BOSENTAN GH bosentan (as monohydrate) 62.5 mg film-coated tablets bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bosentan monohydrate, Quantity: 64.54 mg (Equivalent: bosentan, Qty 62.5 mg)

Available from:

Generic Health Pty Ltd

INN (International Name):

bosentan monohydrate

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: maize starch; pregelatinised maize starch; magnesium stearate; sodium starch glycollate type A; povidone; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow; iron oxide red

Administration route:

Oral

Units in package:

60 tablets in HDPE bottle, 100 tablets in HDPE bottle, 500 tablets in HDPE bottle

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

BOSENTAN GH is indicated for the treatment of ? idiopathic pulmonary arterial hypertension ? familial pulmonary arterial hypertension ? pulmonary arterial hypertension associated with scleroderma or ? pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including Eisenmenger?s physiology,in patients with WHO functional Class II, III or IV symptoms.

Product summary:

Visual Identification: Orange-white, round, biconvex, film-coated tablets, debossed with IB1 on one side and plain on other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2016-03-22

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
BOSENTAN GH
(BOSENTAN MONOHYDRATE) FILM COATED TABLET
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Bosentan GH.
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
this medicine 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 YOUR
MEDICINE. You may need to
read it again.
WHAT BOSENTAN GH IS
USED FOR
Bosentan GH is used for the
treatment of high blood pressure
in the blood vessels between the
heart and the lungs. This
condition is called pulmonary
arterial hypertension.
This medicine acts to reduce
abnormally high blood pressure
by widening these blood
vessels. It belongs to the class
of medicines known as
endothelin receptor antagonists.
Your doctor however, may
prescribe Bosentan GH for
another purpose.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY IT
HAS BEEN PRESCRIBED FOR YOU.
This medicine is only available
with a doctor's prescription.
BEFORE YOU TAKE
BOSENTAN GH
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE THIS MEDICINE IF
YOU ARE:
•
PREGNANT OR INTEND TO
BECOME PREGNANT. YOU
MUST STOP TAKING THE
MEDICINE AT LEAST 3 MONTHS
BEFORE TRYING TO BECOME
PREGNANT.
It is known that this medicine
causes harm to the
developing baby if you take it
during pregnancy and in the
3 months before becoming
pregnant.
•
BREASTFEEDING.
Tell your doctor immediately
if you are breastfeeding. You
are advised to stop
breastfeeding if this medicine
is prescribed for you because
it is not known if this drug
passes into the milk in
women who are taking this
medicine.
•
Being treated with ciclosporin
(a medicine used after a
transplant or to treat
psoriasis).
•
Being treated with
glibenclamide (a medicine
used for diabetes).
DO NOT TAKE BOSENTAN GH IF
YOU ARE ALLERGIC TO IT OR ANY OF
THE INGREDIENTS LISTED A

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – BOSENTAN GH
(BOSENTAN MONOHYDRATE) FILM COATED TABLET
WARNINGS: Cause birth defects and is contraindicated in pregnancy (see
SECTION 4.3
CONTRAINDICATIONS and SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR
USE).
Rare cases of hepatic cirrhosis and hepatic failure have been reported
in patients using bosentan
(see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
1
NAME OF THE MEDICINE
Bosentan monohydrate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bosentan GH tablet contains 64.54 mg bosentan monohydrate is
equivalent to 62.5 mg bosentan.
Bosentan GH tablet contains 129.08 mg bosentan monohydrate is
equivalent to 125 mg bosentan.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Bosentan GH 62.5 mg: Orange-white, round, biconvex, film-coated
tablets, debossed with “IB1” on one
side and plain on other side.
Bosentan GH 125 mg: Orange-white, oval, biconvex, film-coated tablets,
debossed with “IB2” on one
side and plain on other side.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bosentan GH is indicated for the treatment of:
•
idiopathic pulmonary arterial hypertension;
•
familial pulmonary arterial hypertension;
•
pulmonary arterial hypertension associated with scleroderma; or
•
pulmonary arterial hypertension associated with congenital systemic to
pulmonary shunts including
Eisenmenger’s physiology,
in patients with WHO functional Class II, III or IV symptoms.
Bosentan GH v3.0
Page 2 of 27
(bosentan monohydrate) film coated tablet
4.2 DOSE AND METHOD OF ADMINISTRATION
GENERAL
Bosentan
GH
should
be
administered
under
the
supervision
of
a
physician
experienced
in
the
management of pulmonary arterial hypertension. Bosentan GH treatment
should be initiated at a dose
of 62.5 mg twice daily for 4 weeks. Efficacy was demonstrated in
clinical trial subjects who increased to
a maintenance dose of 125 mg twice daily. Doses above 125 mg twice
daily did not appear to confer
additional benefit sufficient to offset the in