Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sotalol hydrochloride
Teva UK Ltd
C07AA07
Sotalol hydrochloride
160mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000; GTIN: 5017007012337
Top of page cut-off to middle of registration mark: 44 mm. PAGE 1: FRONT FACE (INSIDE OF REEL) • amifostine (used during chemo- or radiotherapy) • dipyridamole (administered intravenously) (used to prevent formation of a blood clot) Interactions with laboratory tests: If you have a blood test, please inform your doctor that you are taking sotalol, as it may influence the results of some blood tests. ATHLETES Athletes should be aware that this medicine contains an active substance which may cause a positive reaction to “anti-doping tests”. PREGNANCY AND BREAST-FEEDING If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor may prescribe Sotalol during pregnancy if it is clearly necessary. Do not take Sotalol unless your doctor tells you to and always take it exactly as prescribed. Breast-feeding is not recommended during treatment with Sotalol. DRIVING AND USING MACHINES Sotalol may affect your eyesight or make you feel dizzy. Do not drive or operate any tools or machines if you are affected. SOTALOL CONTAINS LACTOSE If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. HOW TO TAKE SOTALOL Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The recommended dose is: ADULTS (INCLUDING THE ELDERLY): The initial dose is 80 mg sotalol taken once daily or in two divided doses at 12 hour intervals. Your doctor will then gradually increase this according to your needs. The recommended dose is between 160 mg and 320 mg sotalol taken in two or three divided doses each day. For certain patients who have a life-threatening irregular heart beat, the dose can be increased up to 480 mg or 640 mg sotalol daily. Patients with kidney problems may require a lower dose. USE IN CHILDREN: Due to a lack of data Sotalol is not recommended for use Izlasiet visu dokumentu
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sotalol 160 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 160 mg sotalol hydrochloride. Excipient with known effect: Lactose For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet 160 mg: Light blue, oval-shaped tablet, scored on one side and debossed with the number “93” and “62” 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 Izlasiet visu dokumentu