BUDESON 3 MG CAPSULES

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

BUDESONIDE

제공처:

RAFA LABORATORIES LTD

ATC 코드:

A07EA06

약제 형태:

CAPSULES

구성:

BUDESONIDE 3 MG

관리 경로:

PER OS

처방전 유형:

Required

Manufactured by:

DR. FALK PHARMA, GERMANY

치료 영역:

BUDESONIDE

치료 징후:

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.

승인 날짜:

2018-12-13

환자 정보 전단

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 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.
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 YOU TAKE 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
t

제품 특성 요약

1
Budeson caps-DL-May 2016_Jan 2019 notif-04
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 240-276 mg 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
2
daily (morning, midday and evening; corresponding to a total daily
dose of 9 mg
budesonide).
_ _
_Maintenance of remission (adults aged > 18 years) _
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