Etoricoxib 60 mg film-coated tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
07-03-2024
Summary of Product characteristics
(SPC)
07-03-2024
Active ingredient:
Etoricoxib
Available from:
Rowex Ltd
ATC code:
M01AH; M01AH05
INN (International Name):
Etoricoxib
Dosage:
60 milligram(s)
Pharmaceutical form:
Film-coated tablet
Administration route:
Oral use
Units in package:
5, 7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100 tablets
Prescription type:
Product subject to prescription which may be renewed (B)
Manufactured by:
Lek Pharmaceuticals d.d., Salutas Pharma GmbH, Pharmacare Premium Ltd, Delorbis Pharmaceuticals Ltd, Combino Pharm (Malta) Ltd,
Therapeutic group:
Anti-inflammatory and antirheumatic products, non-steroids, coxibs
Therapeutic area:
Coxibs; etoricoxib
Therapeutic indications:
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.
Authorization status:
Not marketed
Authorization date:
2015-06-26
Patient Information leaflet
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 TABLET
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
WHAT IS ETORICOXIB?
•
Etoricoxib contains the active substance etoricoxib. 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).
WHAT IS ETORICOXIB USED FOR?
•
Etoricoxib 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 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 increa
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
07 March 2024
CRN00F21J
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Etoricoxib 60 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 60 mg of etoricoxib.
Excipient with known effect
Each film-coated tablet contains 1.06 mg of lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Dark green, round, biconvex, film-coated tablets, with a diameter of
6.5 mm
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Etoricoxib 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 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 and 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 efficacy. Once t
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