Montelukast Vir 4 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

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

Montelukast is a leukotrien receptor antagonist that blocks substances called leukotrienes.

How Montelukast VIR works

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

When to use Montelukast VIR

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

• Montelukast is used to treat patients aged 2 to 5 years who are not adequately controlled with their current medication and require additional treatment.
• Montelukast is also used as an alternative treatment to inhaled corticosteroids in patients aged 2 to 5 years who have not recently taken oral corticosteroids for their asthma and who have demonstrated inability to use inhaled corticosteroids.
• Montelukast 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 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: coughing, wheezing, and chest tightness.

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

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

Do not give Montelukast VIR to your child

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

Warnings and precautions

Consult your doctor or pharmacist before giving montelukast to your child.

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

• Oral montelukast 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 inhaled rescue medication available for asthma attacks.

• It is important that your child uses all asthma medications prescribed by the doctor.

• Montelukast should not be used instead of other asthma medications prescribed by your doctor for your child.

• If your child is being treated with asthma medications, 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 cause his or her asthma to worsen.

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 the age group.

Taking Montelukast Vir with other medicines

Inform your doctor or pharmacist if your child is taking, has recently been given, or may need to take any other medicines, including those obtained without a prescription.

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

Before taking montelukast, inform your doctor if your child is taking the following medicines:

• phenobarbital (used for the treatment of epilepsy)
• phenytoin (used for the treatment of epilepsy)
• rifampicin (used for the treatment of tuberculosis and certain other infections)

Taking Montelukast Vir with food and drink

Montelukast Vir should not be taken with food; it should be taken at least 1 hour before or 2 hours after meals.

Pregnancy and breastfeeding

This section does not apply to montelukast chewable tablets, as they are indicated for use in children aged between 2 and 5 years.

Driving and using machines

This section does not apply to montelukast chewable tablets, as they are indicated for use in children aged between 2 and 5 years. However, the following information is important regarding the active substance, montelukast.

Montelukast Vir 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 somnolence) reported with montelukast may affect a patient's ability to drive or operate machinery.

Montelukast Vir 4 mg chewable tablets contain aspartame

This medicine contains 1.20 mg of aspartame per tablet. Aspartame is a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

3. How to take Montelukast Vir

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

• This medicine should be administered to children under the supervision of an adult.
• Your child should only take one montelukast 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, make sure they do not take any other medicine containing the same active substance, montelukast.

This medicine is taken orally.

The tablets should be chewed before swallowing.

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

If your child takes more Montelukast Vir 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.

If you forget to give Montelukast Vir to your child

Try to give the montelukast 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 a missed dose.

If your child stops taking Montelukast Vir

Montelukast will only treat your child's asthma if taken continuously.

It is important that your child continues taking montelukast for as long as the doctor has prescribed it.

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 experiences them.

In clinical trials conducted with montelukast 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:

for 4 mg:

• abdominal pain
• drowsiness

Additionally, 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 than with placebo (a pill containing no active medicine).

Serious adverse effects

Consult your doctor immediately if you experience any of the following adverse effects, as they may be serious and 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
• changes in behaviour and mood: excitation including aggressive behaviour or hostility, depression
• seizures

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

• increased tendency to bleed
• 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 pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)
• low platelet count
• changes in behaviour and mood: 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

Frequent (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 hemorrhage

? dry mouth, indigestion

? Bruising, itching, urticaria

? 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).

• stuttering

Reporting of adverse reactions:

If your child experiences any type of adverse reaction, consult your doctor or pharmacist, even if they are possible adverse reactions not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: http://www.notificaRAM.es

By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast Vir

• Keep this medicine out of the sight and reach of children.
• 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.
• Store below 30°C. Keep in the original packaging to protect from light and moisture.
• Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Montelukast Vir

The active substance is montelukast. Each chewable tablet contains 4.16 mg of montelukast sodium, equivalent to 4 mg of montelukast.

The other components are: mannitol (E421), microcrystalline cellulose, sodium croscarmellose, red iron oxide (E172), cherry flavour (E951), aspartame (E951) and magnesium stearate.

Appearance of the product and contents of the pack

Pink, mottled, oval, biconvex tablet.

Packaged in OPA-Al-PVC/Al blister packs.

Pack sizes: 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140 and 200 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-68-70. Polígono Industrial Urtinsa II.

28923 Alcorcón (Madrid)

Spain

This leaflet was approved in August 2025

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