Package leaflet: Information for the user

Triamcinolone acetonide 55 micrograms/dose, nasal spray suspension

Triamcinolone acetonide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you

The name of your medicine is ‘Triamcinolone acetonide 55 micrograms/dose, nasal spray suspension’, throughout the rest of this document it will be referred to as ‘Triamcinolone acetonide Spray”.

This medicine is available without prescription. However, you still need to use Triamcinolone acetonide carefully to get the best results from it.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

•    Keep this leaflet. You may need to read it again.

•    Ask your doctor or pharmacist if you need more information or advice.

•    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.

•    You must talk to a doctor if you do not feel better or if you feel worse after 14 days.

What is in this leaflet

•    What Triamcinolone acetonide is and what it is used for

•    What you need to know before you use Triamcinolone acetonide

•    How to use Triamcinolone acetonide

•    Possible side effects

•    How to store Triamcinolone acetonide

•    Contents of the pack and other information

1. What Triamcinolone acetonide is and what it is used for

Triamcinolone acetonide 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.

This type of allergy, such as hayfever, 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 Triamcinolone acetonide Do not use Triamcinolone acetonide:

• 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 Triamcinolone acetonide 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 Triamcinolone acetonide if:

•    You have any infection of the nose or throat that is not treated. If you get a fungal infection while using Triamcinolone acetonide, stop using the spray until the infection has been treated.

•    You have recently had a nose operation, or had an injury or ulcer in the nose.

•    You are being transferred from steroid injections or tablets to Triamcinolone acetonide spray.

•    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 and adolescents (under 18 years)

This medicine is not recommended for use in children and adolescents under 18 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 Triamcinolone acetonide

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 Triamcinolone acetonide can affect the way some other medicines work. Also some medicines can affect the way Triamcinolone acetonide works.

Pregnancy and 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

Triamcinolone acetonide has no or negligible influence on the ability to drive and use machines.

Important information about some of the ingredients of Triamcinolone acetonide

Triamcinolone acetonide contains benzalkonium chloride which can be an irritant and may cause skin reactions.

3. How to use Triamcinolone acetonide

Triamcinolone acetonide is for nasal use only.

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist 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 Triamcinolone acetonide to use Adults (18 years and over)

•    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

•    If the symptoms do not go away after 14 days, check with your doctor or pharmacist

•    You should not use the spray for longer than three months without consulting your doctor

Children and adolescents (under 18 years)

• This medicine is not recommended for use in children and adolescents under 18 years of age.

How to use the spray

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

1. Preparing the bottle

•    Remove the blue cover by pulling upwards.

•    Pull off the blue plastic clip.

•    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.

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 use

•    Press the blue plastic clip back into place to stop accidental release of the spray

•    Replace the blue cover 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.

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:

•    Remove the blue cover

•    Gently pull off the spray nozzle only

•    Soak the blue cover and spray nozzle in warm water for a few minutes

•    Rinse under the cold running tap water

•    Shake or tap to remove any water that is left

•    Allow to dry in the air

•    Re-fit the spray nozzle

•    Prime the nasal spray until a fine mist is formed

•    Use as normal

If you use more Triamcinolone acetonide than you should

It is important that you take your dose as stated on the pharmacist’s label or as advised by your doctor or pharmacist. You should use only as much as your pharmacist or 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 or pharmacist if you use more Triamcinolone acetonide than you should.

If you forget to use Triamcinolone acetonide

If you have forgotten to use Triamcinolone acetonide, use it as soon as you remember. Do not use a double dose to make up for a forgotten dose.

If you stop using Triamcinolone acetonide

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 Triamcinolone acetonide and see a doctor or go to a hospital straight away if:

•    you have an allergic reaction to Triamcinolone acetonide. 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 (laboratory value)

•    Cloudiness of the lens in the eye (cataract), elevated pressure inside the eye ball (glaucoma)

In some people, Triamcinolone acetonide 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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the yellow card scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Triamcinolone acetonide

•    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 Triamcinolone acetonide 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 Triamcinolone acetonide 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-adjustment)

What Triamcinolone acetonide looks like and contents of the pack

Triamcinolone acetonide is a nasal spray suspension. It comes in a white plastic bottle which has a pump to spray Triamcinolone acetonide into your nostril through the spray nozzle. The bottle has a protective blue cover to keep the nozzle clean and a blue plastic clip to stop it from spraying accidentally.

This one spray bottle holds at least 120 sprays (16.5 g of suspension which contains 9.075 mg triamcinolone acetonide) or at least 30 sprays (6.5 g of suspension which contains 3.575 mg triamcinolone acetonide) .

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Aventis Pharma Limited, One Onslow Street,Guildford, UK.

Tel: 01483 505515

e-mail: uk-medicalinformation@sanofi-aventis.com Manufacturer :

Aventis Pharma, Holmes Chapel,

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: Cortnasal

Belgium: Allegra nasal, 55 micrograms/dose nasal spray suspension Denmark: Triamcinolonacetonid sanofi-aventis

Germany: Nasacort Sanofi-Aventis, 55 Mikrogramm /SpruhstoB Nasenspray, Suspension Greece: Nasacort Allergy™

Ireland: Nasacort Allergy 55 micrograms/dose nasal spray, suspension

Luxembourg: Allegra nasal, 55 micrograms/dose nasal spray suspension

Netherlands: Triamcinolone acetonide sanofi-aventis 55 microgram/dosis neusspray, suspensie

Portugal: Triamcinolona Sanofi

United Kingdom: Triamcinolone acetonide

This leaflet was last revised in 09/2016

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