CELECOXIB SANDOZ celecoxib 100mg hard capsule blister pack
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
07-09-2021
Summary of Product characteristics
(SPC)
14-08-2021
Public Assessment Report
(PAR)
11-11-2017
Active ingredient:
celecoxib, Quantity: 100 mg
Available from:
Sandoz Pty Ltd
INN (International Name):
Celecoxib
Pharmaceutical form:
Capsule, hard
Composition:
Excipient Ingredients: microcrystalline cellulose; carrageenan; Gelatin; magnesium stearate; sodium lauryl sulfate; lactose monohydrate; indigo carmine; titanium dioxide; purified talc; colloidal anhydrous silica
Administration route:
Oral
Units in package:
60
Prescription type:
(S4) Prescription Only Medicine
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.
Product summary:
Visual Identification: 100 mg Capsules: Opaque, white capsules with blue cap.; Container Type: Blister Pack; Container Material: PVC/TE/PVDC/AI; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2014-05-12
Patient Information leaflet
CELECOXIB SANDOZ
®
1
CELECOXIB SANDOZ
®
_celecoxib _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CELECOXIB
SANDOZ. 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 CELECOXIB
SANDOZ against the benefits it is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
READ THIS LEAFLET CAREFULLY BEFORE
YOU START CELECOXIB SANDOZ
AND KEEP IT WITH THE MEDICINE.
You may need to read it again.
WHAT CELECOXIB
SANDOZ IS USED FOR
CELECOXIB SANDOZ is used to
relieve the symptoms of joint pain,
tenderness, swelling and stiffness in:
•
osteoarthritis,
•
rheumatoid arthritis and
•
ankylosing spondylitis, a chronic
inflammatory rheumatic disorder
that primarily affects, but is not
limited to, the spine.
CELECOXIB SANDOZ also
provides short-term pain relief in
conditions such as:
•
menstrual cramps or period pain
•
after surgery
•
muscle and joint injuries.
CELECOXIB SANDOZ belongs to a
group of medicines called coxibs
which are used to relieve pain and
inflammation in a number of
conditions.
Although CELECOXIB SANDOZ
can relieve the symptoms of pain and
inflammation, it will not cure your
condition.
Your doctor, however, may have
prescribed CELECOXIB SANDOZ
for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CELECOXIB
SANDOZ HAS BEEN PRESCRIBED FOR
YOU.
CELECOXIB SANDOZ 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
CELECOXIB SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CELECOXIB
SANDOZ IF:
•
YOU SUFFER FROM CHEST PAINS OR
ANGINA AND THEY OCCUR EVEN
WHEN YOU ARE RESTING AND ARE
BECOMING MORE FREQUENT,
SEVERE, OR LASTING FOR LONGER
THAN USUAL
•
YOU HAVE OR HAVE HAD PROBLEMS
WITH YOUR BLOOD CIRCULATION
•
YOUR DOCTOR H
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Summary of Product characteristics
210806-celecoxib-sandoz-pi
Page 1 of 35
AUSTRALIAN PRODUCT INFORMATION
CELECOXIB SANDOZ
® (CELECOXIB)
1
NAME OF THE MEDICINE
Celecoxib
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Celecoxib Sandoz
®
100 mg capsule contains 100 mg celecoxib.
Each Celecoxib Sandoz
®
200 mg capsule contains 200 mg celecoxib.
_Not all strengths may be marketed in Australia. _
_Excipient with known effect:_
Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Celecoxib Sandoz 100 mg capsules are opaque, white capsules with blue
cap containing white
to slightly yellowish pellets.
Celecoxib Sandoz 200 mg capsules are opaque, white capsules with
orange cap containing
white to slightly yellowish pellets.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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.
4.2
D
OSE 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, such as
every three months, with
regards to efficacy, risk factors and ongoing need for treatment.
_ADULTS_
_Osteoarthritis _
The usual recommended daily dose is 200 mg taken once daily or in two
divided doses.
_Rheumatoid Arthritis _
The recommended daily dose is 200 mg taken in two divided doses.
210806-celecoxib-sandoz-pi
Page 2 of 35
A dose of up to 400 mg daily may be used for short-term management of
disease flares or
exacerbations.
_Ankylosing Spondylitis _
The maximum recommended daily dose is 200 mg taken once daily or in
two divided doses.
_Primary Dysmenorrhoea _
The recommended dose is 400 mg as a single
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