PATIENT INFORMATION LEAFLET

Montelukast Vir 4 mg Chewable Tablets EFG

Read this 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 should 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Montelukast is a leukotriene receptor antagonist that blocks certain 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 for your child to treat 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 asthma treatment and have demonstrated an inability to use inhaled corticosteroids.
• Montelukast also helps prevent airway constriction caused by exercise in patients 2 years of age and older.

The dosage of montelukast will depend on your child's symptoms and the severity of their asthma, as determined by your doctor.

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 conditions
• Sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise
• Inflammation of the inner lining of the airways.

Asthma symptoms include: coughing, wheezing, and congestion in the chest.

Inform your child's doctor about any allergy or medical condition your child has now or has had.

Do not give Montelukast Vir to your child

• If your child is allergic to montelukast or any of the other components of this medication (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.

• Montelukast oral is not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions your doctor has given for your child. Always have your child's rescue inhaler medication available for asthma attacks.
• It is essential that your child uses all medications for asthma prescribed by their doctor.
• Montelukast should not be used in place of other asthma medications prescribed by your child's doctor.
• 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 in arms or legs, worsening respiratory 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 nonsteroidal anti-inflammatory drugs or NSAIDs) if they worsen their asthma.

Children and adolescents

Do not give this medication to children under 2 years of age.

For pediatric patients under 18 years, other presentations of this medication are available based on age range.

Montelukast Vir with other medications

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

Some medications may affect the functioning of montelukast, or montelukast may affect the functioning of other medications your child is using.

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

• phenobarbital (used for epilepsy treatment)
• phenytoin (used for epilepsy treatment)
• rifampicin (used for tuberculosis and some other infections treatment)

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 eating.

Pregnancy and breastfeeding

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

Driving and operating machines

This subsection is not applicable to montelukast chewable tablets, as their use is indicated in children aged 2 to 5 years, however, the following information is important for the active ingredient, montelukast.

Montelukast Vir is not expected to affect your ability to drive a car or operate machines. However, individual responses to the medication may vary. Certain adverse effects (such as dizziness and somnolence) reported with montelukast may affect the patient's ability to drive or operate machines.

Montelukast Vir 4 mg chewable tablets contain aspartame

This medication contains 1.20 mg of aspartame in each tablet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Follow exactly the administration instructions for this medication as indicated by your child's doctor or pharmacist. If in doubt, consult the doctor or pharmacist again.

• This medication should be administered to children under the supervision of an adult.
• Your child should only take one chewable tablet of montelukast 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 aged 2 to 5 years:

The recommended dose is one chewable tablet of 4 mg daily at night.

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

This medication is taken orally.

The tablets should be chewed before swallowing.

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

If your child takes more Montelukast Vir than they should:

Seek help from your child's doctor immediately.

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

If you forgot to give Montelukast Vir to your child:

Try to give montelukast as prescribed. However, if your child forgets a dose, simply resume the regular regimen of one chewable tablet once a day.

Do not give a double dose to make up for missed 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 to take montelukast for the time their doctor prescribes.

This will help control your child's asthma.

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

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

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

• abdominal pain
• fatigue

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 more frequently in patients treated with montelukast than with placebo (a pill that does not contain a medicine).

Severe side effects

Consult your doctor immediatelyif you notice any of the following side effects, as they may be severe and require urgent medical treatment.

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

• allergic reactions that include swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing
• behavioral and mood changes: excitement including aggressive or hostile behavior, depression
• seizures

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

• increased risk of bleeding
• tremors
• palpitations

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

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

Other side effects reported during the marketing of the drug

Very frequent (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

Poorly frequent (may affect up to 1 in 100 people):

?behavioral and mood changes: sleep disturbances, including nightmares, sleep problems, somnambulism, irritability, anxiety, restlessness

?dizziness, somnolence, tingling/numbness

?nasal bleeding

?dry mouth, indigestion

?bruises, itching, urticaria

?joint or muscle pain, muscle cramps

?bedwetting (in children)

?weakness/fatigue, discomfort, swelling

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

?behavioral and mood changes: attention disturbances, memory disturbances, uncontrolled muscle movements.

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

?red, painful bumps under the skin that more frequently appear on the face (erythema nodosum).

• stuttering

Reporting of side effects:

If your child experiences any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano. http://www.notificaRAM.es

By reporting side effects, you can contribute to providing more information about the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the packaging after CAD. The first two numbers indicate the month: the last four numbers indicate the year. The expiration date is the last day of the month indicated.
• Store below 30°C. Store in the original packaging to protect it from light and moisture.
• Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Montelukast Vir

The active ingredient 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 aroma (E 951), aspartame (E 951), and magnesium stearate.

Appearance of the product and content of the container

Tabletpink, speckled, oval, biconvex, with the inscription “M4” engraved on one face and smooth on the other face.

Blister packaged in OPA-Al-PVC/Al.

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

Only some container sizes may be commercially marketed.

Marketing authorization holder

Industria Química y Farmacéutica VIR, S.A.

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

28923 Alcorcón (Madrid)

Spain

Responsible for manufacturing

Accord Healthcare Limited

Sage house, 319 Pinner Road,

North HarrowHA1 4 HF, Middlesex

United Kingdom

Or

IndustriaQuímicayFarmacéuticaVIR,S.A.

C/Laguna,66-68-70

PolígonoIndustrialUrtinsa II

28923Alcorcón(Madrid)

Spain

Spain

This leaflet was approved in March 2025

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