Երկիր: Միացյալ Թագավորություն
Լեզու: անգլերեն
Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sotalol hydrochloride
Apotex UK Ltd
C07AA07
Sotalol hydrochloride
160mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000; GTIN: 5060129470226
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • 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 only. 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. 1. WHAT SOTALOL IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOTALOL 3. HOW TO TAKE SOTALOL 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE SOTALOL 6. CONTENTS OF THE PACK AND OTHER INFORMATION What Sotalol is and what it is used for Sotalol Hydrochloride belongs to a group of medicines called Beta−Blockers and works by slowing the electrical impulses in the heart muscle. This helps to regulate and restore disturbances in the heart rhythm. Sotalol also blocks beta receptors that are found in the heart. This causes the heart to beat more slowly and with less force. Sotalol Hydrochloride (referred to as Sotalol throughout this leaflet) is used: • To treat fast and irregular heartbeat (arrhythmias) some of which may be life-threatening • As prophylaxis, to prevent the occurrence of new arrhythmias. What you need to know before you take DO NOT TAKE SOTALOL: • IF YOU HAVE A HISTORY OF BREATHING DIFFICULTIES, WHEEZING OR ASTHMA • If you are allergic (hypersensitive) to Sotalol, other Beta-Blockers or any of the other ingredients of this medicine (see Section 6 “Contents of the pack and other information”) • If you have an irregular heartbeat caused by sick sinus syndrome, long QT syndromes or Torsades de Pointes • If you suffer from a condition where the heart beats irregularly or much more slowly than normal (2nd or 3rd degree heart block) UNLESS YOU HAVE PACEMAKER • If you have a slower heart beat than normal (bradycardia) • If you suffer Կարդացեք ամբողջական փաստաթուղթը
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sotalol 160 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Sotalol Hydrochloride 160 mg For excipients, see 6.1 3 PHARMACEUTICAL FORM Tablets; Round blue flat bevelled edge tablets with a score line on one side. The score line is not intended for breaking the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ventricular arrhythmias: - Treatment of life-threatening ventricular tachyarrhythmias; - Treatment of symptomatic non-sustained ventricular tachyarrhythmias. Supraventricular arrhythmias: - Prophylaxis of paroxysmal atrial tachycardia, paroxysmal atrial fibrillation, paroxysmal A-V nodal re-entrant tachycardia, paroxysmal A-V re-entrant tachycardia using accessory pathways, and paroxysmal supraventricular tachycardia after cardiac surgery; - Maintenance of normal sinus rhythm following conversion of atrial fibrillation or atrial flutter. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Posology_ Paediatric population There is no relevant use of Sotalol in the paediatric population. The initiation of treatment or changes in dosage with Sotalol should follow an appropriate medical evaluation including ECG control with measurement of the corrected QT interval, and assessment of renal function, electrolyte balance, and concomitant medications (see section 4.4). As with other antiarrhythmic agents, it is recommended that Sotalol be initiated and doses increased in a facility capable of monitoring and assessing cardiac rhythm. The dosage must be individualized and based on the patient's response. Proarrhythmic events can occur not only at initiation of therapy, but also with each upward dosage adjustment. In view of its beta-adrenergic blocking properties, treatment with Sotalol should not be discontinued suddenly, especially in patients with ischaemic heart disease (angina pectoris, prior acute myocardial infarction) or hypertension, to prevent exacerbation of the disease (see section 4.4). _Method of Administration_ _ _ The following dos Կարդացեք ամբողջական փաստաթուղթը