Country: Malta
Language: English
Source: Medicines Authority
ALLOPURINOL
Wockhardt UK Limited
M04AA01
ALLOPURINOL
TABLET
ALLOPURINOL 100 mg
POM
ANTIGOUT PREPARATIONS
Authorised
2006-08-18
PACKAGE LEAFLET: INFORMATION FOR THE USER ALLOPURINOL 100MG TABLETS ALLOPURINOL 300MG TABLETS Allopurinol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TO TAKE THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Allopurinol Tablets are and what they are used for 2. What you need to know before you take Allopurinol Tablets 3. How to take Allopurinol Tablets 4. Possible side effects 5. How to store Allopurinol Tablets 6. Contents of the pack and other information 1. WHAT ALLOPURINOL TABLETS ARE AND WHAT THEY ARE USED FOR The name of your medicine is Allopurinol Tablets. Allopurinol comes in two strengths and is a medicine used to reduce the levels of a chemical in the blood called uric acid. Uric acid is associated with a number of conditions and in high levels can cause gout, kidney disease and kidney stones. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALLOPURINOL TABLETS DO NOT TAKE ALLOPURINOL TABLETS: • if you are allergic to allopurinol or any of the other ingredients of this medicine (listed in section 6) • if you are suffering from an acute attack of gout and do not take this medicine already. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR BEFORE TAKING ALLOPURINOL TABLETS: • if you suffer from kidney or liver disease. Your doctor may give you a lower dose or ask you to take it less often each day. They will also monitor you closely • if you have heart problems or high blood pressure and you take diuretics and/or medicines called ACE-inhibitors • if you suffer from heart failure • if you suffer from diabetes • if you are currently havin Read the complete document
Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Allopurinol 100mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Allopurinol BP 100.00mg 3 PHARMACEUTICAL FORM Oral Tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS GOUT PROPHYLAXIS Allopurinol is used to treat primary or secondary hyperuricaemia, associated with chronic gout, uric acid nephropathy, recurrent uric acid stone formation, enzyme disorders, blood disorders, calcium oxalate renal lithiasis, renal failure, diuretic therapy, psoriasis and neoplastic disease and its treatment. Allopurinol is not used to treat acute gout. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ _Adults:_ Initially 100mg daily as a single dose, after food, gradually increased over 1 to 3 weeks according to the plasma and/or urinary uric acid concentration. The average daily dose is 200 to 300mg for mild gout and 400 to 600mg for moderately severe gout. Up to 300mg may be taken as a single daily dose; larger amounts should be taken in divided doses preferably after food. HYPERURICAEMIA ASSOCIATED WITH CANCER THERAPY: 600 to 800mg daily in divided doses for 2 or 3 days, starting 1 or 2 days before the cancer treatment. Maintenance doses are then given according to response. When given concurrently with azothiaprine or mercaptopurine the dose of the antineoplastic agent should be reduced to one third to one quarter of the usual dose. Treatment with allopurinol should precede treatment with cytotoxic drugs. Page 2 of 11 DOSE IN IMPAIRED RENAL FUNCTION: amount and frequency of the dosage may require reduction as indicated by monitoring serum uric acid levels. As a guide, if the creatinine clearance is between 10 and 20ml per minute (moderate impairment), 100 to 200mg daily should be given, if the creatinine clearance is less than 10ml/minute (severe impairment)100mg on alternate days, maximum 100mg daily, should be given. DOSE IN RENAL DIALYSIS: If frequent dialysis is required, doses should be adjusted accordingly as its metabolites are removed b Read the complete document