Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Amiodarone hydrochloride
Zentiva Pharma UK Ltd
C01BD01
Amiodarone hydrochloride
100mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02030200; GTIN: 5013417102071
fold here 25,5mm 25,5mm 25,5mm 25,5mm fold here PACKAGE LEAFLET: INFORMATION FOR THE USER CORDARONE ® X 100MG AND 200MG TABLETS Amiodarone hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE • Keep this leaflet. 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 symptoms are the same as yours • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist IN THIS LEAFLET: 1. What Cordarone X Tablets are and what they are used for 2. Before you take Cordarone X Tablets 3. How to take Cordarone X Tablets 4. Possible side effects 5. How to store Cordarone X Tablets 6. Further information 1. WHAT CORDARONE X TABLETS ARE AND WHAT THEY ARE USED FOR Cordarone X 100mg or 200mg Tablets (called Cordarone X Tablets in this leaflet) contain a medicine called amiodarone hydrochloride. This belongs to a group of medicines called anti-arrhythmics. It works by controlling the uneven beating of your heart (called ‘arrhythmias’). Taking the tablets helps your heartbeat to return to normal. Cordarone X Tablets can be used to: • Treat uneven heartbeats where other medicines either have not worked or cannot be used • Treat an illness called Wolff-Parkinson-White Syndrome. This is where your heart beats unusually fast • Treat other types of fast or uneven heartbeats known as ‘atrial flutter’ or ‘atrial fibrillation’. Cordarone X Tablets are used only when other medicines cannot be used. • Treat fast heartbeats which may happen suddenly and may be uneven. Cordarone X Tablets are used only when other medicines cannot be used. 2. BEFORE YOU TAKE CORDARONE X TABLETS DO NOT TAKE THIS MEDICINE AND TELL YOUR DOCTOR IF: × You are allergic (hypersensitive) to: − iodine − amiodarone − any of the other ingredients of Cordarone X Tablets (listed in S Läs hela dokumentet
OBJECT 1 CORDARONE X 100MG TABLETS Summary of Product Characteristics Updated 17-Oct-2016 | Zentiva 1. Name of the medicinal product Cordarone X 100 2. Qualitative and quantitative composition Cordarone X 100 contain 100 mg of amiodarone hydrochloride. For excipients, see 6.1 3. Pharmaceutical form Tablet. Round, white tablet with a breakline on one side, imprinted with 100 on the other. 4. Clinical particulars 4.1 Therapeutic indications Treatment should be initiated and normally monitored only under hospital or specialist supervision. Oral Cordarone X is indicated only for the treatment of severe rhythm disorders not responding to other therapies or when other treatments cannot be used. Tachyarrhythmias associated with Wolff-Parkinson-White Syndrome. Atrial flutter and fibrillation when other drugs cannot be used. All types of tachyarrhythmias of paroxysmal nature including: supraventricular, nodal and ventricular tachycardias, ventricular fibrillation: when other drugs cannot be used. 4.2 Posology and method of administration _ADULTS_ 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 generally effective. _INITIAL STABILISATION_ Treatment should be started with 200 mg, three times a day and may be continued for 1 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 appropriate. Rarely, the patient may require a higher maintenance dose. The scored 100 mg tablet should be used to titrate the minimum dosage required to maintain control of the arrhythmia. The maintenance dose should be regularly reviewed, especially where this exceeds 200 mg daily. _GENERAL CONSIDERATIONS_ Initial dosing A high dose is needed in order to achieve adequate tissue levels rapidly. Maintenance Too high a dose during maintenance therapy can cause side effects which are Läs hela dokumentet