Ciavor 20 20 mg FC tablets.

CIAVOR 20 is indicated for the treatment of erectile dysfunction. In order for CIAVOR 20 to be effective, sexual stimulation is required.

For oral use. Use in adult men: The recommended maximum dose of CIAVOR 20 is 20 mg taken prior to anticipated sexual activity and without regard to food. It can be taken up to 36 hours and as early as 16 minutes prior to sexual activity. Patients may initiate sexual activity at varying time points relative to dosing in order to determine their own optimal window of responsiveness. The maximum recommended dosing frequency is once per day.

A known hypersensitivity to tadalafil or to any of the components of the tablet. Administration of CIAVOR 20 to patients who are using any form of organic nitrate. Patients with severe hepatic insufficiency (Child-Pugh Class C). CIAVOR 20 is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION) regardless whether this episode was in connection or not with previous PDE5 inhibitor exposure (See u2018Special Precautionsu2019).

Sexual activity carries a potential cardiac risk for patients with pre-existing cardiovascular disease. CIAVOR 20 should not be used in men with cardiac disease for whom sexual activity is inadvisable. Priapism has been reported with CIAVOR 20. 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. The following groups of patients with cardiovascular disease 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 dysrhythmias, hypotension (< 90/50 mm Hg), or uncontrolled hypertension.
• Patients with a stroke within the last 6 months.

When tadalafil, as contained in CIAVOR 20 was co-administered to healthy subjects taking doxazosin (4-8 mg daily), an alpha[1]-adrenergic blocker, there was an augmentation of the blood-pressure-lowering effect of doxazosin.

CIAVOR 20 does not inhibit or induce CYP450 isoforms, including CYP1A2, CYP3A4, CYP2C9, CYP2C19, CYP2D6 and CYP2E1. CIAVOR 20 is principally metabolised by CYP3A4. A selective inhibitor of CYP3A4, ketoconazole (400 mg daily), increased CIAVOR 20 20 mg single-dose exposure (AUC) by 312 % and C max by 22 % and ketoconazole (200 mg daily) increased CIAVOR 20 10 mg single-dose exposure (AUC) by 107 % and C max by 15 % relative to the AUC and C max values for CIAVOR 20 alone. Ritonavir (200 mg twice daily) an inhibitor of CYP3A4, 2C9, 2C19 and 2D6, increased CIAVOR 20 single-dose exposure (AUC) by 124 % with no change in C max. Although specific interactions have not been studied, other HIV protease inhibitors, such as saquinavir, and other CYP3A4 inhibitors such as erythromycin and itraconazole, would likely increase CIAVOR 20 exposure. A selective CYP3A4 inducer, rifampicin (rifampicin, 600 mg daily), reduced CIAVOR 20 single-dose exposure (AUC) by 88 % and C max by 46 %, relative to the AUC and C max values for CIAVOR 20 alone. It can be expected that concomitant administration of other CYP3A4 inducers will also decrease plasma concentrations of CIAVOR 20. CIAVOR 20 has systemic vasodilatory properties and may augment the blood pressure lowering effects of antihypertensive agents. Additionally, in patients taking multiple antihypertensive agents whose hypertension was not well controlled, greater reductions in blood pressure were observed. These reductions were not associated with hypotensive symptoms in the vast majority of patients. Appropriate clinical advice should be given to patients when they are treated with antihypertensive medications and CIAVOR 20. When tadalafil, as contained in CIAVOR 20 was co-administered to healthy subjects taking doxazosin (4-8 mg daily), an alpha[1]-adrenergic blocker, there was an augmentation of the blood-pressure-lowering effect of doxazosin.

The safety and efficacy of CIAVOR 20 in pregnancy and lactation have not been established.

Patients should be aware of how they react to CIAVOR 20, before driving or operating machinery.

The following adverse events were reported in clinical trials: Frequency of occurrence System organ class Very common Common Uncommon Vascular Disorders Flushing Gastrointestinal Disorders Dyspesia Musculoskeletal, Connetive Tissue and Bone Disorders Back pain Myalgia Nervous System Disorders Headache Dizziness Respiratory, Thoracic and Mediastinal Disorders Nasal congestion Eye Disorders Conjunctival hyperaemia Sensations described as eye pain Swelling of eyelids

Single doses of up to 500 mg have been given to healthy subjects and multiple daily doses up to 100 mg have been given to patients. Adverse events were similar to those seen at lower doses. In cases of overdose, standard supportive measures should be adopted as required. Haemodialysis contributes negligibly to CIAVOR 20 elimination.