Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Allopurinol
Sandoz Ltd
M04AA01
Allopurinol
300mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010400
Package leaflet: Information for the user ALLOPURINOL TABLETS BP 300MG (allopurinol) anyother medicines. • medicines used to reduce your immune response (immunosuppressant) e.g. azathiopine, ciclosporin • antibiotics e.g. amoxicillin or ampicillin • aspirin • theophylline, used for breathing problems • medicines used for fits (epilepsy) e.g. phenytoin This includes medicines obtained without a prescription, including herbal medicines. This is because Allopurinol Tablets can affect the way some medicines work. Also some other medicines can affect the way Allopurinol tablets work. For example - • vidarabine, used to treat herpes or chickenpox • didanosine, used to treat HIV infection • medicines used to treat diabetes e.g. chlorpropamide • 6-mercaptopurine used to treat cancer of the blood cells • medicines used to thin your blood (anticoagulants) such as warfarin • medicines for heart problems or high blood pressure such as ’ACE inihibitors’ or water tablets (diuretics) • any other medicine to treat gout e.g. probenecid If you or someone else swallow several of these tablets together, contact your doctor or nearest hospital emergency department immediately. Always take the box, this leaflet and any tablets that are left over with you, if you can. Signs of an overdose may include nausea, vomiting, diarrhoea and dizziness. The recommended dose is 10 to 20 milligrams per kilogram body weight/day up to a maximum of 400mg daily. Blood count monitoring should therefore be performed at regular intervals. USE IN PATIENTS ON KIDNEY DIALYSIS: ALLOPURINOL TABLET CONTAINS LACTOSE USE IN THE ELDERLY: (OVER 65 YEARS) ADULTS:(OVER 18 YEARS) PREGNANCY AND BREAST-FEEDING DRIVING AND USING MACHINES Allopurinol Tablets may cause drowsiness, affect your co- ordination, affect your vision or make you feel dizzy. If you experience these symptoms you should avoid driving or operating machinery. The recommended dose ranges from 100 to 900 mg each day. Initially 100 to 300mg per day is taken as a single dose Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Allopurinol 300mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 300 mg Allopurinol. Excipient(s) with known effect Each tablet contains 180 mg lactose (as monohydrate) and 3.5 mg sodium laurilsulfate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, biconvex tablets engraved: BERK 2K1 or 2K1 plain on reverse. 4 CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Allopurinol is indicated for reducing urate/uric acid formation in conditions where urate/uric acid deposition has already occurred (e.g. skin tophi, gouty arthritis, and nephrolithiasis) or is a predictable clinical risk (e.g. treatment of malignancy potentially leading to acute uric acid nephropathy). The main clinical conditions where urate/uric acid deposition may occur are: uric acid liathiasis; idiopathic gout; acute uric acid nephropathy; neoplastic disease and myeloproliferative disease with high cell turnover rates, in which high urate levels occur either spontaneously, or after cytotoxic therapy; certain enzyme disorders which lead to overproduction of urate, for example: hypoxanthine-guanine phosphoribosyltransferase, including Lesch-Nyhan syndrome; glucose-6-phosphatase including glycogen storage disease; phosphoribosylpyrophosphate synthetase; phosphoribosylpyrophosphate amidotransferase; adenine phosphoribosyltransferase. Allopurinol is also indicated for the management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to deficient activity of adenine phosphoribosyltransferase. Allopurinol is also indicated for the management of recurrent mixed calcium oxalate renal stones in the presence of hyperuricosuria, when fluid, dietary and similar measures have failed. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology Dosage should be modified by monitoring serum urate concentrations and urinary urate/uric acid levels at appropriate intervals. Dose frequency: Allopurinol may be taken orally once a day after a meal. Izlasiet visu dokumentu