JOVAN T 20 FILM-COATED TABLET 20MG [SIN16564P]

Product Info

JOVAN T 20 FILM-COATED TABLET 20MG

[SIN16564P]

4.1 Therapeutic indications
Treatment of erectile dysfunction in adult males.
In order for tadalafil to be effective, sexual stimulation is required.
Tadalafil is not indicated for use by women.

4.2 Posology and method of administration
Posology
Use in Adult Men
In general, the recommended dose is 10mg taken prior to anticipated sexual activity and with or without food. In those patients in whom tadalafil 10mg does not produce an adequate effect, 20mg might be tried. It may be taken at least 30 minutes prior to sexual activity.
The maximum dose frequency is once per day.
Tadalafil 10mg and 20mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use.
In patients who anticipate a frequent use of tadalafil (i.e., 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 2.5mg taken once a day at approximately the same time of day. The dose may be increased to 5mg once a day based on individual efficacy and tolerability.
The appropriateness of continued use of the daily regimen should be reassessed periodically.

Use in Elderly Men
Dose adjustments are not required in elderly patients.

Use in Men with Impaired Renal Function
Tadalafil for Use as Needed

• Mild (creatinine clearance 51 to 80 ml/min): No dose adjustment is required.

• Moderate (creatinine clearance 31 to 50 ml/min): A starting dose of 5mg not more than once per day is recommended and the maximum dose is 10mg not more than once in every 48 hours.

• Severe (creatinine clearance < 30 ml/min or on hemodialysis): The maximum dose is 5mg not more than once in every 72 hours (see section 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Tadalafil for Once Daily Use

• Mild (creatinine clearance 51 to 80 ml/min): No dose adjustment is required.

• Moderate (creatinine clearance 31 to 50 ml/min): No dose adjustment is required.

• Severe (creatinine clearance < 30 ml/min or on hemodialysis): Cialis for once daily use is not recommended (see section 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in Men with Impaired Hepatic Function
Tadalafil for Use as Needed
The recommended dose is 10mg taken prior to anticipated sexual activity. There is limited clinical data on the safety of Cialis 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 10mg of tadalafil to patients with hepatic impairment.
Tadalafil for Once Daily Use
Once-a-day dosing has not been extensively evaluated in patients with hepatic impairment; therefore, if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician (see section 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in Men with Diabetes
Dose adjustments are not required in diabetic patients.

Paediatric population
Tadalafil should not be used in individuals below 18 years of age.

Patients taking CYP3A4 Inhibitors
Tadalafil for Use as Needed
For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of Tadalafil is 10mg, not to exceed once every 72 hours (see section 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)
Tadalafil for Once Daily Use
For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of Tadalafil is 2.5mg (see section 4.4 and 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information)

4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
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. Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated.
Agents for the treatment of erectile dysfunction, including 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 mmHg) or uncontrolled hypertension,

• patients with a stroke within the last 6 months

Tadalafil is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.
The co-administration of PDE5 inhibitors, including tadalafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).