Quator 20 mg, filmomhulde tabletten

Country: Նիդերլանդեր

language: հոլանդերեն

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

active_ingredient:

TADALAFIL 20 mg/stuk

MAH:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC_code:

G04BE08

INN:

TADALAFIL 20 mg/stuk

pharmaceutical_form:

Filmomhulde tablet

composition:

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)

administration_route:

Oraal gebruik

therapeutic_area:

Tadalafil

authorization_date:

1900-01-01

PIL

Sandoz B.V.
Page 1/9
Quator 2,5/5/10/20 mg, filmomhulde tabletten
RVG 123026-123027-123028-123029
1313-V6
1.3.1.3 Bijsluiter
Januari 2024
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
QUATOR
® 2,5 MG, FILMOMHULDE TABLETTEN
QUATOR
®
5 MG, FILMOMHULDE TABLETTEN
QUATOR
® 10 MG, FILMOMHULDE TABLETTEN
QUATOR
®
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 name] will not help you if yo

SPC

Sandoz B.V.
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Quator 2,5/5/1020 mg, filmomhulde tabletten
RVG 123026-123027-123028-123029
1311-V7
1.3.1.1 Samenvatting van de Product kenmerken
Januari 2024
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Quator 2,5 mg, filmomhulde tabletten
Quator 5 mg, filmomhulde tabletten
Quator 10 mg, filmomhulde tabletten
Quator 20 mg, filmomhulde tabletten
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
Quator 2,5/5/1020 mg, filmomhulde tabletten
RVG 123026-123027-123028-123029
1311-V7
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 shaped film-coated tablet of approximately 11 x
6 mm. On one side debossed
with “10”. The other side of the tablet is plain.
<{[NATIONALLY C