Entocort 2mg/100ml enema

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Budesonide

Available from:

Tillotts Pharma UK Ltd

ATC code:

A07EA06

INN (International Name):

Budesonide

Dosage:

20microgram/1ml

Pharmaceutical form:

Enema

Administration route:

Rectal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01050200; GTIN: 5014162008281

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ENTOCORT
® ENEMA
budesonide 0.02 mg/ml
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Enema is and what it is used for
2. What you need to know before you use Entocort Enema
3. How to use Entocort Enema
4. Possible side effects
5. How to store Entocort Enema
6. Contents of the pack and other information
1. WHAT ENTOCORT ENEMA IS AND WHAT IT IS USED FOR
Entocort Enema contains a medicine called budesonide. This belongs to
a group of medicines
called ‘corticosteroids’. These are used to reduce inflammation.
•
An enema is a liquid that is inserted into the back passage (rectum).
•
Entocort Enema is used to treat inflammation and ulcers in the large
intestine (colon) and
rectum. This is known as ulcerative colitis.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ENTOCORT ENEMA
DO NOT USE ENTOCORT ENEMA:
If you are allergic to budesonide or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Entocort Enema:
•
If you have recently had a bowel infection.
•
If you have ever had liver problems.
•
If you or a member of your family has ever had mental health problems.
OTHER MEDICINES AND ENTOCORT ENEMA
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other
medicines. This includes medicines that you buy without a prescription
and herbal medicines.
This is because Entocort Enema can affect the way some medicines work

Summary of Product characteristics

OBJECT 1
ENTOCORT ENEMA
Summary of Product Characteristics Updated 12-Apr-2018 | Tillotts
Pharma UK Limited
1. Name of the medicinal product
Entocort
®
Enema.
2. Qualitative and quantitative composition
0.02 mg/ml budesonide (2 mg budesonide/100 ml).
Excipient(s) with known effect:
• Lactose anhydrous
• Lactose monohydrate
• Methyl-parahydroxybenzoate
• Propyl-parahydroxybenzoate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Dispersible tablet and solution for rectal suspension_._
Each Entocort enema consists of 2 components
• A 2.3 mg faintly yellow, circular biconvex tablet with the
engraving B
A
1 on one side. On the other side
2.3 is engraved.
• A 115 ml clear colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Ulcerative colitis involving rectal and recto-sigmoid disease.
4.2 Posology and method of administration
Posology
Adults:
One Entocort Enema nightly for 4 weeks. Full effect is usually
achieved within 2–4 weeks. If the patient
is not in remission after 4 weeks, the treatment period may be
prolonged to 8 weeks.
_Paediatric population_
Children: Not recommended.
_Elderly_
Dosage as for adults.
No dosage reduction is necessary in patients with reduced liver
function.
METHOD OF ADMINISTRATION
The route of administration is rectal.
INSTRUCTIONS FOR CORRECT USE OF ENTOCORT ENEMA.
Entocort enema consists of two components: a dispersible tablet and a
vehicle.
NOTE: IT IS IMPORTANT TO INSTRUCT THE PATIENT
• To carefully read the instructions for use in the patient
information leaflet which are packed together
with each product.
• To reconstitute the enema immediately before use, ensuring that
the tablet is completely dissolved.
• To administer in the evening before going to bed.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 Special warnings and precautions for use
Side effects typical of systemic corticosteroids may occur. Potential
systemic effects include glaucoma.
Visua