CARDOL sotalol hydrochloride 80mg tablet blister pack

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

sotalol hydrochloride, Quantity: 80 mg

Commercializzato da:

Sandoz Pty Ltd

INN (Nome Internazionale):

Sotalol hydrochloride

Forma farmaceutica:

Tablet, uncoated

Composizione:

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

Via di somministrazione:

Oral

Confezione:

60 tablets

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

Prevention and treatment of supraventricular and ventricular arrhythmias.

Dettagli prodotto:

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

Stato dell'autorizzazione:

Licence status A

Data dell'autorizzazione:

2015-12-14

Foglio illustrativo

CARDOL
_contains the active ingredient sotalol_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Cardol.
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 Cardol 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 CARDOL IS USED
FOR
The name of your medicine is
Cardol. It contains the active
ingredient sotalol.
Cardol is used for the prevention and
treatment of supraventricular and
ventricular arrhythmias (irregular
heartbeats).
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CARDOL WAS
PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
_HOW CARDOL WORKS_
Cardol 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.
Cardol is available only with a
doctor's prescription.
BEFORE YOU TAKE
CARDOL
_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
Some of the symptoms of an allergic
reaction may include skin rash,
itching or hives; swelling of the face,
lips or tongue which may cause
difficulty in swallowing or breathing;
wheezing or shortness of breath.
•
you are pregnant or breastfeeding,
or if you intend to breast feed
•
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) w

Scheda tecnica

AUSTRALIAN PRODUCT INFORMATION
CARDOL 80 MG TABLETS
_Sotalol hydrochloride tablets _
1
NAME OF THE MEDICINE
Sotalol hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 80 mg of sotalol as the active ingredient.
Excipients with known effect: lactose monohydrate
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
CARDOL 80mg tablet: White, round tablets, scored on one side, convex
with “SOT” embossed on the
other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prevention and treatment of supraventricular and ventricular
arrhythmias.
4.2
DOSE AND METHOD OF ADMINISTRATION
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.
Cardol tablets should be taken preferably one to two hours before
meals. 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 patients with life-threatening refractory ventricular arrhythmias
may require doses as high as 480
to 640 mg/day, however these doses should only be prescribed when the
potential benefit outweighs
the increased risk of adverse event