Sotalol 80mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sotalol hydrochloride

Available from:

Teva UK Ltd

ATC code:

C07AA07

INN (International Name):

Sotalol hydrochloride

Dosage:

80mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02040000; GTIN: 5017007012313

Patient Information leaflet

SOTALOL 80 MG
sotalol
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 belongs to a group of medicines
called beta-blockers, which slow the heart
beat, so the heart beats more efficiently.
• Sotalol is used to prevent a recurrence of
serious heart beat problems.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE SOTALOL
DO NOT TAKE SOTALOL
• if you are allergic to sotalol, sulphonamides
(e.g. co-trimoxazole, sulfadiazine) or any of
the other ingredients of this medicine
(listed in section 6)
• if you have any heart problems, other than
those for which your medicine has been
prescribed, in particular:
−
abnormal heart rhythms called ‘long QT
syndrome’
−
torsades de pointes (life-threatening
irregular heart beat)
−
atrioventricular (AV) block or
−
sick sinus syndrome (without a
pacemaker) (certain types of heart
rhythm disturbances)
−
your heart beats less than 50 times per
minute
−
uncontrolled heart failure
−
shock due to heart problems (a condition
which may be associated with low blood
pressure, cold skin, a weak pulse, mental
confusion and anxiety)
• if you suffer from any of the following
conditions:
−
asthma or any other breathing difficulties
−
Prinzmetal’s angina (chest pain and
palpitations at rest, usually during sleep)
−
problems wi

Summary of Product characteristics

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 with known effect:
Lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
80 mg: Light blue, oval-shaped tablet, scored on one side and debossed
with the
number “93” and “61” on each side of the score, plain on the
other side.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
Sotalol is indicated in adults for prophylaxis of:
-
life-threatening ventricular tachycardias;
-
documented symptomatic and disabling ventricular tachycardias in the
absence of
uncontrolled heart failure;
-
documented supraventricular tachycardias in the absence of
uncontrolled heart
failure when the need for treatment is established. (e.g. maintenance
of sinus rhythm
after conversion of atrial fibrillation or atrial flutter.)
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The initiation of treatment or change in dosage should follow an
appropriate medical
evaluation, including ECG control with measurement of the corrected QT
interval and
potassium levels, assessment of renal function and taking into account
concomitant
medication (see section 4.5).
As with other antiarrhythmic substances, it is recommended that
Sotalol is initiated and
doses increased under ECG control, because proarrhythmic events can
occur not only at
the initiation of therapy but also with every upward dosage
adjustment.
The treatment of life-threatening ventricular tachycardias must be
initiated under
monitoring in a hospital environment.
The initial dose is 80 mg administered either as a single or as two
divided doses
administered at 12 hours interval. Dosing increments should be
separated by an interval
of 2 or 3 days in order to attain a steady state and allow monitoring
of QT intervals.
Most patients respond to a daily dose of 160 to 320 mg in two (e.g. 2x
160 mg) or three
(e.g. 3x 80