Nasacort Allergy 55 Micrograms/Dose Nasal Spray
NASACORT®
Allergy Nasal Spray 55 micrograms/dose, nasal spray suspension
Triamcinolone acetonide SANOFI^
Read all of this leaflet carefully because it contains important information for you
This medicine is available without prescription. However, you still need to use Nasacort Allergy carefully to get the best results from it.
• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• You must contact a doctor if your symptoms worsen or do not improve after 14 days
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Nasacort Allergy is and what it is used for
2. Before you use Nasacort Allergy
3. How to use Nasacort Allergy
4. Possible side effects
5. How to store Nasacort Allergy
6. Further information
Nasacort Allergy Nasal Spray (called Nasacort Allergy throughout this leaflet) 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 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.
Do not use Nasacort Allergy if:
* You are allergic (hypersensitive) to triamcinolone acetonide or any of the other ingredients of Nasacort Allergy (see Section 6: Further Information)
Signs of an allergic reaction to Nasacort Allergy include: a rash (hives), itching, swallowing or breathing problems, swelling of | your lips, face, throat or tongue.
Take special care with Nasacort Allergy
Check with your doctor or pharmacist before using your medicine if:
▲ You have any infection of the nose or throat that is not treated. If you get a fungal infection while using Nasacort Allergy, 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 Nasacort Allergy 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.
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.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is because Nasacort Allergy can affect the way some other medicines work. Also some medicines can affect the way Nasacort Allergy works.
Pregnancy and breast-feeding
If you are pregnant or breast feeding you should not use this medicine unless your doctor has advised you that the benefits of using it are higher than the possible risk to your baby.
Driving and using machines
Nasacort Allergy has no known effect on your ability to drive or use tools or machines.
Important information about some of the ingredients of Nasacort Allergy
Nasacort Allergy contains benzalkonium chloride which is an irritant and may cause skin reactions.
Always use Nasacort Allergy exactly as your doctor or pharmacist has told you. You should 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 Allergy 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 every day for longer than three months without consulting your doctor.
Children or adolescents under 18 years
This medicine is not recommended for children or adolecents 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
• Shake the bottle gently before 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 breathe 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
Correct Position
Wrong Position
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
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
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.
The nasal spray should be cleaned at least once a week. It can be cleaned more often if it gets blocked.
If you use more Nasacort Allergy 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.
Instructions for cleaning the spray: 1. Remove the cap
2. Gently pull off the spray nozzle only
Spray
Nozzle
I
Bottle
Cap
Bottle
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 Allergy than you should.
If you forget to use Nasacort Allergy
If you have forgotten to use Nasacort Allergy, use it as soon as you remember. Do not use a double dose to make up for a forgotten dose.
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 stop using Nasacort Allergy
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 product, ask your doctor or pharmacist.
Like all medicines, Nasacort Allergy can cause side effects, although not everybody gets them.
Stop using Nasacort Allergy and see a doctor or go to a hospital straight away if:
• you have an allergic reaction to Nasacort Allergy. The signs (frequency not known) may include: a rash (hives), itching, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
Tell your doctor or pharmacist if you have any of the following side effects. Also tell them if you notice any side effects not listed in this leaflet.
Common side effects (affects 1 to 10 users in 100)
• 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 (frequency not known)
• 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 Allergy 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
United Kingdom
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting, The Medicines Authority, Post-Licensing Directorate,
203 Level 3, Rue D'Argens, GZR-1368 Gzira Website: www.medicinesauthority.gov.mt e-mail: postlicensing.medicinesauthority@gov.mt
By reporting side effects you can help provide more information on the safety of this medicine.
• Keep this medicine in a safe place where children cannot see or reach it.
• Do not use Nasacort Allergy after the expiry date. This is marked 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.
• Nasacort Allergy should be used within 1 month after first opening the bottle
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Nasacort Allergy contains
The active substance is triamcinolone acetonide. Each spray delivers 55 micrograms triamcinolone acetonide.
The other ingredients are:
- microcrystalline cellulose
- carmellose sodium
- polysorbate 80
- purified water
- anhydrous glucose
- benzalkonium chloride
- disodium edetate
- hydrochloric acid or sodium hydroxide (for pH adjustment)
What Nasacort Allergy looks like and contents of the pack
Nasacort Allergy is a nasal spray suspension.
It comes in a white plastic bottle which has a pump to spray Nasacort Allergy 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 30 sprays (6.5g of suspension which contains 3.575 mg triamcinolone acetonide).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sanofi, One Onslow Street, Guildford, Surrey GU1 4YS,
United Kingdom Tel: 0845 372 7101
Email: uk-medicalinformation@sanofi.com Manufacturer:
Aventis Pharma, Holmes Chapel, 72 London Road, Holmes Chapel, Crewe, Cheshire, CW4 8BE, United Kingdom
This leaflet does not contain all of the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in February 2016
© Sanofi, 1997 -2016