Arcoxia 30 mg film-coated tablets

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Etoricoxib

Disponibil de la:

PCO Manufacturing Ltd.

Codul ATC:

M01AH05

INN (nume internaţional):

Etoricoxib

Dozare:

30 milligram(s)

Forma farmaceutică:

Film-coated tablet

Tip de prescriptie medicala:

Product subject to prescription which may be renewed (B)

Zonă Terapeutică:

etoricoxib

Statutul autorizaţiei:

Authorised

Data de autorizare:

2010-10-08

Prospect

_ _
_ _
_ _
_ _
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 movement

Caracteristicilor produsului

Health Products Regulatory Authority
07 June 2022
CRN00CZ0V
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arcoxia 30 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 30mg of etoricoxib.
Excipient with known effect: lactose (as monohydate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablets (tablets)
_Product imported from France:_
Blue-green, apple-shaped biconvex tablets debossed '101' on one side
and 'ACX 30' on the other side.
4 CLINICAL PARTICULARS
As per PA0964/009/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0964/009/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Core:_
Calcium hydrogen phosphate (anhydrous)
Croscarmellose sodium
Magnesium stearate
Microcrystalline cellulose
_Tablet coating:_
Camauba wax
Lactose monohydrate
Hypromellose
Titanium dioxide (El7l)
Triacetin
Indigo carmine lake (E132)
Yellow ferric oxide (EI72).
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
Health Products Regulatory Authority
07 June 2022
CRN00CZ0V
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in the original package in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium blisters in packs containing 28 tablets
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
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 Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/176/004
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 8th of October 2010
10 DATE OF REVISION OF THE TEXT
June 2022