Arcoxia 90 mg film-coated tablets

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Etoricoxib

MAH:

PCO Manufacturing Ltd.

ATC_code:

M01AH05

INN:

Etoricoxib

dosage:

90 milligram(s)

pharmaceutical_form:

Film-coated tablet

prescription_type:

Product subject to prescription which may be renewed (B)

therapeutic_area:

etoricoxib

authorization_status:

Authorised

authorization_date:

2006-04-07

PIL

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ARCOXIA
® 30 MG FILM-COATED TABLETS
ARCOXIA
®
60 MG FILM-COATED TABLETS
ARCOXIA
®
90 MG FILM-COATED TABLETS
ARCOXIA
®
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 Arcoxia is and what it is used for
2.
What you need to know before you take Arcoxia
3.
How to take Arcoxia
4.
Possible side effects
5.
How to store Arcoxia
6.
Contents of the pack and other information
1.
WHAT ARCOXIA IS AND WHAT IT IS USED FOR
WHAT IS ARCOXIA?

Arcoxia contains the active substance etoricoxib. Arcoxia 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 ARCOXIA USED FOR?

Arcoxia 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.

Arcoxia 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 movemen

SPC

Health Products Regulatory Authority
08 June 2022
CRN00CZ14
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arcoxia 90 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 90 mg of etoricoxib.
Excipient with known effect: lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from Spain, Greece and Romania:_
White, apple-shaped, biconvex film-coated tablets marked ‘Arcoxia
90’ on one side and '202' on the other.
_Product imported from Italy:_
White apple-shaped, biconvex, film-coated tablets which are marked
with ‘ARCOXIA 90’ on one side and ‘202’ on the other.
Or
White apple-shaped, biconvex, film-coated tablets which are blank on
one side and marked with ‘202’ on the other.
4 CLINICAL PARTICULARS
As per PA0964/009/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0964/009/003
5.1 PHARMACODYNAMIC PROPERTIES
M01AH
M01AH05
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Core:
Calcium hydrogen phosphate anhydrous
Croscarmellose sodium
Magnesium stearate
Microcrystalline cellulose.
_Tablet coating:_
Carnauba wax
Lactose monohydrate
Hypromellose
Titanium dioxide (E171)
Triacetin
Health Products Regulatory Authority
08 June 2022
CRN00CZ14
Page 2 of 2
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in the original package in order to protect from moisture. Do
not store above 25
o
C.
6.5 NATURE AND CONTENTS OF CONTAINER
Blisters in packs containing 28 or 30 tablets.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements.
Any unused medicinal product or waste material should be disposed of
in accordance with the local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Busine