Sotalol 40mg tablets

Pays: Royaume-Uni

Langue: anglais

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingrédients actifs:

Sotalol hydrochloride

Disponible depuis:

Kent Pharma (UK) Ltd

Code ATC:

C07AA07

DCI (Dénomination commune internationale):

Sotalol hydrochloride

Dosage:

40mg

forme pharmaceutique:

Oral tablet

Mode d'administration:

Oral

classe:

No Controlled Drug Status

Type d'ordonnance:

Valid as a prescribable product

Descriptif du produit:

BNF: 02040000

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
SOTALOL 40MG TABLETS
(sotalol hydrochloride)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
Ÿ
Keep this leaflet. You may need to read It again.
Ÿ
If you have any further questions, ask your doctor or pharmacist.
Ÿ
This medicine has been prescribed for you. Do not pass It on to
others. It may
harm them, even If their symptoms are the same as yours.
Ÿ
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 are they 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 other information
1. WHAT SOTALOL TABLETS ARE AND WHAT ARE THEY USED FOR
Sotalol belongs to a group of drugs called beta-adrenergic blocking
agents or
"beta-blockers". Sotalol is used to treat irregular heartbeats. This
can be caused
by the lower heart chambers (ventricular arrhythmia) or the upper
heart chambers
(atrial or superventricular arrhythmias)
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOTALOL TABLETS
DO NOT TAKE SOTALOL TABLETS IF YOU:
Ÿ
are allergic to sotalol hydrochloride or any of the other ingredients
in this
medicine (listed in section 6).
Ÿ
suffer from kidney failure or have untreated tumour near your kidney
(phaechromocytoma).
Ÿ
have a history of breathing difficulties due to a narrowing of the
airways
(bronchospasm)
Ÿ
suffer from low blood pressure or circulation failure.
Ÿ
suffer from metabolic acidosis or diabetic ketoacidosis.
Ÿ
suffer from renal failure (creatinine clearance <10 ml/min).
Ÿ
suffer from a condition causing discolouration (white or purple) of
the hands
and feet (Raynaud's syndrome)
Ÿ
suffer from very slow heart beat (bradycardia) including sick sinus
syndrome,
or long QT interval.
Ÿ
are suffering from a second or third degree AV heart block unless a
functi

Résumé des caractéristiques du produit

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.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Sotalol 40mg Tablets are indicated for:
_1. _
_VENTRICULAR ARRHYTHMIAS: _
•
Treatment of life-threatening ventricular tachyarrhythmias;
•
Treatment of symptomatic non-sustained ventricular tachyarrhythmias
_2. _
_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
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 4.4 Warnings).
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).
Method of administration
The following dosing schedule can be recommended:
The ini