Država: Velika Britanija
Jezik: engleski
Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sotalol hydrochloride
DE Pharmaceuticals
C07AA07
Sotalol hydrochloride
80mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000
PACKAGE LEAFLET: INFORMATION FOR THE USER SOTALOL 40 MG, 80 MG & 160 MG TABLETS SOTALOL HYDROCHLORIDE 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 Sotalol belongs to a group of medicines called beta-blockers. It can be used to treat problems affecting the beat of your heart (arrhythmias, tachycardia). If you are not sure why you have been prescribed this medicine then please ask your doctor. DO NOT TAKE SOTALOL AND TELL YOUR DOCTOR IF YOU: are allergic to Sotalol or any of the other ingredients in this medicine (listed in section 6 of this leaflet). The signs of an allergic reaction include a rash, itching or shortness of breath have a history of asthma, wheezing or other lung diseases have any of the following heart problems: - second or third degree heart block (conditions which may make you feel dizzy or light-headed, tired or prone to collapses) - very slow or very uneven heart beats - a problem (common in the elderly) related to poor control of the working of the heart (sick sinus syndrome) - severe blood circulation problems - low blood pressure (hypotension) which can make you feel dizzy or light-headed have severe kidney problems Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Sotalol. YOU WILL NOT BE GIVEN SOTALOL IF YOU: have a sudden and rapid fall in blood pressure (cardiogenic shock) have heart failure which is not under control (signs include breathlessness and swollen ankles) have high blood pressure caused by a tumour on the adrenal gland which has not been treated. This is called phaeochromocytoma have increased levels of acid in your blood (metabolic acidosis) You will not be given this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Sotalol. WARNINGS AND PREC Pročitajte cijeli dokument
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(s) with known effect For the full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Tablet Round, white to off-white, flat, bevelled tablets with the Chatfield logo on one side and a breakline and SOT80 imprinted on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sotalol 80 mg Tablets are indicated for: 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 _Adults _ The recommended initial dose is 40 mg either as a single dose or in two divided doses taken at 12 hour intervals. The dosage of Sotalol 40 mg Tablets should be gradually increased according to the patient’s response. Adjustments to dosage should be made after steady-state has been attained, usually after 2-3 days, and to allow monitoring of QT intervals. Proarrhythmias can occur at initiation and at each upward adjustment of dosage. Most patients respond to a daily dose of 160 to 320 mg, administered in two divided doses at approximately 12 hour intervals. Some patients with life-threatening refractory ventricular arrhythmias may require doses as high as 480 to 640 mg a day but these doses should only be used under specialist supervision and should only be prescribed when the potential benefit outweighs the increased risk of adverse reactions, particularly proarrhythmias, (see section 4.4). _Paediatric population Pročitajte cijeli dokument