Држава: Велика Британија
Језик: Енглески
Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)
Flecainide acetate
Dowelhurst Ltd
C01BC04
Flecainide acetate
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02030200
TBC TAMBOCOR ® 50 MG & 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. 1. WHAT TAMBOCOR IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAMBOCOR TABLETS 3. HOW TO TAKE TAMBOCOR TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE TAMBOCOR TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT TAMBOCOR IS AND WHAT IT IS USED FOR Tambocor tablets belong to a group of medicines called anti-arrhythmics. Anti-arrhythmics work by controlling the rate and rhythm of the heart. Tambocor tablets are used to treat: • Arrhythmias (irregular heart beat) • Tachycardia (heart beating too fast) • Atrial fibrillation (rapid contractions of muscles in the heart). It is important for your doctor to treat these conditions quickly and effectively in order to prevent more serious heart problems from developing. There are two strengths of tablet available, 50 mg and 100 mg. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TAMBOCOR TABLETS DO NOT TAKE TAMBOCOR TABLETS IF YOU: • are allergic to flecainide acetate or any of the other ingredients of this medicine (listed in Section 6) • have heart failure • have cardiogenic shock (your heart is unable to pump as much blood as your body needs) • have heart block (your heart misses beats) • have long-standing atrial fibrillation (rapid contractions of muscles in the heart) • have or have ever had any heart problems, including problems with the valves in your heart or conduction problems • have sinus node dysfunction (a specific condit Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Tambocor ® 100 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 mg of flecainide acetate For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet White, circular, biconvex tablet coded ‘TR100’on one face with a break-line, and ‘3M’ on the other face. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tambocor tablets are indicated for: a) AV nodal reciprocating tachycardia, arrhythmias associated with Wolff-Parkinson- White Syndrome and similar conditions with accessory pathways. b) Paroxysmal atrial fibrillation in patients with disabling symptoms when treatment need has been established and in the absence of left ventricular dysfunction (see section 4.4 Special warnings and special precautions for use). Arrhythmias of recent onset will respond more readily. c) Symptomatic sustained ventricular tachycardia. d) Premature ventricular contractions and/or non-sustained ventricular tachycardia which are causing disabling symptoms, where these are resistant to other therapy or when other treatment has not been tolerated. Tambocor tablets can be used for the maintenance of normal rhythm following conversion by other means. Tambocor tablets are for oral administration. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults: Supraventricular arrhythmias: The recommended starting dosage 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 dosage 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 control of the arrhythmia. It may be possible to reduce dosage during long-term treatment. Children: Tambocor i Прочитајте комплетан документ