Budenofalk 2mg/dose rectal foam

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Budesonide

Available from:

Dr. Falk Pharma GmbH

ATC code:

A07EA; A07EA06

INN (International Name):

Budesonide

Dosage:

2 milligram(s)/dose

Pharmaceutical form:

Rectal foam

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Corticosteroids acting locally; budesonide

Authorization status:

Marketed

Authorization date:

2009-06-05

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

Health Products Regulatory Authority
09 November 2022
CRN00CQG5
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
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: One actuation of Budenofalk 2mg/dose
rectal foam contains 600.3 mg propylene glycol, 8.4 mg
cetyl alcohol and 15.1 mg cetostearyl alcohol (component of
emulsifying wax).
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:
- hypersensitiv