Entocort® CR 3 mg Gastro-resistant Capsule, Hard

Country: আয়ার্লণ্ড

ভাষা: ইংরেজি

সূত্র: HPRA (Health Products Regulatory Authority)

সক্রিয় উপাদান:

Budesonide

থেকে পাওয়া:

Tillotts Pharma GmbH

এটিসি কোড:

A07EA; A07EA06

INN (International Name):

Budesonide

ডোজ:

3 milligram(s)

ফার্মাসিউটিকাল ফর্ম:

Gastro-resistant capsule, hard

প্রেসক্রিপশন টাইপ:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Corticosteroids acting locally; budesonide

অনুমোদন অবস্থা:

Marketed

অনুমোদন তারিখ:

1996-09-24

তথ্য লিফলেট

Page 1 of 5
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 Capsu

পণ্য বৈশিষ্ট্য

Health Products Regulatory Authority
21 August 2023
CRN00DFNX
Page 1 of 9
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(s) with known effect: not more than 295 mg sucrose
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Gastro-resistant, prolonged release capsules, hard.
Hard gelatin capsules with an opaque, light grey body and opaque, pink
cap marked CIR 3MG in black radial print
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Crohn's disease:
Entocort CR Capsules are indicated for the induction of remission in
patients with mild to moderate Crohn's disease affecting
the ileum and/or the ascending colon.
Active microscopic colitis:
Entocort CR Capsules are indicated for the induction of remission in
patients with active microscopic colitis.
Entocort CR Capsules are indicated for the maintenance treatment of
severe, recurrent microscopic colitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS
_Active Crohn's disease:_ The recommended daily dose for induction of
remission is 9 mg once daily in the morning, for up to
eight weeks. The full effect is usually achieved within 2 to 4 weeks
of therapy.
When treatment is to be discontinued, the dose should normally be
reduced for the last 2 to 4 weeks of therapy.
Entocort CR can be used for up to 3 months at the dose of 6 mg
administered once daily in the morning. Long-term use is not
recommended.
To replace prednisolone in steroid dependent patients, the recommended
dose is 6 mg, administered once daily in the
morning. When treatment with Entocort CR Capsules is initiated the
prednisolone dose should be tapered.
To prevent recurrence after surgery in patients with high disease
activity, the recommended dose is 6 mg, administered once
daily in the morning. No benefit of Entocort has been shown in post
surgical patients with obstructive fibrostenotic Crohn's
disease.
_Active Mi