NASACORT 55 micrograms/dose, NASAL SPRAY SUSPENSION

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).

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

Warnings and precautions

Tell your doctor or pharmacist before you start using Nasacort:

• if you have any infection in your nose or throat that is not being treated. If you develop a fungal infection while using Nasacort, stop using the spray until the infection has been treated.
• if you have recently had an operation on your nose, or have had injuries or ulcers in your nose.
• if you are being transferred from steroid injections or tablets to Nasacort nasal spray.
• if you have had glaucoma or cataracts.

Get medical help if you have blurred vision or other changes in your vision.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using this medicine.

Children (under 2 years)

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

Surgery or stressful situations

Your doctor may advise you to take a higher dose of this medicine than usual for medical reasons. If you are going to have an operation or you are not feeling well, tell your doctor. This is because higher than usual doses of this medicine may reduce your body's ability to cope with stress. If this happens, your doctor may decide that you need extra treatment with another medicine to help you.

Using Nasacort with other medicines

Tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Some medicines may increase the effects of Nasacort, so your doctor will monitor you closely if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

Nasacort is not likely to affect your ability to drive or use machines.

Nasacort contains benzalkonium chloride

This medicine 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 time.

Systemic effects

When corticosteroids, including triamcinolone acetonide, are used for long periods of time or in high doses for long periods, side effects can occur due to the medicine being absorbed into the body (e.g. the normal production of steroid hormones may be affected). These side effects are much less likely with nasal steroid sprays than with steroid tablets or injections. Talk to your doctor if you experience any side effects.

3. How to use Nasacort

NASACORT should only be used in the nose

Follow exactly the instructions given to you by your doctor or pharmacist. If you are not sure, talk to your doctor or pharmacist again. This medicine will only work if you use it regularly. It may take 3 to 4 days before you 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 nostril once a day.
• Once your allergy symptoms are under control, you may be able to reduce your dose to 1 spray in each nostril once a day.

Children (6 to 12 years)

• The usual dose is 1 spray in each nostril once a day.
• If symptoms do not improve, your doctor may increase the dose to 2 sprays in each nostril once a day.
• After this, the dose can be reduced to 1 spray in each nostril once a day.

Children (2 to 5 years)

• The usual dose is 1 spray in each nostril once a day.

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

An adult should help a small child use this medicine.

How to use the spray

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

If you have not used the spray for more than 2 weeks:

• You need to prime the spray again, to refill the nozzle with spray.
• Point the nozzle away from you while you are doing this.
• For priming, you need to do one spray into the air, before you use it again.
• Always shake the bottle gently before use.

Cleaning the spray

If the spray does not work, the nozzle may be blocked. Nevertry to unblock it or make the spray hole bigger with a pin or other sharp object. This could make the spray stop working.

You should clean the nasal spray at least once a week. You can clean it more often if it gets blocked.

Instructions for cleaning the spray: Remove the cap Carefully remove only the button Soak the cap and button in warm water for a few minutes Rinse under cold running water Shake or tap gently to remove any remaining water Let it air dry Put the button back on Prime the spray until a fine spray appears Use as usual

Started taking the medicine and have questions? Discuss your symptoms and treatment with a doctor online. Talk to a doctor

If you use more Nasacort than you should

It is important that you take your dose as instructed by your doctor or pharmacist. If you use more Nasacort than you should, talk to a doctor.

If you have used more Nasacort than you should, you may get stomach or intestine problems. If you have taken all the contents of the pack by mouth, talk to a doctor or go to the nearest hospital casualty department. Take the pack with you.

If you forget to use Nasacort

If you forget 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 come back after a few days.

If you get any side effects after stopping this medicine, talk to your doctor. See section 4 “Possible side effects” for more information.

If you have any further questions on the use of this product, 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 tell a doctor or go to a hospital straight away if:

• you have an allergic reaction to Nasacort. The symptoms can include: a rash (hives), itching, problems swallowing or breathing, swelling of the lips, face, throat or tongue.

Common side effects(may affect up to 1 in 10 people)

• Nasal discharge, 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 not known: cannot be estimated from the available data)

• Irritation and dryness inside your nose
• Congestion or blockage of the nasal passages
• Sneezing
• Changes in the way things taste and smell
• Feeling sick (nausea)
• Sleep problems, feeling dizzy or tired
• Shortness of breath (dyspnoea)
• Low levels of cortisol in the blood (blood test results)
• Cloudy vision (cataracts), high pressure in the eye (glaucoma)
• Blurred vision.
• Stopping corticosteroids suddenly after a long time of use can lead to a steroid withdrawal syndrome. Symptoms of withdrawal such as joint pain, muscle pain, tremors, weight loss, anxiety, runny and bleeding nose can occur with intranasal triamcinolone. However, these symptoms are extremely rare with nasal steroid sprays, and are much less likely to occur with nasal steroid sprays than with steroid tablets or injections.

In some people, Nasacort can damage the inside of the nose in the middle (called the “nasal septum”). Talk to your doctor or pharmacist if you have any questions about this.

Other side effects in children

If your child has been using this medicine, it may affect their growth. This means your doctor will need to check their height from time to time. Your doctor may reduce the dose. Your doctor may also consider referring you to a specialist.

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 national reporting system listed in the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 bottle after “EXP”. The expiry date refers to the last day of that month.
• Do not store above 25°C.
• After opening Nasacort for the first time, the 30 spray pack size should be used within 1 month and the 120 spray pack size within 2 months.
• 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 protect the environment.

6. Container Content and Additional Information

Nasacort Composition

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

The other components 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 (for pH adjustment)

Product Appearance and Container Content

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

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

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

Sanofi Group

Manufacturer:

Bespak 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

65926 Frankfurt am Main

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names: Nasacort

Austria: Nasacort Nasenspray

Belgium: Nasacort

Bulgaria: Nasacort

Czech Republic: Triamcinolone sanofi 55 micrograms/dose

Denmark: Nasacort

Estonia: Nasacort

Finland: Nasacort

Germany: Nasacort 55 micrograms/dose

Greece: Nasacort

Hungary: Nasacort

Ireland: Nasacort nasal spray

Italy: Nasacort

Latvia: Nasacort

Lithuania: Triamcinolone acetonide Sanofi 55 μg/dose nasal spray, suspension

Luxembourg: Nasacort

Netherlands: Nasacort

Poland: Nasacort

Portugal: Nasacort

Romania: Nasacort 55 micrograms/dose nasal spray, suspension

Slovakia: Nasacort 55 micrograms/dose

Slovenia: Nasacort

Spain: Nasacort 55 micrograms/dose, nasal spray suspension

Sweden: Nasacort

United Kingdom: Nasacort nasal spray

Date of the last revision of this leaflet: August 2022

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/