TELNASAL ALLERGY SPRAY mometasone furoate (as monohydrate) 50 mcg/actuation suspension spray bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mometasone furoate monohydrate, Quantity: 51.73 microgram/actuation

Available from:

Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare

Pharmaceutical form:

Spray, nasal

Composition:

Excipient Ingredients: benzalkonium chloride; polysorbate 80; sodium citrate dihydrate; purified water; glycerol; citric acid monohydrate; microcrystalline cellulose; carmellose sodium

Administration route:

Nasal

Units in package:

2x140 metered sprays, 140 metered sprays

Prescription type:

(S2) Pharmacy Medicine

Therapeutic indications:

For the treatment of symptoms associated with seasonal allergic rhinitis and perennial allergic rhinitis and the prophylaxis of seasonal allergic rhinitis for up to 6 months in adults and children 12 years of age and over.

Product summary:

Visual Identification: White to off-white viscous suspension.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2020-02-20

Patient Information leaflet

TELNASAL ALLERGY SPRAY
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ACTIVE INGREDIENT: _ _Mometasone furoate monohydrate
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
Telnasal Allergy 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 TELNASAL ALLERGY SPRAY.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1. Why am I using Telnasal Allergy Spray?
2. What should I know before I use Telnasal Allergy Spray?
3. What if I am taking other medicines?
4. How do I use Telnasal Allergy Spray?
5. What should I know while using Telnasal Allergy Spray?
6. Are there any side effects?
7. Product details
1.
WHY AM I USING TELNASAL ALLERGY SPRAY?
TELNASAL ALLERGY SPRAY CONTAINS THE ACTIVE INGREDIENT
MOMETASONE FUROATE MONOHYDRATE. Telnasal Allergy Spray
belongs to a family of medicines called corticosteroids, which
are used to help reduce inflammation.
Allergic Rhinitis (hayfever): Telnasal Allergy Spray is sprayed
into the nose to help relieve symptoms that may occur with
hayfever or other year round allergies, including stuffiness
(congestion) in the nose, discharge, itching and sneezing.
This medicine may also be used to help prevent these
symptoms two to four weeks before the beginning of the
pollen season.
There is no evidence that this medicine is addictive.
2.
WHAT SHOULD I KNOW BEFORE I USE TELNASAL
ALLERGY SPRAY?
WARNINGS
DO NOT USE TELNASAL ALLERGY SPRAY IF:
•
you are allergic to mometasone furoate monohydrate, or
any of the ingredients listed at the end of this leaflet
•
you have a tendency to bleed or recurrent nose bleeding
•
you have severe nose infection, especially fungal
infection
•
you have had recent nose injury or nose surgery; you
may wait until healing has occurred before using this
medicine
•
you have active or inactive tuberculous infections of the
respiratory tract, bacterial, systemic viral infections or in
herpes simplex.
•
the expiry date printed on the pa

Summary of Product characteristics

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Page 1
AUSTRALIAN PRODUCT INFORMATION – TELNASAL ALLERGY
SPRAY (MOMETASONE FUROATE AS MONOHYDRATE) 50
MICROGRAM/SPRAY NASAL SPRAY
1
NAME OF THE MEDICINE
Mometasone furoate monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Telnasal Allergy Spray is a metered-dose, manual pump spray unit
containing a suspension of
mometasone furoate. Each actuation delivers approximately 100 mg of
mometasone furoate
monohydrate suspension, containing mometasone furoate monohydrate
equivalent to mometasone
furoate 50 µg.
Telnasal Allergy Spray contains mometasone furoate 0.5 mg/g (as the
monohydrate).
Mometasone also contains benzalkonium chloride 0.2 mg/g as
preservative.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Aqueous nasal spray.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the treatment of symptoms associated with seasonal allergic
rhinitis and perennial allergic
rhinitis and the prophylaxis of seasonal allergic rhinitis for up to 6
months in adults and children
12 years of age and over.
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4.2
DOSE AND METHOD OF ADMINISTRATION
DO NOT EXCEED THE RECOMMENDED DOSAGE.
The effect of mometasone aqueous nasal spray 0.05 % is not immediate.
Full therapeutic benefit
takes a few days to develop. Dosage should be administered as directed
and not to be taken by the
patients at will for symptomatic relief.
ALLERGIC RHINITIS
In patients who have a history of moderate to severe symptoms of
seasonal allergic rhinitis,
prophylactic treatment with mometasone is recommended two to four
weeks prior to the
anticipated start of the pollen season.
ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER:
The usual recommended dose for prophylaxis
and treatment is two sprays (50 µg/spray) in each nostril once daily
(total daily dose 200 µg).
Once symptoms are controlled, reducing the dose to one spray in each
nostril (total daily dose 100
µg) may be effective for maintenance.
After the first dose of mometasone , clinically significant
impr