Arcoxia 90 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Etoricoxib

Available from:

Merck Sharp & Dohme BV,

ATC code:

M01AH; M01AH05

INN (International Name):

Etoricoxib

Dosage:

90 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Coxibs; etoricoxib

Authorization status:

Marketed

Authorization date:

2002-10-11

Patient Information leaflet

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.
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

Summary of Product characteristics

Health Products Regulatory Authority
24 May 2021
CRN009Y29
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arcoxia 90 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 90 mg of etoricoxib.
Excipients with known effect:
90 mg tablet: 4.0 mg lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets (tablets).
90 mg tablets: White, apple-shaped, biconvex tablets debossed
‘202’ on one side and ‘ARCOXIA 90’ 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.
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 and response to therapy should be
re-evaluated periodically, especially in patients with osteoarthritis
(see sections 4.3, 4.4, 4.8 and 5.1).
_Osteoarthritis_
The recommended dose is 30 mg once daily. In some patients with
insufficient relief from symptoms, an increased dose of 60
mg once daily may increase efficacy. In the absence of an increase in
therapeutic benefit, other therapeutic options should be
considered.
_Rheumatoid arthritis_
The recommended dose is 60 mg once daily. In some patients with
insufficient relief from symptoms, an increased dose of 90
mg once daily may increase effic