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Tolerance of sildenafil has not been studied in the following subgroups of patients: severe hepatic insufficiency, hypotension (blood pressure <90/50 mmHg), recent history of stroke or myocardial infarction, and Of known degenerative hereditary disorders of the retina such as retinitis pigmentosa (a minority of these patients present genetic disorders of retinal phosphodiesterases).
Clinical examination and examination, including cardiovascular function, should be performed prior to any initiation of therapy.
Its use in these patients is therefore contraindicated.
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The number of patients treated is estimated at 250 000 for the first year of marketing, 225 500 for the second year.
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The number of serious adverse reactions notified to the French Agency for the Safety of Health Products (Afssaps) during the 2nd year of marketing (51 of which 17 deaths) is lower than that of the first year (139 of which 35 deaths ).
In 88% of the cases of death, cardiovascular risk factors are present and in 15% of the cases the conditions of use of the product were not respected. However, in 44% of cases, the causal link can not be established (cause of unidentified death, unknown delay between taking Cenforce® and death), and in a few cases, taking Cenforce® did not Not confirmed. We wish you good health and joy!
Pharmacovigilance data have revealed cardiovascular events that are sometimes severe, such as myocardial infarction, sudden cardiac death, ventricular arrhythmia, stroke that may occur when using Cenforce® in patients who have Most cardiovascular risk factors.
These events usually occur during or shortly after sexual intercourse in patients with cardiac risk factors and / or in poor conditions of use of the product.
Cenforce® is contraindicated in combination with nitrates, in combination with nitric oxide-donor drugs such as linsidomine and molsidomine, or when there are severe cardiovascular disorders for which sexual activity is discouraged
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The safety profile of Cenforce is based on 8691 patients who received the recommended doses in 67 placebo-controlled clinical trials. The most commonly reported adverse reactions in clinical trials among patients treated with sildenafil were headache, redness, dyspepsia, impaired vision, nasal congestion, dizziness and impaired vision.
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The Afssaps recalls that any use of Cenforce® must have been the subject of a medical prescription in strict respect of the contraindications and precautions of use mentioned in the Marketing authorization:
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Since its commercialization in October 1998, Cenforce® has been monitored with an analysis of all the safety data available at national and international level.
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Cenforce is contraindicated in patients with visual eye loss due to non-arteritic anterior ischemic optic neuropathy (NOIAN), regardless of whether or not this event was associated with prior exposure to PDE5 inhibitor ( See Warnings and Precautions for Use).
Given the knowledge of its mode of action at the level of cyclic nitrogen monoxide / guanosine monophosphate (cGMP) (see section 5.1 Pharmacodynamic properties), a potentiation of the hypotensive effects of nitrates by the Sildenafil; Its concomitant administration with nitric oxide donors (such as amyl nitrite) or with nitrates in any form is therefore contraindicated.
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Adverse reactions reported during post-marketing surveillance involve an estimated period of more than 9 years.
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As a result, in 2000, medical information for healthcare professionals and patients was modified and reinforced, in particular on cardiovascular risk.
Drugs used in the treatment of erectile dysfunction, including sildenafil, should not be used in men for whom sexual activity is inadvisable (eg patients with severe cardiovascular disorders such as unstable angina or Severe heart failure).
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The frequencies of these effects can not be reliably determined since not all adverse reactions are reported to the Marketing Authorization Holder and included in the Tolerance Database.
Brand Name: Cenforce®
Manufacturer: Centurion Laboratories
Brand Name: Cenforce Soft / Cenforce Super Active / Cenforce Professional