BOSENTAN CIPLA bosentan 125 mg (as monohydrate) tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bosentan monohydrate, Quantity: 129.08 mg (Equivalent: bosentan, Qty 125 mg)

Available from:

Cipla Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: maize starch; sodium starch glycollate type B; povidone; pregelatinised maize starch; glycerol dibehenate; magnesium stearate; titanium dioxide; hypromellose; purified talc; triacetin; iron oxide yellow; iron oxide red; purified water; ethylcellulose; cetyl alcohol; hydrogen peroxide; sodium lauryl sulfate; octamethylcyclotetrasiloxane; silica dimethicone silylate; dimeticone 5000; cyclomethicone

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: Cream to pale yellow coloured, oblong, biconvex, film-coated tablet, debossed with 125 on one side and plain on 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:

Registered

Authorization date:

2018-01-03

Patient Information leaflet

Bosentan Cipla
1
BOSENTAN CIPLA
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING BOSENTAN CIPLA?
Bosentan Cipla contains the active ingredient bosentan. Bosentan Cipla
is used to treat pulmonary arterial hypertension.
For more information, see Section 1. Why am I using Bosentan Cipla? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BOSENTAN CIPLA?
Do not use if you have ever had an allergic reaction to Bosentan Cipla
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Bosentan Cipla? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Bosentan Cipla and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE BOSENTAN CIPLA?
•
Always take this medicine exactly as your doctor has instructed you.
You should check with your doctor or pharmacist if
you are unsure.
•
The usual dose is one tablet, twice daily. For the first 4 weeks you
will take a 62.5 mg tablet twice daily.
More instructions can be found in Section 4. How do I use Bosentan
Cipla? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BOSENTAN CIPLA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist when you visit that you are
using Bosentan Cipla.
•
Your doctor may arrange for regular blood tests to check for changes
in your liver function and
haemoglobin level.
THINGS YOU
SHOULD NOT DO
•
Do not take Bosentan Cipla if you have moderate to severe liver
disorder.
•
Do not take this medicine if you are pregnant or breastfeeding.
•
Do not stop taking this medicine unless your doctor tells you to.
•
Stopping your treatment may lead to a worsening of y

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - BOSENTAN CIPLA (BOSENTAN AS
MONOHYDRATE) TABLETS
WARNING:
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 film coated tablet of Bosentan Cipla contains 62.5 mg or 125 mg
of bosentan as
monohydrate
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Bosentan Cipla 62.5 mg film-coated tablets are cream to pale yellow
coloured, circular,
biconvex, film-coated tablets, debossed with “62.5” on one side
and plain on other side
Bosentan Cipla 125 mg film-coated tablets are cream to pale yellow
coloured, oblong, biconvex,
film-coated tablets, debossed with “125” on one side and plain on
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bosentan Cipla 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 Cipla should be administered under the supervision of a
physician experienced in the
management of pulmonary arterial hypertension. Bosentan Cipla
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 morni