Mometasone Sandoz 50 micrograms/dose nasal spray suspension

Patient Information Leaflet

Introduction

Patient Information Leaflet

Mometasona Sandoz 50 micrograms/dose nasal spray suspension

Mometasone furoate

Read the entire leaflet carefully before you start using this medicine, as 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 should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

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

What is Mometasona Sandoz?

Mometasona 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 relieve inflammation (swelling and irritation of the nose), sneezing, itching, and nasal congestion or runny nose.

What is Mometasona Sandoz used for?

Hay fever and perennial rhinitis

Mometasona 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 years and older.

Hay fever occurs at certain times of the year and is an allergic reaction caused by breathing in tree, grass, and weed pollens, as well as mold and fungal spores. Perennial rhinitis occurs throughout the year, and symptoms may be caused by sensitivity to a variety of substances including house dust mites, animal hair (or epithelial particles), feathers, and certain foods. Mometasona Sandoz reduces inflammation and irritation in the nose, thereby relieving sneezing, itching, and nasal congestion or runny nose caused by hay fever or perennial rhinitis.

Nasal polyps

Mometasona Sandoz is used to treat nasal polyps in adults aged 18 years and older.

Nasal polyps are small growths on the lining of the nasal passages and usually affect both nostrils. Mometasona Sandoz reduces nasal inflammation, causing polyps to gradually shrink, thus reducing the sensation of nasal congestion that can impair breathing through the nose.

2. What you need to know before you start using Mometasone Sandoz

Do not use Mometasona Sandoz

• if you are allergic 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 Mometasona Sandoz while you have an untreated nasal infection, such as herpes, may worsen the infection. You should wait until the infection has cleared before starting to use the nasal spray,
• if you have recently undergone nasal surgery or have sustained a recent injury to the nose. You should not use the nasal spray until your nose has healed.

Warnings and precautions

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

• if you have or 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 using Mometasona Sandoz, consult your doctor if:

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

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

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

If your eyes are itchy or irritated, your doctor may recommend using other treatments alongside Mometasona Sandoz.

Children

When used at high doses over long periods of time, corticosteroid nasal sprays may cause side effects such as slowed growth rate in children.

It is recommended that the height of children receiving long-term treatment with nasal corticosteroids be monitored. If any change is observed, inform your doctor.

Using Mometasona Sandoz with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, 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 medications: 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 discontinuing oral or injectable corticosteroids, some people may experience adverse effects such as muscle or joint pain, muscle weakness, and depression. You may also develop other allergic symptoms, such as watery eyes, itchy eyes, or red, itchy skin rashes. If you experience any of these adverse effects, contact your doctor.

Pregnancy and breastfeeding

There is very limited or no information available on the use of Mometasona Sandoz in pregnant women. It is unknown whether Mometasona Sandoz passes into breast milk.

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

Driving and using machines

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

Mometasona Sandoz contains benzalkonium chloride

This medicine contains 0.200 mg of benzalkonium chloride per 50 microgram/dose nasal spray suspension.

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

3. How to use Mometasona Sandoz

Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Do not use higher doses or use the spray more often or for longer than your doctor has instructed.

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 begin to feel better, consult your doctor, who may advise increasing the dose to the maximum daily dose. The maximum daily dose is 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.

In some patients, mometasone begins to relieve symptoms within 12 hours of the first dose; however, optimal treatment effect is unlikely to be seen before the first two days. If you or your child has severe hay fever, your doctor may advise starting mometasone a few days before the pollen season begins. At the end of the pollen season, hay fever symptoms should improve and treatment may no longer 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 symptoms are not controlled after 5 to 6 weeks of treatment, the dose may be increased to two sprays into each nostril twice daily. Once symptoms are under control, your doctor may advise reducing the dose.
• If there is no improvement in symptoms after 5 to 6 weeks of twice-daily administration, 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 replace it after use.

Shake the container before each use.

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

If you are using the spray for the first time, you need to "prime" the container by actuating the spray 10 times until a fine mist appears:

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 beneath the nozzle (Figure 1). Do not pierce the nasal applicator.
4. Point the nozzle away from yourself and press the spray pump 10 times until a fine mist appears (Figure 1).

If you have not used your nasal spray for 14 days or more, you need to re-prime the container by actuating the spray 2 times until a fine mist appears.

How to use your nasal spray

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

1. Gently blow your nose to clear the nostrils.
2. Close one nostril and insert the nozzle into the other nostril. Tilt your head slightly forward, keeping the container upright.
3. Begin to inhale gently or slowly through your nose and, while inhaling, spray into the 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 required.
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 lukewarm water, then rinse under running water.
• Do not attempt to unblock the nasal applicator by inserting a needle or other sharp object, as this may damage the applicator and result in incorrect dosing.
• Allow the cap and nozzle to dry in a warm place.
• Press the nozzle back onto the container and replace the cap.
• The spray will need to be re-primed with 2 sprays the first time it is used after cleaning.

If you use more Mometasona Sandoz than you should

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

If steroids are used for a long time or in large amounts, they 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, contact your doctor, pharmacist, or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and amount used.

If you forget to use Mometasona Sandoz

If you forget to use your nasal spray at the correct time, use it as soon as you remember, then continue with your normal dosing schedule.

Do not take a double dose to make up for missed doses.

If you stop using Mometasona Sandoz

In some patients, Mometasona Sandoz begins to relieve symptoms within 12 hours of the first dose; however, the full benefit of treatment may not be evident until two days later. 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 adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone gets them.

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

• swollen face, tongue or throat,
• difficulty swallowing,
• hives,
• fatigue or difficulty breathing.

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

Other adverse effects

Most people do not experience any problems after using the nasal spray. However, some people may experience the following after using Mometasone Sandoz or other corticosteroid nasal sprays:

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

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

Adverse 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 separating the two nostrils,
• taste and smell disturbances,
• difficulty breathing or wheezing.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse 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 appears on the label and on the carton after "EXP". The expiry date refers to the last day of the month indicated.
• After opening the container, use within two months. Open only one container at a time.
• Do not freeze.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mometasone Sandoz

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

Appearance of Mometasone Sandoz and contents of the pack

This medicine is a white, homogeneous suspension, contained in a white plastic bottle with a spray pump, and packaged in a cardboard box.

Contents of the pack:

1 pack of 10 g (60 doses)
1 pack of 17 g (120 doses)
1 pack of 18 g (140 doses)
2 packs of 18 g (140 doses)
3 packs of 18 g (140 doses)

Only some pack sizes may be commercially available.

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 medicinal product 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/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

Date of the most recent review of this leaflet: January 2020

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