CELEXI Celecoxib 200 mg capsule blister pack

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

celecoxib, Quantity: 200 mg

Предлага се от:

Arrotex Pharmaceuticals Pty Ltd

INN (Международно Name):

Celecoxib

Лекарствена форма:

Capsule, hard

Композиция:

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

Начин на приложение:

Oral

Броя в опаковка:

30 capsules

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

Celecoxib is indicated for the symptomatic treatment of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.,Celecoxib is indicated for the treatment of primary dysmenorrhoea in adults.,Celecoxib is indicated for the short-term treatment of acute pain in adults following surgery or musculoskeletal and/or soft tissue injury.

Каталог на резюме:

Visual Identification: Opaque, white capsules with 2 gold bands and marked "200" on the body.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 42 Months; Container Temperature: Store below 25 degrees Celsius

Статус Оторизация:

Licence status A

Дата Оторизация:

2014-01-10

Листовка

Page 1 of 6
CELEXI
CELECOXIB
_ _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Celexi. 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
Celexi 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 CELEXI AND
KEEP IT WITH THE MEDICINE.
You may need to read it again.
WHAT CELEXI IS USED FOR
Celexi 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.
Celexi also provides short-term
pain relief in conditions such
as:
•
menstrual cramps or period
pain
•
after surgery
•
muscle and joint injuries.
Celexi 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 Celexi can relieve the
symptoms of pain and
inflammation, it will not cure
your condition.
Your doctor, however, may
have prescribed Celexi for
another purpose.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
CELEXI HAS BEEN PRESCRIBED FOR
YOU.
Celexi 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 IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE CELEXI 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 YOU HAVE
SEVERE HEART OR BLOOD VESSEL
DISEASE AFFECTING THE
CIRCULATION IN YOUR BRAIN OR
LIMBS
•
HAVE SEVERE L

Данни за продукта

1
AUSTRALIAN
PRODUCT
INFORMATION
–
CELEXI
(CELECOXIB)
CAPSULES
1
NAME OF THE MEDICINE
Celecoxib.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
CELEXI 100 mg and 200 mg capsules contain 100 mg or 200 mg of
celecoxib.
EXCIPIENTS WITH KNOWN EFFECT
The capsules also contain 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 capsules with 2 blue bands and marked
“100” on the body.
200 mg capsules: Opaque, white capsules with 2 gold bands and marked
“200” on the body.
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
2
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, 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.
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 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 duratio