CIPLA ETORICOXIB etoricoxib 30 mg tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

etoricoxib, Quantity: 30 mg

Available from:

Cipla Australia Pty Ltd

INN (International Name):

Etoricoxib

Pharmaceutical form:

Tablet, film coated

Composition:

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

Administration route:

Oral

Units in package:

10 tablets, 30 tablets

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CIPLA ETORICOXIB 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: Dark, green, apple-shaped, biconvex film coated tablet debossed with "C1" on one side and plain on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-10-18

Patient Information leaflet

Cipla Etoricoxib
1
CIPLA ETORICOXIB
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
Why am I using CIPLA ETORICOXIB?
CIPLA ETORICOXIB contains the active ingredient etoricoxib. CIPLA
ETORICOXIB is used to treat the symptoms of osteoarthritis,
gout attacks and to relieve short term pain, including cramp-like pain
or discomfort before or during a menstrual period and
pain associated with minor dental procedures. For more information,
see Section 1. Why am I using CIPLA ETORICOXIB? in the
full CMI.
2.
What should I know before I use CIPLA ETORICOXIB?
Do not use if you have ever had an allergic reaction to etoricoxib or
any of the ingredients listed at the end of the CMI. Talk to
your doctor if you have any other medical conditions, take any other
medicines, or are pregnant or plan to become
pregnant or are breastfeeding. Do not use at all during the last three
months of pregnancy. For more information, see Section
2. What should I know before I use CIPLA ETORICOXIB? in the full CMI.
3.
What if I am taking other medicines?
Some medicines may interfere with CIPLA ETORICOXIB and affect how it
works. A list of these medicines is in Section 3. What if
I am taking other medicines? in the full CMI.
4.
How do I use CIPLA ETORICOXIB?
•
For osteoarthritis, the recommended dose is 30 mg once a day,
increased to a maximum of 60 mg once a day if needed.
•
For the relief of gout attacks the recommended dose is 120 mg taken
once a day, which should only be used during the
painful period, to a maximum of 8 days treatment.
•
For the relief of cramp-like pain or discomfort before or during a
menstrual period, the recommended dose is 120 mg
taken once a day, which should only be used during the painful period,
to a maximum of 8 days treatment.
•
For the relief of short term pain after dental procedures, the
recommended dose is 90 mg taken once a day, which should
only be used during the painful perio

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION - CIPLA ETORICOXIB (Etoricoxib)
1
NAME OF THE MEDICINE
Etoricoxib
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of Cipla Etoricoxib for oral administration contains
either 30, 60, 90 or 120 mg of
etoricoxib.
Excipient with known effect
Contains lactose
For the full list of excipients, see Section 6.1 List of excipients
3
PHARMACEUTICAL FORM
Cipla Etoricoxib (etoricoxib) 30 mg are dark green, apple-shaped,
biconvex film coated tablet
debossed with "C1" on one side and plain on the other side
Cipla Etoricoxib (etoricoxib) 60 mg are white to off white,
apple-shaped, biconvex film coated tablet
debossed with "C2" on one side and plain on the other side.
Cipla Etoricoxib (etoricoxib) 90mg are dark green, apple-shaped,
biconvex film coated tablet debossed
with "C3" on one side and plain on the other side.
Cipla Etoricoxib (etoricoxib) 120 mgare dark green, apple-shaped,
biconvex film coated tablet
debossed with "C4" on one side and plain on the other side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cipla Etoricoxib 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
Cipla Etoricoxib is administered orally. Cipla Etoricoxib 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 term treatment
should be reviewed regularly with regards to efficacy, risk factors
and ongoing need for treatment.
Osteoarthritis
The recommended dose is 30 mg once daily. In some patients with
insufficient relief from symptoms,
the dose may be increased to 60 mg once daily. In the ab