PATIENT INFORMATION LEAFLET

Montelukast VIR5 mg chewable tablets EFG

Read this leaflet carefully before you or your child start taking this medicine, as 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 should not be given to others, even if they have the same symptoms, as it may harm them.
• If you or your child experience 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 produce 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 asthma and prevent asthma symptoms during the day and night.

• Montelukast 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 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 asthma treatment and have demonstrated an inability to use inhaled corticosteroids.
• Montelukast also helps prevent airway constriction caused by exercise.

Depending on symptoms and the severity of your asthma or your child's asthma, your doctor will determine how to use montelukast.

Montelukast is a leukotriene receptor antagonist that blocks certain substances called leukotrienes. Leukotrienes produce narrowing and swelling of the airways in the lungs. By blocking leukotrienes, montelukast improves asthma symptoms and helps control asthma.

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 (swelling) of the inner layer of the airways.

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

Inform your doctor of any allergy or medical condition you or your child may have now or have had.

Do not take Montelukast Vir

if you or your child:

• are 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 you or your child start taking montelukast.

• If your asthma or your child's asthma worsens, inform your doctor immediately.
• Montelukast oral is not indicated for treating 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 available.
• It is essential that you or your child use all medications for asthma prescribed by your doctor.
• Montelukast should not be used in place of other asthma medications prescribed by your doctor.
• 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 respiratory 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 nonsteroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.

Children and adolescents

Do not give this medication to children under 6 years of age.

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

Taking Montelukast Vir with other medications

Inform your doctor or pharmacist if you or your child are taking, have recently taken, 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 you are using.

Before taking montelukast, inform your doctor if you or your child are taking the following medications:

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

Taking Montelukast Vir with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Your doctor will evaluate whether you can take montelukast during this period.

Breastfeeding

It is unknown whether montelukast appears in breast milk. If you are breastfeeding or intend to breastfeed, consult your doctor before taking montelukast.

Driving and operating machinery

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

Montelukast Vir 5 mg chewable tablets contain aspartame

This medication contains 1.50 mg of aspartame in each chewable tablet. Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to properly eliminate it.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

You or your child should only take one chewable tablet of montelukast once a day, as prescribed by your doctor. It should be taken even when you or your child do not have symptoms or when they have an acute asthma attack.

For children aged 6 to 14 years:

• The recommended dose is one 5 mg chewable tablet daily at night. If you or your child are taking montelukast, make sure neither you nor your child take any other product containing the same active ingredient, montelukast.

This medication is taken orally.

The tablets should be chewed before swallowing.

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

If you or your child take more Montelukast Vir than you should:

Seek immediate help from your doctor.

In most cases of overdose, no adverse 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 forgot to take Montelukast Vir or forgot to give Montelukast Vir to your child:

Try to take montelukast as prescribed. However, if you or your child forget a dose, simply resume the usual regimen of one chewable tablet once a day.

Do not take a double dose to compensate for the missed doses.

If you or your child interrupt treatment with Montelukast Vir:

Montelukast can only treat your asthma or your child's asthma if you or your child continue to take it.

It is essential to continue taking montelukast for the time your doctor prescribes.

This will help control your asthma or your child's asthma.

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

Like all medicines, this medicine may 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:

For 5 mg:

• Headache

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

• Abdominal pain

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

Severe side effects

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

Uncommon (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
• Pulmonary edema
• Severe skin reactions (erythema multiforme) that may occur without warning
• Liver inflammation (hepatitis)

Other side effects reported during the marketing of the drug.

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):

• Behavioral and mood changes: sleep disturbances, including nightmares, sleep problems, somnambulism, irritability, anxiety, restlessness
• Dizziness, somnolence, tingling/numbness
• Nasal bleeding
• Dry mouth, indigestion
• Bruising, itching, urticaria
• Muscle or joint pain, muscle cramps
• Bedwetting (in children)
• Weakness/fatigue, malaise, 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 side effects

If you or your child experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano.: https://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 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 pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Montelukast VIR

The active ingredient is montelukast. Each chewable tablet contains 5.20 mg of montelukast sodium, which corresponds to 5 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, round, biconvex, with the inscription “M5” engraved on one face and smooth on the other face.

Packaged in blister packaging of 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

This leaflet was approved in March 2025

The 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/