Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Ambrisentan 10mg
GlaxoSmithKline NZ Limited
Ambrisentan 10 mg
10 mg
Tablet
Active: Ambrisentan 10mg Excipient: Croscarmellose sodium Opadry II Red 85G94101 Lactose Magnesium stearate Microcrystalline cellulose
Blister pack, PVC/PvdC/Al foil, 30 tablets, 30 tablets
Prescription
Prescription
Johnson Matthey Pharmaceutical Materials Inc.
Volibris is indicated for the treatment of: · idiopathic pulmonary arterial hypertension (PAH) · pulmonary arterial hypertension associated with connective tissue disease (PAH-CTD) in patients with WHO functional class II, III or IV symptoms.
Package - Contents - Shelf Life: Blister pack, PVC/PvdC/Al foil - 30 tablets - 60 months from date of manufacture stored at or below 30°C
2009-01-21
VOLIBRIS 1 VOLIBRIS _5 MG AND 10 MG FILM COATED TABLETS _ _Ambrisentan _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING VOLIBRIS. This leaflet answers some common questions about VOLIBRIS. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking VOLIBRIS against the benefits they expect it will have for you. IF YOU HAVE ANY QUESTIONS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT VOLIBRIS IS USED FOR VOLIBRIS contains the active ingredient ambrisentan which is a type of medicine called an endothelin receptor antagonist (ERA). It is used to treat adults with pulmonary arterial hypertension (PAH), which is high blood pressure in the blood vessels (the pulmonary arteries) that carry blood from the heart to the lungs. In people with PAH, these arteries get narrower, so the heart has to work harder to pump blood through them. This causes people to become tired, dizzy and short of breath. VOLIBRIS widens the pulmonary arteries, making it easier for your heart to pump blood through them. This lowers the blood pressure and relieves your symptoms. VOLIBRIS is not recommended for use in children as there have been no studies of its effects in children. VOLIBRIS must not be used for the treatment of idiopathic pulmonary fibrosis (IPF) and must not be used in patients who have IPF with or without secondary pulmonary hypertension. VOLIBRIS is available as 5 mg and 10 mg tablets. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE VOLIBRIS DO NOT TAKE VOLIBRIS IF YOU HAVE AN ALLERGY TO: • any medicine containing ambrisentan • any of the ingredients listed at the end of this leaflet • any other similar medicine. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheez Read the complete document
1 NEW ZEALAND DATA SHEET VOLIBRIS (AMBRISENTAN) TABLETS TERATOGENICITY VOLIBRIS MAY CAUSE BIRTH DEFECTS AND IS CONTRAINDICATED IN PREGNANCY (SEE SECTION 4.3 CONTRAINDICATIONS). 1 NAME OF THE MEDICINE VOLIBRIS (ambrisentan) 5 mg and 10 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION VOLIBRIS 5 mg tablets Each film-coated tablet contains 5 mg ambrisentan. The tablet contains lactose. VOLIBRIS 10 mg tablets Each film-coated tablet contains 10 mg ambrisentan. Excipient(s) with known effect: The tablets contain lactose and Allura Red AC Aluminium Lake (E129). For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM VOLIBRIS 5 mg tablets are pale pink, square convex tablet engraved ‘GS’ on one face and ‘K2C’ on the other. VOLIBRIS 10 mg tablets are deep pink, oval convex tablet engraved 'GS' on one face and 'KE3' on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS VOLIBRIS is indicated in adults aged ≥ 18 years for the treatment of: • idiopathic pulmonary arterial hypertension (iPAH), • pulmonary arterial hypertension associated with connective tissue disease (PAH- CTD), in patients with WHO functional class II, III or IV symptoms. 2 4.2 DOSE AND METHOD OF ADMINISTRATION Treatment should only be initiated by a physician experienced in the treatment of PAH. DOSE VOLIBRIS should be taken orally at a dose of 5 mg once daily. Additional benefit may be obtained by increasing the dose to 10 mg (see sections 4.8 UNDESIRABLE EFFECTS and 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Efficacy and Safety). Limited data suggest that the abrupt discontinuation of Volibris is not associated with rebound worsening of PAH. Use with cyclosporin A When co-administered with cyclosporin A, the dose of ambrisentan should be limited to 5 mg once daily (see sections 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTION and 5.2 PHARMACOKINETIC PROPERTIES). Special populations _Paediatric population _ Safety and efficacy of VOLIBRIS have not been establish Read the complete document