Adcirca - tadalafil *
* Formerly known as Tadalafil Lilly
What is Adcirca?
Adcirca is a medicine that contains the active substance tadalafil. It is available as orange almond-shaped tablets (20 mg).
What is Adcirca used for?
Adcirca is used to treat adults with pulmonary arterial hypertension (PAH) to improve their exercise capacity (i.e. the ability to exercise). PAH refers to a blood pressure that is elevated above normal in the arteries of the lungs. Adcirca is used in patients with class II or III PAH. The "class" indicates the severity of the disease: "class II" means a slight limitation of physical activity, while "class III" means a marked limitation of physical activity. Adcirca has been shown to be effective in cases of PAH without a recognized cause and in cases of PAH caused by vascular collagen diseases.
The medicine can only be obtained with a prescription.
How is Adcirca used?
Adcirca therapy should only be initiated and monitored by a physician experienced in the treatment of PAH.
Adcirca should be taken as two tablets (40 mg) once a day, with or without food. Patients with mild or moderate kidney or liver problems should start with a lower dose which, if necessary, can be increased according to the patient's response. Adcirca is not recommended in patients with severe kidney or liver problems.
How does Adcirca work?
PAH is a debilitating disease in which severe constriction (narrowing) of the blood vessels in the lungs occurs. It causes very high pressure in the vessels that carry blood from the heart to the lungs. This pressure reduces the amount of oxygen that the blood can receive in the lungs, making physical activity more difficult. The active substance in Adcirca, tadalafil, belongs to a group of medicines called 'phosphodiesterase type 5 (PDE5) inhibitors'. block the PDE5 enzyme. This enzyme is found in the blood vessels of the lungs and when blocked, a substance called cyclic guanosine monophosphate (cGMP) cannot be broken down and remains in the blood vessels causing them to relax and widen. In patients with PAH, Adcirca widens the blood vessels. blood vessels in the lungs, which causes blood pressure to drop and symptoms to improve.
How has Adcirca been studied?
Four doses of Adcirca (2.5, 10, 20 and 40 mg once daily) were compared with placebo (a dummy treatment) in a main study involving 406 patients with PAH, mostly class II or III, of unknown cause or attributable to vascular collagen diseases. The main measure of effectiveness was the change in the distance patients were able to walk for six minutes after 16 weeks of treatment. This is a method of measuring the change in exercise capacity.
What benefit has Adcirca shown during the studies?
Adcirca was more effective than placebo in improving exercise capacity. Before therapy, patients could walk an average of 343 meters in six minutes. After 16 weeks, this distance had increased by 26 meters more in the patients taking 40 mg of Adcirca than in the patients taking placebo.
What is the risk associated with Adcirca?
The most common side effects with Adcirca (seen in more than 1 in 10 patients) are headache, redness of the skin, nasopharyngitis (inflammation of the nose and throat), including stuffy or runny nose and closed sinuses, nausea, dyspepsia ( heartburn) including stomach pain, myalgia (muscle pain), back pain and pain in the limbs (arms, hands, legs and feet). For the full list of side effects reported with Adcirca, see the Package Leaflet.
Adcirca should not be used in people who may be hypersensitive (allergic) to tadalafil or any of the other substances. Adcirca should not be used in patients who have had an acute myocardial infarction (sudden heart attack) within the past three months or who suffer from severe hypotension (low blood pressure).Adcirca should not be taken with nitrates (a group of medicines used to treat angina). It should not be taken by patients who have had an episode of vision loss in the past due to a problem of non-arteritic anterior ischemic optic neuropathy ( NAION) which impairs blood flow to the optic nerve.
Why has Adcirca been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Adcirca's benefits are greater than its risks and recommended that it be given marketing authorization.
More information about Adcirca
On 1 October 2008, the European Commission issued Eli Lilly Nederland B.V. a "marketing authorization" for Tadalafil Lilly. This authorization was based on the "authorization granted to Cialis in 2002 (" informed consent "). On 21 October 2009 the name of the medicine was changed to Adcirca. The" marketing authorization "is valid for five years and can be renewed after that period.
For the full version of the Adcirca EPAR, click here.
Last update of this summary: 01-2010.
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