MOMETASONE FUROATE STADA 50 micrograms/spray NASAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Mometasone Furoate Stada 50 micrograms/spray suspension for nasal spray

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

1. What is Mometasone Furoate Stada and what is it used for

What is mometasone furoate?

Mometasone Furoate Stada nasal spray 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 is mometasone furoate used for?

Hay fever and perennial rhinitis

Mometasone furoate 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, which occurs at certain times of the year, is an allergic reaction caused by breathing in pollen from trees, grasses, weeds, and also molds and fungal 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. Mometasone furoate 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 furoate is used to treat nasal polyps in adults aged 18 years and older.

Nasal polyps are small growths in the lining of the nose and usually affect both nostrils. Mometasone furoate reduces the inflammation in the nose, causing the polyps to shrink gradually, and thereby relieves nasal congestion that can affect your breathing through your nose.

2. What you need to know before you use Mometasone Furoate Stada

Do not use Mometasone Furoate Stada

• 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 mometasone furoate 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 nose surgery or a nose injury. You should not use the nasal spray until your nose has healed.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Mometasone Furoate Stada:

• if you have or have ever had tuberculosis
• if you have any other infection
• if you are taking other corticosteroids, either orally or by injection
• if you have cystic fibrosis (a genetic multi-organ disease that mainly affects the lungs and digestive system).

While using mometasone furoate, consult your doctor

• if your immune system is not working properly (if you have difficulty getting over infections) 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 nose or throat infection.
• if you have been using this medicine for several months or longer.
• if you have persistent irritation of the nose or throat.
• if you experience 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 mometasone furoate.

Children

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

Other medicines and Mometasone Furoate Stada

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

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

Some medicines may increase the effects of mometasone furoate, so your doctor will monitor you closely if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

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.

There is little or no information 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 information on the effect of mometasone furoate on driving or using machines.

Mometasone Furoate 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 used for a long time.

3. How to use Mometasone Furoate Stada

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are unsure, consult 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 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 your symptoms, your doctor may recommend reducing the dose.
• If you do not start to feel 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 has very severe hay fever, your doctor may advise you to start using mometasone furoate 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 in each nostril once a day.

• If after 5 to 6 weeks the symptoms are not controlled, the dose may be increased to two sprays in each nostril twice a day. Once you have achieved control of your symptoms, your doctor may recommend reducing the dose.
• If there is no improvement in symptoms after 5-6 weeks of administering two sprays twice a day, you should consult your doctor.

Preparing the nasal spray for use

Mometasone furoate 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.

If you are using 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 under 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)

1. Blow your nose gently.
2. Cover one nostril and put the nozzle in the other nostril as shown (Figure 2). Tilt your head slightly forward, keeping the bottle upright.

1. Start to breathe in slowly through your nose and while you are breathing in, spray the fine spray into your nose by pressing ONCE with your fingers.
2. Breathe out through your mouth. Repeat step 4 to inhale a second spray into the same nostril, if applicable.
3. Remove the nozzle from this nostril and breathe out through your mouth.
4. 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 put the cap back on.

Cleaning your nasal spray

• It is important to 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 nottry to unblock the nasal applicator by inserting a needle or other pointed object as you 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 put the cap on.
• 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 Furoate Stada than you should

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

If you use steroids for a long time or in large amounts, you may, in rare cases, affect some of your hormones. 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 indicating the medicine and the amount taken. Phone: 91 562 04 20

If you forget to use Mometasone Furoate Stada

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

If you stop using Mometasone Furoate Stada

In some patients, mometasone furoate should start to relieve symptoms 12 hours after the first dose; however, the full benefit of treatment may not be seen until two days after. 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 other 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 hypersensitivity reactions (allergic reactions) can occur after using this medicine. These reactions can be serious. You should stop treatment with mometasone furoate 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 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 administering two sprays of mometasone furoate in each nostril twice a day.]
• nasal or throat pain
• nasal ulcers
• respiratory infection

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

• increased eye pressure (glaucoma) and/or cataracts that can lead to visual disturbances
• damage to the nasal septum that separates the nostrils
• changes in taste and smell
• difficulty breathing and/or fatigue

• blurred vision

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

5. Storing Mometasone Furoate Stada

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 and bottle after EXP. The expiry date is the last day of the month stated.

The spray should be used within 2 months of first opening. Only open one bottle at a time.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help to protect the environment.

6. Contents of the pack and other information

Composition of Mometasone Furoate Stada

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

Appearance of Mometasone Furoate Stada and contents of the pack

Mometasone Furoate Stada is a suspension for nasal spray.

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

The bottles containing 60 sprays and 120 sprays are presented in packs of 1 nasal spray.

The bottles containing 140 sprays are presented in packs of 1 or 3 nasal sprays.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

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 authorised in the Member States of the European Economic Area under 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

Date of last revision of this leaflet:July 2019

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

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