Celecoxib Pfizer 200 mg capsules, hard

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Celecoxib; Gelatin

Verfügbar ab:

Pfizer Healthcare Ireland

ATC-Code:

M01AH; M01AH01

INN (Internationale Bezeichnung):

Celecoxib; Gelatin

Dosierung:

200 milligram(s)

Darreichungsform:

Capsule, hard

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

Coxibs; celecoxib

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2012-03-16

Gebrauchsinformation

Page 1 of 10
2017-0024283, 2016-0020236, 2016-0019684
PACKAGE LEAFLET: INFORMATION FOR THE USER _ _
CELECOXIB PFIZER
100 MG HARD CAPSULES
CELECOXIB PFIZER 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 CELECOXIB PFIZER IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CELECOXIB PFIZER
3.
HOW TO TAKE CELECOXIB PFIZER
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE CELECOXIB PFIZER
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
_ _
1. WHAT CELECOXIB PFIZER IS AND WHAT IT IS USED FOR_ _
_ _
Celecoxib Pfizer is used in adults for the relief of signs and
symptoms of RHEUMATOID ARTHRITIS,
OSTEOARTHRITIS and ANKYLOSING SPONDYLITIS.
Celecoxib Pfizer belongs to a group of medicines called nonsteroidal
anti-inflammatory drugs
(NSAID), and specifically a
sub-group known as
(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. Celecoxib Pfizer
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 CELECOXIB PFIZER
_ _
You have been prescribed Celecoxib Pfizer by your doctor. The
following information will help
you get the best results with Celecoxib Pfizer. If you have any
further questions please ask you

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Celecoxib Pfizer 200 mg capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 200 mg celecoxib.
Excipient with known effect
Lactose (each capsule contains 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 gold bands marked 7767 and 200.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Celecoxib Pfizer 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.
_Ankylosing spondylitis_
The recommended daily dose is 200 mg taken once daily or in two
divided doses. In a few patients, with insufficient
relief from symptoms, an increased dose of 400 mg once d