Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
dronedarone
Sanofi Winthrop Industrie
C01BD07
dronedarone
Cardiac therapy
Atrial Fibrillation
Multaq is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF). Due to its safety profile, Multaq should only be prescribed after alternative treatment options have been considered.Multaq should not be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure.
Revision: 19
Authorised
2009-11-25
27 B. PACKAGE LEAFLET 28 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MULTAQ 400 MG FILM-COATED TABLETS dronedarone 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 MULTAQ is and what it is used for 2. What you need to know before you take MULTAQ 3. How to take MULTAQ 4. Possible side effects 5 How to store MULTAQ 6. Contents of the pack and other information 1. WHAT MULTAQ IS AND WHAT IT IS USED FOR MULTAQ contains an active substance named dronedarone. It belongs to a group of medicines called anti-arrhythmics that help regulate your heart beat. MULTAQ is used if you have a problem with your heart rhythm (your heart beats out of time - atrial fibrillation) and spontaneously, or through a treatment called cardioversion has changed your heartbeat back to normal rhythm. MULTAQ prevents repetition of your problem of irregular heart rhythm. MULTAQ is used only in adults. Your doctor will consider all available treatment options before prescribing MULTAQ to you. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MULTAQ DO NOT TAKE MULTAQ: - if you are allergic to dronedarone or to any of the other ingredients of this medicine (listed in section 6), - if you have a problem with the nerves in your heart (heart block). Your heart might beat very slowly or you may feel dizzy. If you have had a pacemaker fitted for this problem, you can use MULTAQ, - if you have a very slow heart beat (less than 50 beats a minute), - if your ECG (electrocardiogram) shows a heart problem called “prolonged QT corrected interval” Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT MULTAQ 400 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each tablet contains 400 mg of dronedarone (as hydrochloride). Excipient with known effect: Each tablet also contains 41.65 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). White, oblong shaped tablets, engraved with a double wave marking on one side and “4142”code on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MULTAQ is indicated for the maintenance of sinus rhythm after successful cardioversion in adult clinically stable patients with paroxysmal or persistent atrial fibrillation (AF). Due to its safety profile (see sections 4.3 and 4.4), MULTAQ should only be prescribed after alternative treatment options have been considered. MULTAQ must not be given to patients with left ventricular systolic dysfunction or to patients with current or previous episodes of heart failure. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be initiated and monitored only under specialist supervision (see section 4.4). Treatment with dronedarone can be initiated in an outpatient setting. Treatment with Class I or III antiarrhythmics (such as flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol, amiodarone) must be stopped before starting dronedarone. There is limited information on the optimal timing to switch from amiodarone to dronedarone. It should be considered that amiodarone may have a long duration of action after discontinuation due to its long half-life. If a switch is envisaged, this should be done under the supervision of a specialist (see sections 4.3 and 5.1). Posology The recommended dose is 400 mg twice daily in adults. It should be taken as: • one tablet with the morning meal and • one tablet with the evening meal. Grapefruit juice should not be taken together with to dronedarone (see section 4.5). 3 If a dose is mis Lesen Sie das vollständige Dokument