Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
VARDENAFIL HYDROCHLORIDE TRIHYDRATE
Accord Healthcare Limited
G04BE09
VARDENAFIL HYDROCHLORIDE TRIHYDRATE
10 Milligram
Film Coated Tablet
Product subject to prescription which may not be renewed (A)
vardenafil
Authorised
2017-07-07
PACKAGE LEAFLET: INFORMATION FOR THE USER VARDENAFIL ACCORD 5 MG FILM-COATED TABLETS VARDENAFIL ACCORD 10 MG FILM-COATED TABLETS VARDENAFIL ACCORD 20 MG FILM-COATED TABLETS vardenafil 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 Vardenafil Accord is and what it is used for 2. What you need to know before you take Vardenafil Accord 3. How to take Vardenafil Accord 4. Possible side effects 5. How to store Vardenafil Accord 6. Contents of the pack and other information 1. WHAT VARDENAFIL ACCORD IS AND WHAT IT IS USED FOR Vardenafil Accord 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. Vardenafil Accord will only work when you are sexually stimulated. It reduces the action of the natural chemical in your body which makes erections go away. Vardenafil Accord allows an erection to last long enough for you to satisfactorily complete sexual activity. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VARDENAFIL ACCORD DO NOT TAKE VARDENAFIL ACCORD If you are allergic to vardenafil or any of the other ingredients of this medicine (listed Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vardenafil Accord 10 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg vardenafil (as hydrochloride trihydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Beige coloured, round shaped, approximately 6.8 mm in diameter, biconvex, film-coated tablets debossed with 'FA2' on one side and plain on other 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 Vardenafil Accord 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. Vardenafil Accord 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 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 impairment_ No dose adjustment is required in patients with mild to moderate renal impairment. In patients with severe renal impairment (creatinine clearance <30 mL/min Lees het volledige document