Land: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
amiodarone hydrochloride, Quantity: 200 mg
Sandoz Pty Ltd
Tablet, uncoated
Excipient Ingredients: lactose monohydrate; magnesium stearate; colloidal anhydrous silica; povidone; maize starch
Oral
30 tablets
(S4) Prescription Only Medicine
Severe cases of tachyarrhythmias (e.g Wolf-Parkinson-White syndrome; supraventricular, nodal and ventricular tachycardias; atrial flutter and fibrillation; ventricular fibrillation) not responding to other therapy. Treatment should be initiated in hospital. It is recommended that the patient should be regularly monitored for possible toxicity (eg thyroid function, chest X-ray, ophthalmological examination, hepatic function) during the entire course of therapy and for several months after discontinuation.
Visual Identification: White, round tablets, biconvex with score on one side.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2001-03-02
AMIODARONE SANDOZ ® 1 AMIODARONE SANDOZ ® _amiodarone hydrochloride _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Amiodarone Sandoz. 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 risk of you taking Amiodarone Sandoz against the benefits it 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 need to read it again. WHAT AMIODARONE SANDOZ IS USED FOR Amiodarone Sandoz is used to control a fast or irregular heart beat. It contains the active ingredient amiodarone hydrochloride. Amiodarone hydrochloride belongs to a group of medicines called antiarrhythmics. It works by lengthening the gap between one heart beat and the next, thus helping to bring the heart rate to a slower and more regular pace. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. Amiodarone Sandoz is not recommended for children. There is no evidence that this medicine is addictive. BEFORE YOU TAKE AMIODARONE SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE AMIODARONE SANDOZ IF YOU HAVE AN ALLERGY TO: • amiodarone hydrochloride, the active ingredient, or iodine, or any of the inactive ingredients mentioned at the end of this leaflet under Product Description • any other similar medicines. Symptoms of an allergic reaction 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 TAKE THIS MEDICINE IF YOU HAVE OR HAVE HAD ANY OF THE FOLLOWING MEDICAL CONDITIONS: • thyroid problems • heart problems that may cause you to faint. If you have a pacemaker, your doctor may allow the use of it. • severe breathing problems Lestu allt skjalið
190827-Amiodarone Sandoz-pi Page 1 of 21 AUSTRALIAN PRODUCT INFORMATION AMIODARONE SANDOZ (AMIODARONE HYDROCHLORIDE) TABLETS 1. NAME OF THE MEDICINE Amiodarone hydrochloride 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Amiodarone Sandoz 100 mg tablets contains 100 mg amiodarone hydrochloride. Each Amiodarone Sandoz 200 mg tablets contains 200 mg amiodarone hydrochloride. _Excipients with known effect:_ Lactose monohydrate For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM AMIODARONE SANDOZ 100 mg tablets: white, round tablets, one side convex, the other side scored AMIODARONE SANDOZ 200 mg tablets: white, round tablets, biconvex with one-sided score notch 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS Severe cases of tachyarrhythmias (e.g. Wolff-Parkinson-White syndrome; supraventricular, nodal and ventricular tachycardias; atrial flutter and fibrillation; ventricular fibrillation) not responding to other therapy. Treatment should be initiated in hospital. It is recommended that the patient should be regularly monitored for possible toxicity (e.g. thyroid function, chest X- ray, ophthalmological examination, hepatic function) during the entire course of therapy and for several months after discontinuation. 4.2. D OSE AND METHOD OF ADMINISTRATION DOSAGE Due to poor absorption and wide interpatient variability of absorption, the initial loading and subsequent maintenance, dosage schedules in clinical use of the drug have to be individually titrated. It is particularly important that the minimum effective dose be used. In all cases, the patient's management must be judged on the individual response and well-being. The following dosage regimen is usually effective. _ADULTS _ _Initial stabilisation _ Treatment should be started with 200 mg three times daily and may be continued for one week. The dosage should then be reduced to 200 mg twice daily for a further week. _Maintenance _ After the initial period the dosage should be reduced to 200 mg daily, or less if appro Lestu allt skjalið