Budenofalk 9mg gastro-resistant granules sachets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
19-06-2018
Summary of Product characteristics
(SPC)
19-06-2018
Active ingredient:
Budesonide
Available from:
Dr. Falk Pharma UK Ltd
ATC code:
A07EA06
INN (International Name):
Budesonide
Dosage:
9mg
Pharmaceutical form:
Gastro-resistant granules
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 01050200; GTIN: 5060096430438
Patient Information leaflet
Package leaflet: information for the user
BUDENOFALK
® 9MG GASTRO-RESISTANT GRANULES
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 Budenofalk granules are and what they are used for
2.
What you need to know before you take Budenofalk granules
3.
How to take Budenofalk granules
4.
Possible side effects
5.
How to store Budenofalk
granules
6.
Contents of the pack and other information
_ _
1.
WHAT BUDENOFALK GRANULES ARE AND WHAT THEY ARE USED FOR
Budenofalk granules contain the active substance budesonide, a type of
locally
acting steroid used to treat chronic inflammatory diseases of the
intestine.
Budenofalk granules are used in the treatment of:
•
CROHN’S DISEASE: mild to moderate acute attacks of chronic
inflammation of
the intestine affecting the lower part of the small bowel (ileum)
and/or upper
part of the large bowel (the ascending colon).
•
ACUTE EPISODES OF COLLAGENOUS COLITIS (a disease with chronic
inflammation
of the large bowel which is characterized by chronic watery
diarrhoea).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BUDENOFALK GRANULES
DO NOT TAKE BUDENOFALK granules
if you are ALLERGIC to budesonide or any of the other ingredients in
this medicine
(listed in section 6)
if you have a SEVERE LIVER DISEASE (liver cirrhosis).
WARNINGS AND PRECAUTIONS
Talk to your doctor before taking Budenofalk granules if you have:
tuberculosis
high blood pressure
diabetes, or if diabetes has been diagnosed in your family
brittle bones (osteoporosis)
Read the complete document
Summary of Product characteristics
OBJECT 1
BUDENOFALK 9MG GASTRO-RESISTANT GRANULES
Summary of Product Characteristics Updated 08-Aug-2017 | Dr. Falk
Pharma UK Ltd
1. Name of the medicinal product
Budenofalk
®
9mg gastro-resistant granules
2. Qualitative and quantitative composition
Each sachet contains 9mg budesonide
Excipients with known effect: Each sachet contains 828mg sucrose, 36mg
lactose monohydrate and
900mg sorbitol (E420).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant granules
White to off-white granules with smell of lemon flavour
4. Clinical particulars
4.1 Therapeutic indications
Induction of remission in patients with mild to moderate active
Crohn's disease affecting the ileum and/or
the ascending colon
Induction of remission in patients with active collagenous colitis
4.2 Posology and method of administration
POSOLOGY
Crohn's disease and collagenous colitis
_Adults aged > 18 years _
The recommended daily dose is one sachet (containing gastro-resistant
granules with 9mg budesonide)
once daily in the morning about a half hour before breakfast.
_Paediatric population _
Budenofalk 9mg gastro-resistant granules should not be taken by
children and adolescents due to
insufficient experience in this age group.
_Patients with renal impairment _
There are no specific dosage recommendations for patients with renal
insufficiency (see section 5.2).
_Patients with hepatic impairment _
Since the information is limited in this patient-population a specific
dose recommendation cannot be
made (see sections 4.3, 4.4 and 5.2).
METHOD OF ADMINISTRATION
Oral use
The content of one sachet should be taken before breakfast. The
granules should be placed on the tongue
and swallowed whole, with plenty of liquid (e.g. a glass of water).
The granules should not be chewed or
crushed to avoid destruction of the gastro-resistant coating of the
granules. Premature disintegration will
affect drug disposition in an unpredictable fashion.
Duration of treatment
The duration of treatment should be limited to 8 weeks.
Termin
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