Posology : מינונים

4.2 Posology and method of administration

Posology
Use in adult men
The recommended dose is 10 mg taken as needed approximately 25 to 60 minutes before sexual activity.
When a lower dose than 10mg is required, an alternative treatment should be considered.
Based on efficacy and tolerability the dose may be increased to 20 mg. The maximum recommended dose is 20 mg. The maximum recommended dosing frequency is once per day. Vardenafil Inovamed can be taken with or without food. The onset of activity may be delayed if taken with a high fat meal (see section 5.2).

Special populations
Elderly (>65 years old)
Dose adjustments are not required in elderly patients. However, an increase to a maximum 20 mg dose should be carefully considered depending on the individual tolerability (see sections 4.4 and 4.8).

Hepatic impairment
A starting dose of 5 mg should be considered in patients with mild and moderate hepatic impairment (Child-Pugh A-B) and therefore an alternative treatment should be considered.
The maximum dose recommended in patients with moderate hepatic impairment (Child-Pugh B) is 10 mg (see sections 4.3 and 5.2).
Renal impairment
No dose adjustment is required in patients with mild to moderate renal impairment.
A starting dose of 5 mg should be considered in patients with severe renal impairment (creatinine clearance <30 ml/min), and therefore an alternative treatment should be considered.

Paediatric population
Vardenafil Inovamed is not indicated for individuals below 18 years of age. There is no relevant indication for use of Vardenafil Inovamed in children.

Use in patients using other medicinal products
Concomitant use of CYP3A4 inhibitors
Vardenafil Inovamed 10mg and 20mg are contraindicated in combination with the CYP3A4 inhibitors such as erythromycin or clarithromycin as the dose of vardenafil should not exceed 5 mg (see section 4.3, 4.5).

Method of administration
For oral use.