Package Leaflet: Information for the user

Na acorf

55 micrograms/dose, nasal spray suspension

Triamcinolone acetonide

SANOFlO

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In the UK Phone 0845 372 7101 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

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.

Nasacort

Do not use Nasacort:

* If you are allergic to triamcinolone acetonide or any of the other ' igredients 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

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.

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 which can be an irritant and may cause skin reactions.

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 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

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

•    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

The nasal spray should be cleaned at least once a week. It can be cleaned more often if it gets blocked.

nstructions 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.

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 medici

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

14. 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 eyeball (glaucoma)

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.

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

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.

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:

-    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-adjustmen

What Nasacort looks like and contents of the pack

Nasacort is a 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.

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

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

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

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:    Nasacort Nasenspray

Belgium:    Nasacort

Bulgaria:    Nasacort

Czech Republic: Triamcinolone sanofi 55 mikrogramu/davka Denmark:    Nasacort

Estonia:    Nasacort

Finland:    Nasacort

Germany:    Nasacort 55

Mikrogramm/Dosis Greece:    Nasacort

Hungary:    Nasacort

Ireland:    Nasacort nasal spray

Italy:    Nasacort

Latvia:    Nasacort

Lithuania:    Triamcinolone

acetonide Sanofi 55pg/dose nasal spray, suspension

This leaflet was last revised in 02/2016