Arcoxia 90 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Etoricoxib

Available from:

Primecrown 2010 Limited

ATC code:

M01AH; M01AH05

INN (International Name):

Etoricoxib

Dosage:

90 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Coxibs; etoricoxib

Authorization status:

Authorised

Authorization date:

2012-05-04

Patient Information leaflet

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 in
the joints

Summary of Product characteristics

Health Products Regulatory Authority
23 November 2018
CRN008LM4
Page 1 of 3
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(s) with known effect
Lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
_Product imported from Portugal and Greece_
White, apple-shaped, biconvex tablets debossed ‘202’ on one side
and ‘ARCOXIA 90’
on the other side.
4 CLINICAL PARTICULARS
As per PA1997/001/003
5 PHARMACOLOGICAL PROPERTIES
As per PA1997/001/003
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
Health Products Regulatory Authority
23 November 2018
CRN008LM4
Page 2 of 3
Titanium dioxide (E171)
Triacetin
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blister 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.
6.5 NATURE AND CONTENTS OF CONTAINER
_Product imported from Portugal _
Blisters of 20 or 28 tablets
_Product imported from Greece _
Blisters of 14 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 local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Primecrown 2010 Limited
4/5 Northolt Trading Estate
Belvue Road
Northolt
Middlesex UB5 5QS
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1633/045/003
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Health Products Regulatory Authority
23 November 2018
CRN008LM4
Page 3 of 3
Date of first authorisation: 4
th
May 2