Posology : מינונים

4.2          Posology and method of administration
Posology
Levitra 10 mg orodispersible tablets are not bioequivalent to Levitra 10 mg film-coated tablets (see section 5.1). The maximum dose for Levitra orodispersible tablet is 10 mg/day.

Use in adult men

Levitra 10 mg orodispersible tablets are taken as needed approximately 25 to 60 minutes before sexual activity.

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

Hepatic impairment
Levitra 10 mg orodispersible tablets are not indicated as a starting dose in patients with mild hepatic impairment (Child-Pugh A).

Patients with mild hepatic impairment should start treatment with Levitra 5 mg film-coated tablets.
Based on tolerability and efficacy, the dose may be increased to Levitra 10 mg and 20 mg film-coated tablets, or Levitra 10 mg orodispersible tablets.
The maximum dose recommended in patients with moderate hepatic impairment (Child-Pugh B) is Levitra 10 mg as film-coated tablets (see section 5.2).

Levitra 10 mg orodispersible tablets are not for use in patients with moderate (Child-Pugh B) and severe hepatic impairment (Child-Pugh C; see section 4.3).

Renal impairment
No dose adjustment is required in patients with mild to moderate renal impairment.
In patients with severe renal impairment (creatinine clearance <30 ml/min) a starting dose of Levitra 5 mg film-coated tablets should be considered. Based on tolerability and efficacy, the dose may be increased to Levitra 10 mg and 20 mg film-coated tablets, or Levitra 10 mg orodispersible tablets.
Levitra orodispersible tablet is not for use in patients with end-stage renal failure (see section 4.3).

Paediatric population
Levitra orodispersible tablets are not indicated for individuals below 18 years of age. There is no relevant indication for use of Levitra orodispersible tablets in children and adolescents.

Use in patients using other medicinal products
Concomitant use of moderate or potent CYP3A4 inhibitors
Vardenafil dose adjustment is necessary if moderate or potent CYP3A4 inhibitors are given concomitantly (see section 4.5).

Method of administration
For oral use.
The orodispersible tablet should be placed in the mouth on the tongue, where it will rapidly disintegrate, and then swallowed. Levitra orodispersible tablets must be taken without liquid and immediately upon release from the blister.
Levitra orodispersible tablets can be taken with or without food.