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Posology: Caliberi Orodispersible Film (ODF) 5mg and 20mg: Erectile dysfunction (ED): Adult men: In general, the recommended dose is 10 mg (2 ODF × 5mg) taken prior to anticipated sexual activity without food.
In those patients in whom tadalafil 10 mg (2 ODF × 5mg) does not produce an adequate effect, 20 mg 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 (2 ODF X 5mg) and 20 mg 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 Caliberi (i.e., at least twice weekly) a once daily regimen with the lowest doses of Caliberi might be considered suitable, based on patient choice and the physician's judgement.
In these patients the recommended dose is 5 mg taken once a day at approximately the same time of day.
The appropriateness of continued use of the daily regimen should be reassessed periodically.
Caliberi Orodispersible Film (ODF) 5mg: Benign prostatic hyperplasia in adult men: The recommended dose is 5mg taken at approximately the same time every day without food. For adult men being treated for both benign prostatic hyperplasia and erectile dysfunction the recommended dose is also 5mg taken at approximately the same time every day. Patients who are unable to tolerate tadalafil 5mg or the treatment of benign prostatic hyperplasia should consider an alternative therapy.
Special Populations: Elderly patients: Dosage adjustments are not required in elderly patients.
Men with renal impairment: Dose adjustments are not required in patients with mild to moderate renal impairment. For patients with severe renal impairment 10 mg (2 ODF × 5mg) is the maximum recommended dose.
Once-a-day dosing of 5mg tadalafil both for the treatment of erectile dysfunction or benign prostatic hyperplasia is not recommended in patients with severe renal impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Men with hepatic impairment: The recommended dose of Caliberi is 10 mg (2 ODF x 5 mg) taken prior to anticipated sexual activity without food. There is limited clinical data on the safety of Caliberi 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 10 mg (2 ODF x 5 mg) of tadalafil to patients with hepatic impairment.
Once-a-day dosing has not been evaluated in patients with hepatic impairment; therefore, if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician (see Precautions and Pharmacology: Pharmacodynamics under Actions).
Men with Diabetes: Dosage adjustments are not required in patients with diabetes.
Pediatric population: There is no relevant use of Caliberi in the paediatric population with regard to the treatment of erectile dysfunction.
Method of administration: 1. Open the sachet from top.
2. Roll down the back side of the sachet. The patient can see a thin film edge after rolling down.
3. Pull the film edge and remove the thin film from the sachet and place it immediately on the tongue. Allow it to dissolve without water.
