Vardenafil Chanelle 10 mg Orodispersible Tablets

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

VARDENAFIL HYDROCHLORIDE TRIHYDRATE

Доступна с:

Chanelle Medical Unlimited Company

код АТС:

G04BE; G04BE09

ИНН (Международная Имя):

VARDENAFIL HYDROCHLORIDE TRIHYDRATE

дозировка:

10 milligram(s)

Фармацевтическая форма:

Orodispersible tablet

Тип рецепта:

Product subject to prescription which may not be renewed (A)

Терапевтические области:

Drugs used in erectile dysfunction; vardenafil

Статус Авторизация:

Not marketed

Дата Авторизация:

2018-01-19

тонкая брошюра

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

Характеристики продукта

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