Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Allopurinol
Waymade Healthcare Plc
M04AA01
Allopurinol
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010400
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 onto others. It may harm them, even if their symptoms 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. WHAT IS IN THIS LEAFLET: 1. What Zyloric is and what it is used for 2. What you need to know before you take Zyloric 3. How to take Zyloric 4. Possible side effects 5. How to store Zyloric 6. Contents of the pack and other information 1. WHAT ZYLORIC IS AND WHAT IT IS USED FOR Zyloric tablets contain a medicine called allopurinol. It works by slowing down the speed of certain chemical reactions in your body to lower the level of uric acid in the blood and urine. Zyloric is used: • to reduce or prevent the formation of urate/uric acid deposition in conditions where your body produces too much of a substance called uric acid. These may include gout or some types of kidney stones or certain other types of kidney problems or when you are having treatment for cancer or some other conditions. In gout the uric acid builds up in your joints and tendons as crystals. These crystals cause an inflammatory reaction. The inflammation causes the skin around certain joints to become swollen, tender and sore when only slightly touched. You can also find you get severe pain when the joint is moved. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZYLORIC DO NOT TAKE ZYLORIC IF: • you are allergic (hypersensitive) to allopurinol or any of the other ingredients of Zyloric (listed in Section 6). If you are not sure, talk to your doctor or pharmacist before taking Zyloric. WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking your medicine if: • you are of Han Chinese, African or Indian origin • yo Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zyloric 100 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Allopurinol 100 mg (Zyloric Tablets) For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. Each 100 mg tablet is round, white to off-white, biconvex, bisected tablet, debossed with Z1 on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide the tablet into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zyloric 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. Zyloric is indicated for the management of 2,8-dihydroxyadenine (2,8-DHA) renal stones related to deficient activity of adenine phosphoribosyltransferase. Zyloric 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 _ _ _ Zyloric should be introduced at low dosage e.g. 100 mg/day to reduce the risk of adverse reactions and increased only if the serum urate response is unsatisfactory. Extra caution sho Read the complete document