APO-CELECOXIB Celecoxib 100 mg capsule blister pack

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

celecoxib

Tillgänglig från:

Apotex Pty Ltd

INN (International namn):

Celecoxib

Bemyndigande status:

Registered

Bipacksedel

APO-CELECOXIB
CAPSULES
_Celecoxib_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about celecoxib. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Celecoxib. It contains the active
ingredient celecoxib.
Celecoxib is used to treat:
•
osteoarthritis
•
rheumatoid arthritis
•
ankylosing spondylitis, a chronic
inflammatory rheumatic disorder
that primarily affects, but is not
limited to, the spine.
Celecoxib also provides short term
pain relief in conditions such as:
•
menstrual cramps or period pain
•
after surgery
•
muscle and joint injuries.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS_
Celecoxib belongs to a group of
medicines called NSAIDs which are
used to relieve pain and
inflammation in a number of
conditions.
There is no evidence that this
medication is addictive.
_USE IN CHILDREN_
This medicine should not

Produktens egenskaper

1
AUSTRALIAN PRODUCT INFORMATION
APO-CELECOXIB (CELECOXIB) CAPSULES
1
NAME OF THE MEDICINE
Celecoxib
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100mg and 200mg celecoxib as the active
ingredient.
EXCIPIENTS WITH KNOWN EFFECT
Lactose monohydrate, gelatin, sulfites (as residue).
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS
3
PHARMACEUTICAL FORM
APO-CELECOXIB 100 MG CAPSULES
Opaque, white capsules with 2 blue bands and marked "100" on the body.
APO-CELECOXIB 200 MG CAPSULES
Opaque, white capsules with 2 gold bands and marked "200" on the body.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Symptomatic treatment of osteoarthritis, rheumatoid arthritis and
ankylosing spondylitis
•
Treatment of primary dysmenorrhoea in adults
•
Short-term treatment of acute pain in adults following surgery or
musculoskeletal and/or soft
tissue injury.
4.2
DOSE AND METHOD OF ADMINISTRATION
APO-Celecoxib capsules are intended for oral administration.
DOSAGE
As the cardiovascular (CV) risks of celecoxib may increase with dose
and duration of exposure,
the shortest duration possible and the lowest effective daily dose
should be used (see section
5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS).
Patients on long-term treatment should be reviewed regularly with
regards to efficacy, risk
factors and ongoing need for treatment.
ADULTS
OSTEOARTHRITIS
The usual recommended daily dose is 200 mg taken once daily (OD) or in
two divided doses.
2
RHEUMATOID ARTHRITIS
The recommended daily dose is 200 mg taken in two divided doses.
Up to 400 mg daily may be used for short-term management of disease
flares or exacerbations.
ANKYLOSING SPONDYLITIS
The maximum daily dose is 200 mg taken OD or in two divided doses.
PRIMARY DYSMENORRHOEA
400 mg as a single dose or divided on the first day, followed by 200
mg OD on subsequent
days. Patients may be instructed to take an additional dose of 200 mg
on any given day, if
needed. The maximum recommended treatment duration is 5 days.
ACUTE PAIN FOLLOWING SURG