Etoriax 90mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ETORICOXIB

Available from:

TAD Pharma GmbH Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany

ATC code:

M01AH05

INN (International Name):

ETORICOXIB 90 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

ETORICOXIB 90 mg

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2018-08-03

Patient Information leaflet

1
PACKAGE LEAFLET
PAGE 2 OF 8
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ETORIAX 90 MG FILM-COATED TABLETS
ETORIAX 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 Etoriax is and what it is used for
2.
What you need to know before you take Etoriax
3.
How to take Etoriax
4.
Possible side effects
5.
How to store Etoriax
6.
Contents of the pack and other information
1.
WHAT ETORIAX IS AND WHAT IT IS USED FOR
WHAT IS ETORIAX
•
Etoriax contains the active substance etoricoxib. Etoriax 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 ETORIAX USED FOR?
•
Etoriax 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.
•
Etoriax 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 affects. It
may also cause inflammation in
other are

Summary of Product characteristics

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NAME OF THE MEDICINAL PRODUCT
1.
NAME OF THE MEDICINAL PRODUCT
Etoriax 90 mg film-coated tablets
Etoriax 120 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 90 or 120 mg etoricoxib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Etoriax 90 mg film-coated tablets
Pink, round (diameter: 9 mm), biconvex, film coated tablets with
beveled edges, engraved with mark
“90” on one side of the tablet.
Etoriax 120 mg film-coated tablets
Brownish red, round (diameter: 10 mm), slightly biconvex, film coated
tablets with beveled edges,
scored on one side of the tablet. The score line is not intended for
breaking the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Etoriax 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.
Etoriax 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 _
PAGE 2 OF 18
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