Nasacort
Italy
Table of Contents
Package leaflet: Information for the patient
Nasacort 55 micrograms/dose, nasal spray, suspension
Triamcinolone acetonide
Please read this leaflet carefully before using this medicine because it contains important information for you.
- Always take this medicine exactly as described in this leaflet or as your pharmacist has instructed you.
- Keep this leaflet. You may need to read it again.
- If you need more information or advice, consult your pharmacist.
- If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
- Consult your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment.
Contents of this leaflet:
- What Nasacort is and what it is used for
- What you need to know before using Nasacort
- How to use Nasacort
- Possible side effects
- How to store Nasacort
- 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 medicine belongs to a group of medicines called corticosteroids, which means that it is a cortisone-like substance. It is administered as a nasal spray to treat nasal symptoms of allergic rhinitis in adults and children aged 2 years and older.
Nasal symptoms associated with nasal allergy include sneezing, itching, blocked, stuffy, or runny nose. These symptoms may be caused by:
animal fur or house dust mites. This type of allergy can occur at any time of the year and is known as "perennial allergic rhinitis".
Pollen. This type of allergy, such as hay fever, may be caused by various types of pollen at different times of the year. This allergy is known as "seasonal allergic rhinitis".
This medicine only works if taken regularly and is not intended to provide immediate relief of symptoms. Some people may experience improvement as early as the first day of treatment, but for others it may take 3 or 4 days to achieve relief.
2. What you need to know before taking Nasacort
Do not take Nasacort:
if you are allergic to triamcinolone acetonide or to any of the other ingredients of this
medicinal product (listed in section 6).
Signs of allergic reactions to Nasacort may include: skin rash (urticaria), itching,
difficulty swallowing or breathing problems, swelling of the lips, face, throat or
tongue.
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine:
- if you have an untreated infection of the nose or throat. If you develop a fungal infection while being treated with Nasacort, stop using the spray until the infection has been treated;
- if you have recently had nasal surgery, or if you have sustained an injury or ulceration in the nose;
- if you have recently switched from steroid injections or tablets to Nasacort nasal spray;
- if you have had glaucoma or cataracts.
If you have any doubts whether any of the above conditions apply to you, consult your doctor or pharmacist before taking this medicine.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children (under 2 years)
The use of this medicine in children under 2 years of age is not recommended.
Surgery or stress situations
For medical reasons, your doctor may advise you to take a higher than usual dose of this medicine. If your dose is increased, inform your doctor if you are due to undergo surgery or if you do not feel well. Higher than usual doses may reduce your body's immune defenses or its ability to cope with stressful situations. If this occurs, your doctor may decide to prescribe additional treatment to help you.
Other medicines and Nasacort
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. The use of Nasacort may affect how other medicines work. Likewise, other medicines may affect how Nasacort works.
Some medicines can increase the effects of Nasacort, and your doctor may need to monitor you closely if you are taking these (including certain HIV treatments: ritonavir, cobicistat).
Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Nasacort does not affect or affects negligibly the ability to drive or operate machinery.
Nasacort contains benzalkonium chloride
This medicine contains 15 micrograms of benzalkonium chloride per spray.
Benzalkonium chloride may cause irritation and swelling inside the nose, especially if used for prolonged periods.
Systemic effects
When corticosteroids, including triamcinolone acetonide, are used over long periods of time or at high doses for extended periods, adverse effects due to absorption of the drug into the body may occur (e.g. normal steroid hormone production may be affected). These adverse effects are much less likely with corticosteroid nasal sprays than with orally administered corticosteroids (e.g. tablets). Talk to your doctor if you experience any adverse effects.
Caution for athletes: This product contains substances prohibited in doping. Any use differing from the therapeutic indications, dosage regimen or route of administration specified is forbidden.
3. How to take Nasacort
NASACORT is for intranasal use only.
Always take this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. The medicine is effective only if taken regularly. It may take 3 to 4 days before you notice an improvement in symptoms.
How much Nasacort should you take?
Adults and children (over 12 years of age)
- The initial dose is 2 sprays into each nostril once daily.
- Once allergy symptoms are under control, the dose may be reduced to 1 spray into each nostril once daily.
Children (from 6 to 12 years of age)
- The recommended dose is 1 spray into each nostril once daily.
- If symptoms persist, the dose may be increased to 2 sprays into each nostril once daily.
- The dose may then be reduced again to 1 spray into each nostril once daily.
Children (from 2 to 5 years of age)
- The recommended dose is 1 spray into each nostril once daily.
Do not use Nasacort for longer than 3 months in children under 12 years of age.
An adult should assist the child in using the medicine.
How to use the spray
Before using the nasal spray, gently blow your nose to clear the nostrils.
1. Preparation of the vial
- Remove the cap by pulling upwards.
- Gently shake the vial before use.
2. If you are using the nasal spray for the first time
- Hold the bottle upright.
- Point the nozzle away from you while performing this step.
- Prime the pump by pressing down on the nozzle. This procedure is called priming.
- Press and release five times.
- Repeat this procedure until a fine mist appears.
- The bottle is now ready for use.
3. How to use the spray
- Close one nostril with your finger.
- Hold the bottle upright and properly insert the nozzle into the other nostril.
- Gently inhale through the nose, keeping your mouth closed.
- While doing the above, press down on the nozzle to release a spray.
- Exhale through the mouth.
- Repeat the steps described in points 3 and 4 if another spray is needed in the same nostril and for the other nostril.
6. After use
Clean the spray nozzle carefully with a clean paper or cloth tissue after use.
Replace the cap on the spray nozzle.
If the nasal spray has not been used for more than 2 weeks:
- The pump must be re-primed to allow the nozzle to fill properly.
- Always point the spray away from you when priming.
- Before use, spray once into the air to prime the device.
- 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 spray opening with a needle or any other sharp object, as this may damage the spray and prevent it from working properly.
The nasal spray should be cleaned at least once a week, or more often if it becomes blocked.
Instructions for cleaning the spray
Remove the cap.
Gently remove only the spray nozzle.
Soak both the cap and the spray nozzle in warm water for a few minutes.
Rinse thoroughly under cold running tap water.
Shake to remove excess water.
Allow to air dry completely.
Reattach the spray nozzle to the bottle.
Prime the spray pump as needed until a fine mist is produced.
Use as usual.
If you use more Nasacort than you should
It is important to use Nasacort exactly as prescribed by your doctor or pharmacist. Use only the recommended dose. Using too much or too little may worsen your symptoms.
An overdose is unlikely to cause serious problems; however, if you accidentally ingest the entire contents of the bottle orally, you may experience stomach or intestinal discomfort. Contact your doctor if you use more Nasacort than recommended.
If you forget to use Nasacort
If you forget to use a dose of Nasacort, use it as soon as you remember. Do not use a double dose to make up for the missed dose.
If you stop using Nasacort
If you stop using this medicine, your symptoms may return within a few days.
If, after prolonged use, you experience any adverse effects (withdrawal symptoms) following sudden discontinuation of this medicine, speak to your doctor. For more information, see section 4 “Possible side effects”.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Stop treatment and seek immediate medical attention or go to hospital if:
you experience allergic reactions to Nasacort. Signs (frequency not known) may include:
skin rash (urticaria), itching, difficulty swallowing or breathing problems, swelling of the lips, face, throat or tongue.
Common side effects (may occur in 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 aches, weakness and/or fatigue).
Dental problems.
Other side effects ( Not known: frequency cannot be estimated from the available data)
Irritation and dryness inside the nose.
Nasal-sinus congestion.
Sneezing.
Changes in taste or smell.
Feeling unwell (nausea).
Sleep disturbances, dizziness or tiredness.
Shortness of breath (dyspnoea).
Reduced levels of cortisol in the blood (laboratory finding).
Clouding of the lens of the eye (cataract), increased pressure within the eyeball (glaucoma).
Blurred vision.
Sudden discontinuation of corticosteroids after prolonged use may cause withdrawal symptoms such as joint pain, muscle pain, tremor, weight loss, anxiety, runny nose and nosebleeds. However, these symptoms are extremely rare with the use of nasal corticosteroid sprays and are much less likely with nasal corticosteroid sprays than with orally taken corticosteroids (e.g. tablets).
In some people, Nasacort may cause damage to the middle wall inside the nose (called the “nasal septum”). If you are concerned about this in any way, discuss it with your doctor or pharmacist.
Additional side effects in children
If your child has taken this medicine, it may affect their growth. This means the doctor will regularly monitor your child's height and may decide to reduce the dose. In addition, the doctor may consider referring the child to a paediatric specialist.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you 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 stated on the packaging and on the bottle after "Exp.". The expiry date refers to the last day of that month.
Do not store above 25°C.
Once opened, the bottle should not be kept for longer than 1 month for the 30-spray pack or for longer than 2 months for the 120-spray pack.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Package contents and other information
What Nasacort contains
The active substance is triamcinolone acetonide. Each delivered dose contains 55 micrograms of
triamcinolone acetonide.
The excipients are:
microcrystalline cellulose and sodium carmellose (dispersible cellulose)
polysorbate 80
purified water
anhydrous glucose
benzalkonium chloride (50% w/v solution)
disodium edetate
hydrochloric acid or sodium hydroxide (to adjust pH).
Description of the appearance of Nasacort and contents of the pack
Nasacort is a nasal spray suspension. It is supplied as a white plastic bottle equipped with a pump for spraying Nasacort into the nostril via the spray nozzle. The bottle has a protective cap to keep the spray nozzle clean and prevent accidental leakage of the product.
One bottle delivers at least 120 sprays (16.5 g of suspension containing 9.075 mg of triamcinolone acetonide); another bottle delivers at least 30 sprays (6.5 g of suspension containing 3.575 mg of triamcinolone acetonide).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder:
Opella Healthcare Italy S.r.l.
Viale L. Bodio, 37/B, Milan, Italy
Manufacturer:
Bespack HC Limited
London Road, Holmes Chapel
Cheshire, CW4 8BE
United Kingdom
or:
Sanofi Winthrop Industrie
30-36, avenue Gustave Eiffel 37100 Tours
France
or:
Sanofi-Aventis Deutschland GmbH
Industriepark Höchst Brüningstraße 50
65926 Frankfurt am Main
Germany
This medicinal product is authorised in the European Economic Area countries under the following names:
Belgium: Nasacort
Bulgaria: Nasacort
Czech Republic: Triamcinolone sanofi 55 mikrogramů/dávka
Finland: Nasacort
Germany: Nasacort 55 Mikrogramm/Dosis
Greece: Nasacort
Ireland: Nasacort nasal spray
Italy: Nasacort
Luxembourg: Nasacort
Malta: Nasacort
Netherlands: Nasacort
Portugal: Nasacort
Romania: Nasacort 55 micrograme/doza spray nazal, suspensie
Slovakia: Nasacort 55 mikrogramov/dávka
Slovenia: Nasacort
Spain: Nasacort
Sweden: Nasacort
United Kingdom: Nasacort nasal spray