Prospect: information for the patient

MontelukastViatris4 mg chewable tablets EFG

For children aged 2 to 5 years

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any doubts, consult your doctor, pharmacist, or nurse.

-This medicine has been prescribed only for youor your childand should not be given to other people, even if they have the same symptoms as youor your child, as it may harm them.

-Ifyou or your childexperience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

1. What isMontelukast Viatrisand for what it is used.

2. What you need to know before starting to administerMontelukast Viatris.

3. Howto administerMontelukast Viatris.

4. Possible adverse effects

5. Storage ofMontelukast Viatris.

6. Contents of the package and additional information

Montelukast Viatris contains montelukast, which is a leukotriene receptor antagonist that blocks certain substances called leukotrienes. Leukotrienes produce 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 to treat your child's 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 airway constriction caused by exercise in patients 2 years old and older.

The use of Montelukast Viatris will depend on your child's symptoms and the severity of their asthma, which will be 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.
• The airways are sensitive and react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• Inflammation of the inner lining of the airways.

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

Inform your child's doctor about any allergy or medical condition your child has now or has had.

Do not administer Montelukast Viatris to your child:

• If your child is allergic to montelukast or to any of the other components of this medication (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 treating acute asthma attacks. If an attack occurs, follow the instructions your doctor has given for your child. Always have your child's rescue inhaler medication available for asthma attacks.Speak with yourdoctor if youor your child needmore rescue inhaler medicationthan usual foracute asthma attacks.
• It is essential that your child takes all prescribed asthma medications. Montelukast Viatris should not replace other asthma medications prescribed by your child's doctor.
• If your child is being treated withasthma medications,be awarethat if they develop a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening of lung function and respiratory symptoms, and/or skin rash, they should consult their doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they make their asthma worse.
• Several neuropsychiatric events (e.g., behavior-related changes and mood changes, 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 administer this medication 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 medications and Montelukast Viatris

Some medications may affect the functioning of Montelukast Viatris, or Montelukast Viatris may affect the functioning of other medications your child is using.

Inform your doctor or pharmacist if your child is taking, has taken recently, or may need to take any other medication, including those purchased without a prescription.

Before taking Montelukast Viatris, inform your doctor ifyour childis taking the following medications:

• Phenobarbital (used for the treatment of epilepsy).
• Phenytoin (used for the treatment of epilepsy).
• Rifampicin (used for the treatment of tuberculosis and some other infections).
• Gemfibrozil (used for the treatment of high levels of lipids in plasma).

Pregnancy and lactation

This subsection is not applicable 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 important for the active ingredient, montelukast.

Use during pregnancy

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

Use during breastfeeding

The presence of montelukast in breast milk is unknown. If you are breastfeeding or intend to breastfeed, consult your doctor before taking Montelukast Viatris.

Driving and operating machines

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

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

Montelukast Viatris contains aspartame and sodium

This medication contains 2 mg of aspartame in each tablet.

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

If your childhasphenylketonuriathey shouldbe aware thateach 4 mg tabletcontainsphenylalanine (equivalenta1.12mg of phenylalanineperchewable tablet).

This medication contains less than 1mmol of sodium (23mg) per tablet; this is, essentially “sodium-free”.

Always administer this medication to your child exactly as the doctor or pharmacist has instructed. In case of doubt, consult with your doctor or pharmacist again.

• This medication should be administered to children under the supervision of an adult.
• 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 aged 2 to 5 years:

The recommended dose is one chewable tablet of 4 mg taken daily at night. Montelukast Viatris should not be taken with meals; 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 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 (phone 91 562 04 20) indicating the medication and the amount ingested.

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

If you forgot to administer Montelukast Viatris to your child:

Try to administer Montelukast Viatris as instructed. However, if your child forgets a dose, simply resume the usual regimen of one tablet once a day.

Do not administer a double dose to your child to compensate for missed doses.

If your child interrupts treatment with 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 the time their doctor prescribes. It will help control your child's asthma.

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

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

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

Rare(may affect up to 1 in 100 people)

• Severe allergic reaction (anaphylaxis) that 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 that may be caused by hepatitis (inflammation of the liver) or liver problems (eosinophilic liver infiltration).
• Thoughts and actions of suicide.
• Chest painwith dry cough, fever,difficulty breathing, andsibilant soundsdue toinflammationof the lungs causedby an increase ina type of white blood cell(eosinophilic pneumonia).
• Severe skin rash, which may form blisters and resemble small targets (central dark spots surrounded by a lighter area, with a dark ring around the edge), called erythema multiforme.

In patients with asthma treated with montelukast, there have been reports of very rare cases of a combination of symptoms such as flu-like illness, tingling or numbness of the arms or legs, worsening of lung function (pulmonary symptoms), and/or skin rash (Churg-Strauss syndrome). 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 side effects(occur in up to 1 in 10 children)

• 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 more frequently in patients treated with montelukast tablets than in those treated with placebo (a tablet that does not contain a 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 (feeling sick).
• Unpleasant feeling (vomiting).
• Skin rash.
• Increased liver enzymes, detectable in laboratory results.
• Fever.

Rare(may affect up to 1 in 100 people)

• Changes related to behavior and mood, such as sleep disturbances, including nightmares, difficulty sleeping, somnambulism, irritability, anxiety, restlessness, agitation, including aggressive or hostile behavior, depression.
• Dizziness, somnolence.
• Tingling, numbness.
• Nasal bleeding.
• Dry mouth.
• Indigestion.
• Haematomas, itching, urticaria.
• Muscle or joint pain, muscle cramps.
• Fatigue, discomfort.
• Swelling.
• Bedwetting in children.

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

• Increased tendency to bleeding.
• Tremors.
• Attention deficit.
• Memory deterioration.
• Uncontrolled muscle movements.
• Irregular or rapid heartbeats (palpitations).

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

• Illusions (seeing, feeling, or hearing things that do not exist), disorientation.
• Red, painful bumps under the skin, especially on the elbows (erythema nodosum).
• Obsessive-compulsive symptoms.
• Stammering.
• Reduction of platelets in the blood, which increases the risk of bleeding or bruising more easily or for a longer time than normal.

Reporting of side effects:

If your child experiences 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 the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information about 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 box, bottle, or blister pack after CAD. The expiration date is 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.
• Medications should not be disposed of through drains or trash. Deposit containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of Montelukast Viatris

• The active ingredient is montelukast. Each tablet contains 4 mg of montelukast in the form of montelukast sodium.
• The other components 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 aroma (corn starch, benzyl alcohol (E-1519), triethyl citrate (E-1505)).

Appearance of the product and contents of the package

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

Available in:

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

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

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

For more information about this medication, please contact the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area with 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

Malta: Montelukast Mylan 4 mg

Portugal: Montelucaste Mylan

United Kingdom (NI): Montelukast 4 mg chewable Tablets

Czech Republic: Montelukast Mylan 4 mg žvýkací tablety

Last revision date of this leaflet:April 2024

For detailed information about this medication, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/