البلد: ماليزيا
اللغة: الإنجليزية
المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MEFENAMIC ACID
SUNWARD PHARMACEUTICAL SDN. BHD.
MEFENAMIC ACID
1000Tablet Tablets; 100 Tablet Tablets; 500 Tablet Tablets; 15 Tablet Tablets; 1000 Tablets; 90 Tablets
SUNWARD PHARMACEUTICAL SDN. BHD.
FENAGESIC TABLET MEFENAMIC ACID (500 MG) 1 _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Fenagesic Tablet is used for 2. How Fenagesic Tablet works 3. Before you use Fenagesic Tablet 4. How to use Fenagesic Tablet 5. While you are using it 6. Side effects 7. Storage & Disposal of Fenagesic Tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10.Date of revision WHAT FENAGESIC TABLET IS USED FOR It is used for the treatment or primary dys- menorrhea (period pain) and the relief of moderate pain when therapy will not exceed one week. HOW FENAGESIC TABLET WORKS Fenagesic Tablet 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 TABLET _- When you must not use it _ Do not use Fenagesic Tablet: 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 stroke 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 tablet may cause severe skin reactions, example exfoliative dermatitis, toxic epidermal necrolysis, Steven-Johnson Sydrome. Symptoms may include skin rash, blisters and peel off. These could be signs of a seriou اقرأ الوثيقة كاملة
Tablet / 500 Tablet / Suspension Tablet : 250mg or 500mg Mefenamic Acid per tablet Suspension : 125mg of Mefenamic Acid per 5ml PHARMACODYNAMICS: It is a nonsteroidal agent with demonstrated anti-inflammatory, analgesic and antipyretic activity. In animal studies, it was found to inhibit prostaglandin synthesis and to compete for binding at the prostaglandin receptor site. Its exact mode of action is not known. PHARMACOKINETICS: Following a single one gram oral dose, peak plasma level of 10 mcg/ml occurred in 2 to 4 hours with a half-life of 2 hours. Following multiple doses, plasma levels are proportional to dose with no evidence of drug accumulation. One gram of Mefenamic Acid given four times daily produces peak blood level of 20 mcg/ml by the second day of administration. Following a single dose, sixty-seven percent of the total dose is excreted in the urine as unchanged drug or as one of two metabolites. Twenty to twenty-five percent of the dose is excreted in the faeces during the first three days. INDICATIONS: Mefenamic Acid is indicated for the treatment of primary dysmenorrhea and the relief of moderate pain when therapy will not exceed one week. ADVERSE EFFECTS: Mefenamic Acid may give rise to occasional gastro-intestinal upsets or rashes. Gastro-intestinal haemorrhage may rarely occur. Other haematological effects include haemolytic anaemia, agranulocytosis, pancytopenia, thrombocytopenia, thrombocytopenic purpura and bone marrow aplasia. The occurrence of diarrhoea or skin rash is an indication for discontinuing treatment. PRECAUTIONS / WARNINGS: Cardiovascular Thrombotic Events Observational studies have indicated that non-selective NSAIDs may be associated with an increased risk of serious cardiovascular events, principally myocardial infarction, which may increase with dose or duration of use. Patients with cardiovascular disease or cardiovascular risk of an adverse cardiovascular event in patient taking NSAID, especially in those with cardiovascular risk factors, the lowest effective dose should b اقرأ الوثيقة كاملة