NASACORT 55 micrograms/dose nasal spray, suspension

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
Triamcinolone acetonide
Available from:
Lexon (UK) Ltd
ATC code:
R01AD11
INN (International Name):
Triamcinolone acetonide
Dosage:
55 microgram(s)/dose
Pharmaceutical form:
Nasal spray, suspension
Therapeutic area:
triamcinolone
Authorization number:
PPA1097/032/001
Authorization date:
2019-08-30

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: +353 1 6762517. Website:

www.hpra.ie; E-mail: medsafety@hpra.ie. 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 breathing

problems, swelling of your lips, face, throat or

tongue.

Warnings 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 before using

this medicine.

Contact your doctor if you experience blurred

vision or other visual disturbances.

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, including medicines obtained without a

prescription. This is because Nasacort can affect

the way some other medicines work. Also some

medicines can affect the way Nasacort works.

Some medicines may increase the effects of

Nasacort and your doctor may wish to monitor you

carefully if you are taking these medicines

(including some medicines for HIV: ritonavir,

cobicistat).

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.

Package Leaflet: Information for the user

NASACORT 55 micrograms/ dose nasal spray, suspension

(triamcinolone acetonide)

®

Ref: 1097/032/001/190819/1/F

What Nasacort looks like and contents of the

pack

Nasacort is an off white nasal spray suspension. It

comes in a white 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

accidentally.

One spray bottle contains 120 sprays.

Product procured from within the EU, repackaged

and distributed by the Parallel Product

Authorisation Holder: Lexon (UK) Limited, Unit 18,

Oxleasow Road, East Moons Moat, Redditch,

B98 0RE, UK.

Manufactured by:

Aventis Pharma, Crewe, Cheshire, United

Kingdom.

Nasacort is a registered trademark of the

AVENTIS PHARMA SA

PPA1097/032/001

This leaflet was last revised in August 2019

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited,

Tel: +44 (0) 1527 505414 for

help.

POM

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.

If you stop using Nasacort

If you stop using this medicine, your symptoms

may return within a few days.

If you have any further questions on the use of

this medicine, ask your doctor or pharmacist.

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.

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

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 eye ball

(glaucoma)

Blurred vision

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.

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.

Driving and using machines

Nasacort has no or negligible influence on the

ability to drive or use machines.

Nasacort contains benzalkonium chloride

This medicine contains benzalkonium chloride.

Benzalkonium chloride may cause irritation or

swelling inside the nose, especially if used for a

long time.

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.

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

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

How to use the spray

Before using your nasal spray, blow your nose

gently to clear your nostrils.

1. Preparing the bottle

Remove the cap by pulling

upward.

Shake the bottle gently

before use.

2. If you are using the spray for the first time

Hold the bottle upright.

Point the spray away from you

while doing this.

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

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.

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.

3. Using the spray

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

4. Then breath out through your mouth

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

Replace the cap over the nozzle

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

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.

Ref: 1097/032/001/190819/1/B

1

2

3

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

August 2019

10 DATE OF REVISION OF THE TEXT

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