Arcoxia

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Etoricoxib 90mg; Etoricoxib 90mg

Available from:

Organon (New Zealand) Limited

INN (International Name):

Etoricoxib 90 mg

Dosage:

90 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Etoricoxib 90mg Excipient: Calcium hydrogen phosphate Carnauba wax Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Opadry white 39K18305 Purified water Active: Etoricoxib 90mg Excipient: Calcium hydrogen phosphate dihydrate Carnauba wax Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Opadry white 39K18305 Purified water

Units in package:

Blister pack, Sample, 10 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

MSD International GmbH (Singapore Branch)

Therapeutic indications:

Arcoxia is indicated for: · Acute and chronic treatment of the signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA) · The management of ankylosing spondylitis (AS) · Treatment of acute gouty arthritis · Relief of acute pain, including pain related to minor dental procedures · Relief of chronic musculoskeletal pain The decision to prescribe a selective COX-2 inhibitor should only be made: · if non-pharmacological interventions and simple analgesic therapy i.e.paracetamol have been tried and found to lack analgesic efficacy or to have unacceptable adverse effects in the individual patient; and · after assessment of the individual patient's overall risk factors for developing severe adverse events e.g. history of cardiovascular, renal or gastrointestinal disease.

Product summary:

Package - Contents - Shelf Life: Blister pack, Sample - 10 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, - 30 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2001-09-14

Patient Information leaflet

ARCOXIA
®
TABLETS
1
New Zealand Consumer Medicine Information
ARCOXIA
®
_Etoricoxib_
30 mg, 60 mg, 90 mg & 120 mg tablets
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using ARCOXIA.
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:
•
acute and chronic treatment of the signs and symptoms of
osteoarthritis (OA) and
rheumatoid arthritis (RA)
•
management of ankylosing spondylitis
•
relief of chronic musculoskeletal pain
•
relief of acute pain, including pain associated with minor dental
procedures
•
to treat acute gouty arthritis
Your doctor will prescribe ARCOXIA for you only after you have used
other medicines, i.e
paracetamol for your condition and it has not been suitable for you.
Your doctor will want to discuss your treatment with ARCOXIA from time
to time. It is
important that you use the lowest dose that controls your pain and you
should not take
ARCOXIA for longer than necessary. This is because the risk of heart
attacks and strokes
might increase after prolonged treatment, especially with high doses.
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
develop

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Page 1 of 29
1 ARCOXIA® (etoricoxib) film coated tablets
ARCOXIA® 30mg film coated tablets
ARCOXIA® 60mg film coated tablets
ARCOXIA® 90mg film coated tablets
ARCOXIA® 120mg 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 tablet: 1.4 mg lactose (as monohydrate)
60 mg tablet: 2.8 mg lactose (as monohydrate)
90 mg tablet: 4.2 mg lactose (as monohydrate)
120 mg tablet: 5.6 mg lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
30mg tablet: A blue green apple shaped biconvex film coated tablet
debossed 101 on one
side and ACX 30 on the other. Dimensions are 5.69 mm x 5.54 mm.
60mg tablet: A dark green apple shaped biconvex film coated tablet
debossed 200 on one
side and ARCOXIA 60 on the other. Dimensions are 7.16 mm x 6.99 mm.
90mg tablet: A white apple shaped biconvex film coated tablet debossed
202 on one side
and ARCOXIA 90 on the other. Dimensions are 8.20 mm x 8.00 mm.
120mg tablet: A pale green apple shaped biconvex film coated tablet
debossed 204 on one
side and ARCOXIA 120 on the other. Dimensions are 9.03 mm x 8.80 mm.
Do not halve tablet. Studies on divided tablets have not been
performed.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
ARCOXIA is indicated for:
•
Acute and chronic treatment of the signs and symptoms of
osteoarthritis (OA)
and
rheumatoid arthritis (RA)
•
The management of ankylosing spondylitis (AS)
•
Treatment of acute gouty arthritis
•
Relief of acute pain, including pain related to minor dental
procedures
•
Relief of chronic musculoskeletal pain
The decision to prescribe a selective COX-2 inhibitor should only be
made:
NEW ZEALAND DATA SHEET
Page 2 of 29
•
if non-pharmacological interventions and simple analgesic therapy i.e
paracetamol have
been tried and found to lack analgesic efficacy or to have
unacceptable adverse effects
in
the individual patient; and
•
after assessment of