Product Information for the Patient

Nasacort 55 micrograms/dose, Nasal Suspension for Inhalation

Triamcinolone Acetonide

Read this entire product information carefully before starting to use this medication, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

1.What Nasacort is and for what it is used

2.What you need to know before starting to use Nasacort

3.How to use Nasacort

4.Possible adverse effects

5Storage of Nasacort

6.Contents of the package and additional information

Nasacortcontains a medication called triamcinolone acetonide. Thisbelongs to a group of medications known as corticosteroids, which means it is a type of steroid. It is administered as a nasal spray to treat nasal symptoms of allergic rhinitis in adults and children over 2 years old.

Nasal symptoms of allergy include sneezing, itching, and blockage, congestion, or nasal discharge. They may be caused by:

• Pet hair or dust mites. This type of allergy can occur at any time of the year and is called “perennial allergic rhinitis”.
• Pollen. This type of allergy, such as hay fever, may be caused by different pollens at different times of the year. It is called “seasonal allergic rhinitis”.

This medication is only effective if used regularly and it is possible that your symptoms will not improve immediately. It may help some people from the first day of treatment, however, in others it may take 3 to 4 days to feel an improvement.

No use Nasacort:

• if you are allergic to triamcinolone acetonide or any of the other components of this medication (listed in section 6).

The symptoms of an allergic reaction to Nasacort include: rash (urticaria), itching, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Nasacort:

• if you have any infection in the nose or throat that is not being treated. If you develop a fungal infection while using Nasacort, stop using the inhaler until the infection has been treated.
• if you have recently undergone nasal surgery, or have had injuries or ulcers in the nose.
• if you are in the process of transferring from injectable or oral steroids to Nasacort nasal spray.
• if you have had glaucoma or cataracts.

Contact your doctor if you experience blurred vision or other visual disturbances.

If you are unsure whether the above applies to you, consult your doctor or pharmacist before using this medication.

Children (under 2 years)

This medication is not recommended for use in children under 2 years.

Surgery or stress situations

Your doctor may advise you to take a higher dose of this medication for medical reasons. In the event of a higher dose, inform your doctor if you are to be operated on or are not feeling well. This is because higher-than-usual doses of this medication may reduce your body's ability to heal or cope with stress. If this occurs, your doctor may decide that you need additional treatment with another medication to help you.

Using Nasacort with other medications

Inform your doctor if you are taking or have recently taken other medications, including those purchased without a prescription.

Some medications may increase the effects of Nasacort, so your doctor will perform close monitoring if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machinery

No significant effects of Nasacort on the ability to drive or operate machines have been reported.

Nasacort contains benzalkonium chloride

This medication contains 15 micrograms of benzalkonium chloride in each spray.

Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for a long treatment period.

Systemic effects

When corticosteroids, including triamcinolone acetonide, are used for long periods of time or at high doses for long periods of time, they may produce adverse effects due to the medication being absorbed into the body (e.g., normal hormone production may be affected). These adverse effects are much less likely with nasal corticosteroid sprays than with oral corticosteroids (e.g., tablets). Discuss any adverse effects with your doctor.

NASACORT should only be used by nasal administration

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. This medication is only effective if used regularly. You may take 3 to 4 days to notice an improvement in your symptoms.

How much Nasacort to use

Adults and children (over 12 years)

• The usual starting dose is 2 sprays in each nasal passage per day.
• Once allergy symptoms are controlled, the dose can be reduced to 1 spray in each nasal passage per day.

Children (6 to 12 years)

• The usual dose is 1 spray in each nasal passage per day.
• If symptoms do not disappear, it is possible to increase the dose to 2 sprays in each nasal passage per day.
• Then the dose can be reduced to 1 spray in each nasal passage per day.

Children (2 to 5 years)

• The usual dose is 1 spray in each nasal passage per day.

Do not use Nasacort for more than 3 months in children under 12 years.

An adult should help a small child to use this medication.

How to use the sprayer

Before using your nasal sprayer, you must carefully blow your nose to clear your nasal passages.

If you have not used the sprayer for more than two weeks:

• You need to prime the sprayer again, to refill the nozzle with spray.
• You must direct the nozzle away from you while doing this operation.
• To prime, you must make a spray into the air, before using it again.
• Always shake the bottle gently before use.

Cleaning the sprayer

If the sprayer does not work, it is possible that the nozzle is blocked.Nevertry to unblock it or make the nozzle larger with a pin or a sharp object. This could make the sprayer stop working.

You must clean the nasal sprayer at least once a week. You can clean it more often if it becomes blocked.

If you use more Nasacort than you should

It is essential that you take your dose exactly as indicated on the prescription or as advised by your doctor.

You should only use this medication as recommended by your doctor; your symptoms may worsen if you use it more or less than indicated.

A overdose is unlikely, however, if you have ingested the entire contents of the container at once orally, you may experience stomach or intestinal discomfort. Talk to your doctor if you have used more Nasacort than you should.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Nasacort

If you have forgotten to use Nasacort, use it as soon as possible. Do not use a double dose to compensate for the missed dose.

If you interrupt treatment with Nasacort

If you stop using this medication, your symptoms may reappear in a few days.

If you experience any adverse effects (withdrawal symptoms) after stopping use of this medication suddenly after prolonged use, talk to your doctor. See section 4 “Possible adverse effects” for more information.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Stop using Nasacort and seek immediate medical attention if:

• You experience an allergic reaction to Nasacort. Symptoms (frequency unknown) may include: a rash (urticaria), itching, difficulty swallowing or breathing, swelling of the 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)
• Dental problems

Other side effects(frequency unknown: cannot be estimated from available data)

• Irritation and dryness inside your nose
• Blockage or congestion of the nasal passages
• Sniffles
• Changes in taste and smell
• Unpleasant feeling (nausea)
• Problems with sleep, feeling dizzy or tired
• Shortness of breath (dyspnea)
• Decreased cortisol levels in the blood (analytical values)
• Cloudy vision (cataracts), high pressure inside the eye (glaucoma)
• Blurry vision.
• The sudden discontinuation of corticosteroids after prolonged use may cause steroid withdrawal syndrome. Withdrawal symptoms such as joint pain, muscle pain, tremors, weight loss, anxiety, runny nose, and nosebleeds may be observed with intranasal triamcinolone. However, these symptoms are extremely rare in the case of nasal sprays with corticosteroids, and it is much less likely to occur with nasal sprays with corticosteroids than with oral corticosteroids (e.g., tablets).

In some people, Nasacort may damage the middle part of the nose (known as the "nasal septum"). Consult your doctor or pharmacist about any concerns you may have about this.

Other side effects in children

If your child has been using this medicine, it may affect your child's growth. This means that your doctor will need to check your child's height periodically and may reduce the dose. Additionally, your doctor may consider referring your child to a pediatric specialist.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the national notification system included in theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

Composition of Nasacort

The active ingredient is acetonide of triamcinolona. One application contains 55 micrograms of acetonide of triamcinolona.

The other components are:

• microcrystalline cellulose and sodium carmellose (dispersible cellulose)
• polisorbate 80
• purified water
• anhydrous glucose
• benzalkonium chloride (50% solution v/v),
• disodium edetate
• hydrochloric acid or sodium hydroxide (to adjust the pH)

Appearance of the product and contents of the package

Nasacort is a nasal spray suspension. It is presented in a white plastic bottle with a pump to supply the spray through a nozzle. The bottle has a protective cap to keep the nozzle clean and to prevent accidental pulsations.

This unique bottle contains at least 120 sprays (16.5 g of suspension with 9.075 mg of acetonide of triamcinolona) or at least 30 sprays (6.5 g of suspension with 3.575 mg of acetonide of triamcinolona).

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Opella Healthcare Spain, S.L.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Grupo Sanofi

Manufacturer:

Bespak HC LimitedLondon 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

65926 Frankfurt am Main

Germany

This medicine is authorized in the member states of the European Economic Area with the following name: Nasacort

Austria:Nasacort Nasenspray

Belgium:Nasacort

Bulgaria:Nasacort

Czech Republic:Triamcinolone sanofi 55 mikrogramu/dávka

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 55μg/dose nasal spray, suspension

Luxembourg:Nasacort

Netherlands:Nasacort

Poland:Nasacort

Portugal:Nasacort

Romania:Nasacort 55 micrograme/doza spray nazal, suspensie

Slovakia:Nasacort 55 mikrogramov/dávka

Slovenia:Nasacort

Spain:Nasacort 55 microgramos/dosis, suspensión para pulverización nasal

Sweden:Nasacort

United Kingdom:Nasacort nasal spray

Last review date of this leaflet: August 2022

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/