Etoricoxib 60mg tablets

Land: Storbritannien

Språk: engelska

Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiva substanser:

Etoricoxib

Tillgänglig från:

DE Pharmaceuticals

ATC-kod:

M01AH05

INN (International namn):

Etoricoxib

Dos:

60mg

Läkemedelsform:

Oral tablet

Administreringssätt:

Oral

Klass:

No Controlled Drug Status

Receptbelagda typ:

Valid as a prescribable product

Produktsammanfattning:

BNF: 10010100

Bipacksedel

ARCOXIA 60MG TABLETS/ETORICOXIB 60MG TABLETS
(etoricoxib)
®
Ref: 0898/130519/1/F
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 60mg Tablets / Etoricoxib 60mg Tablets
and
will be referred to as Arcoxia throughout the leaflet. Other strengths
are
available.
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 in

Produktens egenskaper

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Etoricoxib
60 mg film-coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH film-COATED TABLET CONTAINS 60 MG OF ETORICOXIB.
Excipient with known effect: Also contains 1.68 mg of lactose
monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Film-coated tablet
60 mg: Green, round, biconvex, film-coated tablets debossed with
‘444’ on
one side and ‘L’ on other side. The tablet diameter is 8.00 mm.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Etoricoxib 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.
Etoricoxib 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 with
insufficient
relief from symptoms, an increased dose of 60 mg once daily may
increase
efficacy. In the absence of an increase in therapeutic benefit, other
therapeutic
options should be considered.
_Rheumatoid arthritis _
The recommended dose is 60 mg once daily.
In some patients with insufficient
relief from symptoms, an increased dose of 90 mg once daily may
increase
efficacy. Once the patient is clinically stabilised, down-