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This is a summary of the European public assessment report (EPAR) for Tadalafil Mylan. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Tadalafil Mylan. For practical information about using Tadalafil Mylan, patients should read the package leaflet or contact their doctor or pharmacist.

How is Tadalafil Mylan used?

 For treating erectile dysfunction, the recommended dose of Tadalafil Mylan is 10 mg taken ‘on demand’ at least 30 minutes before sexual activity. The dose may be increased to 20 mg for men who do not respond to the 10 mg dose. The maximum recommended dosing frequency is once per day, but continuous daily use of 10 or 20 mg Tadalafil Mylan is not recommended. Tadalafil Mylan can be used at a lower dose once a day in men who intend to use it frequently (twice a week or more), based on the doctor’s judgment.

The dose is 5 mg once a day, but can be lowered to 2.5 mg once a day depending on how well it is tolerated. The medicine should be taken around the same time every day and the appropriateness of the once-a-day dosing should be re-assessed regularly. For treating men with benign prostatic hyperplasia, or men with both benign prostatic hyperplasia and erectile dysfunction, the recommended dose is 5 mg once a day.

Patients with severely impaired liver or kidney function should not take more than 10 mg in one dose. Once-a-day dosing is not recommended in patients with severely impaired kidney function, and should only be prescribed to patients with impaired liver function after a careful evaluation of the benefits and risks of taking the medicine. Tadalafil Mylan can only be obtained with a prescription.

How does Tadalafil Mylan work?

 The active substance of Tadalafil Mylan, tadalafil, belongs to a group of medicines called 'phosphodiesterase type 5 (PDE5) inhibitors'. It works by blocking the phosphodiesterase enzyme, which normally breaks down a substance known as cyclic guanosine monophosphate (cGMP). During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax, allowing the flow of blood into the corpora, producing the erection.

Men with erectile dysfunction do not have enough cGMP to produce or maintain an erection. By blocking the breakdown of cGMP, Tadalafil Mylan restores erectile function. However, sexual stimulation is still needed. By blocking the phosphodiesterase enzyme and preventing the breakdown of cGMP, Tadalafil Mylan also improves the blood flow to, and relaxes the muscles of, the prostate and bladder. This may reduce the problems with the flow of urine which are symptoms of benign prostatic hyperplasia.

Warning and precautions of use

Before treatment with Tadalafil Mylan

Medical history and clinical examination should be performed to diagnose erectile dysfunction or benign prostatic hypertrophy and to identify potential underlying causes before considering pharmacologic therapy.

Before initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, with sexual activity associated with some cardiac risk. Tadalafil has vasodilating properties, causing mild and transient decreases in blood pressure (see section 5.1 ), and, as such, potentiates the hypotensive effect of nitrates (see section 4.3 ).

Before initiating any treatment of benign prostatic hypertrophy with tadalafil, patients should be examined to rule out the presence of prostate cancer. An assessment of cardiovascular status should be made carefully (see section 4.3 ).

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