Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dronedarone hydrochloride
Accord-UK Ltd
C01BD07
Dronedarone hydrochloride
400mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02030200
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT DRONEDARONE ARISTO 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 Dronedarone Aristo is and what it is used for 2. What you need to know before you take Dronedarone Aristo 3. How to take Dronedarone Aristo 4. Possible side effects 5 How to store Dronedarone Aristo 6. Contents of the pack and other information 1. WHAT DRONEDARONE ARISTO IS AND WHAT IT IS USED FOR Dronedarone Aristo contains an active substance named dronedarone. It belongs to a group of medicines called anti-arrhythmics that help regulate your heart beat. Dronedarone Aristo is used if you have a problem with your heart beat (your heart beats out of time – known as ‘atrial fibrillation’) and a treatment called ‘cardioversion’ has changed your heartbeat back to a normal rhythm. Dronedarone Aristo prevents your irregular heart beat returning. Your doctor will consider all available treatment options before prescribing Dronedarone Aristo to you. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DRONEDARONE ARISTO DO NOT TAKE DRONEDARONE ARISTO 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 Dronedarone Aristo, if you have a very slow heart beat (less than 50 beats a minute), if Read the complete document
Dronedarone Aristo 400mg film-coated tablets Summary of Product Characteristics Updated 23-Oct-2020 | Aristo Pharma Limited 1. Name of the medicinal product Dronedarone Aristo 400 mg film-coated tablets 2. Qualitative and quantitative composition Each tablet contains dronedarone hydrochloride salt corresponding to 400 mg of dronedarone. Excipient with known effect Each tablet contains 108.92 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 with dimensions of 17.6 × 8.1 mm. 4. Clinical particulars 4.1 Therapeutic indications Dronedarone Aristo 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), Dronedarone Aristo should only be prescribed after alternative treatment options have been considered. Dronedarone Aristo 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 Aristo 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 Aristo There is limited information on the optimal timing to switch from amiodarone to Dronedarone Aristo. 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 eveni Read the complete document