Generic drug of the therapeutic class: Cardiology and angiology
Active ingredients: Tadalafil
laboratory: Lilly France Sas
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ADCIRCA is indicated for the treatment of pulmonary arterial hypertension (PAH) in patients in functional class II and III according to the WHO classification, in order to improve exercise capacity (see section 5.1 Pharmacodynamic properties ).
Efficacy has been demonstrated in idiopathic PAH and in PAH associated with connective tissue disease.
Dosage ADCIRCA 20 mg Film-coated tablet Box of 28
Oral way. 20 mg film-coated tablets.
Treatment should be initiated and controlled only by a physician experienced in the management of patients with pulmonary hypertension.
The recommended dose is 40 mg (2 x 20 mg) once daily with or without food intake.
Use in patients with renal insufficiency:
In patients with mild to moderate renal impairment, an initial dose of 20 mg once daily is recommended. Depending on the efficacy and individual tolerance, the dosage can be increased up to 40 mg once a day. The use of ADCIRCA is not recommended in patients with severe renal impairment (see sections Warnings and Precautions and Pharmacokinetic Properties ).
Use in patients with hepatic insufficiency:
Since clinical experience is limited to single doses of 10 mg, in patients with mild to moderate hepatic cirrhosis (Child-Pugh Class A and B), an initial dose of 20 mg once daily may be considered. An individual careful assessment of the benefit / risk ratio is recommended if tadalafil is prescribed. Patients with severe hepatic cirrhosis (Child-Pugh, class C) have not been studied and therefore tadalafil is not recommended in these cases (see sections Warnings and Precautions and Properties). pharmacokinetics ).
Use in children and adolescents
ADCIRCA is not indicated for patients under 18 years of age.
Hypersensitivity to the active substance or to any of the excipients.
Recent myocardial infarction, during the 90 days following the acute episode.
Severe hypotension (<90/50 mmHg).
In clinical trials, tadalafil has been shown to potentiate the hypotensive effect of nitrates. This effect would result from the combined action of nitrates and tadalafil on cGMP and the formation of nitric oxide. ADCIRCA is therefore contraindicated in patients who receive nitrates in any form of administration (see section Interactions with other medicinal products and other forms of interaction ).
ADCIRCA is contraindicated in patients with loss of vision of an eye related to non-arteritic anterior ischemic optic neuropathy (NAION), whether or not this event has been associated with previous exposure to a PDE5 inhibitor ( see section Warnings and precautions for use ).
Adcirca Adverse Effects
In the placebo-controlled pivotal study of ADCIRCA in the treatment of PAH, a total of 323 patients were treated with ADCIRCA at doses ranging from 2.5 mg to 40 mg once daily and 82 patients were treated. by placebo. The duration of treatment was 16 weeks. The total frequency of discontinuation due to adverse effects was low (ADCIRCA 11%, placebo 16%). Three hundred and fifty seven (357) subjects completing the pivotal study were included in a long-term follow-up study. The doses studied were 20 mg and 40 mg once a day.
The table below presents the adverse effects observed in the placebo-controlled clinical trial in patients with PAH and treated with ADCIRCA. Adverse reactions reported were transient and generally mild or moderate. Headaches may appear at the beginning of treatment and decrease over time even if treatment is continued. There are few data on adverse reactions in patients over 75 years of age. Certain events / adverse reactions reported during clinical trials and / or post-marketing use of tadalafil in the treatment of erectile dysfunction in humans have also been included in the table. Since the frequency in patients with PAH can not be estimated from the available data, these events were classified as "unknown frequency".
Frequency estimate: Very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1/100), rare (≥ 1/10 000, <1 / 1000), very rare (<1 / 10, 000) and indeterminate frequency.
(≥ 1/100, <1/10)
(≥ 1/1000, <1/100)
(≥ 1/10 000,
Immune system disorders
Nervous system disorders
cerebral 2 (including
Anomaly of the field
Affections of the ear and labyrinth
Sudden loss of hearing
Respiratory, thoracic and
sinus congestion and rhinitis)
pain / discomfort
abdominal 3 )
Skin and subcutaneous tissue disorders
Musculoskeletal and systemic disorders
Myalgia, Back Pain, Member Pain
Reproductive system disorders
Increased uterine bleeding 4
General disorders and administration site conditions
Facial edema, Chest pain 2
(1) Events not reported during registration tests and can not be estimated from the available data.
(2) Most of the patients in whom these events were reported had pre-existing cardiovascular risk factors.
(3) The terms MedDRA (current version) included are abdominal discomfort, abdominal pain, low abdominal pain (hypogastralgia), upper abdominal pain (epigastralgia) and gastric discomfort.
(4) The non-MedDRA clinical terms to include abnormal / excessive menstrual bleeding are menorrhagia, metrorrhagia, meningorrhagia or vaginal bleeding.