Leaflet: information for the user

Mometasona Sandoz 50 micrograms/dose nasal suspension for inhalation

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 Mometasona Sandoz is and for what it is used

2. What you need to know before starting to use Mometasona Sandoz

3. How to use Mometasona Sandoz

4. Possible side effects

5. Storage of Mometasona Sandoz

6. Contents of the pack and additional information

What is Mometasona Sandoz?

Mometasona Sandoz nasal spray suspension contains mometasone furoate, a medication in a group of medications called corticosteroids. When small amounts of mometasone furoate are sprayed into the nose, it may help to relieve inflammation (swelling and irritation of the nose), sneezing, itching, and nasal congestion or runny nose.

What is Mometasona Sandoz used for?

Allergic rhinitis and perennial rhinitis

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

Allergic rhinitis, which occurs at certain times of the year, is an allergic reaction caused by breathing in pollen from trees, grasses, weeds, and also mold spores and fungi. 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. Mometasona Sandoz reduces inflammation and irritation of the nose and thereby relieves sneezing, itching, and nasal congestion or runny nose caused by allergic rhinitis or perennial rhinitis.

Nasal polyps

Mometasona Sandoz is 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. Mometasona Sandoz reduces nasal inflammation, causing the polyps to shrink gradually, thereby reducing the sensation of nasal congestion that can affect breathing through the nose.

Do not use Mometasona Sandoz

• if you are allergic to mometasone furoate or any of the other ingredients in this medicine (listed in section 6),
• if you have an untreated nasal infection. Using Mometasona Sandoz 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. You should not use the nasal spray until the nose has healed.

Warnings and precautions

Consult your doctor or pharmacist or nurse before starting to use Mometasona Sandoz:

• if you have or have had tuberculosis,
• if you have any other infection,
• if you are taking other corticosteroids, either by mouth or by injection,
• if you have cystic fibrosis.

While you are using Mometasona Sandoz, consult your doctor if:

• your immune system is not working properly (if you have problems fighting off an infection) or if you have come into contact with someone who has measles or chickenpox. You must avoid contact with anyone who has these infections,
• you have a nasal or throat infection,
• you are using the medicine for several months or more,
• you have a persistent nasal or throat infection.

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

When nasal corticosteroids are used at high doses for long periods of time, side 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 Mometasona Sandoz.

Children

When used at high doses for long periods of time, nasal corticosteroids 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 noted, you should inform your doctor.

Using Mometasona Sandoz with other medicines

Inform your doctor or pharmacist if you are using, have used recently or may need to use any other medicine, including over-the-counter medicines.

Some medicines may increase the effects of mometasone and your doctor may wish to monitor you closely if you are taking these medicines (including some HIV medicines: ritonavir, cobicistat).

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 Mometasona Sandoz. When stopping corticosteroids, by mouth or by injection, some people may experience side effects such as muscle pain or joint pain, muscle weakness and depression. You may also develop other allergies, such as itchy eyes, runny eyes, or skin with red patches and itching. If you develop any of these side effects, you should see your doctor.

Pregnancy and breastfeeding

There is very little information available or none about the use of Mometasona Sandoz in pregnant women. It is not known if Mometasona Sandoz has been found in breast milk.

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

Driving and operating machinery

There is no known information about the effect of Mometasona Sandoz on driving or operating machinery.

Mometasona Sandoz contains benzalkonium chloride

This medicine contains 0.200 mg of benzalkonium chloride in each 50 micrograms/dose nasal suspension.

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

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

Treatment for 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 to feel better, you must consult your doctor and they may indicate increasing the dose to the maximum daily dose. The maximum daily dose is 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.

Mometasona may start to alleviate symptoms within 12 hours after the first dose in some patients; however, it is unlikely that the optimal effect of treatment will be observed before the first two days. If you or your child has severe hay fever, your doctor may advise you to start using mometasona some days before the start of the pollen season. At the end of the pollen season, the symptoms of hay fever should improve and treatment may not be necessary.

Nasal polyps

Use in adults over 18 years of age

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

• If after 5 to 6 weeks of treatment 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 doctor may advise you to reduce the dose.
• If no improvement of symptoms is observed after 5 to 6 weeks administering twice a day, you must consult your doctor.

Preparing the nasal spray for use

Mometasona Sandoz nasal spray suspension has a cap that protects the nozzle and keeps it clean. Remember to remove it before using the spray and put it back on after use.

Shakethe containerbefore each use.

Do not pierce the nasal applicator (nozzle) with a pin or other sharp object.

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

1.Shake the container well.

2.Remove the plastic cap.

3.Place your index and middle fingers on either side of the nozzle and your thumb under the nozzle (Figure 1).Do notpierce the nasal applicator.

4.Do not point the nozzle towards you and then press the spray pump 10 times until a fine mist is produced (Figure 1).

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

How to use your nasal spray

1.Shake the container well and remove the cap (Figure 2).

2.Blow your nose gently to clean the nasal passages.

3.Block one nostril and place the nozzle in the other nostril. Lean your head slightly downwards, keeping the container vertical.

4.Start to breathe in slowly or gently through your nose and while breathing in, spray into your nose by pressing ONCE with your fingers (Figure 3).

5.Breathe out through your mouth. Repeat step 4 to inhale a second spray in the samenostril 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.

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

Cleaning your nasal spray

• It is essential to clean your nasal spray regularly, otherwise it may not work properly.
• Remove the cap and carefully remove the nozzle.
• Clean the nozzle and cap with warm water and then rinse with running water.
• Do not attempt to unclog the nasal applicator by inserting a needle or other sharp object, as this may damage the applicator 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 container and place the cap.
• The spray will need to be primed again with 2 sprays when used for the first time after cleaning.

If you use more Mometasona Sandoz than you should

If you accidentally use more than you should, consult 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.

If you have taken more Mometasona Sandoz than you should, consult your doctor immediately, your pharmacist or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount used.

If you forget to use Mometasona Sandoz

If you forget to use your nasal spray at the right time, use it as soon as you remember, following the normal administration rhythm afterwards.

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Mometasona Sandoz

In some patients, Mometasona Sandoz may start to alleviate symptoms 12 hours after the first dose; however, it is unlikely that the full benefit of treatment will be observed before the first two days. It is very important to use your nasal spray regularly. Do not interrupt your treatment even if you feel better unless your doctor advises you to.

If you have any other doubts 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 interruptthe treatment with Mometasona Sandozand 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 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 Mometasona Sandoz 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 twoinhalations offuroate mometasonein each nasal passage twice a day],
• nasal or throat pain,
• ulcers in the nose,
• respiratory infection.

Side effects of unknown frequency (cannot be estimated from available data)

• increased intraocular pressure (glaucoma) and/or cataracts, causing visual disturbances,
• blurred vision,
• damage to the nasal septum that separates both nasal passages,
• alterations in taste and smell,
• difficulty breathing or wheezing.

Reporting of 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 Spanish System for the Pharmacovigilance of Medicinal Products 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 use this medication after the expiration date that appears on the label and on the carton packaging after “CAD”. The expiration date is the last day of the month indicated.
• Once the container is opened, it must be used within two months. Open only one container at a time.
• Do not freeze.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need.This will help protect the environment.

Composition of Mometasona Sandoz

• The active ingredient is furoate of mometasona. Each spray releases a dose of 50 micrograms of furoate of mometasona (as monohydrate of furoate of mometasona).
• The other components are: microcrystalline cellulose, sodium croscarmellose, glycerol, citric acid monohydrate, sodium citrate dihydrate, polisorbate 80, benzalkonium chloride, injection water.

Appearance of Mometasona Sandoz and contents of the package

This medicine is a white, homogeneous suspension, packaged in a white plastic container with a sprayer and conditioned in a cardboard container.

Contents of the package:

1 container of 10 g (60 doses)

1container of17 g (120 doses)

1container of18 g (140 doses)

2containers of18 g (140 doses)

3containers of18 g (140 doses)

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Responsible for manufacturing

Lek Pharmaceuticals d.d.

Verovškova 57, 1526

Ljubljana,

Slovenia

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

Germany:Mometasonfuroat - 1 A Pharma 50 Mikrogramm/Sprühstoß Nasenspray, Suspension

Belgium:Mometasone Sandoz 50 mcg/dosis neusspray, suspensie

Denmark:Mometasone Sandoz

Slovakia:Mometasone Sandoz 50 mikrogramov

Slovenia:Mommox 50 mikrogramov/vpih pršilo za nos, suspenzija

Estonia:Nasometin

Finland:Mommox 50 mikrogrammaa/annos, nenäsumute, suspensio

France:Mometasone Sandoz 50 microgrammes/dose, suspension pour pulvérisation nasale

Netherlands:Mometasonfuroatt Sandoz 50 microgram/dosis, neusspray, suspensie

Czech Republic:Mommox 0,05 mg/dávku

Hungary:Mometason Sandoz 50 mikrogramm/adag oldatos orrspray

Italy:ZHEKORT

Norway:Mometasone Sandoz, 50 mikrogram/dose, nesespray, suspensjon

Poland:NASOMETIN, 50 MIKROGRAMÓW/DAWKE ODMIERZONA, AEROZOL DO NOSA, ZAWIESINA

Portugal:Mometasona Sandoz

United Kingdom:Mometasone Furoate 50 micrograms/dose, nasal spray suspension

Romania:Furoat de mometazona Sandoz 50 micrograme/doza spray nazal, suspensie

Sweden:Mommox 50 mikrogram/dos, nässpray, suspension

Last review date of this leaflet:January 2020

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