Nasacort 55 micrograms/dose nasal spray, suspension

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TRIAMCINOLONE ACETONIDE

Available from:

Opella Healthcare France SAS T/A Sanofi 157 avenue Charles de Gaulle, 92200 Neuilly-sur-Seine , France

ATC code:

R01AD11

INN (International Name):

TRIAMCINOLONE ACETONIDE 55 µg

Pharmaceutical form:

NASAL SPRAY, SUSPENSION

Composition:

TRIAMCINOLONE ACETONIDE 55 µg

Prescription type:

POM

Therapeutic area:

NASAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2005-11-17

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NASACORT 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.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
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
WHAT IS IN THIS LEAFLET
1.
What Nasacort is and what it is used for
2.
What you need to know before you use Nasacort
3.
How to use Nasacort
4.
Possible side effects
5.
How to store Nasacort
6.
Contents of the pack and other information
1.
WHAT NASACORT IS AND WHAT IT IS USED FOR
Nasacort 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 in adults and children 2 years of
age and over.
Nasal symptoms of allergy include sneezing, itching, and having a
blocked, stuffy or runny nose.
These can be caused by things such as:
•
Animal fur or house dust mites. This type of allergy can happen at any
time of the year and is
called ‘perennial allergic rhinitis’.
•
Pollen. 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. It
helps some people within the first day of treatment, however, for
other people
it
may take 3 to 4 days
to feel a relief.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE NASACORT
DO NOT USE NASACORT:
•
If you are allergic to triamcinolone acetonide or any of the oth

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
NASACORT 55 micrograms/dose, nasal spray, suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bottles of NASACORT 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 an unscented, off-white, thixotropic suspension of
microcrystalline triamcinolone acetonide in an
aqueous medium.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NASACORT is indicated for the treatment of symptoms of seasonal and
perennial allergic rhinitis
in
adults and children 2 years of age and over.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
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).
_Paediatric population _
Children aged 12 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).
Children aged 6 to 12 years
The recommended dose is 110 micrograms as 1 spray in each nostril once
daily. In patients with more
severe symptoms, a dose of 220 micrograms may be used. But once
symptoms are controlled, patients
should be maintained on the lowest effective dose (see sections 4.4
and 5.1).
Children aged 2 to 5 years
The recommended and maximum dose is 110 micrograms as 1 spray in each
nostril once daily (see sections 4.4
and 5.1).
2
Continuous use beyond 3 months in children under 12 years is not
recommended.
Method of administration
NASACORT is for nasal use only.
It is important to shake the bottle gently before each use.
Each actuation del