Arcoxia 90 mg film-coated tablets

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Etoricoxib

Доступна з:

Imbat Limited

Код атс:

M01AH; M01AH05

ІПН (Міжнародна Ім'я):

Etoricoxib

Дозування:

90 milligram(s)

Фармацевтична форма:

Film-coated tablet

Тип рецепту:

Product subject to prescription which may be renewed (B)

Терапевтична области:

Coxibs; etoricoxib

Статус Авторизація:

Authorised

Дата Авторизація:

2012-06-28

інформаційний буклет

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ARCOXIA
® 90MG FILM-COATED TABLETS
(etoricoxib)
Your medicine is available using the above name but it will be
referred to as Arcoxia throughout this 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
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

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ARCOXIA 90mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 90mg of etoricoxib.
Excipients with known effect: lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from: Hungary and Spain_
White, apple-shaped, biconvex tablets debossed ‘202’ on one side
and ‘ARCOXIA 90’ on the other side.
_Product imported from: Italy_
White, apple-shaped, biconvex tablets debossed ‘202’ on one side
and plain on the other side.
4 CLINICAL PARTICULARS
As per PA1286/007/003
5 PHARMACOLOGICAL PROPERTIES
As per PA1286/007/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_Product imported from Hungary & Spain:_
_Core:_
Calcium hydrogen phosphate anhydrous
Croscarmellose sodium
Magnesium stearate
Microcrystalline cellulose
_Tablet coating:_
Carnauba wax
Lactose monohydrate
Hypromellose
Titanium dioxide (E171)
Triacetin
_Product imported from Italy:_
_Core:_
Calcium phosphate dibasic anhydrous
Croscarmellose sodium
Magnesium stearate
Microcrystalline cellulose
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_Tablet coating:_
Carnauba wax
Lactose monohydrate
Hypromellose
Titanium dioxide (E171)
Triacetin
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The she