Leaflet: information for the user

PLURALAIS 10 mg film-coated tablets EFG

(Montelukast)

Read the entire leaflet carefully before starting to take the medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What PLURALAIS is and for what it is used

2. What you need to know before starting to take PLURALAIS

3. How to take PLURALAIS

4. Possible side effects

5. Storage of PLURALAIS

6. Contents of the pack and additional information

PLURALAIS is a leukotriene receptor antagonist that blocks certain substances called leukotrienes. Leukotrienes produce bronchospasm and inflammation of the airways in the lungs and can also cause allergy symptoms. By blocking leukotrienes, PLURALAIS improves asthma symptoms, helps control asthma, and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).

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

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

The dosage of PLURALAIS will depend on your symptoms and the severity of your asthma, and your doctor will determine how you should use it.

What is asthma?

Asthma is a chronic disease.

Asthma includes:

• Difficulty breathing due to bronchospasm. This bronchospasm worsens and improves in response to various conditions.
• Respiratory airways that are sensitive and react to many things, such as cigarette smoke, pollen, or cold air, or exercise.
• Inflammation (inflammation) of the inner layer of the respiratory 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: Stuffy nose, runny nose, nasal itching; sneezing; or red, itchy, watery eyes.

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

Do not take PLURALAIS if you

• are allergic (hypersensitive) to montelukast or to any of the other components of PLURALAIS (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take PLURALAIS

• If your asthma or breathing worsens, inform your doctor immediately.

• PLURALAIS oral 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.

• It is essential that you or your child use all medications for asthma prescribed by your doctor. PLURALAIS 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 of arms or legs, worsening of respiratory 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 changes) in adults, adolescents, and children (see section 4). If you or your child develop these symptoms while taking montelukast, consult your doctor or your child's doctor.

Children and adolescents

Do not give this medication to children under 15 years of age.

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

Other medications and PLURALAIS

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

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

Before taking PLURALAIS, 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)

Taking PLURALAIS with food and beverages

PLURALAIS 10 mg can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Your doctor will evaluate whether you can take PLURALAIS during this period.

Breastfeeding

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

Driving and operating machinery

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

PLURALAIS contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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

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

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

For adults and adolescents 15 years of age and older:

The recommended dose is one 10 mg tablet daily at night.

If you are taking PLURALAIS, make sure you do not take any other product that contains the same active ingredient, montelukast.

This medication is taken orally.

You can take PLURALAIS with or without food.

If you take more PLURALAIS than you should

If you have taken Pluralais more than you should, consult your doctor or pharmacist immediately.

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, dizziness, headache, vomiting, and hyperactivity.

Consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take PLURALAIS

Try to take PLURALAIS as prescribed. However, if you forget a dose, simply resume the usual regimen of one tablet once a day.

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

If you interrupt treatment with PLURALAIS

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

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

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

In clinical trials conducted with PLURALAIS 10 mg film-coated tablets, the side effects related to the administration of the drug and reported most frequently (in more than 1 in 10) were:

• abdominal pain
• headache

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

Severe side effects

Consult your doctor immediatelyif you notice any of the following side effects, which

may be severe and may require urgent medical treatment.

Not common (may affect up to 1 in 100 people):

• allergic reactions that include swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing
• behavioral and mood changes: excitement including aggressive or hostile behavior, depression
• seizures

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

• increased risk of bleeding
• tremors
• palpitations

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

• a combination of symptoms such as flu-like illness, tingling or numbness of arms and legs, worsening of respiratory symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)
• low platelet count
• behavioral and mood changes: hallucinations, disorientation, suicidal thoughts and actions
• lung inflammation
• severe skin reactions (erythema multiforme) that may occur without warning
• liver inflammation (hepatitis)

Other side effects reported during the marketing of the drug

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
• fever
• elevated liver enzymes

Not common (may affect up to 1 in 100 people):

• behavioral and mood changes: sleep disturbances, including nightmares, sleep problems, somnambulism, irritability, anxiety, restlessness
• dizziness, somnolence, tingling/numbness
• nasal bleeding
• dry mouth, indigestion
• bruising, itching, urticaria
• joint or muscle pain, muscle cramps
• bedwetting (in children)
• weakness/fatigue, malaise, swelling

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

• behavioral and mood changes: attention alteration, memory alteration, uncontrolled muscle movements

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

• red, painful lumps under the skin that more frequently appear on the face (erythema nodosum)
• behavioral and mood changes: obsessive-compulsive symptoms, stuttering

Reporting of side effects

If you 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 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 blister pack after CAD. The first two numbers indicate the month; the last four numbers indicate the year. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not dispose of medications through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of PLURALAIS

• The active ingredient is montelukast. Each tablet contains 10 mg of montelukast.
• The other components are:Core:monohydrate lactose, microcrystalline cellulose, sodium croscarmellose, hydroxypropylcellulose, and magnesium stearate.Covering:Opadry Blanco.

Appearance of the product and contents of the packaging

Pluralais 10 mg are film-coated, round, and white tablets.

They are presented in packs of 28 tablets.

Holder of the marketing authorization and responsible manufacturer

Laboratorios ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

or

Laboratorios Alter S.A.

C/ Zeus, 6

Polígono Industrial R2

28880 Meco (Madrid)

Spain

Last review date of this leaflet:March 2025

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