Krajina: Malajzia
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MEFENAMIC ACID
PHARMANIAGA MANUFACTURING BERHAD
MEFENAMIC ACID
250 Tablets; 100 Tablets; 1000Tablet Tablets; 500 Tablets
PHARMANIAGA MANUFACTURING BERHAD
PHARMANIAGA MEFENAMIC TABLET / CAPSULE Mefenamic Acid (250mg,500mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What PHARMANIAGA MEFENAMIC is used for 2. How PHARMANIAGA MEFENAMIC works 3. Before you use PHARMANIAGA MEFENAMIC 4. How to use PHARMANIAGA MEFENAMIC 5. While you are using it 6. Side effects 7. Storage and Disposal of PHARMANIAGA MEFENAMIC 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT PHARMANIAGA MEFENAMIC IS USED FOR PHARMANIAGA MEFENAMIC contains mefenamic acid. It is used for the relief of mild to moderate pain including headache, toothache, pain following an operation or after childbirth and period pain. It is also used for muscle and joint pain such as rheumatoid arthritis and osteoarthritis. It can also be used to treat excessively heavy periods. HOW PHARMANIAGA MEFENAMIC WORKS PHARMANIAGA MEFENAMIC belongs to a group of medicines called non-steroidal anti- inflammatory drugs (NSAIDs). These medicines reduce pain and inflammation by blocking the production of a chemical produced by the body called prostaglandins. BEFORE YOU USE PHARMANIAGA MEFENAMIC _-When you must not use it _ Do not take PHARMANIAGA MEFENAMIC if: • You are allergic to mefenamic acid or any of the other ingredients in the tablet or capsule. • You have had an allergy to aspirin or other NSAIDs. • You currently have a stomach ulcer or suffer from inflammatory bowel disease. • You have severe problems with your kidneys, liver or heart. • You previously having diarrhea on taking this medicine. • You are breast feeding or pregnant. Do not give PHARMANIAGA MEFENAMIC children under 14 years of age. Do not take PHARMANIAGA MEFENAMIC if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking PHARMANIAGA MEFENAMIC. _ _ _-Before you start to use it _ Before you take PHARMANIAGA MEFENAMIC, your doctor or pharmacist needs to know if you have or have had any of the following conditions: • Ulcer or s Prečítajte si celý dokument
MEFENA ablet ® apsule C T MIC Mefenamic Tablet Capsule Leaflet Size: 297 mm (W) x 210 mm (H) Version 23 Date: 17-09-2020 DESCRIPTION _PHARMANIAGA MEFENAMIC TABLET 250 MG._ A yellow, round, biconvex film-coated tablet with a breakline on one side and plain on the other. _PHARMANIAGA MEFENAMIC TABLET 500 MG._ A yellow, oblong, film-coated tablet with Pharmaniaga icon on one side and scoreline on the other. _PHARMANIAGA MEFENAMIC CAPSULE 250 MG._ Opaque ivory/light blue, size 1, hard gelatin capsule with Pharmaniaga icon and '250' markings. COMPOSITION Each film-coated tablet contains Mefenamic acid 250 mg or 500 mg. Each capsule contains Mefenamic acid 250 mg. PHARMACODYNAMICS Mefenamic acid has analgesic, anti-inflammatory and anti-py- retic properties. It is an inhibitor of cyclo-oxygenase, resulting in decreased formation of precursors of prostaglandins and thromboxanes from arachidonic acid. Also Mefenamic acid has been shown to inhibit competitively the actions of prostaglan- dins. PHARMACOKINETICS ABSORPTION Mefenamic acid is rapidly absorbed after oral administration from the gastrointestinal tract. Following administration of a one gram oral dose to adults, peak plasma levels of 10 µg/mL occur in 1 to 4 hours, with a half-life of 2 hours. Plasma levels are proportional to dose, following multiple doses, with no drug accumulation. One gram of mefenamic acid administered four times daily produces peak blood levels of 20 µg/mL by the second day of administration. Concomitant ingestion of antacids containing magnesium hydroxide has been shown to significantly increase the rate and extent of mefenamic acid absorption. DISTRIBUTION Mefenamic acid is extensively bound to plasma proteins. METABOLISM Mefenamic acid metabolism is predominantly mediated via cytochrome P450 (CYP) 2C9 in the liver. Patients who are known or suspected to be poor CYP 2C9 metabolizers based on previous history/experience with other CYP 2C9 substrates should be administered mefenamic acid with caution as they may have abnormally high pla Prečítajte si celý dokument