Etoricoxib Tablet, film coated 60mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ETORICOXIB

Available from:

Chanelle Medical

ATC code:

M01AH05

INN (International Name):

ETORICOXIB

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ETORICOXIB 60 milligram(s)

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2016-03-04

Patient Information leaflet

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ETORICOXIB 30 MG FILM-COATED TABLETS
ETORICOXIB 60 MG FILM-COATED TABLETS
ETORICOXIB 90 MG FILM-COATED TABLETS
ETORICOXIB 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 is and what it is used for
2.
What you need to know before you take Etoricoxib
3.
How to take Etoricoxib
4.
Possible side effects
5.
How to store Etoricoxib
6.
Contents of the pack and other information
1.
WHAT ETORICOXIB IS AND WHAT IT IS USED FOR

Etoricoxib 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 with osteoarthritis, rheumatoid arthritis, ankylosing
spondylitis and gout.

Etoricoxib is also used for the short term treatment of moderate pain
after dental surgery.
Etoricoxib is indicated in adults and adolescents over 16 years of
age.
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 causes pain, stiffness,
swelling, and increasing loss of movement in the joints it affects. It
may also cause inflammation

Summary of Product characteristics

Page 1 of 19
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Etoricoxib 30 mg Film-coated Tablets
Etoricoxib 60 mg Film-coated Tablets
Etoricoxib 90 mg Film-coated Tablets
Etoricoxib 120 mg Film-coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Etoricoxib 30 mg:
Each film-coated tablet contains 30 mg of etoricoxib.
Excipients with known effect: 2.52 mg lactose (as lactose
monohydrate).
Etoricoxib 60 mg:
Each film-coated tablet contains 60 mg of etoricoxib.
Excipients with known effect: 5.04 mg lactose (as lactose
monohydrate).
Etoricoxib 90 mg:
Each film-coated tablet contains 90 mg of etoricoxib.
Excipients with known effect: 7.56 mg lactose (as lactose
monohydrate).
Etoricoxib 120 mg:
Each film-coated tablet contains 120 mg of etoricoxib.
Excipients with known effect: 10.08 mg lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Etoricoxib 30 mg: Blue-green, apple-shaped, biconvex film coated
tablets engraved ‘30’ on one
face and other face plain.
Etoricoxib 60 mg: Dark-green, apple-shaped, biconvex film coated
tablets engraved ‘60’ on one
face and other face plain.
Etoricoxib 90 mg: White, apple-shaped, biconvex film coated tablets
engraved ‘90’ on one face and
other face plain.
Etoricoxib 120 mg: Pale-green, apple-shaped, biconvex film coated
tablets engraved ‘120’ on one
face and other face plain.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Page 2 of 19
For the symptomatic relief of osteoarthritis (OA), rheumatoid
arthritis (RA), ankylosing spondylitis,
and the pain and signs of inflammation associated with acute gouty
arthritis.
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).
Etoricoxib is indicated in adults and adolescents over 16 years of
age.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
As