CELEBREX celecoxib 100 mg capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

celecoxib, Quantity: 100 mg

Available from:

Viatris Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: lactose monohydrate; Gelatin; sodium lauryl sulfate; magnesium stearate; croscarmellose sodium; povidone; titanium dioxide; propylene glycol; indigo carmine; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution

Administration route:

Oral

Units in package:

60 capsules, 20 capsules, 10 capsules, 50 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the symptomatic treatment of osteoarthritis and rheumatoid arthritis and ankylosing spondylitis. For the treatment of primary dysmenorrhoea in adults. For the short term treatment of acute pain in adults following surgery or musculoskeletal and/or soft tissue injury.

Product summary:

Visual Identification: Opaque, white capsules with 2 blue bands marked "7767" and "100".; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1999-08-25

Patient Information leaflet

CELEBREX
®
_celecoxib_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Celebrex. 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 Celebrex
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 CELEBREX IS USED
FOR
Celebrex is used to relieve the
symptoms of joint pain, tenderness,
swelling and stiffness in:
•
osteoarthritis
•
rheumatoid arthritis
•
ankylosing spondylitis, a chronic
inflammatory rheumatic disorder
that primarily affects, but is not
limited to, the spine.
Celebrex also provides short-term
pain relief in conditions such as:
•
menstrual cramps or period pain
•
after surgery
•
muscle and joint injuries.
Celebrex contains celecoxib and
belongs to a group of medicines
called coxibs which are used to
relieve pain and inflammation in a
number of conditions.
Although Celebrex can relieve the
symptoms of pain and inflammation,
it will not cure your condition.
Your doctor, however, may have
prescribed Celebrex for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CELEBREX HAS
BEEN PRESCRIBED FOR YOU.
Celebrex is not recommended for use
in children or adolescents under 18
years of age.
This medicine is only available with
a doctor's prescription.
BEFORE YOU TAKE
CELEBREX
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE CELEBREX IF YOU
•
SUFFER FROM CHEST PAINS OR
ANGINA AND THEY OCCUR EVEN
WHEN YOU ARE RESTING AND ARE
BECOMING MORE FREQUENT,
SEVERE, OR LASTING LONGER THAN
USUAL
•
HAVE OR HAVE HAD PROBLEMS WITH
YOUR BLOOD CIRCULATION
•
HAVE OR IF YOUR DOCTOR HAS TOLD
YOU THAT SEVERE HEART OR BLOOD
VESSEL DISEASE AFFECTING THE
CIRCULATION IN YOUR BRAIN OR
LIMBS.
•
HAVE SEVERE LIVER PROBLEMS
Your doctor will decide if

Summary of Product characteristics

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Page 1 of 40
AUSTRALIAN PRODUCT
INFORMATION –
CELEBREX
® (CELECOXIB) CAPSULES
1.
NAME OF THE MEDICINE
Celecoxib
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each CELEBREX 100 mg capsule contains 100 mg celecoxib.
Each CELEBREX 200 mg capsule contains 200 mg celecoxib.
EXCIPIENT(S) WITH KNOWN EFFECT
CELEBREX
100 mg
and
200 mg
capsules
contain
149.7
mg
and
49.8
mg
of
lactose
monohydrate, respectively.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Capsule, hard.
CELEBREX 100 mg capsule is opaque, white capsules with 2 blue bands
marked 7767 and
100.
CELEBREX 200 mg capsule is opaque, white capsules with 2 gold bands
marked 7767 and
200.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For
the
symptomatic
treatment
of
osteoarthritis,
rheumatoid
arthritis
and
ankylosing
spondylitis.
For the treatment of primary dysmenorrhoea in adults.
For the short-term treatment of acute pain in adults following surgery
or musculoskeletal and/or
soft tissue injury.
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Page 2 of 40
4.2 DOSE AND METHOD OF 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 _
200 mg taken once daily (OD) or in two divided doses.
_Rheumatoid arthritis _
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