Land: Malaysia
Sprog: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
COLCHICINE
UNIMED SDN BHD
COLCHICINE
10 x 10 Tablets
XL Laboratories Pvt. Ltd.
Page 1 of 2 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ COLSYN (COLCHICINE TABLET USP 500 MCG) Colchicine (0.5 mg) WHAT IS IN THIS LEAFLET 1. What COLSYN is used for 2. How COLSYN works 3. Before you use COLSYN 4. How to use COLSYN 5. While you are using it 6. Side effects 7. Storage and Disposal of COLSYN 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT COLSYN IS USED FOR COLSYN is used for the relief of acute gout when the dramatic response can be diagnostic. It is also used for the prevention of recurrent gout and to prevent acute attacks during the first few months of treatment with Allopurinol or gout suppressants. HOW COLSYN WORKS Colchicine produces a dramatic response in acute gout probably by reducing the inflammatory reaction to urate crystals. Colchicine also inhibits cell division. BEFORE YOU USE COLSYN - _When you must not use it _ _Pregnancy and lactation_ _ _ Do not take COLSYN if you are pregnant, trying to get pregnant or think you may be pregnant. Do not take COLSYN if you are breast- feeding. Ask your doctor or pharmacist for advice before taking any medicine. - _Before you start use it_ _ _ Tell your doctor if you have: • Hypersensitivity to the active substance or to any of the excipients. • Blood dyscrasias. • Pregnancy. • Breastfeeding. • Childbearing potential unless using effective contraceptive measures. • Severe renal impairment. • Severe hepatic impairment. • Undergoing haemodialysis. • Renal or hepatic impairment who are taking a P-glycoprotein (P-gp) inhibitor or a strong CYP3A4 inhibitor. - _Taking other medicines_ _ _ Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from a pharmacy, supermarket or health food shop. Potential risk of severe drug interactions, including death, in certain individual treated with: - Clarithromycin (Antibiotic) - Cyclosporin (prevent organ rejection in people who have received organ transplant) - Erythromycin (Antibiotic) Læs hele dokumentet
• Patients with severe renal impairment • Patients with severe hepatic impairment • Colchicine should not be used in patients undergoing haemodialysis since it cannot be removed by dialysis or exchange transfusion. • Colchicine is contraindicated in patients with renal or hepatic impairment who are taking a P- glycoprotein (P-gp) inhibitor or a strong CYP3A4 inhibitor. • Hypersensitivity to the active substance or to any of the excipients WARNINGS & PRECAUTIONS: Colchicine is potentially toxic so it is important not to exceed the dose prescribed by a physician with the necessary knowledge and experience. Colchicine has a narrow therapeutic window. The administration should be discontinued if toxic symptoms such as nausea, vomiting, abdominal pain, diarrhoea occur. Colchicine may cause severe bone marrow depression (agranulocytosis, aplastic anaemia, thrombocytopenia). The change in blood counts may be gradual or very sudden. Aplastic anaemia in particular has a high mortality rate. Periodic checks of the blood picture are essential. If patients develop signs or symptoms that could indicate a blood cell dyscrasia, such as fever, stomatitis, sore throat, prolonged bleeding, bruising or skin disorders, treatment with colchicine should be immediately discontinued and a full haematological investigation should be conducted straight away. Caution is advised in case of: • liver or renal impairment • cardiovascular disease • gastrointestinal disorders • elderly and debilitated patients • patients with abnormalities in blood counts Patients with liver or renal impairment should be carefully monitored for adverse effects of colchicine. Co- administration with P-gp inhibitors and/or moderate or strong CYP3A4 inhibitors will increase the exposure to colchicine, which may lead to colchicine induced toxicity including fatalities. If treatment with a P-gp inhibitor or a moderate or strong CYP3A4 inhibitor is required in patients with normal renal and hepatic function, a reduction in colchicine dosage or inte Læs hele dokumentet