Etoricoxib Mylan 120 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ETORICOXIB

Beschikbaar vanaf:

Mylan B.V. Dieselweg 25 3752 LB BUNSCHOTEN

ATC-code:

M01AH05

INN (Algemene Internationale Benaming):

ETORICOXIB

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CARNAUBAWAS (E 903) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; INDIGOKARMIJN ALUMINIUMLAK (E 132) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Etoricoxib

Product samenvatting:

Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341); CARNAUBAWAS (E 903); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); INDIGOKARMIJN ALUMINIUMLAK (E 132); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisatie datum:

2015-09-14

Bijsluiter

1
Bijsluiter
Etoricoxib Mylan 30, 60, 90 en 120 mg, filmomhulde tabletten
RVG 115518, 9, 20, 21
Versie: november 2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Etoricoxib Mylan 30 mg, filmomhulde tabletten
Etoricoxib Mylan 60 mg, filmomhulde tabletten
Etoricoxib Mylan 90 mg, filmomhulde tabletten
Etoricoxib Mylan 120 mg, filmomhulde tabletten
etoricoxib
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 Etoricoxib Mylan is and what it is used for
2.
What you need to know before you take Etoricoxib Mylan
3.
How to take Etoricoxib Mylan
4.
Possible side effects
5.
How to store Etoricoxib Mylan
6.
Contents of the pack and other information
1.
WHAT ETORICOXIB MYLAN IS AND WHAT IT IS USED FOR
Etoricoxib Mylan is one of a group of medicines called selective
cyclooxygenase-2 (COX-2) inhibitors.
These belong to a family of medicines called non-steroidal
anti-inflammatory drugs (NSAIDs).
-
Etoricoxib helps to reduce the pain and swelling (inflammation) in the
joints and muscles of
people 16 years of age and older with osteoarthritis, rheumatoid
arthritis, ankylosing
spondylitis and gout.
-
Etoricoxib is also used for the short term treatment of moderate pain
after dental surgery in
people 16 years of age and older.
WHAT IS OSTEOARTHRITIS?
Osteoarthritis is a disease of the joints. It results from the gradual
breakdown of cartilage that cushions the
ends of the bones. This causes swelling (inflammation), pain,
tenderness, stiffness and disability.
WHAT IS RHEUMATOID ARTHRITIS?
Rheumatoid arthritis is a lo

Productkenmerken

1
Samenvatting van de Productkenmerken
Etoricoxib Mylan 30, 60, 90 en 120 mg, filmomhulde tabletten
RVG 115518, 9, 20, 21
Versie: September 2020
1.
NAME OF THE MEDICINAL PRODUCT
Etoricoxib Mylan 30 mg, filmomhulde tabletten
Etoricoxib Mylan 60 mg, filmomhulde tabletten
Etoricoxib Mylan 90 mg, filmomhulde tabletten
Etoricoxib Mylan 120 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30 mg of etoricoxib.
Each film-coated tablet contains 60 mg of etoricoxib.
Each film-coated tablet contains 90 mg of etoricoxib.
Each film-coated tablet contains 120 mg of etoricoxib.
Excipients with known effect:
Each film-coated tablet contains 0.80 mg lactose (as monohydrate).
Each film-coated tablet contains 1.60 mg lactose (as monohydrate).
Each film-coated tablet contains 2.39 mg lactose (as monohydrate).
Each film-coated tablet contains 3.19 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Blue green, film-coated, round, biconvex, bevelled edge tablet
debossed with ‘E’ on one side and
‘30’ on the other side, approximately 6.5 mm in diameter.
Green, film-coated, round, biconvex, bevelled edge tablet debossed
with ‘E’ on one side and
‘60’ on
the other side
, approximately 8 mm in diameter
.
White, film-coated, round, biconvex, bevelled edge tablet debossed
with ‘E’ on one side and
‘90’ on
the other side
, approximately 9 mm in diameter
.
Pale green, film-coated, round, biconvex, bevelled edge tablet
debossed with ‘E’ on one side and
‘120’ on the other side, approximately 10 mm in diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Etoricoxib is indicated in adults and adolescents 16 years of age and
older for the symptomatic relief
of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing
spondylitis, and the pain and signs of
inflammation associated with acute gouty arthritis.
Etoricoxib is indicated in adults and adolescents 16 years of age and
older for the