Patient Information Leaflet

MontelukastViatris5 mg Chewable Tablets EFG

For children aged 6 to 14 years

Read this leaflet carefully before starting toadminister/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 prescribedonlyfor you or your child, and should not be given to others even if they have the same symptoms as you or your child, as it may harm them.

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

1. What isMontelukast Viatrisand what is it used for

2. What you need to know before starting toadminister/takeMontelukast Viatris

3.How to take Montelukast Viatris

4. Possible side effects

5. Storage ofMontelukast Viatris

6. Contents of the pack 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 asthma and prevent asthma symptoms in you or your child during the day and night.

• Montelukast Viatris is used for the treatment of patients who are not adequately controlled with their medication and require additional treatment.
• Montelukast Viatris can also be used as an alternative treatment to inhaled corticosteroids for patients aged 6-14 years who have not recently taken oral corticosteroids for asthma and have demonstrated an inability to use inhaled corticosteroids.

• Montelukast Viatris also helps prevent airway constriction caused by exercise.

The use of Montelukast Viatris will depend on the symptoms and severity of your or your child's asthma, as 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 doctor about any allergy or medical condition you or your child have now or have had.

Do not take or administer Montelukast Viatris if you or your child:

• Are allergic to montelukast or any of the other components of this medication (listed in section 6.1).

Warnings and precautions

• If your or 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 given by your doctor for you or your child. Always have your child's rescue inhaler medication available for asthma attacks.Consult your doctor if you or your child need more rescue inhaler medication than usual for acute asthma attacks.
• It is essential that you or your child take all prescribed asthma medications. Montelukast Viatris should not replace other asthma medications prescribed by your doctor for you or your child.
• 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, and/or skin rash, they should consult their doctor.
• You or your child should not take aspirin or nonsteroidal anti-inflammatory drugs (also known as NSAIDs) if they make your asthma worse.
• Several neuropsychiatric events (e.g., behavioral changes and mood 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, consult your doctor.
• .

Children and adolescents

Do not administer this medication to children under 6 years of age.

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

For children aged 6 months to 5 years, Montelukast Viatris 4 mg granules 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.

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

Before taking Montelukast Viatris, inform your doctor if you or your child are 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 breastfeeding

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 machinery

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) that have been reported with montelukast tablets may affect the patient's ability to drive or operate machinery.

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 harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

If your child has phenylketonuria, be aware that each 5 mg tablet contains phenylalanine (equivalent to 1.12 mg of phenylalanine per chewable tablet).

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

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

• You or your child must take one Montelukast Viatris tablet once a day, as prescribed by your doctor.
• It must be taken even when you or your child do not have symptoms or when experiencing an acute asthma attack.
• It must be taken orally.

For children aged 6 to 14 years:

The recommended dose is one chewable tablet of 5 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 you or your child are taking Montelukast Viatris, make sure you do not take any other product containing the same active ingredient, montelukast.

If you or your child take more Montelukast Viatris than you should:

Seek immediate help from your doctor.

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 adults and children who experienced an overdose were abdominal pain, drowsiness, drowsiness, headache, discomfort (vomiting), and hyperactivity.

If you forgot to take or administer Montelukast Viatris to your child:

Try to take or administer Montelukast Viatris as prescribed. However, if you or your child forget a dose, simply resume the usual regimen of one tablet once a day.

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

If you or your child interrupt treatment with Montelukast Viatris:

Montelukast Viatris can only treat your asthma or your child's asthma if it is continued.

It is essential to continue taking Montelukast Viatris for the time your doctor prescribes. It will help control your asthma or your child's asthma.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

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

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

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 resembles 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 the lung (pulmonary symptoms) and/or skin rash (Churg-Strauss syndrome). You should inform your doctor immediately if you or your child experience one or more of these symptoms.

In clinical trials with montelukast 5 mg chewable tablets, the most frequently reported side effects(occur in up to 1 in 10 children),related to montelukast chewable tablets were:

• Headache.

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

• Abdominal pain.

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 like vomiting).
• Unpleasantness (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, for example, 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, unpleasantness.
• Swelling.
• Bedwetting in children.

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

• Increased tendency to bleeding.
• Agitation (tremors).
• Attention disorder.
• Memory deterioration.
• Uncontrollable 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 that increases the risk of bleeding and bruising more easily or for a longer time than normal.

Reporting of side effects

If you or your child experience 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 on 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: use once opened 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 5 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 (maize maltodextrin, benzyl alcohol (E-1519), triethyl citrate (E-1505)).

Appearance of the product and contents of the package

White or off-white, round, curved-sided tablets, marked with “M” on one side and “MS2” on the other side.

It is available in:

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

White plastic bottles with a white non-transparent stopper 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 responsible manufacturer

Marketing authorization holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible 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

Further information about this medicine can be obtained 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 with the following names:

Germany:Montelukast Mylan 5 mg Kautabletten

Spain:Montelukast Viatris 5 mg chewable tablets EFG

Finland: Montelukast Mylan 5 mg

France: Montelukast Mylan 5 mg, chewable tablet

Ireland:Montelukast Mylan 5 mg chewable Tablets

Italy:Montelukast Mylan

Malta: Montelukast Mylan 5 mg

Portugal: Montelucaste Mylan

United Kingdom (NI):Montelukast 5 mg chewable Tablets

Czech Republic:Montelukast Mylan 5 mg žvýkací tablety

Last review date of this leaflet: April 2024

Further detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/