Label: information for the user

Pluralais 4 mg chewable tablets EFG

montelukast

What isPluralais

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

How Pluralais works

Leukotrienes produce 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 for the treatment of 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 the treatment of their asthma and who have demonstrated that they are unable to use inhaled corticosteroids.

• Pluralais also helps prevent airway constriction caused by exercise in patients 2 years of age and older.

Depending on symptoms and the severity of 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 conditions.

• Airway sensitivity that reacts to many things, such as cigarette smoke, pollen, cold air, or exercise.

• Inflammation (swelling) of the inner layer of the airways.

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

Inform your child's doctor about any allergy or medical condition your child has now or has had.

Do not give Pluralais to your child

•if your child is allergic to montelukast or any of the other components of this medication (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, inform your doctor immediately.

•Pluralais oral is not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions your doctor has given for your child. Always have your child's rescue inhaler medication available for asthma attacks.

•It is essential that your child uses all asthma medications prescribed by their doctor. Pluralais should not be used in place of other asthma medications prescribed by your child's doctor.

•If your child is being treated with asthma medications, be aware that if they develop a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening respiratory symptoms, and/or skin rash, they should consult their doctor.

•Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they worsen their asthma.

Children and adolescents

Do not give this medication to children under 2 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 your child is taking, has recently given, or may need to give any other medication, including those purchased without a prescription.

Some medications may affect the functioning of Pluralais, or Pluralais may affect the functioning of other medications your child is using.

Before takingPluralais, inform your doctor if your child is taking the following medications:

•phenobarbital (used for epilepsy treatment)

•phenytoin (used for epilepsy treatment)

•rifampicin (used for tuberculosis and some other infections treatment)

TakingPluralaiswith food and beverages

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

Pregnancy and breastfeeding

This subsection is not applicable to Pluralais 4 mg chewable tablets since its use is indicated in children aged 2 to 5 years.

Driving and operating machinery

This subsection is not applicable toPluralais4 mg chewable tablets, as its use is indicated in children aged 2 to 5 years, however, the following information is important for the active ingredient, montelukast.

Pluralaisis 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) reported with Pluralais may affect the patient's ability to drive or operate machinery.

Pluralais 4 mg chewable tablets contain aspartame and sodium

Each tablet contains 2.40 mg of aspartame.

Aspartame contains a source of phenylalanine that may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

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

Follow exactly the administration instructions of this medication as indicated by your child's doctor or pharmacist. In case of doubt, consult the doctor or pharmacist again.

•This medication must be administered to children under the supervision of an adult.

•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 aged2 to5 years:

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

If your child is taking Pluralais, ensure they do not take any other medication containing the same active ingredient, montelukast.

This medication is taken orally.

The tablets must be chewed before swallowing.

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

If your child takes more Pluralais than they should

Seek immediate help from your child's doctor.

In most cases of overdose, no adverse effects were reported. The symptoms that were most frequently reported in adult and child overdose cases were abdominal pain, drowsiness, lethargy, headache, vomiting, and hyperactivity.

In case of overdose or accidental ingestion, 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 your child forgets to take Pluralais

Try to givePluralaisas prescribed. However, if your child forgets a dose, limit yourself to resuming the usual regimen of one chewable tablet once a day.

Do not give a double dose to compensate for missed doses.

If your child interrupts treatment withPluralais

Pluralaiscan only treat your child's asthma if they continue to take it.

It is essential that your child continues to takePluralaisfor the time their doctor prescribes. It will help control your child's asthma.

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

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

In clinical trials conducted 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

•fatigue

In addition, 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 more frequently in patients treated with montelukast tablets than with placebo (a pill that does not contain medicine).

Severe side effects

Consult your doctor immediatelyif you notice any of the following side effects in your child, which may be severe and your child may require urgent medical treatment

Uncommon (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
• tremor
• 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
• 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):

• behavioral and mood changes: sleep disturbances, including nightmares, sleep problems, sleepwalking, 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 disturbances, memory disturbances, 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 your child experiences 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.

•Store in the original packaging to protect it from light and moisture.

•Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point (or any other medication waste collection system) at the 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 4 mg:

•The active ingredient is montelukast. Each tablet contains montelukast sodium equivalent to 4 mg of montelukast.

•The other components are: Mannitol, microcrystalline cellulose, hydroxypropyl cellulose, iron oxide red (E 172), sodium croscarmellose, strawberry flavor, aspartame (E 951), and magnesium stearate.

Appearance of the product and contents of the packaging

The 4 mg chewable tablets are pink, oval, biconvex, and have the inscription “4” on one face.

They are presented in packs of 28 tablets.

Marketing Authorization Holder

Laboratorios Alter, S.A

C/ Mateo Inurria, 30

28036 Madrid-Spain

Responsible for manufacturing

LaboratoriosNeuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970Sant Joan Despí, Barcelona

Spain

Last review date of this leaflet:March 2025

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