CELECOXIB GH celecoxib 100 mg capsules blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

celecoxib, Quantity: 100 mg

Available from:

Lupin Australia Pty Limited

INN (International Name):

Celecoxib

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: croscarmellose sodium; lactose monohydrate; sodium lauryl sulfate; magnesium stearate; povidone; titanium dioxide; brilliant blue FCF; purified water; allura red AC; Gelatin; acetic acid; silicon dioxide; citric acid; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; ethanol absolute

Administration route:

Oral

Units in package:

60, 20, 50, 30, 10, 120

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: Size '3' hard gelatin capsule having Blue opaque cap imprinted with 'CX' in black ink and white opaque body with '100' in black ink. Containing white to off-white powder.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-06-13

Patient Information leaflet

CONSUMER MEDICINE INFORMATION
CELECOXIB GH
(CELECOXIB) CAPSULES
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Celecoxib GH. 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 GH 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 CELECOXIB GH IS
USED FOR
Celecoxib GH 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.
Celecoxib GH also provides
short term pain relief in
conditions such as:
•
Menstrual cramps or period
pain.
•
After surgery.
•
Muscle and joint injuries.
Celecoxib GH 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 celecoxib can relieve
the symptoms of pain and
inflammation, it will not cure your
condition.
Your doctor, however, may have
prescribed Celecoxib GH for
another purpose.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
CELECOXIB GH HAS BEEN
PRESCRIBED FOR YOU.
Celecoxib GH 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 GH
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CELECOXIB GH 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 LI

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – CELECOXIB GH
(CELECOXIB) CAPSULES
1
NAME OF THE MEDICINE
Celecoxib.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Celecoxib GH capsules containing 100 mg or 200 mg celecoxib.
List of excipients with known effects: lactose monohydrate.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Celecoxib GH capsules containing celecoxib 100 mg: Size ‘3’ hard
gelatin capsule having blue opaque
cap imprinted with ‘CX’ in black ink and white opaque body with
‘100’ in black ink. Containing white to
off-white powder.
Celecoxib GH capsules containing celecoxib 200 mg: Size ‘0’
elongated hard gelatin capsule having gold
opaque cap, imprinted with ‘CX’ in black ink and white opaque body
imprinted with ‘200’ in black ink
containing white to off-white powder.
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.
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.
Celecoxib GH v4
Page 2 of 36
(celecoxib) capsules
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 b