Celecoxib 200 mg hard capsules

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Celecoxib

Tilgængelig fra:

Lexon Pharmaceuticals (Ireland) Limited

ATC-kode:

M01AH; M01AH01

INN (International Name):

Celecoxib

Dosering:

200 milligram(s)

Lægemiddelform:

Capsule, hard

Terapeutisk område:

Coxibs; celecoxib

Autorisation status:

Not marketed

Autorisation dato:

2017-06-30

Indlægsseddel

PACKAGE LEAFLET
KEY PHARMACEUTICALS LTD.
CELECOXIB 100 MG AND 200 MG HARD CAPSULES PL 34424/0003-0004 PA23176/002/001-002
VERSION NO.: 07 (FEBRUARY 2021)_MM
Page
1
of
10
Package leaflet: Information for the user
CELECOXIB 100 MG HARD CAPSULES
CELECOXIB 200 MG HARD CAPSULES
celecoxib
Your medicine is called Celecoxib 100 mg and 200 mg hard capsules, but
it will be referred
to as Celecoxib capsules throughout this leaflet.
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 CAPSULES ARE AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CELECOXIB CAPSULES
3.
HOW TO TAKE CELECOXIB CAPSULES
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE CELECOXIB CAPSULES
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT CELECOXIB CAPSULES ARE AND WHAT THEY ARE USED FOR
Celecoxib capsules are used for the relief of signs and symptoms of
RHEUMATOID
ARTHRITIS, OSTEOARTHRITIS AND ANKYLOSING SPONDYLITIS
in adults.
Celecoxib capsules belong to a group of medicinal products called
nonsteroidal anti-
inflammatory drugs (NSAIDs), 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 capsules act 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.

Produktets egenskaber

Health Products Regulatory Authority
03 February 2022
CRN00CS1D
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Celecoxib 200 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Celecoxib 200 mg: Each capsule contains 200 mg celecoxib.
Excipient(s) with known effect: lactose (each capsule contains 48.35
mg lactose monohydrate; see section 4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Celecoxib 200 mg: Celecoxib 200 mg capsule is opaque, white with two
yellow bands, one of which is marked ‘200’.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Celecoxib is indicated in adults for the symptomatic relief in the
treatment of osteoarthritis, rheumatoid arthritis and ankylosing
spondylitis.
The decision to prescribe a selective 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 revaluated 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 200mg 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