Țară: Regatul Unit
Limbă: engleză
Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)
Allopurinol
Alliance Healthcare (Distribution) Ltd
M04AA01
Allopurinol
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010400
PI Size : 280 mm x 240 mm Color : Black Font : 9 Pt. Track : 19/07/2018, 01/08/2018, 24/09/2018 PACKAGE LEAFLET: INFORMATION FOR THE USER ALLOPURINOL 100MG AND 300MG 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. 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 (See section 4). WHAT IS IN THIS LEAFLET: 1. What Allopurinol tablets is and what it is 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 TABLET IS AND WHAT IT IS USED FOR These tablets contain Allopurinol and are available in strengths of 100mg and 300mg. Allopurinol works by slowing down the speed of certain chemical reactions in your body. Allopurinol is used to treat high levels of uric acid in the body, which can cause gouty arthritis, skin and kidney problems. Some people may not get any symptoms. Allopurinol is also used to prevent and treat kidney stones in patients who have high uric acid levels. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALLOPURINOL TABLETS: Serious skin rashes (Hypersensitivity syndrome, Stevens- Johnson syndrome, toxic epidermal necrolysis) have been reported with the use of allopurinol. Frequently, the rash can involve ulcers of the mouth, throat, nose, genitals and conjunctivitis (red and swollen eyes). These serious skin rashes are often preceded by influenza-like symptoms fever, headache, body ache (flu-like symptoms). The rash may progress to widespread blistering and peeling of the skin. These serious skin re Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Allopurinol Tablets 100 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Allopurinol 100 mg per tablet. Excipient with known effect: Each tablet contains 180 mg lactose, For the full list of excipients, see 6.1. 3 PHARMACEUTICAL FORM Tablet. Allopurinol Tablets 100 mg are presented as white, normal convex tablets engraved with the company logo on one side and A329 on the other side. 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 over production 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 the 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. 100 mg/day to reduce the risk of adverse reactions and increased only if the serum urate response is unsatisfactory. Extra caution should be ex Citiți documentul complet