Budesonide Te Arai

Země: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktivní složka:

Budesonide 3mg

Dostupné s:

Te Arai BioFarma Limited

Dávkování:

3 mg

Léková forma:

Modified release capsule

Složení:

Active: Budesonide 3mg Excipient: Gelatin   Ethylcellulose dispersion Type B Ink black 10A2 Iron oxide black Iron oxide red Methacrylic acid copolymer Polysorbate 80 Purified talc Sugar spheres Titanium dioxide   Triethyl citrate

Druh předpisu:

Prescription

Terapeutické indikace:

Indicated for the induction of remission in patients with mild to moderate Crohn's disease affecting the ileum and/or the ascending colon.

Přehled produktů:

Package - Contents - Shelf Life: Bottle, plastic, HDPE with cap containing desiccant in outer carton - 20 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, plastic, HDPE with cap containing desiccant in outer carton - 45 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, plastic, HDPE with cap containing desiccant in outer carton - 90 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture - Bottle, plastic, HDPE with cap containing desiccant in outer carton - 100 capsules - 24 months from date of manufacture stored at or below 25°C protect from light and moisture

Datum autorizace:

2022-02-04

Informace pro uživatele

New Zealand Consumer Medicine Information
BUDESONIDE TE ARAI
_BUDESONIDE _
3 mg, Controlled-Release Capsules
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Budesonide
Te Arai.
This leaflet answers some common questions about Budesonide Te Arai.
It does not
contain all the available information. It does not take the place of
talking to your
doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you using
Budesonide Te Arai against the benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT BUDESONIDE TE ARAI IS USED FOR
Budesonide is used to treat Crohn’s disease. It can be used to treat
acute attacks.
Crohn’s disease is an inflammatory disease of the bowel. It mainly
affects the small
bowel and the first part of the large bowel and causes symptoms such
as stomach
pain, diarrhoea and fever.
Budesonide Te Arai contains budesonide. It belongs to the group of
medicines called
corticosteroids, which are used to help reduce inflammation in many
parts of the
body. Budesonide capsules are designed to release their contents
gradually in the
last part of the small bowel (the ileum) and the first part of the
large bowel.
Ask your doctor if you have any questions about why budesonide has
been
prescribed for you.
Your doctor may have prescribed budesonide for another reason.
1
Ask your doctor if you have any questions about why budesonide has
been
prescribed for you.
This medicine is available only with a doctor's prescription.
This medicine is not addictive.
This medicine is not expected to affect your ability to drive a car or
operate
machinery.
BEFORE YOU USE BUDESONIDE TE ARAI
_ _
_ _
_WHEN YOU MUST NOT USE IT _
Do not use budesonide if you have an allergy to:
•
any medicine containing budesonide
•
any ingredients listed at the end of this leaflet.
Some of the symptoms of an allergic reaction may

Charakteristika produktu

Budesonide Te Arai Data Sheet v 3.0 July 2023
Page 1 of 8
1
PRODUCT NAME
Budesonide Te Arai 3 mg controlled-release capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 3 mg of budesonide.
Excipient(s) with known effect
•
Each 3mg capsule contains approximately 285 mg of sucrose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Number 1 gelatin capsules, light grey opaque body and swedish orange
opaque cap.
Each capsule contains budesonide 3 mg as gastro-resistant, prolonged
release pellets.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
Indicated for the induction of remission in patients with mild to
moderate Crohn’s disease affecting
the ileum and/or the ascending colon.
4.2
Dose and method of administration
The capsules should be swallowed whole with water. For patients with
difficulty swallowing, the
capsules may be opened, and the contents swallowed after mixing with a
tablespoon of apple sauce.
It is important that the contents of the capsules are not crushed or
chewed.
Adults
The recommended daily dose for induction of remission is 9 mg,
administered once daily for up to
eight weeks. The dose should be taken in the morning before breakfast.
Full effect is usually
achieved within 2-4 weeks. When treatment with budesonide capsules is
to be discontinued, the
dose should be tapered for 2 to 4 weeks and not stopped abruptly.
Children
There are limited data on the use of budesonide capsules in children.
The available data are
insufficient to support safety and efficacy in the paediatric
population, therefore such use cannot be
recommended until further data become available.
Influence on Growth
It is recommended that the height of children receiving prolonged
treatment with corticosteroids is
regularly monitored. If growth is slowed, therapy should be
re-evaluated. The benefits of
corticosteroid therapy and the possible risk of growth suppression
must be carefully weighed. Long-
term studies have not been performed in children treated with
budesonide capsules.