Sotalol 160mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sotalol hydrochloride

Available from:

Accord-UK Ltd

ATC code:

C07AA07

INN (International Name):

Sotalol hydrochloride

Dosage:

160mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02040000; GTIN: 5060149313299

Patient Information leaflet

PACKAGE LEAFLET – INFORMATION FOR THE USER
SOTALOL HYDROCHLORIDE 80 MG TABLETS
SOTALOL HYDROCHLORIDE 160 MG TABLETS
(Sotalol Hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.

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. 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.
_ _
IN THIS LEAFLET:
1.
What are Sotalol Hydrochloride tablets and what are they used for
2.
What you need to know before you take Sotalol Hydrochloride tablets
3.
How to take Sotalol Hydrochloride tablets
4.
Possible side effects
5.
How to store Sotalol Hydrochloride tablets
6.
Contents of the pack and other information
_ _
1.
WHAT ARE SOTALOL HYDROCHLORIDE TABLETS AND WHAT ARE THEY USED FOR
_ _
Sotalol belongs to a group of medicines called ‘Beta-blockers’ or
beta-adrenergic
receptor blocking drugs.
Sotalol tablets are used for the treatment of certain types of
irregular heartbeats.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOTALOL HYDROCHLORIDE TABLETS
DO NOT TAKE SOTALOL TABLETS IF ANY OF THE FOLLOWING APPLY TO YOU.


if you are ALLERGIC to sotalol hydrochloride or any of the other
ingredients in this medicine
(listed in section 6).

if you suffer from ASTHMA, attacks of wheezing or any other lung
disease.

if you have a very slow heart beat or LOW BLOOD PRESSURE.

if you suffer from a condition causing discolouration (white or
purple) of the hands and feet
(Raynaud’s syndrome).

if you suffer from any severe CIRCULATION DISORDERS.

if you have suffered from HEART DISEASE (such as untreated heart
failure) or had a recent heart
attack that your doctor does not know about.

if you suffer from a condition called METABOLIC ACIDOSIS.

if you suffer from an

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sotalol 160 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sotalol Hydrochloride 160 mg
For excipients, see 6.1
3
PHARMACEUTICAL FORM
Tablets;
Round blue flat bevelled edge tablets with a score line on one side.
The score line is not intended for breaking the tablet.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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_
Paediatric population
There is no relevant use of Sotalol in the paediatric population.
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 section 4.4).
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 individualized and based on the patient's response.
Proarrhythmic
events can occur not only at initiation of therapy, but also with each
upward dosage
adjustment.
In view of its beta-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 section 4.4).
_Method of Administration_
_ _
The following dos