Land: Storbritannien
Sprog: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Sotalol hydrochloride
Apotex UK Ltd
C07AA07
Sotalol hydrochloride
80mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02040000; GTIN: 5060129470202
PACKAGE LEAFLET: INFORMATION FOR THE USER SOTALOL 80MG TABLETS SOTALOL 160MG TABLETS (sotalol hydrochloride) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. Ÿ Keep this leaflet. You may need to read It again. Ÿ If you have any further questions, ask your doctor or pharmacist. Ÿ 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. Ÿ 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. IN THIS LEAFLET: 1. What Sotalol Tablets are and what are they used for 2. What you need to know before you take Sotalol Tablets 3. How to take Sotalol Tablets 4. Possible side effects 5. How to store Sotalol Tablets 6. Contents of the pack and other information 1. WHAT SOTALOL TABLETS ARE AND WHAT ARE THEY USED FOR Sotalol belongs to a group of drugs called beta-adrenergic blocking agents or "beta-blockers". Sotalol is used to treat irregular heartbeats. This can be caused by the lower heart chambers (ventricular arrhythmia) or the upper heart chambers (atrial or superventricular arrhythmias) 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOTALOL TABLETS DO NOT TAKE SOTALOL TABLETS IF YOU: Ÿ are allergic to sotalol hydrochloride or any of the other ingredients in this medicine (listed in section 6). Ÿ suffer from kidney failure or have untreated tumour near your kidney (phaechromocytoma). Ÿ suffer from asthma, attacks of wheezing on any other lung disease Ÿ suffer from low blood pressure or circulation failure. Ÿ suffer from metabolic acidosis or diabetic ketoacidosis. Ÿ suffer from renal failure (creatinine clearance <10 ml/min) Ÿ suffer from a condition causing discolouration (white or purple) of the hands and feet (Raynaud's syndrome) Ÿ suffer from very slow heart beat (bradycardia) including sick sinus syndrome, or long QT interval. Ÿ are suffering from a second or third degree AV heart block unless a function Læs hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sotalol Hydrochloride 80mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains sotalol hydrochloride 80mg. Excipient with known effect: Each tablet contains 26.75mg of lactose (as lactose monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablets for oral administration. White, round, biconvex tablets of diameter 6.9mm–7.1mm and height of 2.8mm- 3.2mm, marked “SOT” on one side and scored on the other. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Sotalol hydrochloride tablets are indicated for: Ventricular arrhythmias: treatment of life-threatening ventricular tachyarrhythmias; treatment of symptomatic non-sustained ventricular tachyarrhythmias. Supraventricular arrythmias: 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 The initiation of treatment or changes in dosage with Sotalol hydrochloride 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 4.4 Warnings and precautions). As with other antiarrhythmic agents, it is recommended that Sotalol hydrochloride 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. Proarrhytbmic events can occur not only at initiation of therapy, but also with each upward dosage adjustment. In view of its β -adrenergic blocking properties, trea Læs hele dokumentet