ETORICOXIB

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ETORICOXIB

Available from:

Generics (UK) Limited

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:

etoricoxib

Authorization status:

Marketed

Authorization date:

2015-09-11

Patient Information leaflet

Colours
Non-Print
Colours
Date:
Time:
Equate CMYK
with
Dimensions
Main Font
Body Text Size
Min Text Size used
Page Count
No. of colours
Pharma Code
SAP No.
Vendor Job No.
Trackwise Proof No.
Client Market
Keyline/Drawing No.
Barcode Info
Description
Component Type
Affiliate Item Code
Superceded Affiliate Item Code
TrackWise PR No.
MA No.
Packing Site/Printer
Supplier Code
Sign-offs
v2/Oct 2016
1/2
1
Myriad Pro
9 pt
9 pt
130 x 600mm
Etoricoxib 60 mg,30 mg,90 mg,120 mg
28,30,84,49,50,20,7,5,14,98,2,100,10
Leaflet
999393
n/a
999393
n/a
Mylan Laboratories
Ltd (Nashik - IN)
TBC
TBC
n/a
292084
6
IE, UK
n/a
n/a
Black
Codes
area
15 Dec 2016
15:53
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 which is one of
a group of medicines called selective
cyclooxygenase-2 (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 16 years

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Etoricoxib 60mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 60 mg of etoricoxib.
Excipients with known effect:
Each film-coated tablet contains 1.60 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Green, film-coated, round, biconvex, bevelled edge tablet debossed
with ‘E’ on one side and ‘60’ on the other side,
approximately 8 mm in diameter.
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 cyclooxygenase-2 (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 effic