AZEP NASAL SPRAY azelastine 125?g/actuation (as hydrochloride) nasal spray aerosol, pump actuated-metered dose

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

azelastine hydrochloride, Quantity: 0.137 mg/actuation (Equivalent: azelastine, Qty 0.125 mg/actuation)

Saatavilla:

Viatris Pty Ltd

INN (Kansainvälinen yleisnimi):

Azelastine hydrochloride

Lääkemuoto:

Spray, nasal

Koostumus:

Excipient Ingredients: dibasic sodium phosphate dodecahydrate; disodium edetate; hypromellose; purified water; citric acid; sodium chloride

Antoreitti:

Nasal

Kpl paketissa:

10mL, 20mL, 5mL

Prescription tyyppi:

(S2) Pharmacy Medicine

Käyttöaiheet:

For the symptomatic treatment of seasonal allergic rhinitis, perennial allergic rhinitis.

Tuoteyhteenveto:

Visual Identification: Clear, colourless to almost colourless solution, in amber glass bottle fitted with a metered dose, pump, actuator & overcap.; Container Type: Aerosol - Pump Actuated Metered Dose; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Valtuutuksen tilan:

Licence status A

Valtuutus päivämäärä:

2004-07-21

Pakkausseloste

AZEP
® NASAL SPRAY
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ACTIVE INGREDIENT(S): _azelastine hydrochloride_
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using AZEP
NASAL SPRAY. YOU SHOULD ALSO SPEAK TO YOUR DOCTOR
OR PHARMACIST IF YOU WOULD LIKE FURTHER INFORMATION OR IF
YOU HAVE ANY CONCERNS OR QUESTIONS ABOUT USING AZEP
NASAL SPRAY.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1. Why am I using AZEP NASAL SPRAY?
2. What should I know before I use AZEP NASAL SPRAY?
3. What if I am taking other medicines?
4. How do I use Azep Nasal Spray?
5. What should I know while using AZEP NASAL SPRAY?
6. Are there any side effects?
7. Product details
1.
WHY AM I USING AZEP NASAL SPRAY?
AZEP NASAL SPRAY is used to relieve runny nose,
sneezing, itching or blocked nose caused by allergies, such
as to pollen (hay fever) house dust mites or pet hair.
AZEP NASAL SPRAY belongs to a group of medicines called
antihistamines. It works by blocking the action of histamine
and other substances produced by the body, which are
causing your allergies.
AZEP NASAL SPRAY is not addictive.
2.
WHAT SHOULD I KNOW BEFORE I USE AZEP
NASAL SPRAY?
WARNINGS
DO NOT USE AZEP NASAL SPRAY IF YOU HAVE AN ALLERGY TO
AZEP NASAL SPRAY OR ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET
Always check the ingredients to make sure you can use this
medicine.
DO NOT GIVE AZEP NASAL SPRAY TO A CHILD UNDER 5
YEARS, UNLESS DIRECTED BY THE CHILD’S DOCTOR.
The safety and effectiveness of AZEP NASAL SPRAY in
children under 5 years have not been established.
CHECK WITH YOUR DOCTOR OR PHARMACIST IF YOU:
•
have any other medical conditions, especially kidney
disease
•
take any medicines for any other condition
During treatment, you may be at risk of developing certain
side effects. It is important you understand these risks and
how to monitor for them. See additional information under
Section 6. Are there any side effects?
PREGNANCY AND BREASTFEEDING
Check with your doctor or pharmacist if you are pregnant or
intend to become pre

Valmisteyhteenveto

AUSTRALIAN PRODUCT INFORMATION
AZEP
® NASAL SPRAY
_Azelastine hydrochloride Nasal Spray _
1
NAME OF THE MEDICINE
Azelastine hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each actuation (0.137 mL) contains 137 µg azelastine hydrochloride
(equivalent to 125 µg azelastine as the base).
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
AZEP NASAL SPRAY is a clear, colourless, buffered, isotonic aqueous
solution with a pH of 6.8.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the symptomatic treatment of seasonal allergic rhinitis and
perennial allergic rhinitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN AGED 5 YEARS AND OVER:
Each spray contains 125 µg of azelastine (as hydrochloride).
One spray into each nostril twice daily as necessary (equivalent to a
daily dose of 0.50 mg azelastine (as
hydrochloride)).
LONG TERM TREATMENT:
Azelastine nasal spray may be used until symptoms cease, but no longer
than 6 months, uninterruptedly.
INSTRUCTIONS FOR HANDLING:
The spray should be used with the head held upright, after first
blowing the nose.
1.
The protective cap should be removed.
2.
Before the first use, the pump should be primed by spraying 2-3 times,
until an even spray is produced.
3.
One spray should be used in each nostril with the head tilted forward
(looking at toes). Do not keep the
head upright or tilted backwards.
4.
Sniffing should only be slow and gentle.
5.
The nozzle should be wiped and the protective cap replaced.
The pump should also be primed again after storage for 3 or more days.
4.3
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients.
AZEP
®
NASAL SPRAY – PRODUCT INFORMATION
2
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
USE IN THE ELDERLY
A pharmacokinetic study in elderly patients (n=15) receiving oral
azelastine hydrochloride 4.4 mg twice daily
found a prolongation of the T
max
and an increase in C
max
and AUC compared to results in healthy volunteers. There
have been no specific studies in the elderly with