Montelukast Viatris 4 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Montelukast Viatris 4 mg chewable tablets EFG

For children aged 2 to 5 years

Read the entire leaflet carefully before starting to take 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, pharmacist, or nurse.
• This medicine has been prescribed for you or your child only and must not be given to other people, even if they have the same symptoms as you or your child, as it may harm them.
• If you or your child experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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 leukotrienos. Leukotrienos cause narrowing and swelling of the airways in the lungs. By blocking leukotrienos, Montelukast Viatris improves asthma symptoms and helps control asthma.

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

• Montelukast Viatris is used for the treatment of patients aged 2 to 5 years who are not adequately controlled with their current medication and require additional treatment.

• Montelukast Viatris may also be used as an alternative to inhaled corticosteroids in patients aged 2–5 years who have not recently taken oral corticosteroids for asthma and who have been shown to be unable to use inhaled corticosteroids.

• Montelukast Viatris also helps prevent exercise-induced narrowing of the airways in patients aged 2 years and older.

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

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: coughing, wheezing, and chest tightness.

2. What you need to know before starting Montelukast Viatris

Inform your doctor of any allergies or medical conditions your child currently has or has had in the past.

Do not give Montelukast Viatris to your child:

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

Warnings and precautions

• If your child's asthma or breathing worsens, inform your doctor immediately.
• Montelukast Viatris is not indicated for the treatment of acute asthma attacks. If an asthma attack occurs, follow the instructions your doctor has given you for your child. Always keep your child’s rescue inhaled medication available for asthma attacks. Speak with your doctor if you or your child need more rescue inhaled medication than usual for acute asthma attacks.
• It is important that your child takes all asthma medications prescribed by their doctor. Montelukast Viatris should not replace other asthma medications 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 in arms or legs, worsening of lung or respiratory symptoms, and/or skin rash, you should consult your doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if these worsen their 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 such symptoms occur while taking montelukast, you should consult your doctor.
• .

Children and adolescents

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

For children aged 2 to 5 years, Montelukast Viatris 4 mg may be available.

For children aged 6 to 14 years, 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 taking work.

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

Before taking Montelukast Viatris, inform your doctor if your child is 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 high plasma lipid levels).

Pregnancy and breastfeeding

This subsection does not apply to Montelukast Viatris 4 mg chewable tablets EFG, as it is intended for use in children aged 2 to 5 years. However, the following information is relevant for the active substance, montelukast.

Use during 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 during 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 Viatris.

Driving and use of machines

This subsection does not apply to Montelukast Viatris 4 mg, as it is intended for use in children aged 2 to 5 years. However, the following information is relevant for the active substance, montelukast.

Montelukast is not expected to affect your ability to drive a car or operate machinery. However, individual responses to medication may vary. Certain adverse effects (such as dizziness and somnolence), which have been reported very rarely with montelukast, may affect a patient’s ability to drive or operate machinery.

Montelukast Viatris contains aspartame and sodium

This medicine contains 2 mg of aspartame per tablet.

Aspartame is a source of phenylalanine, which may be harmful if the patient has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

If your child has phenylketonuria, you should be aware 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 directed by the doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• This medicine should be given to children under the supervision of an adult.
• Your child should take one tablet of Montelukast Viatris once daily, as prescribed by the doctor.
• It should be taken even when your child has no symptoms or during an acute asthma attack.
• It must be taken by mouth.

For children aged 2 to 5 years:

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 meals.

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

If your child takes more Montelukast Viatris than they should

Seek immediate help from your child's doctor.

In case of overdose or accidental ingestion, contact 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 most frequently reported symptoms in cases of overdose in adults and children were abdominal pain, drowsiness, thirst, headache, malaise (vomiting), and hyperactivity.

If you forgot to give Montelukast Viatris to your child

Try to give Montelukast Viatris as prescribed. However, if your child misses a dose, simply resume the usual regimen of one tablet once daily.

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 important that your child continues taking Montelukast Viatris for as long as the doctor has prescribed it. It will help control your child's asthma.

If you have any further questions about using this medicine, ask your child's doctor or pharmacist.

4. Possible adverse effects

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

If your child experiences any of the following adverse effects, you must stop taking this medicine and consult your doctor immediately or go to the nearest hospital emergency department:

Uncommon (may affect up to 1 in 100 people)

• Severe allergic reaction (called anaphylaxis) which may 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 may cause difficulty swallowing or breathing (angioedema).

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

• Yellowing of the skin or eyes, which may be caused by hepatitis (liver inflammation) or liver problems (hepatic eosinophilic infiltration).
• Suicidal thoughts and actions.
• Chest pain with dry cough, fever, difficulty breathing, and wheezing due to lung inflammation caused by an increase in a type of white blood cells (pulmonary eosinophilia).
• Severe skin rash, which may blister and resemble small targets (dark central spots surrounded by a paler area, with a dark ring around the edge), known as erythema multiforme.

In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flu-like illness, tingling or numbness in the arms or legs, worsening lung condition (pulmonary symptoms), and/or skin rash (Churg-Strauss syndrome) have been reported. You must inform 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 adverse effects (occurring in up to 1 in 10 children) were:

• Abdominal pain.
• Thirst.

Additionally, the following adverse 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 more frequently in patients treated with montelukast tablets than in those treated with placebo (a pill containing no active medicine).

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 infection.

Common (may affect up to 1 in 10 people)

• Diarrhea.
• Feeling of nausea (nausea).
• Malaise (vomiting).
• Skin rash.
• Increased liver enzymes, detectable in blood test results.
• Fever.

Uncommon (may affect up to 1 in 100 people)

• Changes in behaviour and mood, for example, sleep disturbances, including nightmares, difficulty sleeping, sleepwalking, irritability, anxious feelings, restlessness, agitation, including aggressive behaviour or hostility, depression.
• Dizziness, drowsiness.
• Tingling, numbness.
• Nosebleeds.
• Dry mouth.
• Indigestion.
• Bruising, itching, hives.
• Joint or muscle pain, muscle cramps.
• Tiredness, malaise.
• Swelling.
• Bedwetting in children.

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

• Increased tendency to bleed.
• Tremors.
• Attention disturbance.
• Memory impairment.
• Involuntary muscle movements.
• Rapid or irregular heartbeat (palpitations).

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

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

Reporting of adverse effects:

If your child experiences any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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 the sight and reach of children.
• Do not use this medicine after the expiry date stated on the carton, bottle, or blister after EXP. The expiry date refers to the last day of the month indicated.
• 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. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. 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 4 mg of montelukast in the form of montelukast sodium.
• The other components are: mannitol, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, sodium lauryl sulfate, colloidal anhydrous silica, aspartame (E-951) (see section 2 “Montelukast Viatris contains aspartame”), cherry flavour (maltodextrin from maize, benzyl alcohol (E-1519), triethyl citrate (E-1505)).

Appearance of the product and contents of the pack

White or almost white, oval, biconvex tablets, marked with “M” on one side and “MS1” on the other.

Available in:

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

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

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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

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

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

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany: Montelukast Mylan 4 mg Kautabletten
Spain: Montelukast Viatris 4 mg chewable tablets EFG
Ireland: Montelukast Mylan 4 mg chewable Tablets
Italy: Montelukast Mylan
Portugal: Montelucaste Mylan
United Kingdom (NI): Montelukast 4 mg chewable Tablets
Czech Republic: Montelukast Mylan 4 mg žvýkací tablety

Date of the most recent revision of this leaflet: April 2024

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