Land: Nederland
Språk: nederlandsk
Kilde: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
VARDENAFILHYDROCHLORIDE 3-WATER SAMENSTELLING overeenkomend met ; VARDENAFIL
Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)
G04BE09
VARDENAFILHYDROCHLORIDE 3-WATER COMPOSITION corresponding to ; VARDENAFIL
Filmomhulde tablet
CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; CROSPOVIDON (E 1202) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; POLYVINYLALCOHOL (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),
Oraal gebruik
Vardenafil
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); CROSPOVIDON (E 1202); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 4000; MAGNESIUMSTEARAAT (E 470b); NATRIUMWATERSTOFCARBONAAT (E 500 (II)); POLYVINYLALCOHOL (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);
2017-11-27
PACKAGE LEAFLET: INFORMATION FOR THE USER VARDENAFIL STADA 5 MG FILMOMHULDE TABLETTEN VARDENAFIL STADA 10 MG FILMOMHULDE TABLETTEN VARDENAFIL STADA 20 MG FILMOMHULDE TABLETTEN READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. − Keep this leaflet. You may need to read it again. − If you have any further questions, ask your doctor or pharmacist. − This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. − If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What [Product name] is and what it is used for 2. What you need to know before you take [Product name] 3. How to take [Product name] 4. Possible side effects 5. How to store [Product name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR [Product name] contains vardenafil, a member of a class of medicines called phosphodiesterase type 5 inhibitors. They are used for the treatment of erectile dysfunction in adult men, a condition which implies difficulties in getting or keeping an erection. At least one in ten men has trouble getting or keeping an erection at some time. There may be physical or psychological causes, or a mixture of both. Whatever the cause is, due to muscle and blood vessel changes not enough blood stays in the penis to make it hard and keep it hard. [Product name] will only work when you are sexually stimulated. It reduces the action of the natural chemical in your body which makes erections go away. [Product name] allows an erection to last long enough for you to satisfactorily complete sexual activity. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [PRODUCT NAME] DO NOT TAKE [PRODUCT NAME] • If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). Signs of an aller Les hele dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Vardenafil STADA 5 mg filmomhulde tabletten Vardenafil STADA 10 mg filmomhulde tabletten Vardenafil STADA 20 mg filmomhulde tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 5 mg of vardenafil (as vardenafil hydrochloride trihydrate). Each tablet contains 10 mg of vardenafil (as vardenafil hydrochloride trihydrate). Each tablet contains 20 mg of vardenafil (as vardenafil hydrochloride trihydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Light yellow round film-coated tablets of 6 mm marked ´A719´ on one side. Light yellow round film-coated tablets of 7 mm marked ´A721´ on one side. Light yellow round film-coated tablets of 8.5 mm marked ´A723´ on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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 [Product name] to be effective, sexual stimulation is required. 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. 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. [Product name] 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). Based on tolerability and efficacy, the dos Les hele dokumentet