País: Malta
Idioma: anglès
Font: Malta Medicines Authority
COLCHICINE
Wockhardt UK Limited
M04AC01
COLCHICINE
TABLET
COLCHICINE 500 µg
POM
ANTIGOUT PREPARATIONS
Authorised
2006-12-29
1 PACKAGE LEAFLET: INFORMATION FOR THE USER COLCHICINE 500 MICROGRAM TABLETS COLCHICINE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Colchicine Tablets are and what they are used for 2. Before you take Colchicine Tablets 3. How to take Colchicine Tablets 4. Possible side effects 5. How to store Colchicine Tablets 6. Further information 1. WHAT COLCHICINE TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Colchicine Tablets. The active ingredient, colchicine, in Colchicine Tablets is an anti-gout agent. Colchicine Tablets are used to treat gout attacks. They are also used to prevent flare-ups of gout when treatment is started with other drugs such as allopurinol, probenecid and sulfinpyrazone. 2. BEFORE YOU TAKE COLCHICINE TABLETS DO NOT TAKE COLCHICINE TABLETS IF YOU ARE: allergic to colchicine or any of the other ingredients of Colchicine Tablets (see list under ‘What Colchicine Tablets contain’) pregnant under 12 years of age undergoing haemodialysis suffering from severe kidney impairment suffering from any severity of kidney or liver impairment and taking the following drugs: - clarithromycin, erythromycin or telithromycin (used to treat infections) - ritonavir, atazanavir or indinavir (anti-viral drugs, used to treat HIV infection) - ciclosporin (used to prevent organ rejection after a transplant, psoriasis and rheumatoid arthritis) - ketoconazole or itraconazole (used to treat fungal infections) - verapamil (used to treat high blood pressure or angina) - quinidine (used to treat abnormal heart rhythms). TAKE SPECIAL Llegiu el document complet
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Colchicine 500 micrograms Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Colchicine Ph Eur 535 micrograms (equivalent to Colchicine 500 micrograms on a dry weight basis). For excipients, see 6.1. 3 PHARMACEUTICAL FORM Tablet - oral use. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Colchicine tablets may be used for the treatment of acute gout and for short term prophylaxis during initial therapy with allopurinol and uricosuric drugs. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults only: _ _ _Gout_: 1mg initially, followed by 500 micrograms every two to three hours until relief of pain is obtained or vomiting or diarrhoea occurs. A total dose of 6mg_ _should not be exceeded. The course should not be repeated within three days. _Renal Impairment: _ For mild/moderate renal impairment (creatinine clearance 10-50 ml/minute), reduce dose or increase interval between doses (see section 4.3 Contraindications). _ _ _For use with allopurinol or uricosuric drugs:_ 500 micrograms two to three times daily. Page 2 of 7 Elderly: To be given with great care. Children: Not recommended. 4.3 CONTRAINDICATIONS The use of colchicine is contraindicated in pregnancy. Colchicine should not be used in patients undergoing haemodialysis since it cannot be removed by dialysis or exchange transfusion. Colchicine should not be used in patients with severe renal impairment (creatinine clearance less than 10ml/minute). Colchicine is contraindicated in patients with renal or hepatic impairment who are taking a P-glycoprotein or a strong CYP3A4 inhibitor (see section 4.5, Interaction with other medicinal products and other forms of interaction). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Colchicine should be given with care to elderly and debilitated patients as there is a greater risk of cumulative toxicity. Care should also be exercised in those with cardiac, hepatic, gastrointestinal disease or if patients are breast-feeding. Colchicine should be avoid Llegiu el document complet