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Before treatment with CALIBERI ODF: A medical history and physical examination should be undertaken to diagnose ED or BPH and determine potential underlying causes, before pharmacological treatment is considered.
Prior to initiating any treatment for ED, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Tadalafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see Pharmacology: Pharmacodynamics under Actions) and as such potentiate the hypotensive effect of nitrates (see Contraindications).
The evaluation of ED 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.
Prior to initiating treatment with CALIBERI ODF for BPH, patients should be examined to rule out the presence of carcinoma of the prostate and carefully assessed for cardiovascular conditions.
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 anti‐hypertensive 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 anti‐hypertensive therapy.
In patients who are taking alpha1 blockers, such as doxazosin, concomitant administration of Tadalafil may lead to symptomatic hypotension in some patients (see Interactions). Therefore, the combination of Tadalafil and alpha blockers is not recommended.
Vision: Visual defects and cases of NAION have been reported in connection with the intake of Tadalafil and other PDE5 inhibitors. Analyses of observational data suggest an increased risk of acute NAION in men with erectile dysfunction following exposure to tadalafil or other PDE5 inhibitors. As this may be relevant for all patients exposed to tadalafil, the patient should be advised that in case of sudden visual defect, he should stop taking Tadalafil and consult a physician immediately (see Contraindications).
Renal and hepatic impairment: 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 are limited clinical data on the safety of single‐dose administration of Tadalafil in patients with severe hepatic impairment (Child‐Pugh Class C). Once‐a‐day administration has not been evaluated in patients with hepatic impairment. If Tadalafil 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).
Use with CYP3A4 inhibitors: Caution should be exercised when prescribing Tadalafil to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole and erythromycin) as increased Tadalafil exposure (AUC) has been observed if the medicinal products are combined (see Dosage & Administration and Interactions).
Tadalafil and other treatments for erectile dysfunction: The safety and efficacy of combinations of Tadalafil and other PDE5 inhibitors or other treatments for ED have not been studied. Therefore, the use of such combinations is not recommended.
Hearing: 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.
Effects on ability to drive and use machines: No studies on the effect on the ability to drive or use machines have been performed. Although the frequency of reports of dizziness in placebo and Tadalafil arms in clinical trials was similar, patients should be aware of how they react to Tadalafil, before driving or using machines.
