MONTELUKAST NORMON 4 mg CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

Montelukast Normon 4 mg Chewable Tablets EFG

Read this package leaflet carefully before giving this medicine to your child, as it contains important information.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed to your child only. Do not give it to others, even if they have the same symptoms as your child, as it may harm them.
• If your child experiences side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Montelukast Normon and what is it used for
2. What you need to know before your child takes Montelukast Normon
3. How to take Montelukast Normon
4. Possible side effects
5. Storage of Montelukast Normon
6. Contents of the pack and further information

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

What is Montelukast Normon

Montelukast Normon is a leukotriene receptor antagonist that blocks substances called leukotrienes.

How Montelukast Normon works

Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, Montelukast Normon improves asthma symptoms and helps control asthma.

When to use Montelukast Normon

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 old 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 old who have not recently taken oral corticosteroids for the treatment of their asthma and have demonstrated that they are unable to use inhaled corticosteroids.
• Montelukast Normon also helps prevent exercise-induced narrowing of the airways in patients 2 years of age and older.

Depending on your child's symptoms and the severity of their 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 diseases.
• Airways that are sensitive to many things, such as cigarette smoke, pollen, cold air, or exercise.
• Swelling (inflammation) of the inner layer of the airways.

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

2. What you need to know before your child takes Montelukast Normon

Tell your doctor about any allergy or medical problem your child has now or has had.

Do not give Montelukast Normon to your child

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

Warnings and precautions

Consult your doctor or pharmacist before giving Montelukast Normon to your child.

• If your child's asthma or breathing worsens, inform your doctor immediately.
• Montelukast Normon oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions your doctor has given your child. Always have your child's rescue inhaler medication for asthma attacks.
• It is essential that your child uses all asthma medications prescribed by their doctor. Montelukast Normon should not be used instead of other asthma medications prescribed by your doctor.
• If your child is being treated with asthma medications, they should be aware that if they develop a combination of symptoms such as flu-like illness, tingling or numbness of arms or legs, worsening of lung 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 non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen their asthma.

Several neuropsychiatric events (e.g., changes in behavior and mood, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If your child develops these symptoms while taking montelukast, they should contact their doctor.

Children and adolescents

Do not give this medicine to children under 2 years of age.

For pediatric patients under 18 years of age, other formulations of this medicine are available based on the age range.

Other medicines and Montelukast Normon

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines may affect the way Montelukast Normon works, or Montelukast Normon may affect the way other medicines work that your child is using.

Before taking Montelukast Normon, tell your doctor if your child is taking the following medicines:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)

Taking Montelukast Normon with food and drinks

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 meals.

Pregnancy and breastfeeding

This subsection is not applicable to Montelukast Normon 4 mg chewable tablets, as its use is indicated in children between 2 and 5 years of age.

Driving and using machines

This subsection is not applicable to Montelukast Normon 4 mg chewable tablets, as its use is indicated in children between 2 and 5 years of age. However, the following information is important for the active substance, montelukast.

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

Montelukast Normon contains aspartame, sodium, and benzyl alcohol

This medicine contains 1.2 mg of aspartame in each chewable tablet. Aspartame is a source of phenylalanine that may be harmful if your child has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

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

This medicine contains 0.031 mg of benzyl alcohol in each ml.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been linked to the risk of serious side effects, including respiratory problems ("gasping syndrome") in children.

Do not give this medicine to your newborn (up to 4 weeks of age) unless your doctor recommends it.

This medicine should not be used for more than one week in children under 3 years of age unless indicated by your doctor or pharmacist.

Consult your doctor or pharmacist if you are pregnant or breastfeeding or if you have liver or kidney disease. This is because large amounts of benzyl alcohol can accumulate in your body and cause side effects (metabolic acidosis).

3. How to take Montelukast Normon

Follow the administration instructions for this medicine indicated by your doctor or pharmacist for your child. In case of doubt, consult your doctor or pharmacist again.

• This medicine should be administered to children under adult supervision. For children who have problems taking a chewable tablet, an oral granule formulation is available.
• Your child should only take one Montelukast Normon chewable 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.

For children from 2 to 5 years of age

The recommended dose is one 4 mg chewable tablet daily in the evening.

If your child is taking Montelukast Normon, ensure they do not take any other medicine that contains the same active substance, montelukast.

This medicine is taken orally.

The tablets should be chewed before swallowing.

Singulair 4 mg chewable tablets should not be taken with meals; they should be taken at least 1 hour before or 2 hours after meals.

For children from 2 to 5 years of age, Montelukast Normon 4 mg chewable tablets and Montelukast Normon 4 mg oral granules are available.

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

If your child takes more Montelukast Normon than they should

Seek help from your child's doctor immediately.

In most cases of overdose, no side effects were reported. The symptoms that occurred most frequently in overdose in adults and children were abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

Consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken. It is recommended to take the packaging and the package leaflet of the medicine to the healthcare professional.

If you forget to give Montelukast Normon to your child

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

Do not give a double dose to make up for forgotten doses.

If your child stops taking Montelukast Normon

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

It is essential that your child continues taking Montelukast Normon for the time their doctor prescribes it.

It will help control your child's asthma.

If you have any further questions about the use of this medicine, ask your child's doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In clinical trials with Montelukast Normon 4 mg chewable tablets, the side effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 100 people) were:

• abdominal pain
• thirst

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 with a higher frequency in patients treated with Montelukast Normon than with placebo (a pill that does not contain medicine).

Serious side effects

Consult your doctor immediatelyif you observe any of the following side effects in your child, which may be serious and require urgent medical treatment.

Uncommon (may affect up to 1 in 100 people):

• allergic reactions that include swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing
• behavior and mood changes: excitement including aggressive or hostile behavior, depression
• seizures

Rare (may affect up to 1 in 1,000 people):

• increased risk of bleeding
• tremors
• palpitations

Very rare (may affect up to 1 in 10,000 people):

• a combination of symptoms such as flu-like illness, tingling or numbness of arms and legs, worsening of lung symptoms, and/or skin rash (Churg-Strauss syndrome) (see section 2)
• low platelet count
• behavior and mood changes: hallucinations, disorientation, suicidal thoughts and actions
• swelling (inflammation) of the lungs
• severe skin reactions (erythema multiforme) that can occur without warning
• inflammation of the liver (hepatitis)

Other side effects reported during the marketing of the medicine

Very common (may affect more than 1 in 10 people):

• upper respiratory tract infection

Common (may affect up to 1 in 10 people):

• diarrhea, nausea, vomiting
• skin rash
• fever
• elevated liver enzymes

Uncommon (may affect up to 1 in 100 people):

• behavior and mood changes: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, tingling/numbness
• nosebleeds
• dry mouth, indigestion
• bruises, itching, hives
• joint or muscle pain, muscle cramps
• bedwetting (in children)
• weakness/fatigue, malaise, swelling

Rare (may affect up to 1 in 1,000 people):

• behavior and mood changes: attention disturbance, memory disturbance, uncontrolled muscle movements

Very rare (may affect up to 1 in 10,000 people):

• red, painful lumps under the skin that most frequently appear on the shins (erythema nodosum)

1. behavior and mood changes: obsessive-compulsive symptoms, stuttering

Reporting of side effects:

If your child experiences any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast Normon

Keep this medicine out of the sight and reach of children.

Store below 30 °C.

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

Do not use this medicine after the expiry date that appears on the packaging after "EXP". The first two numbers indicate the month; the last four numbers indicate the year. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. If in doubt, 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 further information

Composition of Montelukast Normon

• The active substance is montelukast. Each chewable 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 (contains benzyl alcohol), and red iron oxide (E-172).

Appearance of the product and contents of the pack

Montelukast Normon 4 mg chewable tablets are pink, round, biconvex, and engraved.

Blister packs in packs of 28 tablets.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Date of the last revision of this package leaflet:July 2025

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

You can access detailed and updated information about this medicine by scanning the QR code included in the package 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.htm