Celebrex 100 mg capsules, hard

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Celecoxib

Dostupno od:

Pfizer Healthcare Ireland

ATC koda:

M01AH; M01AH01

INN (International ime):

Celecoxib

Doziranje:

100 milligram(s)

Farmaceutski oblik:

Capsule, hard

Tip recepta:

Product subject to prescription which may be renewed (B)

Područje terapije:

Coxibs; celecoxib

Status autorizacije:

Marketed

Datum autorizacije:

2000-05-12

Uputa o lijeku

Page 1 of 10
2018-0040882
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
Page 2 of 10
2018-0040882
TELL YOUR DOCTOR IF ANY OF THE FOLLOWING ARE TRUE F

Svojstava lijeka

Health Products Regulatory Authority
11 December 2019
CRN008RLM
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Celebrex 100 mg capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg celecoxib.
Excipient with known effect
Lactose (each capsule contains 149.7 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.
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.
_Ankylosing spondylitis_
The recommended daily dose is 200 mg taken once daily or in two
divided doses. In a few patients, with insuffi