NOUMED CELECOXIB celecoxib 100 mg hard capsule blister pack

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

celecoxib, Quantity: 100 mg

Disponible desde:

AVALLON PHARMACEUTICALS PTY LTD

Designación común internacional (DCI):

Celecoxib

formulario farmacéutico:

Capsule, hard

Composición:

Excipient Ingredients: microcrystalline cellulose; carrageenan; Gelatin; magnesium stearate; sodium lauryl sulfate; lactose monohydrate; indigo carmine; titanium dioxide; purified talc; colloidal anhydrous silica

Vía de administración:

Oral

Unidades en paquete:

60

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

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.

Resumen del producto:

Visual Identification: 100 mg Capsules: Opaque, white capsules with blue cap.; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Estado de Autorización:

Licence status A

Fecha de autorización:

2017-06-08

Información para el usuario

NOUMED CELECOXIB
1
NOUMED CELECOXIB
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING NOUMED CELECOXIB?
NOUMED CELECOXIB contains the active ingredient celecoxib. NOUMED
CELECOXIB 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. NOUMED CELECOXIB also provides
short‐term pain relief in conditions such as menstrual cramps or
period pain, after surgery, muscle and joint injuries. For more
information, see Section 1. Why am I using NOUMED CELECOXIB? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NOUMED CELECOXIB?
Do not use if you have ever had an allergic reaction to celecoxib or
any of the ingredients listed at the end of the CMI. TALK TO
YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER
MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2.
What should I know before I use NOUMED CELECOXIB? in
the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with NOUMED CELECOXIB and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE NOUMED CELECOXIB?
•
Follow all directions given to you by your doctor and pharmacist
carefully. They may differ from the information in this
leaflet. If you do not understand the instructions on the label, ask
your doctor or pharmacist for help.
More instructions can be found in Section 4. How do I use NOUMED
CELECOXIB? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NOUMED CELECOXIB?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Noumed Celecoxib.
•
If you become pregnant while taking NOUMED CELECOXIB, tell your d

Ficha técnica

Product Information - Australia
Page 1 of 27
▼
This medicinal product is subject to additional monitoring in
Australia. This will allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse events at
https://www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION – NOUMED
CELECOXIB 100MG AND 200MG CAPSULES
(CELECOXIB)
1.
NAME OF THE MEDICINE
Celecoxib
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Noumed Celecoxib 100 mg capsule contains 100 mg celecoxib
Each Noumed Celecoxib 200 mg capsule contains 200 mg celecoxib
Excipients with known effect: Lactose
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3.
PHARMACEUTICAL FORM
100 mg Capsules: Opaque, white capsules with blue cap containing white
to slightly yellowish pellets.
200 mg Capsules: Opaque, white capsules with orange cap containing
white to slightly yellowish pellets.
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
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, such as
every three months, with regards to efficacy,
risk factors and ongoing need for treatment.
_ADULTS _
The following doses can be given without regard to timing of meals.
_OSTEOARTHRITIS _
The usual recommended daily dose is 200 mg taken in two divided doses.
_RHEUMATOID ARTHRITIS _
The recommended daily dose is 200 mg taken in two divided doses.
A dose of up to 400 mg daily may be used for short-term management of
disease flares or exacerbations.