Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sotalol hydrochloride
Teva UK Ltd
C07AA07
Sotalol hydrochloride
80mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000; GTIN: 5017007012313
SOTALOL 80 MG sotalol 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 belongs to a group of medicines called beta-blockers, which slow the heart beat, so the heart beats more efficiently. • Sotalol is used to prevent a recurrence of serious heart beat problems. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOTALOL DO NOT TAKE SOTALOL • if you are allergic to sotalol, sulphonamides (e.g. co-trimoxazole, sulfadiazine) or any of the other ingredients of this medicine (listed in section 6) • if you have any heart problems, other than those for which your medicine has been prescribed, in particular: − abnormal heart rhythms called ‘long QT syndrome’ − torsades de pointes (life-threatening irregular heart beat) − atrioventricular (AV) block or − sick sinus syndrome (without a pacemaker) (certain types of heart rhythm disturbances) − your heart beats less than 50 times per minute − uncontrolled heart failure − shock due to heart problems (a condition which may be associated with low blood pressure, cold skin, a weak pulse, mental confusion and anxiety) • if you suffer from any of the following conditions: − asthma or any other breathing difficulties − Prinzmetal’s angina (chest pain and palpitations at rest, usually during sleep) − problems wi Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sotalol 80 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg sotalol hydrochloride. Excipient with known effect: Lactose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet 80 mg: Light blue, oval-shaped tablet, scored on one side and debossed with the number “93” and “61” on each side of the score, plain on the other side. The tablet can be divided into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ Sotalol is indicated in adults for prophylaxis of: - life-threatening ventricular tachycardias; - documented symptomatic and disabling ventricular tachycardias in the absence of uncontrolled heart failure; - documented supraventricular tachycardias in the absence of uncontrolled heart failure when the need for treatment is established. (e.g. maintenance of sinus rhythm after conversion of atrial fibrillation or atrial flutter.) 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Posology The initiation of treatment or change in dosage should follow an appropriate medical evaluation, including ECG control with measurement of the corrected QT interval and potassium levels, assessment of renal function and taking into account concomitant medication (see section 4.5). As with other antiarrhythmic substances, it is recommended that Sotalol is initiated and doses increased under ECG control, because proarrhythmic events can occur not only at the initiation of therapy but also with every upward dosage adjustment. The treatment of life-threatening ventricular tachycardias must be initiated under monitoring in a hospital environment. The initial dose is 80 mg administered either as a single or as two divided doses administered at 12 hours interval. Dosing increments should be separated by an interval of 2 or 3 days in order to attain a steady state and allow monitoring of QT intervals. Most patients respond to a daily dose of 160 to 320 mg in two (e.g. 2x 160 mg) or three (e.g. 3x 80 Les hele dokumentet