Таблетки Arcoxia

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) -1986

The dispensing of this medicine requires a doctor's prescription. Read the package insert carefully in its entirety before using this medicine. The format of this leaflet was determined by the Ministry of Health and its content was checked and approved in March 2006

ARCOXIA™ 60 mg

Tablets

COMPOSITION:

Each tablet contains: Etoricoxib 60 mg Each tablet also contains: Lactose 4 mg

ARCOXIA™ 90 mg

Tablets

COMPOSITION:

Each tablet contains: Etoricoxib 90 mg Each tablet also contains: Lactose 6 mg

ARCOXIA™ 120 mg

Tablets

COMPOSITION:

Each tablet contains: Etoricoxib 120 mg Each tablet also contains: Lactose 8 mg

THERAPEUTIC ACTIVITY:

Arcoxia is a member of a group of medicines called coxibs. Anti-inflammatory and analgesic preparation which acts by inhibiting a substance in the body known as COX-2. Indicated for the treatment of osteoarthritis, or rheumatoid arthritis, or gout.

Терапевтическая активность:

Arcoxia является членом группы препаратов, называемых коксибами. Противовоспалительный и болеутоляющий препарат, который действует путем ингибирования вещества в орган, известный как ЦОГ-2. Показан для лечения остеоартрита, ревматоидного артрита или подагры.

WHEN SHOULD THE PREPARATION NOT BE USED?

Do not use this medicine: if you are allergic to any of its ingredients; if you have an active stomach ulcer or bleeding in the stomach or intestines; if you have serious liver disease; if you have serious kidney disease; if you have previously experienced any of the following after taking aspirin (acetylsalicylic acid) or other anti-inflammatory medications (NSAIDs) including COX-2 inhibitors: asthma (wheezing or inability to breathe easily), nasal irritation, nasal polyps, or allergic symptoms such as swelling of the face, lips, tongue or throat and/or itching skin rash; if you are or could be pregnant or if you are breast-feeding (see 'WARNINGS'); if you are under 16 years of age; if you have inflammatory bowel disease; if you have or have had heart failure (moderate or severe types), angina (chest pain), or a heart attack, bypass surgery, peripheral arterial disease (narrow or blocked arteries), or any kind of stroke (including mini-stroke, transient ischemic attack - TIA); Arcoxia may slightly increase your risk of heart attack and stroke and this is why it should not be used in those who have already had heart problems or stroke, if you have a high blood pressure that has not been controlled by treatment.

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Do not take this medicine without consulting a doctor before starting treatment:

If you have a history of stomach bleeding or ulcers.

If you are dehydrated, for example by a prolonged bout of vomiting or diarrhea. If you have a tendency to swelling due to fluid retention.

If you have a history of heart failure, heart attack or any other form of heart disease. If you have a history of stroke or mini-stroke. If you have or have previously had raised blood pressure.

If you have or have previously had liver or kidney disease.

If you are being treated for an infection, Arcoxia can mask or hide a fever which is a sign of infection.

If you are a woman trying to become pregnant. If you suffer or have suffered in the past from a digestive system disorder. If you have conditions which increase your risk of heart disease such as high blood pressure, diabetes, high cholesterol or smoking. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

WARNINGS:

Arcoxia tablets should not be taken during pregnancy.

If you are pregnant or think you could be pregnant, or if you are planning to become pregnant, do not take the tablets. If you become pregnant, stop taking the tablets and consult your doctor. Consult your doctor if you are unsure or need more advice.

It is not known if Arcoxia is excreted in human milk. If you are taking Arcoxia you should not breast-feed.

Arcoxia is not a substitute for aspirin (acetylsalicylic acid), does not thin the blood or prevent platelet aggregation (formation of small blood clots) in the way that aspirin does. Low- dose aspirin should not be discontinued without consulting your doctor if you have been prescribed aspirin for heart problems (such as heart attack) or any kind of stroke (including mini-stroke or TIA), where the blood vessels to the heart or brain may be damaged.

You should be aware that the risk of stomach ulcers is greater if you are taking aspirin with Arcoxia and you should not take anti-inflammatory medications or higher doses of aspirin while taking Arcoxia.

If you are elderly (i.e. over 65 years of age) or have heart, liver or kidney disease, your doctor will want to keep a regular check on you. If you develop any symptoms that could indicate liver problems, such as yellowing of the skin and whites of the eyes, it is important to reach the doctor as soon as possible. If you develop severe or persistent abdominal pain and/or your stools become black, you must consult a doctor immediately. If any of the following symptoms: shortness of breath, chest pains or ankle swelling appear or worsen, stop your treatment with Arcoxia and consult a doctor as soon as it is practical. If you develop any symptoms that could indicate a severe allergic reaction, such as inability to breathe or a serious skin reaction, you must consult a doctor on an urgent basis. Your doctor will want to discuss your treatment from time to time. It is important that you use the lowest dose that controls your pain and you should not take Arcoxia for longer than necessary. This is because the risk of heart attacks and strokes might increase after prolonged treatment, especially with high doses. Arcoxia can increase blood pressure in some people, especially in high doses, and this could increase the risk of heart attacks and strokes. Your doctor will want to check your blood pressure from time to time, to make sure that it is safe to continue treatment.

DRUG INTERACTIONS:

If you are taking another drug concomitantly or if you have just finished treatment with another medicine, including a non-prescription medicine, inform the attending doctor in-order to prevent hazards or lack of efficacy arising from drug interactions. This is especially important for the following medicines: ACE inhibitors and angiotensin receptor blockers (medicines for high blood pressure and heart failure), anticlotting agents such as warfarin or other anticoagulants which are used to thin the blood and prevent blood clots, beta-blockers (medicines for treatment of high blood pressure), birth control pills, cyclosporin or tacrolimus (drugs used for suppressing the immune system), digoxin (a medicine for treatment of heart failure and irregular heart rhythm), diuretics (water tablets), lithium (a medicine used to treat some types of depression), methotrexate (a drug used for suppressing the immune system, and often used in rheumatoid arthritis), minoxidil (a drug used to treat high blood pressure), saibutamol in tablet or oral solution (a medicine for treatment of asthma), rifampicin (an antibiotic), hormone replacement therapy.

Arcoxia can be taken with low-dose aspirin (see 'WARNINGS'). If you are currently taking low- dose aspirin for the prevention of heart attack or stroke, you should not stop this without consulting your doctor because Arcoxia cannot substitute for aspirin for this purpose. You should be aware that the risk of stomach ulcers is greater if you are taking aspirin with Arcoxia, and you should not take anti-inflammatory medications or higher doses of aspirin while taking Arcoxia.

SIDE EFFECTS:

In addition to the desired effect of the drug, adverse reactions may occur during the course of taking this medicine. In studies and in general use, the side effects that occurred in patients treated with Arcoxia were as follows: 

Common:

Weakness and fatigue; dizziness; flu-like illness; diarrhea; wind; indigestion (dyspepsia); stomach pain or discomfort; heartburn; nausea; headache; swelling of the legs and/or feet due to fluid retention (edema) and raised blood pressure. 

Uncommon:

Abdominal bloating; chest pain; swelling of the face; flushing; upper respiratory infection; heart failure; heart attack; stroke; bruising; bowel movement pattern change; constipation; dry mouth; taste alteration; gastroenteritis; stomach ulcer; irritable bowel syndrome; mouth ulcers; vomiting; blurred vision; nose bleed; ringing in the ears; appetite increase or decrease; weight gain; muscle cramps/spasm; muscle pain/stiffness; inability to sleep; numbness or tingling; sleepiness; anxiety; depression; decrease in mental acuity; breathlessness; cough; skin rash or itchy skin; urinary tract infection. 

Very rare:

Allergic reactions (which may be serious enough to require immediate medical attention), including hives, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing; wheezing; severe skin reactions; inflammation of the stomach lining or stomach ulcers that may become serious and may bleed; liver problems; serious kidney problems; severe increase in blood pressure; confusion; hallucinations.

In the event that you experience side effects not mentioned in this leaflet, or if there is a change in your general health, consult your doctor immediately.

ADMINISTRATION AND DOSAGE:

Dosage is according to doctor's instructions only. Take Arcoxia tablets by mouth once a day. Arcoxia can be taken with or without food.

Do not exceed the recommended dose for treatment of your condition. Osteoarthritis:

The recommended dose is 60 mg once a day.

Rheumatoid arthritis:

The recommended dose is 90 mg once a day.

Gout:

The recommended dose is 120 mg once a day, which should only be used for the acute painful period. Doses greater than those recommended for each condition have either not demonstrated additional efficacy or have not been studied. Therefore, the dose stated above for each condition is the maximum recommended dose. Important dose information for patients with liver disease:

If you have mild liver disease, you should not take more than 60 mg a day regardless of what disease you are taking Arcoxia for. If you have moderate liver disease, you should not take more than 60 mg Arcoxia every other day. This medicine is not intended for administration to children and adolescents under the age of 16 years.

It is important to keep to the dose the doctor has prescribed.

If you miss a dose, leave out that dose completely, do not take an extra dose to make up and just resume your usual schedule the following day. You should never take more tablets than the doctor recommends. If you do take too many Arcoxia tablets, you should seek medical attention immediately. Make sure you take the original package of the tablets with you.

DIRECTIONS FOR USE:

Swallow the tablets with a small amount of water. Arcoxia can be taken with or without food.

Complete the full course of treatment as instructed by the doctor.

Even if there is an improvement in your health, do not discontinue use of this medicine before consulting your doctor.

AVOID POISONING!

This medicine, as all other medicines, must be stored in a safe place out of the reach of children and/or infants in order to avoid poisoning. If you have taken an overdose, or if a child has accidentally swallowed the medicine, proceed immediately to a hospital emergency room, and bring the package of the medicine with you. Do not induce vomiting unless explicitly instructed to do so by a doctor!

This medicine has been prescribed for the treatment of your ailment; in another patient it may cause harm. Do not give this medicine to your relatives, neighbors or acquaintances. Do not take medicines in the darkl Check the label and the dose each time you take your medicine. Wear glasses if you need them. 

STORAGE:

Store this medicine in a cool place. Even if kept in their original container and stored as recommended, medicines may be kept for a limited period only. Please note the expiry date of the medicine! In case of doubt, consult the pharmacist who dispensed the medicine to you. Do not store different medications in the same package.

PRODUCT LICENSE NUMBERS:

ARCOXIA™ 60 mg Tablets: 129 42 30786 00/05/06 ARCOXIA™ 90 mg Tablets: 129 43 30787 00/05/06 ARCOXIA™ 120 mg Tablets: 129 44 30788 00/05/06

Manufactured by:

Frosst Iberica S.A., Madrid, Spain, or Merck Sharp & Dohme B.V., Haarlem, Holland, or Merck Sharp & Dohme (Italia) S.p.A, Pavia, Italy, for Merck Sharp & Dohme (lsrael-1996) Company Ltd., P.O.Box 7121, Petah-Tikva 49170.