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A medical history and clinical examination should be performed to diagnose erectile dysfunction and determine potential underlying causes before considering pharmacological treatment.

Before initiating any treatment for erectile dysfunction, physicians must take into account the cardiovascular status of their patients, and sexual activity is accompanied by a certain cardiac risk. Tadalafil has vasodilating properties, causing mild and transient drops in blood pressure (see section 5.1) and, as such, it potentiates the hypotensive effect of nitrates (see section Contraindications).

The evaluation of erectile dysfunction should include the search for possible underlying causes and the identification of an adequate treatment after an appropriate medical examination. The effectiveness of 시알리스 in patients who have undergone pelvic surgery or radical prostatectomy without nerve strip preservation is not known.

Cardiovascular damage

Serious cardiovascular events, such as myocardial infarction, sudden cardiac death, unstable angina, ventricular arrhythmia, ischemic strokes, transient ischemic attacks, chest pain, palpitations, and tachycardia have been reported post-marketing and/or in clinical tests. Most patients in whom these events were observed had pre-existing cardiovascular risk factors. However, it is not possible to determine with certainty whether these events are directly related to these risk factors, to CIALIS, to sexual activity, to a combination of these factors, or to other factors.

In some patients receiving alpha1 blockers such as doxazosin, concomitant administration of 시알리스 may lead to symptomatic hypotension (see section Interactions with other medicinal products and other forms of interaction). Simultaneous administration of tadalafil and doxazosin is therefore not recommended.

Ophthalmic disorders

Visual abnormalities and cases of NAION (non-arteritic anterior ischemic optic neuropathy) have been reported following the use of CIALIS and other PDE5 inhibitors. Analyzes of observational data suggest an increased risk of acute NAION after administration of tadalafil or other PDE5 inhibitors in men with erectile dysfunction. This risk may affect all patients exposed to tadalafil. Therefore, patients should be advised that, in the event of a sudden visual abnormality, they should stop taking 시알리스 and seek immediate medical attention (see section Contraindications).

Sudden decrease or loss of hearing

Cases of sudden hearing loss have been reported following the use of tadalafil. Although associated risk factors were present in some cases (such as age, diabetes, hypertension, or history of hearing loss), patients should be advised to discontinue tadalafil and consult a doctor promptly in the event of a sudden decrease or loss of hearing.

Hepatic insufficiency

Clinical data on the safety of single-dose CIALIS in patients with severe hepatic impairment (Child-Pugh Class C) are limited. If CIALIS is prescribed, the prescribing physician should carry out an individual risk/benefit assessment.

Priapism and anatomical malformation of the penis

Patients with erections lasting 4 hours or more should be advised to seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent impotence can result.