Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
bosentan monohydrate, Quantity: 64.5 mg (Equivalent: bosentan, Qty 62.5 mg)
Cipla Australia Pty Ltd
Tablet, film coated
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
Oral
60
(S4) Prescription Only Medicine
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.
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
Registered
2018-01-03
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 Přečtěte si celý dokument