Montelukast Vir 5 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Montelukast VIR 5 mg chewable tablets EFG

Read the entire leaflet carefully before you or your child starts 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 must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you or your child experience any adverse effects, consult your doctor or pharmacist, even if these adverse effects are 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 taking Montelukast VIR
3. How to take Montelukast VIR
4. Possible adverse 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 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 Montelukast VIR should be used

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

• Montelukast 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 is also used as an alternative to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for their asthma and who have demonstrated inability to use inhaled corticosteroids.
• Montelukast 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 should be used.

Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause 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 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 starting to take Montelukast VIR

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 VIR

if you or your child:

• Are 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 you or your child start taking montelukast.

• If your asthma or breathing, or that of your child, worsens, inform your doctor immediately.
• Oral montelukast is not indicated for the treatment of acute asthma attacks. If an asthma attack occurs, follow the instructions your doctor has given you for yourself or for your child. Always keep your rescue inhaled medication available for asthma attacks.
• It is important that you or your child use all asthma medications prescribed by your doctor.
• Montelukast must not be used instead of other asthma medications prescribed by your doctor 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 medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they cause your asthma to worsen.

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 the age range.

Taking Montelukast Vir with other medicines

Inform 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 works, or montelukast may affect how other medicines you are taking work.

Before taking montelukast, inform your doctor if you or your child are taking any of the following medicines:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and certain other infections)

Taking Montelukast Vir with food and drink

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

It is unknown whether montelukast passes into breast milk. If you are breastfeeding or planning to breastfeed, you should consult your doctor before taking montelukast.

Driving and using machines

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

Montelukast Vir 5 mg chewable tablets contain aspartame

This medicine contains 1.50 mg of aspartame per chewable tablet. Aspartame is a source of phenylalanine, which may be harmful if you have 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 use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

You or your child should take only one montelukast chewable 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 daily in the evening. If you or your child are taking montelukast, 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 should be chewed before swallowing.

Montelukast should not be taken with food; 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 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 or your child forget to take Montelukast Vir or forget to give it to your child

Try to take montelukast 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 missed doses.

If you or your child stop taking Montelukast Vir

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

It is important that you continue taking montelukast for as long as your doctor has prescribed it.

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

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 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 5 mg:

• Headache

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

• Abdominal pain

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 notice 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 in 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):

• A 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
• Behaviour- and mood-related changes: hallucinations, disorientation, suicidal thoughts and actions
• Swelling (inflammation) of the lungs
• Severe skin reactions (erythema multiforme) that may occur without warning
• Inflammation of the liver (hepatitis)

Other adverse effects reported during post-marketing surveillance 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, feeling anxious, restlessness
• Dizziness, drowsiness, tingling/numbness
• Epistaxis (nosebleeds)
• Dry mouth, indigestion
• Bruising, itching, urticaria (hives)
• Joint or muscle pain, muscle cramps
• Bedwetting (in children)
• Weakness/fatigue, malaise, swelling

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

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

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

• Painful red lumps under the skin, most commonly appearing on the shins (erythema nodosum)
• 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 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 expiry date refers to the last day of the month indicated.
• 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. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers 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 5.20 mg of montelukast sodium, equivalent to 5 mg of montelukast.

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

Appearance of the product and contents of the pack

Pink, speckled, round, biconvex tablet.

Packaged in an OPA-Al-PVC/Al blister pack.

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

Only certain 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 August 2025

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