Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
lesinurad
Grünenthal GmbH
M04AB05
lesinurad
Antigout preparations
Hyperuricemia
Zurampic, in combination with a xanthine oxidase inhibitor, is indicated in adults for the adjunctive treatment of hyperuricaemia in gout patients (with or without tophi) who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor alone.,
Revision: 4
Withdrawn
2016-02-18
23 B. PACKAGE LEAFLET 24 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ZURAMPIC 200 MG FILM-COATED TABLETS lesinurad This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 signs of illness 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 Zurampic is and what it is used for 2. What you need to know before you take Zurampic 3. How to take Zurampic 4. Possible side effects 5. How to store Zurampic 6. Contents of the pack and other information 1. WHAT ZURAMPIC IS AND WHAT IT IS USED FOR Zurampic contains the active ingredient lesinurad and is used to treat gout in adult patients by lowering the levels of uric acid in the blood. Zurampic must be taken together with allopurinol or febuxostat, which are medicines called ‘xanthine oxidase inhibitors’ and are also used to treat gout by lowering the amount of uric acid in your blood. Your doctor will prescribe Zurampic if your current medicine is not controlling your gout. You must use Zurampic together with either allopurinol or febuxostat. HOW ZURAMPIC WORKS: Gout is a type of arthritis caused by an accumulation of urate crystals around the joints. By lowering the amount of uric acid in the blood, Zurampic stops this accumulation and may prevent further joint damage. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZURAMPIC DO NOT TAKE ZURAMPIC: - if you are allergic to lesinurad or any of the other ingred Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Zurampic 200 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 200 mg of lesinurad. Excipient with known effect: Each tablet contains 52.92 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Oval, 5.7 x 12.9 mm, blue tablets. Tablets are engraved with “LES200” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zurampic, in combination with a xanthine oxidase inhibitor, is indicated in adults for the adjunctive treatment of hyperuricaemia in gout patients (with or without tophi) who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor alone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Zurampic is 200 mg once daily in the morning. This is also the maximum dose (see section 4.4). Zurampic tablets must be co-administered at the same time as the morning dose of a xanthine oxidase inhibitor, i.e. allopurinol or febuxostat. The recommended minimum dose of allopurinol is 300 mg, or 200 mg for patients with moderate renal impairment (creatinine clearance [CrCL] of 30-59 mL/min). If treatment with the xanthine oxidase inhibitor is interrupted, Zurampic dosing must also be interrupted. Patients should be informed that failure to follow these instructions may increase the risk of renal events (see section 4.4). Patients should be instructed to stay well hydrated (e.g. 2 litres of liquid per day). The target serum uric acid level is less than 6 mg/dL (360 µmol/L). In patients with tophi or persistent symptoms, the target is less than 5 mg/dL (300 µmol/L). Testing for t Aqra d-dokument sħiħ