Arcoxia 90 mg film-coated tablets

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Etoricoxib

Commercializzato da:

IMED Healthcare Ltd.

Codice ATC:

M01AH05

INN (Nome Internazionale):

Etoricoxib

Dosaggio:

90 milligram(s)

Forma farmaceutica:

Film-coated tablet

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

etoricoxib

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2010-08-06

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER
ARCOXIA® 60 mg film-coated tablets
ARCOXIA® 90 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 in the joints it affects. It
may also cause
inflammation in other areas of the body.
WHAT I

Scheda tecnica

Health Products Regulatory Authority
30 November 2021
CRN00CP6X
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.
Excipients with known effect:
90 mg tablet: 4.0 mg lactose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablets).
_Product imported from Romania_:
White, apple shaped, biconvex film-coated tablets debossed '202' on
one side and 'ARCOXIA 90' on the other side
4 CLINICAL PARTICULARS
As per PA0964/009/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0964/009/003
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
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
30 November 2021
CRN00CP6X
Page 2 of 2
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
blister strips and outer carton of the product on the market
in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 25° C. Store in the original package in order to protect
from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Aluminium/aluminium blisters in over-labelled cardboard cartons
containing 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/041/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 6
th
August 2010
10 DATE OF REVISION OF THE TEXT
November 2021