Esculap (Tadalafil)

Tadalafilum

Esculap 5 mg film-coated tablets: each tablet contains tadalafil 5 mg. Esculap 20 mg film-coated tablets: each tablet contains tadalafil 20 mg. Excipients with known effect: lactose monohydrate and the azo dye Sunset Yellow (E110).

Indication: Treatment of erectile dysfunction in adult men; sexual stimulation is required for Esculap to be effective.

Contraindications (SmPC sec. 4.3): 4.3 Contraindications
− Hypersensitivity to tadalafil or to any of the excipients listed in section 6.1.
− In clinical studies, tadalafil has been shown to increase the hypotensive effect of nitrates. This is considered to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway. Therefore, administration of Esculap is contraindicated in patients using any form of organic nitrate (see section 4.5).
− Esculap is contraindicated in patients who have lost vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was or was not related to previous exposure to a PDE5 inhibitor (see section 4.4).
− Concomitant administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated because it may cause symptomatic hypotension (see section 4.5).
− Esculap must not be used in men for whom sexual activity is not advisable because of cardiac disease. Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease. The following groups of patients with cardiovascular disease were not included in clinical trials and, therefore, use of tadalafil is contraindicated:
− patients with myocardial infarction within the last 90 days,
− patients with unstable angina or angina occurring during sexual intercourse,
− patients with New York Heart Association (NYHA) Class 2 or greater heart failure occurring within the last 6 months,
− patients with uncontrolled arrhythmias, hypotension (< 90/50 mmHg) or uncontrolled hypertension,
− patients who have had a stroke within the last 6 months.

Special warnings and precautions (SmPC sec. 4.4, excerpt): 4.4 Special warnings and precautions for use
Before starting treatment with Esculap
To diagnose erectile dysfunction and identify potential underlying causes, a medical history should be taken and a physical examination performed before deciding on pharmacological treatment. Before initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of patients, since sexual activity is associated with a certain degree of cardiac risk. Tadalafil has vasodilatory properties, causing mild and transient decreases in blood pressure (see section 5.1) and thereby potentiating the hypotensive effects of nitrates (see section 4.3). The diagnosis of erectile dysfunction should also include identification of potential underlying causes, as well as identification of the appropriate treatment, following clinical examination […]