Package Insert: Information for the User

Mometasona furoate Stada 50 micrograms/pulverization suspension for nasal pulverization

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

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

1. What is Mometasona furoate Stada and what is it used for

2. What you need to know before starting to use Mometasona furoate Stada

3. How to use Mometasona furoate Stada

4. Possible adverse effects

5. Storage of Mometasona furoate Stada

6. Contents of the package and additional information

What is mometasona furoato?

Mometasona furoato Stada nasal spray contains mometasona furoato, a medication that belongs to the class of medications called corticosteroids. When mometasona furoato is 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 furoato used for?

Hay fever and perennial rhinitis

Mometasona furoato is 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 pollen from trees, grasses, weeds, and also mold and fungal spores. Perennial rhinitis occurs throughout the year and symptoms may be caused by sensitivity to a variety of things including dust mites, pet hair (or epithelium), feathers, and certain foods.Mometasona furoato 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

Mometasona furoato is used to treat nasal polyps in adults 18 years of age and older.

Nasal polyps are small formations in the mucous membrane of the nose and generally affect both nasal passages.Mometasona furoato reduces the inflammation in the nose, causing the polyps to shrink gradually, thereby relieving nasal congestion that may affect your breathing through the nose.

Do not use Mometasona furoato Stada

• if you are allergic (hypersensitive) to mometasona furoato or to any of the other ingredients of this medicine (listed in section 6)
• if you have an untreated nasal infection.The use of mometasona furoato 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 Mometasona furoato Stada:

• 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 (a genetic multi-organ disease, mainly affecting the lungs and digestive system).

While usingmometasona furoato, consult your doctor

• if your immune system is not functioning 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.
• 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 medication 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 asmometasona furoato.

Children

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

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

Other medicines and Mometasona furoato Stada

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine, including those obtained without a prescription.

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 furoato. When discontinuing oral or injected corticosteroids, some people may experience some adverse effects, such as muscle pain or joint pain, weakness, and depression. You may also develop other allergies, such as itchy eyes, watery eyes, or red, itchy skin. If you develop any of these adverse effects, see your doctor.

Some medicines may increase the effects of mometasona furoato, 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 intend to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Driving and operating machinery

There is no known information about the effect of mometasona furoato on driving or operating machinery.

Mometasona furoato Stada contains benzalkonium chloride

This medicine contains 0.02 mg of benzalkonium chloride per spray. Benzalkonium chloride may cause irritation or swelling of the nasal cavity, especially if you use it for a long period of time.

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 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 you have achieved control of symptoms, your doctor may recommend reducing the dose.
• If you do not start feeling better, you should 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 experiences severe hay fever, your doctor may advise you to start usingmometasona furoatobefore the start of the pollen season, as it will help you to 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 symptoms are not controlled, the dose may be increased to two sprays in each nostril twice a day. Once you have achieved control of symptoms, your doctor may advise you to reduce the dose.
• If no improvement of symptoms is observed after 5-6 weeks administering twice a day, you should consult your doctor.

Preparing the nasal spray for use

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

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

If you are going to use the nasal spray for the first time, you need to "prime" the bottle by pressing the nasal 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 under the bottle.

Do notperforate the nasal spray.

3.Do not point the nozzle at yourself and then press the nasal 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 nasal 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.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, spray the fine spray into your nose by pressing ONCE with your fingers.

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 nasal spray, clean the nozzle carefully with a clean handkerchief or 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 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 this may damage the nasal 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 nasal spray will need to be primed again with 2 sprays when it is used for the first time after cleaning.

If you use more Mometasona furoato Stada than 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, in rare cases, 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 indicating the medication and the amount ingested. Phone: 91 562 04 20

If you forget to use Mometasona furoato Stada

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 make up for the missed dose.

If you interrupt treatment with Mometasona furoato Stada

In some patients, mometasona furoato should 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 to use your nasal spray regularly.

Do not stop 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 medications, this medication may produce adverse effects, although not all people will experience them.

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

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

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

Other Adverse Effects

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

Frequent Adverse 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 mometasona furoato 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 intraocular pressure (glaucoma) and/or cataracts that may lead to visual disturbances
• damage to the nasal septum that separates the nostrils
• alterations in taste and smell
• difficulty breathing and/or fatigue

• blurred vision

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use. https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 30°C. Do not freeze.

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

The inhaler must be used within 2 months from its first opening. Only open one bottle at a time.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Mometasona furoato Stada

• The active substance is: mometasona furoate. Each inhalation contains 50 micrograms of mometasona furoate as monohydrate.
• The other components are: benzalkonium chloride, glycerol, polisorbate 80, microcrystalline cellulose and sodium carmellose, citric acid monohydrate, sodium citrate, purified water

Appearance of Mometasona furoato Stada and contents of the package

Mometasona furoato Stada is a nasal spray suspension.

Bottles containing 60 inhalations (10 g), 120 inhalations (16 g) or 140 inhalations (18 g).

The bottles containing 60 inhalations and 120 inhalations are presented in 1 nasal spray containers.

The bottles containing 140 inhalations are presented in 1 or 3 nasal spray containers.

Only some package sizes may be commercially available

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern(Barcelona)

Spain

[email protected]

Responsible for manufacturing

Farmea

10, rue Bouché Thomas

Z.A.C d’Orgemont

49000 Angers

France

or

STADA Arzneimittel AG

Stadastrasse 2- 18

D-61118 Bad Vilbel

Germany

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

Belgium:Mometasone EG 50 microgram/verstuiving, Neusspray, suspensie

Germany:Mometasonfuroat AL 50 Mikrogramm/Sprühstoß Nasenspray, Suspension

Italy:Mometasone EG 50 microgrammi / erogazione, Spray nasale, sospensione

Spain:Mometasona furoato Stada 50 microgramos / pulverización, suspensión para pulverización nasal

Last review date of this leaflet:July 2019

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

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