MONTELUKAST VIATRIS 5 mg CHEWABLE TABLETS

2. What You Need to Know Before You Start Taking/Administering Montelukast Viatris

Tell your doctor about any allergy or medical problem that 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 ingredients 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 the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor for you or your child. Always have your or your child's rescue inhaler medication for asthma attacks. Talk to 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 asthma medications prescribed by your doctor. Montelukast Viatris should not replace other asthma medications that your doctor has prescribed 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 of arms or legs, worsening lung symptoms, and/or skin rash, they should consult their doctor.
• Neither you nor your child should take aspirin or non-steroidal anti-inflammatory drugs (also known as non-steroidal anti-inflammatory medications or NSAIDs) if they make your or your child's asthma worse.
• Several neuropsychiatric events (such as behavior 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, you should 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.

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

Before taking Montelukast Viatris, inform your doctor if you or your child are taking the following medications:

• Phenobarbital (used to treat epilepsy).
• Phenytoin (used to treat epilepsy).
• Rifampicin (used to treat tuberculosis and some other infections).
• Gemfibrozil (used to treat high plasma lipid levels).

Pregnancy and Breastfeeding

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 medication. 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, consult your doctor before taking Montelukast Viatris.

Driving and Using Machines

Montelukast is not expected to affect your ability to drive or use machines. However, individual responses to the medication may vary. Certain side effects (such as dizziness and drowsiness) that have been reported very rarely with montelukast tablets may affect the patient's ability to drive or use 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 harmful in case 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 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; this is, essentially "sodium-free".

3. How to Take Montelukast Viatris

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

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

For Children from 6 to 14 Years of Age:

The recommended dose is one 5 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 you or your child are taking Montelukast Viatris, ensure that you or your child 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 medical attention.

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 medication and the amount ingested.

In most cases of overdose, no side 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 or Your Child Miss a Dose of Montelukast Viatris

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

Do not take or administer a double dose to your child to make up for missed doses.

If You or Your Child Stop Taking Montelukast Viatris

Montelukast Viatris will only treat your or your child's asthma if you continue taking it.

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

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everybody gets them.

If You or Your Child Experience Any of the Following Side Effects, Stop Taking this Medication 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) 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, which can form blisters, and looks like small targets (dark central 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 inform your doctor immediately if you or your child have one or more of these symptoms.

In clinical trials with montelukast 5 mg chewable tablets, the most frequently reported side effects related to montelukast chewable tablets (occurring in up to 1 in 10 children) 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 with a higher frequency in patients treated with montelukast tablets than in those treated with placebo (a pill that does not contain medication).

Additionally, since the medication 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)

• Behavior and mood changes, 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, urticaria.
• Joint or muscle pain, muscle cramps.
• Fatigue, malaise.
• Swelling.
• Bedwetting in 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 heartbeat (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.
• Decreased platelet count, which increases the risk of bruising and bleeding more easily or for longer than usual.

Reporting of Side Effects

If you or your child experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Montelukast Viatris

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date stated on the carton, bottle, or blister after EXP. 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 via wastewater or household waste. Place the packaging and any unused medication in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Further Information

Composition of Montelukast Viatris

• The active ingredient is montelukast. Each tablet contains 5 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 and Package Contents

White or almost white, round tablets with curved sides, marked with "M" on one side and "MS2" 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 unit-dose blister packs 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, or 500 tablets.

Not all pack 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 obtain further information on this medication by contacting 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 Under the Following Names:

Germany: Montelukast Mylan 5 mg Chewable Tablets

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

UK (NI): Montelukast 5 mg Chewable Tablets

Czech Republic: Montelukast Mylan 5 mg Chewable Tablets

Date of Last Revision of this Package Leaflet: April 2024

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