CELECOXIB APOTEX celecoxib 100 mg capsule blister pack

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Principio attivo:

celecoxib, Quantity: 100 mg

Commercializzato da:

Arrotex Pharmaceuticals Pty Ltd

INN (Nome Internazionale):

Celecoxib

Forma farmaceutica:

Capsule, hard

Composizione:

Excipient Ingredients: croscarmellose sodium; Gelatin; lactose monohydrate; magnesium stearate; colloidal anhydrous silica; sodium lauryl sulfate; titanium dioxide; povidone; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Via di somministrazione:

Oral

Confezione:

20, 50, 10, 60

Tipo di ricetta:

(S4) Prescription Only Medicine

Indicazioni terapeutiche:

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.

Dettagli prodotto:

Visual Identification: Opaque, white to off-white capsules imprinted with 'CC' and '100' in black ink.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Stato dell'autorizzazione:

Licence status A

Data dell'autorizzazione:

2014-05-29

Foglio illustrativo

CELECOXIB APOTEX CAPSULES
1
CELECOXIB APOTEX
CAPSULES
_Contains the active ingredient 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
Celecoxib APOTEX. It contains the
active ingredient celecoxib.
It 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 Coxibs which are
used to relieve pain and
inflammation in a number of
conditions. Although Celecoxib
APOTEX can relieve

Scheda tecnica

1
AUSTRALIAN PRODUCT INFORMATION –
CELECOXIB APOTEX (CELECOXIB) CAPSULES
1
NAME OF THE MEDICINE
Celecoxib
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg or 200 mg celecoxib as the active
ingredient.
Excipients with known effect:
lactose monohydrate.
For the full list of excipients see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Capsule, hard.
100 mg capsules: opaque, white to off-white capsules imprinted with
‘CC’ and ‘100’ in black
ink.
200 mg capsules: white to off-white capsules imprinted with ‘CC’
and ‘200’ in black ink.
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 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
regard to efficacy, risk
factors and ongoing need for treatment.
Adults
_Osteoarthritis _
200 mg taken once daily or in two divided doses.
_Rheumatoid arthritis _
200 mg taken in two divided doses.
2
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 once daily or in two divided
doses.
_Primary dysmenorrhoea _
400 mg as a single dose or divided on the first day, followed by 200
mg once daily 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 surgery or musculoskeletal and/or soft tissue
injury _
Loading dose of 400 mg then 200 mg once