Страна: Швеція
мова: шведська
Джерело: Läkemedelsverket (Medical Products Agency)
vardenafilhydrokloridtrihydrat
Krka d.d., Novo mesto
G04BE09
vardenafilhydrokloridtrihydrat
5 mg
Filmdragerad tablett
vardenafilhydrokloridtrihydrat 5,93 mg Aktiv substans
Receptbelagt
Avregistrerad
2017-03-30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VARDEGIN 5 MG FILM-COATED TABLETS VARDEGIN 10 MG FILM-COATED TABLETS VARDEGIN 20 MG FILM-COATED TABLETS Vardenafil READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Vardegin is and what it is used for 2. What you need to know before you take Vardegin 3. How to take Vardegin 4. Possible side effects 5. How to store Vardegin 6. Contents of the pack and other information 1. WHAT VARDEGIN IS AND WHAT IT IS USED FOR Vardegin 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. Vardegin will only work when you are sexually stimulated. It reduces the action of the natural chemical in your body which makes erections go away. Vardegin allows an erection to last long enough for you to satisfactorily complete sexual activity. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VARDEGIN DO NOT TAKE VARDEGIN: - if you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of breath. Прочитайте повний документ
1. NAME OF THE MEDICINAL PRODUCT Vardegin 5 mg film-coated tablets Vardegin 10 mg film-coated tablets Vardegin 20 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 5 mg film-coated tablets: Each film-coated tablet contains 5 mg vardenafil (as vardenafil hydrochloride trihydrate). 10 mg film-coated tablets: Each film-coated tablet contains 10 mg vardenafil (as vardenafil hydrochloride trihydrate). 20 mg film-coated tablets: Each film-coated tablet contains 20 mg vardenafil (as vardenafil hydrochloride trihydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) 5 mg film-coated tablets: Orange-brown, round, slightly biconvex, film-coated tablets with bevelled edges, engraved with 5 on one side, 5.5 mm in diameter. 10 mg film-coated tablets: Orange-brown, oval, slightly biconvex, film-coated tablets, scored on one side and engraved with 10 on the other side, dimensions 10.5 mm x 5.5 mm. The tablet can be divided into equal doses. 20 mg film-coated tablets: Orange-brown, round, biconvex, film-coated tablets with bevelled edges, scored on one side and engraved with 20 on the other side, 10 mm in diameter. The tablet can be divided into equal doses. 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 Vardegin 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. Vardegin 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 Прочитайте повний документ