Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
VARDENAFIL HYDROCHLORIDE TRIHYDRATE
Chanelle Medical Unlimited Company
G04BE; G04BE09
VARDENAFIL HYDROCHLORIDE TRIHYDRATE
10 milligram(s)
Orodispersible tablet
Product subject to prescription which may not be renewed (A)
Drugs used in erectile dysfunction; vardenafil
Not marketed
2018-01-19
ID: PL191M (IE) VERSION: 06 REVISION DATE: 31/10/2022 Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER VARDENAFIL CHANELLE 10 MG ORODISPERSIBLE 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 Chanelle 10 mg Orodispersible Tablets is and what it is used for 2. What you need to know before you take Vardenafil Chanelle 10 mg Orodispersible Tablets. 3. How to take Vardenafil Chanelle 10 mg Orodispersible Tablets 4. Possible side effects 5. How to store Vardenafil Chanelle 10 mg Orodispersible Tablets 6. Contents of the pack and other information 1. WHAT VARDENAFIL CHANELLE 10 MG ORODISPERSIBLE TABLETS IS AND WHAT IT IS USED FOR Vardenafil Chanelle 10 mg Orodispersible Tablets contains verdenafil, 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 Chanelle 10 mg Orodispersible Tablets 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 Chanelle 10 mg Orodispersible Tablets allows an erection to last long enou Baca dokumen lengkap
Health Products Regulatory Authority 03 February 2023 CRN00D8CV Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vardenafil Chanelle 10 mg Orodispersible Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each orodispersible tablet contains 10 mg of vardenafil (as vardenafil hydrochloride trihydrate). Excipients with known effect: 1.80 mg aspartame (E951) per orodispersible tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Orodispersible tablet. White to off white plain round tablets (approximately 9 mm). 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 Chanelle to be effective, sexual stimulation is required. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Vardenafil Chanelle 10 mg Orodispersible Tablets are not bioequivalent to vardenafil 10 mg film-coated tablets (see section 5.1). The maximum dose for Vardenafil Chanelle 10 mg Orodispersible Tablets is 10 mg/day. Use in adult men Vardenafil Chanelle 10 mg Orodispersible Tablets are taken as needed approximately 25 to 60 minutes before sexual activity. Special populations _Elderly (≥65 years old) _ Dose adjustments are not required in elderly patients. However, an increase to a maximum dose of vardenafil 20 mg film-coated tablets should be carefully considered depending on the individual tolerability (see sections 4.4 and 4.8). _Hepatic impairment_ Vardenafil 10 mg orodispersible tablets are not indicated as a starting dose in patients with mild hepatic impairment (Child-Pugh A). Patients with mild hepatic impairment should start treatment with vardenafil 5 mg film-coated tablets. Based on tolerability and efficacy, the dose may be increased to vardenafil 10 mg and 20 mg film-coated tablets, or vardenafil 10 mg orodispersible tablets. The maximum dose recommended in patients with moderate hepatic i Baca dokumen lengkap