SOTALOL SANDOZ sotalol hydrochloride 80mg tablet blister pack

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

sotalol hydrochloride, Quantity: 80 mg

Dostępny od:

Sandoz Pty Ltd

Forma farmaceutyczna:

Tablet, uncoated

Skład:

Excipient Ingredients: lactose monohydrate; maize starch; sodium starch glycollate; hyprolose; magnesium stearate; colloidal anhydrous silica

Droga podania:

Oral

Sztuk w opakowaniu:

60 tablets

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

Prevention and treatment of supraventricular and ventricular arrhythmias.

Podsumowanie produktu:

Visual Identification: White, round tablets, scored on one side, convex with "SOT" embossed on the other.; Container Type: Blister Pack; Container Material: PP/Al; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Status autoryzacji:

Licence status A

Data autoryzacji:

2001-06-06

Ulotka dla pacjenta

SOTALOL SANDOZ
®
1
SOTALOL SANDOZ
®
_Sotalol Tablets _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Sotalol Sandoz.
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
Sandoz against the benefits it is
expected to 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 want to read it again.
WHAT SOTALOL
SANDOZ IS USED
FOR
The name of your medicine is Sotalol
Sandoz. It contains the active
ingredient sotalol.
Sotalol Sandoz is used for the
prevention and treatment of
supraventricular and ventricular
arrhythmias (irregular heartbeats).
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY SOTALOL
SANDOZ WAS PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
_HOW SOTALOL SANDOZ WORKS _
Sotalol Sandoz belongs to a group of
medicines called beta-blockers.
It works by changing the body's
response to some nerve impulses,
especially in the heart.
It decreases the heart's need for blood
and oxygen and therefore reduces the
amount of work the heart has to do.
As a result, it helps the heart to beat
more regularly.
This medicine is not addictive.
BEFORE YOU TAKE
SOTALOL SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF:
•
you are allergic to the active
ingredient or any of the inactive
ingredients mentioned at the end
of this leaflet under Product
Description
•
it is past its expiry date or the
packaging appears to have been
tampered with, or if the tablets do
not look right
•
you are pregnant or breastfeeding
•
you have a condition that causes
narrowing of the airways, ie
bronchial asthma or chronic
obstructive airway disease
•
you have allergic disorders
(including hay fever) which may
suggest a predisposition to
narrowing of the airways
•
you have a particular type of

Charakterystyka produktu

210722-Sotalol Sandoz-pi
Page 1 of 14
AUSTRALIAN PRODUCT INFORMATION
SOTALOL SANDOZ
® TABLETS (SOTALOL HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Sotalol hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Sotalol Sandoz 80 mg tablet contains 80 mg sotalol hydrochloride.
Each Sotalol Sandoz 160 mg tablet contains 160 mg sotalol
hydrochloride.
Excipients with known effect: Sugars as lactose
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Sotalol Sandoz 80 mg sotalol hydrochloride tablets are white, round
tablets, scored on one side,
convex with “SOT” embossed on the other.
Sotalol Sandoz 160 mg sotalol hydrochloride tablets are white, round,
biconvex tablets, scored
on one side and “SOT” embossed on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Prevention and treatment of supraventricular and ventricular
arrhythmias.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
Sotalol is administered orally for the prevention and treatment of
arrhythmias.
As with other antiarrhythmic agents, sotalol 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.
Oral dosage of sotalol 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 dosing schedule is 160 mg
daily, given in two
divided doses at approximately twelve-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 dose of 160 to 320 mg/day, given in two
divided doses. Some patie