Cialis - NPS MedicineWise

4.4 Special Warnings and Precautions for Use

Before treatment with Cialis.

A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered. The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following an appropriate medical assessment. Prior to initiating treatment with tadalafil for lower urinary tract symptoms associated with benign prostatic hyperplasia, a medical history and physical examination should be undertaken to rule out the presence of carcinoma of the prostate as well as other potential underlying causes of urinary symptoms and the patient should be carefully assessed for cardiovascular conditions. (See Section 4.3 Contraindications; Section 5.1 Pharmacodynamic Properties, Clinical trials.)

Cardiovascular.

Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease. Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and should report the episode to their physician. As with other PDE5 inhibitors, tadalafil has systemic vasodilatory properties that may result in mild and transient decreases in blood pressure. Prior to prescribing Cialis, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by vasodilatory effects. Tadalafil potentiates the hypotensive effect of nitrates. Therefore, coadministration of Cialis and nitrates is contraindicated (see Section 4.3 Contraindications). Tadalafil also potentiates the effect of some classes of antihypertensive medications, and this may be clinically important in some individuals. When initiating daily treatment with tadalafil, appropriate clinical considerations should be given to a possible dose adjustment of the antihypertensive therapy (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions, Potential for Cialis to affect other medicines). Caution should be exercised when prescribing Cialis to patients who are taking alpha1 blockers, such as doxazosin, as simultaneous administration may lead to symptomatic hypotension in some patients. The efficacy of the coadministration of an alpha-blocker and Cialis for the treatment of BPH has not been adequately studied and therefore not recommended for use. (See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions, Potential for Cialis to affect other medicines.) Specific studies examining potential withdrawal effects from daily use have not been conducted. Rebound effects on blood pressure have not been observed after follow-up assessments at 2 weeks and 4 weeks following cessation of up to 1 year of chronic daily treatment of Cialis. Blood pressure was not specifically monitored leading up to or between the 2 and 4 weeks post-treatment assessments. Based upon the limited clinical data examining withdrawal effects, it is recommended that physicians continue monitoring the cardiovascular status, including blood pressure changes, of their patients after discontinuation of Cialis.

Hearing.

Physicians should advise patients to stop taking PDE5 inhibitors, including Cialis, and seek prompt medical attention in the event of sudden decrease or loss of hearing. This may be accompanied by tinnitus, which has been reported in association with the use of PDE5 inhibitors, including Cialis. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors (see Section 4.8 Adverse Effects (Undesirable Effects)).

Vision.

Visual defects including central serous chorioretinopathy (CSCR) have been reported in connection with the intake of tadalafil and other PDE5 inhibitors. Most cases of CSCR resolved spontaneously after stopping tadalafil. Physicians should advise patients to stop use of all PDE5 inhibitors, including Cialis, and seek medical attention in the event of sudden visual defect, visual acuity impairment, visual distortion and/or loss of vision in one or both eyes (see Section 4.3 Contraindications). Such an event may be a sign of nonarteritic anterior ischaemic optic neuropathy (NAION), a cause of decreased vision, including permanent loss of vision that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. An increased risk of acute NAION has been suggested from analyses of observation data in men with erectile dysfunction within 1 to 4 days of episodic PDE5 inhibitor use (see Section 4.8 Adverse Effects (Undesirable Effects), Post-marketing experience).

Cialis and other treatments of erectile dysfunction.

The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.

Priapism and anatomical deformation of the penis.

Priapism has been reported with PDE5 inhibitors, including tadalafil. 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 who have conditions that might predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease).

Use with CYP3A4 inhibitors.

Caution should be exercised when prescribing Cialis 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.

Lactose.

Cialis tablets contain lactose.

Use in hepatic impairment.

Caution should be exercised when prescribing Cialis to patients with severe hepatic insufficiency (Child-Pugh class C) or to those taking CYP3A4 inhibitors or HIV protease inhibitors. Once a day administration either for the treatment of erectile dysfunction or lower urinary tract symptoms associated with benign prostatic hyperplasia has not been evaluated extensively in patients with hepatic insufficiency. If tadalafil is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. Once a day dosing is not recommended for patients with severe hepatic impairment.

Use in renal impairment.

In a clinical pharmacology study, administration of tadalafil 10 mg to patients with moderate renal failure (creatinine clearance = 31 to 50 mL/min) was determined to be safe but appeared to be less well tolerated in terms of back pain than in patients with mild renal failure (creatinine clearance = 51 to 80 mL/min) and in healthy subjects. In a single dose, pharmacodynamic study of 8 patients with endstage renal disease who were stable on haemodialysis, the reported adverse effects included headache, dizziness and somnolence. Tadalafil should be prescribed with caution for patients with creatinine clearance ≤ 50 mL/min. 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.

Use in the elderly.

The number of patients aged 75 years and older who received tadalafil 5 mg for more than 12 weeks is small and therefore the safety and efficacy of long-term use of tadalafil for the treatment of LUTS/BPH for this age group is limited. 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. In the clinical pharmacology study LVHN, the mean maximum decrease in standing and supine systolic and diastolic BP at both day 1 (following a single dose of tadalafil 20 mg) and day 10, (following once daily dosing with tadalafil 20 mg) was higher in the elderly subjects (70-85 years) compared with younger subjects aged ≤ 60 years. In addition, a higher number of elderly subjects (70-85 years) experienced clinically significant decreases in blood pressure compared with younger subjects. In study LVHS of men with BPH-LUTS on concomitant alpha-blockers, a higher proportion of patients aged ≥ 75 years in the tadalafil group had at least one treatment emergent positive orthostatic test compared with patients aged < 75 years. Based on these data, hypotensive events are a potential risk in patients aged ≥ 75 years treated with tadalafil 5 mg. If tadalafil is prescribed in this patient group, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician, including an evaluation of concomitant illnesses, any renal impairment and other medications, at treatment initiation and during treatment. (See Section 5.1 Pharmacodynamic Properties, Clinical trials; Section 4.8 Adverse Effects (Undesirable Effects).)

Paediatric use.

Tadalafil has not been studied in subjects under 18 years of age.

Effects on laboratory tests.

There are no data available that shows that tadalafil has an effect on laboratory tests.