Država: Malta
Jezik: engleski
Izvor: Medicines Authority
AMIODARONE HYDROCHLORIDE
Sanofi Malta Limited
C01BD01
AMIODARONE HYDROCHLORIDE
TABLET
AMIODARONE HYDROCHLORIDE 200 milligram(s)
POM
CARDIAC THERAPY
Authorised
2005-11-30
PACKAGE LEAFLET: INFORMATION FOR THE USER CORDARONE 200 MG SCORED TABLETS AMIODARONE HYDROCHLORIDE READ ALL OF THIS LEAFLET CAREFULLY BEFORE TAKING THIS MEDICINE. IT CONTAINS IMPORTANT INFORMATION REGARDING YOUR TREATMENT. • Keep this leaflet as 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. 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. IN THIS LEAFLET: 1. What Cordarone 200mg scored tablets are and what they are used for 2. What you need to know before you take Cordarone 200 mg scored tablets 3. How to take Cordarone 200mg scored tablets 4. Possible side effects 5. How to store Cordarone 200mg scored tablets 6. Contents of the pack and other information 1. WHAT CORDARONE 200MG SCORED TABLETS ARE AND WHAT THEY ARE USED FOR. Pharmacotherapeutic group: CLASS III ANTIARRHYTHMIC, ATC code: C01BD01. This medicine is used to prevent and treat certain serious heartbeat problems 2. TABLETSWHAT YOU NEED TO KNOW BEFORE YOU TAKE CORDARONE 200 MG SCORED TABLETS If your doctor has told you that you have an intolerance to certain sugars, contact him/her before taking this medicine. DO NOT TAKE CORDARONE 200 MG SCORED TABLETS: • If you are allergic (hypersensitive) to amiodarone or any of the other ingredients of this medicine listed in section 6 • if you are allergic to iodine, • if you have hyperthyroidism (disease of the thyroid gland), • if you have certain problems with your heartbeat or problems with the system that sends the signals that cause your heart to contract, • if your heartbeat is too slow, • if you are more than 3 months pregnant, • if you are breast-feeding, • If you are taking other medicines, make sure that combined use with Cordarone 200 mg is not contraindicated (see “Other medicines and Co Pročitajte cijeli dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT CORDARONE 200 mg, scored tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Amiodarone hydrochloride ................................................................ 200 mg Excipient with known effect: lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Scored tablet 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PREVENTION OF RECURRENCES OF - life-threatening ventricular tachycardia: the treatment should be instituted in a hospital environment under monitoring; - documented symptomatic and incapacitating ventricular tachycardia; - documented supraventricular tachycardia in patients refractory to therapy or in whom other treatments are contraindicated; - ventricular fibrillation. TREATMENT OF SUPRAVENTRICULAR TACHYCARDIA : slowing or reduction in atrial fibrillation or atrial flutter. Amiodarone can be used in the presence of coronary artery disease and/or impaired left ventricular function (see Section 5.1 ). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Loading dose _ _ _ The usual dosage regimen is 3 tablets per day, for 8 to 10 days. In some cases, the patient may require higher loading doses (4 to 5 tablets per day), always for short periods and under electrocardiographic monitoring. _Maintenance treatment_ Use the minimum effective dose, which will depend on the patient, and ranges from 1/2 tablet per day (1 tablet every 2 days) to 2 tablets every day. _Paediatric population_ The safety and efficacy of amiodarone in children has not been established. Sections 5.1. and 5.2. for currently available data. METHOD OF ADMINISTRATION Oral route. 4.3 CONTRAINDICATIONS This medicinal product is contraindicated in the following situations: • sinus bradycardia and sinoatrial heart block in unpaced patients; • sinus node disease in unpaced patients (risk of sinus arrest); • high-degree atrioventricular conduction disorders in unpaced patients; • hyperthyroidism because of possible exacerbation by amiodar Pročitajte cijeli dokument