PLURALAIS 5 mg CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

Pluralais 5 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 taking 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 is Pluralais

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 asthma and prevent asthma symptoms during the day and night.

• Pluralais is used to treat pediatric patients between 6 and 14 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 6 and 14 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.

Depending on the symptoms and severity of your asthma or your child's 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 taking Pluralais

Tell your doctor about any allergies or medical problems you or your child have now or have had.

Do not take Pluralais

• if you or your child 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 you or your child start taking Pluralais

• If your asthma or breathing or your child's asthma or breathing worsen, 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 for you or your child. 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 5 mg should not be used instead of other asthma medications prescribed by your doctor 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 of lung symptoms, and/or skin rash, they should consult their doctor.
• You or your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

Do not give this medicine to children under 6 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 or your child are taking or have recently taken or may need to take any other medicine, including those obtained without a prescription.

Some medicines may affect the way Pluralais works, or Pluralais may affect the way other medicines work.

Before taking Pluralais, tell your doctor if you or your child are taking the following medicines:

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

Taking Pluralais with food and drinks

Pluralais 5 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

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using 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, you should 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 with Pluralais may affect the patient's ability to drive or operate machinery.

Pluralais 5 mgchewable tablets contain aspartame and sodium

This medicine contains 3.0 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease 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 given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

• You or your child should only take one 5 mg chewable 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.

For children from6 to14 years of age:

The recommended dose is one 5 mg chewable tablet daily in the evening.

If you or your child are taking Pluralais 5, make sure that neither your child nor you take any other product that contains the same active ingredient, montelukast.

This medicine is taken orally.

The tablets should be chewed before swallowing.

Pluralais 5 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after food.

If you or your child take more Pluralais than you should

Seek help from your 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 or pharmacist immediately 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 package leaflet of the medicine to the healthcare professional.

If you or your child forget to take Pluralais

Try to take Pluralais as prescribed. However, if you or your child forget a dose, just resume your usual routine of one tablet once a day.

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

If you or your child stop taking Pluralais

Pluralais can only treat your asthma or your child's asthma if you or your child continue to take it. It is essential that you continue taking Pluralais for as long as your doctor prescribes it. It will help control your asthma or your child's asthma.

If you have any other questions about the use of this medicine, ask your 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 5 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:

• headache

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

• abdominal pain

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).

Severe side effects

Consult your doctor immediately if you notice any of the following side effects, which may be serious and you or your child may need 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
• inflammation (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, hives
• 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):

• red painful 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 you or your child experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects 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 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.
• Store in the original packaging to protect from light and moisture.
• Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE Collection Point (or any other medicine waste collection system) 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 5 mg:

• The active substance is: montelukast. Each tablet contains montelukast sodium equivalent to 5 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 packaging contents

The 5 mg chewable tablets are pink, round, biconvex, and have the inscription "5" 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

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/