Entranin 100 mg, kauwtabletten

Страна: Нідерланди

мова: голландська

Джерело: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Активний інгредієнт:

SILDENAFILCITRAAT 140,5 mg/stuk SAMENSTELLING overeenkomend met ; SILDENAFIL 100 mg/stuk

Доступна з:

LABORMED-PHARMA S.A. 44B Theodor Pallady Blvd, 3rd District 032266 BUCHAREST (ROEMENIË)

Код атс:

G04BE03

ІПН (Міжнародна Ім'я):

SILDENAFILCITRAAT 140,5 mg/stuk SAMENSTELLING overeenkomend met ; SILDENAFIL 100 mg/stuk

Фармацевтична форма:

Kauwtablet

Склад:

ASPARTAAM (E 951) ; CROSCARMELLOSE NATRIUM (E 468) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; PEPERMUNTSMAAKSTOF ; POLACRILINE KALIUM ; POVIDON K 30 (E 1201) ; SILICIUMDIOXIDE (E 551),

Адміністрація маршрут:

Oraal gebruik

Терапевтична области:

Sildenafil

Огляд продуктів:

Hulpstoffen: ASPARTAAM (E 951); CROSCARMELLOSE NATRIUM (E 468); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); PEPERMUNTSMAAKSTOF; POLACRILINE KALIUM; POVIDON K 30 (E 1201); SILICIUMDIOXIDE (E 551);

Дата Авторизація:

1900-01-01

інформаційний буклет

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Entranin 50 mg, kauwtabletten
Entranin 100 mg, kauwtabletten
Sildenafil
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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [Product name] is and what it is used for
2.
What you need to know before you take [Product name]
3.
How to take [Product name]
4.
Possible side effects
5.
How to store [Product name]
6.
Contents of the pack and other information
1.
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product name] contains the active substance sildenafil which belongs
to a group of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to
relax the blood vessels in your
penis, allowing blood to flow into your penis when you get sexually
excited. [Product name] will only
help you to get an erection if you are sexually stimulated.
[Product name] is a treatment for adult men with erectile dysfunction,
sometimes known as impotence.
This is when a man cannot get, or keep a hard, erect penis suitable
for sexual activity.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [PRODUCT NAME]
DO NOT TAKE [PRODUCT NAME]
-
If you are allergic to sildenafil or any of the other ingredients of
this medicine (listed in section
6).
-
If you are taking medicines called nitrates, as the combination may
lead to a dangerous fall in
your blood pressure. Tell your doctor if you are taking any of these
medicines which are often
given for relief of

Характеристики продукта

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1.
NAME OF THE MEDICINAL PRODUCT
Entranin 50 mg kauwtabletten
Entranin 100 mg kauwtabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains sildenafil citrate equivalent to 50 mg
sildenafil.
Excipients with known effect:
Each tablet contains 4.30 mg of aspartame (E951) and 140.915 mg of
lactose monohydrate.
Each chewable tablet contains sildenafil citrate equivalent to 100 mg
sildenafil.
Excipients with known effect:
Each tablet contains 8.60 mg of aspartame (E951) and 281.83 mg of
lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet.
White, triangular, biconvex tablets, embossed with “50” on one
side, with a diameter of
8.8 x 8.6±0.2 mm.
White, triangular, biconvex tablets, embossed with “100” on one
side, with a diameter of
11.8 x 11.6±0.2 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Product name] is indicated in adult men with erectile dysfunction,
which is the inability to achieve or
maintain a penile erection sufficient for satisfactory sexual
performance.
In order for [Product name] to be effective, sexual stimulation is
required.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Use in adults _
The recommended dose is 50 mg taken as needed approximately one hour
before sexual activity.
Based on efficacy and tolerability, the dose may be increased to 100
mg or decreased to 25 mg*. The
maximum recommended dose is 100 mg. The maximum recommended dosing
frequency is once per
day. If [Product name] is taken with food, the onset of activity may
be delayed compared to the fasted
state (see section 5.2).
*The dose of 25 mg is not available with this product. For doses not
achievable with [Product name]
chewable tablets, other brands of sildenafil are available and can be
used.
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Special populations
_Elderly