What is Tadalafil Mylan - tadalafil and what is it used for?
Tadalafil Mylan is used to treat men with erectile dysfunction (also called "impotence"), a condition that is the inability to achieve or maintain an erection sufficient to have satisfactory sexual intercourse. In order for Tadalafil Mylan to be effective in this condition, sexual stimulation is required. Tadalafil Mylan can also be used in male patients to treat the signs and symptoms of benign prostatic hyperplasia (an increase in prostate volume of a non-tumor nature), which causes problems with the leakage of urine. Tadalafil Mylan contains the active substance tadalafil . Tadalafil Mylan is a "generic" medicine. This means that Tadalafil Mylan is similar to a 'reference medicine' already authorized in the European Union (EU) called Cialis. For more information on generic medicines, see the questions and answers by clicking here.
How is Tadalafil Mylan - tadalafil used?
To treat erectile dysfunction, the recommended dose of Tadalafil Mylan is 10 mg taken as needed, at least 30 minutes before sexual activity. The dose can be increased to 20 mg in patients who do not respond to the 10 mg dose. The maximum frequency of administration is once a day. However, continuous daily intake of 10 or 20 mg of Tadalafil Mylan is not recommended. Tadalafil Mylan can be used at lower doses once a day in patients who intend to use it frequently (twice a week or more), depending on the doctor's judgment. In these patients the recommended dose is 5 mg taken once a day, but can be decreased to 2.5 mg once a day based on the degree of tolerability. The medicine should be taken at about the same time each day and, in the case of daily intake, the adequacy of the dose should be regularly re-evaluated. For the treatment of men suffering from benign prostatic hyperplasia, or suffering from both benign prostatic hyperplasia and erectile dysfunction, the recommended dose is 5 mg once a day. Patients with severe liver or kidney disease should not take a dose greater than 10 mg. Taking a daily dose is not recommended in patients with severe renal dysfunction, while in patients with hepatic impairment the medicine should only be prescribed after careful consideration of the risks and therapeutic benefits. Tadalafil Mylan can only be obtained with a prescription.
How does Tadalafil Mylan - tadalafil work?
The active substance in Tadalafil Mylan, tadalafil, belongs to a group of medicines called "phosphodiesterase type 5 inhibitors (PDE5)". It works by blocking the enzyme phosphodiesterase, which normally breaks down a substance called cyclic guanosine monophosphate (cGMP). During normal sexual stimulation, the penis produces cGMP, which causes the relaxation of the musculature of its spongy tissue (cavernous bodies), allowing the inflow of blood into the corpora cavernosa which produces an erection. Men with erectile dysfunction do not have enough cGMP to produce or maintain an erection. By blocking cGMP degradation, Tadalafil Mylan restores erectile function. However, sexual stimulation is always necessary. By blocking the enzyme phosphodiesterase and avoiding the degradation of cGMP, Tadalafil Mylan also improves the blood supply to the prostate and bladder, relaxing the muscles. This can reduce the problems of urine leakage which are the symptoms of benign prostatic hyperplasia.
What studies have been performed on Tadalafil Mylan - tadalafil?
Because Tadalafil Mylan is a generic medicine, studies in patients have been limited to tests to determine its bioequivalence to the reference medicine, Cialis. Two medicines are bioequivalent when they produce the same levels of active ingredient in the body.
What are the benefits and risks of Tadalafil Mylan - tadalafil?
Because Tadalafil Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Tadalafil Mylan - tadalafil been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Tadalafil Mylan has been shown to have comparable quality and to be bioequivalent to Cialis. Therefore, the CHMP considered that, as in the case of Cialis, the benefits outweigh the identified risks and recommended to approve the use of Tadalafil Mylan in the EU.
What measures are being taken to ensure the safe and effective use of Tadalafil Mylan - tadalafil?
A risk management plan has been developed to ensure that Tadalafil Mylan is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Tadalafil Mylan, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information on Tadalafil Mylan - tadalafil
On 21 November 2014, the European Commission issued a marketing authorization for Tadalafil Mylan, valid throughout the European Union. For more information on Tadalafil Mylan therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The full EPAR for the reference medicine can also be found on the Agency's website. Last update of this summary: 11-2014.
