NASOALDO 50 micrograms/actuation nasal spray suspension

Introduction

Package Leaflet: Information for the User

NASOALDO 50 micrograms/actuation nasal spray suspension

mometasone furoate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What NASOALDO is and what it is used for
2. What you need to know before you use NASOALDO
3. How to use NASOALDO
4. Possible side effects
5. Storing NASOALDO
6. Contents of the pack and other information

1. What NASOALDO is and what it is used for

What isNASOALDO?

NASOALDO 50 micrograms/actuation nasal spray suspension contains mometasone furoate, a medicine that belongs to a group of medicines called corticosteroids. When mometasone furoate is sprayed into the nose, it can help to relieve inflammation (swelling and irritation of the nose), sneezing, itching and nasal congestion or runny nose.

What isNASOALDOused for?

Hay fever and perennial rhinitis

NASOALDO is used to treat the symptoms of hay fever (also called seasonal allergic rhinitis) and perennial rhinitis in adults and children aged 3 and above.

Hay fever, which occurs at certain times of the year, is an allergic reaction caused by breathing in pollen from trees, grasses, weeds and also mould and fungus spores. Perennial rhinitis occurs throughout the year and the symptoms can be caused by sensitivity to a variety of things including house dust mites, animal hair (or dander), feathers and certain foods. This medicine reduces the inflammation and irritation of your nose and in this way relieves sneezing, itching and nasal congestion or runny nose caused by hay fever or perennial rhinitis.

Nasal polyps

NASOALDO is used to treat nasal polyps in adults aged 18 and above.

Nasal polyps are small growths on the lining of the nose and usually affect both nostrils. This medicine reduces the inflammation in the nose, making the polyps shrink gradually, and in this way relieves the nasal congestion that can affect your breathing through your nose.

2. What you need to know before you use NASOALDO

Do not useNASOALDO

• if you are allergic (hypersensitive) to mometasone furoate or 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, can make the infection worse. You should wait until the infection has cleared up before starting to use the nasal spray.
• if you have had recent nasal surgery or injury. You should not use the nasal spray until your nose has healed.

Warnings and precautions

Tell your doctor or pharmacist before you start using this medicine:

• if you have ever 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 genetic multi-organ disease that mainly affects the lungs and digestive system).

While you are using this medicine, tell your doctor:

• if your immune system is not working properly (if you get infections easily) and you come into contact with someone who has measles or chickenpox. You should avoid contact with anyone who has these infections.
• if you get a nasal or throat infection.
• if you have been using this medicine for several months or longer.
• if you get persistent irritation of your nose or throat.

Tell your doctor if you get blurred vision or other visual disturbances.

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

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

Children

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

It is recommended that the height of children on long-term treatment with nasal corticosteroids is regularly monitored, and if any changes are observed, they should be reported to the doctor.

Other medicines andNASOALDO

Tell your doctor if you are taking, have recently taken or might take any other medicines.

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

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

Pregnancy and breast-feeding

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 using this medicine.

There is limited or no data on the use of mometasone furoate in pregnant women. It is not known whether mometasone furoate is excreted in breast milk.

Driving and using machines

There is no known effect of this medicine on driving or using machines.

NASOALDOcontains 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 long-term treatment.

3. How to use NASOALDO

Follow exactly the instructions for administration of this medicine given to you by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist again. Do not use more than the recommended dose or use the spray more often or for longer than your doctor tells you.

Treatment of hay fever and perennial rhinitis

Use in adults and children over 12 years of age

The usual dose is two sprays into each nostril once daily.

• Once symptoms are under control, your doctor may recommend reducing the dose.
• If you do not start to feel better, you should talk to your doctor and they may tell you to increase the dose to the maximum daily dose of four sprays into each nostril once daily.

Use in children aged 3 to 11 years

The usual dose is one spray into each nostril once daily.

If you or your child has very severe hay fever, your doctor may advise you to start using NASOALDO before the start of the pollen season, as it will help to prevent the symptoms of hay fever 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 usual initial dose is two sprays into each nostril once daily.

• If after 5 to 6 weeks the symptoms are not controlled, the dose may be increased to two sprays into each nostril twice daily. Once symptoms are under control, your doctor may recommend reducing the dose.
• If there is no improvement in symptoms after 5-6 weeks using two sprays into each nostril twice daily, you should talk to your doctor.

Method of administration

Preparing the nasal spray for use

NASOALDO has a cap that protects the nozzle and keeps it clean.

Remember to remove it before using the spray and replace it after use.

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

1. First, shake the bottle carefully.
2. Put your index and middle fingers on either side of the nozzle and your thumb underneath the bottle.

Do notpuncture the nasal spray.

1. Do not point the nozzle at yourself and then press the 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 pumping 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. Blow your nose gently.
3. Block one nostril and put the nozzle in the other nostril as shown (Figure 2). Tilt your head slightly forward, keeping the bottle upright.
4. Start to breathe in slowly through your nose and while you are breathing in, press the pump ONCEwith 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 paper tissue and replace the cap.

Cleaning your nasal spray

-It is important that you clean your nasal spray regularly, otherwise it may not work properly.

-Remove the cap and gently pull off the nozzle.

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

-Do not try to unblock the nasal spray by inserting a needle or other pointed object as this may damage the spray so that you do not receive the correct dose of medicine.

-Let the cap and nozzle dry in a warm place.

-Press the nozzle back onto the bottle and replace the cap.

-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, talk to your doctor.

If you use steroids for a long time or in high doses, you may, rarely, get side effects. In children, this can affect growth and development.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to useNASOALDO

If you forget to use your nasal spray at the right time, use it as soon as you remember, then follow your normal routine. Do not use a double dose to make up for forgotten doses.

If you stop usingNASOALDO

In some patients, NASOALDO starts to relieve symptoms 12 hours after the first dose; however, it may take up to two days for the full benefit of the treatment to be shown. It is very important that you use your nasal spray regularly.

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

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. Immediate allergic reactions (hypersensitivity) can occur after using this medicine. These reactions can be serious. You should stop using NASOALDO and seek medical help immediately if you experience symptoms such as:

• swollen face, tongue or pharynx
• difficulty swallowing
• hives
• fatigue or difficulty breathing

If nasal corticosteroid sprays are used at high doses for long periods of time, side effects can occur due to the medicine being absorbed into 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 get:

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

• headache
• sneezing
• nasal bleeding [very common (may affect more than 1 in 10 people) in people with nasal polyps who are using two sprays of mometasone furoate into each nostril twice daily.]
• nasal or throat pain
• nasal ulcers
• respiratory infection

Frequency not known (cannot be estimated from the available data)

• increased pressure in the eye (glaucoma) and/or cataracts which can cause visual disturbances
• damage to the wall between the nostrils
• changes in taste and smell
• difficulty breathing and/or fatigue
• blurred vision

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 Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing NASOALDO

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

Do not store above 30°C. Do not freeze.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

The spray should be used within 2 months of first opening.

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. Contents of the pack and other information

What is inNASOALDO

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

Appearance and packaging

NASOALDO is a nasal spray suspension. It is available in a white opaque plastic bottle of 115 or 140 sprays, fitted with a metered-dose pump, a nasal adapter and a dust cap.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Laboratorio Aldo-Unión, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat

Barcelona - Spain

Date of last revision of this leaflet: 10/2017

Detailed and up-to-date information on this medicine is available on the website of the Spanish Medicines and Healthcare Products Agency (AEMPS) http://www.aemps.gob.es/