Entocort CR 3mg capsules

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Budesonide

Διαθέσιμο από:

Tillotts Pharma UK Ltd

Φαρμακολογική κατηγορία (ATC):

A07EA06

INN (Διεθνής Όνομα):

Budesonide

Δοσολογία:

3mg

Φαρμακοτεχνική μορφή:

Modified-release capsule

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 01050200; GTIN: 5014162008298 7640129621880

Φύλλο οδηγιών χρήσης

Package leaflet: Information for the user
Entocort
®
CR 3 mg 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 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).
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.
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.
Warnings and precautions
Talk to 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

Αρχείο Π.Χ.Π.

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