Mometasone furoate Alter Genericos 50 micrograms/dose nasal suspension for spray

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Mometasone furoate Alter Genéricos 50 micrograms/spray nasal spray suspension

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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 Mometasone furoate Alter Genéricos is and what it is used for
2. What you need to know before using Mometasone furoate Alter Genéricos
3. How to use Mometasone furoate Alter Genéricos
4. Possible side effects
5. How to store Mometasone furoate Alter Genéricos
6. Contents of the pack and other information

1. What Mometasona furoato Alter Genéricos is and what it is used for

What is Mometasona furoato Alter Genéricos?

Mometasona furoato Alter Genéricos nasal spray contains mometasone furoate, a medicine belonging to a class of drugs known as corticosteroids. When mometasone furoate is sprayed into the nose, it helps 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 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 inhaling pollen from trees, grasses, weeds, as well as mold and fungal spores. Perennial rhinitis occurs throughout the year, and symptoms may be triggered by sensitivity to various substances including house dust mites, animal hair (or epithelial cells), feathers, and certain foods. Mometasona furoato Alter Genéricos 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 furoato Alter Genéricos is used to treat nasal polyps in adults aged 18 years and older.

Nasal polyps are small growths on the lining of the nose and usually affect both nostrils. Mometasona furoato Alter Genéricos reduces inflammation in the nose, gradually shrinking the polyps and thereby relieving nasal congestion that may impair your ability to breathe through the nose.

2. What you need to know before using Mometasona furoato Alter Genéricos

Do not use Mometasona furoato Alter Genéricos

• 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 furoato Alter Genéricos 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 had 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 or pharmacist before starting to use Mometasona furoato Alter Genéricos if:

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

While using Mometasona furoato Alter Genéricos, consult your doctor:

• if your immune system is not working properly (if you have difficulty fighting infections) and you come into contact with someone who has measles or chickenpox. You should avoid contact with anyone who has these infections.
• if you develop a nasal or throat infection.
• if you have been using this medicine for several months or longer.
• if you experience persistent irritation of the nose or throat.

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.

If your eyes are itchy or irritated, your doctor may recommend using other treatments in addition to Mometasona furoato Alter Genéricos.

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

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 to monitor the height of children undergoing long-term treatment with nasal corticosteroids, and any changes should be reported to the doctor.

Other medicines and Mometasona furoato Alter Genéricos

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, 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 begin using Mometasona furoato Alter Genéricos. 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, you should see your doctor.

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

Pregnancy and breastfeeding

There is limited or no information available on the use of Mometasona furoato Alter Genéricos in pregnant women. It is unknown whether Mometasona furoato Alter Genéricos is excreted in human breast milk.

If you are pregnant or 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 furoato Alter Genéricos on driving or operating machinery.

Mometasona furoato Alter Genéricos contains benzalkonium chloride

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

This medicine contains less than 23 mg of sodium (1 mmol) per spray, which means it is essentially “sodium-free”.

3. How to use Mometasona furoato Alter Genéricos

Follow exactly the instructions for administration of this medicine as given by your doctor. 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 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 into each nostril once daily.

• Once symptom control has been achieved, your doctor may recommend reducing the dose.
• If you do not start feeling better, you should consult your doctor, who may advise increasing the dose to the maximum daily dose of four sprays into each nostril once daily.

Use in children aged between 3 and 11 years

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

In some patients, Mometasona furoato Alter Genéricos begins to relieve symptoms within 12 hours of the first dose; however, the optimal effect of treatment is unlikely to be seen before the first two days. Therefore, you should maintain regular use to achieve the optimal effect of treatment.

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

Nasal polyps

Use in adults over 18 years of age

The initial usual dose is two sprays into each nostril once daily.

• If symptoms are not controlled after 5 to 6 weeks, the dose may be increased to two sprays into each nostril twice daily. Once symptom control has been achieved, your doctor may advise reducing the dose.
• If there is no improvement in symptoms after 5–6 weeks of twice-daily administration, you should consult your doctor.

Preparing 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 to replace it after use.

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

1. First, gently shake the bottle.
2. Place your index and middle fingers on either side of the nozzle and your thumb beneath the bottle. Do not puncture the nasal spray.
3. Point the nozzle away from you and then press the spray pump 10 times until a fine mist is produced.

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

How to use your nasal spray

1. Gently shake the bottle and remove the cap (Figure 1).
2. Gently blow your nose.
3. Block one nostril and insert the nozzle into the other nostril as shown (Figure 2). Tilt your head slightly forward, keeping the bottle upright.
4. Begin to inhale gently or slowly through your nose, and while inhaling, press ONCE with your fingers to release the spray into your nose.
5. Breathe out through your mouth. Repeat step 4 to inhale a second spray into the same nostril, if required.
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 spray, carefully clean the nozzle 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 gently pull off 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 any other sharp object, as this may damage the applicator and prevent you from receiving the correct dose of medication.
• Allow the cap and nozzle to dry in a warm place.
• Reattach the nozzle to the bottle 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 furoato Alter Genéricos than you should

If you accidentally use more Mometasona furoato Alter Genéricos than you should, inform your doctor.

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

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Mometasona furoato Alter Genéricos

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 use a double dose to make up for missed doses.

If you stop treatment with Mometasona furoato Alter Genéricos

In some patients, this medicine should begin 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 can cause adverse effects, although not everyone will experience them.

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

• swollen face, tongue or throat
• difficulty swallowing
• hives
• 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 medicine 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 Alter Genéricos or other nasal corticosteroid sprays may experience:

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

• headache
• sneezing
• nosebleed [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 into each nostril twice daily.]
• pain in the nose or throat
• ulcers in the nose
• respiratory infection

Frequency not known (cannot be estimated from available data)

• increased eye pressure (glaucoma) and/or cataracts which may lead to visual disturbances
• damage to the nasal septum that separates the nostrils
• taste and smell disturbances
• difficulty breathing and/or fatigue
• blurred vision

Reporting of adverse effects:

If you experience any type of 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mometasone furoate Alter Genéricos

• Keep this medicine out of the sight and reach of children.
• Unopened container: This medicine does not require any special storage conditions. Do not freeze.
• After opening: Do not store above 25°C. Do not freeze.
• Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
• The bottle should be used within 2 months of first opening.

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

6. Contents of the pack and other information

Composition of Mometasone furoate Alter Genericos

• The active substance is mometasone furoate. Each spray contains 50 micrograms of mometasone furoate (as mometasone furoate monohydrate).
• The other components are microcrystalline cellulose and sodium carboxymethylcellulose, glycerol, benzalkonium chloride, polysorbate 80, sodium citrate, citric acid monohydrate, water for injections.
• This medicine contains 0.02 mg of benzalkonium chloride in each spray.

Nature of the product and contents of the container

White HDPE bottle equipped with a white polypropylene (PP) metered manual spray pump, white PP nasal applicator covered with a transparent PP cap, contained in a box.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Date of the last revision of this leaflet: March 2022

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