ENTOCORT CR 3 Milligram Capsules Gastro-Resistant

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

BUDESONIDE

Commercializzato da:

AstraZeneca UK Limited

INN (Nome Internazionale):

BUDESONIDE

Dosaggio:

3 Milligram

Forma farmaceutica:

Capsules Gastro-Resistant

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

0000-00-00

Foglio illustrativo

PACKAGE LEAFLET: INFORMATION FOR THE USER 
ENTOCORT
®
 CR 3 MG GASTRO-RESISTANT PROLONGED-RELEASE HARD CAPSULES  
budesonide 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.  
•
  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. Do not pass it on to
others. It may harm them, 
even if their symptoms are the same as yours. 
•
  If any of the side effects get serious, or if you notice any
side effects not listed in this 
leaflet, please tell your doctor or pharmacist. 

IN THIS LEAFLET:  
1.   What Entocort Capsules are and what they are used for 
2.   Before you take Entocort Capsules 
3.   How to take Entocort Capsules 
4.   Possible side effects 
5.   How to store Entocort Capsules 
6.   Further information 

1. WHAT ENTOCORT CAPSULES ARE AND WHAT THEY ARE USED FOR 
Entocort Capsules contain a medicine called budesonide. This belongs
to a group of 
medicines called ‘corticosteroids’. These are used to reduce
inflammation. 
Entocort Capsules are used to treat an inflammation of the small bowel
and the first part of 
the large bowel. This is known as Crohn’s disease. 

2.  BEFORE YOU TAKE ENTOCORT CAPSULES 
DO NOT TAKE ENTOCORT CAPSULES IF: 
•
  You are allergic (hypersensitive) to budesonide or any of
the other ingredients of Entocort 
Capsules (listed in Section 6: Further information). 
•
  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. 

TAKE SPECIAL CARE WITH ENTOCORT CAPSULES 
Check with your doctor or pharmacist before taking Entocort Capsules
if: 
•
  You have ever had tuberculosis (TB). 
•
  You have ever had high blood pressure. 
•
  You have diabetes. 
•
  You have ever had

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Entocort CR 3 mg Gastro-Resistant Prolonged-Release Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains budesonide 3 mg
Excipients: not more than 295 mg sucrose
For 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
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_. _The full effect is usually achieved within 2-4 weeks.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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 2-4 weeks.
When treatment is to be discontinued, the dose should normally be reduced for the last 2 to 4 weeks of therapy.
For long-term use, to prolong remission, the recommended dose is 6 mg, administered once daily in the morning.
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 6mg, administered
once daily in the morning. No benefit of Entocort has been shown in post surgical patients with obstructive
fibrostenotic Crohn’s disease.
Children:
There is presently no experience with Entocort CR Capsules in children. Entocort is not