LEVITRA 5MG TABLET

Land: Malaysia

Språk: engelska

Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiva substanser:

VARDENAFIL MONOHYDROCHLORIDE

Tillgänglig från:

BAYER CO. (MALAYSIA) SDN. BHD.

INN (International namn):

VARDENAFIL MONOHYDROCHLORIDE

Enheter i paketet:

4 Tablets

Tillverkad av:

BAYER AG

Produktens egenskaper

Date of revision : 11 November 2019
Reference : Levitra / tablets/ CCDS / version 1 8/ 03 Sept 2019
Levitra ®
1. NAME OF THE MEDICINAL PRODUCT
Levitra 5 mg / 10 mg / 20 mg film- coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Levitra 5 mg film -coated tablets: each film -coated tablet contains 5 mg of vardenafil
(5.926 mg of vardenafil monohydrochloride trihydrate)
Levitra 10 mg film -coated tablets: each film-coated tablet contains 10 mg of vardenafil
(11.852 mg of vardenafil monohydrochloride trihydrate)
Levitra 20 mg film -coated tablets: each film-coated tablet contains 20 mg of vardenafil
(23.705 mg of vardenafil monohydrochloride trihydrate)
For a full list of excipients see section “List of Excipients.”
3. PHARMACEUTICAL FORM
Levitra film- coated tablet: orange round, marked with BAYER -cross on one side and “ 5“,
“ 10“, or ‘ 20“ on the other side
4. CLINICAL PARTICULARS
4.1 Indication (s)
Treatment of erectile dysfunction (inability to achieve or maintain penile erection
sufficient for satisfactory sexual performance)
In order for Levitra to be effective, sexual stimulation is requir ed.
4.2 Dosage and m ethod of administration
4.2.1 Method of administration
.Levitra film- coated tablets can be taken with or without food.
4.2.2 Dosage regimen
The recommended starting dose is one Levitra 10 mg film- coated tablet taken as needed
approxim ately 25 - 60 minutes before sexual activity.
Based on efficacy and tolerability, the dose may be increased to one Levitra 20 mg film-
coated tablet or decreased to one Levitra 5 mg film-coated tablet.
The maximum daily -recommended dose is one Levitra 20 mg film- coated tablet.
The maximum recommended dose frequency is once per day.