NASACORT 55 micrograms/dose nasal spray, suspension

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Triamcinolone acetonide

Tillgänglig från:

Lexon (UK) Ltd

ATC-kod:

R01AD11

INN (International namn):

Triamcinolone acetonide

Dos:

55 microgram(s)/dose

Läkemedelsform:

Nasal spray, suspension

Terapiområde:

triamcinolone

Tillstånd datum:

2019-08-30

Bipacksedel

ADDITIONAL SIDE EFFECTS IN CHILDREN
If your child has been using this medicine, it can
affect how fast your child grows. This means that
your doctor will need to regularly check your
child’s height and therefore your doctor may lower
the dose. In addition, your doctor may consider
referring your child to a paediatric specialist.
REPORTING OF SIDE EFFECTS
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. You can also
report side
effects directly via HPRA Pharmacovigilance,
Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1
6764971; Fax: [phone]. Website:
www.hpra.ie; E-mail: [e-mail]. By
reporting side effects you can help provide
more information on the safety of this medicine.
5. HOW TO STORE NASACORT
•
Keep this medicine out of the sight and reach of
children.
•
Do not use this medicine after the expiry date
which is stated on the carton and the bottle
after “EXP”. The expiry date refers to the last
day of that month.
•
Do not store above 25°C.
•
Following the first opening Nasacort should be
used with 2 months.
•
Do not throw away any medicines via waste
water or household waste. Ask your pharmacist
how to throw away medicines you no longer
use. These measures will help protect the
environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT NASACORT CONTAINS
The active substance is triamcinolone acetonide.
One delivered dose contains 55 micrograms of
triamcinolone acetonide.
The other ingredients are:
- disodium edetate
- anhydrous glucose
- microcrystalline cellulose and carmellose sodium
(AVICEL CL 611)
- polysorbate 80
- benzalkonium chloride
- dilute hydrochloric acid
- sodium hydroxide
- purified water
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 other ingredients of this medicine
(listed in section 6)
Signs of an allergic reaction to Nasacort include:
a rash (hives), itching, swallowing or breath

Produktens egenskaper

Health Products Regulatory Authority
30 August 2019
CRN008LKF
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NASACORT 55 micrograms/dose nasal spray, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One delivered dose contains 55 micrograms of triamcinolone acetonide.
Excipient with known effect
Benzalkonium chloride
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal spray, suspension
_Product imported from France _
Off-white, nasal spray suspension.
4 CLINICAL PARTICULARS
As per PA0540/011/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/011/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Disodium edetate
Microcrystalline cellulose and carmellose sodium (AVICEL CL 611)
Polysorbate 80
Benzalkonium chloride
Anhydrous glucose
Dilute hydrochloric acid
Sodium hydroxide
Purified water
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the bottle and outer package of the product on the
market in the country of origin.
After first opening: 2 months
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 °C.
Health Products Regulatory Authority
30 August 2019
CRN008LKF
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
NASACORT is contained in a bottle fitted with a metered-dose spray
pump unit, providing 120 actuations.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Lexon (UK) Limited
Unit 18, Oxleasow Road
East Moons Moat
Redditch
Worcestershire
B98 0RE
United Kingdom
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1097/032/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 30
th
August 2019
10 DATE OF REVISION OF THE TEXT