SOTACOR sotalol hydrochloride 80mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sotalol hydrochloride, Quantity: 80 mg

Available from:

Arrotex Pharmaceuticals Pty Ltd

Pharmaceutical form:

Tablet, uncoated

Composition:

Excipient Ingredients: lactose; microcrystalline cellulose; indigo carmine; maize starch; colloidal anhydrous silica; magnesium stearate; stearic acid

Administration route:

Oral

Units in package:

60 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

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

Product summary:

Visual Identification: Light blue, biconvex, capsule shaped tablets, plain on one side and engraved 'S', '80' and a break bar on the other side; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1999-11-16

Patient Information leaflet

SOTACOR- Consumer Medicine Information
Page 1 of 3
SOTACOR

_sotalol hydrochloride _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
SOTACOR. 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 using SOTACOR
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT SOTACOR IS
USED FOR
SOTACOR contains sotalol
hydrochloride as the active
ingredient which belongs to the
family of drugs known as beta-
blockers.
SOTACOR is used to treat
“arrhythmias”, which is a problem
when the heart beats too quickly
or with the wrong rhythm.
SOTACOR slows down and
steadies the heart beat, reducing
the effort the heart has to put into
pumping blood.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SOTACOR
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
it for another reason.
There is no evidence that this
medicine is addictive.
SOTACOR is only available with a
doctor’s prescription.
BEFORE USING IT
_WHEN YOU MUST NOT USE IT _
_ _
DO NOT USE SOTACOR IF YOU
HAVE AN ALLERGY TO:
•
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
•
skin rash, itching or hives
•
swelling of the face, lips,
tongue or any part of the body.
DO NOT TAKE SOTACOR IF YOU
HAVE ASTHMA.
YOU SHOULD NOT TAKE THIS
MEDICINE IF YOU HAVE ALLERGIES,
OR PROBLEMS WITH YOUR KIDNEYS
OR THYROID GLAND, UNLESS YOU
HAVE DISCUSSED IT WITH YOUR
DOCTOR.
YOU SHOULD NOT TAKE THIS
MEDICINE IF YOU ARE PREGNANT OR
ARE BREAST FEEDING, OR IF YOU
INTEND TO BREAST FEED.
IF YOU HAVE ANY PROBLEMS WITH
YOUR HEART OR CIRCULATION,
DISCUSS THEM WITH YOUR DOCTOR.
Y

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION – SOTACOR (SOTALOL
HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Sotalol hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SOTACOR tablets contain sotalol hydrochloride 80mg or 160mg.
Excipients with known effect: lactose.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
SOTACOR sotalol hydrochloride 80mg are light blue, biconvex, capsule
shaped tablets, plain on one
side and engraved 'S', '80' and a break bar on the other side.
SOTACOR sotalol hydrochloride 160mg are light blue, biconvex, capsule
shaped tablets, plain on one
side and engraved 'S', '160' and a break bar on the other side.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
SOTACOR is indicated for use in the prevention and treatment of
supraventricular and ventricular
arrhythmias.
4.2
D
OSE AND METHOD OF ADMINISTRATION
SOTACOR is administered orally for the prevention and treatment of
arrhythmias.
An intravenous formulation is useful for the management of acute
arrhythmias.
As with other antiarrhythmic agents, SOTACOR should be initiated and
doses increased in a facility
capable of monitoring and assessing cardiac rhythm. The dosage must be
individualized 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.
ORAL: SOTACOR should be taken preferably 1-2 hours before meals.
Oral dosage of SOTACOR should be adjusted gradually allowing 2-3 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
2
recommended initial oral dosing schedule is 160 mg/daily, given in two
divided doses at
approximately 12 hour intervals. This dose may be increased, if
necessary, after appropriate
evaluation to 240 or 320 mg/day. In most patients, a therapeutic
response is obtained at a total
daily do