Celecoxib 100mg hard capsules

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Celecoxib

Tillgänglig från:

Accord Healthcare Ireland Ltd.

ATC-kod:

M01AH; M01AH01

INN (International namn):

Celecoxib

Dos:

100 milligram(s)

Läkemedelsform:

Capsule, hard

Terapiområde:

Coxibs; celecoxib

Bemyndigande status:

Marketed

Tillstånd datum:

2014-02-14

Bipacksedel

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CELECOXIB 100 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 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 belongs to a group of medicinal products 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 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 CAPSULES
You have been prescribed this medicine by your doctor. The following
information will help you get
the best results from this medicine. If you have any further questions
please ask your doctor or
pharmacist.
DO NOT TAKE CELECOXIB CAPSULES IF:
_ _

you are ALLERGIC TO CELECOXIB OR ANY OF T

Produktens egenskaper

Health Products Regulatory Authority
18 February 2022
CRN00CPH7
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Celecoxib 100mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 100 mg celecoxib.
Excipients(s) with known effect: each capsule contains 23.56 mg
lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Opaque, white, hard gelatin capsule. The body contains a blue band and
white text C90X-100
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Symptomatic relief in the treatment of osteoarthritis, rheumatoid
arthritis and ankylosing spondylitis in adults.
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, 4.4).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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. 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 dos