Krajina: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Flecainide acetate 100mg;
Boucher & Muir (New Zealand) Limited t/a BNM Group
Flecainide acetate 100 mg
100 mg
Tablet
Active: Flecainide acetate 100mg Excipient: Croscarmellose sodium Magnesium stearate Maize starch Microcrystalline cellulose Pregelatinised maize starch Purified water
Blister pack, PVC/PVDC/Al foil, 60 tablets
Prescription
Prescription
Unimark Remedies Limited
In patients without structural heart disease and without myocardial infarction, Flecainide BNM tablets are indicated for the prevention of: Supraventricular arrhythmias · paroxysmal supraventricular tachycardias (PSVT) including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms; · paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms. Ventricular arrhythmias · documented life-threatening ventricular arrhythmias such as sustained ventricular tachycardia (VT) if they are considered life-threatening in the judgement of the attending physician. Not indicated for less severe ventricular arrhythmias even if symptomatic. Use of flecainide in chronic atrial fibrillation has not been adequately studied and is not recommended.
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al foil - 60 tablets - 36 months from date of manufacture stored at or below 25°C
2013-03-11
1 FLECAINIDE BNM Consumer Medicine Information FLECAINIDE BNM _FLECAINIDE ACETATE 50 MG & 100 MG TABLETS _ WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Flecainide BNM. This leaflet answers some common questions about Flecainide BNM. It does not contain all the available information. The most up-to-date Consumer Medicine Information can be downloaded from www.medsafe.govt.nz. Reading this leaflet does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Flecainide BNM against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may want to read it again. WHAT FLECAINIDE BNM IS USED FOR Flecainide BNM is used to treat a heart condition called arrhythmia, which is an irregular or abnormal heart beat. The active ingredient, flecainide acetate, belongs to a group of medicines called anti-arrhythmics, which slow down the impulses that cause the heart to beat in an irregular or abnormal way. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Flecainide BNM is only available with a doctor's prescription. Flecainide BNM is not addictive. 2 FLECAINIDE BNM BEFORE YOU TAKE FLECAINIDE BNM _ _ Flecainide BNM is not suitable for everyone. _WHEN YOU MUST NOT TAKE IT _ _ _ DO NOT TAKE FLECAINIDE BNM IF YOU ARE ALLERGIC TO ANY MEDICINE CONTAINING FLECAINIDE OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. DO NOT TAKE FLECAINIDE BNM IF YOU: ▪ suffer from certain other heart conditions, different from the heart condition for which you are taking this medicine ▪ are taking certain other medicines for arrhythmia (irregular or abnormal heart beat) ▪ have severe liver or kidney disease unless your doctor says it is suitable for you. DO NOT TAKE IT AFTER THE EXPIRY DA Prečítajte si celý dokument
1 FLECAINIDE BNM FLECAINIDE ACETATE TABLETS 50 MG AND 100 MG NEW ZEALAND DATA SHEET 1 FLECAINIDE BNM FLECAINIDE BNM 50 mg and 100 mg tablet. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Flecainide acetate 50 mg Each tablet contains flecainide acetate 50 mg. Flecainide acetate 100 mg Each tablet contains flecainide acetate 100 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Flecainide 50 mg tablets: White, circular, biconvex, uncoated tablets embossed “C” on one face and the identifying letters “FI” on the reverse. Flecainide 100 mg tablets: White, circular, biconvex, uncoated tablets embossed with a break line on one face with the identifying letters “C” above the line and “FJ” below, the reverse with a break line. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In patients without structural heart disease and without myocardial infarction, Flecainide BNM tablets are indicated for the prevention of: SUPRAVENTRICULAR ARRHYTHMIAS • paroxysmal supraventricular tachycardias (PSVT) including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms; • paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms. 2 FLECAINIDE BNM FLECAINIDE ACETATE TABLETS 50 MG AND 100 MG VENTRICULAR ARRHYTHMIAS • documented life-threatening ventricular arrhythmias such as sustained ventricular tachycardia (VT) if they are considered life-threatening in the judgement of the attending physician. Not indicated for less severe ventricular arrhythmias even if symptomatic. Use of flecainide in chronic atrial fibrillation has not been adequately studied and is not recommended. 4.2 DOSE AND METHOD OF ADMINISTRATION The following regimen is suggested as a guideline. However, dosage may need to be modified as dictated by the weight, age or clinical status of the patient. GENERAL CONSIDERATIONS • Prior to Prečítajte si celý dokument