PLURALAIS 4 mg CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

Pluralais 4 mg Chewable Tablets EFG

montelukast

Contents of the Package Leaflet:

1. What is Pluralais and what is it used for
2. What you need to know before your child takes 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

What isPluralais

Pluralais is a leukotriene receptor antagonist that blocks substances called leukotrienes.

How Pluralais works

Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, Pluralais improves asthma symptoms and helps control asthma.

When to use Pluralais

Your doctor has prescribed Pluralais to treat your child's asthma and prevent asthma symptoms during the day and night.

• Pluralais is used to treat patients between 2 and 5 years of age who are not adequately controlled with their medication and need additional treatment.
• Pluralais is also used as an alternative treatment to inhaled corticosteroids in patients between 2 and 5 years of age who have not recently taken oral corticosteroids for their asthma and have demonstrated that they are unable to use inhaled corticosteroids.
• Pluralais also helps prevent exercise-induced narrowing of the airways in patients 2 years of age and older.

Depending on your child's symptoms and the severity of their asthma, your doctor will determine how to 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.

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

2. What you need to know before your child takes Pluralais

Tell your doctor about any allergy or medical problem your child has now or has had.

Do not give Pluralais to your child

• if they are allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before giving Pluralais to your child.

• If your child's 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 your doctor has given your child. Always have your child's rescue inhaler medication for asthma attacks.
• It is essential that your child uses all asthma medications prescribed by their doctor. Pluralais should not be used instead of other asthma medications prescribed by your child's doctor.
• If your child is being treated with asthma medications, they 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.
• Your child should not take aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) if they make their asthma worse.

Children and adolescents

Do not give this medicine to children under 2 years of age.

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

Other medicines and Pluralais

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines may affect the way Pluralais works, or Pluralais may affect the way other medicines work that your child is using.

Before taking Pluralais, tell your doctor if your child is taking the following medicines:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)

TakingPluralaiswith food and drinks

Pluralais 4 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after food.

Pregnancy and breastfeeding

This subsection is not applicable to Pluralais 4 mg chewable tablets, as their use is indicated in children between 2 and 5 years of age.

Driving and using machines

This subsection is not applicable to Pluralais 4 mg chewable tablets, as their use is indicated in children between 2 and 5 years of age. However, the following information is important for the active substance, montelukast.

Pluralais is not expected to affect your child's 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 with Pluralais may affect the patient's ability to drive or operate machinery.

Pluralais 4 mg chewable tablets contain aspartame and sodium

This medicine contains 2.40 mg of aspartame in each tablet.

Aspartame is a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

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

3. How to take Pluralais

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist for your child. If in doubt, consult your child's doctor or pharmacist again.

• This medicine should be administered to children under adult supervision.
• Your child should only take one Pluralais tablet once a day, as prescribed by their doctor.
• It should be taken even when your child does not have symptoms or when they have an acute asthma attack.

For children from2 to5 years of age:

The recommended dose is one 4 mg chewable tablet daily in the evening.

If your child is taking Pluralais, ensure they do not take any other medicine that contains the same active substance, montelukast.

This medicine is taken orally.

The tablets should be chewed before swallowing.

Pluralais 4 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after food.

If your child takes more Pluralais than they should

Seek help from your child's doctor immediately.

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, vomiting, and hyperactivity.

In case of overdose or accidental ingestion, 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 take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to give Pluralais to your child

Try to give Pluralais as prescribed. However, if your child forgets a dose, just resume the usual routine of one chewable tablet once a day.

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

If your child stops takingPluralais

Pluralais can only treat your child's asthma if they continue taking it.

It is essential that your child continues taking Pluralais for the time their doctor prescribes it. It will help control your child's asthma.

If you have any other questions about the use of this medicine, ask your child's doctor or pharmacist.

4. Possible side effects

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

In clinical trials with Pluralais 4 mg chewable tablets, the side effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:

• abdominal pain
• thirst

Additionally, the following side effects were reported in clinical trials with montelukast 10 mg film-coated tablets and 5 mg chewable tablets:

• headache

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

Serious side effects

Consult your doctor immediatelyif you observe any of the following side effects in your child, which may be serious and 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
• tremor
• 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 tract 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
• bruising, itching, urticaria
• joint or muscle pain, muscle cramps
• bedwetting (in children)
• weakness/tiredness, malaise, swelling

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

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

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

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

Reporting of side effects

If your child experiences any side effects, consult your doctor or pharmacist, even if they are not listed in this 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 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 stated on the blister pack 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.
• Store in the original packaging to protect from light and moisture.
• Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy or other authorized collection point for proper disposal. This will help protect the environment.

6. Contents of the pack and further information

Composition of Pluralais 4 mg:

• The active substance is montelukast. Each tablet contains montelukast sodium equivalent to 4 mg of montelukast.
• The other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, red iron oxide (E 172), sodium croscarmellose, strawberry flavor, aspartame (E 951), and magnesium stearate.

Appearance of the product and pack contents

The 4 mg chewable tablets are pink, oval, biconvex, and have the inscription "4" on one side.

They are available in packs of 28 tablets.

Marketing authorization holder

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid, Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí, Barcelona

Spain

Date of last revision of this leaflet:March 2025

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