Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DICLOFENAC SODIUM
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
DICLOFENAC SODIUM
100Tablet Tablets; 30Tablet Tablets
NOVARTIS FARMA S.P.A.
_Consumer Medication Information Leaflet (RiMUP) _ VOLTAREN ® SLOW RELEASE TABLET Diclofenac Sodium (75mg, 100mg) 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 IT 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF VOLTAREN 8. PRODUCT DESCRIPTION 9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10. DATE OF REVISION 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), 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). Post-traumatic and post-operative pain, inflammation and swelling. Primary dysmenorrhea (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 the 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/aspirin, diclofenac or ibuprofen). Reactions may include asthma, runny nose, skin rash, swelling of the face, lips, tongue, throat, and/or extremities (signs of angioedema). If y Baca dokumen lengkapnya
Novartis Page 2 Malaysia Package Leaflet 04-Aug-2021 Voltaren prolonged-release tablets VOLTAREN Anti-inflammatory and anti-rheumatic product, non-steroid, acetic acid derivative. DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Film-coated tablets. ACTIVE SUBSTANCE The active substance is diclofenac sodium. One prolonged-release tablet contains 75 mg or 100 mg of diclofenac sodium. DESCRIPTION Voltaren SR 75mg Tablets: Pale pink, triangular tablet with slightly convex faces and bevelled edges. Debossing of ‘ID’ on the first side and ‘CG’ on the second side. Voltaren SR 100mg Tablets: Pink, round tablet with slightly convex faces with bevelled edges. Debossing of ‘CGC’ on the first side and ‘CG’ on the second side. ACTIVE MOIETY Diclofenac Certain dosage strengths may not be available in all countries. EXCIPIENTS TABLET CORE FOR 75 MG AND 100 MG: Cetyl alcohol; magnesium stearate; povidone; silica; colloidal anhydrous; sucrose; TABLET COATING FOR 75 MG AND 100 MG: hypromellose; iron oxide red (E172); macrogol 8000; polysorbate 80; sucrose; talc; titanium dioxide (E171) Pharmaceutical formulations may vary between countries. INDICATIONS Treatment of: Inflammatory and degenerative forms of rheumatism: rheumatoid arthritis, ankylosing spondylitis, osteoarthritis and spondylarthritis, painful syndromes of the vertebral column, non-articular rheumatism. Painful post-traumatic and post-operative inflammation and swelling. Primary dysmenorrhoea. Novartis Page 3 Malaysia Package Leaflet 04-Aug-2021 Voltaren prolonged-release tablets DOSAGE AND ADMINISTRATION DOSAGE 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, administered as 1 tablet of Voltaren prolonged-released 100 mg or as 2 tablets of Voltaren prolonged-released 7 Baca dokumen lengkapnya