Etoricoxib Teva Tablet, film coated 60mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ETORICOXIB

Available from:

TEVA NETHERLAND BV Swensweg 5, 2031 GA HAARLEM, Netherlands

ATC code:

M01AH05

INN (International Name):

ETORICOXIB 60 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ETORICOXIB 60 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Withdrawn

Authorization date:

2016-03-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
Etoricoxib Teva 30 mg Film-coated Tablets
Etoricoxib Teva 60 mg Film-coated Tablets
Etoricoxib Teva 90 mg Film-coated Tablets
Etoricoxib Teva 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 Teva is and what it is used for
2.
What you need to know before you take Etoricoxib Teva
3.
How to take Etoricoxib Teva
4.
Possible side effects
5.
How to store Etoricoxib Teva
6.
Contents of the pack and other information
1. WHAT ETORICOXIB TEVA IS AND WHAT IT IS USED FOR
WHAT IS ETORICOXIB TEVA?

Etoricoxib Teva contains the active substance etoricoxib. Etoricoxib
Teva 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 TEVA USED FOR?

Etoricoxib Teva 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 Teva 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 disea

Summary of Product characteristics

Page 1 of 20
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Etoricoxib Teva 30 mg Film-coated Tablets
Etoricoxib Teva 60 mg Film-coated Tablets
Etoricoxib Teva 90 mg Film-coated Tablets
Etoricoxib Teva 120 mg Film-coated Tablets
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.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
30 mg Tablets: Blue, round biconvex film-coated tablet, debossed "30"
on one side and plain on the
other, approx. 6 mm diameter.
60 mg Tablets: Dark green, round biconvex film-coated tablet, debossed
"60" on one side and plain
on the other, approx. 8 mm diameter.
90 mg Tablets: White, round biconvex film-coated tablet, debossed "90"
on one side and plain on
the other, approx. 9 mm diameter.
120 mg Tablets: Pale-green, round biconvex film-coated tablet,
debossed "120" on one side and
plain on the other, approx. 10 mm diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Etoricoxib Teva 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 Teva 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 used. The patient's need for
symptomatic relief and re