ARCOXIA etoricoxib 30mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

etoricoxib, Quantity: 30 mg

Available from:

ORGANON PHARMA PTY LTD

INN (International Name):

Etoricoxib

Pharmaceutical form:

Tablet

Composition:

Excipient Ingredients: microcrystalline cellulose; magnesium stearate; calcium hydrogen phosphate; Carnauba Wax; croscarmellose sodium; titanium dioxide; lactose monohydrate; hypromellose; triacetin; iron oxide yellow; indigo carmine aluminium lake

Administration route:

Oral

Units in package:

5 tablets, 10 tablets, 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Arcoxia is indicated for: - Symptomatic treatment of the signs and symptoms of osteoarthritis (OA). - Treatment of acute gouty arthritis. - Treatment of acute pain, including that related to primary dysmenorrhea and minor dental procedures. The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risks.

Product summary:

Visual Identification: Blue-green, apple-shaped, biconvex film coated tablet debossed "101" on one side and "ACX 30" on the other side; Container Type: Blister Pack; Container Material: PA/Al/PVC/Al - polyamide-aluminium foil-polyvinylchloride/aluminium foil; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2008-04-11

Patient Information leaflet

ARCOXIA
®
_Etoricoxib (pronounced ee-TOR-ee-cox-ib)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ARCOXIA. It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking ARCOXIA
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ARCOXIA IS
USED FOR
ARCOXIA is used for the following:
•
to treat the symptoms of
osteoarthritis
•
to treat gout attacks
•
to relieve short term pain,
including cramp-like pain or
discomfort before or during a
menstrual period, and pain
associated with minor dental
procedures.
OSTEOARTHRITIS
Osteoarthritis is a joint disease. It
results from the gradual breakdown
of the cartilage that covers the joints
and cushions the ends of bones.
Symptoms of osteoarthritis include
pain, tenderness, stiffness of one or
more joints, and physical disability.
The hips and knees are the most
commonly affected joints, but other
joints, such as those of the hands and
spine, may also be affected.
Osteoarthritis is more common in
women than in men. Many factors
can lead to the development of
osteoarthritis, including obesity and
joint injury (e.g. from sport).
GOUT
Gout is a disease that causes attacks
of arthritis, usually in a single joint.
The affected joint is red, swollen,
painful and extremely tender. A gout
attack usually lasts a few days and it
may recur.
For more information about
osteoarthritis or gout, contact the
Arthritis Foundation in the capital
city of your state.
_HOW ARCOXIA WORKS_
ARCOXIA belongs to a group of
medicines called Coxibs. It works in
a similar way to traditional anti-
inflammatory medicines, known as
Non-Steroidal Anti-Inflammatory
Drugs (NSAIDs), by blocking the
production of substances that cause
pain and inflammat

Summary of Product characteristics

Page 1 of 29
AUSTRALIAN PRODUCT INFORMATION
ARCOXIA
® (ETORICOXIB)
1
NAME OF THE MEDICINE
etoricoxib
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Etoricoxib
is
a
white
to
off-white
powder.
Etoricoxib
is
freely
soluble
in
methanol,
tetrahydrofuran, dimethyl sulfoxide, methyl ethyl ketone, dimethyl
formamide, and chloroform.
Etoricoxib is soluble in isopropyl acetate, ethanol and toluene,
sparingly soluble in 2-propanol,
and practically insoluble in water.
Each tablet of ARCOXIA for oral administration contains either 30, 60,
90 or 120 mg of
etoricoxib.
Excipients with known effect: lactose monohydrate
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
ARCOXIA (etoricoxib) 30 mg is a blue-green, apple-shaped, biconvex
film coated tablet
debossed "101" on one side and "ACX 30" on the other side.
ARCOXIA (etoricoxib) 60 mg is a dark green, apple-shaped, biconvex
film coated tablet
engraved "200" on one side and "ARCOXIA 60" on the other side.
ARCOXIA (etoricoxib) 90 mg is a white, apple-shaped, biconvex film
coated tablet debossed
"202" on one side and "ARCOXIA 90" on the other side.
ARCOXIA (etoricoxib) 120 mg is a pale green, apple-shaped, biconvex
film coated tablet
engraved "204" on one side and "ARCOXIA 120" on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ARCOXIA is indicated for:
•
Symptomatic treatment of the signs and symptoms of osteoarthritis (OA)
•
Treatment of acute gouty arthritis
•
Treatment of acute pain, including that related to primary
dysmenorrhoea and minor dental
procedures
The decision to prescribe a selective COX-2 inhibitor should be based
on an assessment of
the individual patient's overall risks.
4.2
DOSE AND METHOD OF ADMINISTRATION
ARCOXIA is administered orally. ARCOXIA may be taken with or without
food.
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. Patients on long
Page 2 of 29
term treatment sho