Etoricoxib 30 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Etoricoxib

Available from:

Chanelle Medical Unlimited Company

ATC code:

M01AH; M01AH05

INN (International Name):

Etoricoxib

Dosage:

30 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:

2014-11-28

Patient Information leaflet

ID:
PL
171-174M
(DCP – IE)
VERSION:
10
REVISION DATE:
30/08/2022
Page 1 of 8
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 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).
•
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 cau

Summary of Product characteristics

Health Products Regulatory Authority
04 May 2023
CRN00DFDW
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Etoricoxib 30 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30 mg of etoricoxib.
Excipients with known effect: 2.52 mg lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Blue-green, apple-shaped, biconvex film coated tablets engraved
‘30’ on one face and other face plain
4 CLINICAL PARTICULARS
4.1 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.
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 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 a day. In some patients with
insufficient symptom relief, increasing the dose to 90 mg
once daily may increase efficacy. Once the patient is clinically
stable, a downward dose adjustment to 60 mg once daily may be
app