Leaflet: information for the user

Pluralais 5 mg chewable tablets EFG

montelukast

What is Pluralais

Pluralaisis 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 prescribedPluralaisto treat asthma and prevent asthma symptoms during the day and night.

•Pluralaisis used for the treatment of pediatric patients aged 6 to 14 years who are not adequately controlled with their medication and require additional treatment.

•Pluralais is also used as an alternative treatment to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for the treatment of their asthma and have demonstrated an inability to use inhaled corticosteroids.

•Pluralaisalso helps prevent airway constriction caused by exercise.

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

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.

•sensitive airways that react 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 doctor about any allergy or medical condition 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 components of this medication (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 gets worse, inform your doctor immediately.

• Pluralais oral is not indicated for treating 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 available.

• It is essential that you or your child use all asthma medications prescribed by your doctor. Pluralais 5 mg should not be used in place 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 respiratory 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 nonsteroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.

Do not give this medication to children under 6 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 you or your child are taking or have recently taken or may need to take 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 you are using.

Before taking Pluralais, inform your doctor if you or your child are taking the following medications:

• Fenobarbital (used for the treatment of epilepsy)

• Phenitoin (used for the treatment of epilepsy)

• Rifampicin (used for the treatment of tuberculosis and some other infections)

Taking Pluralais with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Your doctor will evaluate whether you can take Pluralais during this period.

Breastfeeding

The presence of Pluralais in breast milk is unknown. If you are breastfeeding or plan to breastfeed, consult your doctor before taking Pluralais.

Driving and operating machinery

Pluralais is 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 5 mg chewable tablets contain aspartame and sodium

This medication contains 3.0 mg of aspartame in each tablet.

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.

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

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

• You or your child should only take one chewable tablet of 5 mg once a day, as prescribed by your doctor.

• You should take it even when you or your child do not have symptoms or when you have an acute asthma attack.

For children aged 6 to 14 years:

The recommended dose is one chewable tablet of 5 mg daily at night.

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

This medication is taken orally.

The tablets should be chewed before swallowing.

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

If you or your child take more Pluralais than you should

Seek help from your doctor immediately.

In most cases of overdose, no adverse effects were reported. The symptoms that were most frequently reported in adults and children who overdosed were abdominal pain, drowsiness, drowsiness, 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 medication and the amount taken.It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take Pluralais or forgot to give Pluralais to your child

Try to takePluralaisas prescribed. However, if you or your child forget a dose, simply resume the usual regimen of one tablet once a day.

Do not take a double dose to compensate for the missed doses.

If you or your child interrupt treatment withPluralais

Pluralaiswill only treat your asthma or your child's asthma if you or your child continue to take it. It is essential to continue takingPluralaisfor the time 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 medication, ask your doctor or pharmacist.

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

In clinical trials conducted with Pluralais 5 mg chewable tablets, the side effects related to the administration of the drug and reported most frequently (may affect up to 1 in 10 people), were:•headache

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

Severe side effects

Consult your doctor immediately if you observe any of the following side effects, which may be severe and you or your child may need 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
• Tremors
• 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
• Pulmonary edema
• Severe skin reactions (erythema multiforme) that may occur without warning
• Liver inflammation (hepatitis)

Other side effects reported during the marketing of the drug

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, drowsiness, tingling/numbness
• Nasal bleeding
• Dry mouth, indigestion
• Bruising, itching, urticaria
• Muscle or joint 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 bumps 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 you or your child experience 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 5 mg:

•The active ingredient is: montelukast.Eachtablet contains montelukast sodium equivalent to 5 mg of montelukast.

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

Appearance of the product and content of the packaging

The 5 mg chewable tablets are pink, round, biconvexand with the inscription “5” on one face.

SThey are presented in packs of 28 tablets.

Marketing Authorization Holder

Alter S.A Laboratories

C/ Mateo Inurria 30

28036 Madrid-Spain

Responsible for manufacturing

Neuraxpharm Pharmaceuticals, S.L. Laboratories

Avda. Barcelona, 69

Sant Joan Despí, Barcelona

Spain

Last review date of this leaflet:March 2025

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