What is Tadalafil Lilly - Cialis used for and what is it used for?
Tadalafil Lilly is a medicine used to treat men with erectile dysfunction (sometimes called impotence).
It can also be used in men to treat the signs and symptoms of benign prostatic hyperplasia (enlarged, non-carcinogenic prostate gland, which causes urine leakage problems).
Tadalafil Lilly contains the active ingredient tadalafil and is equivalent to Cialis, which is already authorized in the European Union (EU). The company that makes Cialis has agreed that its scientific data can be used for Tadalafil Lilly ("informed consent").
How is Tadalafil Lilly - Cialis used?
Tadalafil Lilly is available as tablets (2.5; 5; 10 and 20 mg) to be taken orally (by mouth). To treat erectile dysfunction, the usual dose is 10 mg taken at least 30 minutes before sexual activity. The dose can be increased up to 20 mg if the 10 mg dose is not effective. Men who intend to use Tadalafil Lilly frequently (twice a week or more) may take a lower dose (5 or 2.5 mg) once a day, in the opinion of the doctor. The medicine should be taken at about the same time each day and it is necessary to regularly re-evaluate the dose in the case of a single daily intake.
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.
The medicine can only be obtained with a prescription. For more information, see the package leaflet.
How does Tadalafil Lilly - Cialis work?
The active substance in Tadalafil Lilly, tadalafil, belongs to a group of medicines called "phosphodiesterase type 5 inhibitors (PDE5)". The substance works by blocking the enzyme phosphodiesterase, which normally breaks down a substance called cyclic guanosine monophosphate (cGMP).
During normal sexual stimulation cGMP occurs in the penis. This causes relaxation of the spongy tissue of the penis (cavernous bodies), allowing the flow of blood into this region, which produces an erection. By blocking the degradation of cGMP, Tadalafil Lilly restores erectile function during sexual stimulation and also improves the blood supply to the prostate and bladder, relaxing the muscles. This can reduce the problems of urine leakage which are symptoms of benign prostatic hyperplasia.
What benefit has Tadalafil Lilly - Cialis shown during the studies?
Tadalafil Lilly has been shown to improve the ability to have and maintain an erection in nine main studies involving over 2, 000 men with erectile dysfunction. All studies compared Tadalafil Lilly with a placebo (a dummy treatment) and measured improvements using questionnaires filled out before and after treatment.
Six of the studies involved 1 328 patients who took the medicine before sexual activity. The results of a questionnaire, in which men evaluated their condition on a scale from 0 (indicating severe erectile dysfunction) to 30 (no erectile dysfunction), showed that patients improved from about 15 before treatment to 23 and 25 after treatment with Tadalafil Lilly of 10 and 20 mg, respectively. The other three studies involved 853 patients, who took Tadalafil Lilly once a day in 2.5 or 5 mg doses. The results also reported an improvement in erections with Tadalafil Lilly compared with patients who took the placebo.
Tadalafil Lilly has also been shown to improve the symptoms of benign prostatic hyperplasia measured using the international prostate symptom test (IPSS), which ranges from 0 (no symptoms) to 35 (severe symptoms). In four main studies involving 1 500 patients, some with erectile dysfunction, patients taking Tadalafil Lilly 5 mg experienced greater reductions in IPSS (4.8 to 6.3 points) after 12 weeks compared to those taking placebo (2.2 to 4.4 points).
What are the risks associated with Tadalafil Lilly - Cialis?
The most common side effects of Tadalafil Lilly are headache, indigestion, back pain and myalgia (muscle pain), which are more common at higher dosages. For the full list of all side effects reported with Tadalafil Lilly, see the package leaflet.
Tadalafil Lilly should not be used in men with certain cardiovascular conditions (of the heart and blood vessels) or when sexual activity is not advisable. The medicine should not be taken by patients who have suffered loss of vision in the past due to a deficiency of blood supply to the optic nerve (non-arteritic anterior ischemic optic neuropathy, NAION). Tadalafil Lilly should not be taken with nitrates (a type of medicine used for angina) or medicines of the class "guanilate cyclase stimulators" such as riociguat (a medicine for high blood pressure in the vessels that supply the lungs, known as pulmonary hypertension) . For the full list of limitations, see the package leaflet.
Why has Tadalafil Lilly - Cialis been approved?
As the studies show, Tadalafil Lilly is effective in improving the ability to have and maintain erections and in alleviating the symptoms of benign prostatic hyperplasia. The side effects associated with the use of the medicine are considered manageable. As a result, the Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Tadalafil Lilly's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Tadalafil Lilly - Cialis?
Recommendations and precautions to be followed by healthcare professionals and patients for Tadalafil Lilly to be used safely and effectively have been included in the summary of product characteristics and the package leaflet.
More information on Tadalafil Lilly - Cialis
The full EPAR for Tadalafil Lilly can be found on the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Tadalafil Lilly, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
