Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Flecainide acetate
Teva UK Ltd
C01BC04
Flecainide acetate
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02030200; GTIN: 5017007027713
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FLECAINIDE ACETATE 50 MG TABLETS FLECAINIDE ACETATE 100 MG TABLETS flecainide acetate 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 Flecainide is and what it is used for 2. What you need to know before you take Flecainide 3. How to take Flecainide 4. Possible side effects 5. How to store Flecainide 6. Contents of the pack and other information 1. WHAT FLECAINIDE IS AND WHAT IT IS USED FOR Flecainide belongs to a group of medicines called antiarrhythmic agents. Flecainide is used to treat an irregularity in the heartbeat (known as an arrhythmia). It works by correcting irregular heartbeats to a normal rhythm. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLECAINIDE DO NOT TAKE FLECAINIDE: • if you are allergic to flecainide acetate or any of the other ingredients of this medicine (listed in section 6). • if you suffer from heart failure or some types of heart rhythm disorders • if you suffer from heart valve disease • if you have a history of heart attacks • if you have low blood pressure or a slow beating heart • if you have a serious heart condition called cardiogenic shock which causes rapid breathing, weakness, looking pale, confusion and can lead to a loss of consciousness • if you have a heart condition called Brugada Syndrome, which causes you to have a potentially life-threatening heart rhythm disorder • if you are already taking Disopyramide to regulate your heartbeat WARNINGS AND PRECAUTIONS Talk to your doctor or pharma Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Flecainide Acetate Tablets 100mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100mg Flecainide Acetate For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet. White, circular, biconvex, uncoated tablets one side embossed with a breakline and the identifying letters “C” above the line and “FJ” below, the reverse side embossed with a breakline. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of AV nodal reciprocating tachycardia; arrhythmias associated with Wolff-Parkinson-White Syndrome and similar conditions with accessory pathways, when other treatment has been ineffective. Treatment of severe symptomatic and life-threatening paroxysmal ventricular arrhythmia which has failed to respond to other forms of therapy or where other treatments have not been tolerated. Treatment of paroxysmal atrial arrhythmias (atrial fibrillation, atrial flutter and atrial tachycardia) in patients with disabling symptoms after conversion provided that there is definite need for treatment on the basis of severity of clinical symptoms, when other treatment has been ineffective. Structural heart disease and/or impaired left ventricular function should be excluded because of the increased risk for pro-arrhythmic effects. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology Adults: Supraventricular arrhythmias: The recommended starting dose is 50mg twice daily and most patients will be controlled at this dose. If required the dose may be increased to a maximum of 300mg daily. Ventricular arrhythmias: The recommended starting dose is 100mg twice daily. The maximum daily dose is 400mg and this is normally reserved for patients of large build or where rapid control of the arrhythmia is required. After 3-5 days it is recommended that the dosage be progressively adjusted to the lowest level which maintains cont Les hele dokumentet