Alanase
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
18-01-2021
Summary of Product characteristics
(SPC)
04-01-2021
Active ingredient:
Beclometasone dipropionate 0.5 mg/g;
Available from:
Viatris Limited
INN (International Name):
Beclometasone dipropionate 0.5 mg/g
Dosage:
50 mcg/dose
Pharmaceutical form:
Nasal spray solution
Composition:
Active: Beclometasone dipropionate 0.5 mg/g Excipient: Benzalkonium chloride Dispersible cellulose Glucose Phenethyl alcohol Polysorbate 80 Purified water
Units in package:
Spray bottle, metered, 1 x 200 metered doses, 200 dose units
Class:
Pharmacy only
Prescription type:
Pharmacy only
Manufactured by:
Farmabios SpA
Therapeutic indications:
For the short term prevention and treatment of seasonal allergic rhinitis (hay fever).
Product summary:
Package - Contents - Shelf Life: Spray bottle, metered, amber glass bottle, fitted with metered atomising polyethylene pump unit - 200 dose units - 36 months from date of manufacture stored at or below 25°C
Authorization date:
1991-07-09
Patient Information leaflet
Page 1 of 4
NEW ZEALAND CONSUMER MEDICINE INFORMATION
ALANASE
_BECLOMETASONE DIPROPIONATE NASAL SPRAY _
_50 MICROGRAM (ΜG) PER SPRAY _
_ _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start using ALANASE.
This leaflet answers some common
questions about ALANASE.
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
ALANASE 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 ALANASE IS
USED FOR
ALANASE is used to prevent and
treat seasonal allergic rhinitis (hay
fever). It 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.
ALANASE contains 50 micrograms
(µg) of beclometasone dipropionate
per spray. 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.
ALANASE Your doctor or
pharmacist, may have
recommended this medicine for
another reason.
ALANASE is available at a
pharmacy.
There is no evidence that
ALANASE is addictive.
Do not use ALANASE for children
under 12 years of age without first
consulting with a doctor.
There is not enough information to
recommend the use of this medicine
for children under the age of 6
years.
BEFORE YOU USE
ALANASE
_WHEN YOU MUST NOT USE _
_IT _
DO NOT USE ALANASE IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
beclometasone
•
any of the ingredients listed
at the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:
shortness of breath; wheezing
or difficulty breathing; swelling
of the face, lips, tongue or other
parts of the body; rash, itching
or hives on the skin.
DO NOT USE THIS ME
Read the complete document
Summary of Product characteristics
Page 1 of 7
NEW ZEALAND DATA SHEET
ALANASE
1. PRODUCT NAME
ALANASE, 50 micrograms per actuation, nasal spray solution.
ALANASE 100, 100 micrograms per actuation, nasal spray solution.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100 mg spray delivered by the nasal applicator contains 50
micrograms or 100 micrograms of
beclometasone dipropionate.
Excipient with known effect:
Benzalkonium chloride
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
ALANASE aqueous nasal spray (50 micrograms per actuation) is an almost
white opaque
suspension of microfine beclometasone dipropionate delivered by a
metering, atomising pump.
ALANASE 100 aqueous nasal spray (100 micrograms per actuation) is an
almost white opaque
suspension of microfine beclometasone dipropionate delivered by a
metering, atomising pump.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS _
ALANASE aqueous nasal spray (50 micrograms per actuation) is indicated
for the short-term
prevention and treatment of seasonal allergic rhinitis (hay fever).
ALANASE 100 aqueous nasal spray (100 micrograms per actuation) is
indicated for the prevention
and treatment of seasonal and perennial allergic rhinitis and
vasomotor rhinitis.
ALANASE 100 can significantly delay the recurrence of nasal polyps in
those patients who have
undergone nasal polypectomy. In those polyps that do recur, ALANASE
100 can suppress their
increase in size.
_4.2 _
_DOSE AND METHOD OF ADMINISTRATION _
DOSE
ALANASE and ALANASE 100 should be shaken before use.
Page 2 of 7
_ALANASE (50 MICROGRAMS PER ACTUATION) _
FOR ADULTS AND CHILDREN OVER 12 YEARS OF AGE:
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.
Do not use ALANASE (50 micrograms per actuation) for children under 12
years of age without first
consulting with a doctor.
If hayfever symptoms do not improve within 7 days of treatment with
ALANASE, consult with a
doctor.
_ALANASE 100 (100 MICROGRAMS PER ACTUATION) _
FOR
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