TADALAFIL SANDOZ

Posology Use in adult men. The recommended dose is one 10 mg tablet taken at least 30 minutes prior to anticipated sexual activity. Tadalafil is not recommended for continuous daily use. at least twice weekly) should consult their physician to discuss whether a once daily regimen with the lowest doses of tadalafil would be more suitable.

Tadalafil may be taken with or without food. The maximum dosing frequency is once per day. Most men will achieve an erection the first or second time they use tadalafil. However, patients should be advised that they may need to take tadalafil a number of times on different occasions (a maximum of one 10 mg tablet per day), before they can achieve a penile erection satisfactory for sexual activity.

If after several attempts on different dosing occasions patients are still not able to achieve a penile erection sufficient for satisfactory sexual activity, they should be advised to consult a physician. 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 or moderate renal impairment. 4). Men with hepatic impairment Dose adjustments are not required in patients with mild or moderate hepatic impairment. 4).

Men with diabetes Dose adjustments are not required in people with diabetes. Paediatric population Tadalafil is not indicated for individuals below 18 years of age. Use in patients taking other medicinal products Tadalafil is predominantly metabolised by the cytochrome P450 (CYP) 3A4 isoform.

Tadalafil exposure is increased with CYP3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, erythromycin, clarithromycin, cimetidine and grapefruit juice). 5). g. alfuzosin, doxazosin or tamsulosin), patients should be stabilised on alpha blocker therapy prior to initiating tadalafil treatment in the pharmacy setting.

5). Method of administration 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 studies.

(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.

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. uk/yellowcard or search for MHRA Yellow Card in the Google play or Apple App store.

Patients are advised that erection problems can be a sign of another medical condition such as heart disease, hypertension, diabetes or depression. As a result, all men with erectile dysfunction should be advised to consult their physician within 6 months for a clinical review of potential underlying conditions and risk factors associated with erectile dysfunction (ED).

If symptoms of ED have not improved after taking tadalafil on several consecutive occasions, or if their erectile dysfunction worsens, patients should be advised to consult their physician. Patients who have undergone pelvic surgery or radical non nerve sparing prostatectomy should be advised to consult their physician as it is not known if tadalafil is effective in these patients.

Patients with known hereditary degenerative retinal disorders such as retinitis pigmentosa should be advised to consult their physician as it is not known if tadalafil is safe in these sub-groups of patients. Cardiovascular Patients with cardiovascular disease and/or risk factors should be informed that sexual activity could carry a cardiac risk.

Patients who experience chest pain during sexual activity should be advised to refrain from further sexual activity and seek medical attention immediately. Agents for the treatment of erectile dysfunction, including tadalafil, are not recommended to be used by those men who with light or moderate physical activity, such as walking briskly for 20 minutes or climbing 2 flights of stairs, feel very breathless or experience chest pain.

g. via coronary artery bypass grafting, stenting, or angioplasty), patients with asymptomatic controlled hypertension, and those with mild valvular disease. These patients may be suitable for treatment but should consult a doctor before resuming sexual activity.

Patients previously diagnosed with the following must be advised to consult with their doctor before resuming sexual activity: uncontrolled hypertension, moderate to severe valvular disease, left ventricular dysfunction, hypertrophic obstructive and other cardiomyopathies, or significant arrhythmias.

Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Since there are no clinical data on administration of tadalafil to patients with veno-occlusive disease, administration of tadalafil to such patients is not recommended.

Should signs of pulmonary oedema occur when tadalafil is administered, the possibility of associated PVOD should be considered. 1). , aortic stenosis), or those with the rare syndrome of multiple system atrophy manifesting as severely impaired autonomic control of blood pressure.

Men with these conditions must not use the product without consulting a doctor. 3) 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.

5). The concomitant treatment with tadalafil and doxazosin is not recommended. Patients should not take tadalafil in combination with doxazosin without first having talked to a physician. In addition, it is advisable for the patient to check with the physician before taking tadalafil if they are taking other alpha blockers (used for benign prostatic hypertrophy or hypertension).

Treatment should be stopped if symptoms of postural hypotension occur, and patients should seek advice from their doctor on what to do. Vision Visual defects, including Central Serous Chorioretinopathy (CSCR), and cases of non-arteritic anterior ischaemic optic neuropathy (NAION) have been reported in connection with the intake of tadalafil and other PDE5 inhibitors.

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 inhibitor.

3). Decreased or sudden hearing loss Cases of sudden hearing loss have been reported after the use of tadalafil. 8). 2). There is limited clinical data on the safety of single dose administration of tadalafil in patients with severe hepatic […]

1. 5). 4). Tadalafil is contraindicated in the following groups of patients with cardiovascular disease, who were not included in clinical trials: • 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). Tadalafil should not be used in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease). Tadalafil is not indicated for use by women. Tadalafil is not intended for men without erectile dysfunction.

Tadalafil is not intended for men under 18 years of age