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NASACORT 55 MCG/DOSE NASAL SPRAY SUSPENSION

Active substance(s): TRIAMCINOLONE ACETONIDE

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631663.qxp_631663 09/02/2016 11:14 Page 1

55 micrograms/dose, nasal spray suspension
Triamcinolone acetonide

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In the UK Phone 0845 372 7101 for help.
In the Republic of Ireland Phone
01 4035600

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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.

before using this medicine.
Children (under 6 years)
This medicine is not recommended for use in children under 6 years of age.
Operations or times of stress
Your doctor may advise you to take a higher than normal dose of this
medicine for medical reasons. If your dose is increased, tell your doctor if
you are going to have an operation or are feeling unwell. This is because higher than
normal doses of this medicine can lower your body's ability to heal or cope with
stress. If this happens, your doctor may decide you need further treatment with
another medicine to help.
Other medicines and Nasacort
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines. This is because Nasacort can affect the way some other
medicines work. Also some medicines can affect the way Nasacort works.

How much Nasacort to use
Adults and children (over 12 years)
The usual starting dose is 2 sprays in each nostril each day
● Once the symptoms of allergy are under control, the dose may be lowered to 1
spray in each nostril each day


Children (6 to 12 years)
The usual dose is 1 spray in each nostril each day
If the symptoms do not go away, then the dose may be increased to 2 sprays in
each nostril each day
● The dose can then be lowered again to 1 spray in each nostril each day
● Do not use Nasacort for more than 3 months in children under 12 years old


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 breathing problems, swelling of your lips, face, throat or
tongue.
Warning and precautions
Talk to your doctor or pharmacist before using Nasacort:
▲ If you have any infection of the nose or throat that is not treated. If you get a
fungal infection while using Nasacort, stop using the spray until the infection has
been treated.
▲ If you have recently had a nose operation, or had an injury or ulcer in the nose.
▲ If you are being transferred from steroid injections or tablets to Nasacort spray.
▲ If you have had glaucoma or cataracts
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask your doctor or pharmacist for advice before taking this medicine.

3. How to use Nasacort
NASACORT is for nasal use only.
Always use this medicine exactly as your doctor has told you. Check with your doctor
or pharmacist if you are not sure. The medicine only works if it is used regularly. It
can take 3 to 4 days before you notice your symptoms getting better.

4. Then breath out through your mouth

3

5. Repeat steps 3 and 4 if you have to spray again in the same
nostril and for the other nostril
6. After using the spray
To keep the spray nozzle clean, wipe it carefully with a clean
tissue or handkerchief after each use
Replace the cap over the nozzle

How to use the spray
Before using your nasal spray, blow your nose gently to clear your nostrils.



Wrong Position



1. Preparing the bottle
Remove the cap by pulling upward
Shake the bottle gently before use

1

If the nasal spray has not been used for more than 2 weeks:
It needs to be primed again, to fill the nozzle with the spray
The nozzle should be pointed away from you while you are doing this
To prime, spray into the air once before use
● Always shake the bottle gently before use







Driving and using machines
Nasacort has no or negligible influence on the ability to drive or use machines.
Nasacort contains benzalkonium chloride which can be an irritant and may cause
skin reactions.







2. What you need to know before you use Nasacort

3. Using the spray
3
Close one nostril with your finger
Hold the bottle upright and put the nozzle into the other nostril
as far as is comfortable
● Breathe in gently through your nose with your mouth closed
● While you are doing this, press the nozzle to deliver one spray
Correct Position


2. If you are using the spray for the first time
● Hold the bottle upright
● Point the spray away from you while doing this
● Fill the pump with spray by pressing the nozzle downwards.
This is called priming
● Press and release it 5 times
● Do this until a fine spray is produced
● The spray is now ready to use

Cleaning the spray
If the spray does not work, the nozzle may
be blocked. Never try to unblock it or
enlarge the tiny spray hole with a pin or
other sharp objects. This is because it can
stop the spray from working.

2

COUNTRY

UK CRGB - V1 – 05 /2012

OPERATOR

Graham

LOGO VERSION

N/A

MINIMUM POINT SIZE

10

PACKAGING ADMINISTRATION
HOLMES CHAPEL, UK

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Package Leaflet: Information for the user

Turn
Over

FOR CUSTOMER USE ONLY

PAD

17867

COLOURS USED

COMP. CODE

631663

Pantone Reflex Blue

BASED ON

613688

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DATE

09/02/16

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631663.qxp_631663 09/02/2016 11:14 Page 2

The nasal spray should be cleaned at least once a week. It can be cleaned more often
if it gets blocked.
Instructions for cleaning the spray:
1. Remove the cap
2. Gently pull off the spray nozzle only

Spray
Nozzle

Bottle
Cap

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets
them.
Stop using Nasacort and see a doctor or go to a hospital straight away if:
● you have an allergic reaction to Nasacort. The signs (frequency not known)
may include: a rash (hives), itching, swallowing or breathing problems,
swelling of your lips, face, throat or tongue.

Bottle

3. Soak the cap and spray nozzle in warm water
for a few minutes
4. Rinse under the cold running tap water
5. Shake or tap to remove any water that is left
6. Allow to dry in the air
7. Re-fit the spray nozzle
8. Prime the nasal spray until a fine mist is formed
9. Use as normal
If you use more Nasacort than you should
It is important that you take your dose as stated on the pharmacist's
label or as advised by your doctor. You should use only as much as
your doctor recommends; using more or less may make your
symptoms worse.
An overdose is unlikely to cause problems, however, if you have taken the entire
contents of the bottle by mouth you may have stomach or gut discomfort. Talk to a
doctor if you use more Nasacort than you should.
If you forget to use Nasacort
If you have forgotten to use Nasacort, use it as soon as you remember. Do not use a
double dose to make up for a forgotten dose.

In some people, Nasacort can cause damage to the middle part of the inside of the
nose (called ‘nasal septum’). Discuss any worries you may have about this with your
doctor or pharmacist.

Ireland
IRELAND: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1
6764971; Fax: +353 1 6762517; Website: www.hpra.ie; e-mail: medsafety@hpra.ie.
Malta
You can also report side effects directly via ADR Reporting
Website: www.medicinesauthority.gov.mt/adrportal
United Kingdom
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
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 within 1 month for the 30
spray pack or 2 months for the 120 spray pack.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help protect the environment.

The other ingredients are:
- microcrystalline cellulose and carmellose sodium (dispersible cellulose)
- polysorbate 80
- purified water
- anhydrous glucose
- benzalkonium chloride (50% w/v solution)
- disodium edetate
- hydrochloric acid or sodium hydroxide (for pH-adjustment)
What Nasacort looks like and contents of the pack
Nasacort is a nasal spray suspension. It comes in a white
Spray Nozzle
plastic bottle which has a pump to spray Nasacort into your
nostril through the spray nozzle. The bottle has a protective
cap to keep the nozzle clean and to stop it from spraying
Bottle
accidentally.
Cap

Marketing Authorisation Holder :
In the United Kingdom:
Sanofi, One Onslow Street, Guildford, Surrey GU1 4YS, United Kingdom
Tel: 0845 372 7101
email: uk-medicalinformation@sanofi.com
In Ireland :
sanofi-aventis Ireland Ltd. T/A SANOFI, National Digital Park, Citywest Business

Manufacturer :
Aventis Pharma, 72 London Road, Holmes Chapel, Crewe, Cheshire CW4 8BE,
United Kingdom
This medicinal product is authorised in the Member States of the EEA under
the following names :
Austria:
Belgium:
Bulgaria:
Czech Republic:

Bottle

This one spray bottle holds at least 120 sprays (16.5g of suspension which contains
9.075 mg triamcinolone acetonide) or at least 30 sprays (6.5g of suspension which
contains 3.575 mg triamcinolone acetonide).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer

Campus, Dublin 24, Ireland
Tel: 00353 (0) 1 403 5600
Fax: 00353 (0)1 403 5601
email: IEmedinfo@sanofi.com

Nasacort Nasenspray
Nasacort
Nasacort
Triamcinolone sanofi
55 mikrogramů/dávka
Nasacort
Nasacort
Nasacort
Nasacort 55
Mikrogramm/Dosis
Nasacort
Nasacort
Nasacort nasal spray
Nasacort
Nasacort
Triamcinolone
acetonide Sanofi
55μg/dose nasal
spray, suspension

Denmark:
Estonia:
Finland:
Germany:
Greece:
Hungary:
Ireland:
Italy:
Latvia:
Lithuania:

Luxembourg:
Netherlands
Poland:
Portugal:
Romania:

Nasacort
Nasacort
Nasacort
Nasacort
Nasacort 55
micrograme/doza
spray nazal, suspensie
Slovakia:
Nasacort 55
mikrogramov/dávka
Slovenia:
Nasacort
Spain:
Nasacort
Sweden:
Nasacort
United Kingdom: Nasacort nasal spray

NASACORT AQ

If you have any further questions on the use of this medicine, ask your doctor or
pharmacist.

Other side effects (Not known: frequency cannot be estimated from the available
data)
Irritation and dryness on the inside of your nose
● Sinuses become congested or blocked
● Sneezing
● Changes in the way things taste or smell
● Feeling sick (nausea)
● Sleeping problems, feeling dizzy or tired
● Shortness of breath (dyspnoea)
● A decrease in the levels of cortisol in the blood (lab value)
● Cloudiness of the lens in the eye (cataract), elevated pressure inside the eyeball
(glaucoma)


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
(see details below). By reporting side effects you can help provide more information
on the safety of this medicine.

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.

631663

If you stop using Nasacort
If you stop using this medicine, your symptoms may return within a few days.

Common side effects (may affect up to 1 in 10 people)
● Runny nose, headache, sore throat and/or cough
● Nosebleeds
● Inflammation/irritation of the airways (bronchitis)
● Heartburn or indigestion
● Flu-like symptoms (fever, muscle pain, weakness and/or fatigue)
● Problems with teeth

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.

This leaflet was last revised in 02/2016

COUNTRY

UK CRGB - V1 – 05 /2012

OPERATOR

Graham

LOGO VERSION

N/A

MINIMUM POINT SIZE

10

PACKAGING ADMINISTRATION
HOLMES CHAPEL, UK

FOR CUSTOMER USE ONLY

PAD

17867

COLOURS USED

COMP. CODE

631663

Pantone Reflex Blue

BASED ON

613688

Print free

APPROVED BY:

DATE:

FOR PACK ADMIN USE ONLY
PROOF NO.

1

CPRO

1-53

SIZE (mm)

625 x 150

DATE

PHARMACODE

1357

OVERPRINT
AREA

CHECK BY:

09/02/16

Pantone Reflex Blue 50%

AUTHORISED BY:

CHECK BY:

DATE:

2ND CHECK BY:
PREFIX
POSITION

CHECK BY:

THIS ARTWORK PROOF INDICATES COLOUR POSITION ONLY
Please refer to Pantone Colour Formula Guide 1000 for exact colour references

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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