Country: Մալայզիա
language: անգլերեն
source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DICLOFENAC SODIUM
SUNWARD PHARMACEUTICAL SDN. BHD.
DICLOFENAC SODIUM
1000Tablet Tablets; 100 Tablet Tablets; 500 Tablet Tablets; 1000 Tablets
SUNWARD PHARMACEUTICAL SDN. BHD.
1 _ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ FENADIUM TABLET Diclofenac Sodium (25mg) WHAT IS IN THIS LEAFLET 1. What Fenadium Tablet is used for 2. How Fenadium Tablet works 3. Before you use Fenadium Tablet 4. How to use Fenadium Tablet 5. While you are using it 6. Side effects 7. Storage & Disposal of Fenadium Tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10.Date of revision WHAT FENADIUM TABLET IS USED FOR It is used to relief; inflammatory and degenerative due to arthritis that affects bones and joints. musculoskeletal aches and pains which do not arise from joints. acute attacks of gout. mestrual pain. HOW FENADIUM TABLET WORKS Fenadium Tablet contains a substance called Diclofenac. It belongs to a group of medicines called non steroidal anti- inflammatory agents (NSAIDs) which reduces fever, pain and inflammation. BEFORE YOU USE FENADIUM TABLET _- When you must not use it _ Do not use Fenadium Tablet:- If you have allergy or hypersensitivity to Diclofenac, Aspirin, other NSAIDs or any other ingredients listed at the end of this leaflet. If you have had nasal polyps (growth in the nasal), angioedema (swelling around the eyes and lips and sometimes of the genitals, hands, and feet), bronchospastic (constriction of the airway) and the symptoms become worsen caused by Aspirin or NSAIDs. _ _ _-Before you start to use it _ You should check with your doctor:- If you have heart problem or stroke. If you have high blood pressure. Diclofenac may cause severe skin reactions, e.g. toxic epidermal necrolysis, Steven-Johnson Sydrome. Symptoms may include skin rash, blisters and peel off. These could be signs of a serious condition. If these reactions occur, stop use and seek medical assistance right away. If you have or have had ulceration, bleed- ing and perforation of the stomach and intestinal If you suffering from dyspepsia (discomfort at the epigastric region due to digestion problem). If you have bleeding disorder. If you h read_full_document
PRODUCT DESCRIPTION: Fenadium Tablets 25mg: Round, convex, yellow, enteric-film coated tablet without markings. Fenadium F Tablets 50mg: Round, convex, beige, enteric-film coated tablets without markings. PHARMACODYNAMICS: Diclofenac sodium is a phenylacetic acid derivative which has analgesic, anti-pyretic and anti-inflammatory actions. Its mode of action, like that of other non-steroidal anti-inflammatory agents, is not completely understood, but may be related to prostaglandin synthetase inhibitor. It is usually used in the treatment of rheumatoid arthritis and other rheumatic disorders. PHARMACOKINETICS: Diclofenac is absorbed from the gastro-intestinal tract. Peak plasma concentrations are generally attained one to two hours after administration. At therapeutic concentration, it is more than 99% bound to the plasma proteins. It is metabolised and excreted mainly in the urine. Small amounts are excreted in the bile. INDICATION: It is indicated for inflammatory and degenerative forms of rheumatism; rheumatoid arthritis; ankylosing spondylitis; osteoarthritis and spondyloarthritis; non-articular rheumatism; acute attacks of gout. Symptomatic treatment for primary dysmenorrhoea. RECOMMENDED DOSAGE: It is generally given in doses of 25mg to 50mg three times daily with food. As a general recommendation, the dose should be individually adjusted. Adverse effects may be minimized by using the lowest effective dose for shortest duration necessary to control symptoms (see section WARNINGS AND PRECAUTIONS). ESTABLISHED CARDIOVASCULAR DISEASE OR SIGNIFICANT CARDIOVASCULAR RISK FACTORS Treatment with diclofenac is generally not recommended in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension. If needed, patients with established cardiovascular disease, uncontrolled hypertension, or significant risk factors for cardiovascular disease (e.g. hypertension, hyperlipidemia, diabetes mellitus and smoking) shoul read_full_document