Celecoxib Krka 100mg capsules, hard

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Celecoxib

MAH:

KRKA, d.d., Novo mesto

ATC_code:

M01AH; M01AH01

INN:

Celecoxib

dosage:

100 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:

2013-11-29

PIL

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
CELECOXIB KRKA 100 MG CAPSULES, HARD
CELECOXIB KRKA 200 MG CAPSULES, HARD
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 Krka is and what it is used for
2.
What you need to know before you take Celecoxib Krka
3.
How to take Celecoxib Krka
4.
Possible side effects
5.
How to store Celecoxib Krka
6.
Contents of the pack and other information
1.
WHAT CELECOXIB KRKA IS AND WHAT IT IS USED FOR
Celecoxib Krka is used in adults for the relief of signs and symptoms
of
RHEUMATOID ARTHRITIS
,
OSTEOARTHRITIS
and
ANKYLOSING SPONDYLITIS
.
Celecoxib Krka 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. Celecoxib Krka 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 KRKA
You have been prescribed Celecoxib Krka by your doctor. The following
information will help you
get the best results with Celecoxib Krka. If you have any further
questions please ask your doctor or
pharmacist.
DO NOT TAKE CELECOXIB KRKA
TELL YOUR DOCTOR IF

SPC

Health Products Regulatory Authority
21 October 2021
CRN00CKHJ
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Celecoxib Krka 100mg capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 100 mg celecoxib.
Excipient with known effect:
Lactose: 24 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard (capsule)
Each capsule has a white body and the cap, of length 15.4 mm – 16.2
mm; the capsules contain white or almost white granulate.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Celecoxib Krka 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