Tadalafil 1A Pharma 5 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

TADALAFIL 5 mg/stuk

Beschikbaar vanaf:

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

ATC-code:

G04BE08

INN (Algemene Internationale Benaming):

TADALAFIL 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

Product samenvatting:

Hulpstoffen: 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);

Autorisatie datum:

1900-01-01

Bijsluiter

Tadalafil 1A Pharma 2,5/5/10/20 mg, filmomhulde
tabletten
RVG 118148-11852-11853-11854
1313-V13
1.3.1.3 Leaflet
24 januari 2024
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
TADALAFIL 1A PHARMA 2,5 MG, FILMOMHULDE TABLETTEN
TADALAFIL 1A PHARMA 5 MG, FILMOMHULDE TABLETTEN
TADALAFIL 1A PHARMA 10 MG, FILMOMHULDE TABLETTEN
TADALAFIL 1A PHARMA 20 MG, FILMOMHULDE TABLETTEN
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

Productkenmerken

Page 1/20
Tadalafil 1A Pharma 2,5/5/10/20 mg, filmomhulde tabletten
RVG 118148-118152-11853-11854
20231005
1.3.1.1 Summary of product characteristics
Januari 2024
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Tadalafil 1A Pharma 2,5 mg, filmomhulde tabletten
Tadalafil 1A Pharma 5 mg, filmomhulde tabletten
Tadalafil 1A Pharma 10 mg, filmomhulde tabletten
Tadalafil 1A Pharma 20 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 2.5 mg of tadalafil.
Excipient with known effect
Each tablet contains 41.9 mg of lactose (as monohydrate).
Each film-coated tablet contains 5 mg of tadalafil.
Excipient with known effect
Each tablet contains 83.8 mg of lactose (as monohydrate).
Each film-coated tablet contains 10 mg of tadalafil.
Excipient with known effect
Each tablet contains 167.7 mg of lactose (as monohydrate9.
Each film-coated tablet contains 20 mg of tadalafil.
Excipient with known effect
Each tablet contains 335.4 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_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.
_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.
Page 2/20
Tadalafil 1A Pharma 2,5/5/10/20 mg, filmomhulde tabletten
RVG 118148-118152-11853-11854
20231005
1.3.1.1 Summary of product characteristics
Januari 2024
_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 side of the tablet is plain.
_20 mg film-coated tablets _
Ochre to yellow, oval shaped film-coated tablet of approximately 15 x
9 mm. On one side debossed
with “20”. The other side of the tablet is bi-scored.
The tablet can be divided into equal halves and/or qua