Entocort CR 3mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Budesonide

Available from:

CST Pharma Ltd

ATC code:

A07EA06

INN (International Name):

Budesonide

Dosage:

3mg

Pharmaceutical form:

Modified-release capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01050200; GTIN: 5055946800615

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENTOCORT
® CR 3MG CAPSULES
(
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 CR 3mg Capsules are and what they are
used for
2.
What you need to know before you take Entocort CR
3mg Capsules
3.
How to take Entocort CR 3mg Capsules
4.
Possible side effects
5.
How to store Entocort CR 3mg Capsules
6.
Contents of the pack and other information
1.
WHAT ENTOCORT CR 3MG CAPSULES ARE AND
WHAT THEY ARE USED FOR
Entocort CR 3mg Capsules contain the active substance
budesonide. This belongs to a group of medicines called
‘corticosteroids’. These are used to reduce inflammation.
Entocort CR 3mg 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ENTOCORT CR 3MG CAPSULES
DO NOT TAKE ENTOCORT CR 3MG 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.
Do not take Entocort CR 3mg Capsules if any of the above
apply to you. If you are not sure, talk to your doctor or
pharmacist before taking Entocort CR 3mg Capsules.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Entocort CR
3mg Capsules if:

You have ever had tuberculosis (TB).

You have ever had high blood pressure.

You have diabetes.

You have ever had brittle bones.

You have ever had stomach ulcers.

You ha

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Entocort CR 3 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains budesonide 3 mg
Excipient(s) with known effect:
Sucrose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Hard gelatin capsules for oral administration with an opaque, light
grey body and
opaque, pink cap marked CIR
3MG in black radial print.
Each capsule contains budesonide 3 mg as gastro-resistant,
prolonged-release
granules.
4.1
THERAPEUTIC INDICATIONS
Crohn’s disease - Induction of remission in patients with mild to
moderate active
Crohn’s disease affecting the ileum and/or the ascending colon.
Microscopic colitis - Induction of remission in patients with active
microscopic colitis
Maintenance of remission in patients with 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 2–4 weeks.
When treatment is to be discontinued, the dose should normally be
reduced for the last
2 to 4 weeks of therapy.
_Active Microscopic colitis_: The recommended dose is 9 mg once daily
in the morning
(corresponding to 3 capsules).
_Maintenance of Microscopic colitis: _The recommended dose is 6 mg
once daily in the
morning (corresponding to 2 capsules), or the lowest effective dose.
_ _
_Paediatric population _
There are limited data on the use of Entocort CR Capsules in children
(see Sections
5.1 and 5.2). The available data are insufficient to support safety
and efficacy in the
paediatric population, therefore such use cannot be recommended until
further data
become available.
_Older people _
No special dose adjustment is recommended. However, experience with
Entocort CR
Capsules in older people is limited.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance(s) or to any of the
excipients listed in section
6.1.
4.4
SPECIAL WARNINGS