Celecoxib 200mg hard capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Celecoxib

Available from:

Actavis Group PTC ehf

ATC code:

M01AH; M01AH01

INN (International Name):

Celecoxib

Dosage:

200 milligram(s)

Pharmaceutical form:

Capsule, hard

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Coxibs; celecoxib

Authorization status:

Marketed

Authorization date:

2014-02-14

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CELECOXIB 100 MG HARD CAPSULES
CELECOXIB 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 is and what it is used for
2.
What you need to know before you take Celecoxib
3.
How to take Celecoxib
4.
Possible side effects
5.
How to store Celecoxib
6.
Contents of the pack and other information
1.
WHAT CELECOXIB IS AND WHAT IT IS USED FOR
Celecoxib is 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CELECOXIB
You have been prescribed this medicine by your doctor. The following
information will help you get
the best results with this medicine. If you have any further questions
please ask your doctor or
pharmacist.
DO NOT TAKE CELECOXIB
TELL YOUR DOCTOR IF ANY OF THE FOLLOWING ARE TRUE FOR YOU AS PATIENTS
WITH THESE CONDITIONS SHOULD
NOT TAKE CELECOXIB._ _

if you are
ALLERGIC (HYPERSENSITIVE) TO CELECOXIB OR ANY OF THE OTHER INGREDIENTS
of this
medicine (listed in section 6)

Summary of Product characteristics

Health Products Regulatory Authority
13 September 2019
CRN0097KN
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Celecoxib 200mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 200 mg celecoxib.
Excipients(s) with known effect: each capsule contains 47.12 mg
lactose (as monohydrate).
3 PHARMACEUTICAL FORM
Capsule, hard.
Opaque, white, hard gelatin capsule. The body contains a yellow band
and white text C90X-200
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
(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 daily or in two divided
doses may increase e