Etoricoxib 60 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Etoricoxib

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

M01AH; M01AH05

INN (International Name):

Etoricoxib

Dosage:

60 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Not applicable

Therapeutic area:

Coxibs; etoricoxib

Authorization status:

Not marketed

Authorization date:

2017-03-24

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ETORICOXIB 30 MG, 60 MG, 90 MG AND 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
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 increasing loss of movement in the joints it affects. It
may also cause inflammation in
other areas of the b

Summary of Product characteristics

Health Products Regulatory Authority
12 November 2018
CRN008M9D
Page 1 of 24
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Etoricoxib 60 milligram Film Coated Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 60 mg of etoricoxib.
Excipients with known effect:
60 mg tablet: 1.44 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
White to off white, 11.5 x 5.75 mm oval film-coated tablet debossed
'722' on one
side and 'A' on the other side.
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, 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
Health Products Regulatory Authority
12 November 2018
CRN008M9D
Page 2 of 24
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
insufficien