Prospect: information for the patient

Mometasona furoate Alter Generics 50 micrograms/pulse suspension for nasal spray

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others who 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 prospect. See section 4.

What is Mometasona furoato Alter Genéricos?

Mometasona furoato Alter Genéricos nasal spray contains furoate of mometasone, a medication that belongs to the class of drugs called corticosteroids. When furoate of mometasone 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 Alter Genéricos used for?

Hay fever and perennial rhinitis

Mometasona furoato Alter Genéricos 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 spores and fungi. 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 Alter Genéricos reduces 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 Alter Genéricos 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 Alter Genéricos reduces 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 furoate Alter Generics

• if you are allergic to mometasone furoate or any of the other ingredients of this medication (listed in section 6).
• if you have an untreated nasal infection. Using Mometasona furoate Alter Generics 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 recently undergone surgery or had 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 before starting to use Mometasona furoate Alter Generics.

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

While using Mometasona furoate Alter Generics, consult your doctor

• if your immune system is not functioning properly (if you have difficulty recovering from an 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 medication for several months or more.
• if you have persistent nasal or throat irritation.

If corticosteroid nasal 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 in addition to Mometasona furoate Alter Generics.

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

Children

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

It is recommended to monitor the height of children on long-term treatment with corticosteroids and if any changes are observed, inform your doctor.

Other medications and Mometasona furoate Alter Generics

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

If you are taking other corticosteroids for allergies, either orally or by injection, your doctor may advise you to stop taking them when you start using Mometasona furoate Alter Generics. When discontinuing corticosteroids, orally or by injection, some people may experience adverse effects such as muscle pain or joint pain, muscle weakness, and depression. You may also develop other allergies, such as itchy eyes, runny nose, or red, itchy skin. If you develop any of these adverse effects, see your doctor.

Some medications may increase the effects of Mometasona furoate Alter Generics, so your doctor will perform close monitoring if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding

There is little or no information available on the use of Mometasona furoate Alter Generics in pregnant women. It is unknown whether Mometasona furoate Alter Generics is excreted in breast milk.

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

Driving and operating machinery

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

Mometasona furoate Alter Generics contains benzalkonium chloride

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

This medication contains less than 23 mg of sodium (1mmol) per pulse, which is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. 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 must 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.

Mometasona furoato Alter Genéricos may start to relieve symptoms in 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. Therefore, you must maintain regular use to achieve the optimal effect of treatment.

If you or your child experiences severe hay fever, your doctor may advise you to start using Mometasona furoato Alter Genéricos some days before the start of the pollen season, as this will help prevent hay fever symptoms before they occur.

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 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 must consult your doctor.

Preparation of the nasal spray for use

Mometasona furoato Alter Genéricos nasal spray 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 going to use the spray for the first time, you need to "prime" the bottle by pressing 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.
3. Do not point the nozzle at yourself and then press the 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 spray 2 times until a fine spray is produced.

How to use your nasal spray

After using the spray, clean the nozzle carefully with a clean tissue or a 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 pull out the nozzle.
• Clean 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 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 spray will need to be primed again with 2 sprays when used for the first time after cleaning.

If you use more Mometasona furoato Alter Genéricos than you should

If you accidentally use more Mometasona furoato Alter Genéricosthan you should, tell your doctor.

If you use steroids for a long period or in large quantities, it may, in rare cases, affect some of your hormones. In children, it may affect growth and development.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Mometasona furoato Alter Genéricos

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 compensate for the missed doses.

If you interrupt treatment with Mometasona furoato Alter Genéricos

In some patients, this medication should start to relieve 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 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 may experience them.

Immediate hypersensitivity reactions (allergic) may occur after using this medication. These reactions can be severe. You must interrupt treatment with Mometasona furoato Alter Genéricos and 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 by the body.

Other Adverse Effects

Most people do not have any problems after using the nasal spray. However, some people after using Mometasona furoato Alter Genéricos or other nasal corticosteroid sprays may present:

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 Alter Genéricos 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 nasal passages
• 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 directly through the Spanish System of Pharmacovigilance of Medicines 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.
• Unopened packaging: This medication does not require any special storage temperature. Do not freeze.
• Once opened: do not store at a temperature above 25°C. Do not freeze.
• Do not use this medication after the expiration date that appears on the packaging after EXP. The expiration date is the last day of the month indicated.
• The bottle should be used within 2 months following the first opening.

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. By doing so, you will help protect the environment.at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

CompositionofMometasonafuroateAlterGeneric

• The active ingredient is furoate of mometasona. Each inhalation contains 50 micrograms of furoate of mometasona (as monohydrate of furoate of mometasona).
• The other components are microcrystalline cellulose and sodium carmelose, glycerol, benzalkonium chloride, polisorbate 80, sodium citrate, citric acid monohydrate, and water for injection preparations.
• This medication contains 0.02 mg of benzalkonium chloride in each inhalation.

Aspect of the product and contents of the packaging

HDPE white bottle equipped with a manual polypropylene (PP) dosing pump, white nasal applicator covered with a transparent PP lid, and contents in a box.

Each bottle contains 18 g of suspension (140 applications) or 10 g of suspension (60 applications).

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Date of the last review of this prospectus: March 2022

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