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Tadalafil Mylan is a brand name for Tadalafil. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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.
Verbatim from this product's EMA label. Tap a section to expand.
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. , 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. 5 mg once a day based on individual tolerability. The appropriateness of continued use of the daily regimen should be reassessed periodically.
3 Special populations Elderly men Dose adjustments are not required in elderly patients. Men with renal impairment Dose adjustments are not required in patients with mild to moderate renal impairment. For patients with severe renal impairment 10 mg is the maximum recommended dose.
2). Men with hepatic impairment The recommended dose of tadalafil is 10 mg taken prior to anticipated sexual activity and with or without food. There is limited clinical data on the safety of tadalafil in patients with severe hepatic impairment (Child-Pugh Class C); if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
There are no available data about the administration of doses higher than 10 mg of tadalafil to patients with hepatic impairment. 2). Men with diabetes Dose adjustments are not required in diabetic patients. Paediatric population There is no relevant use of tadalafil in the paediatric population with regard to the treatment of erectile dysfunction.
5, 5, 10, and 20 mg film-coated tablets for oral use.
Summary of the safety profile The most commonly reported adverse reactions in patients taking tadalafil for the treatment of erectile dysfunction or benign prostatic hyperplasia were headache, dyspepsia, back pain and myalgia, in which the incidences increase with increasing dose of tadalafil.
The adverse reactions reported were transient, and generally mild or moderate. The majority of headaches reported with tadalafil once-a-day dosing are experienced within the first 10 to 30 days of starting treatment. Tabulated summary of adverse reactions The table below lists the adverse reactions observed from spontaneous reporting and in placebo controlled clinical trials (comprising a total of 8022 patients on tadalafil and 4422 patients on placebo) for on-demand and once-a-day treatment of erectile dysfunction and the once-a-day treatment of benign prostatic hyperplasia.
Frequency convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data). 4). (2) Postmarketing surveillance reported adverse reactions not observed in placebo-controlled clinical trials.
(3) More commonly reported when tadalafil is given to patients who are already taking antihypertensive medicinal products. Description of selected adverse reactions A slightly higher incidence of ECG abnormalities, primarily sinus bradycardia, has been reported in patients treated with tadalafil once a day as compared with placebo.
Most of these ECG abnormalities were not associated with adverse reactions. Other special populations Data in patients over 65 years of age receiving tadalafil in clinical trials, either for the treatment of erectile dysfunction or the treatment of benign prostatic hyperplasia, are limited.
In clinical trials with tadalafil taken on demand for the treatment of erectile dysfunction, diarrhoea was reported more frequently in patients over 65 years of age. In clinical trials with tadalafil 5 mg taken once a day for the treatment of benign prostatic hyperplasia, dizziness and diarrhoea were reported more frequently in patients over 75 years of age.
Before treatment with Tadalafil Mylan A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered. Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity.
3). The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following an appropriate medical assessment. It is not known if tadalafil is effective in patients who have undergone pelvic surgery or radical non-nerve sparing prostatectomy.
Cardiovascular Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations and tachycardia, have been reported either post marketing and/or in clinical trials.
Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors. However, it is not possible to definitively determine whether these events are related directly to these risk factors, to tadalafil, to sexual activity, or to a combination of these or other factors.
In patients receiving concomitant antihypertensive medicinal products, tadalafil may induce a blood pressure decrease. When initiating daily treatment with tadalafil, appropriate clinical considerations should be given to a possible dose adjustment of the antihypertensive therapy.
5). The combination of tadalafil and doxazosin is not recommended. Vision Visual defects, including Central Serous Chorioretinopathy (CSCR), and cases of NAION have been reported in connection with the intake of tadalafil and other PDE5 inhibitors.
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. 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.
4). 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Most cases of CSCR resolved spontaneously after stopping tadalafil. Regarding NAION, analyses of observational data suggest an increased risk of acute NAION in men with erectile dysfunction following exposure to tadalafil or other PDE5 inhibitors.
3). Decreased or sudden hearing loss Cases of sudden hearing loss have been reported after the use of tadalafil. Although other risk factors were present in some cases (such as age, diabetes, hypertension and previous hearing loss history) patients should be advised to stop taking tadalafil and seek prompt medical attention in the event of sudden decrease or loss of hearing.
Renal and hepatic impairment 5 Due to increased tadalafil exposure (AUC), limited clinical experience and the lack of ability to influence clearance by dialysis, once-a-day dosing of tadalafil is not recommended in patients with severe renal impairment.
There is limited clinical data on the safety of single-dose administration of tadalafil in patients with severe hepatic insufficiency (Child-Pugh Class C). Once-a-day administration has not been evaluated in patients with hepatic insufficiency.
If Tadalafil Mylan is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. Priapism and anatomical deformation of the penis Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance.
If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result. Tadalafil should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
5). Tadalafil and other treatments for erectile dysfunction The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied. The patients should be informed not to take Tadalafil Mylan in such combinations.
Lactose content Tadalafil Mylan contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. Sodium content Tadalafil Mylan contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.