Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Allopurinol
Milpharm Ltd
M04AA01
Allopurinol
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010400; GTIN: 5060035111251
Package leaflet: Information for the user ALLOPURINOL TABLETS BP 100MG (allopurinol) PREGNANCY AND BREAST-FEEDING 3. HOW TO TAKE ALLOPURINOL TABLETS Allopurinol and its by-products are removed by dialysis. If dialysis is done frequently 300 to 400mg of Allopurinol may be given after each dialysis with none in the interim. Blood count monitoring should therefore be performed at regular intervals. Allopurinol is excreted in the human breast milk. Allopurinol during breastfeeding is not recommended. When allopurinol is taken at the same time as some chemotherapy medicines (e.g. cyclophosphamide, doxorubicin, bleomycin, procarbazine, alkyl halogenides), blood disorders occur more frequently. USE IN CHILDREN: (UNDER 15 YEARS) The lowest dosage possible will be given as recommended by your doctor. The level and frequency of dosage should be recommended by your doctor. The dose may need to be decreased depending on blood uric acid levels due to kidney damage which mean it takes longer to excrete Allopurinol. 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. DRIVING AND USING MACHINES USE IN PATIENTS ON KIDNEY DIALYSIS: USE IN THE ELDERLY: (OVER 65 YEARS) This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. The recommended dose ranges from 100 to 900 mg each day. Initially 100 to 300mg per day is taken as a single dose which will be increased if necessary. ALLOPURINOL TABLET CONTAINS LACTOSE INFORMATION ON SODIUM CONTENT You doctor will usually start with a low dose of allopurinol (e.g. 100 mg/day), to reduce the risk of possible side effects. Your dose will be increased if necessary. If you have been told by your doctor that you have an intolerance to some s Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Allopurinol Tablets BP 100mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg Allopurinol. Excipient with known effect: Lactose For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. White round tablets with convex sides, with emboss MAL 100 on one side and 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. gouty arthritis, skin tophi, 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: idiopathic gout; uric acid lithiasis; 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 indicated for management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to deficient activity of adenine phosphoribosyltransferase. Allopurinol is 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 Adults: 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 Patients with renal impairmen Läs hela dokumentet