Quator 10 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

TADALAFIL

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

G04BE08

INN (Algemene Internationale Benaming):

TADALAFIL

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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:

2017-02-15

Bijsluiter

Sandoz B.V.
Page 1/10
Quator Sandoz 2,5/5/10/20 mg, filmomhulde tabletten
RVG 118135-40-1-2
1313-V7
1.3.1.3 Leaflet
Juni 2022
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
_ _
_For medicines available only on prescription: _
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.
_For medicines available without a prescription: _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
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.
-
You must talk to a doctor if you do not feel better or if you feel
worse.
[To be completed nationally]
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
m

Productkenmerken

Sandoz B.V.
Page 1/27
Quator Sandoz 2,5/5/10/20 mg, filmomhulde tabletten
RVG 118135-40-1-2
1311-v9
1.3.1.1 Samenvatting van de Productkenmerken
Juni 2022
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
Each film-coated tablet contains 2.5 mg of tadalafil.
Excipient with known effect
Each tablet contains 41.9 mg lactose (as monohydrate).
Each film-coated tablet contains 5 mg of tadalafil.
Excipient with known effect
Each tablet contains 83.8 mg lactose (as monohydrate).
Each film-coated tablet contains 10 mg of tadalafil.
Excipient with known effect
Each tablet contains 167.7 mg lactose (as monohydrate).
Each film-coated tablet contains 20 mg of tadalafil.
Excipient with known effect
Each tablet contains 335.4 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
_2.5 mg 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.
Sandoz B.V.
Page 2/27
Quator Sandoz 2,5/5/10/20 mg, filmomhulde tabletten
RVG 118135-40-1-2
1311-v9
1.3.1.1 Samenvatting van de Productkenmerken
Juni 2022
_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 quarters.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
[Nationally completed nam