Arcoxia 90 mg film-coated tablets

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Etoricoxib

थमां उपलब्ध:

LTT Pharma Limited

ए.टी.सी कोड:

M01AH; M01AH05

INN (इंटरनेशनल नाम):

Etoricoxib

डोज़:

90 milligram(s)

फार्मास्यूटिकल फॉर्म:

Film-coated tablet

प्रिस्क्रिप्शन प्रकार:

Product subject to prescription which may be renewed (B)

चिकित्सीय क्षेत्र:

Coxibs; etoricoxib

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2012-06-01

सूचना पत्रक

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
and redness in the joints. It is caused by deposits of mineral
crystals in

उत्पाद विशेषताएं

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 90mg of etoricoxib.
Excipient with known effect:
lactose monohydrate
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet/tablet.
_Product imported from Italy_
90 mg Tablets: White, apple-shaped, biconvex tablets debossed
‘202’ on one side and plain 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
Titanium dioxide (E171)
Triacetin.
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf life expiry date for 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
Blisters: Store in the original package in order to protect from
moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Aluminum/aluminium blisters in packs containing 30 tablets.
Not all pack sizes may be marketed.
6.6 SPECIAL PRECAU