Entocort CR 3 mg Gastro-resistant Capsule, Hard

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Budesonide

थमां उपलब्ध:

PCO Manufacturing Ltd.

ए.टी.सी कोड:

A07EA; A07EA06

INN (इंटरनेशनल नाम):

Budesonide

डोज़:

3 milligram(s)

फार्मास्यूटिकल फॉर्म:

Gastro-resistant capsule, hard

चिकित्सीय क्षेत्र:

Corticosteroids acting locally; budesonide

प्राधिकरण की तारीख:

2021-04-01

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE USER
ENTOCORT
® CR 3 MG GASTRO-RESISTANT
CAPSULE, HARD
budesonide
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 Entocort Capsules are and what they are used for
2.
What you need to know before you take Entocort Capsules
3.
How to take Entocort Capsules
4.
Possible side effects
5.
How to store Entocort Capsules
6.
Contents of the pack and other information
1.
WHAT ENTOCORT CAPSULES ARE AND WHAT THEY ARE USED FOR
Entocort Capsules contain the active substance budesonide.
This belongs to a group of medicines called ‘corticosteroids’.
These are used to reduce inflammation.
Crohn’s disease: Entocort Capsules are used to treat an
inflammation of the small bowel and the first part of the large
bowel.
Microscopic colitis: Entocort Capsules are used to treat
microscopic colitis (a disease with chronic inflammation of the
large bowel which is typically with chronic watery diarrhoea):
Entocort Capsules can be used to treat both active illness as
well as in severe cases to prevent recurring problems
(maintenance treatment).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENTOCORT
CAPSULES
DO NOT TAKE ENTOCORT CAPSULES:
•
If you are allergic to budesonide or any of the other
ingredients of this medicine (listed in section 6).
•
If you have an infection, including viral, bacterial or fungal
infections.
Do not take Entocort Capsules if any of the above apply to you.
If you are not sure, talk to your doctor or pharmacist before
taking Entocort Capsules.
WARNING

उत्पाद विशेषताएं

Health Products Regulatory Authority
08 November 2023
CRN00DWPD
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Entocort CR 3 mg Gastro-resistant Capsule, Hard
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains budesonide 3 mg.
Excipient with known effect: sucrose
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Gastro-resistant, prolonged release capsules, hard.
_The product imported from Greece and Belgium:_
Hard gelatin capsules with an opaque, light grey body and opaque, pink
cap marked 'CIR 3 mg' in black radial print.
4 CLINICAL PARTICULARS
As per PA2018/003/001
5 PHARMACOLOGICAL PROPERTIES
As per PA2018/003/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
_The product imported from Greece contains: _
Ethyl cellulose
Tributyl acetyl citrate
Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 per cent
Triethyl citrate
Simethicone (Antifoam M)
Polysorbate 80
Talc
Sugar spheres (consisting of sucrose and maize starch).
Capsule shell:
Black iron oxide (E172)
Titanium dioxide (E171)
Gelatine
Red iron oxide (E172)
Yellow iron oxide (E172)
_The product imported from Belgium contains: _
Ethylcellulose
Tributyl acetylcitrate
Methacrylic acid Copolymer C
Health Products Regulatory Authority
08 November 2023
CRN00DWPD
Page 2 of 3
Triethyl citrate
Antifoam M
Polysorbate 80
Talc
Sucrose spheres
Capsule shell:
Black iron oxide (E172)
Titanium dioxide (E171)
Gelatin
Sodium lauril sulfate
Colloidal anhydrous silica
Red iron oxide (E172)
Yellow iron oxide (E172)
Ink (der. 41/370-42/1015)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the bottle 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 ºC. Store in the original package.
Keep the container tightly closed.
6.5 NATURE AND CONTENTS OF CONTAINER
_Product imported from Greece: _
White, polyethylene bottles of 50 capsules, having a ta