দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Etofenamate
Phoenix Labs
M02AA; M02AA06
Etofenamate
5 percent weight/weight
Gel
Product subject to prescription which may be renewed (B)
Anti-inflammatory/analgesic for the treatment of inflammatory musculoskeletal system disorder
Antiinflammatory preparations, non-steroids for topical use; etofenamate
For the treatment of inflammatory disorders of the musculoskeletal system.
Marketed
1990-04-04
210 ETOFLAM 5% w/w GEL Package Leaflet: Information for the user Active Ingredient: Etofenamate Read all of this leaflet carefully before you start using this medicine. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 1. WHAT ETOFLAM GEL IS AND WHAT IT IS USED FOR: The name of this medicine is Etoflam 5% w/w Gel. The gel contains etofenamate as the active ingredient. Etofenamate belongs to a class of drugs called nonsteroidal, anti- inflammatory drugs, which are commonly used to relieve pain and reduce swelling. Etoflam 5% w/w Gel is used to relieve pain and inflammation locally in muscles and soft tissues. Such pain and inflammation can occur with sprains, tennis elbow, strains, rheumatoid arthritis or osteoarthritis and other similar conditions. When you apply the gel to your skin, the etofenamate is readily transported through your skin and concentrated in the inflamed area. Here it reduces the inflammation and eases the pain by preventing the release of substances in the tissues which cause inflammation and pain. 2. BEFORE YOU TAKE ETOFLAM 5% W/W GEL Do Not use Etoflam 5% w/w Gel: • If you are allergic (hypersensitive) to any of the ingredients in Etoflam 5% w/w gel or to other non-steroidal anti-inflammatory agents including aspirin • Etoflam 5% w/w gel contains alcohol and should not be applied to broken skin • Etoflam 5% w/w gel should not be used with tight bandages or dressings, in the presence of local infection or applied to the same area where other gels or creams are being used Take special care with Etoflam 5% w/w Gel Etoflam 5% w/w gel is for external use only and contact with your eyes or other mucus membranes should be avoided. Hands should be w সম্পূর্ণ নথি পড়ুন
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Etoflam 5% w/w Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The gel contains 5% w/w etofenamate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gel A nearly transparent yellowish gel. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of inflammatory disorders of the musculo-skeletal system. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Recommended dosage: Adults (including the elderly): Etoflam 5% w/w gel is applied topically. A 5-10cm strip of gel (according to the area affected) should be rubbed in gently. This may be repeated up to 4 times daily. Clinical studies in patients with impaired renal function or undergoing anti-coagulant therapy have not indicated a need to change the recommended dosage in these patients. Children and infants: The use of Etoflam 5% w/w gel is not recommended in children or infants. It is recommended that treatment should be reviewed after 14 days. Treatment should not extend beyond 6 weeks. In symptomatic treatment of osteoarthritis, therapy should be reviewed after 4 weeks. 4.3 CONTRAINDICATIONS 1. Etoflam 5% w/w gel contains alcohol and should not be applied to broken skin. 2. Use with occlusive dressings. 3. Use in patients hypersensitive to any of the ingredients or to non-steroidal anti-inflammatory agents including aspirin. 4. Use simultaneously to the same site with any other topical preparation. 5. Use in the presence of local infection. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ সম্পূর্ণ নথি পড়ুন