MOMETASONE FUROATE ALTER GENERICOS 50 micrograms/actuation NASAL SPRAY SUSPENSION

Introduction

Leaflet: Information for the patient

Mometasone furoate Alter Generics 50 micrograms/actuation nasal suspension

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 pack

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

1. What Mometasone furoate Alter Generics is and what it is used for

What is Mometasone furoate Alter Generics?

Mometasone furoate Alter Generics 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 stuffiness or runny nose.

What is Mometasone furoate Alter Generics used for?

Hay fever and perennial rhinitis

Mometasone furoate Alter Generics 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 mold and fungus 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 Alter Generics reduces the inflammation and irritation of your nose and thereby relieves sneezing, itching, and nasal stuffiness or runny nose caused by hay fever or perennial rhinitis.

Nasal polyps

Mometasone furoate Alter Generics 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 Alter Generics reduces the inflammation in the nose, causing the polyps to shrink gradually, thereby relieving nasal stuffiness that can affect your breathing through your nose.

2. What you need to know before you use Mometasone furoate Alter Generics

Do not use Mometasone furoate Alter Generics

• if you are allergic 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 Alter Generics 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 nasal surgery or 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 Alter Generics.

• if you 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 you are using Mometasone furoate Alter Generics, 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 who has 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 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 Alter Generics.

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

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 Alter Generics

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 your allergy, either by mouth or by injection, your doctor may advise you to stop taking them when you start using Mometasone furoate Alter Generics. When stopping corticosteroids, either by mouth or by injection, some people may experience side effects such as muscle or joint pain, muscle weakness, and depression. You may also develop other allergies, such as itchy eyes, itchy skin with red rashes, or hives. If you experience any of these side effects, you should consult your doctor.

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

Pregnancy and breastfeeding

There is little or no information on the use of Mometasone furoate Alter Generics in pregnant women. It is not known whether Mometasone furoate Alter Generics is excreted in breast milk.

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

Driving and using machines

There is no known information on the effect of Mometasone furoate Alter Generics on driving or using machines.

Mometasone furoate Alter Generics contains benzalkonium chloride

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

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

3. How to use Mometasone furoate Alter Generics

Follow the instructions for administration of this medicine exactly as told by your doctor. 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 tells 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 symptoms are under control, 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 into each nostril once daily.

Use in children aged 3 to 11 years

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

Mometasone furoate Alter Generics may start to relieve symptoms within 12 hours of the first dose; however, it is unlikely that the full benefit of treatment will be seen before the first two days. You should use your nasal spray regularly to achieve the full benefit of treatment.

If you or your child has very severe hay fever, your doctor may advise you to start using Mometasone furoate Alter Generics a few days before the start of the pollen season, as this will help to prevent the symptoms of hay fever before they occur.

Nasal polyps

Use in adults over 18 years of age

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

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

Preparing the nasal spray for use

Mometasone furoate Alter Generics nasal spray has a cap that protects the nozzle and keeps it clean. Remember to remove it before using the spray and replace it 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 underneath the bottle. Do notpuncture the nasal spray.
3. Do not point the nozzle towards you 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).
2. Gently blow your nose.
3. Close one nostril and put the nozzle in the other nostril as shown (Figure 2). Tilt your head slightly forward, keeping the bottle upright.
4. Start to breathe in gently or slowly through your nose and while you are breathing in press ONCEwith your fingers to allow the spray to enter your nose.
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 spray, clean the nozzle carefully with a clean tissue or paper tissue 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 warm water and then rinse with running water.
• Do not try to unblock the nasal applicator by inserting a needle or other pointed object as this may damage the applicator so that you do not receive the correct dose of medicine.
• Leave the cap and nozzle to dry in a warm place.
• Press the nozzle back onto the bottle and replace the cap.
• 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 Alter Generics than you should

If you accidentally use more Mometasone furoate Alter Generics than you should, tell your doctor.

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

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

If you forget to use Mometasone furoate Alter Generics

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

If you stop using Mometasone furoate Alter Generics

In some patients, this medicine may 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 that you 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 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 allergic reactions (hypersensitivity) can occur after using this medicine. These reactions can be serious. You should stop treatment with Mometasone furoate Alter Generics 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 Alter Generics 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 using two sprays of Mometasone furoate Alter Generics into each nostril twice daily.]
• pain in the nose or throat
• ulcers in the nose
• 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
• alterations 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 Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Mometasone furoate Alter Generics

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

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mometasone furoate Alter Generics

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

Appearance of the product and pack contents

White HDPE bottle with a white manual pump spray (PP) doser, white PP nasal applicator covered with a transparent PP cap, and packaged in a carton.

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

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Date of last revision of this leaflet: March 2022

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/