Sotalol Tablets 80mg

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

SOTALOL HYDROCHLORIDE

Tilgjengelig fra:

McDermott Laboratories Ltd, T/A Gerard Laboratories Unit 35, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC-kode:

C07AA07

INN (International Name):

SOTALOL HYDROCHLORIDE 80 mg

Legemiddelform:

TABLET

Sammensetning:

SOTALOL HYDROCHLORIDE 80 mg

Resept typen:

POM

Terapeutisk område:

BETA BLOCKING AGENTS

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2007-06-04

Informasjon til brukeren

 
COLOURS:
Black & 20% tint
PL 11896/0003
0004
Text free area
APPROVED TO PRINT:
Marketing
Registration
Production
Customer
Quality Assurance
Generics [UK] Limited, Design Department
Albany Gate, Darkes Lane, Potters Bar, Herts, EN6 1AG
CUSTOMER:  ANY OLS
DESIGNER:  Sarah Menen
PRODUCT:  Sotolol tablets 80 & 160 mg x 28's
ITEM CODE:  SU-I03
PHARMACODE:  1947
DIMENSIONS:  110 x 210 mm
PROOF NO & DATE:  2   17/05/02
REVISION:  Intro of non-specific a/w. Packed @ Letchworth.
SUPERSEDES:  n/a  
ARTWORK FOR SUBMISSION
BEFORE YOU TAKE YOUR MEDICINE PLEASE READ 
THIS LEAFLET CAREFULLY. This leaflet contains a summary 
of the information about your medicine, Sotalol Tablets.
YOUR MEDICINE
Your medicine is in the form of a tablet. There are two strengths 
of Sotalol Tablets available, 80 mg and 160 mg. The 80 mg 
tablet contains 80 mg of Sotalol Hydrochloride and the 160 mg 
tablet contains 160 mg of Sotalol Hydrochloride. Each tablet 
also contains calcium hydrogen phosphate, maize starch, 
povidone, sodium starch glycollate, talc and magnesium 
stearate. Sotalol Tablets 80 mg are marked "SL/80" on one 
side. Sotalol Tablets 160 mg are marked "SL/160" on one 
side. Sotalol Tablets are available in blister packs of 28 tablets. Your pharmacist will 
dispense the number of tablets prescribed by your doctor.
HOW DOES YOUR MEDICINE WORK?
Sotalol is a beta-adrenoreceptor antagonist or BETA-BLOCKER. Sotalol helps to block the 
effects of naturally occurring substances within your body (catecholamines). In some 
patients catecholamines may cause the heart to beat too quickly or irregularly. By blocking 
these effects, Sotalol can slow the heart, and enable the heart to beat more normally and 
regularly.
Product Licence Holder: McDermott Laboratories, trading as Gerard Laborat

Preparatomtale

 
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS 

PRODUCT SUMMARY 

1.  
NAME OF THE MEDICINAL PRODUCT 

Sotalol Tablets 80mg 

2.   
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Sotalol Hydrochloride 80mg 

3.   
PHARMACEUTICAL FORM 

 Tablets 

4. CLINICAL 
PARTICULARS 

4.1  
THERAPEUTIC INDICATIONS 

SOTALOL 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 nodal 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 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 be
initiated and doses 
increased in a facility capable of monitoring and assessing cardiac
rhythm.  The dosage must be 
individualised and based on the patient’s response.  Proarrhythmic
events can occur not only at 
initiation of therapy, but also with each upward dosage adjustment. 

Page 2 of 10
In view of its ß-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 4.4 
Warnings). 

The following dosing s