MONTELUKAST NORMON 5 mg CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

Montelukast Normon 5 mg Chewable Tablets EFG

Read this package leaflet carefully before you or your child start taking this medicine, as it contains important information for you or your child.

• 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 for you or your child only. Do not give it to others, as it may harm them, even if their symptoms are the same as yours or your child's.
• If you or your child experience any 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 taking 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 asthma and prevent asthma symptoms during the day and night.

• Montelukast Normon is used to treat pediatric patients between 6 and 14 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 6 and 14 years of age who have not recently taken oral corticosteroids for their asthma and have demonstrated that they are unable to use inhaled corticosteroids.
• Montelukast Normon also helps prevent exercise-induced narrowing of the airways.

Depending on the symptoms and severity of your asthma or 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 diseases.
• Airways that are sensitive and react 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 taking Montelukast Normon

Tell your doctor about any allergy or medical problem that you or your child have now or have had.

Do not take Montelukast Normon

• If you or your child are allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before you or your child start taking Montelukast Normon

• If your asthma or breathing or your child's asthma or breathing worsen, inform your doctor immediately.
• Montelukast Normon oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor for you or your child. Always have your rescue inhaler medication for asthma attacks.
• It is essential that you or your child use all asthma medications prescribed by your doctor. Montelukast Normon should not be used instead of other asthma medications that your doctor has prescribed for you or your child.
• Any patient being treated with asthma medications 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.
• You or your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory medications or NSAIDs) if they worsen your 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 you develop these symptoms while taking montelukast, you should contact your doctor.

Children and adolescents

Do not give this medicine to children under 6 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 you or your child are taking, have 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.

Before taking Montelukast Normon, tell your doctor if you or your child are 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 5 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after food.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Your doctor will assess whether you can take Montelukast Normon during this period.

Breastfeeding

It is not known whether Montelukast Normon appears in breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Montelukast Normon.

Driving and using machines

Montelukast Normon is not expected to affect your ability to drive a car or operate machines. 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 machines.

Montelukast Normon contains aspartame, sodium, and benzyl alcohol

This medicine contains 1.5 mg of aspartame in each tablet. Aspartame is a source of phenylalanine that may be harmful if you or your child have 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 0.039 mg of benzyl alcohol in each ml.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with reports 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 has recommended it.

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

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 instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

• You or your child should only take one Montelukast Normon tablet once a day, as prescribed by your doctor.

This should be taken even when you or your child do not have symptoms or when you or your child have an acute asthma attack.

For children from 6 to 14 years of age:

The recommended dose is one 5 mg chewable tablet daily in the evening.

If you or your child are taking Montelukast Normon, ensure that neither you nor your child take any other product containing the same active ingredient, montelukast.

This medicine is taken orally.

The tablets should be chewed before swallowing.

Montelukast Normon 5 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after food.

If you or your child take more Montelukast Normon than you should

Seek immediate medical attention from your doctor.

In most cases of overdose, no side effects were reported. The symptoms that occurred most frequently 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 or your child forget to take Montelukast Normon

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

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

If you or your child stop taking Montelukast Normon

Montelukast Normon will only treat your asthma or your child's asthma if you or your child continue to take it. It is essential that you continue taking Montelukast Normon for the time your doctor prescribes. It will help control your asthma or your child's asthma.

If you have any further 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.

In clinical trials with montelukast 5 mg chewable tablets, the side effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:

• Headache

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

• Abdominal pain

These side effects were generally mild and occurred with a higher frequency in patients treated with montelukast than with placebo (a pill that does not contain medicine).

Serious side effects

Consult your doctor immediatelyif you notice any of the following side effects, which may be serious and you or your child may need 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
• Changes related to behavior and mood: excitement including aggressive or hostile behavior, depression
• Seizures

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

• Increased risk of 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 of arms and legs, worsening of lung symptoms, and/or skin rash (Churg-Strauss syndrome) (see section 2)
• Low platelet count
• Changes related to behavior and mood: hallucinations, disorientation, suicidal thoughts and actions
• Swelling (inflammation) of the lungs
• Severe skin reactions (erythema multiforme) that can occur without warning
• Liver inflammation (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):

• Changes related to behavior and mood: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness
• Dizziness, drowsiness, tingling/numbness
• Nasal bleeding
• Dry mouth, indigestion
• Bruising, 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):

• Changes related to behavior and mood: attention disturbance, memory disturbance, uncontrolled muscle movements

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

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

Changes related to behavior and mood: obsessive-compulsive symptoms, stuttering

Reporting of side effects:

If you or your child experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's (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 from light and moisture.

Do not use this medicine after the expiry date stated 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. Return any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Montelukast Normon

• The active ingredient is montelukast. Each chewable tablet contains montelukast sodium equivalent to 5 mg of montelukast.
• The other ingredients are:

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

Appearance of the product and pack contents

The 5 mg chewable tablets are reddish, 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 Healthcare 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