Montelukast Viatris 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Montelukast Viatris 10 mg film-coated tablets EFG

Read the 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Montelukast Viatris is and what it is used for
2. What you need to know before taking Montelukast Viatris
3. How to take Montelukast Viatris
4. Possible side effects
5. How to store Montelukast Viatris
6. Contents of the pack and other information

1. What Montelukast Viatris is and what it is used for

Montelukast Viatris contains montelukast, which is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs and can also cause allergy symptoms. By blocking leukotrienes, Montelukast Viatris improves asthma symptoms, helps control asthma, and relieves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

Your doctor has prescribed Montelukast Viatris to treat your asthma and to prevent asthma symptoms during the day and night.

• Montelukast Viatris is used to treat adults and adolescents aged 15 years and older whose asthma is not adequately controlled with their current medication and who need additional treatment.
• Montelukast Viatris also helps prevent narrowing of the airways caused by exercise.
• In those asthmatic patients for whom Montelukast Viatris is indicated for asthma, it 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 Viatris.

Montelukast Viatris 10 mg tablets are used in adults and adolescents aged 15 years and older.

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.

Symptoms of asthma include: coughing, 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: stuffy nose, runny nose, itchy nose; sneezing; watery, swollen, red, and itchy eyes.

2. What you need to know before taking Montelukast Viatris

Inform your doctor of any allergies or medical conditions you currently have or have previously had.

Do not take Montelukast Viatris:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Montelukast Viatris.

• If your asthma or breathing worsens, inform your doctor immediately.
• Montelukast Viatris is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor. Always have your rescue inhaled medication available for asthma attacks.

Consult your doctor if you need more inhaled medication than usual for severe asthma attacks.

• It is important that you take all asthma medications prescribed by your doctor. Montelukast Viatris 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 function (pulmonary 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.

Various neuropsychiatric events (e.g., behavioral and mood-related changes, depression, suicide) have been reported in patients of all ages treated with montelukast (see section 4). If you develop such symptoms while taking montelukast, you must consult your doctor.

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 age group.

Other medicines and Montelukast Viatris

Some medicines may affect how Montelukast Viatris works, or Montelukast Viatris may affect how other medicines you are taking work.

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.

Before taking Montelukast Viatris, inform your doctor if you are taking the following medicines:

• Phenobarbital (used to treat epilepsy).
• Phenytoin (used to treat epilepsy).
• Rifampicin (used to treat tuberculosis and certain other infections).
• Gemfibrozil (used to treat high lipid levels in plasma).

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will assess whether you can take Montelukast Viatris during this period.

Breastfeeding

It is unknown whether Montelukast Viatris passes into breast milk. If you are breastfeeding or planning to breastfeed, you must inform your doctor before taking Montelukast Viatris.

Driving and using machines

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

Montelukast Viatris contains sunset yellow FCF and sodium

Sunset yellow FCF (E-110) may cause allergic-type reactions.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., essentially "sodium-free".

3. How to take Montelukast Viatris

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

• You should take only one Montelukast Viatris 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 (including elderly patients) and adolescents aged 15 years and older:

The recommended dose is:

• One 10 mg tablet daily, taken in the evening.

Use in children and adolescents

Montelukast Viatris is not suitable for children and adolescents under 15 years of age.

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

This medicine is taken orally.

You may take Montelukast Viatris with or without food.

If you take more Montelukast Viatris than you should

Seek immediate help from your doctor.

In most overdose cases, no adverse effects were reported. The symptoms most frequently reported in overdose cases were abdominal pain, somnolence, thirst, headache, vomiting, and hyperactivity.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Montelukast Viatris

Try to take Montelukast Viatris 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 Viatris

Montelukast Viatris can treat your asthma only if you continue taking it. It is important that you continue taking Montelukast Viatris 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 adverse effects

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

In clinical trials with montelukast, the adverse effects related to montelukast administration and reported most frequently (occurring in up to 1 in 10 people) were:

• Abdominal pain.
• Headache.

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

Serious adverse effects

Contact a doctor immediately if you experience any of the following adverse effects, which may be serious and for which you may require urgent medical treatment.

Uncommon (may affect up to 1 in 100 people)

• Allergic reactions including swelling of the face, lips, tongue, or throat, which may cause difficulty breathing or swallowing.
• Changes in behaviour and mood: agitation including aggressive behaviour and 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 in arms and legs, worsening of lung disease (pulmonary symptoms) and/or rash (Churg-Strauss syndrome) (see section 2).
• Low platelet count in blood.
• Changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions.
• Inflammation of the lungs.
• Severe skin reactions (erythema multiforme) that may occur without warning.
• Inflammation of the liver (hepatitis).

Additionally, since the medicine has been marketed, the following adverse effects have been reported:

Very common (may affect more than 1 in 10 people)

• Upper respiratory tract infections.

Common (may affect up to 1 in 10 people)

• Diarrhoea.
• Nausea.
• Vomiting.
• Rash.
• Fever.
• Increased liver enzymes.

Uncommon (may affect up to 1 in 100 people)

• Changes in behaviour and mood: sleep disturbances, including nightmares, difficulty sleeping, sleepwalking, irritability, anxiety, restlessness, dizziness, somnolence, tingling/numbness.
• Nosebleeds.
• Dry mouth, indigestion.
• Bruising, itching, urticaria.
• Joint or muscle pain, muscle cramps.
• In children, bedwetting.
• Weakness/fatigue, malaise, swelling.

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

• Changes in behaviour and mood: 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 on the lower legs (erythema nodosum).
• Changes in behaviour and mood: obsessive-compulsive symptoms, stuttering.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast Viatris

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after CAD or EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Montelukast Viatris

• The active substance is montelukast.
• Each tablet contains 10 mg of montelukast as montelukast sodium.
• The other components are:

Core: microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, sodium lauryl sulfate, colloidal anhydrous silica.

Coating: polydextrose, titanium dioxide (E-171), hypromellose, triacetin, indigo carmine (E-132), macrogol, sunset yellow FCF (E-110) (see section 2 “Montelukast Viatris contains sunset yellow FCF (E-110)”)

Appearance of the product and contents of the pack

Film-coated, blue, round, biconvex tablets with bevelled edges, engraved with “MO” over “10” on one side and “M” on the other.

Available in blisters of 10, 14, 20, 28, 30, 50, 56, 60, 84, 90 and 100 tablets, in single-dose perforated blisters of 28x1 tablet, or in bottles with silica gel desiccant containing 28, 30, 56, 60, 84, 90, 100, 112, 120, 180 and 500 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer:

McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road, Dublin 13
Ireland

or

Mylan Hungary Kft.
H-2900 Komárom
Mylan utca 1
Hungary

or

Logiters, Logística Portugal, S.A.
Estrada dos Arneiros, 4
Azambuja, 2050-306
Portugal

or

Mylan B.V.
Krijgsman 20
1186 DM Amstelveen
Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.
C/ General Aranaz, 86
28027 - Madrid
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria: Montelukast Arcana 10 mg Filmtabletten
Germany: Montelukast dura 10 mg filmtabletten
Cyprus: Montelukast Mylan επικαλυμμ?νο με λεπτ? υμ?νιο δισκ?ο 10 mg
Denmark: Montelukast Mylan
Slovakia: Montelukast Mylan 10 mg
Spain: Montelukast Viatris 10 mg film-coated tablets EFG
Finland: Montelukast Mylan
France: MONTELUKAST VIATRIS 10 mg, comprimé pelliculé
Greece: Montelukast Mylan επικαλυμμ?νο με λεπτ? υμ?νιο δισκ?ο 10 mg
Ireland: Montelukast Mylan 10 mg film-coated tablets
Italy: Montelukast Mylan Generics
Netherlands: Montelukast Mylan 10 mg, filmomhulde tabletten
Portugal: Montelucaste Mylan
United Kingdom (Northern Ireland): Montelukast 10 mg film coated tablets
Czech Republic: Montelukast Mylan 10 mg, potahované tablety
Sweden: Montelukast Mylan

Date of the most recent revision of this product information: January 2025

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