Etoricoxib Actavis 120 mg film-coated tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ETORICOXIB

Available from:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

ATC code:

M01AH05

INN (International Name):

ETORICOXIB 120 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ETORICOXIB 120 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2017-01-02

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ETORICOXIB ACTAVIS 30 MG FILM-COATED TABLETS
ETORICOXIB ACTAVIS
60 MG FILM-COATED TABLETS
ETORICOXIB ACTAVIS 90 MG FILM-COATED TABLETS
ETORICOXIB ACTAVIS 120 MG FILM-COATED TABLETS
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 Actavis is and what it is used for
2.
What you need to know before you take Etoricoxib Actavis
3.
How to take Etoricoxib Actavis
4.
Possible side effects
5.
How to store Etoricoxib Actavis
6.
Contents of the pack and other information
1.
WHAT ETORICOXIB ACTAVIS IS AND WHAT IT IS USED FOR
WHAT IS ETORICOXIB ACTAVIS?
-
Etoricoxib Actavis contains the active substance etoricoxib.
Etoricoxib Actavis 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).
WHAT IS ETORICOXIB ACTAVIS USED FOR?
-
Etoricoxib Actavis 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 Actavis 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 ARTHRIT

Summary of Product characteristics

Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Etoricoxib Actavis 30 mg film-coated tablets
Etoricoxib Actavis 60 mg film-coated tablets
Etoricoxib Actavis 90 mg film-coated tablets
Etoricoxib Actavis 120 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30, 60, 90 or 120 mg of etoricoxib.
Excipients with known effect:
30 mg tablet: 0.72 mg lactose monohydrate
60 mg tablet: 1.44 mg lactose monohydrate
90 mg tablet: 2.16 mg lactose monohydrate
120 mg tablet: 2.88 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
30 mg tablet: White to off white, 8.5 x 4.25 mm oval film-coated
tablet debossed '716' on one
side and 'A' on the other side.
60 mg tablet: White to off white, 11.5 x 5.75 mm oval film-coated
tablet debossed '722' on
one side and 'A' on the other side.
90 mg tablet: White to off white, 12.5 x 6.25 mm oval film-coated
tablet debossed '729' on
one side and 'A' on the other side.
120 mg tablet: White to off white, 13.5 x 6.75 mm oval film-coated
tablet debossed '752' on
one side and 'A' on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Etoricoxib Actavis 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 Actavis 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).
Page 2 of 20
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 lowest effective daily dose should
be