מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: myHealthbox
vardenafil
Zentiva
G04BE09
vardenafil
5mg
Film-coated tablets
Oral use
Packs of: 2, 4, 8, 12 and 24 film-coated tablets.
POM - Prescription Only Medicine
Zentiva k.s
Urologicals, Drugs used in erectile dysfunction
Treatment of erectile dysfunction in adult men. Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
Authorised
2015-03-30
PACKAGE LEAFLET: INFORMATION FOR THE USER STAREXON 5 MG FILM-COATED TABLETS STAREXON 10 MG FILM-COATED TABLETS STAREXON 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 starexon is and what it is used for 2. What you need to know before you take starexon_ _ 3. How to take starexon 4. Possible side effects 5. How to store starexon 6. Contents of the pack and other information 1. WHAT STAREXON IS AND WHAT IT IS USED FOR The name of your medicine is Starexon 5mg, 10mg and 20mg film-coated tablets (called starexon throughout this leaflet). It 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. Starexon will only work when you are sexually stimulated. It reduces the action of the natural c קרא את המסמך השלם
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Starexon 5 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 5 mg vardenafil (as hydrochloride trihydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Slightly yellow to slightly brown round tablets of size approx. 6 mm, embossed with “5” 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 starexon 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 – 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. Starexon 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 population (> 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 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). _Renal קרא את המסמך השלם