BOSENTAN CA bosentan 62.5 mg (as monohydrate) tablet blister pack

Երկիր: Ավստրալիա

Լեզու: անգլերեն

Աղբյուրը: Department of Health (Therapeutic Goods Administration)

Ակտիվ բաղադրիչ:

bosentan monohydrate, Quantity: 64.5 mg (Equivalent: bosentan, Qty 62.5 mg)

Հասանելի է:

Cipla Australia Pty Ltd

Դեղագործական ձեւ:

Tablet, film coated

Կազմը:

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

Կառավարման երթուղին:

Oral

Միավորները փաթեթում:

10

Ռեկվիզորի տեսակը:

(S4) Prescription Only Medicine

Թերապեւտիկ ցուցումներ:

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.

Ապրանքի ամփոփագիր:

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: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Լիազորման կարգավիճակը:

Registered

Հաստատման ամսաթիվը:

2018-01-03

Տեղեկատվական թերթիկ

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