Montelukast Normon 5 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast Normon 5 mg chewable tablets EFG

Read the entire leaflet carefully before you or your child start taking this medicine, because it contains important information for you or your child.

• 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 you or your child only, and you must not give it to others, even if they have the same symptoms as you or your child, because it may harm them.
• If you or your child experience 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 taking 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 Montelukast Normon should be used

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

• Montelukast Normon is used for the treatment of pediatric patients aged 6 to 14 years who are not adequately controlled with their current medication and require additional treatment.
• Montelukast Normon is also used as an alternative treatment to inhaled corticosteroids in patients aged 6 to 14 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 airway narrowing caused by exercise.

Depending on the symptoms and severity of your asthma or your child's 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 taking Montelukast Normon

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

Do not take Montelukast Normon

• If you or your child are 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 you or your child start taking Montelukast Normon

• If your asthma or breathing, or that of your child, 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 given by your doctor for you or your child. Always have your inhaled rescue medication available for asthma attacks.
• It is important that you or your child use all asthma medications prescribed by your doctor. Montelukast Normon should not be used instead of other asthma medications 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 in arms or legs, worsening of pulmonary symptoms, and/or skin rash, they should consult their doctor.
• You or your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they cause your asthma to worsen.

Several neuropsychiatric events (e.g., behavioral and mood-related changes, depression, and suicidal thoughts) have been reported in patients of all ages treated with montelukast (see section 4). If you develop these symptoms while taking montelukast, you must 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 depending on age range.

Other medicines and Montelukast Normon

Tell your doctor or pharmacist if you or your child are taking, have 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 you are taking work.

Before taking Montelukast Normon, inform 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 certain 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 meals.

Pregnancy and breast-feeding

Pregnancy

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

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

Breast-feeding

It is unknown whether Montelukast Normon passes into breast milk. If you are breast-feeding or planning to breast-feed, you should 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 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 1.5 mg of aspartame per tablet. Aspartame is a source of phenylalanine, which may be harmful if you or your child have 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 0.039 mg of benzyl alcohol per ml.

Benzyl alcohol may cause allergic reactions.

Benzyl alcohol has been associated with reports 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 advised you to do so.

This medicine should not be used for longer 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 breast-feeding, or if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in your body and cause adverse effects (metabolic acidosis).

3. How to take Montelukast Normon

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

For children aged 6 to 14 years:

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

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

This medicine is taken orally.

The tablets must 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 meals.

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

Seek immediate help from your 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, stating the name of the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet 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 miss a dose, simply resume the usual regimen of one chewable tablet once daily.

Do not take a double dose to make up for a missed dose.

If you or your child stop taking Montelukast Normon

Montelukast Normon can only treat your asthma or that of your child if you or your child continue taking it. It is important that you continue taking Montelukast Normon for the length of time prescribed by your doctor. It will help control your asthma or that of your child.

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

4. Possible adverse effects

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

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

• Abdominal pain

These adverse effects were generally mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a pill containing no active medicine).

Serious adverse effects

Contact your doctor immediately if you notice any of the following adverse effects, which may be serious and may require urgent medical treatment for you or your child.

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
• Behaviour- and mood-related changes: excitation including aggressive behaviour 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 lung symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)
• Low platelet count
• Behaviour- 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
• Inflammation of the liver (hepatitis)

Other adverse effects reported during post-marketing use 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):

• Diarrhoea, nausea, vomiting
• Skin rash
• Fever
• Elevated liver enzymes

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

• Behaviour- and mood-related changes: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, anxious feeling, restlessness
• Dizziness, drowsiness, tingling/numbness
• Nosebleeds
• Dry mouth, indigestion
• Bruising, itching, hives
• Joint or muscle pain, muscle cramps
• Bed-wetting (in children)
• Weakness/tiredness, malaise, swelling

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

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

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

• Painful red lumps under the skin, which most commonly appear on the shins (erythema nodosum)

Behaviour- and mood-related changes: obsessive-compulsive symptoms, stuttering

Reporting of adverse effects:

If you or your child experience 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 Medicinal Products: 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 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 packaging 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 unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. 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 5 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 iron oxide red (E-172)).

Appearance of the product and contents of the pack

The 5 mg chewable tablets are reddish, round, biconvex, and printed.

Blister packs containing 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 revision of this leaflet: July 2025

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

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