Ülke: İsrail
Dil: İngilizce
Kaynak: Ministry of Health
ETODOLAC
TARO PHARMACEUTICAL INDUSTRIES LTD
M01AB08
TABLETS EXTENDED RELEASE
ETODOLAC 400 MG
PER OS
Required
TARO PHARMACEUTICAL INDUSTRIES LTD
ETODOLAC
ETODOLAC
For the management of signs and symptoms of osteoarthrities and rheumatoid arthritis.
2021-06-30
Etopan PIL _–_ _ final September 2023 _ 1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only ETOPAN XL 400 EXTENDED- RELEASE TABLETS ETOPAN XL 600 EXTENDED- RELEASE TABLETS ACTIVE INGREDIENT AND ITS QUANTITY: Each extended- release tablet contains: etodolac 400 mg ACTIVE INGREDIENT AND ITS QUANTITY: Each extended- release tablet contains: etodolac 600 mg Inactive ingredients and allergens in this medicine: see section 2 ‘Important information about some of this medicine’s ingredients’, and section 6 ‘Additional information'. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1 . WHAT IS THIS MEDICINE INTENDED FOR? For the management of signs and symptoms of osteoarthritis and rheumatoid arthritis. THERAPEUTIC GROUP: Non-steroidal anti-inflammatory drugs (NSAIDs). 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredient (etodolac) or to any of the other ingredients in this medicine (see section 6). • You have SEVERE HEART FAILURE. • You have an ulcer (a peptic ulcer, a small lesion or hole in the stomach or duodenum) or bleeding in the stomach, or have had two or more episodes of ulcers, stomach bleeding or perforation. • You have had an ALLERGIC REACTION OR ASTHMATIC REACTION (wheezing, itching or skin rash) after taking aspirin, Etopan or another NSAID. • You have severe liver failure and kidney failure. • YOU ARE IN THE LAST TRIMESTER OF PREGNANCY. • You have previously had bleeding from the stomach or bowel due to taking a NSAID. Etopan PIL _–_ _ final September 2023 _ 2 SPECIAL WARNINGS ABOUT USING THIS MEDICINE BE Belgenin tamamını okuyun
Etopan XL Physician Leaflet Notification September 2023 1 Physician’s Prescribing Information Etopan XL 400 Etopan XL 600 Extended Release Tablets 1. Name of the medicinal product Etopan XL 400 Etopan XL 600 2. Qualitative and quantitative composition Each tablet of Etopan XL 400 mg contains 400 mg etodolac. Each tablet of Etopan XL 600 mg contains 600 mg etodolac. Excipients with known effect Each Etopan XL 400 mg tablet contains 37.33 mg of lactose anhydrous. Each Etopan XL 600 mg tablet contains 56 mg of lactose anhydrous. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Extended release tablets Etopan XL 400: pink, round, bi-convex, film coated tablet. One side is engraved with 'T400', other side is plain. Etopan XL 600: gray, oval, bi-convex, film coated tablets. One side is engraved with 'T600', other side is plain. 4. Clinical particulars 4.1 Therapeutic indications For the management of signs and symptoms of osteoarthritis and rheumatoid arthritis. 4.2 Posology and method of administration 400 mg XL - One to two tablets twice daily but no more than three tablets a day. 600 mg XL - One tablet once or twice daily. The total daily dose of Etopan XL should not exceed 1,200 mg. As with other NSAIDs, the lowest dose and longest interval should be sought for each patient. Therefore, after observing the response to initial therapy with Etopan XL, the dose and frequency should be adjusted to suit individual patient’s needs (tolerance and response). In responsive patients, partial symptomatic relief of symptoms usually occurs within 1 Etopan XL Physician Leaflet Notification September 2023 2 or 2 weeks, although maximum effectiveness may occur only after several weeks of therapy. During long-term administration the dose of Etopan XL may be adjusted, up or down, depending on the patient’s clinical response (maximum dose 1200 mg/day). As with other NSAIDs, Etopan XL is preferably taken after meals or with food or antacids to reduce gastrointestinal irritation, especially during chronic u Belgenin tamamını okuyun