Arcoxia 120mg tablets

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Etoricoxib

Beszerezhető a:

Waymade Healthcare Plc

ATC-kód:

M01AH05

INN (nemzetközi neve):

Etoricoxib

Adagolás:

120mg

Gyógyszerészeti forma:

Oral tablet

Az alkalmazás módja:

Oral

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 10010100

Betegtájékoztató

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.
Your medicine is called Arcoxia 120mg film-coated tablets but will be
referred
to as Arcoxia throughout the leaflet.
Please note that the leaflet also contains information about other
strengths
of the medicine, Arcoxia 30mg film-coated tablets, Arcoxia 60mg
film-coated
tablets and Arcoxia 90mg film-coated tablets.
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?
R

Termékjellemzők

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 30, 60, 90 or 120 mg of etoricoxib.
Excipients with known effect:
30 mg: lactose 1.3 mg
60 mg: lactose 2.7 mg
90 mg: lactose 4.0 mg
120 mg: lactose 5.3 mg
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablets (tablets).
30 mg tablets: Blue-green, apple-shaped biconvex tablets debossed
‘101’ on one side
and ‘ACX 30’ on the other side.
60 mg tablets: Dark green, apple-shaped, biconvex tablets debossed
‘200’ on one side
and ‘ARCOXIA 60’ on the other side.
90 mg tablets: White, apple-shaped, biconvex tablets debossed
‘202’ on one side and
‘ARCOXIA 90’ on the other side.
120 mg tablets: Pale-green, apple-shaped, biconvex tablets debossed
‘204’ on one
side and ‘ARCOXIA 120’ on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ARCOXIA is indicated in adults and adolescents 16 years of age and
older for the
symptomatic relief of osteoarthritis (OA), rheumatoid arthritis (RA),
ankylosing
spondylitis, and the pain and signs of inflammation associated with
acute gouty
arthritis.
ARCOXIA is indicated in adults and adolescents 16 years of age and
older for the
short-term treatment of moderate pain associated with dental surgery.
The decision to prescribe a selective COX-2 inhibitor should be based
on an
assessment of the individual patient’s overall risks (see sections
4.3, 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
As the cardiovascular risks of etoricoxib may increase with dose and
duration of
exposure, the shortest duration possible and the lowest effective
daily dose should be
used. The patient's need for symptomatic relief and response to
therapy should be re-
evaluated periodically, especially in patients with osteoarthritis
(see sections 4.3, 4.4,
4.8 and 5.1).
_Osteoarthritis _
The recommended dose is 30 mg once daily. In some patients wit