BOSENCIP bosentan 62.5 mg (as monohydrate) tablet bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bosentan monohydrate, Quantity: 64.5 mg (Equivalent: bosentan, Qty 62.5 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, cirular, biconvex, film-coated tablet, debossed with 62.5 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

Bosencip
1
BOSENCIP
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 BOSENCIP?
Bosencip contains the active ingredient bosentan. Bosencip is used to
treat pulmonary arterial hypertension.
For more information, see Section 1. Why am I using Bosencip? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BOSENCIP?
Do not use if you have ever had an allergic reaction to Bosencip 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
Bosencip? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Bosencip 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 BOSENCIP?
•
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 Bosencip? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BOSENCIP?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist when you visit that you are
using Bosencip.
•
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 Bosencip 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 your symptoms. Your
doctor may tell you to
reduce the dose over a few days before stopping