Celecoxib Rowex 100 mg capsules, hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Celecoxib

Available from:

Rowex Ltd

ATC code:

M01AH; M01AH01

INN (International Name):

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:

2014-10-03

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CELECOXIB ROWEX 100 MG CAPSULES, HARD
CELECOXIB ROWEX 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 Rowex is and what it is used for
2.
What you need to know before you take Celecoxib Rowex
3.
How to take Celecoxib Rowex
4.
Possible side effects
5.
How to store Celecoxib Rowex
6.
Contents of the pack and other information
1.
WHAT CELECOXIB ROWEX IS AND WHAT IT IS USED FOR
Celecoxib Rowex contains the active substance celecoxib which belongs
to a group of medicines
called nonsteroidal anti-inflammatory drugs (NSAID), and specifically
a sub-group known as
cyclooxygenase-2 (COX-2) inhibitors. These work by lowering the amount
of prostaglandins.
Prostaglandins are substances made by your body. Some prostaglandins
cause pain and inflammation,
but others help protect the stomach lining. Celecoxib Rowex reduces
the production of prostaglandins
that cause pain and inflammation and not the ones that protect the
stomach.
Celecoxib Rowex is used in adults for pain relief and to alleviate
swelling of tissue in the degenerative
joint disease (osteoarthritis), inflammatory rheumatic joint disease
(rheumatoid arthritis) and in certain
types of inflammation of intervertebral joints (ankylosing
spondylitis).
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 ROWEX
DO NOT TAKE CELECOX

Summary of Product characteristics

Health Products Regulatory Authority
24 July 2020
CRN009T2P
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Celecoxib Rowex 100 mg capsules, hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 100 mg celecoxib.
Excipient(s) with known effect: Each hard capsule contains 6.65 mg
lactose (as lactose monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard
Capsule (length 17.7 – 18.3 mm): white body and blue cap, containing
white to slightly yellowish pellets.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In adults for the symptomatic relief in the treatment of:
- osteoarthritis
- rheumatoid arthritis
- 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 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