Tadalafil 1A Pharma 2,5 mg, filmomhulde tabletten 2,5 mg

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

TADALAFIL 2,5 mg/stuk

Beschikbaar vanaf:

1A Pharma GmbH Keltenring 1 + 3 82041 OBERHACHING (DUITSLAND)

ATC-code:

G04BE08

INN (Algemene Internationale Benaming):

TADALAFIL 2,5 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 IA Pharma 2,5, 5, 10 en 20 mg, filmomhulde tabletten 2,5, 5,
10 en 20 mg
RVG 123034-5-6-7
V8
1.3.1.3 Bijsluiter
Januari 2024
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TADALAFIL IA PHARMA
® 2,5 MG, FILMOMHULDE TABLETTEN 2,5 MG
TADALAFIL IA PHARMA
® 5 MG, FILMOMHULDE TABLETTEN 5 MG
TADALAFIL IA PHARMA
® 10 MG, FILMOMHULDE TABLETTEN 10 MG
TADALAFIL IA PHARMA
® 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 res

Productkenmerken

Sandoz B.V.
Page 1/18
Tadalafil 1A Pharma 2,5/5/1020 mg, filmomhulde tabletten 2,5, 5, 10 en
20 mg
RVG 123034-123035-123036-123037
1311-V8
1.3.1.1 Samenvatting van de Product kenmerken
Januari 2024
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tadalafil 1A Pharma 2,5 mg, filmomhulde tabletten 2,5 mg
Tadalafil 1A Pharma 5 mg, filmomhulde tabletten 5 mg
Tadalafil 1A Pharma 10 mg, filmomhulde tabletten 10 mg
Tadalafil 1A Pharma 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 1A Pharma 2,5/5/1020 mg, filmomhulde tabletten 2,5, 5, 10 en
20 mg
RVG 123034-123035-123036-123037
1311-V8
1.3.1.1 Samenvatting van de Product kenmerken
Januari 2024
<{[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 sh