APX-SOTALOL sotalol hydrochloride 160 mg tablet blister pack

Country: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

sotalol hydrochloride, Quantity: 160 mg

Disponibbli minn:

Arrotex Pharmaceuticals Pty Ltd

Għamla farmaċewtika:

Tablet, uncoated

Kompożizzjoni:

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

Rotta amministrattiva:

Oral

Unitajiet fil-pakkett:

60 tablets

Tip ta 'preskrizzjoni:

(S4) Prescription Only Medicine

Indikazzjonijiet terapewtiċi:

APX-SOTALOL is indicated for use in the prevention and treatment of supraventricular and ventricular arrhythmias.

Sommarju tal-prodott:

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 Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2020-05-04

Fuljett ta 'informazzjoni

APX-SOTALOL- Consumer Medicine Information
Page 1 of 3
APX-SOTALOL

_sotalol hydrochloride _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about APX-
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 using APX-
SOTALOL 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 APX-SOTALOL
IS USED FOR
APX-SOTALOL contains sotalol
hydrochloride as the active
ingredient which belongs to the
family of drugs known as beta-
blockers.
APX-SOTALOL is used to treat
“arrhythmias”, which is a problem
when the heart beats too quickly
or with the wrong rhythm.
APX-SOTALOL 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 APX-
SOTALOL HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed
it for another reason.
There is no evidence that this
medicine is addictive.
APX-SOTALOL is only available
with a doctor’s prescription.
BEFORE USING IT
_WHEN YOU MUST NOT USE IT _
_ _
DO NOT USE APX-SOTALOL 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 APX-SOTALOL 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 HEA

Karatteristiċi tal-prodott

1
AUSTRALIAN PI
APX-SOTALOL
(SOTALOL HYDROCHLORIDE) TABLETS
1
NAME OF THE MEDICINE
Sotalol hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
APX-SOTALOL sotalol hydrochloride 80mg
tablet contains 80 mg sotalol hydrochloride.
APX-SOTALOL sotalol hydrochloride 160mg
tablet contains 160 mg sotalol hydrochloride.
Excipients with known effect: Contains "Sugars as lactose".
For the full list of excipients, SEE SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
APX-SOTALOL 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.
APX-SOTALOL 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
APX-SOTALOL is indicated for use in the prevention and treatment of
supraventricular and
ventricular arrhythmias.
4.2
D
OSE AND METHOD OF ADMINISTRATION
APX-SOTALOL 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, APX-SOTALOL 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.
2
Proarrhythmic events can occur not only at initiation of therapy, but
also with each upward
dosage adjustment.
ORAL
APX-SOTALOL should be taken preferably 1-2 hours before meals.
Oral dosage of APX-SOTALOL 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 recommended initial oral dosing schedule is 160mg/daily, given in
two
divided doses at approximately 12 hour intervals. This dose may be
increased