Nasacort Allergy 55 micrograms/dose nasal spray, suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Triamcinolone acetonide

Available from:

Opella Healthcare France SAS T/A Sanofi

ATC code:

R01AD; R01AD11

INN (International Name):

Triamcinolone acetonide

Dosage:

55 microgram(s)/dose

Pharmaceutical form:

Nasal spray, suspension

Therapeutic area:

Corticosteroids; triamcinolone

Authorization status:

Not marketed

Authorization date:

2011-12-09

Patient Information leaflet

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
NASACORT
® ALLERGY 55 MICROGRAMS/DOSE, NASAL SPRAY SUSPENSION
triamcinolone acetonide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU
The name of your medicine is ‘Nasacort Allergy 55 micrograms/dose,
nasal spray suspension’,
throughout the rest of this document it will be referred to as
‘Nasacort Allergy.
This medicine is available without prescription. However, you still
need to use Nasacort Allergy
carefully to get the best results from it.
Always use this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you.
•
Keep this leaflet. You may need to read it again.
•
Ask your doctor or pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
•
You must talk to a doctor if you do not feel better or if you feel
worse after 14 days.
WHAT IS IN THIS LEAFLET
1.
What Nasacort Allergy is and what it is used for
2.
What you need to know before you use Nasacort Allergy
3.
How to use Nasacort Allergy
4.
Possible side effects
5.
How to store Nasacort Allergy
6.
Contents of the pack and other information
1.
WHAT NASACORT ALLERGY IS AND WHAT IT IS USED FOR
Nasacort Allergy Nasal spray (called Nasacort Allergy throughout this
leaflet) contains a medicine
called triamcinolone acetonide. This belongs to a group of medicines
called corticosteroids which
means it is a type of steroid. It is given as a spray in the nose to
treat the nasal symptoms of allergic
rhinitis.
Nasal symptoms of allergy include sneezing, itching, and having a
blocked, stuffy or runny nose This
type of allergy, such as hay fever, can be caused by different pollens
in different seasons of the year.
This is called ‘seasonal allergic rhinitis’.
This medicine only works if used on a regular basis and may not help
your symptoms straight away.

Summary of Product characteristics

Health Products Regulatory Authority
25 August 2023
CRN00DR85
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nasacort Allergy 55 micrograms/dose nasal spray, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Triamcinolone acetonide
Bottles of NASACORT Allergy contain either 6.5 g or 16.5 g of
suspension (with 3.575 mg or 9.075 mg triamcinolone acetonide
respectively). One delivered dose contains 55 micrograms of
triamcinolone acetonide.
Excipient with known effect: 15 micrograms of benzalkonium
chloride/delivered dose.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Nasal spray,suspension.
It is anunscented, off-white thixotropic suspension of
microcrystalline triamcinoloneacetonide in an aqueous medium.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NASACORT Allergy is indicated for the treatment of symptoms of
seasonal allergic rhinitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Patients aged 18 years and over:_ The recommended starting dose is
220 micrograms as 2 sprays in each nostril once daily. Once
symptoms are controlled patients can be maintained on 110 micrograms
(1 spray in each nostril once daily).
Without medical supervision, Nasacort Allergy is not recommended for
use longer than three months. If symptoms of seasonal
allergic rhinitis are not relieved or if they worsen within 14 days, a
physician must be consulted.
Special population
_Paediatric population_
NASACORT Allergy is not recommended in children and adolescents under
18 years of age.
Method of administration
NASACORT Allergyis for nasal use only.
It is important to shake the bottle gently before each use.
Each actuation delivers 55 micrograms of triamcinolone acetonide from
the nose piece to the patient (estimated from in vitro
testing) after an initial priming of 5 sprays until a fine mist is
achieved. NASACORT Allergy will remain adequately primed for
2 weeks. If the product is unused for more than 2 weeks, then it can
be adequately reprimed with one spray. The nozzl