Leaflet: information for the user

Montelukast Normon 4 mg chewable tablets EFG

Read this leaflet carefully before your child starts taking the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribedonlyfor you or your child and should not be given to others, even if they have the same symptoms as you or your child, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Montelukast Normon is and what it is used for

2. What you need to know before starting to take Montelukast Normon

3. How to take Montelukast Normon

4. Possible side effects

5. Storage of Montelukast Normon

6. Contents of the pack and additional information

Montelukast Normon is a leukotriene receptor antagonist that blocks certain substances called leukotrienes. Leukotrienes produce narrowing and swelling of the airways in the lungs. By blocking leukotrienes, Montelukast Normon improves asthma symptoms and helps control asthma.

Your doctor has prescribed Montelukast Normon to treat your child's asthma and prevent asthma symptoms during the day and night.

• Montelukast Normon is used to treat patients between 2 and 5 years of age who are not adequately controlled with their medication and need additional treatment.

• Montelukast Normon is also used as an alternative treatment to inhaled corticosteroids in patients between 2 and 5 years of age who have not recently taken oral corticosteroids for asthma treatment and have demonstrated an inability to use inhaled corticosteroids.

• Montelukast Normon also helps prevent airway constriction caused by exercise in patients 2 years of age and older.

Depending on symptoms and the severity of your child's asthma, your doctor will determine how to use Montelukast Normon.

What is asthma?

Asthma is a chronic disease.

Asthma includes:

• difficulty breathing due to narrowing of the airways. This narrowing of the airways worsens and improves in response to various conditions.

• sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.

• inflammation of the inner lining of the airways.

Asthma symptoms include: Coughing, wheezing, and congestion in the chest.

Inform your child's doctor about any allergy or medical condition your child has now or has had.

Do not give Montelukast Normon to your child if

• they are allergic to montelukast or to any of the other components of this medication (listed in section 6).

Be extra careful with Montelukast Normon

• If your child's asthma or breathing worsens, inform your doctor immediately.

• Montelukast Normon oral is not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions your doctor has given for your child. Always have your child's rescue inhaler medication available for asthma attacks.

• It is essential that your child uses all medications for asthma prescribed by their doctor. Montelukast Normon should not be used in place of other asthma medications prescribed by your child's doctor.

• If your child is being treated with asthma medications, be aware that if they develop a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening respiratory symptoms, and/or skin rash, they should consult their doctor.

• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they worsen their asthma.

Patients should be aware that several neuropsychiatric events have been reported with Montelukast Normon (e.g., changes in behavior and mood-related) in adults, adolescents, and children (see section 4). If you or your child develop these symptoms while taking Montelukast Normon, you should consult your doctor or your child's doctor.

Use of other medications

Some medications may affect the functioning of Montelukast Normon, or Montelukast Normon may affect the functioning of other medications your child is using.

Inform your doctor or pharmacist if your child is using or has recently used other medications, including those purchased without a prescription.

Before taking Montelukast Normon, inform your doctor if your child is taking the following medications:

• phenobarbital (used for the treatment of epilepsy)

• phenytoin (used for the treatment of epilepsy)

• rifampicin (used for the treatment of tuberculosis and some other infections)

Taking Montelukast Normon with food and beverages

Montelukast Normon 4 mg chewable tablets should not be taken with meals; it should be taken at least 1 hour before or 2 hours after eating.

Pregnancy and breastfeeding

This subsection is not applicable to Montelukast Normon 4 mg chewable tablets, as its use is indicated in children aged 2 to 5 years, however, the following information is important for the active ingredient, montelukast.

Pregnancy

Women who are pregnant or intend to become pregnant should consult their doctor before taking Montelukast Normon. Your doctor will evaluate whether you can take Montelukast Normon during this period.

Breastfeeding

The passage of Montelukast Normon into breast milk is unknown. If you are breastfeeding or intend to breastfeed, you should consult your doctor before taking Montelukast Normon.

Driving and operating machinery

This subsection is not applicable to Montelukast Normon 4 mg chewable tablets, as its use is indicated in children aged 2 to 5 years, however, the following information is important for the active ingredient, montelukast.

Montelukast Normon is not expected to affect your ability to drive a car or operate machinery. However, individual responses to the medication may vary. Certain adverse effects (such as dizziness and drowsiness) that have been reported rarely with Montelukast Normon may affect the patient's ability to drive or operate machinery.

Montelukast Normon contains aspartame and sodium

This medication contains 1.2 mg of aspartame in each tablet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free".

• This medication should be administered to children under adult supervision. For children who have difficulty taking a chewable tablet, an oral granule formulation is available.

• Your child should only take one Montelukast Normon tablet once a day, as prescribed by their doctor.

• It should be taken even when your child does not have symptoms or when they have an acute asthma attack.

• Make sure your child takes Montelukast Normon as instructed by their doctor. Consult their doctor or pharmacist if you have any doubts.

• It should be taken orally.

For children aged 2 to 5 years:

One chewable tablet of 4 mg should be taken daily at night. Montelukast Normon 4 mg chewable tablets should not be taken with meals; they should be taken at least 1 hour before or 2 hours after food.

If your child is taking Montelukast Normon, ensure they do not take any other medication containing the same active ingredient, montelukast.

For children aged 2 to 5 years, Montelukast Normon 4 mg chewable tablets and Montelukast Normon 4 mg granules are available.

For children aged 6 to 14 years, Montelukast Normon 5 mg chewable tablets are available. Montelukast Normon 4 mg chewable tablets are not recommended for children under 2 years of age.

If your child takes more Montelukast Normon than they should

In most cases of overdose, no adverse effects were reported. The symptoms that were most frequently reported in adults and children who experienced an overdose were abdominal pain, drowsiness, drowsiness, headache, vomiting, and hyperactivity.

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

If you forgot to give Montelukast Normon to your child

Try to give Montelukast Normon as prescribed. However, if your child forgets a dose, simply resume the usual regimen of one tablet once a day.

Do not give a double dose to compensate for missed doses.

If your child interrupts treatment with Montelukast Normon

Montelukast Normon can only treat your child's asthma if they continue to take it.

It is essential that your child continues to take Montelukast Normon for the duration prescribed by their doctor.

This will help control your child's asthma.

If you have any other questions about using this product, ask your child's doctor or pharmacist.

Like all medicines, Montelukast Normon can cause side effects, although not everyone will experience them.

In clinical trials conducted with Montelukast Normon 4 mg chewable tablets, the side effects related to the administration of the medication and reported most frequently (occurring in at least 1 in 100 patients and less than 1 in 10 patients treated), were:

• abdominal pain

• drowsiness

Additionally, the following side effects were reported in clinical trials with montelukast 10 mg film-coated tablets and 5 mg chewable tablets:

• headache

These side effects were generally mild and occurred more frequently in patients treated with Montelukast Normon than with placebo (a tablet that does not contain a medication).

Additionally, since the medication has been marketed, the following side effects have been reported:

• upper respiratory tract infection

• increased risk of bleeding

• allergic reactions that include skin rash, swelling of the face, lips, tongue, and/or

throat that can cause difficulty breathing or swallowing

• behavior and mood changes [sleep disturbances, including nightmares, hallucinations, irritability, anxiety, restlessness, excitement including aggressive or hostile behavior, tremors, depression, sleep problems, somnambulism, suicidal thoughts and actions (in very rare cases)]

• dizziness, somnolence, paresthesia, convulsions

• palpitations

• nasal bleeding

• diarrhea, dry mouth, indigestion, nausea, vomiting

• hepatitis (inflammation of the liver)

• hematomas, pruritus, urticaria, painful red nodules under the skin that more frequently appear on the skin (erythema nodosum)

• joint or muscle pain, muscle cramps

• fatigue, malaise, swelling, fever

• stuttering (very rare, may affect up to 1 in 10,000 people)

In patients with asthma treated with montelukast, very rare cases of a combination of symptoms such as flu-like illness, paresthesia or numbness of arms and legs, worsening of respiratory symptoms, and/or skin rash (Churg-Strauss syndrome) have been reported. Inform your doctor immediately if your child has one or more of these symptoms.

Ask your doctor or pharmacist for more information about side effects. If you consider that any of the side effects you are experiencing is severe or if you notice side effects not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of side effects:

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

Keep out of the sight and reach of children.

Store below 30 °C.

Store in the original packaging to protect it from light and humidity.

Do not use Montelukast Normon after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

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

Composition of Montelukast Normon

• The active ingredient is montelukast. Each tablet contains montelukast sodium equivalent to 4 mg of montelukast.
• The other components are:

Microcrystalline cellulose, mannitol (E-421), sodium carboxymethyl starch (from potato), aspartame (E-951), magnesium stearate, cherry flavor, and iron oxide red (E-172).

Appearance of the product and contents of the packaging

Montelukast Normon 4 mg chewable tablets are reddish, round, biconvex, and printed.

Blister packs in packs of 28 tablets.

Holder of the marketing authorization and responsible manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

This leaflet was revised in January 2022

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.es/

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/74233/P_74233.html