Tadalafil Sandoz 10 mg, filmomhulde tabletten 10 mg

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

TADALAFIL 10 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

G04BE08

INN (Algemene Internationale Benaming):

TADALAFIL 10 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CROSPOVIDON (E 1202) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; NATRIUMLAURILSULFAAT ; NATRIUMSTEARYLFUMARAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 12 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CROSPOVIDON (E 1202) ; IJZEROXIDE GEEL (E 172) ; LACTOSE 1-WATER ; MACROGOL 3350 ; NATRIUMLAURILSULFAAT (E 487) ; NATRIUMSTEARYLFUMARAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; POVIDON K 12 (E 1201) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Tadalafil

Autorisatie datum:

1900-01-01

Bijsluiter

Sandoz B.V.
Page 1/8
Tadalafil Sandoz 5/10/20 mg, filmomhulde tabletten 5, 10 en 20 mg
RVG 123038-123039-123040
1313-V5
1.3.1.3 Bijsluiter
September 2023
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TADALAFIL SANDOZ
® 5 MG, FILMOMHULDE TABLETTEN 5 MG
TADALAFIL SANDOZ
® 10 MG, FILMOMHULDE TABLETTEN 10 MG
TADALAFIL SANDOZ
® 20 MG, FILMOMHULDE TABLETTEN 20 MG
tadalafil
_ _
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 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 [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 tadalafil
which belongs to a group of
medicines called phosphodiesterase type 5 inhibitors.
[Nationally completed name] 2.5 MG, 5 MG, 10 MG AND 20 MG film-coated
tablets is used to treat
adult men with ERECTILE DYSFUNCTION. This is when a man cannot get, or
keep a hard, erect penis
suitable for sexual activity. [Nationally completed name] has been
shown to significantly improve the
ability of obtaining a hard erect penis suitable for sexual activity.
Following sexual stimulation [nationally completed name] works by
helping the blood vessels in your
penis to relax, allowing the flow of blood into your penis. The result
of this is improved erectile
function. [Nationally completed name]

Productkenmerken

Sandoz B.V.
Page 1/18
Tadalafil Sandoz 5/10/20 mg, filmomhulde tabletten 5, 10 en 20 mg
RVG 123038-123039-123040
1311-v6
1.3.1.1 Samenvatting van de Product kenmerken
December 2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tadalafil Sandoz 5 mg, filmomhulde tabletten 5 mg
Tadalafil Sandoz 10 mg, filmomhulde tabletten 10 mg
Tadalafil Sandoz 20 mg, filmomhulde tabletten 20 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
{[NATIONALLY COMPLETED NAME] 2.5 MG FILM-COATED TABLETS}
Each film-coated tablet contains 2.5 mg tadalafil.
Excipient(s) with known effect
Each tablet contains 44 mg lactose monohydrate.
{[NATIONALLY COMPLETED NAME] 5 MG FILM-COATED TABLETS}
Each film-coated tablet contains 5 mg tadalafil.
Excipient(s) with known effect
Each tablet contains 88 mg lactose monohydrate.
{[NATIONALLY COMPLETED NAME] 10 MG FILM-COATED TABLETS}
Each film-coated tablet contains 10 mg tadalafil.
Excipient(s) with known effect
Each tablet contains 177 mg lactose monohydrate.
{[NATIONALLY COMPLETED NAME] 20 MG FILM-COATED TABLETS}
Each film-coated tablet contains 20 mg tadalafil.
Excipient(s) with known effect
Each tablet contains 353 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
<{[NATIONALLY COMPLETED NAME] 2.5 MG FILM-COATED TABLETS}>
Ochre to yellow, round shaped film-coated tablet of approximately 5 mm
in diameter. On one side
debossed with “2.5” and plain on the other side.
Sandoz B.V.
Page 2/18
Tadalafil Sandoz 5/10/20 mg, filmomhulde tabletten 5, 10 en 20 mg
RVG 123038-123039-123040
1311-v6
1.3.1.1 Samenvatting van de Product kenmerken
December 2023
<{[NATIONALLY COMPLETED NAME] 5 MG FILM-COATED TABLETS}>
Ochre to yellow, oval shaped film-coated tablet of approximately 8 x 4
mm. On one side debossed
with “5” and plain on the other side.
<{[NATIONALLY COMPLETED NAME] 10 MG FILM-COATED TABLETS}>
Ochre to yellow, oval shaped film-coated tablet of approximately 11 x
6 mm. On one side debossed
with “10”. The other si