CALIBERI ORODISPERSIBLE FILM 20MG

4.1. Therapeutic indications

Treatment of erectile dysfunction (ED) in adult males. In order for CALIBERI ODF to be effective for the treatment of ED, sexual stimulation is required.

Treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

Treatment of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia (ED/BPH).

CALIBERI ODF is not indicated for use by women.

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 (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Tadalafil should 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 (<90/50mmHg), 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 (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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).

4.2. Posology and method of administration

For oral use. CALIBERI ODF should be taken without food. CALIBERI ODF must be immediately used once taken out of the pouch and it can be dissolved on the tongue, with or without any water.

Erectile Dysfunction in adult men

CALIBERI ODF for Use as Needed

The recommended dose is 10mg (2x 5mg CALIBERI ODF) taken prior to anticipated sexual activity. In those patients in whom CALIBERI ODF 10mg does not produce an adequate effect, the maximum dose is 20mg and the maximum dosing frequency is once per day. It may be taken from 30 minutes to 36 hours prior to sexual activity. CALIBERI ODF 10mg and 20mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use.

CALIBERI ODF for Once Daily Use

In patients who anticipate a frequent use of CALIBERI ODF (i.e. at least twice weekly) a once daily regimen with the lowest doses of CALIBERI ODF might be considered suitable, based on patient choice and the physician’s judgement. The maximum recommended dose is 5mg (one 5mg CALIBERI ODF) once a day, taken at approximately the same time every day, without regard to timing of sexual activity. The appropriateness of continued use of the daily regimen should be reassessed periodically.

Benign Prostatic Hyperplasia

The recommended dose is 5mg, taken at approximately the same time every day.

Erectile Dysfunction and Benign Prostatic Hyperplasia

The recommended dose is 5mg, taken at approximately the same time every day, without regard to timing of sexual activity.

Use in elderly men

Dose adjustments are not required in elderly patients.

Use in men with renal impairment

CALIBERI ODF for Use as Needed

• Mild (creatinine clearance 51 to 80mL/min): No dose adjustment is required.
• Moderate (creatinine clearance 31 to 50mL/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 <30mL/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).

CALIBERI ODF for Once Daily Use

• Mild (creatinine clearance 51 to 80mL/min): No dose adjustment is required.
• Moderate (creatinine clearance 31 to 50mL/min): No dose adjustment is required.
• Severe (creatinine clearance <30mL/min or on hemodialysis): CALIBERI ODF 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 hepatic impairment

CALIBERI ODF for Use as Needed

The recommended dose is 10mg taken prior to anticipated sexual activity. There is limited clinical data on the safety of CALIBERI ODF 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 CALIBERI ODF to patients with hepatic impairment.

CALIBERI ODF 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

CALIBERI ODF should not be used in individuals below 18 years of age.

Use in patients taking CYP3A4 Inhibitors

CALIBERI ODF for Use as Needed

For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of CALIBERI ODF 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).

CALIBERI ODF for Once Daily Use

For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of CALIBERI ODF 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). Caliberi ODF should not be used in these patients since the 2.5mg film dosage is unavailable.