Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 23 August 2018

Indication(s)

- Tadalafil Mylan 2.5 mg film-coated tablets
- Tadalafil Mylan 10 mg film-coated tablets
- Tadalafil Mylan 20 mg film-coated tablets:


Treatment of erectile dysfunction in adult males.

In order for tadalafil to be effective, sexual stimulation is required.

Tadalafil Mylan is not indicated for use by women.



- Tadalafil Mylan 5 mg film-coated tablets:

Treatment of erectile dysfunction in adult males.

In order for tadalafil to be effective for the treatment of erectile dysfunction, sexual stimulation is required.

Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males.

Tadalafil Mylan is not indicated for use by women.

Full Prescribing information

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Advisory information

contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway.
Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated (see section 4.5).

Tadalafil must not be used in men with cardiac disease for whom sexual activity is inadvisable.
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 the use of tadalafil is therefore 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 Class 2 or greater heart failure in the last 6 months,
- patients with uncontrolled arrhythmias, hypotension (< 90/50 mm Hg), or uncontrolled hypertension,
- patients with a stroke within the last 6 months.

Tadalafil is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).

The co-administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5).

Usage information

Dosing and administration

Posology
Adult men
In general, the recommended dose is 10 mg taken prior to anticipated sexual activity and with or without food.
In those patients in whom tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried.
It may be taken at least 30 minutes prior to sexual activity.

The maximum dose frequency is once per day.

Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use.

In patients who anticipate a frequent use of tadalafil (i.e., at least twice weekly) a once daily regimen with the lowest doses of tadalafil might be considered suitable, based on patient choice and the physician’s judgement.

In these patients the recommended dose is 5 mg taken once a day at approximately the same time of day. The dose may be decreased to 2.5 mg once a day based on individual tolerability.

The appropriateness of continued use of the daily regimen should be reassessed periodically.

Benign prostatic hyperplasia in adult men
The recommended dose is 5 mg, taken at approximately the same time every day with or without food. For adult men being treated for both benign prostatic hyperplasia and erectile dysfunction the recommended dose is also 5 mg taken at approximately the same time every day. Patients who are unable to tolerate tadalafil 5 mg for the treatment of benign prostatic hyperplasia should consider an alternative therapy as the efficacy of tadalafil 2.5 mg for the treatment of benign prostatic hyperplasia has not been demonstrated.

Pregnancy and lactation
Tadalafil Mylan is not indicated for use by women.

Pregnancy
There are limited data from the use of tadalafil in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). As a precautionary measure, it is preferable to avoid the use of Tadalafil
Mylan during pregnancy.

Breastfeeding
Available pharmacodynamic/toxicological data in animals have shown excretion of tadalafil in milk.
A risk to the suckling child cannot be excluded. Tadalafil Mylan should not be used during breast feeding.

Fertility
Effects were seen in dogs that might indicate impairment of fertility. Two subsequent clinical studies suggest that this effect is unlikely in humans, although a decrease in sperm concentration was seen in some men (see sections 5.1 and 5.3).

More information

Category Value
Agency product number EMEA/H/C/003787
Orphan designation No
Date First Approved 21-11-2014
Type Medicinal product subject to medical prescription
Marketing authorisation holder Mylan S.A.S.