BOSENTAN RBX bosentan (as monohydrate) 125 mg film-coated tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bosentan monohydrate, Quantity: 129.083 mg

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

bosentan monohydrate

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

60, 56

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Bosentan 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: The 125mg film-coated tablets are light peach to peach colored, oval shaped, biconvex & debossed with '125' on one side & plain on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2016-07-11

Patient Information leaflet

Bosentan CMI Aug 2015 v1
Page 1 of 4
BOSENTAN RBX
CONSUMER MEDICINE INFORMATION
_______________________
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
BOSENTAN RBX.
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 THE
MEDICINE.
You may need to read it again.
________________________
WHAT BOSENTAN
RBX IS USED FOR
BOSENTAN RBX 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 RBX for
another purpose.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available
with a doctor’s prescription.
_________________________
BEFORE YOU TAKE
BOSENTAN RBX
_WHEN YOU MUST NOT TAKE _
_BOSENTAN RBX _
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 three
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
cyclosporine A (a medicine
used after a transplant or to
treat psoriasis)

Being treated with
glibenclamide (a medicine
used for diabe

Summary of Product characteristics

Bosentan RBX PI v1.1 Page 1 of 27
AUSTRALIAN PRODUCT INFORMATION
BOSENTAN RBX
Bosentan (as monohydrate)
1 NAME OF THE MEDICINE
Bosentan (as monohydrate)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 62.5mg bosentan (as monohydrate)
Each tablet contains 125 mg bosentan (as monohydrate)
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3 PHARMACEUTICAL FORM
BOSENTAN RBX (bosentan) 62.5 mg film-coated tablets are light peach to
peach
coloured, round shaped, biconvex and debossed with ‘62.5’ on one
side and plain
on the other side.
BOSENTAN RBX (bosentan)125 mg film-coated tablets are light peach to
peach
coloured, oval shaped, biconvex and debossed with ‘125’ on one
side and plain on the
other side
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bosentan
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
4.2 DOSE AND METHOD OF ADMINISTRATION
GENERAL
BOSENTAN RBX should be administered under the supervision of a
physician
experienced in the management of pulmonary arterial hypertension.
BOSENTAN RBX 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
Bosentan may 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.
Bosentan RBX PI v1.1 Page 2 of 27
appear to confer additional benefit sufficient to offset the increased
risk o