Sotalol 40mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sotalol hydrochloride

Available from:

Mawdsley-Brooks & Company Ltd

ATC code:

C07AA07

INN (International Name):

Sotalol hydrochloride

Dosage:

40mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02040000

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 further questions, please ask your doctor or your
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.
IN THIS LEAFLET:
1.
What Sotalol Tablets are and what they are 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 further information
1. WHAT SOTALOL TABLETS ARE AND WHAT THEY ARE USED FOR
Sotalol Tablets contain the active ingredient Sotalol. Sotalol belongs
to a group of drugs called beta-adrenergic blocking agents or
“beta-blockers.” Sotalol is used to treat irregular heartbeats.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOTALOL TABLETS
Do not take Sotalol Tablets:
•
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 untreated tumour of the adrenal gland
•
if you suffer from KIDNEY FAILURE
If you are affected by any of the above you should tell your doctor
before taking this medicine.
WARNINGS AND PRECAUTIONS
Talk to your d

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sotalol 40 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sotalol Hydrochloride 40 mg
For excipients, see 6.1
3
PHARMACEUTICAL FORM
Tablets;
Round white to off white flat bevelled edge tablets.
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 dosing schedule can be recommended:
The initial dose is 80 mg, administered eith