Sotalol 80mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Sotalol hydrochloride

Dostopno od:

DE Pharmaceuticals

Koda artikla:

C07AA07

INN (mednarodno ime):

Sotalol hydrochloride

Odmerek:

80mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

No Controlled Drug Status

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 02040000

Navodilo za uporabo

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

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Sotalol 80 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg Sotalol hydrochloride.
Excipient(s) with known effect
For the full list of excipients see section 6.1
3
PHARMACEUTICAL FORM
Tablet
Round, white to off-white, flat, bevelled tablets with the Chatfield
logo on one
side and a breakline and SOT80 imprinted on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sotalol 80 mg 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
_Adults _
The recommended initial dose is 40 mg either as a single dose or in
two divided doses
taken at 12 hour intervals. The dosage of Sotalol 40 mg Tablets should
be gradually
increased according to the patient’s response. Adjustments to dosage
should be made
after steady-state has been attained, usually after 2-3 days, and to
allow monitoring of
QT intervals. Proarrhythmias can occur at initiation and at each
upward adjustment of
dosage.
Most patients respond to a daily dose of 160 to 320 mg, administered
in two divided
doses at approximately 12 hour intervals. Some patients with
life-threatening
refractory ventricular arrhythmias may require doses as high as 480 to
640 mg a day
but these doses should only be used under specialist supervision and
should only be
prescribed when the potential benefit outweighs the increased risk of
adverse
reactions, particularly proarrhythmias, (see section 4.4).
_Paediatric population