ETORICOXIB 60 Milligram Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ETORICOXIB

Available from:

Actavis Group PTC ehf

ATC code:

M01AH05

INN (International Name):

ETORICOXIB

Dosage:

60 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Coxibs

Authorization status:

Authorised

Authorization date:

2017-03-24

Patient Information leaflet

* Please note that ONLY Artwork Studio is permitted to make changes to
the above artwork.
No changes are permitted by any 3rd party other than added notes and
mark ups for required changes.
approved for print/date
PROOF ROUND
[e-mail]
Technical
Approval
NON PRINTING COLOURS
COLOURS
DATE SENT:
DATE RECEIVED:
Item no:
ORIGINATOR:
ORIGINATION DATE:
REVISION DATE:
REVISED BY:
DIMENSIONS:
MIN BODY TEXT SIZE:
SUPPLIER:
1.
2.
3.
4.
5.
6.
1.
2.
3.
ETORICOXIB 30MG, 60MG, 90MG & 120MG 28 TABLETS PIL - UK
Black
BBBA0322
S.Anson
12.12.16
13.12.16
S.Anson
190 x 380
9pts
Actavis Malta Zejtun
12.12.16
2
ETORICOXIB 30 MG, 60 MG, 90 MG
AND 120 MG FILM-COATED TABLETS
etoricoxib
_Continued top of next column_
_Continued over page_
PACKAGE LEAFLET: INFORMATION FOR THE USER
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
osteoarth

Summary of Product characteristics

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 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.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
__