MONTELUKAST VIATRIS 4 mg CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the Patient

MontelukastViatris4 mg Chewable Tablets EFG

For Children from 2 to 5 Years of Age

Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for them.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child's.
• If your child gets any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Montelukast Viatris and what is it 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. By blocking leukotrienes, Montelukast Viatris improves asthma symptoms and helps control asthma.

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

• Montelukast Viatris is used for the treatment of patients between 2 and 5 years old who are not adequately controlled with their medication and need additional treatment.
• Montelukast Viatris can also be used as an alternative treatment to inhaled corticosteroids for patients 2-5 years old who have not recently taken oral corticosteroids for asthma and have demonstrated that they are unable to use inhaled corticosteroids.

• Montelukast Viatris also helps prevent narrowing of the airways caused by exercise in patients 2 years of age and older.

Depending on your child's symptoms and the severity of their asthma, your doctor will determine how your child should use Montelukast Viatris.

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.
• The airways are sensitive and react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• Swelling (inflammation) of the inner layer of the airways.

Asthma symptoms include: coughing, wheezing, and chest congestion.

2. What you need to know before your child takes Montelukast Viatris

Tell your doctor about any allergy or medical problem your child has now or has had.

Do not give Montelukast Viatris to your child:

• If they are allergic to montelukast or any of the other ingredients of this medicine (listed in section 6.1).

Warnings and Precautions

• If your child's 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 your doctor has given your child. Always have your child's rescue inhaler medication for asthma attacks. Talk to your doctor if you or your child needs more rescue inhaler medication than usual for acute asthma attacks.
• It is essential that your child takes all asthma medications prescribed by their doctor. Montelukast Viatris should not replace other asthma medications that the doctor has prescribed for your child.
• If your child is being treated with asthma medications, 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, and/or skin rash, they should consult their doctor.
• Your child should not take aspirin or non-steroidal anti-inflammatory drugs (also known as non-steroidal anti-inflammatory medications or NSAIDs) if they make their asthma worse.
• Several 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 your child develops such symptoms while taking montelukast, they should consult their doctor.
• .

Children and Adolescents

Do not give this medicine to children under 2 years of age.

For children from 2 to 5 years of age, Montelukast Viatris 4 mg may be available.

For children from 6 to 14 years of age, Montelukast Viatris 5 mg may be available.

Other Medicines and Montelukast Viatris

Some medicines may affect how Montelukast Viatris works, or Montelukast Viatris may affect how other medicines your child is using work.

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those obtained without a prescription.

Before taking Montelukast Viatris, tell your doctor if your child is 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 the blood).

Pregnancy and Breastfeeding

This subsection is not applicable to Montelukast Viatris 4 mg chewable tablets EFG, as it is intended for use in children between 2 and 5 years of age. However, the following information is important for the active ingredient, montelukast.

Use in Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine. Your doctor will assess whether you can take montelukast during this period.

Use in Breastfeeding

It is unknown whether montelukast appears in breast milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking Montelukast Viatris.

Driving and Using Machines

This subsection is not applicable to Montelukast Viatris 4 mg, as it is intended for use in children between 2 and 5 years of age. However, the following information is important for the active ingredient, montelukast.

Montelukast is not expected to affect your child's ability to drive a car or operate machinery. However, individual responses to the medication may vary. Certain side effects (such as dizziness and drowsiness) that have been rarely reported with montelukast may affect your child's ability to drive or operate machinery.

Montelukast Viatris Contains Aspartame and Sodium

This medicine contains 2 mg of aspartame in each tablet.

Aspartame is a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

If your child has phenylketonuria, note that each 4 mg tablet contains phenylalanine (equivalent to 1.12 mg of phenylalanine per chewable tablet).

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

3. How to Take Montelukast Viatris

Always give this medicine to your child exactly as their doctor or pharmacist has told them. If you are not sure, ask your doctor or pharmacist again.

• This medicine should be given to children under adult supervision.
• Your child should take one Montelukast Viatris tablet once a day, as prescribed by their doctor.
• It should be taken even when your child does not have symptoms or when they have an acute asthma attack.
• It should be taken orally.

For Children from 2 to 5 Years of Age:

The recommended dose is one 4 mg chewable tablet taken daily in the evening. Montelukast Viatris should not be taken with food; it should be taken 1 hour before or 2 hours after food.

If your child is taking Montelukast Viatris, ensure they do not take any other product containing the same active ingredient, montelukast.

If Your Child Takes More Montelukast Viatris Than They Should

Seek help from your child's doctor immediately.

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

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

If You Forget to Give Montelukast Viatris to Your Child

Try to give Montelukast Viatris as prescribed. However, if your child misses a dose, just resume the usual routine of one tablet once a day.

Do not give your child a double dose to make up for missed doses.

If Your Child Stops Taking Montelukast Viatris

Montelukast Viatris can only treat your child's asthma if they continue taking it.

It is essential that your child continues taking Montelukast Viatris for as long as their doctor prescribes it. It will help control your child's asthma.

If you have any other questions about the use of this medicine, ask your child's doctor or pharmacist.

4. Possible Side Effects

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

If your child experiences any of the following side effects, stop giving them this medicine and consult their doctor immediately or go to the nearest hospital emergency department:

Uncommon(may affect up to 1 in 100 people)

• Severe allergic reaction (called anaphylaxis) that can include difficulty breathing, dizziness, and collapse.
• Seizures.

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

• Swelling of the face, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing (angioedema).

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

• Yellowing of the skin or eyes that can be caused by hepatitis (inflammation of the liver) or liver problems (eosinophilic hepatic infiltration).
• Suicidal thoughts and actions.
• Chest pain with dry cough, fever, difficulty breathing, and wheezing due to inflammation of the lungs caused by an increase in the number of a type of white blood cell (eosinophilic pneumonia).
• Severe skin rash that can form blisters and looks like small targets (small dark spots surrounded by a paler area, with a dark ring around the edge), called erythema multiforme.

In patients with asthma treated with montelukast, very rare cases of a combination of symptoms such as flu-like illness, tingling or numbness of arms or legs, worsening lung symptoms, and/or skin rash (Churg-Strauss syndrome) have been reported. You should tell your doctor immediately if your child has one or more of these symptoms.

In clinical trials with montelukast 4 mg chewable tablets, the most frequently reported side effects (occurring in up to 1 in 10 children) were:

• Abdominal pain.
• Thirst.

Additionally, the following side effect was reported in clinical trials with montelukast 10 mg film-coated tablets and montelukast 5 mg chewable tablets:

• Headache.

These were generally mild and occurred with a higher frequency in patients treated with montelukast tablets than in those treated with placebo (a pill that does not contain medicine).

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 infection.

Common(may affect up to 1 in 10 people)

• Diarrhea.
• Nausea.
• Vomiting.
• Skin rash.
• Increased liver enzymes, observable in blood test results.
• Fever.

Uncommon(may affect up to 1 in 100 people)

• Changes related to behavior and mood, such as sleep disturbances, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness, agitation, including aggressive or hostile behavior, depression.
• Dizziness, drowsiness.
• Tingling, numbness.
• Nosebleeds.
• Dry mouth.
• Indigestion.
• Bruising, itching, hives.
• Joint or muscle pain, muscle cramps.
• Fatigue, malaise.
• Swelling.
• Bedwetting in the case of children.

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

• Increased tendency to bleeding.
• Shakiness (tremors).
• Attention disturbance.
• Memory impairment.
• Uncontrolled muscle movements.
• Fast or irregular heartbeats (palpitations).

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

• Hallucinations (seeing, feeling, or hearing things that do not exist), disorientation.
• Painful red lumps under the skin, especially on the shins (erythema nodosum).
• Obsessive-compulsive symptoms.
• Stuttering.
• Decrease in blood platelets that increases the risk of bruising and bleeding more easily or for longer than normal.

Reporting of Side Effects:

If your child experiences any side effects, talk to their doctor or pharmacist. This includes any possible side effects not listed in this 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, bottle, or blister after EXP. The expiry date refers to the last day of the month stated.
• Bottles: once opened, use within 100 days.
• Store in the original packaging to protect from light and moisture.
• 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. Package Contents and Additional Information

Composition of Montelukast Viatris

• The active ingredient is montelukast. Each tablet contains 4 mg of montelukast in the form of montelukast sodium.
• The other ingredients are: mannitol, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, anhydrous colloidal silica, aspartame (E-951) (see section 2 "Montelukast Viatris contains aspartame"), cherry flavor (corn maltodextrin, benzyl alcohol (E-1519), triethyl citrate (E-1505)).

Appearance of the Product and Package Contents

White or almost white, oval-shaped tablets, with curved sides, marked with "M" on one side and "MS1" on the other side.

It is available in:

Blisters of 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 112 or 200 tablets, or in single-dose perforated blisters of 28 tablets.

White plastic bottles with a non-transparent white cap, containing absorbent cotton and a desiccant (do not eat the desiccant), containing 28, 56, 100, 112, 200 and 500 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

Mylan Germany GmbH

Zweigniederlassung Bad Homburg v. d. Hoehe

Benzstrasse 1

Bad Homburg v. d. Hoehe

Hessen, 61352

Germany

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:

Germany: Montelukast Mylan 4 mg Chewable Tablets

Spain: Montelukast Viatris 4 mg chewable tablets EFG

Ireland: Montelukast Mylan 4 mg chewable Tablets

Italy: Montelukast Mylan

Malta: Montelukast Mylan 4 mg

Portugal: Montelucaste Mylan

United Kingdom (NI): Montelukast 4 mg chewable Tablets

Czech Republic: Montelukast Mylan 4 mg chewable tablets

Date of the last revision of this leaflet:April 2024

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