Arcoxia 120 mg film-coated tablets

国家: 爱尔兰

语言: 英文

来源: HPRA (Health Products Regulatory Authority)

有效成分:

Etoricoxib

可用日期:

LTT Pharma Limited

ATC代码:

M01AH; M01AH05

INN（国际名称）:

Etoricoxib

剂量:

120 milligram(s)

药物剂型:

Film-coated tablet

处方类型:

Product subject to prescription which may be renewed (B)

治疗领域:

Coxibs; etoricoxib

授权状态:

Marketed

授权日期:

2014-11-03

资料单张

ARCOXIA 120MG FILM-COATED TABLETS
(etoricoxib)
PATIENT INFORMATION LEAFLET
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
What Arcoxia is and what it is used for
What you need to know before you take Arcoxia
How to take Arcoxia
Possible side effects
How to store Arcoxia
Contents of the pack and other information
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 IS GOUT?
Gout is a disease of sudden, recurring attacks of very painful
inflammation
a

产品特点

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arcoxia 120 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 120mg of etoricoxib.
Excipients with known effect:
lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet).
_Product imported from Greece_
120 mg Tablets: Pale-green, apple-shaped, biconvex tablets debossed
‘204’ on one side and ‘ARCOXIA 120’ on the
other side.
4 CLINICAL PARTICULARS
As per PA1997/001/004
5 PHARMACOLOGICAL PROPERTIES
As per PA1997/001/004
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.
Indigo carmine lake (E 132)
Yellow ferric oxide (E 172)
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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.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in the original package in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Aluminum/aluminium blisters in packs con