Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Allopurinol
Teva Pharma B.V.
M04AA; M04AA01
Allopurinol
100 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Preparations inhibiting uric acid production; allopurinol
Marketed
2010-09-10
PACKAGE LEAFLET: INFORMATION FOR THE USER ALLOPURINOL TEVA 100 MG AND 300 MG TABLETS Allopurinol READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Teva is and what it is used for 2. What you need to know before you take Allopurinol Teva 3. How to take Allopurinol Teva 4. Possible side effects 5. How to store Allopurinol Teva 6. Contents of the pack and other information 1. WHAT ALLOPURINOL TEVA IS AND WHAT IT IS USED FOR • Allopurinol Teva belongs to a group of medicines called enzyme inhibitors, which act to control the speed at which special chemical changes occur in the body. • Allopurinol Teva tablets are used for the long term, preventive treatment of gout and may be used in other conditions associated with an excess of uric acid in the body, including kidney stones and other types of kidney disease. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALLOPURINOL TEVA DO NOT TAKE ALLOPURINOL TEVA: • if you are allergic to allopurinol or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING ALLOPURINOL TEVA IF: • you have problems with your liver and kidneys. Your doctor may give you a lower dose or ask you to take it less often than each day. They will also monitor you more closely. • you have heart problems or high blood pressure and if you are taking diuretics and/or a medicine called ACE inhibitor. • you are currently having an attack of gout. • you are of Han Chinese, Thai or Kor Belgenin tamamını okuyun
Health Products Regulatory Authority 08 August 2022 CRN00D3R2 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Allopurinol Teva 100 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg allopurinol. Excipient(s) with known effect: Each tablet contains lactose monohydrate, equivalent to 57 mg lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White, round biconvex tablets, debossed "4K1 4K1" on one side and break line on both sides. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ALLOPURINOL TEVA IS INDICATED IN ADULTS, CHILDREN AND ADOLESCENTS: Adults All forms of hyperuricaemia not controllable by diet including secondary hyperuricaemia of differing origin and in clinical complications of hyperuricaemic states, particularly manifest gout, urate nephropathy and for the dissolution and prevention of uric acid stones The management of recurrent mixed calcium oxalate stones in concurrent hyperuricaemia, when fluid, dietary and similar measures have failed. Children and adolescents Secondary hyperuricaemia of differing origin Uric acid nephropathy during treatment of leukaemia Hereditary enzyme deficiency disorders, Lesch-Nyhan syndrome (partial or total hypoxanthin-guanin phosphoribosyl transferase deficiency) and adenine phosophoribosyl transferase deficiency. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For oral use. _Adults_ 2 - 10 mg/kg bodyweight/day or 100 - 200 mg daily in mild conditions, 300 - 600 mg daily in moderately severe conditions, or 700 - 900 mg daily in severe conditions. Allopurinol should be introduced at low dosage, e.g. 100mg/day, to reduce the risk of adverse reactions and increased only if the serum urate response is unsatisfactory. Extra caution should be exercised if renal function is poor (see Dosage recommendations in renal disorders). _Paediatric population_ ( Belgenin tamamını okuyun