Label: information for the patient

Montelukast Viatris 10 mg film-coated tablets EFG

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

• Keep this label, as you may need to read it again.
  If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What isMontelukast Viatrisand what it is used for

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

3. How to takeMontelukast Viatris

4. Possible adverse 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 and can also cause allergy symptoms. By blocking leukotrienes, Montelukast Viatris improves asthma symptoms, helps control asthma, and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).

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

• Montelukast Viatris is used for the treatment of adults and adolescents 15 years of age or older who are not adequately controlled with their medication and need additional treatment.
• Montelukast Viatris also helps prevent airway constriction caused by exercise.
• In asthmatic patients for whom Montelukast Viatris is indicated for asthma, it may also provide symptomatic relief of seasonal allergic rhinitis.

Depending on symptoms and the severity of asthma, your doctor will determine how to use Montelukast Viatris.

Montelukast Viatris 10 mg tablets are used in adults and adolescents 15 years of age or older.

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.
• Sensitive airways that react to many things, such as cigarette smoke, pollen, or cold air, or exercise.
• Inflammation of the inner layer of the airways.

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

What are seasonal allergies?

Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic response often caused by airborne pollen from trees, grass, and weeds. Typical symptoms of seasonal allergies may include: a stuffy nose, runny nose, itchy nose; sneezing; or red, itchy, and watery eyes.

Inform your doctor about any allergy or medical condition you have now or have had.

Do not take Montelukast Viatris:

• If you are allergic to montelukast or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult with your doctor or pharmacist before starting to take Montelukast Viatris.

• If your 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. Always have your rescue inhaler medication for asthma attacks available.

Consult with your doctor if you need more inhaler medication, which is usually prescribed for severe asthma attacks.

• It is essential to take all prescribed asthma medications. Montelukast Viatris should not replace other asthma medications prescribed by your doctor.
• 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 (pulmonary symptoms), and/or skin rash, they should consult their doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.
• Patients should be aware that several neuropsychiatric events have been reported with montelukast (e.g., changes in behavior and mood-related symptoms) in adults, adolescents, and children (see section 4). If you or your child develops these symptoms while taking Montelukast Viatris, consult your doctor.

Children and adolescents

Do not administer this medication to children under 15 years old.

For pediatric patients under 18 years of age, other presentations of this medication are available based on age range.

Other medications and Montelukast Viatris

Some medications may affect the functioning of Montelukast Viatris, or Montelukast Viatris may affect the functioning of other medications you are using.

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

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

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

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Your doctor will evaluate if you can take Montelukast Viatris during this period.

Breastfeeding

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

Driving and operating machinery

Montelukast Viatris is not expected to affect your ability to drive a car or operate machinery. However, individual responses to medication may vary. Some reported side effects (such as drowsiness or dizziness) associated with Montelukast Viatris may affect patients' ability to drive or operate machinery.

Montelukast Viatris contains yellow orange S and sodium

The yellow orange S (E-110) may cause allergic reactions.

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

.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

For adults (including elderly patients) and adolescents 15 years of age and older:

The recommended dose is:

• One 10 mg tablet, daily, at night.

Use in children and adolescents

Montelukast Viatris is not suitable for children and adolescents under 15 years of age.

If you are taking Montelukast Viatris, make sure you do not take any other product containing the same active ingredient, montelukast.

This medication is taken orally.

You can take Montelukast Viatris with or without food.

If you take more Montelukast Viatris than you should

Seek help from your doctor immediately.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Montelukast Viatris

Try to take Montelukast Viatris as prescribed. However, if you forget a dose, limit yourself to resuming the usual regimen of one tablet once a day.

Do not take a double dose to compensate for missed doses.

If you interrupt treatment with Montelukast Viatris

Montelukast Viatris can only treat your asthma if you continue taking it. It is essential that you continue taking Montelukast Viatris for the time your doctor prescribes. It will help control your asthma.

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

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

In clinical trials conducted with montelukast, the side effects related to the administration of montelukast and reported most frequently (which occur in up to 1 in 10 people), were:

• Abdominal pain.

• Headache.

These side effects were generally mild and occurred more frequently in patients treated with montelukast than with placebo (a pill that does not contain a medicine).

Severe side effects

Contact a doctor immediatelyif you notice any of the following side effects, which may be severe and for which you may need urgent medical treatment.

Uncommon(may affect up to 1 in 100 people)

• Allergic reactions that include swelling in the face, lips, tongue, or throat that may cause difficulty breathing or swallowing.
• Behavioral and mood changes: agitation that includes aggressive and hostile behavior, depression.
• Seizures.

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

• Increased risk of bleeding.
• Palpitations.
• Tremor.

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

• A combination of symptoms such as flu-like illness, tingling or numbness in arms and legs, worsening of lung function (pulmonary symptoms) and/or rash (Churg-Strauss syndrome) (see section 2).
• Low platelet count in the blood.
• Behavioral and mood changes: hallucinations, disorientation, suicidal thoughts and actions.
• Pneumonitis.
• Severe skin reactions (erythema multiforme) that may appear without warning.
• Liver inflammation (hepatitis).

In addition, 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 infections.

Common(may affect up to 1 in 10 people)

• Diarrhea.
• Nausea, vomiting.
• Rash.
• Fever.
• Increased liver enzymes.

Uncommon(may affect up to 1 in 100 people)

• Behavioral and mood changes, e.g. sleep disturbances, including nightmares, difficulty sleeping, somnambulism, irritability, anxiety, restlessness.
• Dizziness, somnolence.
• Tingling, numbness.
• Nasal bleeding.
• Dry mouth.
• Indigestion.
• Bruising, itching, urticaria.
• Muscle or joint pain, muscle cramps.
• Fatigue, malaise.
• Swelling.
• Bedwetting in children.
• Weakness/fatigue, malaise, swelling.

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

• Behavioral and mood changes: altered attention, memory loss, and involuntary muscle movements.

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

• Behavioral and mood changes: obsessive-compulsive symptoms, stuttering
• Red painful lumps under the skin that more frequently appear on the acne (erythema nodosum).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 Pharmacovigilance 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 packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Montelukast Viatris

• The active ingredient is montelukast.
• Each tablet contains 10 mg of montelukast in the form of montelukast sodium.
• The other components are:

Core:microcrystalline cellulose, mannitol, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, anhydrous colloidal silica.

Coating:polydextrose, titanium dioxide (E-171), hypromellose, triacetin, indigo carmine (E132), macrogol, yellow Orange S (E110) (see section 2 “Montelukast Mylan contains yellow Orange S (E-110)”).

Appearance of the product and contents of the package

Coated tablets, blue, round, biconvex, beveled edges, engraved with “MO” over “10” on one side and “M” on the other.

Montelukast Viatris 10 mg tablets are available in blisters of 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, and 100 tablets, in perforated single-dose blisters of 28x1 tablets or in bottleswith silica gel desiccantcontaining 28, 30, 56, 60, 84, 90, 100, 112, 120, 180, and 500 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder:

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing:

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

Logiters, Logística Portugal, S.A.

Estrada dos Arneiros, 4

Azambuja, 2050-306

Portugal

or

Mylan B.V.

Krijgsman 20

Amstelveen

1186DM

Netherlands

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 with the following names:

Germany:Montelukast dura 10 mg filmtabletten

Cyprus:Montelukast Mylan επικαλυμμ?νο με λεπτ? υμ?νιο δισκ?ο 10 mg

Denmark:Montelukast Viatris

Slovakia:Montelukast Viatris 10 mg

Spain:Montelukast Viatris 10 mg comprimidos recubiertos con película EFG

France:Montelukast Viatris 10 mg, comprimé pelliculé

Greece:Montelukast Mylan επικαλυμμ?νο με λεπτ? υμ?νιο δισκ?ο 10 mg

Ireland:Montelukast Viatris 10 mg film-coated tablets

Italy:Montelukast Mylan Generics

Netherlands:Montelukast Viatris 10 mg, filmomhulde tabletten

Portugal:Montelucaste Mylan

United Kingdom (Northern Ireland): Montelukast 10 mg film coated tablets

Czech Republic:Montelukast Viatris 10 mg, potahované tablety

Sweden:Montelukast Viatris

Last review date of thisleaflet:April 2020

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