Celebrex 200mg capsule, hard

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CELECOXIB

Available from:

Pfizer Hellas S.A.

ATC code:

M01AH01

INN (International Name):

CELECOXIB

Pharmaceutical form:

HARD CAPSULE

Composition:

CELECOXIB 200 milligram(s)

Prescription type:

POM

Therapeutic area:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Authorization status:

Authorised

Authorization date:

2005-11-23

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
CELEBREX
100 MG HARD CAPSULES
CELEBREX 200 MG HARD CAPSULES
Celecoxib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Celebrex is and what it is used for
2.
What you need to know before you take Celebrex
3.
How to take Celebrex
4.
Possible side effects
5.
How to store Celebrex
6.
Contents of the pack and other information
_ _
1. WHAT CELEBREX IS AND WHAT IT IS USED FOR_ _
_ _
Celebrex is used
in adults for the relief of signs and symptoms of
RHEUMATOID ARTHRITIS
,
OSTEOARTHRITIS
and
ANKYLOSING SPONDYLITIS
.
Celebrex belongs to a group of medicines called nonsteroidal
anti-inflammatory drugs (NSAID), and
specifically a sub-group known as cyclooxygenase-2 (COX-2) inhibitors.
Your body makes prostaglandins
that may cause pain and inflammation. In conditions such as rheumatoid
arthritis and osteoarthritis your
body makes more of these. Celebrex acts by reducing the production of
prostaglandins, thereby reducing
the pain and inflammation.
You should expect your medicine to start working within hours of
taking the first dose, but you may not
experience a full effect for several days.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CELEBREX
_ _
You have been prescribed Celebrex by your doctor. The following
information will help you get the best
results with Celebrex. If you have any further questions please ask
your doctor or pharmacist.
DO NOT TAKE CELEBREX
Tell your doctor if any of the following are true for you as patients
with these condition

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Celebrex 100 mg capsules, hard
Celebrex 200 mg capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg or 200 mg celecoxib.
Excipient with known effect
Lactose (each capsule, respectively, contains 149.7 mg or 49.8 mg
lactose monohydrate; see section
4.4).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
Opaque, white with two blue bands marked 7767 and 100.
Opaque, white with two gold bands marked 7767 and 200.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Celebrex is indicated in adults for the symptomatic relief in the
treatment of osteoarthritis, rheumatoid
arthritis and ankylosing spondylitis.
The decision to prescribe a selective cyclooxygenase-2 (COX-2)
inhibitor should be based on an
assessment of the individual patient's overall risks (see sections 4.3
and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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. The patient's need for
symptomatic relief and response to therapy should be re-evaluated
periodically, especially in patients
with osteoarthritis (see sections 4.3, 4.4, 4.8 and 5.1).
_ _
_Osteoarthritis _
The usual recommended daily dose is 200 mg taken once daily or in two
divided doses. In some
patients, with insufficient relief from symptoms, an increased dose of
200 mg twice daily may increase
efficacy. In the absence of an increase in therapeutic benefit after
two weeks, other therapeutic options
should be considered.
_Rheumatoid arthritis_
The initial recommended daily dose is 200 mg taken in two divided
doses. The dose may, if needed,
later be increased to 200 mg twice daily. In the absence of an
increase in therapeutic benefit after two
weeks, other therapeutic options should be considered.
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_Ankylosing spondylitis _
The recommended daily dose is 200