Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
DICLOFENAC SODIUM
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
DICLOFENAC SODIUM
15ml mL
Delpharm Huningue S.A.S.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ CATAFLAM ® 1.5% DROPS Diclofenac Resinate (15 mg/mL) _ _ 1 WHAT IS IN THIS LEAFLET 1. What Cataflam Drops is used for 2. How Cataflam Drops works 3. Before you use Cataflam Drops 4. How to use Cataflam Drops 5. While you are using Cataflam Drops 6. Side Effects 7. Storage and Disposal of Cataflam Drops 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT CATAFLAM IS USED FOR The active substance in Cataflam oral drops suspension is diclofenac resinate that is used to treat pain and inflammation. Cataflam oral drops can be used for short-term treatment of the following conditions in children aged 1 year or over: Pain and swelling after surgery. Infections of the ear, nose or throat. Cataflam oral drops are intended primarily for use in children, but doctors may decide to prescribe them in certain cases for adults. HOW CATAFLAM WORKS Cataflam belongs to a group of medicines called “non-steroidal anti- inflammatory drugs” (NSAIDs) that relieves the symptoms of inflammation, such as pain and swelling, by blocking the synthesis of the molecules (prostaglandins). It has no effect on the causes of inflammation or fever. BEFORE YOU USE CATAFLAM 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 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 extremeties (signs of angioedema). If you think you may be allergic, ask your doctor for advice. If you have a stomach or intestinal ulcer. If you have gastrointestinal bleeding or perforation, symptoms of which may include blood in your stools Soma hati kamili
Novartis Page 2 Malaysia Package Leaflet 04-Aug-2021 Cataflam ® Oral drops suspension CATAFLAM Anti-inflammatory and anti-rheumatic product, non-steroid, acetic acid derivative. DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORM Oral drops suspension. ACTIVE SUBSTANCE The active substance is diclofenac resinate. Diclofenac is bound on resinate as an ion exchanger. Resinate is a basic ion exchanger consisting of polymers of styrol and approx. 2% divinylbenzene with groups of quaternary ammonium included in the net structure. One hundred millilitres of Cataflam ® suspension (oral drops) contain diclofenac resinate equivalent to 1.5 g diclofenac sodium (0.5 mg per drop or 15 mg per mL). DESCRIPTION White to pale beige homogeneous oily suspension with a fruity odour. ACTIVE MOIETY Diclofenac EXCIPIENTS Castor oil, hydrogenated powder; paraffin liquid; saccharin sodium; copolymer of acrylic and methacrylic acid with divinylbenzene and ethylvinylbenzene (Zerolite 236 SRC 48), washed; tutti-frutti flavour. INDICATIONS Short-term treatment in the following acute conditions: Post-traumatic and post-operative pain, inflammation and swelling, e.g. following dental or orthopedic surgery. As an adjuvant in severe painful inflammatory infections of the ear, nose or throat, 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. Novartis Page 3 Malaysia Package Leaflet 04-Aug-2021 Cataflam ® Oral drops suspension 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 Specific pharmaceutical forms (e.g. tablets, suppositories, solution for injection) are available for use in adults. The initial daily dose is 100 to 150 mg di Soma hati kamili