What is Tadalafil Lilly - Cialis 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 (an enlarged, non-cancerous prostate gland that causes problems with passing urine).
Tadalafil Lilly contains the active substance 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 used - Cialis?
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 with frequency (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 approximately the same time each day and should be re-evaluated regularly the dose in the case of single daily intake.
For the treatment of men with benign prostatic hyperplasia or with both benign prostatic hyperplasia and erectile dysfunction, the recommended dose is 5 mg once daily.
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 (PDE5) inhibitors'. The substance works by blocking the enzyme phosphodiesterase, which normally breaks down a substance called cyclic guanosine monophosphate (cGMP).
During normal sexual stimulation, cGMP is produced in the penis. This causes the muscles of the spongy tissue of the penis (corpora cavernosa) to relax, allowing the flow of blood to this region, which produces an erection. By blocking the breakdown of cGMP, Tadalafil Lilly restores erectile function during sexual stimulation and also improves blood supply to the prostate and bladder by relaxing the muscles. This can reduce urine leakage problems that are symptoms of prostatic hyperplasia. benign.
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 of the studies compared Tadalafil Lilly with placebo (a dummy treatment) and measured the improvements using questionnaires completed before and after treatment.
Six of the studies involved 1,228 patients who took the medicine before sexual activity. The results of a questionnaire, in which men rated their condition on a scale from 0 (indicating severe erectile dysfunction) to 30 (no dysfunction erectile), showed that patients improved from about 15 before treatment to 23 and 25 after treatment with Tadalafil Lilly 10 and 20 mg, respectively. The other three studies involved 853 patients, who took Tadalafil Lilly once daily in doses of 2.5 or 5 mg.The results also reported improved erections with Tadalafil Lilly compared to patients taking placebo.
Tadalafil Lilly has also been shown to improve symptoms of benign prostatic hyperplasia as measured using the international prostate symptom score (IPSS), ranging from 0 (no symptoms) to 35 (severe symptoms). In four studies involving 1,500 patients, some of whom had erectile dysfunction, patients taking Tadalafil Lilly 5 mg experienced greater reductions in IPSS (4.8 to 6.3 points) after 12 weeks compared to to those who took 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 side effects reported with Tadalafil Lilly, see the package leaflet.
Tadalafil Lilly should not be used in men with certain cardiovascular (heart and blood vessel) conditions or when sexual activity is not advisable. The medicine should not be taken by patients who have experienced loss of vision in the past due to a lack 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 "guanylate 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 restrictions, see the package leaflet.
Why has Tadalafil Lilly - Cialis been approved?
As studies show, Tadalafil Lilly is effective in improving the ability to have and maintain erections and in relieving the symptoms of benign prostatic hyperplasia. Side effects associated with the use of the medicine are considered manageable. Consequently, 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?
The recommendations and precautions that healthcare professionals and patients need to observe in order for Tadalafil Lilly to be used safely and effectively have been set out in the Summary of Product Characteristics and Package Leaflet.
More information about Tadalafil Lilly - Cialis
For the complete version of Tadalafil Lilly's EPAR, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Tadalafil Lilly therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
The information on Tadalafil Lilly - Cialis published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
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