SOLAVERT sotalol hydrochloride 160mg tablet blister pack

Land: Australien

Sprache: Englisch

Quelle: Department of Health (Therapeutic Goods Administration)

Wirkstoff:

sotalol hydrochloride, Quantity: 160 mg

Verfügbar ab:

Arrotex Pharmaceuticals Pty Ltd

Darreichungsform:

Tablet, uncoated

Zusammensetzung:

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

Verabreichungsweg:

Oral

Einheiten im Paket:

60 tablets

Verschreibungstyp:

(S4) Prescription Only Medicine

Anwendungsgebiete:

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

Produktbesonderheiten:

Visual Identification: Light blue, biconvex, capsule shaped tablets, plain on one side and engraved 'S', '160' and a break bar on the other; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Berechtigungsstatus:

Licence status A

Berechtigungsdatum:

2001-08-22

Gebrauchsinformation

SOLAVERT- Consumer Medicine Information
Page 1 of 4
SOLAVERT

sotalol hydrochloride
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SOLAVERT. It
does not contain all of 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 SOLAVERT
against the benefits this medicine is
expected to have for you.
ASK YOUR DOCTOR OR PHARMACIST
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT SOLAVERT IS
USED FOR
This medicine is used to treat
“arrhythmias”, which is a problem
when the heart beats too quickly or
with the wrong rhythm.
SOLAVERT contains sotalol
hydrochloride, which belongs to the
family of drugs known as beta-
blockers. It slows down and
steadies the heart beat, reducing
the effort the heart has to put into
pumping blood.
Your doctor will have explained
why you are being treated with this
medicine and told you what dose to
take.
SOLAVERT is only available with a
doctor’s prescription.
There is no evidence that this
medicine is addictive.
BEFORE YOU TAKE IT
When you must not take it
DO NOT TAKE SOLAVERT IF YOU
ARE ALLERGIC TO SOTALOL
HYDROCHLORIDE OR 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 parts of the body.
DO NOT TAKE SOLAVERT 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
MAY BECOME PREGNANT OR
INTEND TO BREAST FEED.
IF YOU HAVE ANY PROBLEMS WITH
YOUR HEART OR CIRCULATION,
DISCUSS THEM WITH YOUR DOCTOR.
YOU SHOULD NOT TAKE SOLAVER

Fachinformation

1
AUSTRALIAN PRODUCT INFORMATION – SOLAVERT (SOTALOL
HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Sotalol hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SOLAVERT 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
SOLAVERT 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.
SOLAVERT 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
SOLAVERT is indicated for use in the prevention and treatment of
supraventricular and ventricular
arrhythmias.
4.2
D
OSE AND METHOD OF ADMINISTRATION
SOLAVERT 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, SOLAVERT 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: SOLAVERT should be taken preferably 1-2 hours before meals.
Oral dosage of SOLAVERT 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
2
arrhythmia. The 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