Sotalol 40mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Sotalol hydrochloride

Verfügbar ab:

DE Pharmaceuticals

ATC-Code:

C07AA07

INN (Internationale Bezeichnung):

Sotalol hydrochloride

Dosierung:

40mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 02040000

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
SOTALOL 40 MG, 80 MG
& 160 MG TABLETS
SOTALOL HYDROCHLORIDE
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
Sotalol
belongs
to
a
group
of
medicines
called
beta-blockers. It can be used to treat problems affecting the
beat of your heart (arrhythmias, tachycardia).
If you are not sure why you have been prescribed this
medicine then please ask your doctor.
DO NOT TAKE SOTALOL AND TELL YOUR DOCTOR IF YOU:

are allergic to Sotalol or any of the other ingredients in
this medicine (listed in section 6 of this leaflet). The
signs of an allergic reaction include a rash, itching or
shortness of breath

have a history of asthma, wheezing or other lung
diseases

have any of the following heart problems:
- second or third degree heart block (conditions which
may make you feel dizzy or light-headed, tired or prone
to collapses)
- very slow or very uneven heart beats
- a problem (common in the elderly) related to poor
control of the working of the heart (sick sinus
syndrome)
- severe blood circulation problems
- low blood pressure (hypotension) which can make you
feel dizzy or light-headed

have severe kidney problems
Do not take this medicine if any of the above apply to you. If
you are not sure, talk to your doctor or pharmacist before
taking Sotalol.
YOU WILL NOT BE GIVEN SOTALOL IF YOU:

have a sudden and rapid fall in blood pressure
(cardiogenic shock)

have heart failure which is not under control (signs
include breathlessness and swollen ankles)

have high blood pressure caused by a tumour on the
adrenal gland which has not been treated. This is called
phaeochromocytoma

have increased levels of acid in your blood (metabolic
acidosis)
You will not be given this medicine if any of the above apply
to you. If you are not sure, talk to your doctor or pharmacist
before taking Sotalol.
WARNINGS AND PREC

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sotalol 40mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 40mg Sotalol hydrochloride
For excipients: see 6.1
3.
PHARMACEUTICAL FORM
Tablet
Round, white to off-white, flat bevelled edged tablets.
4.1
THERAPEUTIC INDICATIONS
Sotalol 80mg 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 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
40mg Tablets 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
β
-adrenergic blocking properties, treatment with Sotalol 40mg Tablets
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 ca