  sudden severe headache, confusion, problems with vision, speech, or balance;

  
  


• 
  

  sudden cough, wheezing, rapid breathing, coughing up blood;

  
  


• 
  

  pain, swelling, warmth, or redness in one or both legs;

  
  


• 
  

  chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  
  


• 
  

  a change in the pattern or severity of migraine headaches;

  
  


• 
  

  pain in your upper stomach, jaundice (yellowing of the skin or eyes);

  
  


• 
  

  a lump in your breast;

  
  


• 
  

  swelling in your hands, ankles, or feet; or

  
  


• 
  

  symptoms of depression (sleep problems, weakness, mood changes).

  
  

Less serious side effects may include:

• 
  

  mild nausea or vomiting, appetite or weight changes;

  
  


• 
  

  breast swelling or tenderness;

  
  


• 
  

  headache, nervousness, dizziness;

  
  


• 
  

  problems with contact lenses;

  
  


• 
  

  freckles or darkening of facial skin, loss of scalp hair; or

  
  


• 
  

  vaginal itching or discharge.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Gildess FE 1/0.2 (ethinyl estradiol and norethindrone)?

Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:

• 
  

  acetaminophen (Tylenol) or ascorbic acid (vitamin C);

  
  


• 
  

  bosentan (Tracleer);

  
  


• 
  

  prednisolone (Orapred);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Uniphyl);

  
  


• 
  

  an antibiotic;

  
  


• 
  

  HIV or AIDS medications;

  
  


• 
  

  phenobarbital (Solfoton) and other barbiturates; or

  
  


• 
  

  seizure medication.

  
  

This list is not complete and other drugs may interact with birth control pills. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Gildess FE 1/0.2 resources

• Gildess FE 1/0.2 Side Effects (in more detail)
• Gildess FE 1/0.2 Use in Pregnancy & Breastfeeding
• Gildess FE 1/0.2 Drug Interactions
• 0 Reviews for Gildess FE/0.2 - Add your own review/rating

• Aranelle Prescribing Information (FDA)


• Balziva Prescribing Information (FDA)


• Brevicon Prescribing Information (FDA)


• Briellyn Prescribing Information (FDA)


• Cyclafem 1/35 Prescribing Information (FDA)


• Cyclafem 7/7/7 Prescribing Information (FDA)


• Estrostep Fe Prescribing Information (FDA)


• Femcon FE Prescribing Information (FDA)


• Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Femhrt Consumer Overview


• Femhrt Prescribing Information (FDA)


• Femhrt MedFacts Consumer Leaflet (Wolters Kluwer)


• Jevantique Prescribing Information (FDA)


• Jinteli Prescribing Information (FDA)


• Leena Prescribing Information (FDA)


• Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer)


• Lo Loestrin Fe Consumer Overview


• Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information


• Lo Loestrin Fe Prescribing Information (FDA)


• Loestrin 24 FE Prescribing Information (FDA)


• Loestrin 24 Fe Consumer Overview


• Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer)


• Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer)


• Tilia FE Prescribing Information (FDA)


• Tri-Norinyl Prescribing Information (FDA)


• Zenchent FE Prescribing Information (FDA)


• Zeosa Prescribing Information (FDA)

Compare Gildess FE 1/0.2 with other medications

• Abnormal Uterine Bleeding
• Acne
• Birth Control
• Endometriosis
• Gonadotropin Inhibition
• Menstrual Disorders
• Polycystic Ovary Syndrome
• Postmenopausal Symptoms

Where can I get more information?

• Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

See also: Gildess FE/0.2 side effects (in more detail)

measles, mumps, rubella, and varicella virus vaccine live Subcutaneous

MEE-zuls VYE-rus VAX-een, lyve, mumps VYE-rus VAX-een, lyve, roo-BELL-a VYE-rus VAX-een, lyve, var-i-SEL-a VYE-rus VAX-een

Commonly used brand name(s)

In the U.S.

• ProQuad

Available Dosage Forms:

• Powder for Solution


• Powder for Suspension

Therapeutic Class: Vaccine

Uses For measles, mumps, rubella, and varicella virus vaccine live

Measles, mumps, rubella, and varicella virus vaccine (live) is an active immunizing agent that is given to protect against infections caused by measles (rubeola), mumps, rubella (German measles), and varicella (chickenpox) viruses. The combination vaccine works by causing the body to produce its own protection (antibodies) against these diseases.

Measles (also known as coughing measles, hard measles, morbilli, red measles, rubeola, and 10-day measles) is an infection that is easily spread from one person to another. Infection with measles can cause serious problems, such as stomach problems, pneumonia, ear infections, sinus problems, convulsions (seizures), brain damage, and possibly death. The risk of serious complications and death is greater for adults and infants than for children and teenagers.

Mumps is an infection that can cause serious problems, such as encephalitis and meningitis, which affect the brain. In addition, teenage boys and men are very susceptible to a condition called orchitis, which causes pain and swelling in the testicles and scrotum, and in rare cases, sterility. Also, mumps infection can cause spontaneous abortion (miscarriage) in women during the first 3 months of pregnancy.

Rubella (also known as German measles) is a serious infection that causes miscarriages, stillbirths, or birth defects in unborn babies when pregnant women get the disease.

Varicella (commonly known as chickenpox) is an infection that is easily spread from one person to another. Chickenpox is usually a mild infection but sometimes it can cause serious problems, such as pneumonia, inflammation of the brain, and a rare disease called Reye's syndrome.

Immunization against measles, mumps, german measles, and chickenpox is recommended for children 12 months to 12 years of age who has not had these diseases. Immunization against these diseases is not recommended for infants younger than 12 months of age and for children 13 years of age and older.

This vaccine is to be administered only by or under the supervision of your child’s doctor or other authorized healthcare professional.

Before Using measles, mumps, rubella, and varicella virus vaccine live

In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to measles, mumps, rubella, and varicella virus vaccine live or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of measles, mumps, rubella, and varicella virus vaccine in children 12 months to 12 years of age. However, this vaccine is not recommended for infants younger than 12 months of age and for children 13 years of age and older.

Geriatric

This vaccine is not recommended for use in adult patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aclarubicin


• Acyclovir


• Adalimumab


• Aldesleukin


• Alemtuzumab


• Altretamine


• Amonafide


• Amsacrine


• Asparaginase


• Aspirin


• Azacitidine


• Azathioprine


• Benorilate


• Bleomycin


• Broxuridine


• Busulfan


• Capecitabine


• Carboplatin


• Carmustine


• Certolizumab Pegol


• Chlorambucil


• Choline Magnesium Trisalicylate


• Cisplatin


• Cladribine


• Cyclophosphamide


• Cytarabine


• Cytarabine Liposome


• Dacarbazine


• Dactinomycin


• Daunorubicin


• Daunorubicin Citrate Liposome


• Decitabine


• Docetaxel


• Doxifluridine


• Doxorubicin Hydrochloride


• Doxorubicin Hydrochloride Liposome


• Edatrexate


• Eflornithine


• Epirubicin


• Estramustine


• Etanercept


• Etoposide


• Everolimus


• Fingolimod


• Floxuridine


• Fludarabine


• Fluorouracil


• Fotemustine


• Gallium Nitrate


• Gemcitabine


• Golimumab


• Hydroxyurea


• Idarubicin


• Ifosfamide


• Irinotecan


• Lomustine


• Mechlorethamine


• Melphalan


• Meningococcal Vaccine


• Mercaptopurine


• Mesalamine


• Methotrexate


• Mitolactol


• Mitomycin


• Mitotane


• Mitoxantrone


• Mycophenolic Acid


• Olsalazine


• Oxaliplatin


• Paclitaxel


• Pegaspargase


• Pentostatin


• Pipobroman


• Pirarubicin


• Plicamycin


• Pneumococcal Vaccine Polyvalent


• Procarbazine


• Raltitrexed


• Rilonacept


• Rituximab


• Salicylamide


• Salicylic Acid


• Salsalate


• Sirolimus


• Sodium Salicylate


• Sodium Thiosalicylate


• Streptozocin


• Tacrolimus


• Teceleukin


• Tegafur


• Temsirolimus


• Teniposide


• Thioguanine


• Thiotepa


• Topotecan


• Treosulfan


• Trimetrexate


• Trofosfamide


• Trolamine Salicylate


• Uracil Mustard


• Ustekinumab


• Vinblastine


• Vincristine


• Vincristine Liposome


• Vindesine


• Vinorelbine

Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept


• Leflunomide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood disorder (weak immune system) or


• Bone marrow cancer or


• Immune deficiency condition, or family history of or


• Illness with a fever or


• Leukemia (cancer of the blood) or


• Lymphoma (cancer of the immune system) or


• Receiving immunosuppressive therapy or


• Tuberculosis, active and untreated—Should not be used in patients with these conditions.

• Brain injury or


• Seizures, history of or


• Thrombocytopenia (not enough platelets in the blood) or history of—Use with caution. May make these conditions worse.

Proper Use of measles, mumps, rubella, and varicella virus vaccine live

A nurse or other trained health professional will give your child this vaccine. This vaccine is given as a shot under your skin (usually in the upper arms or thighs).

Your child should receive one shot of the vaccine at 12 to 15 months of age and possibly a second shot at 4 to 6 years of age.

Your child may receive certain other vaccines at the same time as this one, but in a different body area.

You should receive a patient information sheet about all of the vaccines your child receives. Make sure you understand all of the information that is given to you.

It is important to receive this vaccine at the proper time. If your child misses a scheduled shot, call your child's doctor to make another appointment as soon as possible.

Precautions While Using measles, mumps, rubella, and varicella virus vaccine live

It is very important that your child return to your doctor’s office at the right time if your child needs a second dose of the vaccine. Be sure to notify your doctor of any side effects that occur after your child receive this vaccine.

Do not become pregnant for 3 months after receiving this vaccine without first checking with your doctor. There is a chance that this vaccine may cause problems during pregnancy. If you think you have become pregnant, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients receiving this vaccine.

Children who have received this vaccine have developed a fever and in some cases a fever with seizures. Talk with your child's doctor if you have concerns about this.

Your child should avoid close contact with people at high risk for catching the varicella virus for 6 weeks after receiving this vaccine. People who are at risk for catching the virus are pregnant women, newborn babies, and anyone who has a weak immune system that keeps them from fighting infections.

Tell your doctor that you have received this vaccine:

• If you are to receive blood transfusions or other blood products within 3 months of receiving this vaccine.


• If you are to receive varicella-zoster immune globulin (VZIG) or other immune globulins within 3 to 5 months after receiving this vaccine.


• If you are to have a tuberculin skin test within 4 to 6 weeks after receiving this vaccine.


• If you are to receive any other live virus vaccines within 1 or 3 months of receiving this vaccine.

Do not take aspirin or medicines that contain aspirin (such as cold medicines) for 6 weeks after receiving this vaccine. Carefully check the label of any pain, headache, or cold medicine you give to your child to be sure it does not contain aspirin or salicylic acid.

This vaccine contains albumin, which comes from human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the manufacture of these medicines. Although the risk is low, talk with your child's doctor if you have concerns.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

measles, mumps, rubella, and varicella virus vaccine live Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Fever over 39 °C (102 °F)

Less common

• Body aches or pain


• chills


• cough


• ear congestion


• fever


• headache


• loss of voice


• nasal congestion


• rash that looks like chickenpox or measles


• runny nose


• sneezing


• sore throat


• unusual tiredness or weakness

Incidence not known

• Agitation


• back pain, sudden and severe


• bleeding gums


• blistering, peeling, or loosening of the skin


• bloating or swelling of the face, arms, hands, lower legs, or feet


• blood in the urine or stools


• bloody nose


• bloody or black, tarry stools


• blurred vision


• burning or stinging of the skin


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• chest pain


• coma


• confusion


• cough or hoarseness


• cough producing mucus


• diarrhea


• difficulty with breathing


• difficulty with swallowing


• dizziness


• drowsiness


• fainting


• fast heartbeat


• general feeling of discomfort or illness


• hallucinations


• hives


• inability to move the arms and legs


• inability to speak


• irritability


• itching, pain, redness, swelling, tenderness, or warmth on the skin


• joint or muscle pain


• large, flat, blue, or purplish patches in the skin


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• loss of appetite


• lower back or side pain


• mood or mental changes


• muscle aches and pains


• muscle weakness, sudden and progressing


• nausea


• noisy breathing


• numbness, tingling, pain, or weakness in the hands or feet


• pain, numbness, or tingling of the hands, arms, legs, or feet


• pain, tenderness, or swelling in the testicles and scrotum


• painful blisters on the trunk of the body


• painful cold sores or blisters on the lips, nose, eyes, or genitals


• painful knees and ankles


• painful or difficult urination


• pinpoint red spots on the skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• raised red swellings on the skin, buttocks, legs, or ankles


• rapid weight gain


• red skin lesions, often with a purple center


• red, irritated eyes


• seizures


• severe or sudden headache


• shakiness and unsteady walk


• shakiness in the legs, arms, hands, or feet


• shivering


• shortness of breath


• skin rash


• skin rash on the face, scalp, or stomach


• slurred speech


• sores, ulcers, or white spots on the lips or in the mouth


• stiff neck or back


• stomach pain


• sudden numbness and weakness in the arms and legs


• sweating


• swelling or puffiness of the face


• swollen or painful glands


• swollen, painful, or tender lymph glands in the neck, armpit, or groin


• swollen, painful, or tender lymph glands on the side of the face or neck


• temporary blindness


• tenderness


• thickening of bronchial secretions


• tightness in the chest


• tingling of the hands or feet


• trembling or shaking of the hands or feet


• trouble sleeping


• unsteadiness, trembling, or other problems with muscle control or coordination


• unusual bleeding or bruising


• unusual weight gain or loss


• vomiting


• warmth on the skin


• weakness in the arm or leg on one side of the body, sudden and severe


• weakness of the muscles in your face


• wheezing


• white patches in the mouth or throat or on the tongue


• white patches with diaper rash

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Incidence not known

• Abnormal dreams


• blindness


• bloated


• blue-yellow color blindness


• deafness


• decreased vision


• difficulty with moving


• double vision


• ear pain


• excess air or gas in the stomach or intestines


• eye pain


• full feeling


• irritation and swelling of the eyelids


• lack of feeling or emotion


• muscle or bone pain


• muscle pain or stiffness


• nervousness


• pain and swelling in the scrotum


• pain in the hip, leg, or neck


• pain or tenderness around the eyes and cheekbones


• passing gas


• red rash with watery, yellow-colored, or pus filled blisters


• thick yellow to honey-colored crusts


• uncaring


• unusually deep sleep


• unusually long duration of sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More measles, mumps, rubella, and varicella virus vaccine live Subcutaneous resources

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Rheumox capsules

1. Name Of The Medicinal Product

Rheumox Capsules

2. Qualitative And Quantitative Composition

Azapropazone Dihydrate 300mg

3. Pharmaceutical Form

Rheumox Capsules: Two-tone orange size 1 capsule, containing Azapropazone Dihydrate 300mg. This product also contains sunset yellow (E110) and erythrosine lake (E127).

4. Clinical Particulars

4.1 Therapeutic Indications

Rheumox is a non-steroidal anti-inflammatory analgesic agent indicated in the treatment of rheumatoid arthritis, ankylosing spondylitis and attacks of acute arthritis in patients for whom other therapy has been ineffective.

Rheumox should be used in suitable low-risk patients (see contraindications, precaution and warnings).

4.2 Posology And Method Of Administration

Route of Administration: Oral.

The lowest effective dose of Rheumox should be used for the shortest duration.

Dosage recommendations for Rheumox are lower for patients older than 60 years and for patients of any age who have reduced renal function. Rheumox is contraindicated in severe renal insufficiency. If any abnormality is suspected, renal function should be investigated before commencing treatment with Rheumox.

Rheumatoid arthritis and ankylosing spondylitis

Adults under 60 years with adequate renal function.

Rheumox 600 Tablets: One 600mg tablet night and morning.

Rheumox 300mg Capsules: One 300mg capsule four times daily or two 300mg capsules night and morning.

Adults over 60 years:

Rheumox 300mg capsules: One 300mg capsule twice daily.

Adults of any age with reduced renal function:

Please follow dosage instructions for adults over 60 years, given above.

Acute Gout

Adults under 60 years with adequate renal function: 1,800mg per day in divided doses until the acute symptoms subside, normally by the fourth day, after which 1200mg per day in divided doses is taken until symptoms have resolved. If symptoms persist then appropriate alternative therapy for chronic gout should be considered. In treating acute gout, it is good practice to ensure that the patient increases their fluid intake.

Adults over 60 years: Rheumox is not recommended in acute gout in patients with a creatinine clearance of less than 60ml per minute.

1,800mg in divided doses during the first 24 hours followed by 1,200mg per day in divided doses. A maximum maintenance dose of 600mg per day in divided doses should be achieved doses should be achieved as early as possible preferably by the fourth day. Treatment with Rheumox should only be continued until the acute symptoms resolve. If symptoms persist then appropriate alternative therapy for chronic gout should be considered. In treating acute gout, it is good practice to ensure that the patient increases their fluid intake.

Adults of any age with reduced renal function: Please follow dosage instructions for adults over 60 years, given above.

Children: Not recommended.

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

4.3 Contraindications

I: Use in patients with a history or evidence of peptic ulceration or ulcerative colitis.

II: Use in patients with severe renal insufficiency.

III: Rheumox should not be given to patients with a history or evidence of blood dyscrasia.

IV: Use in patients with a history or evidence of blood insufficiency.

V: Use in patients with severe hepatic insufficiency.

VI: Rheumox significantly potentiates the action of warfarin in many patients and must not be used with this or other oral anticoagulants.

VII: Rheumox increases the plasma concentration of phenytoin and should not be given to patients taking this drug.

VIII: Rheumox should not be given to patients taking methotrexate.

IX: Rheumox, as with other non-steroidal anti-inflammatory drugs (NSAIDs) should not be used in patients suffering from porphyria.

X: Rheumox should not be given to patients with Severe heart failure.

4.4 Special Warnings And Precautions For Use

I: Rheumox should only be considered for use in rheumatoid arthritis, ankylosing spondylitis and attacks of acute gouty arthritis in patients for whom other therapy has been ineffective.

II: Azapropazone should not be used in patients who are at a high risk of developing serious adverse events known to be associated with NSAID therapy, for example, patients who are suffering from gastrointestinal, severe renal or heart disease, or who are taking diuretics. This would include elderly patients and particularly those who are already have or are suspected to have any of these conditions. In addition, patients who are on long-term therapy or multiple therapies should be carefully evaluated before treatment with Rheumox is initiated.

III: Serious gastrointestinal adverse effects such as bleeding, ulceration and perforation can occur at any time with or without warning symptoms in patients treated with Rheumox. Although this applies to all patients treated with Rheumox. Although this applies to all patients, elderly or debilitated patients are less able to tolerate serious ulceration or bleeding events. If any sign of gastrointestinal bleeding occurs, Rheumox should be stopped immediately.

IV: Azapropazone is excreted unchanged mainly by the kidney and should therefore be used with caution in older patients and in adults with any reduced renal function. NSAIDs in general inhibit renal prostaglandin synthesis and in patients with reduced renal function this action may result in overt renal decompensation. In such cases, the reduced dosage recommendations for the treatment of adults over 60 years should be followed. If any abnormality is suspected, renal function should be fully investigated before commencing therapy with Rheumox. See also contraindications.

V: A large number of photosensitivity reactions have been reported in association with Rheumox. Patients taking azapropazone should be advised to avoid direct exposure to sunlight or to use sunblock preparations.

VI: Rheumox can cause fluid retention. It should therefore be used with caution in patients with fluid retention, hypertension or heart failure.

VII: If abnormal liver function tests occur, persist or worsen, or if clinical signs and symptoms indicate the development of liver disease, Rheumox should be discontinued.

VIII: Inhibition of renal lithium clearance by Rheumox has not been reported but the possibility of this occurring should be borne in mind.

IX: Rheumox may be precipitate bronchospasm in patients with bronchial asthma or allergic disease.

X: The concomitant administration of corticosteroids with Rheumox may increase the risk of gastrointestinal bleeding and ulceration.

XI: Patients on long-term treatment with Rheumox should be carefully monitored and regularly reviewed. Haematological effects associated with chronic NSAID therapy should be borne in mind.

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below).

Cardiovascular and cerebrovascular effects

Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). There are insufficient data to exclude such a risk for Azapropazone.

Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with Azapropazone after careful consideration.

Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

I: Consult the section 'Contraindication' with phenytoin, warfarin and methotrexate.

II: Since azapropazone is highly protein bound, it may possibly displace other protein bound drugs. It may therefore interfere with the blood sugar lowering effect of oral hypoglycaemic agents. Concurrent use of the drugs is not recommended.

III: Concomitant use with azapropazone of lithium or digoxin may cause an increase in serum levels of these compounds. Concomitant use of cimetidine may cause an increase in azapropazone and decrease in cimetidine plasma levels respectively.

4.6 Pregnancy And Lactation

Animal reproduction studies did not result in foetal abnormalities but safety in human pregnancy cannot be assumed and its use should be avoided in pregnancy whenever possible.

Azapropazone is excreted in small quantities in breast milk and should not therefore be used in breast feeding women.

4.7 Effects On Ability To Drive And Use Machines

None stated (presumed to be safer or unlikely) to produce any effect).

4.8 Undesirable Effects

See also contraindications, precautions and warnings.

I: Serious gastrointestinal events including bleeding, gastric and duodenal ulceration, perforation and haemorrhage have been reported.

Epidemiological studies show that these reactions occur more frequently than for other NSAIDs. In addition diarrhoea, dyspepsia, nauseam, vomiting, melaena, and stomatitis have also been reported.

II: Blood disorders including thrombocytopenia, pancytopenia, neutropenia and leucopenia have been reported. Anaemia and haemolytic anaemia have also been reported and some patients may develop a positive direct Coombs test with haemolytic anaemia. Rheumox should be discontinued in the presence of haemolytic anaemia or a positive direct Coombs test.

III: NSAIDs have been reported to cause nephrotoxicity in various forms and their use can lead to interstitial nephritis, nephrotic syndrome and renal failure. Renal impairment and renal failure have been reported in association with Rheumox.

IV: Oedema and angioneurotic oedema.

V: Occasional central nervous system effects including dizziness, headache, and fatigue.

VI: Skin rashes including a high frequency of photosensitivity reactions.

VII: Allergic alveolitis, pulmonary fibrosis and fibrosing alveolitis has been reported rarely and if this occurs Rheumox should be continued. Many NSAIDs may propitiate bronchospasm in patients with bronchial asthma or allergic disease, and this has been reported in association with Rheumox.

VIII: Hepatic side effects including jaundice and hepatitis have been reported rarely.

Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.

Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction or stroke) (see section 4.4).

4.9 Overdose

If overdosage should occur, two specific courses of action are suggested on theoretical grounds. Since Rheumox is poorly soluble in gastric juice, stomach lavage should recover any gastric residue of the drug, provided of course that it is done early enough. Since Rheumox is predominantly excreted by the kidney, forced alkaline diuresis is theoretically indicated.

In addition to the above mentioned treatment, patients should be managed with symptomatic and supportive care.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Azapropazone is a non-steroidal anti-inflammatory agent with anti-inflammatory analgesic and antipyretic actively established by standard animal pharmacology tests and confirmed via clinical studies and use in man. In addition, this active ingredient is hyperuricaemic, reducing serum urate by enhancing urate excretion.

5.2 Pharmacokinetic Properties

Rheumox 600 and Rheumox Capsules are immediate release preparations containing the active ingredient azapropazone dihydrate. Human pharmacokinetic studies with azapropazone have demonstrated rapid absorption following oral dosing with the attainment of maximum plasma levels at approximately 4 hours post dosing.

Azapropazone is reported to be highly bound to the plasma protein following absorption and in animal studies its distributions throughout body tissues is related to plasma concentration.

Only low concentrations are reported in the brain and fatty tissues thus confirming the low lipophilic activity of azapropazone.

Metabolic studies have demonstrated that azapropazone is not extensively metabolised and is excreted primarily as unchanged azapropazone by the kidney.

5.3 Preclinical Safety Data

The oral LD50 of azapropazone in rats was 4200mg/kg. This value is equivalent to 150 times the maximum recommended human dose.

When administered to animals at the maximum tolerated daily doses, azapropazone did not exhibit a carcinogenic effect.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium Lauryl sulphate, silica, gelatin, erythrosine E127, sunset yellow E110 and titanium dioxide E171.

6.2 Incompatibilities

None started.

6.3 Shelf Life

Blister packs 36 months

Amber glass bottle 60 months

6.4 Special Precautions For Storage

Protect from light.

6.5 Nature And Contents Of Container

Screw cap amber glass bottle (pack sizes: 12, 28, 56, 100, 112, 500)

PVC/aluminium foil blisters (pack sizes: 4, 14, 28, 56, 112)

6.6 Special Precautions For Disposal And Other Handling

None stated.

Administrative Data

7. Marketing Authorisation Holder

Goldshield Pharmaceuticals Ltd.

NLA Tower

Croydon

Surrey

CR0 OXT

UK.

8. Marketing Authorisation Number(S)

PL 12762/0021

9. Date Of First Authorisation/Renewal Of The Authorisation

01st February 1998

10. Date Of Revision Of The Text

12/04/2007

Zomestine 40 mg prolonged-release tablets

1. Name Of The Medicinal Product

Zomestine 40 mg prolonged-release tablets

2. Qualitative And Quantitative Composition

Each prolonged-release tablet contains 40 mg oxycodone hydrochloride equivalent to 36 mg oxycodone.

Excipient:

The prolonged-release tablets contain a maximum of 24 mg sucrose.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Prolonged-release tablet.

Pink, oblong, biconvex, tablets with break scores on both sides. The tablet can be divided into equal halves.

4. Clinical Particulars

4.1 Therapeutic Indications

Severe pain, which can be adequately managed only with opioid analgesics.

4.2 Posology And Method Of Administration

The dosage depends on the intensity of pain and the patient's individual susceptibility to the treatment. For doses not realisable/practicable with this medicinal product, other strengths and medicinal products are available.

The following general dosage recommendations apply:

Adults and adolescents (> 12 years)

Dose titration and adjustment

In general, the initial dose for opioid naïve patients is 10 mg oxycodone hydrochloride given at intervals of 12 hours. Some patients may benefit from a starting dose of 5 mg to minimise the incidence of adverse reactions.

Patients already receiving opioids may start treatment with higher dosages taking into account their experience with former opioid therapies.

According to well-controlled clinical studies 10-13 mg oxycodone hydrochloride correspond to approximately 20 mg morphine sulphate, both in the prolonged-release formulation.

Because of individual differences in sensitivity for different opioids, it is recommended that patients should start conservatively with Zomestine prolonged-release tablets after conversion from other opioids, with 50-75% of the calculated oxycodone dose.

Some patients who take Zomestine prolonged-release tablets following a fixed schedule need rapid release analgesics as rescue medication in order to control breakthrough pain. Zomestine prolonged-release tablets are not indicated for the treatment of acute pain and/or breakthrough pain. The single dose of the rescue medication should amount to 1/6 of the equianalgesic daily dose of Zomestine prolonged-release tablets. Use of the rescue medication more than twice daily indicates that the dose of Zomestine prolonged-release tablets needs to be increased.

The dose should not be adjusted more often than once every 1-2 days until a stable twice daily administration has been achieved.

Following a dose increase from 10 mg to 20 mg taken every 12 hours dose adjustments should be made in steps of approximately one third of the daily dose. The aim is a patient specific dosage which, with twice daily administration, allows for adequate analgesia with tolerable undesirable effects and as little rescue medication as possible as long as pain therapy is needed.

Even distribution (the same dose mornings and evenings) following a fixed schedule (every 12 hours) is appropriate for the majority of the patients. For some patients it may be advantageous to distribute the doses unevenly. In general, the lowest effective analgesic dose should be chosen. For the treatment of non malignant pain a daily dose of 40 mg is generally sufficient; but higher dosages may be necessary. Patients with cancer-related pain may require dosages of 80 to 120 mg, which in individual cases can be increased to up to 400 mg. If even higher doses are required, the dose should be decided individually balancing efficacy with the tolerance and risk of undesirable effects.

Method of administration

For oral use.

Zomestine prolonged-release tablets should be taken twice daily based on a fixed schedule at the dosage determined.

The prolonged-release tablets may be taken with or independent of meals with a sufficient amount of liquid. Zomestine prolonged-release tablets must be swallowed whole, not chewed.

Zomestine prolonged-release tablets should not be used with alcoholic beverages.

Duration of administration

Zomestine should not be taken longer than necessary. If long-term treatment is necessary due to the type and severity of the illness careful and regular monitoring is required to determine whether and to what extent treatment should be continued. If opioid therapy is no longer indicated it may be advisable to reduce the daily dose gradually in order to prevent symptoms of a withdrawal syndrome.

Children under 12 years of age

Zomestine prolonged-release tablets are not recommended for children under 12 years of age.

Elderly patients

Elderly patients without clinical manifestation of impaired liver and/or kidney function usually do not require dose adjustments.

Risk patients

Risk patients, for example patients with impaired renal or hepatic function, low body weight or slow metabolism of medicinal products, should initially receive half the recommended adult dose if they are opioid naïve. Therefore the lowest recommended dosage, i.e. 10 mg, may not be suitable as a starting dose. Dose titration should be performed in accordance with the individual clinical situation.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients

• severe respiratory depression with hypoxia and/or hypercapnia

• severe chronic obstructive pulmonary disease

• Cor pulmonale

• severe bronchial asthma

• Paralytic ileus

• acute abdomen, delayed gastric emptying.

4.4 Special Warnings And Precautions For Use

Zomestine prolonged-release tablets have not been studied in children younger than 12 years of age. The safety and efficacy of the tablets have not been demonstrated and the use in children younger than 12 years of age is therefore not recommended.

Caution is required in elderly or debilitated patients, in patients with severe impairment of lung, liver or kidney function, myxoedema, hypothyroidism, Addison's disease (adrenal insufficiency), intoxication psychosis (e.g. alcohol), prostatic hypertrophy, alcoholism, known opioid dependence, delirium tremens, pancreatitis, diseases of the biliary tract, biliary or ureteric colic, conditions with increased brain pressure, disturbances of circulatory regulation, epilepsy or seizure tendency and in patients taking MAO inhibitors.

Special care should be taken when oxycodone is applied in patients undergoing bowel-surgery. Opioids should only be administered post-operatively when the bowel function has been restored.

Patients with severe hepatic impairment should be closely monitored.

Respiratory depression is the most significant risk induced by opioids and is most likely to occur in elderly or debilitated patients. The respiratory depressant effect of oxycodone can lead to increased carbon dioxide concentrations in blood and hence in cerebrospinal fluid. In predisposed patients opioids can cause severe decrease in blood pressure.

Long-term use of Zomestine prolonged-release tablets can cause the development of tolerance which leads to the use of higher doses in order to achieve the desired analgesic effect. There is a cross-tolerance to other opioids. Chronic use of Zomestine prolonged-release tablets can cause physical dependence. Withdrawal symptoms may occur following abrupt discontinuation of therapy. If therapy with oxycodone is no longer required it may be advisable to reduce the daily dose gradually in order to avoid the occurrence of a withdrawal syndrome.

Zomestine prolonged-release tablets have a primary dependence potential. However, when used as directed in patients with chronic pain the risk of developing physical or psychological dependence is markedly reduced or needs to be assessed in a differentiated manner. There are no data available on the actual incidence of psychological dependence in chronic pain patients. In patients with a history of alcohol and drug abuse the medicinal product must be prescribed with special care.

The safety of Zomestine prolonged-release tablets used pre-operatively has not been established and cannot be recommended.

In case of abusive parenteral venous injection the tablet excipients may lead to necrosis of the local tissue, granulomas of the lung or other serious, potentially fatal events. To avoid damage to the controlled release properties of the tablets the prolonged-release tablets must not be chewed or crushed. The administration of chewed or crushed tablets leads to rapid release and absorption of a potentially fatal dose of oxycodone (see section 4.9).

Zomestine prolonged-release tablets must not be taken with alcoholic beverages, since this might result in an increased incidence of undesirable effects (e.g. somnolence, respiratory depression).

Athletes must be aware that this medicine may cause a positive reaction to 'anti-doping' tests.

Use of Zomestine as a doping agent may become a health hazard.

This medicinal product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase- isomaltase insufficiency should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Central nervous system depressants (e.g. sedatives, hypnotics, phenothiazines, neuroleptics, anaesthetics, antidepressants, muscle relaxants, antihistamines, antiemetics) and other opioids or alcohol can enhance the adverse reactions of oxycodone, in particular respiratory depression.

Anticholinergics (e.g. neuroleptics, antihistamines, antiemetics, antiparkinson medicinal products) can enhance the anticholinergic undesirable effects of oxycodone (such as constipation, dry mouth or micturition disorders).

Cimetidine can inhibit the metabolism of oxycodone.

MAO inhibitors are known to interact with narcotic analgesics, producing CNS excitation or depression with hyper- or hypotensive crisis (see section 4.4).

The inhibition of cytochrome P450 2D6 and 3A4 has no clinical relevance, however, strong CYP2D6 inhibitors may have an effect on the elimination of oxycodone. The effect of other relevant isoenzyme inhibitors on the metabolism of oxycodone is not known. Potential interactions should be taken into account.

Clinically relevant changes in International Normalised Ratio (INR) in both directions have been observed in individuals if coumarin anticoagulants are co-applied with Zomestine prolonged-release tablets.

There are no studies investigating the effect of oxycodone on CYP catalysed metabolism of other active substances.

4.6 Pregnancy And Lactation

Pregnancy

Limited data on the use of oxycodone during pregnancy in humans reveal no evidence of an increased risk of congenital abnormalities. Oxycodone crosses the placenta. Animal studies with oxycodone have not revealed any teratogenic or embryotoxic effects.

Prolonged use of oxycodone during pregnancy can cause withdrawal symptoms in newborns. Use of oxycodone during labour can cause foetal respiratory depression.

Oxycodone should only be used during pregnancy if the benefit outweighs the possible risks to the unborn child or neonate.

Lactation

Zomestine prolonged-release tablets should not be taken during lactation (see section 4.3).

Oxycodone passes into breast milk. The milk/plasma concentration ratio was 3.4:1 and oxycodone effects in the suckling infant are therefore conceivable. A risk to the suckling child cannot be excluded in particular following intake of multiple doses of oxycodone by the breast-feeding mother. Breast-feeding should be discontinued during treatment with oxycodone.

4.7 Effects On Ability To Drive And Use Machines

Oxycodone can impair alertness and reactivity to such an extent that the ability to drive and operate machinery is affected or ceases altogether. With stable therapy, a general ban on driving a vehicle is not necessary. The treating physician must assess the individual situation.

4.8 Undesirable Effects

Oxycodone can cause respiratory depression, miosis, bronchial spasms and spasms of the smooth muscles and can suppress the cough reflex.

The adverse reactions considered at least possibly related to treatment are listed below by system organ class and absolute frequency. Frequencies are defined as:

Very common (

Common (

Uncommon (

Rare (

Very rare (< 1/10,000)

Not known (cannot be estimated from the available data)

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Blood and lymphatic system disorders

Rare: lymphadenopathy

Endocrine disorders

Uncommon: syndrome of inappropriate antidiuretic hormone secretion

Metabolism and nutrition disorders

Common: anorexia

Rare: dehydration

Psychiatric disorders

Common: various psychological adverse reactions including changes in mood (e.g. anxiety, depression, euphoria), changes in activity (mostly supression sometimes associated with lethargy, occasionally increase with agitation, nervousness and insomnia) and changes in cognitive performance (abnormal thinking, confusion, amnesia, isolated cases of speech disorders)

Uncommon: change in perception such as depersonalisation, hallucinations, change in taste, visual disturbances, hyperacousis

Nervous system disorders

Very common: somnolence, dizziness, headache

Common: asthenia, paraesthesia

Uncommon: both increased and decreased muscle tone, tremor, involuntary muscle contractions, hypaesthesia, coordination disturbances, malaise, vertigo

Rare: seizures, in particular in epileptic patients or patients with tendency to convulsions, muscle spasm

Eye disorders

Uncommon: lacrimation disorder, miosis

Cardiac and vascular disorders

Common: lowering of blood pressure, rarely accompanied by secondary symptoms such as palpitations, syncope, bronchospasm

Uncommon: supraventricular tachycardia, vasodilatation

Respiratory, thoracic and mediastinal disorders

Common: respiratory depression

Uncommon: increased coughing, pharyngitis, rhinitis, voice changes

Gastrointestinal disorders

Very common: constipation, nausea, vomiting

Common: dry mouth, rarely accompanied by thirst and difficulty swallowing; gastrointestinal disorders such as abdominal pain, diarrhoea, eructation, dyspepsia, loss of appetite

Uncommon: biliary colics, oral ulcers, gingivitis, stomatitis, flatulence

Rare: gum bleeding, increased appetite, tarry stool, tooth staining and damage, ileus

Skin and subcutaneous tissue disorders

Very common: itching

Common: skin eruptions including rash, in rare cases increased photosensitivity, in isolated cases urticaria or exfoliative dermatitis

Rare: dry skin, herpes simplex

Renal and urinary disorders

Common: micturition disturbances (urinary retention, but also increased urge to urinate)

Rare: haematuria

Reproductive system and breast disorders

Uncommon: reduced libido, impotence

Rare: amenorrhoea

General disorders and administration site conditions

Common: sweating and even chills

Uncommon: accidental injuries, pain (e.g. chest pain), oedema, migraine, physical dependence with withdrawal symptoms, allergic reactions

Rare: weight changes (increase or decrease), cellulitis

Very rare: anaphylactic reactions

Tolerance and dependence may develop.

4.9 Overdose

Symptoms of overdose

Miosis, respiratory depression, somnolence, reduced skeletal muscle tone and drop in blood pressure. In severe cases circulatory collapse, stupor, coma, bradycardia and non-cardiogenic lung oedema may occur; abuse of high doses of strong opioids such as oxycodone can be fatal.

Therapy of overdose

Primary attention should be given to the establishment of a patent airway and institution of assisted or controlled ventilation

In the event of overdosing intravenous administration of an opiate antagonist (e.g. 0.4-2 mg intravenous naloxone) may be indicated. Administration of single doses must be repeated depending on the clinical situation at intervals of 2 to 3 minutes. Intravenous infusion of 2 mg of naloxone in 500 ml isotonic saline or 5% dextrose solution (corresponding to 0.004 mg naloxone/ml) is possible. The rate of infusion should be adjusted to the previous bolus injections and the response of the patient. Gastric lavage can be taken into consideration. Consider activated charcoal (50 g for adults, 10 -15 g for children), if a substantial amount has been ingested within 1 hour, provided the airway can be protected. It may be reasonable to assume that late administration of activated charcoal may be beneficial for prolonged-release preparations; however there is no evidence to support this.

For speeding up the passage a suitable laxative (e.g. a PEG based solution) may be useful.

Supportive measures (artificial respiration, oxygen supply, administration of vasopressors and infusion therapy) should, if necessary, be applied in the treatment of accompanying circulatory shock. Upon cardiac arrest or cardiac arrhythmias cardiac massage or defibrillation may be indicated. If necessary, assisted ventilation as well as maintenance of water and electrolyte balance.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Natural opium alkaloids, ATC-Code: N02AA05

Oxycodone shows an affinity to kappa, mu and delta opioid receptors in the brain and spinal cord. It acts at these receptors as an opioid agonist without an antagonistic effect. The therapeutic effect is mainly analgesic and sedative. Compared to rapid- release oxycodone, given alone or in combination with other substances, the prolonged-release tablets provide pain relief for a markedly longer period without increased occurrence of undesirable effects.

5.2 Pharmacokinetic Properties

Absorption

The relative bioavailability of Zomestine prolonged-release tablets is comparable to that of rapid release oxycodone with maximum plasma concentrations being achieved after approximately 3 hours after intake of the prolonged-release tablets compared to 1 to 1.5 hours. Peak plasma concentrations and oscillations of the concentrations of oxycodone from the prolonged-release and rapid-release formulations are comparable when given at the same daily dose at intervals of 12 and 6 hours, respectively.

A fat-rich meal before the intake of the tablets does not affect the maximum concentration or the extent of absorption of oxycodone.

The tablets must not be crushed or chewed as this leads to rapid oxycodone release due to the damage of the prolonged-release properties.

Distribution

The absolute bioavailability of oxycodone is approximately two thirds relative to parenteral administration. In steady state, the volume of distribution of oxycodone amounts to 2.6 l/kg; plasma protein binding to 38-45%; the elimination half-life to 4 to 6 hours and plasma clearance to 0.8 l/min. The elimination half-life of oxycodone from prolonged-release tablets is 4-5 hours with steady state values being achieved after a mean of 1 day.

Metabolism

Oxycodone is metabolised in the intestine and liver via the P450 cytochrome system to noroxycodone and oxymorphone as well as to several glucuronide conjugates. In vitro studies suggest that therapeutic doses of cimetidine probably have no relevant effect on the formation of noroxycodone. In man, quinidine reduces the production of oxymorphone while the pharmacodynamic properties of oxycodone remain largely unaffected. The contribution of the metabolites to the overall pharmacodynamic effect is irrelevant.

Elimination

Oxycodone and its metabolites are excreted via urine and faeces. Oxycodone crosses the placenta and is found in breast milk.

Linearity/non-linearity

The 5, 10, 20, 40 and 80 mg prolonged-release tablets are bioequivalent in a dose proportional manner with regard to the amount of active substance absorbed as well as comparable with regard to the rate of absorption.

5.3 Preclinical Safety Data

Oyxcodone had no effect on fertility and early embryonic development in male and female rats in doses of up to 8 mg/kg body weight and induced no malformations in rats in doses of up to 8 mg/kg and in rabbits in doses of 125 mg/kg bodyweight. However, in rabbits, when individual foetuses were used in statistical evaluation, a dose related increase in developmental variations was observed (increased incidences of 27 presacral vertebrae, extra pairs of ribs). When these parameters were statistically evaluated using litters, only the incidence of 27 presacral vertebrae was increased and only in the 125 mg/kg group, a dose level that produced severe pharmacotoxic effects in the pregnant animals. In a study on pre- and postnatal development in rats F1 body weights were lower at 6 mg/kg/d when compared to body weights of the control group at doses which reduced maternal weight and food intake (NOAEL 2 mg/kg body weight). There were neither effects on physical, reflexological, and sensory developmental parameters nor on behavioural and reproductive indices.

Long-term carcinogenicity studies were not performed.

Oxycodone shows a clastogenic potential in in vitro assays. No similar effects were observed, however, under in vivo conditions, even at toxic doses. The results indicate that the mutagenic risk of oxycodone to humans at therapeutic concentrations may be ruled out with adequate certainty.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tablet core:

Sugar spheres (sucrose, maize starch)

Hypromellose

Talc

Ethylcellulose

Hyprolose

Propylene glycol

Carmellose sodium

Microcrystalline cellulose

Magnesium stearate

Colloidal anhydrous silica

Tablet coating:

Titanium dioxide (E171)

Hypromellose

Macrogol 6000

Talc

Red iron oxide (E 172)

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

2 year

6.4 Special Precautions For Storage

This medicinal product does not require any special storage conditions.

6.5 Nature And Contents Of Container

Child resistant PVC/PE/PVDC-aluminium blisters consisting of a white opaque PVC/PE/PVDC laminated foil and an aluminium foil.

HDPE bottles with child-resistant PP twist-off caps.

Pack sizes:

10, 14, 20, 28, 30, 50, 56, 98, 100 prolonged-release tablets in blister.

10, 20, 30, 50, 100 prolonged-release tablets in HDPE bottles.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Accord Healthcare Limited,

Sage house, 319 Pinner road,

North Harrow, Middlesex, HA1 4HF

United Kingdom

8. Marketing Authorisation Number(S)

PL20075/0329

9. Date Of First Authorisation/Renewal Of The Authorisation

21/09/2011

10. Date Of Revision Of The Text

21/09/2011

Boots Allergy Relief Antihistamine 2 mg / 5ml Syrup

Boots Allergy Relief Antihistamine 2 mg/5 ml Syrup

(Chlorphenamine Maleate)

Suitable for children over 1 year

• Hayfever


• Allergy


• Insect bites


• Skin Reactions

150 ml e

Read all of this carton for full instructions

What this medicine is for

This medicine contains an antihistamine which relieves itching and redness of the skin and swelling associated with allergies, insect bites, hayfever and other allergic conditions including reactions to food and medicines, and year round sneezing and runny nose.

Before you take this medicine

! Warning: May cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.

X Do not take:

• 
  If you are having an asthma attack
  


• 
  If you are allergic to any of the ingredients, or any other antihistamines (you may have had a rash, difficulty breathing, swollen lips or face after taking them)


• 
  If you are taking monoamine oxidase inhibitors (for depression) or have taken them in the last 14 days


• 
  If you are pregnant or breastfeeding
  

! Talk to your pharmacist or doctor:

• If you have epilepsy, heart or circulatory disease, liver problems


• If you have high blood pressure, or glaucoma


• If you have asthma, bronchitis or bronchiectasis


• If you have an overactive thyroid


• If you have difficulty passing urine


• If you have an obstruction in your intestine


• If you have the rare blood disease porphyria


• If you take other medicines
  
  
  • Other antihistamines, atropine
  • Strong painkillers, sleeping tablets
  • Tranquillisers, antidepressants, other medicines for mental problems
  • Phenytoin (for epilepsy)


• If you are a man with prostate problems

Information about some of the ingredients:

This medicine contains maltitol liquid which may have a mild laxative effect. If you have been told by your doctor that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Each 5 ml spoonful contains 1 g maltitol. This provides 2 kcal per spoonful.

This medicine contains small amounts of alcohol (ethanol), less than 100 mg per 5 ml spoonful.

How to take this medicine

Check that the seal is not broken before first use. If it is, do not take the medicine.

• Age: Adults and children of 12 years and over
  
  • Two 5 ml spoonfuls
  
  
  • Every 4 to 6 hours, if you need to. Don’t take more than 12 spoonfuls in 24 hours
  
  


• 
  


• Age: Children of 6 to 11 years
  
  • One 5 ml spoonful
  
  
  • Every 4 to 6 hours, if you need to. Don’t give more than 6 spoonfuls in 24 hours
  
  


• 
  


• Age: Children of 2 to 5 years
  
  • Half a 5 ml spoonful
  
  
  • Every 4 to 6 hours, if you need to. Don’t give more than 6 half spoonfuls in 24 hours
  
  


• 
  


• Age: Children of 12 to 23 months
  
  • Half a 5 ml spoonful
  
  
  • Twice a day. Don’t give more than 2 half spoonfuls in 24 hours
  
  

Swallow the medicine.

Do not give to children under 1 year.

If symptoms do not go away within 5 days, talk to your pharmacist or doctor.

! If you take or give too much: Talk to your doctor or go to your nearest hospital casualty department straight away. Take the medicine with you.

Possible side effects

Most people will not have problems but some may get some of these:

• Drowsiness (which may make you sleep), dizziness, blurred vision, headaches, fits


• Dry mouth, difficulty passing urine, sweating


• Skin rash, sensitivity to sunlight, other allergic reactions


• Indigestion, stomach pain, loss of appetite


• Tremors, muscle pain or weakness, impaired movement or co-ordination, pins and needles


• Change in heart rate, palpitations, low blood pressure, ringing in the ears, hair loss


• Blood problems such as anaemia, weariness, sleep disturbances, liver problems


• Chest pain, thickened bronchial secretions (which may cause a cough or phlegm)


• Difficulty concentrating, irritability, depression


• Confusion in the elderly


• Hyperactivity in children

Very young children and elderly adults may be more likely to have some of these side effects.

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

Keep all medicines out of the sight and reach of children.

Use by the date on the end of flap of the carton.

Active Ingredient

Each 5 ml of oral solution contains Chlorphenamine Maleate 2 mg.

Also contains: purified water, glycerol (E422), maltitol liquid (E965), citric acid monohydrate, sodium benzoate (E211), mint flavour (containing ethanol 0.2 vol %).

PL 00014/0606

[P]

Text prepared 9/06

Manufactured by the Marketing Authorisation holder

The Boots Company PLC

Nottingham

NG2 3AA

If you need more advice ask your pharmacist.

BTC12087 vC 18-04-07