국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DICLOFENAC SODIUM
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
DICLOFENAC SODIUM
100Tablet Tablets
NOVARTIS SAGLIK
_Consumer Medication Information Leaflet (RiMUP) _ VOLTAREN ® TABLET Diclofenac Sodium (50 mg) 1 WHAT IS IN THIS LEAFLET 1. WHAT VOLTAREN IS USED FOR 2. HOW VOLTAREN WORKS 3. BEFORE YOU USE VOLTAREN 4. HOW TO USE VOLTAREN 5. WHILE YOU ARE USING VOLTAREN 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF VOLTAREN 8. PRODUCT DESCRIPTION 9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10. DATE OF REVISION 11. SERIAL NUMBER WHAT VOLTAREN IS USED FOR Voltaren belongs to a group of medicines called “non-steroidal anti-inflammatory drugs” (NSAIDs), which are used to treat pain and inflammation as listed below. _Indicated for treatment of:_ Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis (systemic inflammatory disorder that affects joints), juvenile rheumatoid arthritis, ankylosing spondylitis (chronic inflammatory disease of the skeleton), osteoarthritis (degenerative joint disease) and spondylarthritis (inflammation of the joint), painful syndromes of the vertebral column, non- articular rheumatism (musculoskeletal aches and pains which do not arise from joints). Acute attacks of gout. Post-traumatic and post- operative pain, inflammation and swelling. Primary dysmenorrhoea (period pain). HOW VOLTAREN WORKS Voltaren relieves the symptoms of inflammation, such as pain and swelling, by blocking the synthesis of the molecules (prostaglandins) responsible for inflammation, pain and fever. It has no effect on the causes of inflammation or fever. BEFORE YOU USE VOLTAREN Follow all your doctor’s instructions carefully. They may differ from the general information contained in this leaflet. - _When you must not use it _ If you are allergic (hypersensitive) to diclofenac or to any of the other ingredients of Voltaren listed at the end of this leaflet. If you have ever had an allergic reaction after taking medicines to treat inflammation or pain (e.g. acetylsalicylic acid, diclofenac or ibuprofen. Reactions may include asthma, runny nose, skin rash, swelling of the face, lips, tongu 전체 문서 읽기
Novartis Page 2 Malaysia Package Leaflet 08-Sep-2022 Voltaren gastro-resistant tablets VOLTAREN Anti-inflammatory and anti-rheumatic product, non-steroid, acetic acid derivative. DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Gastro-resistant tablets. ACTIVE SUBSTANCE The active substance is diclofenac sodium. One gastro-resistant tablet contains 50 mg of diclofenac sodium. DESCRIPTION Light brown round tablet with slightly convex faces and bevelled edges with debossed “GT” on the first side and “CG” on the second side. ACTIVE MOIETY Diclofenac Certain dosage strengths may not be available in all countries. EXCIPIENTS CORE: Cellulose microcrystalline; lactose monohydrate; magnesium stearate; maize starch; povidone; silica, colloidal anhydrous; sodium starch glycolate (type A). COATING: hypromellose; iron oxide red (E172); iron oxide yellow (E172); macrogoglycerol hydroxystearate; Methacrylic acid – ethyl acrylate copolymer; macrogol 8000; talc; titanium dioxide (E171); Simeticone; alpha-octadecyl-omega-hydroxy-polyglykolether; sorbic acid. Pharmaceutical formulations may vary between countries. INDICATIONS Treatment of: Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis, painful syndromes of the vertebral column, non-articular rheumatism. Acute attacks of gout. Painful post-traumatic and post-operative inflammation and swelling. Primary dysmenorrhoea. Novartis Page 3 Malaysia Package Leaflet 08-Sep-2022 Voltaren gastro-resistant tablets DOSAGE REGIMEN AND ADMINISTRATION DOSAGE REGIMEN As a general recommendation, the dose should be individually adjusted. Adverse effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section WARNINGS AND PRECAUTIONS). GENERAL TARGET POPULATION ADULTS The recommended initial daily dose is 100 to 150 mg. In milder cases, as well as for long-term therapy, 75 to 100 mg daily is 전체 문서 읽기