Pluralais 4 mg chewable tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Pluralais 4 mg chewable tablets EFG

montelukast

Package leaflet contents:

1. What Pluralais is and what it is 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 other information

1. What Pluralais is and what it is used for

What Pluralais is

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 Pluralais should be used

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

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

Depending on your child's symptoms and the severity of their asthma, your doctor will determine how Pluralais should be used.

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

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

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

Inform your doctor of any allergies or medical conditions your child currently has or has had in the past.

Do not give Pluralais to your child

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

Warnings and precautions

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

• If your child's asthma or breathing worsens, inform 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 provided for your child. Always keep your child's rescue inhaled medication available for asthma attacks.
• It is important that your child uses all asthma medications prescribed by the doctor. Pluralais should not be used instead of other asthma medications prescribed for your child by the doctor.
• If your child is being treated with asthma medications, you should be aware that if he or she develops a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening of lung symptoms, and/or skin rash, you should consult your doctor.
• Your child should not take acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (also known as NSAIDs) if these worsen his or her asthma.

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 depending on the age range.

Other medicines and Pluralais

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

Some medicines may affect how Pluralais works, or Pluralais may affect how other medicines your child is taking work.

Before taking Pluralais, inform 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)

Taking Pluralais with food and drinks

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

Pregnancy and breastfeeding

This section does not apply to Pluralais 4 mg chewable tablets, as this formulation is indicated for use in children aged 2 to 5 years.

Driving and using machines

This section does not apply to Pluralais 4 mg chewable tablets, as this formulation is indicated for children aged 2 to 5 years. However, the following information is relevant for the active substance, montelukast.

Pluralais is not expected to affect the ability to drive a car or operate machinery. However, individual responses to the medicine may vary. Certain adverse effects (such as dizziness and somnolence) reported with Pluralais may affect a 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 per tablet.

Aspartame is a source of phenylalanine, which may be harmful if the patient has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.

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

3. How to take Pluralais

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

• This medicine should be administered to children under the supervision of an adult.
• Your child should take only one tablet of Pluralais once daily, as prescribed by the doctor.
• It should be taken even when your child has no symptoms or during an acute asthma attack.

For children aged 2 to 5 years:

The recommended dose is one 4 mg chewable tablet taken once daily at night.

If your child is taking Pluralais, make sure they do not take any other medicine containing the same active substance, montelukast.

This medicine is taken orally.

The tablets must 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 meals.

If your child takes more Pluralais than they should

Seek immediate help from your child's doctor.

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

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.

If you forget to give Pluralais to your child

Try to give Pluralais as prescribed. However, if your child misses a dose, simply resume the usual regimen of one chewable tablet once daily.

Do not give a double dose to make up for a missed dose.

If your child stops taking Pluralais

Pluralais can only treat your child's asthma if treatment is continued.

It is important that your child continues taking Pluralais for the length of time prescribed by the doctor. It will help control your child's asthma.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

• abdominal pain
• thirst

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

• headache

These adverse effects were generally mild and occurred more frequently in patients treated with montelukast tablets than with placebo (a tablet that does not contain any active medicine).

Serious adverse effects

Contact your doctor immediately if you notice any of the following adverse effects in your child, which may be serious 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, which may cause difficulty breathing or swallowing
• changes in behaviour and mood: agitation, including aggressive behaviour or hostility, depression
• seizures

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

• increased tendency to 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 in arms and legs, worsening of lung symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)
• low platelet count
• changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and actions
• swelling (inflammation) of the lungs
• serious skin reactions (erythema multiforme) which may occur without warning
• inflammation of the liver (hepatitis)

Other adverse effects reported during post-marketing use 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):

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

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

• changes in behaviour and mood: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, anxious feelings, restlessness
• dizziness, somnolence, 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 in behaviour and mood: attention disturbance, memory impairment, uncontrolled muscle movements

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

• painful red lumps under the skin, which most commonly appear on the shins (erythema nodosum)
• changes in behaviour and mood: obsessive-compulsive symptoms, stuttering

Reporting of adverse effects

If your child experiences any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 digits indicate the month; the last four digits indicate the year. The expiry date refers to the last day of the specified month.
• Store in the original packaging to protect from light and moisture.
• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point (or any other medicine waste collection system) at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pluralais 4 mg:

• The active substance is montelukast. Each tablet contains sodium montelukast equivalent to 4 mg of montelukast.
• The other components 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 contents of the pack

The 4 mg chewable tablets are pink, oval-shaped, biconvex, with the inscription "4" on one side.

They are supplied 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 the most recent revision of this leaflet: March 2025

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