BUDESON 3 MG CAPSULES

Land: Israël

Taal: Engels

Bron: Ministry of Health

Werkstoffen:

BUDESONIDE

Beschikbaar vanaf:

RAFA LABORATORIES LTD

ATC-code:

A07EA06

farmaceutische vorm:

CAPSULES

Samenstelling:

BUDESONIDE 3 MG

Toedieningsweg:

PER OS

Prescription-type:

Required

Geproduceerd door:

DR. FALK PHARMA, GERMANY

Therapeutische categorie:

BUDESONIDE

Therapeutisch gebied:

BUDESONIDE

therapeutische indicaties:

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

Autorisatie datum:

2022-02-28

Bijsluiter

1
PATIENT LEAFLET ACCORDING TO THE PHARMACISTS' REGULATIONS
(PREPARATIONS) –
1986
This medicine is sold with a doctor's prescription only
BUDESON 3 MG
CAPSULES
ACTIVE INGREDIENT:
Each capsule of Budeson contains: Budesonide 3 mg
For a list of the additional 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.
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 acute mild to moderate Crohn’s disease in the
small intestine
and/or the large intestine.
•
For the treatment of collagenous inflammation of the large intestine
(Collagenous
colitis).
•
For the treatment of autoimmune inflammation of the liver (Autoimmune
hepatitis).
THERAPEUTIC GROUP: Steroidal (glucocorticosteroidal) anti-inflammatory
medicine with
local activity.
2. BEFORE USING THE MEDICINE
DO NOT USE THIS MEDICINE IF:
•
You are sensitive (allergic) to the active ingredient or to any of the
additional
ingredients this medicine contains (for a list of the additional
ingredients, please see
section 6).
•
You suffer from liver cirrhosis (a severe liver disease).
SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE
:
BEFORE STARTING (AND DURING) TREATMENT WITH BUDESON TELL YOUR DOCTOR
IF:
•
You suffer or have suffered in the past from impaired function of the:
eyes (e.g., high
pressure in the eye/glaucoma or cataract), liver, immune system.
•
You suffer or have suffered in the past from tuberculosis, high blood
pressure,
diabetes, ulcers in the stomach or the intestine, brittle bones
(osteoporosis).
•
You suffer from an infection (e.g. parasitic, fungal, bacte

Productkenmerken

1
Budeson caps-DL_Jan 2022 notif-05
DOCTOR LEAFLET
1.
NAME OF THE MEDICINAL PRODUCT:
BUDESON 3 MG CAPSULES
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_ _
Each capsule with gastro-resistant granules contains 3 mg budesonide.
Excipients with known effect: Each capsule contains 240mg sucrose and
12 mg
lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gastro-resistant capsules.
Appearance: pink capsule
containing white, gastro-resistant granules.
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.
•
Autoimmune hepatitis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Crohn’s disease
_ _
_Adults aged > 18 years _
The recommended daily dose is 9 mg budesonide: three capsules once
daily in the
morning or one capsule (containing 3 mg budesonide) three times daily
(morning,
midday and evening; if this is more convenient to the patient, about
½ hour before
meals.
Collagenous colitis
_Adults aged > 18 years _
The recommended dose is three capsules once daily in the morning
before breakfast
(corresponding to a daily dose of 9 mg budesonide).
Autoimmune hepatitis
_Induction of remission (adults aged > 18 years)_
_ _
For the induction of remission (i.e. normalisation of laboratory
parameters), the
recommended daily dose is one capsule (containing 3 mg budesonide)
three times
daily (morning, midday and evening; corresponding to a total daily
dose of 9 mg
budesonide).
_ _
_Maintenance of remission (adults aged > 18 years) _
2
After achievement of remission the recommended daily dose is one
capsule
(containing 3 mg budesonide) twice daily (one capsule in the morning
and one capsule
in the evening; corresponding to a total daily dose of 6 mg
budesonide). If the
transaminases ALAT and/or ASAT increase during maintenance treatment,
the dose
should be increased to 3 capsules per day (corresponding to a total
daily