Entocort CR 3mg capsules

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Budesonide

Prieinama:

Waymade Healthcare Plc

ATC kodas:

A07EA06

INN (Tarptautinis Pavadinimas):

Budesonide

Dozė:

3mg

Vaisto forma:

Modified-release capsule

Vartojimo būdas:

Oral

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 01050200

Pakuotės lapelis

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.
•
The name of this medicine is Entocort
®
CR 3mg Capsules but it will be
referred to as Entocort Capsules throughout the remainder of this
leaflet.
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 applies 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

Prekės savybės

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