BUDESON 9 MG GRANULES

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

BUDESONIDE

Available from:

RAFA LABORATORIES LTD

ATC code:

A07EA06

Pharmaceutical form:

GRANULES GASTRO-RESISTANT

Composition:

BUDESONIDE 9 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

DR. FALK PHARMA, GERMANY

Therapeutic area:

BUDESONIDE

Therapeutic indications:

Acute mild to moderate Crohn’s disease with involvement of the ileium (twisted intestine) and/or ascending colon (part of large bowel).Collagenous colitis.

Authorization date:

2021-12-31

Patient Information leaflet

1
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
This medicine is sold with a doctor's prescription only
BUDESON 9 MG GRANULES
SACHETS CONTAINING GASTRO-RESISTANT GRANULES
ACTIVE INGREDIENT:
Each sachet of Budeson 9 mg granules contains: 9 mg Budesonide
For a list of the other ingredients, please see section 6. See also
'Important information
about some of the medicine's ingredients' in section 2.
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE.
This leaflet contains concise information about the medicine. If you
have any further
questions, please refer to your doctor or pharmacist.
The medicine is intended for adults over the age of 18.
This medicine has been prescribed for the treatment of your illness.
Do not pass it on to
others. It may harm them, even if it seems to you that their illness
is similar to yours.
1.
WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended:
•
For the treatment of mild to moderate Crohn’s disease in the small
intestine and/or
the large intestine.
•
For the treatment of collagenous colitis.
THERAPEUTIC GROUP: Steroidal (glucocorticoid) anti-inflammatory
medicine with local
activity.
2.
BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
•
Do not use if you are sensitive (allergic) to the active ingredient or
to any of the other
ingredients this medicine contains (for a list of the other
ingredients, please see section
6).
•
Do not use if you suffer from liver cirrhosis.
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
:
•
Do not use this medicine frequently or for a prolonged period without
consulting your
doctor.
•
During the use of the medicine, typical steroidal side effects may
occur. It may occur
especially if you are taking the medicine at a high dosage or for a
prolonged period.
Please see section 'Side effects'.
•
Contact your doctor if you experience blurred vision or other visual
disturbances.
•
Inform your doctor if you are about to undergo surgery during the
treatment period
with Budeson.
•
Info

Summary of Product characteristics

1
Budeson 9 mg granules-DL-January 2017_October2020 notif -rev 04
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
BUDESON 9 MG 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 and white to pale yellow powder with lemon
flavour,
filled into one sachet.
4.
CLINICAL PARTICULARS
_ _
4.1
THERAPEUTIC INDICATIONS
Acute mild to moderate Crohn’s disease with involvement of the ileum
(twisted
intestine) and/or ascending colon (part of large bowel).
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 _
Budeson 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).
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.
Termination of treatment
The treatment with Budeson 9 mg Granules sh