PLURALAIS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

PLURALAIS 10 mg film-coated tablets EFG

(Montelukast)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist, even if you have read it in this leaflet. See section 4.

Contents of the pack:

1. What is PLURALAIS and what is it used for
2. What you need to know before you take PLURALAIS
3. How to take PLURALAIS
4. Possible side effects
5. Storage of PLURALAIS
6. Contents of the pack and further information

1. What is PLURALAIS and what is it used for

PLURALAIS is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in your lungs and can also cause allergy symptoms. By blocking leukotrienes, PLURALAIS improves asthma symptoms, helps control asthma, and improves symptoms of seasonal allergies (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 narrowing of the airways caused by exercise.
• In patients with asthma who are indicated for PLURALAIS for asthma, PLURALAIS may also provide symptomatic relief of seasonal allergic rhinitis.

Depending on your symptoms and the severity of your asthma, your doctor will determine how you should use PLURALAIS.

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 diseases.
• airways that are sensitive to many things, such as cigarette smoke, pollen, cold air, or exercise.
• swelling (inflammation) of the inner layer of the airways.

The symptoms of asthma include: Cough, wheezing, and chest congestion.

What are seasonal allergies?

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

2. What you need to know before taking PLURALAIS

Tell your doctor about any allergy or medical problem you have now or have had.

Do not take PLURALAIS if you

• are allergic (hypersensitive) to montelukast or any of the other ingredients 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, tell your doctor immediately.

• PLURALAIS oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor. Always have your rescue inhaler medication for asthma attacks.

• It is essential that you or your child use all asthma medications 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 lung symptoms, and/or skin rash, they should consult their doctor.

• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

• Patient must be aware that several neuropsychiatric events have been reported with montelukast (e.g., changes in behavior and mood) in adults, adolescents, and children (see section 4). If you or your child develop these symptoms while taking montelukast, you must consult your doctor or your child's doctor.

Children and adolescents

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

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

Other medicines and PLURALAIS

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines may affect how PLURALAIS works, or PLURALAIS may affect how other medicines you are using work.

Before taking PLURALAIS, tell your doctor if you are taking the following medicines:

• 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)

Taking PLURALAIS with food and drinks

PLURALAIS 10 mg can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breastfeeding

It is unknown whether PLURALAIS appears in breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking PLURALAIS.

Driving and using machines

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

PLURALAIS contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take PLURALAIS

Follow the administration instructions of Pluralais 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.
• It should be taken 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 in the evening.

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

This medicine 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 occurred most frequently reported in overdose in adults and children were abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

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

If you forget to take PLURALAIS

Try to take PLURALAIS as prescribed. However, if you forget a dose, just resume your regular schedule of one tablet once a day.

Do not take a double dose to make up for forgotten doses.

If you stop taking PLURALAIS

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

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

4. Possible side effects

Like all medicines, PLURALAIS can cause side effects, although not everybody gets them.

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

• abdominal pain
• headache

These side effects were generally mild and occurred with a higher frequency in patients treated with PLURALAIS or with placebo (a pill that does not contain 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.

Uncommon (may affect up to 1 in 100 people):

• allergic reactions including swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing
• changes related to behavior and mood: 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):

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

Other side effects reported during the marketing of the medicine

Very common (may affect more than 1 in 10 people):

• upper respiratory infection

Common (may affect up to 1 in 10 people):

• diarrhea, nausea, vomiting
• skin rash
• fever
• elevated liver enzymes

Uncommon (may affect up to 1 in 100 people):

• changes related to behavior and mood: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, tingling/numbness
• nosebleeds
• dry mouth, indigestion
• bruises, itching, hives
• joint or muscle pain, muscle cramps
• bedwetting (in children)
• weakness/fatigue, malaise, swelling

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

• changes related to behavior and mood: attention disturbances, memory disturbances, uncontrolled muscle movements

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

• red painful lumps under the skin that most frequently appear on your shins (erythema nodosum)
• changes related to behavior and mood: obsessive-compulsive symptoms, stuttering

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects that are not listed in this leaflet. You can also report side effects 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 medicine.

5. Storage of PLURALAIS

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the blister after EXP. The first two numbers indicate the month; the last four numbers indicate the year. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any further questions, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of PLURALAIS

• The active substance is montelukast. Each tablet contains 10 mg of montelukast.
• The other ingredients are: Core:lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hydroxypropylcellulose, and magnesium stearate. Coating:Opadry White.

Appearance of the product and pack contents

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

They are available in packs of 28 tablets.

Marketing authorization holder and 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

Date of the last revision of this leaflet: March 2025

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