Nasacort Aqueous Nasal Spray 120D

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Nasacort Aqueous Nasal Spray


Nasacort AQ is a nasal spray that contains triamcinolone - an adrenocortical steroid.  It prevents the release of substances in the body that cause inflammation.  Nasacort AQ is used to treat nasal allergy symptoms such as sneezing, itching, and runny nose caused by seasonal allergies or hay fever

Nasacort Aqueous Nasal Spray 120D


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.
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.
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.
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 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 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:
1.  Remove the blue cover
2.  Gently pull off the spray nozzle only
3.  Soak the blue cover 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 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 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:
FREEPOST
Pharmacovigilance Section
Irish Medicines Board
Kevin O'Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2Ireland
Tel: +353 1 6764971
Fax: +353 1 6762517
Website:
e-mail: imbpharmacovigilance@imb.ie
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3
Rue D'Argens
GŻR-1368 Gżira
Website:
e-mail: postlicensing.medicinesauthority@gov.mt
United Kingdom
Yellow Card Scheme at:
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-adjustment)
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 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 (16.5g 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

Nasacort Aqueous Nasal Spray 120D

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