Entocort CR 3 mg Gastro-resistant Capsule, Hard

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Budesonide

Доступна с:

IMED Healthcare Ltd.

код АТС:

A07EA06

ИНН (Международная Имя):

Budesonide

дозировка:

3 milligram(s)

Фармацевтическая форма:

Gastro-resistant capsule, hard

Терапевтические области:

budesonide

Дата Авторизация:

2021-07-23

тонкая брошюра

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

Характеристики продукта

Health Products Regulatory Authority
26 July 2021
CRN00CDQ7
Page 1 of 2
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.
Product imported from _Belgium_
Hard gelatin capsules with an opaque, light grey body and opaque, pink
cap marked CIR 3MG 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
Ethylcellulose
Tributyl acetylcitrate
Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30 per cent
Triethyl citrate
Simeticone (Antifoam M) Polysorbate 80
Talc
Sucrose spheres
Capsule shell:
Black iron oxide (E172) Titanium dioxide (E171) Gelatin
Sodium laurilsulfate 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 container and outer package of the product on the
market in the country of origin.
Health Products Regulatory Authority
26 July 2021
CRN00CDQ7
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30 °C. Store in the original package. Keep the
container tightly closed.
6.5 NATURE AND CONTENTS OF CONTAINER
White, polyethylene bottles of 100 capsules, having a tamper-evident,
childproof polypropylene screw cap, with an integral
desiccant.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
White, polyethylene bottles of 100 capsules, having a tamper-evident,
childproof polypropylene screw cap, with an integral
desiccant.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/178/00