Country: Малезија
Језик: Енглески
Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DICLOFENAC POTASSIUM
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
DICLOFENAC POTASSIUM
100Tablet Tablets; 500Tablet Tablets; 10 Tablet Tablets
NOVARTIS SAGLIK
_Consumer Medication Information Leaflet (RiMUP) _ CATAFLAM ® TABLET _ _ Diclofenac Potassium (50mg) 1 WHAT IS IN THIS LEAFLET 1. WHAT CATAFLAM TABLET IS USED FOR 2. HOW CATAFLAM TABLET WORKS 3. BEFORE YOU USE CATAFLAM TABLET 4. HOW TO USE CATAFLAM TABLET 5. WHILE YOU ARE USING IT 6. SIDE EFFECTS 7. STORAGE AND DISPOSAL OF CATAFLAM TABLET 8. PRODUCT DESCRIPTION 9. MANUFACTURER AND PRODUCT REGISTRATION HOLDER 10. DATE OF REVISION 11. SERIAL NUMBER WHAT CATAFLAM IS USED FOR The active substance in Cataflam tablet is diclofenac potassium. Cataflam belongs to a group of medicines called “non-steroidal anti-inflammatory drugs” (NSAIDs), which are used to treat pain and inflammation. Cataflam can be used for short-term treatment of the following conditions: • Sprains, strains, or other injuries. • Pain and swelling after surgery. • Painful inflammatory conditions in gynecology, including painful menstrual periods. • Back pain, frozen shoulder, tennis elbow, and other forms of soft-tissue rheumatism. • As an adjuvant in severe painful inflammatory infections of the throat, nose or ears. • Migraine attacks. Cataflam may also be used to treat other conditions as determined by your doctor. HOW CATAFLAM WORKS Cataflam 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 CATAFLAM 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 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, tongue, throat, and/or extremities (sig Прочитајте комплетан документ
Novartis Page 2 Malaysia Package Insert 08-Sep-2022 Cataflam tablets CATAFLAM Anti-inflammatory and anti-rheumatic product, non-steroid, acetic acid derivative. DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Sugar-coated tablets. ACTIVE SUBSTANCE The active substance is diclofenac potassium. In Cataflam ® the sodium ion of diclofenac sodium (Voltaren ® ) has been replaced by a potassium ion. One Cataflam sugar-coated tablet contains 50 mg of diclofenac potassium. DESCRIPTION Reddish-brown round biconvex sugar-coated tablets. EXCIPIENTS CORE: Magnesium stearate; povidone; silica colloidal anhydrous; sodium starch glycollate; maize starch; calcium phosphate. SUGAR-COAT: Microcrystalline cellulose; polyethylene glycol 8000; red iron oxide (E172) and titanium dioxide (E171) (dispersed Anstead); povidone; talc; sucrose. POLISH: polyethylene glycol 8000; sucrose. IMPRINT with printing ink white. Pharmaceutical formulations may vary between countries. INDICATIONS As short-term treatment for the following acute conditions in cases where particular importance is attached to a prompt onset of effect (within 30 minutes): Painful post-traumatic inflammatory states, e.g. due to sprains. Post-operative inflammation and pain, e.g. following dental or orthopaedic surgery. Painful and/or inflammatory conditions in gynaecology, e.g. primary dysmenorrhoea or adnexitis. Acute migraine attacks. Cataflam should not be used for migraine prophylaxis. Painful syndromes of the vertebral column. Non-articular rheumatism. Novartis Page 3 Malaysia Package Insert 08-Sep-2022 Cataflam tablets As an adjuvant in severe painful inflammatory infections of the throat, nose, or ears, e.g. pharyngotonsillitis, otitis. In keeping with general therapeutic principles, the underlying disease should be treated with basic therapy, as appropriate. Fever alone is not an indication. DOSAGE REGIMEN AND ADMINISTRATION DOSAGE REGIMEN As a general recommendation, the dose should be individually adjusted. Adverse effects may be m Прочитајте комплетан документ