Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
flecainide acetate, Quantity: 50 mg
AUBEX PHARMA Pty Ltd
Tablet, uncoated
Excipient Ingredients: pregelatinised maize starch; magnesium stearate; microcrystalline cellulose; hydrogenated vegetable oil; purified water; croscarmellose sodium
Oral
60
(S4) Prescription Only Medicine
BPA-Flecainide is indicated for:,1. Supraventricular arrhythmias:,a) due to pre-excitation syndromes, e.g. Wolff-Parkinson-White and Lown-Ganong-Levine syndromes,b) due to dual AV nodal pathways in patients with debilitating symptoms,c) paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms,Although BPA-Flecainide may be effective in supraventricular arrhythmias in patients with structural heart disease, its use has been associated with life-threatening and occasionally fatal ventricular arrhythmias. In these patients, particularly in the presence of impaired left ventricular function, BPA-Flecainide should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate.,Use of BPA-Flecainide in chronic atrial fibrillation has not been adequately studied and is not recommended.,2. Life threatening ventricular arrhythmias not controlled by other drugs.,BPA-Flecainide tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous (available in other brands) therapy or conversion by other means.,Prescribers should also consult the "Special Warnings and Precautions for Use" section of this Product Information.
Visual Identification: 50mg tablets are white to off-white, round shaped oral tablet with debossed "BPL025" on one side and plain on the other side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2020-04-15
BPA-FLECAINIDE Consumer Medicine Information WHAT IS IN THIS LEAFLET This leaflet answers some common questions about BPA-FLECAINIDE. It does not contain all the available information. It 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 BPA-FLECAINIDE against the benefits they expect it can 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 need to read it again. WHAT BPA-FLECAINIDE IS USED FOR BPA-FLECAINIDE is used to treat a heart condition called arrhythmia. Arrhythmia is an irregular or abnormal heartbeat. The active ingredient in BPA-FLECAINIDE, flecainide acetate, belongs to a group of drugs called antiarrhythmic medicines which slow down the impulses that cause the heart to beat in an irregular or abnormal way. Your doctor may have prescribed BPA-FLECAINIDE for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. BPA-FLECAINIDE is available only with a doctor's prescription. BEFORE USING OR BEING GIVEN BPA-FLECAINIDE _WHEN YOU MUST NOT USE OR HAVE BPA-FLECAINIDE _ DO NOT USE OR HAVE BPA-FLECAINIDE IF YOU HAVE AN ALLERGY TO: • flecainide acetate • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin DO NOT GIVE BPA-FLECAINIDE TO CHILDREN. DO NOT TAKE OR HAVE THIS MEDICINE: • if you have severe heart, liver or kidney disease unless your doctor says it is suitable for you • after the USE BY date. The USE BY date can be found on the box and tablet blister. • if the packaging is torn or shows signs of tampering IF YOU ARE NOT SURE WHETHER YOU SHOULD START TAKING OR BE GIVEN THIS MEDICINE, TALK TO YOUR DOCTOR. _BEFORE YOU START Lugege kogu dokumenti
AUSTRALIAN PRODUCT INFORMATION – BPA-FLECAINIDE (FLECAINIDE ACETATE) TABLETS 1 NAME OF THE MEDICINE Flecainide Acetate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION BPA-FLECAINIDE 50 contains 50 mg of Flecainide Acetate and BPA-FLECAINIDE 100 contains 100 mg of Flecainide Acetate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM BPA-FLECAINIDE 50 are white to off-white, round shaped oral tablet with debossed "BPL025" on one side and plain on the other side. BPA-FLECAINIDE 100 are white to off-white, round shaped tablets with debossed "BPL026" on one side and scored on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS BPA-Flecainide is indicated for: 1. Supraventricular arrhythmias: a) due to pre-excitation syndromes, e.g. Wolff-Parkinson-White and Lown-Ganong-Levine syndromes b) due to dual AV nodal pathways in patients with debilitating symptoms c) paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms Although BPA-Flecainide may be effective in supraventricular arrhythmias in patients with structural heart disease, its use has been associated with life-threatening and occasionally fatal ventricular arrhythmias. In these patients, particularly in the presence of impaired left ventricular function, BPA-Flecainide should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate. Use of BPA-Flecainide in chronic atrial fibrillation has not been adequately studied and is not recommended. 2. Life threatening ventricular arrhythmias not controlled by other drugs. BPA-Flecainide tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous (available in other brands) therapy or conversion by other means. Prescribers should also consult the "Special Warnings and Precautions for Use" section of this Product Information. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS The dosage of BPA-Flecainide must be adjusted to the individual needs of each pat Lugege kogu dokumenti