البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MEFENAMIC ACID
SUNWARD PHARMACEUTICAL SDN. BHD.
MEFENAMIC ACID
500 Capsule Capsules; 100 Capsule Capsules; 1000 Capsule Capsules; 1000Capsule Capsules
SUNWARD PHARMACEUTICAL SDN. BHD.
FENAGESIC CAPSULE MEFENAMIC ACID (250MG) 1 _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Fenagesic Capsule is used for 2. How Fenagesic Capsule works 3. Before you use Fenagesic Capsule 4. How to use Fenagesic capsule 5. While you are using it 6. Side effects 7. Storage & Disposal of Fenagesic Capsule 8. Product Description 9. Manufacturer and Product Registration Holder 10.Date of revision WHAT FENAGESIC CAPSULE IS USED FOR It is used for the treatment or primary dysmenorrhea (period pain) and the relief of moderate pain when therapy will not exceed one week. HOW FENAGESIC CAPSULE WORKS Fenagesic capsule contains a substance called Mefenamic acid. It belongs to a group of medicines called non steroidal anti- inflammatory agents (NSAIDs) which reduces fever, pain and inflammation. BEFORE YOU USE FENAGESIC CAPSULE _- When you must not use it _ Do not use Fenagesic capsule : If you have allergy or hypersensitivity to Mefenamic acid or any other ingredients listed at the end of this leaflet. If you have had asthma, rhinitis (Inflammation of the nasal mucous membrane) , urticaria (itching or hives) or the symptoms become worsen caused by Aspirin or NSAIDs. If you have active ulceration If you have chronic inflammation of either the upper or lower stomach and intestinal tract If you have kidney disease _ _ _- Before you start to use it _ You should check with your doctor:- If you have heart problem or stoke If you have hypertension If you have kidney or liver problem If you are concomitantly taking anti- coagulant (blood thinning agent) If you have or have had ulceration, bleeding and perforation of the stomach and intestinal If you are suffering from dyspepsia (discomfort at the epigastric region due to digestion problem). Fenagesic capsule may cause severe skin reactions, e.g. exfoliative dermatitis, toxic epidermal necrolysis, Steven-Johnson Sydrome. Symptoms may include skin rash, blisters and peel off. These could be signs of a s اقرأ الوثيقة كاملة
Caution should be observed when anti-coagulant is administered concomitantly with nonsteroidal anti-inflammatory drugs (NSAIDS), to be certain that no change in anticoagulation dosage is required . In addition to specific drug interactions that might affect prothrombin time, NSAIDs can inhibit platelet aggregation, and can cause gastrointestinal bleeding, peptic ulceration and/or perforation. Safety and effectiveness in children below the age of 14 have not been established. PREGNANCY AND LACTATION: As there are no adequate and well-controlled studies in pregnant women, this drug should be used only it clearly needed. The use of this drug in late pregnancy is not recommended because of the effects in the foetal cardiovascular system. For the same reason, Mefenamic Acid should not be taken by nursing mothers. CONTRAINDICATIONS: Mefenamic Acid should not be used in patients who have previously exhibited hypersensitivity to it. Because the potential exists for cross-sensitivity to aspirin or other NSAIDs, mefenamic acid should not be given to patients in whom these drugs induce symptoms of bronchospasm, allergic rhinitis or urticaria. Mefenamic Acid is contraindicated in patients with active ulceration or chronic inflammation of either the upper or lower gastrointestinal tract. Mefenamic Acid should be avoided in patients with pre existing renal disease. Since Mefenamic Acid is eliminated primarily by the kidneys, the drug should not be administered to patients with significantly impaired renal function. DOSAGE: Oral administration. The recommended regimen in acute pain for adults and children over 14 years of age is 500mg three times daily, usually not to exceed one week. For the treatment of primary dysmenorrhoea, the recommended dosage is 500mg three times daily starting with the onset of bleeding and associated symptoms. Mefenamic Acid should not be used for more than 7 days at a time. After assessing the risk/benefit ratio in each individual patient, the lowest effective dose for the shortest possible duration اقرأ الوثيقة كاملة