Montelukast Normon 4 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast Normon 4 mg chewable tablets EFG

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for your child only and must not be given to other people, even if they have the same symptoms as your child, as it may harm them.
• If your child experiences 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 Montelukast Normon is and what it is 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. How to store Montelukast Normon
6. Contents of the pack and other information

1. What Montelukast Normon is and what it is 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 to prevent asthma symptoms during the day and night.

• Montelukast Normon is used for the treatment of patients aged 2 to 5 years who are not adequately controlled with their current medication and require additional therapy.
• Montelukast Normon is also used as an alternative to inhaled corticosteroids in patients aged 2 to 5 years who have not recently taken oral corticosteroids for the treatment of their asthma and who have demonstrated inability to use inhaled corticosteroids.
• Montelukast Normon also helps prevent exercise-induced narrowing of the airways in patients aged 2 years and older.

Depending on your child's symptoms and the severity of their asthma, your doctor will determine how Montelukast Normon should be used.

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 triggers.
• Sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• Swelling (inflammation) of the inner lining of the airways.

Asthma symptoms include: Cough, wheezing, and chest tightness.

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

Inform your doctor of any allergies or medical conditions your child currently has or has had in the past.

Do not give Montelukast Normon to your child

• If he or she is allergic to montelukast or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to 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 you for your child. Always keep your child’s rescue inhaled medication available for asthma attacks.
• It is important that your child uses all asthma medications prescribed by the doctor. Montelukast Normon must not be used instead of other asthma medications prescribed for your child.
• If your child is being treated for asthma, you should be aware that if he or she develops a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening of pulmonary symptoms, and/or skin rash, you should consult your doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen his or her asthma.

Neuropsychiatric events (e.g., behavioral and mood-related changes, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If such symptoms occur while taking montelukast, you must contact your 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 depending on age group.

Other medicines and Montelukast Normon

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

Some medicines may affect how Montelukast Normon works, or Montelukast Normon may affect how other medicines your child is taking work.

Before taking Montelukast Normon, inform 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 certain other infections)

Taking Montelukast Normon with food and drinks

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

Pregnancy and breastfeeding

This section does not apply to Montelukast Normon 4 mg chewable tablets, as this medicine is indicated for use in children aged 2 to 5 years.

Driving and using machines

This section does not apply to Montelukast Normon 4 mg chewable tablets, as this medicine is indicated for use in children aged 2 to 5 years. However, the following information is relevant for the active substance, montelukast.

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

Montelukast Normon contains aspartame, sodium, and benzyl alcohol

This medicine contains 1.2 mg of aspartame per chewable tablet. Aspartame is a source of phenylalanine, which may be harmful if your child has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

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 per ml.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with the risk of serious adverse effects, including breathing problems (“gasping syndrome”) in children.

Do not administer this medicine to your newborn (up to 4 weeks of age) unless your doctor has specifically recommended it.

This medicine should not be used for more than one week in children under 3 years of age unless directed 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 may accumulate in the body and cause adverse effects (metabolic acidosis).

3. How to take Montelukast Normon

Follow exactly the instructions for using this medicine as given by your child's doctor or pharmacist. If you are unsure, please consult your child's doctor or pharmacist again.

• This medicine should be administered to children under the supervision of an adult. For children who have difficulty taking a chewable tablet, an oral granule formulation is available.
• Your child should take only one Montelukast Normon chewable tablet once daily, as prescribed by the doctor.
• It should be taken even when your child has no symptoms or during an acute asthma attack.

For children aged 2 to 5 years

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

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

This medicine is taken orally.

The tablets must be chewed before swallowing.

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

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. The Montelukast Normon 4 mg chewable tablet is not recommended for children under 2 years of age.

If your child takes more Montelukast Normon than they should

Seek immediate help from your child's doctor.

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

Contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine's packaging and leaflet 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 misses a dose, simply resume the usual regimen of one chewable tablet once daily.

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

If your child stops taking Montelukast Normon

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

It is important that your child continues taking Montelukast Normon for as long as prescribed by the doctor.

It will help control your child's asthma.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

• abdominal pain
• thirst

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

• headache

These adverse effects were generally mild and occurred more frequently in patients treated with Montelukast Normon than with placebo (a tablet containing no active ingredient).

Serious adverse effects

Consult your doctor immediately if you notice any of the following adverse effects in your child, as they may be serious and your child may require urgent medical treatment.

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

• allergic reactions including swelling of the face, lips, tongue and/or throat, which may cause difficulty breathing or swallowing
• behavior and mood-related changes: excitation including aggressive behavior or hostility, depression
• seizures

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

• increased tendency to bleeding
• tremor
• palpitations

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

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

Other adverse effects reported during the post-marketing period

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-related changes: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, somnolence, tingling/numbness
• nosebleeds
• dry mouth, indigestion
• bruising, itching, urticaria
• joint or muscle pain, muscle cramps
• bedwetting (in children)
• weakness/tiredness, malaise, swelling

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

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

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

• painful red lumps under the skin, most frequently appearing on the shins (erythema nodosum)
• behavior and mood-related changes: obsessive-compulsive symptoms, stuttering

Reporting of adverse effects:

If your child experiences any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Montelukast Normon

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

Store below 30 °C.

Keep in the original packaging to protect from light and moisture.

Do not use this medicine after the expiry date stated on the container after “EXP”. The first two digits indicate the month; the last four digits indicate the year. The expiry date refers to the last day of the stated month.

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

6. Contents of the pack and other 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 flavour (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 reddish, round, biconvex and printed.

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 most recent review of this leaflet: July 2025

Detailed information on 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 up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74233/P_74233.htm