Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
Tadalafil
Eli Lilly Australia Pty Ltd
Medicine Registered
ADCIRCA ® _tadalafil_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ADCIRCA. 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 ADCIRCA against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ADCIRCA IS USED FOR ADCIRCA is used in adults as a treatment for pulmonary arterial hypertension. ADCIRCA belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors which work by helping the blood vessels around your lungs relax, improving the flow of blood into your lungs. The result of this is an improved ability to do physical activity. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ADCIRCA HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. ADCIRCA is available only with a doctor's prescription. ADCIRCA is not intended for use by children under the age of 18 years. BEFORE YOU TAKE ADCIRCA _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE ADCIRCA IF YOU ARE CURRENTLY TAKING ANY NITRATES OR AMYL NITRITE. Nitrates are medicines used for the treatment of angina ("chest pain") or other heart conditions. ADCIRCA has been shown to increase the effects of these medicines. If you are taking any form of nitrate or are unsure talk to your doctor. DO NOT TAKE ADCIRCA: • IF YOU HAVE SUFFERED A HEART ATTACK IN THE LAST 3 MONTHS • IF YOU HAVE VISION LOSS IN ONE EYE BECAUSE OF NON-ARTERITIC ANTERIOR ISCHAEMIC OPTIC NEUROPATHY (NAION) • SEVERE HYPOTENSION DO NOT TAKE ADCIRCA IF YOU HAVE AN ALLERGY TO: • any of the ingredients listed at the end of this leaflet Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, to Soma hati kamili
adcirca-pi-v1-05aug11 Page 1 of 19 ADCIRCA ® (tadalafil) NAME OF THE MEDICINE ADCIRCA ® (tadalafil). Chemically, tadalafil is pyrazino[1’, 2’:1, 6]pyrido[3, 4-b]indole-1, 4-dione, 6-(1, 3- benzodioxol-5-yl)-2, 3, 6, 7, 12, 12a-hexahydro-2-methyl-, (6R, 12aR)-. Tadalafil has the empirical formula C 22 H 19 N 3 O 4 representing a molecular weight of 389.41. Tadalafil is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. The CAS number for tadalafil is 171596-29-5. Tadalafil has the following structural formula: DESCRIPTION ADCIRCA 20 mg tablets are orange, almond shaped tablets, for oral administration, marked "4467" on one side. The active ingredient in ADCIRCA tablets is tadalafil. ADCIRCA tablets also contain the following excipients: croscarmellose sodium, hydroxypropylcellulose, hypromellose, lactose, magnesium stearate, cellulose - microcrystalline, sodium lauryl sulfate, talc - purified, titanium dioxide, glycerol triacetate, iron oxide yellowand iron oxide red. PHARMACOLOGY PharmacodynamicsTadalafil is a reversible inhibitor of cyclic guanosine monophosphate (cGMP) – specific phosphodiesterase type 5 (PDE5). Pulmonary arterial hypertension is associated with impaired release of nitric oxide by the vascular endothelium and consequent reduction of cGMP concentrations within the pulmonary vascular smooth muscle. PDE5 is the predominant phosphodiesterase in the pulmonary vasculature. Inhibition of PDE5 by tadalafil increases the concentrations of cGMP resulting in relaxation of the pulmonary vascular smooth muscle cell and vasodilation of the pulmonary vascular bed. Studies in vitro have shown that tadalafil inhibits PDE5 more potently than other PDEs. PD Soma hati kamili