Celebrex 200 mg hard capsules

Երկիր: Իռլանդիա

Լեզու: անգլերեն

Աղբյուրը: HPRA (Health Products Regulatory Authority)

Ակտիվ բաղադրիչ:

Celecoxib

Հասանելի է:

PCO Manufacturing Ltd.

ATC կոդը:

M01AH; M01AH01

INN (Միջազգային անվանումը):

Celecoxib

Դոզան:

200 milligram(s)

Դեղագործական ձեւ:

Capsule, hard

Ռեկվիզորի տեսակը:

Product subject to prescription which may be renewed (B)

Թերապեւտիկ տարածք:

Coxibs; celecoxib

Լիազորման կարգավիճակը:

Authorised

Հաստատման ամսաթիվը:

2004-03-19

Տեղեկատվական թերթիկ

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
CELEBREX
® 100 MG HARD CAPSULES
CELEBREX
® 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 Celebrex is and what it is used for
2.
What you need to know before you take Celebrex
3.
How to take Celebrex
4.
Possible side effects
5.
How to store Celebrex
6.
Contents of the pack and other information
1.
WHAT CELEBREX IS AND WHAT IT IS USED FOR
Celebrex 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. Celebrex
acts by reducing the
production of prostaglandins, thereby reducing the pain and
inflammation.
Celebrex is used in adults for the relief of signs and symptoms of
RHEUMATOID ARTHRITIS,
OSTEOARTHRITIS and 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 CELEBREX
You have been prescribed Celebrex by your doctor. The following
information will help you get
the best results with Celebrex. If you have any further questions
please ask your doctor or
pharmacist.
DO NOT TAKE CELEBREX
Tell your doctor if any of the following are true for you as patients
with these conditions should
not take

Ապրանքի հատկությունները

Health Products Regulatory Authority
01 November 2021
CRN00CMF2
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Celebrex 200 mg hard capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 200 mg celecoxib.
Excipient(s) with known effect: Lactose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
_Product imported from France, Italy, Poland and Greece_
Opaque, white capsule with two yellow bands marked ‘7767’ and
‘200’.
4 CLINICAL PARTICULARS
As per PA23055/006/002
5 PHARMACOLOGICAL PROPERTIES
As per PA23055/006/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_CAPSULES CONTENT:_
Lactose monohydrate
Sodium laurilsulfate
Povidone K30
Croscarmellose sodium
Magnesium stearate
_CAPSULE SHELLS:_
Gelatin
Titanium dioxide (E171)
Sodium laurilsulfate
Sorbitan monolaurate
_PRINTING INK:_
Shellac
Propylene glycol
Iron oxide (E172)
Product sourced from Poland also contains the following excipients;
Shellac, ethanol, anhydrous isopropyl alcohol, butyl alcohol,
propylene glycol and ammonium hydroxide.
6.2 INCOMPATIBILITIES
Not applicable.
Health Products Regulatory Authority
01 November 2021
CRN00CMF2
Page 2 of 2
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
6.5 NATURE AND CONTENTS OF CONTAINER
Blister pack of 10, 20 or 30 capsules in a cardboard carton.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
Any unused medicinal product or waste material should be disposed of
in accordance with local requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/118/002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 19
th
March 2004
Date of last renewal: 19
th
March 2009
10 DATE OF REVISION OF THE TEX