Nasacort

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

TRIAMCINOLONE ACETONIDE

Available from:

Sanofi Malta Limited

ATC code:

R01AD11

INN (International Name):

TRIAMCINOLONE ACETONIDE

Pharmaceutical form:

NASAL SPRAY, SUSPENSION

Composition:

TRIAMCINOLONE ACETONIDE 55 microgram(s)

Prescription type:

POM

Therapeutic area:

NASAL PREPARATIONS

Authorization status:

Authorised

Authorization date:

2005-11-17

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
55 MICROGRAMS/DOSE, NASAL SPRAY SUSPENSION
Triamcinolone acetonide
Is this leaflet hard to see or read?
In the UK Phone [phone] for help.
In the Republic of Ireland Phone
01 4035600
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.
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:
✖

Summary of Product characteristics

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 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_PATIENTS 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).
_PAEDIATRIC PATIENTS 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).
Special population
_Paediatric population _
Until further evidence is available, continuous use beyond 3 months in
children under 12 years is not
recommended.
PAGE 2 OF 7
Method of administration
NASACORT is for nasal use only.
It is important to shake the bottle gently before each use.
Each actuation delivers 55 micrograms 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
will remain adequately primed for 2 weeks. If the product is unused
for more than 2 weeks, then it can
be adequately re-primed with one