Sotalol 160mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sotalol hydrochloride

Available from:

Apotex 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: 5060129470226

Patient Information leaflet

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
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 only. 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.
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
What Sotalol is and what it is used for
Sotalol Hydrochloride belongs to a group of medicines
called Beta−Blockers and works by slowing the electrical
impulses in the heart muscle. This helps to regulate and
restore disturbances in the heart rhythm.
Sotalol also blocks beta receptors that are found in the
heart. This causes the heart to beat more slowly and
with less force.
Sotalol Hydrochloride (referred to as Sotalol throughout
this leaflet) is used:
•
To treat fast and irregular heartbeat (arrhythmias)
some of which may be life-threatening
•
As prophylaxis, to prevent the occurrence of new
arrhythmias.
What you need to know before you take
DO NOT TAKE SOTALOL:
•
IF YOU HAVE A HISTORY OF BREATHING DIFFICULTIES,
WHEEZING OR ASTHMA
•
If you are allergic (hypersensitive) to Sotalol, other
Beta-Blockers or any of the other ingredients of this
medicine (see Section 6 “Contents of the pack and
other information”)
•
If you have an irregular heartbeat caused by sick sinus
syndrome, long QT syndromes or Torsades de Pointes
•
If you suffer from a condition where the heart beats
irregularly or much more slowly than normal (2nd or
3rd degree heart block) UNLESS YOU HAVE PACEMAKER
•
If you have a slower heart beat than normal
(bradycardia)
•
If you suffer

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