Montelukast Vir 10 mg film-coated tablets EFG

Patient Leaflet: Information for the User

Introduction

Patient Leaflet: Information for the Patient

Montelukast VIR 10 mg Film-Coated Tablets EFG

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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 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 VIR is a leukotriene receptor antagonist that blocks substances called leukotrienes.

How Montelukast works

Leukotrienes cause narrowing and swelling of the airways in the lungs and can also trigger allergy symptoms. By blocking leukotrienes, montelukast improves asthma symptoms, helps control asthma, and improves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

When Montelukast 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 adults and adolescents 15 years of age and older whose asthma is not adequately controlled with their current medication and who require additional treatment.
• Montelukast also helps prevent airway narrowing caused by exercise.
• In asthmatic patients for whom montelukast is indicated for asthma, Montelukast VIR may also provide symptomatic relief of seasonal allergic rhinitis.

Depending on your symptoms and the severity of your asthma, your doctor will determine how you should use Montelukast VIR.

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: cough, wheezing, and chest tightness.

What are seasonal allergies?

Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic response often caused by airborne pollen from trees, grass, and weeds. Symptoms of seasonal allergies typically include: nasal congestion, runny nose, itchy nose; sneezing; watery, swollen, red, and itchy eyes.

2. What you need to know before you start taking Montelukast Vir

Inform your doctor of any allergies or medical conditions you currently have or have had in the past.

Do not take Montelukast Vir

• if you are allergic to montelukast or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take montelukast.

• If your 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 given to you by your doctor. Always have your inhaled rescue medication available for asthma attacks.
• It is important that you or your child use all asthma medications prescribed by your doctor. Montelukast should not replace 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 in arms or legs, worsening of lung symptoms, and/or skin rash, they should consult their doctor.
• You should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Children and adolescents

Do not give this medicine to children under 15 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 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 are 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), gemfibrozil (used for the treatment of elevated lipid levels in plasma)

Taking Montelukast Vir with food and drinks

Montelukast may be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 plan 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 somnolence) reported with montelukast may affect a patient's ability to drive or operate machinery.

Montelukast contains lactose.

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Montelukast Vir

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• You should take only one montelukast tablet once daily, as prescribed by your doctor.
• It should be taken even when you do not have symptoms or during an acute asthma attack.

For adults and adolescents 15 years of age and older:

The recommended dose is one 10 mg tablet daily, taken in the evening.

If you are taking montelukast, make sure you do not take any other product containing the same active substance, montelukast.

This medicine is taken orally.

You may take montelukast with or without food.

If you take more Montelukast Vir than you should

Seek medical help immediately.

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, somnolence, thirst, headache, vomiting, and hyperactivity.

If you have taken more montelukast than you should, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915620420, indicating the medicine and the amount ingested.

If you forget to take Montelukast Vir

Try to take montelukast as prescribed. However, if you miss a dose, simply resume your usual regimen of one tablet once daily.

Do not take a double dose to make up for missed doses.

If you stop taking Montelukast Vir

Montelukast can only treat your asthma if you continue taking it.

It is important that you continue taking montelukast for as long as your doctor prescribes it. It will help control your asthma.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In clinical trials with montelukast 10 mg film-coated tablets, the side effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:

• abdominal pain
• headache

These side effects were generally mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a tablet containing no active medicine).

Serious side effects

Consult your doctor immediately if you experience any of the following side effects, as they may be serious and you 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 side effects reported during post-marketing 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):

• changes in behaviour and mood: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, somnolence, tingling/numbness
• nosebleeds
• dry mouth, indigestion
• bruising, itching, urticaria
• joint or muscle pain, muscle cramps
• bed-wetting (in children)
• weakness/tiredness, malaise, swelling

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

• changes in behaviour 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 which usually appear on the shins (erythema nodosum)
• stuttering

Reporting of side effects

If you experience any type of side effect, talk to your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines. Website: 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 blister after EXP. The first digits indicate the month; the last four digits indicate the year. The expiry date refers to the last day of the stated month.
• Store 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 a SIGRE point in your pharmacy. If you are unsure, 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 montelukast sodium, equivalent to 10 mg of montelukast.

The other components are: microcrystalline cellulose, sodium croscarmellose, titanium dioxide (E-171), magnesium stearate, hydroxypropyl methylcellulose, hydroxypropyl cellulose (E-463), lactose monohydrate, macrogol 6000, yellow iron oxide (E-172), red iron oxide (E-172).

Appearance of the product and contents of the pack

Beige-colored, square-rounded, biconvex tablet.

Packed in OPA-Al-PVC/Al blister packs containing 28 and 30 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

Date of the most recent review of this leaflet: April 2025

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