Negara: Israel
Bahasa: Inggris
Sumber: Ministry of Health
ETODOLAC
TARO PHARMACEUTICAL INDUSTRIES LTD
M01AB08
CAPSULES
ETODOLAC 300 MG
PER OS
Required
TARO PHARMACEUTICAL INDUSTRIES LTD
ETODOLAC
ETODOLAC
For the management of signs and symptoms of osteoarthritis and rheumatoid arthritis. For the management of pain.
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 200 ETOPAN 300 ETOPAN 400 ETOPAN 500 Capsules Capsules Tablets Tablets ACTIVE INGREDIENT Each capsule contains: Each capsule contains: Each tablet contains: Each tablet contains: etodolac 200 mg etodolac 300 mg etodolac 400 mg etodolac 500 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. For the management of pain. 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. SPECIAL WARNINGS ABOUT USING THIS MEDICINE BEFORE USING ETOPAN, TELL YOUR D Baca dokumen lengkapnya
1. Name of the medicinal product Etopan 200 Etopan 300 Etopan 400 Etopan 500 2. Qualitative and quantitative composition Etopan 200 Etopan 300 Etopan 400 Etopan 500 Each capsule contains: etodolac 200 mg Each capsule contains: etodolac 300 mg Each tablet contains: etodolac 400 mg Each tablet contains: etodolac 500 mg Excipients with known effect Each Etopan 200 mg capsule contains 22.87 mg of lactose monohydrate. Each Etopan 300 mg capsule contains 34.30 mg of lactose monohydrate. Each Etopan 400 mg tablet contains 121.30 mg of lactose monohydrate, 0.7-1.05 mg sodium. Each Etopan 500 mg tablet contains 151.60 mg of lactose monohydrate, 0.88-1.31 mg sodium. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Capsules (200, 300 mg) Tablets (400, 500 mg) Etopan 200: dark pink, gelatine capsule with black imprint "ETO 200 MG" on cap and body, white to off white powder filling. Etopan 300: light pink, gelatine capsule with black imprint "ETO 300 MG" on cap and body, white to off white powder filling. Etopan 400: peach colored, film coated, capsule shaped tablet. One side is engraved with "T88", other side is smooth. Etopan 500: blue, oval shaped, film coated tablet. One side is engraved with "Taro", other side is engraved with "89". 4. Clinical particulars 4.1 Therapeutic indications Etodolac is indicated for the: Treatment of osteoarthritis and rheumatoid arthritis - acute and long term use in the management of signs and symptoms. Management of pain-relief of mild to moderate pain, especially when anti-inflammatory actions may also be desired, e.g., following dental, obstetric or orthopedic surgery, and for the relief of musculoskeletal pain due to soft tissue athletic injuries. Relief of mild to moderate bone pain caused by metastatic neoplastic disease. Treatment of acute gouty arthritis or calcium pyrophosphate deposition disease - uricosuric activity, relief of acute attacks, long-term prophylactic use may decrease the incidence or severity of recurrent acute gout attacks, especially during t Baca dokumen lengkapnya