Budenofalk 2mg/application foam enema

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Budesonide

Available from:

Dr. Falk Pharma UK Ltd

ATC code:

A07EA06

INN (International Name):

Budesonide

Dosage:

2mg/1actuation

Pharmaceutical form:

Rectal foam

Administration route:

Rectal

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01050200; GTIN: 5060096430209

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BUDENOFALK
2MG/DOSE RECTAL FOAM
budesonide
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 Budenofalk Rectal Foam is and what it is used for
2.
What you need to know before you use Budenofalk Rectal Foam
3.
How to use Budenofalk Rectal Foam
4.
Possible side effects
5.
How to store Budenofalk Rectal Foam
6.
Contents of the pack and other information
1.
WHAT BUDENOFALK RECTAL FOAM IS AND WHAT IT IS USED FOR
Budenofalk Rectal Foam contains the active substance budesonide, a
type of locally
acting steroid used to treat inflammatory bowel disease.
Budenofalk Rectal Foam is used for the treatment of:
•
Inflammation of the rectum (back passage) and the lower part of the
colon
(sigmoid colon), known by doctors as ulcerative colitis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BUDENOFALK RECTAL FOAM
DO NOT USE BUDENOFALK RECTAL FOAM
•
if you are
ALLERGIC
to budesonide or any of the other ingredients of this
medicine (listed in section 6)
•
if you have a
SEVERE LIVER DISEASE
(liver cirrhosis).
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Budenofalk Rectal Foam if you have:
-
tuberculosis
-
high blood pressure
-
diabetes, or if diabetes has been diagnosed in your family
-
brittle bones (osteoporosis)
-
ulcers in the stomach or first part of the small intestine (peptic
ulcer)
-
increased pressure in your eye (glaucoma) or eye problems such as
clouding of
the lens (cataracts) or if glaucoma has been diagnosed in your family
-
severe liver proble

Summary of Product characteristics

OBJECT 1
BUDENOFALK 2MG/DOSE RECTAL FOAM
Summary of Product Characteristics Updated 18-May-2017 | Dr. Falk
Pharma UK Ltd
1. Name of the medicinal product
Budenofalk 2mg/dose rectal foam
2. Qualitative and quantitative composition
Each dose of 1.2 g foam contains 2 mg of budesonide.
Excipients with known effect: cetyl alcohol, propylene glycol.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Rectal foam, pressurised container
White to pale white, creamy firm foam
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of active ulcerative colitis that is limited to the
rectum and the sigmoid colon.
4.2 Posology and method of administration
Posology
_Adults aged_ _>_ _18 years_
One actuation of 2 mg budesonide daily.
_Paediatric population _
Budenofalk 2mg rectal foam should not be used in children due to
insufficient experience in this age
group.
Method of administration
Budenofalk 2mg rectal foam can be applied in the morning or evening.
The canister is first fitted with an applicator and then shaken for
about 15 seconds before the applicator is
inserted into the rectum as far as comfortable. Note that the dose is
only sufficiently accurate when the
pump dome is held downwards as vertically as possible. To administer a
dose of Budenofalk 2mg rectal
foam, the pump dome is fully pushed down and very slowly released.
Following the activation the
applicator should be held in position for 10 - 15 seconds before being
withdrawn from the rectum.
The best results are obtained when the intestine is evacuated prior to
administration of Budenofalk 2mg
rectal foam.
Duration of treatment
The attending physician determines the duration of use. An acute
episode generally subsides after 6 to 8
weeks. Budenofalk 2mg rectal foam should not be used after this period
of time.
4.3 Contraindications
Budenofalk 2mg rectal foam must not be used in patients with:
- hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
- hepatic cirrhosis.
4.4 Special warnings and