Երկիր: Միացյալ Թագավորություն
Լեզու: անգլերեն
Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)
Allopurinol
Accord-UK Ltd
M04AA01
Allopurinol
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 10010400; GTIN: 5060149310366
* Please note that ONLY Artwork Studio is permitted to make changes to the above artwork. No changes are permitted by any 3rd party other than added notes and mark ups for required changes. approved for print/date PROOF ROUND Technical Approval NON PRINTING COLOURS COLOURS DATE SENT: DATE RECEIVED: Item number: ORIGINATOR: ORIGINATION DATE: REVISION DATE: REVISED BY: DIMENSIONS: MIN BODY TEXT SIZE: SUPPLIER: 1. 2. 3. 4. 5. 6. 1. 2. 3. EU-Artwork-Support@accord-healthcare.com ALLOPURINOL 100MG & 300MG TABLETS PIL (REEL FED) - UK Black Profile BBBB3518 S.Anson 15.12.2021 350 x 275 9pts Accord Fawdon n/a n/a 1 Version 7 12.02.2020 German GTIN 14 (incorporating PZN): Cartons and label leaflets only (labels only when specified) Front side Back side V3 BBBB3518 UKP002 0000000000 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 only. Do not pass it on to 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 are and what are they 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 TABLETS ARE AND WHAT ARE THEY USED FOR Allopurinol belongs to a group of medicines called enzyme inhibitors. These medicines inhibit the amount of uric acid production in your body. Allopurinol works by slowing down the speed of certain chemical reactions in your body to lower the level of uric acid in the blood and uri Կարդացեք ամբողջական փաստաթուղթը
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Allopurinol 100mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Allopurinol 100mg. Excipients with known effect: Each 100 mg tablet contains 34.765 mg of lactose monohydrate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM White to off white, round, biconvex, uncoated tablet with inscription "AW" on one side and plain 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 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 _ _ _ 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 exe Կարդացեք ամբողջական փաստաթուղթը