MOMETASONE SANDOZ 50 micrograms/dose NASAL SPRAY SUSPENSION

Introduction

Package Leaflet: Information for the User

Mometasone Sandoz 50 micrograms/dose 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 package leaflet

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

1. What is Mometasone Sandoz and what is it used for

What is Mometasone Sandoz?

Mometasone Sandoz nasal spray suspension contains mometasone furoate, a medicine belonging to a group of medicines called corticosteroids. When very small amounts of mometasone furoate are 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 is Mometasone Sandoz used for?

Hay fever and perennial rhinitis

Mometasone Sandoz is used to treat the symptoms of hay fever (also known as 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 inhaling pollen from trees, grasses, weeds, and also spores from molds and fungi. Perennial rhinitis occurs throughout the year and symptoms can be caused by sensitivity to a variety of things including house dust mites, animal hair (or dander), feathers, and certain foods. Mometasone Sandoz reduces the inflammation and irritation of your nose and thereby relieves sneezing, itching, and nasal congestion or runny nose caused by hay fever or perennial rhinitis.

Nasal polyps

Mometasone Sandoz 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. Mometasone Sandoz reduces the inflammation of the nose, causing the polyps to shrink gradually, and thereby reduces the feeling of nasal congestion that can affect breathing through the nose.

2. What you need to know before you use Mometasone Sandoz

Do not use Mometasone Sandoz

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

Warnings and precautions

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

• if you have ever 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 Mometasone Sandoz, consult your doctor if:

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

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

When 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 Mometasone Sandoz.

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 to monitor the height of children on long-term treatment with nasal corticosteroids and if any changes are noticed, they should be reported to the doctor.

Using Mometasone Sandoz with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including those without a prescription.

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 medicines for HIV: ritonavir, cobicistat).

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

Pregnancy and breastfeeding

There is very little information available on the use of Mometasone Sandoz in pregnant women. It is not known if Mometasone Sandoz is found in breast milk.

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

There is no known effect of Mometasone Sandoz on driving or using machines.

Mometasone Sandoz contains benzalkonium chloride

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

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

3. How to use Mometasone Sandoz

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist again. Do not use higher doses or use the spray more often or for longer than your doctor has told you.

Treatment for 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 consult your doctor and they may advise you to increase the dose to the maximum daily dose. The maximum daily dose is four sprays into each nostril once daily.

Use in children from 3 to 11 years of age

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

In some patients, mometasone starts to relieve symptoms within 12 hours of the first dose; however, it is unlikely that the optimal effect of treatment will be seen before the first two days. If you or your child has very severe hay fever, your doctor may advise you to start using mometasone a few days before the start of the pollen season. At the end of the pollen season, hay fever symptoms 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 into each nostril once daily.

• If after 5 to 6 weeks of treatment 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 to 6 weeks of treatment twice daily, you should consult your doctor.

Preparing the nasal spray for use

Mometasone Sandoz nasal spray suspension has a cap that protects the nozzle and keeps it clean. Remember to remove it before using the spray and replace it after use.

Shake the bottle before each use.

Do not puncture the nasal applicator (nozzle) with a needle or other sharp object.

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. Shake the bottle well.
2. Remove the plastic cap.
3. Put your index and middle fingers on either side of the nozzle and your thumb below the nozzle (Figure 1). Do not puncture the nasal applicator.
4. Do not point the nozzle at yourself and then press the pump 10 times until a fine mist comes out (Figure 1).

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 well and remove the cap (Figure 2).

1. Blow your nose gently to clear your nostrils.
2. Block one nostril and put the nozzle in the other nostril. Tilt your head slightly forward, keeping the bottle upright.
3. Start to breathe in slowly through your nose and while you are breathing in, spray into your nose by pressing ONCE with your fingers (Figure 3).

1. Breathe out through your mouth. Repeat step 4 to inhale a second spray into the same nostril if necessary.
2. Remove the nozzle from this nostril and breathe out through your mouth.
3. Repeat steps 3 to 6 in the other nostril.

After using the spray, clean the nozzle carefully with a clean tissue or paper towel and replace the cap.

Cleaning your nasal spray

• It is important to clean your nasal spray regularly, otherwise, it may not work properly.
• Remove the cap and carefully remove the nozzle.
• Wash the nozzle and cap with warm water and then rinse with running water.
• Do not try to unblock the nasal applicator by inserting a needle or other sharp object as this may damage the applicator so that you do not receive the correct dose of medicine.
• Put the cap and nozzle to dry in a warm place.
• Press the nozzle 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 more Mometasone Sandoz than you should

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

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

If you have taken more Mometasone Sandoz than you should, consult your doctor immediately, or contact your pharmacist or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount used.

If you forget to use Mometasone Sandoz

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 take a double dose to make up for forgotten doses.

If you stop using Mometasone Sandoz

In some patients, Mometasone Sandoz may start to relieve symptoms 12 hours after the first dose; however, it may take two days for the full benefit of treatment to be seen. 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 about 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 must stoptreatment with Mometasone Sandoz 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 when using the nasal spray. However, some people after using Mometasone Sandoz or other nasal corticosteroid sprays may experience:

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 taking two sprays of mometasone furoate into each nostril twice daily],
• nasal or throat pain,
• nasal ulcers,
• respiratory infection.

Uncommon side effects (frequency cannot be estimated from the available data)

• increased eye pressure (glaucoma) and/or cataracts, causing visual disturbances,
• blurred vision,
• damage to the nasal septum that separates the two nostrils,
• changes in taste and smell,
• difficulty breathing or wheezing.

Reporting of side effects

If you experience 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Mometasone Sandoz

• 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 label and carton after “EXP”. The expiry date is the last day of the month stated.
• Once the bottle is opened, it should be used within two months. Only open one bottle at a time.
• Do not freeze.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. If you have any further questions about the disposal of your unused medicine, ask your pharmacist. This will help protect the environment.

6. Container Content and Additional Information

Composition of Mometasona Sandoz

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

Appearance of Mometasona Sandoz and Container Content

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

Container content:

1 container of 10 g (60 doses)

1 container of 17 g (120 doses)

1 container of 18 g (140 doses)

2 containers of 18 g (140 doses)

3 containers of 18 g (140 doses)

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova 57, 1526

Ljubljana,

Slovenia

This medication is authorized in the Member States of the European Economic Area under the following names:

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

Belgium: Mometasone Sandoz 50 mcg/dose 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

Date of the last revision of this prospectus:January 2020

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