Package Insert: Information for the Patient

Montelukast VIR 10 mg Film-Coated Tablets

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who 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 not listed in this package insert. See section 4.

Montelukast VIR is a leukotriene receptor antagonist that blocks certain substances called leukotrienes.

How Montelukast works

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

When to use Montelukast

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

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

The use of Montelukast VIR will depend on your symptoms and the severity of your 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
• Airways that are sensitive and react to many things, such as cigarette smoke, pollen, or cold air, or exercise
• Inflammation of the inner layer of the airways.

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

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. Typical symptoms of seasonal allergies may include: Stuffy nose, runny nose, sneezing; itchy nose; watery, swollen, red, and itchy eyes.

Inform your doctor about any allergy or medical condition you have now or have had.

Do not take Montelukast Vir

• if you 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 starting to take montelukast.

• If your 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 given by your doctor. Always have your rescue inhaler medication for asthma attacks available.
• It is essential 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 respiratory symptoms, and/or skin rash, they should consult their doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Children and adolescents

Do not give this medication to children under 15 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 are taking, have taken recently, 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 are taking the following medications:

• phenobarbital (used for epilepsy treatment), phenytoin (used for epilepsy treatment), rifampicin (used for tuberculosis and some other infections treatment), gemfibrozil (used for elevated plasma lipid levels treatment)

Taking Montelukast Vir with food and drinks

Montelukast can be taken with or without food.

Pregnancy and breastfeeding

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

Pregnancy

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

Breastfeeding

The safety of montelukast in breastfeeding women is unknown. If you are breastfeeding or plan 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 somnolence) reported with montelukast may affect the patient's ability to drive or operate machinery.

Montelukast contains lactose.

This medication contains lactose.If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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 should only take one Montelukast tablet once a day, as prescribed by your doctor.
• You should take it even when you do not have symptoms or when you have an acute asthma attack.

For adults and adolescents 15 years of age and older:

The recommended dose is one 10 mg tablet daily at night.

If you are taking Montelukast, make sure you do not take any other product that contains the same active ingredient, Montelukast.

This medication is taken orally.

You can take Montelukast with or without food.

If you take more Montelukast Vir than you should:

Seek help from your doctor immediately.

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

If you have taken more Montelukast than you should, consult your doctor or pharmacist immediately or call the toxicology information service, phone 915620420, indicating the medication and the amount ingested.

If you forget to take Montelukast Vir:

Try to take Montelukast as prescribed. However, if you forget a dose, simply resume the usual regimen of one tablet once a day.

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

If you interrupt treatment with Montelukast Vir:

Montelukast can only treat your asthma if you continue to take it.

It is essential that you continue taking Montelukast for the time your doctor prescribes. It will help control your asthma.

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

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

In clinical trials conducted with montelukast 10 mg film-coated 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
• headache

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 immediately if you notice any of the following side effects, as they may be serious and require urgent medical treatment:

Not common (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
• behavior 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
• Behavior 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 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
• enzymes elevated in the liver

Not common (may affect up to 1 in 100 people):

• Behavior 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):

• Behavior and mood changes: attention alteration, memory alteration, uncontrolled muscle movements

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

• red, painful lumps under the skin that more frequently appear on the face (erythema nodosum)
• stammering

Reporting side effects

If you 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 theSpanish System for Pharmacovigilance of Medicines for Human Use. Website: http://www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on 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 blister pack after CAD. The first numbers indicate the month: the last four numbers indicate the year. The expiration date is the last day of the month indicated.
• 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. By doing so, you will help protect the environment.

Composition of Montelukast Vir

The active ingredient is montelukast. Each chewable tablet contains montelukast sodium, which corresponds 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, iron oxide yellow (E-172), iron oxide red (E-172).

Appearance of the product and contents of the packaging

TabletBeige, square-rounded, biconvex, with the inscription “M10” engraved on one face and smooth on the other face.

Packed in blister packaging of OPA-Al-PVC/Al.

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

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Industria Química y Farmacéutica VIR, S.A.

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

28923 Alcorcón (Madrid)

Spain

Last review date of this leaflet: 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/