国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
flecainide acetate, Quantity: 100 mg
Arrotex Pharmaceuticals Pty Ltd
Tablet
Excipient Ingredients: magnesium stearate; maize starch; silicified microcrystalline cellulose; croscarmellose sodium
Oral
20, 30, 50, 40, 60
(S4) Prescription Only Medicine
APO-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 flecainide acetate 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, APO-FLECAINIDE should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate.,Use of flecainide acetate in chronic atrial fibrillation has not been adequately studied and is not recommended.,2. Life threatening ventricular arrhythmias not controlled by other drugs.,APO-FLECAINIDE tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous therapy or conversion by other means.,Prescribers should also consult the "Precautions" section of this Product Information.
Visual Identification: White to off white, circular, biconvex, tablets debossed with F & 2 separated by scoreline on one side and plain on other side with approximate diameter of 8.8 mm.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2018-06-19
APO-FLECAINIDE _Flecainide acetate_ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. 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 this medicine against the benefits they expect it will 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 THIS MEDICINE IS USED FOR APO-FLECAINIDE is used to treat a heart condition called arrhythmia. Arrhythmia is an irregular or abnormal heart beat. The active ingredient 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 this medicine for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. APO-FLECAINIDE is available only with a doctor's prescription. BEFORE YOU USE/ARE GIVEN THIS MEDICINE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE THIS MEDICINE 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 THIS MEDICINE TO CHILDREN. DO NOT TAKE THIS MEDICINE IF YOU HAVE SEVERE HEART, LIVER OR KIDNEY DISEASE UNLESS YOUR DOCTOR SAYS IT IS SUITABLE FOR YOU DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If it has expired or is damaged, return it to your pharmacist for disposal. IF YOU ARE NOT SURE WHETHER YOU SHOULD START TAKING 阅读完整的文件
1 AUSTRALIAN PRODUCT INFORMATION; APO-FLECAINIDE 50 MG & 100MG TABLETS (FLECAINIDE ACETATE) 1. NAME OF THE MEDICINE Flecainide acetate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 50 mg and 100 mg of APO-FLECAINIDE Tablets contain 50 mg and 100 mg of Flecainide acetate respectively. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM 50 MG TABLETS: White to off white, circular, biconvex, tablets debossed with F1 on one side and plain on other side with an approximate diameter of 6.5 mm. 100 MG TABLETS: White to off white, circular, biconvex, tablets debossed with F & 2 separated by scoreline on one side and plain on other side with an approximate diameter of 8.8 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Flecainide acetate 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 flecainide acetate 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, Flecainide acetate should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate. Use of flecainide acetate in chronic atrial fibrillation has not been adequately studied and is not recommended. 2. Life threatening ventricular arrhythmias not controlled by other drugs: Flecainide acetate tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous therapy or conversion by other means. PRESCRIBERS SHOULD ALSO CONSULT THE SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE, OF THIS PRODUCT INFORMATION. 2 4.2 DOSE AND METHOD OF ADMINISTRATION ADU 阅读完整的文件