Arcoxia 120mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ETORICOXIB

Available from:

Merck Sharp & Dohme B.V. Waarderweg 39, Haarlem Noord-Holland, 2031 BN, Netherlands

ATC code:

M01AH05

INN (International Name):

ETORICOXIB

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ETORICOXIB 120 milligram(s)

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2005-09-12

Patient Information leaflet

PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
ARCOXIA 30 mg film-coated tablets
ARCOXIA 60 mg film-coated tablets
ARCOXIA 90 mg film-coated tablets
ARCOXIA 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 ARCOXIA is and what it is used for
2.
What you need to know before you take ARCOXIA
3.
How to take ARCOXIA
4.
Possible side effects
5.
How to store ARCOXIA
6.
Contents of the pack and other information
1.
WHAT ARCOXIA IS AND WHAT IT IS USED FOR
WHAT IS ARCOXIA?

ARCOXIA contains the active substance etoricoxib. ARCOXIA 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 ARCOXIA USED FOR?

ARCOXIA 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.

ARCOXIA 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.
Page 3 of 11
WHAT IS RHEUMATOID ARTHRITIS?
Rheumatoid arthritis is a long term inflammatory disease of the
joints. It causes pain, stiffness,
swelling, and increasing l

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 22
1.
NAME OF THE MEDICINAL PRODUCT
ARCOXIA 30 mg film-coated tablets
ARCOXIA 60 mg film-coated tablets
ARCOXIA 90 mg film-coated tablets
ARCOXIA 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: 1.3 mg lactose (as monohydrate)
60 mg tablet: 2.7 mg lactose (as monohydrate)
90 mg tablet: 4.0 mg lactose (as monohydrate)
120 mg tablet: 5.3 mg lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets (tablets).
30 mg tablets: Blue-green, apple-shaped biconvex tablets debossed
‘101’ on one side and ‘ACX
30’ on the other side.
60 mg tablets: Dark green, apple-shaped, biconvex tablets debossed
‘200’ on one side and
‘ARCOXIA 60’ on the other side.
90 mg tablets: White, apple-shaped, biconvex tablets debossed
‘202’ on one side and ‘ARCOXIA
90’ on the other side.
120 mg tablets: Pale-green, apple-shaped, biconvex tablets debossed
‘204’ on one side and
‘ARCOXIA 120’ on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ARCOXIA 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.
ARCOXIA is indicated in adults and adolescents 16 years of age and
older for the short-term
treatment of moderate pain associated with dental surgery.
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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 lowest effective daily dose should
be used. The patient's need
for symptomatic relief