MONTELUKAST VIATRIS 10 mg FILM-COATED TABLETS

2. What you need to know before you take Montelukast Viatris

Tell your doctor about any allergy or medical problem you have now or have had.

Do not take Montelukast Viatris:

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

Warnings and Precautions

Consult your doctor or pharmacist before starting Montelukast Viatris.

• If your asthma or breathing gets worse, tell 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 inhaler medication for asthma attacks.

Consult your doctor if you need more inhaler 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 of arms or legs, worsening lung symptoms (pulmonary symptoms), and/or skin rash, they should consult their doctor.
• Do not take aspirin or non-steroidal anti-inflammatory drugs (also known as non-steroidal anti-inflammatory medications or NSAIDs) if they make your asthma worse.

Neuropsychiatric events (such as changes related to behavior and mood, 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 should 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 based on the age range.

Other Medicines and Montelukast Viatris

Some medicines may affect the way Montelukast Viatris works, or Montelukast Viatris may affect the way other medicines work.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Before taking Montelukast Viatris, tell 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 some 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 plan 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 not known whether Montelukast Viatris appears in breast milk. If you are breastfeeding or plan to breastfeed, you should 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 the medication may vary. Some side effects (such as drowsiness or dizziness) reported with Montelukast Viatris may affect the patient's ability to drive or operate machinery.

Montelukast Viatris contains Orange Yellow S and Sodium

Orange Yellow S (E-110) may cause allergic reactions.

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

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3. How to take Montelukast Viatris

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

• You should take only one Montelukast Viatris 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 (including elderly patients) and Adolescents 15 years of age and older:

The recommended dose is:

• One 10 mg tablet, once daily, 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 that contains the same active ingredient, montelukast.

This medicine is taken orally.

You can take Montelukast Viatris with or without food.

If you take more Montelukast Viatris than you should

Seek help from your doctor immediately.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 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, just resume your regular schedule of one tablet once a day.

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

If you stop taking Montelukast Viatris

Montelukast Viatris may only treat your asthma if you continue to take it. It is important that you continue to take Montelukast Viatris for the time your doctor prescribes. 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 conducted with montelukast, the side effects related to the administration of montelukast and reported most frequently (occurring in 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 pill that does not contain medicine).

Serious side effects

Contact a doctor immediatelyif you notice any of the following side effects, which may be serious and require urgent medical treatment.

Uncommon(may affect up to 1 in 100 people)

• Allergic reactions including swelling of the face, lips, tongue, or throat that may cause difficulty breathing or swallowing.
• Changes related to behavior and mood: agitation including aggressive behavior and hostility, depression.
• Seizures

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

• Increased risk of 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 lung symptoms (pulmonary symptoms), and/or skin rash (Churg-Strauss syndrome) (see section 2).
• Low platelet count in blood.
• Changes related to behavior and mood: hallucinations, disorientation, suicidal thoughts and actions.
• Lung inflammation.
• Severe skin reactions (erythema multiforme) that may appear without warning.
• Liver inflammation (hepatitis).

Additionally, since the medicine has been marketed, the following side 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)

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

Uncommon(may affect up to 1 in 100 people)

• Changes related to behavior and mood: sleep disturbances, including nightmares, sleepwalking, irritability, anxiety, restlessness, dizziness, drowsiness, tingling/numbness.
• Nosebleeds.
• Dry mouth, indigestion.
• Bruising, itching, urticaria.
• Joint or muscle pain, muscle cramps.
• In the case of children, bedwetting.
• Weakness/tiredness, malaise, swelling.

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

• Changes related to behavior 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 shins (erythema nodosum).
• Changes related to behavior and mood: obsessive-compulsive symptoms, stuttering.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast Viatris

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Montelukast Viatris

• The active substance is montelukast.
• Each tablet contains 10 mg of montelukast in the form of montelukast sodium.
• The other ingredients are:

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

Coating:polydextrose, titanium dioxide (E-171), hypromellose, triacetin, carmine indigo (E-132), macrogol, orange yellow S (E-110) (see section 2 "Montelukast Viatris contains orange yellow S (E-110)")

Appearance of the product and pack contents

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

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

Not all pack sizes may be marketed.

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

1186DM Amstelveen

Netherlands

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medicine 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, film-coated tablet

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 last revision of this package leaflet:January 2025

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