Страна: Австралия
Език: английски
Източник: 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
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 Прочетете целия документ
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 Прочетете целия документ