Sotalol

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Sotalol hydrochloride 160mg

Available from:

Viatris Limited

INN (International Name):

Sotalol hydrochloride 160 mg

Dosage:

160 mg

Pharmaceutical form:

Tablet

Composition:

Active: Sotalol hydrochloride 160mg Excipient: Calcium hydrogen phosphate Magnesium stearate Maize starch Povidone Purified talc Sodium starch glycolate

Units in package:

Blister pack, 1x60, 60 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Cambrex Profarmaco Milano Srl

Therapeutic indications:

Sotalol hydrochloride is indicated for use in the prevention and treatment of supraventricular and ventricular arrhythmias.

Product summary:

Package - Contents - Shelf Life: Blister pack, 1x60 - 60 tablets - 36 months from date of manufacture stored at or below 30°C - Bottle, plastic, 1x100 - 100 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

1991-11-29

Patient Information leaflet

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
SOTALOL
_SOTALOL HYDROCHLORIDE 80 MG AND 160 MG TABLETS_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking SOTALOL.
This leaflet answers some common
questions about SOTALOL.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking SOTALOL
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT SOTALOL IS
USED FOR
SOTALOL is used to prevent and
treat an irregular heart rhythm or
beat, also called arrhythmia.
SOTALOL tablets contain the active
ingredient sotalol hydrochloride. It
belongs to a group of medicines
known as beta-blockers.
It works by changing the body's
response to some nerve impulses,
especially in the heart. As a result, it
helps the heart to beat more
regularly.
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
This medicine is available only with
a doctor’s prescription.
There is no evidence that
SOTALOL is addictive.
BEFORE YOU TAKE
SOTALOL
_WHEN YOU MUST NOT TAKE _
_IT_
DO NOT TAKE SOTALOL IF YOU HAVE
AN ALLERGY TO:

any medicine containing sotalol
hydrochloride

any of the ingredients listed at
the end of this leaflet
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezing or
difficulty breathing; swelling of the
face, lips, tongue or other parts of
the body; rash, itching or hives on
the skin.
DO NOT TAKE SOTALOL IF:

you have certain heart
conditions such as uncontrolled
heart failure or an enlarged
heart

you have low levels of
potassium or magnesium in
your blood.

you suffer or have ever suffered
from asthma, wheezing,
difficulty breathing or other

Summary of Product characteristics

Page 1 of 20
NEW ZEALAND DATA SHEET
SOTALOL
1. PRODUCT NAME
SOTALOL, 80 mg and 160 mg, tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg or 160 mg of sotalol hydrochloride.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
The 80 mg tablet is round, white, flat bevel edged, 7 mm in diameter,
debossed SL/80 on one
side and plain on the other.
The 160 mg tablet is round, white, flat bevel edged, 9.5 mm in
diameter, debossed SL/160 on
one
side and ‘
__
‘ on the other.
4. CLINICAL PARTICULARS
_4.1_
_THERAPEUTIC INDICATIONS_
Sotalol hydrochloride is indicated for use in the prevention and
treatment of supraventricular
and ventricular arrhythmias.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
DOSE
Sotalol hydrochloride is administered orally for the prevention and
treatment of arrhythmias.
ADULTS
Patients with a history of myocardial infarction or severe heart
failure should be monitored
particularly closely in the titration phase with this antiarrhythmic
agent. As with other
antiarrhythmic agents, sotalol hydrochloride should be initiated and
doses increased in a
facility capable of monitoring and assessing cardiac rhythm. The
dosage must be individualised
for each patient on the basis of therapeutic response and tolerance.
Proarrhythmic events can
occur not only at initiation of therapy, but also with each upward
dosage adjustment. In patients
with myocardial infarction and/or cardiac arrhythmias or who have been
receiving long-term
therapy, the medication should be gradually tapered off since abrupt
discontinuation can have
a detrimental effect on the clinical condition.
Page 2 of 20
SEVERE SYMPTOMATIC VENTRICULAR TACHYCARDIA
Oral dosage of sotalol hydrochloride should be adjusted gradually
allowing two to three days
between dosing increments in order to attain steady-state and to allow
monitoring of QT
intervals. Graded dose adjustment will help prevent the use of doses
which are higher than
necessary to control the arrhythmia. The recommended initial oral
dosi