Etoricoxib DOC Generici 60 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

ETORICOXIB 60 mg/stuk

Beschikbaar vanaf:

DOC Generici S.r.l. Via Filippo Turati 40 20121 MILANO (ITALIË)

ATC-code:

M01AH05

INN (Algemene Internationale Benaming):

ETORICOXIB 60 mg/stuk

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; TITAANDIOXIDE (E 171), CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Etoricoxib

Product samenvatting:

Hulpstoffen: CALCIUMWATERSTOFFOSFAAT 0-WATER (E 341); CELLULOSE, MICROKRISTALLIJN (E 460); CROSCARMELLOSE NATRIUM (E 468); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); TITAANDIOXIDE (E 171);

Autorisatie datum:

2015-12-28

Bijsluiter

Dec 2015: Marketing Authorisation – var 02: proposed text
Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
ETORICOXIB DOC GENERICI 60 MG FILMOMHULDE TABLETTEN
ETORICOXIB DOC GENERICI 90 MG FILMOMHULDE TABLETTEN
ETORICOXIB DOC GENERICI 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 [Product name] is and what it is used for
2.
What you need to know before you take [Product name]
3.
How to take [Product name]
4.
Possible side effects
5.
How to store [Product name]
6.
Contents of the pack and other information
1
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR

[Product name] contains the active substance etoricoxib, and is one of
a group of medicines
called selective 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 long term inflammatory disease of the
joints. It

Productkenmerken

SAMENVATTING VAN DE PRODUCTKENMERKEN
Page 1 of 20
1.
NAME OF THE MEDICINAL PRODUCT
Etoricoxib DOC Generici 60 mg filmomhulde tabletten
Etoricoxib DOC Generici 90 mg filmomhulde tabletten
Etoricoxib DOC Generici 120 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 60, 90 or 120 mg of etoricoxib.
Excipient(s) with known effect
60 mg: each tablet contains 2.5 mg lactose (as monohydrate).
90 mg: each tablet contains 3.7 mg lactose (as monohydrate).
120 mg: each tablet contains 4.9 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
60 mg tablet: White round biconvex film-coated tablet (approximately 8
mm) debossed with “E9OX” on one
side and “60” on the other side.
90 mg tablet: White round biconvex film-coated tablet (approximately 9
mm) debossed with “E9OX” on one
side and “90” on the other side.
120 mg tablet: White round biconvex film-coated tablet (approximately
10 mm) debossed with “E9OX” on
one side and “120” on the other side.
Dec 2015: Marketing Authorisation – Jul 2017: approval var IB/002
– July 2018: approval var. IB/003 – Apr
2020: renewal approval
Page 2 of 20
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 short-term treatment of
moderate pain associated with dental surgery.
The decision to prescribe a selective COX-2 inhibitor should be based
on an assessment of the individual
patient's overall risks (see sections 4.3, 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
As the cardiovascular risks of etoricoxib may increase with dose and
duration of exposure, the shortest
duration possible and the lo