MONTELUKAST VIR 4 mg CHEWABLE TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Montelukast Vir 4 mg chewable tablets EFG

Read all of this leaflet carefully before giving this medicine to your child, because it contains important information.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for 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 leaflet. See section 4.

Contents of the pack:

1. What is Montelukast Vir and what is it 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. Storage of Montelukast Vir
6. Contents of the pack and further information

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

Montelukast is a leukotriene 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 prevent asthma symptoms during the day and night.

• Montelukast is used to treat patients between 2 and 5 years of age who are not adequately controlled with their medication and need additional treatment.
• Montelukast is also used as an alternative treatment to inhaled corticosteroids in patients between 2 and 5 years of age 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 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.

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 VIR

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

Do not give Montelukast Vir to your child

• If they 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 giving montelukast to your child.

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

• Montelukast 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 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 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 medications or NSAIDs) if they worsen their asthma.

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.

Taking Montelukast Vir with other medicines

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

Before taking montelukast, 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 Vir with food and drinks

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

Pregnancy and breastfeeding

This subsection is not applicable to montelukast chewable tablets, as their use is indicated in children between 2 and 5 years of age.

Driving and using machines

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

Montelukast Vir 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 may affect the patient's ability to drive or operate machinery.

Montelukast Vir 4 mg chewable tablets contain aspartame

This medicine contains 1.20 mg of aspartame in each tablet. Aspartame is a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it properly.

3. How to take Montelukast Vir

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

• This medicine should be administered to children under adult supervision.
• Your child should only take one montelukast 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 isone 4 mg chewable tablet daily in the evening.

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

This medicine is taken orally

The tablets should be chewed before swallowing.

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

If your child takes more Montelukast Vir 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 reported in 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 montelukast 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 Vir

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

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

It will help control your child's asthma.

If you have any other 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 conducted with montelukast chewable tablets, the side effects related to the administration of the medicine and most frequently reported (may affect up to 1 in 10 people) were:

for 4 mg:

• 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 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, 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 that can cause difficulty breathing or swallowing
• mood-related changes: 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
• mood-related 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

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

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

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

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

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• 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 leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's (AEMPS) online system: http://www.notificaRAM.es

By reporting side effects, 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 carton 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.
• Store below 30°C. Store in the original packaging to protect from light and moisture.
• Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, 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 Vir

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

The other ingredients are: mannitol (E421), microcrystalline cellulose, croscarmellose sodium, red iron oxide (E172), cherry flavor (E 951), aspartame (E 951), and magnesium stearate.

Appearance of the product and packaging

Pink, speckled, oval, biconvex tablet with "M4" engraved on one side and smooth on the other side.

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

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

Not all pack sizes may be marketed.

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 March 2025

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