BOSENTAN APO 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:

Arrotex Pharmaceuticals Pty Ltd

INN (International Name):

bosentan monohydrate

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

60

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 APO
_Bosentan monohydrate_
CONSUMER MEDICINE INFORMATIO
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about bosentan. 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
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
Bosentan is used to treat high blood
pressure in the blood vessels between
the heart and the lungs. This
condition is called pulmonary arterial
hypertension.
Bosentan belongs to a group of
medicines called endothelin
antagonists.
_HOW IT WORKS_
Bosentan acts to reduce abnormally
high blood pressure by widening the
blood vessels between the heart and
lungs.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
This medicine is not addictive.
There is limited experience with the
use of this medicine in children.
BEFORE YOU TAKE THIS
MEDICINE
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE THIS MEDICINE IF YOU
HAVE AN ALLERGY TO:
•
bosentan
•
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
•
swelling of the face, lips, tongue,
throat or other parts of the body
•
rash, itching or hives on the skin
DO NOT TAKE THIS MEDICINE IF YOU
ARE PREGNANT OR INTEND TO BECOME
PREGNANT. YOU MUST STOP TAKING
THIS MEDICINE AT LEAST 3 MONTHS
BEFORE TRYING TO BECOME PREGNANT.
Bosentan is known to cause harm to
a developing baby if you take it in
the three months before becoming
pregnant and duri

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION –
BOSENTAN APO (BOSENTAN AS MONOHYDRATE)
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.
1
NAME OF THE MEDICINE
Bosentan monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 62.5 mg or 125 mg bosentan (as monohydrate),
For the full list of excipients, see section 6.1LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
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 (AUST
R 257754).
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 (AUST
R 257734).
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 should be administered under the supervision of a physician
experienced in the
management of pulmonary arterial hypertension .
Bosentan 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 increased risk of liver injury.
Tablets should be administered morning and evening with or without
food.
2
Serum liver aminotransferase (AST & ALT)