Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Bayer AG, 51368, Leverkusen, Germany
Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
In order for Vivanza to be effective, sexual stimulation is required.
The recommended dose is 10 mg taken as needed approximately 25 to 60 minutes before sexual activity. Based on efficacy and tolerability the dose may be increased to 20 mg or decreased to 5 mg. The maximum recommended dose is 20 mg. The maximum recommended dosing frequency is once per day. Vivanza 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).
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).
A starting dose of 5 mg should be considered in patients with mild and moderate hepatic impairment (Child-Pugh A-B). Based on tolerability and efficacy, the dose may subsequently be increased. The maximum dose recommended in patients with moderate hepatic impairment (Child-Pugh B) is 10 mg (see sections 4.3 and 5.2).
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 5 mg should be considered. Based on tolerability and efficacy the dose may be increased to 10 mg and 20 mg.
Vivanza is not indicated for individuals below 18 years of age. There is no relevant indication for use of Vivanza in children.
Concomitant use of CYP3A4 inhibitors: When used in combination with the CYP3A4 inhibitors such as erythromycin or clarithromycin, the dose of vardenafil should not exceed 5 mg (see section 4.5).
For oral use.
In single dose volunteer studies, doses up to and including 80 mg vardenafil (film-coated tablets) per day were tolerated without exhibiting serious adverse reactions.
When vardenafil was administered in higher doses and more frequently than the recommended dose regimen (40 mg film-coated tablets twice daily) cases of severe back pain have been reported. This was not associated with any muscle or neurological toxicity.
In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance, as vardenafil is highly bound to plasma proteins and not significantly eliminated in the urine.
3 years.
This medicinal product does not require any special storage conditions.
PP/Aluminium foil blisters in cartons of 2, 4, 8, 12 and 20 tablets.
Not all pack sizes may be marketed.
No special requirements for disposal.
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