SildeHEXAL 25 mg, tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

SILDENAFILCITRAAT SAMENSTELLING overeenkomend met ; SILDENAFIL

Beschikbaar vanaf:

Hexal AG Industriestrasse 25 D-83607 HOLZKIRCHEN (DUITSLAND)

ATC-code:

G04BE03

INN (Algemene Internationale Benaming):

SILDENAFILCITRAAT COMPOSITION corresponding to ; SILDENAFIL

farmaceutische vorm:

Tablet

Samenstelling:

CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; CROSCARMELLOSE NATRIUM (E 468) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; SACCHAROIDE NATRIUM X-WATER (E 954), CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOVIDON ; CROSCARMELLOSE NATRIUM (E 468) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; MAGNESIUMSTEARAAT (E 470b) ; SACCHAROIDE NATRIUM X-WATER (E 954),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Sildenafil

Product samenvatting:

Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341); CELLULOSE, MICROKRISTALLIJN (E 460); COPOVIDON; CROSCARMELLOSE NATRIUM (E 468); INDIGOKARMIJN ALUMINIUMLAK (E 132); MAGNESIUMSTEARAAT (E 470b); SACCHAROIDE NATRIUM 0-WATER (E 954);

Autorisatie datum:

2010-05-06

Bijsluiter

Hexal AG
Page 1
SildeHEXAL 25/50/75/100 mg, tabletten
RVG 103563-4-5-6
1313-V11
1.3.1.3 Package Leaflet
December 2019
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SILDEHEXAL 25 MG, TABLETTEN
SILDEHEXAL 50 MG, TABLETTEN
SILDEHEXAL 75 MG, TABLETTEN
SILDEHEXAL 100 MG, TABLETTEN
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 [nationally completed name] is and what it is used for
2.
What you need to know before you take [nationally completed name]
3.
How to take [nationally completed name]
4.
Possible side effects
5.
How to store [nationally completed name]
6.
Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[nationally completed 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.
[nationally completed name] will only help you to get an erection if
you are sexually stimulated.
[nationally completed 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 [NATIONALLY COMPLETED NAME]
DO NOT TAKE [NATIONALLY COMPLETED NAME]
-
if you are allergic to sildenafil or any of the other ingredients of
this medicine (listed in section 6).
-
if you are takin

Productkenmerken

HEXAL A.G.
Page 1
SildeHEXAL 25/50/75/100 mg, tabletten
RVG 103563-4-5-6
1311-V11
1.3.1.1 Summary of Product Characteristics
December 2019
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
SildeHEXAL 25 mg, tabletten
SildeHEXAL 50 mg, tabletten
SildeHEXAL 75 mg, tabletten
SildeHEXAL 100 mg, tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
[nationally completed name] 25 mg tablets
Each tablet contains 25 mg of sildenafil (as citrate).
[nationally completed name] 50 mg tablets
Each tablet contains 50 mg of sildenafil (as citrate).
[nationally completed name] 75 mg tablets
Each tablet contains 75 mg of sildenafil (as citrate).
[nationally completed name] 100 mg tablets
Each tablet contains 100 mg of sildenafil (as citrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
[nationally completed name] 25 mg tablet is a light blue, round,
slightly dotted tablet with breaking
notch on one side and debossment “25” on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
[nationally completed name] 50 mg tablet is a light blue, round,
slightly dotted tablet with cross
breaking notch on one side and debossment “50” on the other side.
The tablet can be divided into four equal doses.
Only intake of the whole tablet or concomitant intake of two quarters
is covered by posology.
[nationally completed name] 75 mg tablet is a light blue, round,
slightly dotted tablet with breaking
notch (divisible in 3 parts) on both sides and debossment “75” on
one side.
The tablet can be divided into three equal doses.
[nationally completed name] 100 mg tablet is a light blue, round,
slightly dotted tablet with cross
breaking notch on both sides and debossment “100” on one side.
The tablet can be divided into four equal doses.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sildenafil is indicated in adult men with erectile dysfunction, which
is the inability to achieve or
HEXAL A.G.
Page 2
SildeHEXAL