Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
ETODOLAC
TARO PHARMACEUTICAL INDUSTRIES LTD
M01AB08
TABLETS EXTENDED RELEASE
ETODOLAC 500 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
1 Etopan XL Patient Leafletnotification-06.21 - PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) 1986 The medicine is dispensed in accordance with a doctor’s prescription only ETOPAN XL 600 DELAYED-RELEASE TABLETS ETOPAN XL 400 DELAYED-RELEASE TABLETS ACTIVE INGREDIENT AND ITS QUANTITY: Each delayed-release tablet contains: etodolac 600 mg ACTIVE INGREDIENT AND ITS QUANTITY: Each delayed-release tablet contains: etodolac 400 mg For the list of inactive ingredients, see section 2 under "Important information about some of the ingredients of the medicine" and section 6 “Additional information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for the treatment of your illness. Do not pass it on to others. It may harm them, even if their illness appears to be similar. This medicine is not recommended for children and infants. 1. WHAT IS THIS MEDICINE INTENDED FOR? For the treatment of symptoms of osteoarthritis and rheumatoid arthritis. THERAPEUTIC GROUP: Non-steroidal anti-inflammatory drugs (NSAIDs) 2. BEFORE USING THE MEDICINE : DO NOT TAKE THE MEDICINE IF: you are hypersensitive (allergic) to the active ingredient (etodolac) or any of the other ingredients of this medicine (listed in section 6) you are sensitive to other analgesics of the NSAID class, such as aspirin or ibuprofen. you are in the last trimester of pregnancy. you have previously experienced shortness of breath, rhinitis (congested or runny nose) or urticaria (allergic skin reaction) after taking aspirin, ibuprofen or another medicine of the NSAID class. you suffer from severe heart failure, hepatic failure or renal failure. 2 Etopan XL Patient Leafletnotification-06.21 you have experienced gastrointestinal bleeding or perforation as a result of taking another NSAID. you have a peptic ulcer (an ulcer Soma hati kamili
Etopan XL 500 Physician Leaflet Notification Nov 2021 1 PHYSICIAN’S PRESCRIBING INFORMATION ETOPAN XL 500 EXTENDED RELEASE TABLETS 1. NAME OF THE MEDICINAL PRODUCT Etopan XL 500 mg Extended Release Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet of Etopan XL 500 mg contains 500 mg etodolac. Excipient with known effect Each Etopan XL 500 mg tablet contains 46.67 mg of lactose anhydrous. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Extended Release Tablets 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 500mg XL ‐ one tablet once or twice daily The total daily dose of Etopan XL should not exceed 1,200mg. 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 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 use. Etopan XL 500 Physician Leaflet Notification Nov 2021 2 However, for faster absorption when a rapid initial effect is required, the first 1 or 2 doses may be taken 30 minutes before meals or at least 2 hours after meals. If an antacid is taken concurrently, an aluminum and magnesium‐ containing formulation may be preferred. It is recommended to take Etopan XL tablets with a full glass of water and that the patient remains in an upright position for 15‐30 minutes after administrati Soma hati kamili