Butacort

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Budesonide 2 mg/mL

Available from:

Viatris Limited

INN (International Name):

Budesonide 2 mg/mL

Dosage:

100 mcg/dose

Pharmaceutical form:

Nasal spray suspension

Composition:

Active: Budesonide 2 mg/mL Excipient: Disodium edetate dihydrate Dispersible cellulose Glucose Hydrochloric acid Polysorbate 80 Potassium sorbate Purified water

Units in package:

Spray bottle, metered, 200 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sicor (Societa Italiana Corticosteroidi) Srl

Therapeutic indications:

For the prevention and treatment of seasonal and perennial allergic rhinitis and vasomotor rhinitis.

Product summary:

Package - Contents - Shelf Life: Spray bottle, metered, - 200 dose units - 24 months from date of manufacture stored at or below 25°C protect from light

Authorization date:

1991-08-23

Patient Information leaflet

Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
BUTACORT 50
_BUDESONIDE NASAL SPRAY, 50 MICROGRAMS (ΜG) PER SPRAY_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using Butacort 50.
This leaflet answers some common
questions about Butacort 50.
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 or pharmacist
has weighed the risks of you using
Butacort 50 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 BUTACORT 50 IS
USED FOR
Butacort 50 is used to prevent and
treat seasonal allergic rhinitis
(hayfever), which is an inflammation
or swelling of the nose lining. This
is often, but not always, due to an
allergy to something in the air.
Butacort 50 contains the active
ingredient budesonide. It belongs
to a group of medicines known as
corticosteroids, frequently referred
to as ‘steroids’. They are not
anabolic steroids that are
sometimes misused by athletes.
Butacort 50 works by reducing the
swelling and irritation in the lining of
the nose. It relieves the symptoms
of blocked nose, runny nose, itchy
nose and sneezing.
Your doctor or pharmacist,
however, may recommend Butacort
50 for another purpose.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT
WHY THIS MEDICINE HAS BEEN
RECOMMENDED FOR YOU.
Butacort 50 is only available at a
pharmacy.
DO NOT GIVE THIS MEDICINE TO A
CHILD UNDER THE AGE OF 12 YEARS
UNLESS RECOMMENDED OR
PRESCRIBED BY YOUR DOCTOR.
There is not enough information to
recommend the use of this medicine
for children under the age of 6
years.
There is no evidence that Butacort
50 is addictive.
BEFORE YOU USE
BUTACORT 50
_WHEN YOU MUST NOT USE_
_IT_
DO NOT USE BUTACORT 50 IF YOU
HAVE AN ALLERGY TO:

any medicine containing
budesonide

any other corticosteroid

any of the

Summary of Product characteristics

Page 1 of 11
NEW ZEALAND DATA SHEET
BUTACORT
1. PRODUCT NAME
BUTACORT, 50 micrograms or 100 micrograms per actuation, aqueous nasal
suspension.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
BUTACORT 50: Each actuation contains 50 micrograms of budesonide.
BUTACORT 100: Each actuation contains 100 micrograms of budesonide.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
50 micrograms/actuation:
An almost white opaque suspension, almost odourless.
Amber glass
bottle fitted with a metered pump device delivering 50 micrograms
budesonide per actuation.
Delivery of valve: 50 microliters (each 50 microliter contains 50
micrograms of budesonide).
100 micrograms/actuation:
An almost white opaque suspension, almost odourless.
Amber glass
bottle fitted with a metered pump device delivering 100 micrograms
budesonide per actuation.
Delivery of valve: 50 microliters (each 50 microliters contains 100
micrograms of budesonide).
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
BUTACORT 50 Aqueous Nasal Spray is indicated for the short-term
prevention and treatment of
seasonal allergic rhinitis (hayfever).
BUTACORT 100 Aqueous Nasal Spray is indicated for the prevention and
treatment of seasonal
and perennial allergic rhinitis and vasomotor rhinitis.
BUTACORT 100 Aqueous Nasal Spray is also indicated for the symptomatic
relief of nasal
polyposis.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
BUTACORT 50
_FOR ADULTS AND CHILDREN OVER 12 YEARS:_
Initially one or two sprays into each nostril twice a day (morning and
night), then after 2 to 3 days,
one spray into each nostril twice a day.
Page 2 of 11
BUTACORT 100
_FOR ADULTS AND CHILDREN OVER 6 YEARS:_
Initially one or two sprays into each nostril in the morning, then
after 2 to 3 days, one spray into
each nostril in the morning.
For patients with only mild initial symptoms, a total daily dose of
200 micrograms may be sufficient.
For long term treatment, the lowest dose which keeps the patient
symptom-free should be used.
Continuous long-term use in childre