Leaflet: information for the patient user

NASOALDO 50 micrograms/pulse suspension for nasal spray

furoate of mometasone

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What is NASOALDO and for what it is used

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

3. How to use NASOALDO

4. Possible side effects

5. Storage of NASOALDO

6. Contents of the pack and additional information

What isNASOALDO?

NASOALDO50 micrograms/pulse suspension for nasal spray contains furoate mometasone, a medication that belongs to a group of medications called corticosteroids.When furoate mometasone is sprayed into the nose, it may help to alleviate inflammation (swelling and irritation of the nose), sneezing, itching, and nasal congestion or discharge.

For what it is usedNASOALDO?

Hay fever and perennial rhinitis

NASOALDOis used to treat the symptoms of hay fever (also known as seasonal allergic rhinitis) and perennial rhinitis in adults and children 3 years of age and older.

Hay fever, which occurs at certain times of the year, is an allergic reaction caused by breathing in tree, grass, weed pollen, and also mold and fungus spores. Perennial rhinitis occurs throughout the year and symptoms can be caused by sensitivity to a variety of things including dust mites, pet hair (or epithelium), feathers, and certain foods. This medicationreduces the inflammation and irritation of your nose and thereby relieves sneezing, itching, and nasal congestion or discharge caused by hay fever or perennial rhinitis.

Nasal polyps

NASOALDOis used to treat nasal polyps in adults 18 years of age and older.

Nasal polyps are small formations in the nasal mucosa and generally affect both nasal passages. This medication reduces inflammation in the nose, causing the polyps to decrease gradually, thereby relieving nasal congestion that may affect your breathing through your nose.

No useNASOALDO

-if you are allergic (hypersensitive) to mometasone furoate or to any of the other ingredients of this medicine (listed in section 6),

-if you have an untreated nasal infection. Using this medicine while you have an untreated nasal infection, such as herpes, may worsen the infection. You should wait until the infection has cleared up before starting to use the nasal spray.

-if you have had recent surgery or a recent injury to the nose. Do not use the nasal spray until the nose has healed.

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine:

- if you have or have had tuberculosis,

- if you have any other type of infection,

-if you are taking other corticosteroids, by mouth or by injection,

- if you have cystic fibrosis (a multi-organ genetic disorder, mainly affecting the lungs and digestive system).

While using this medicine, consult your doctor

- if your immune system is not working properly (if you have difficulty in overcoming the infection) and you come into contact with someone with measles or chickenpox. You should avoid contact with anyone who has these infections.

- if you have a nasal or throat infection.

- if you have been using this medicine for several months or more.

- if you have persistent nasal or throat irritation.

Get in touch with your doctor if you experience blurred vision or other visual disturbances.

If nasal corticosteroid sprays are used at high doses for long periods of time, adverse effects may occur, as the medicine is absorbed into the body.

If your eyes itch or are irritated, your doctor may advise you to use other treatments at the same time as NASOALDO.

Children

When used at high doses for long periods of time, nasal corticosteroid sprays may cause side effects, such as slowing down growth in children.

It is recommended to monitor the height of children on long-term treatment with corticosteroids and if any change is observed, inform your doctor.

Other medicines and NASOALDO

Inform your doctor if you are taking, have taken recently or may need to take any other medicines.

If you are taking other corticosteroids for allergies, either by mouth or by injection, your doctor may advise you to stop taking them when you start using mometasone furoate. When discontinuing corticosteroids, by mouth or by injection, some people may experience side effects such as muscle pain or joint pain, muscle weakness and depression.They may also develop other allergies, such as itchy eyes, runny eyes, or red, itchy skin with hives. If you develop any of these side effects, you should see your doctor.

Some medicines may increase the effects of Nasoaldo 50 micrograms/pulse suspension for nasal spray, so your doctor will make close checks if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

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 medicine.

There is little or no information available on the use of mometasone furoate in pregnant women. It is unknown whether mometasone furoate is excreted in breast milk.

Driving and operating machines

There is no known information about the effect of this medicine on driving or operating machines.

NASOALDO contains benzalkonium chloride

This medicine contains 20 micrograms of benzalkonium chloride per dose. Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for a long treatment.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Do not use higher doses or use the nasal spray more frequently or for a longer period than your doctor has told you.

Treatment of hay fever and perennial rhinitis

Use in adults and children over 12 years of age

The usual dose is two sprays in each nostril once a day.

- Once the symptoms are under control, your doctor may recommend reducing the dose.

- If you do not start feeling better, you must consult your doctor and they may tell you to increase the dose to the maximum daily dose of four sprays in each nostril once a day.

Use in children aged 3 to 11 years

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

If you or your child has severe hay fever, your doctor may advise you to start usingNASOALDObefore thepollen season, as it will help you prevent hay fever symptoms before they occur. At the end of the pollen season, your hay fever symptoms should have improved and treatment may then not be necessary.

Nasal polyps

Use in adults over 18 years of age

The initial usual dose is two sprays in each nostril once a day.

• If after 5 to 6 weeks the symptoms are not controlled, the dose may be increased to two sprays in each nostril twice a day. Once the symptoms are under control, your doctormay advise you to reduce the dose.
• If no improvement of symptoms is observed after 5-6 weeks administering twice a day, you must consult your doctor.

Method of administration

Preparation of the nasal spray for use

NASOALDOhas a cap that protects the nozzle and keeps it clean.

Remember to remove it before using the spray and put it back on after using it.

If you are going to use the spray for the first time, you need to "prime" the bottle by pressing the spray 10 times until a fine spray is produced:

1.First, shake the bottle carefully..

2. Place your index and middle fingers on either side of the nozzle and your thumb under the bottle.

Donot pierce the nasal spray.

3. Do not point the nozzle at yourself and then press the spray pump 10 times until a fine spray is produced.

If you have not used your nasal spray for 14 days or more, you need to "prime" the bottle again by pressing the spray 2 times until a fine spray is produced.

How to use your nasal spray

1. Shake the bottle carefully and remove the cap (Figure 1).

2. Gently blow your nose.

3. Plug one nostril and place the nozzle in the other nostril as indicated (Figure 2). Lean your head slightly downwards, keeping the bottle vertical.

4. Start breathing in gently or slowly through your nose and while breathing in, press ONCE with your fingers to allow the spray to enter your nose.

5. Breathe out through your mouth. Repeat step 4 to inhale a second spray in the same nostril, if necessary.

6. Remove the nozzle from this nostril and breathe out through your mouth.

7. Repeat steps 3 to 6 in the other nostril (Figure 3).

After using the spray, clean the nozzle carefully with a clean tissue or a paper tissue and put the cap back on.

Cleaning of your nasal spray

- It is essential to clean your nasal spray regularly, otherwise it may not work properly.

- Remove the cap and carefully pull out the nozzle.

- Wash the nozzle and cap with warm water and then rinse with running water.

-Do not try to unclog the nasal spray by inserting a needle or other pointed object, as it may damage the spray so that the correct dose of medication is not received.

-Put the cap and nozzle to dry in a warm place.

- Press the nozzle onto the bottle and put the cap back on.

- The spray will need to be primed again with 2 sprays when it is used for the first time after cleaning.

If you use moreNASOALDOthan you should

If you accidentally use more than you should, tell your doctor.

If you use steroids for a long period of time or in large quantities, it may, rarely, affect some of your hormones. In children, this may affect growth and development.

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 useNASOALDO

If you forget to use your nasal spray at the right time, use it as soon as you remember, and then follow the normal administration schedule. Do not use a double dose to compensate for the missed doses.

If you interrupt treatment withNASOALDO

In some patientsNASOALDOmay start to relieve symptoms 12 hours after the first dose; however, the full benefit of treatment may not be shown until two days later. It is very important to use your nasal spray regularly.

Do not interrupt your treatment even if you feel better unless your doctor tells you to.

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.Immediate hypersensitivity reactions (allergic) may occur after using this medicine. These reactions can be severe. You must stop treatment withNASOALDOand seek immediate medical help if you experience symptoms such as:

•swollen face, tongue, or throat

•difficulty swallowing

•hives

•fatigue or difficulty breathing

If nasal corticosteroid sprays are used at high doses for long periods of time, side effects may occur due to the medication being absorbed by the body.

Other side effects

Most people do not have any problems after using the nasal spray. However, some people after using mometasone furoate or other nasal corticosteroid sprays may experience:

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

•headache

•runny nose

•nasal bleeding [very frequent (may affect more than 1 in 10 people) in people with nasal polyps who are administering two sprays of mometasone furoate in each nostril twice a day.]

•nasal or throat pain

•ulcers in the nose

•respiratory infection

Unknown frequency (cannot be estimated from available data)

•increased eye pressure (glaucoma) and/or cataracts that may cause visual disturbances

•damage to the nasal septum that separates the nostrils

•alterations in taste and smell

•difficulty breathing and/or fatigue

•blurred vision

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 prospectus. You can also report them through the Spanish System for Pharmacovigilance of Medicines for Human Use. https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 86°F (30°C). Do not freeze.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

The aerosol must be used within 2 months of its first opening.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofNASOALDO

• The active ingredient is furoate of mometasone. Each nasal spray contains 50 micrograms of furoate of mometasone as monohydrate.
• The other components are dispersible cellulose (microcrystalline cellulose and sodium carmellose), glycerol, sodium citrate, anhydrous citric acid, benzalkonium chloride, polisorbate 80, and purified water.

Appearance of the product and contents of the packaging

NASOALDOis a nasal spray suspension. It is presented in a white opaque plastic bottle of 115 or 140 sprays equipped with a dosing spray pump, a nasal adapter, and a dust cap.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Laboratorio Aldo-Unión, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat

Barcelona - Spain

Last review date of this leaflet: 10/2017

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