Pluralais 5 mg chewable tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Pluralais 5 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 taking 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 asthma and to prevent asthma symptoms during the day and night.

• Pluralais is used for the treatment of pediatric patients aged 6 to 14 years who are not adequately controlled with their current 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 their asthma and who have demonstrated inability 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 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 starting to take Pluralais

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

Do not take Pluralais

• if you or your child are allergic to montelukast or to any of the other components 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 that of your child, worsens, inform your doctor immediately.
• Oral Pluralais is not indicated for the treatment of acute asthma attacks. If an asthma attack occurs, follow the instructions given to you by your doctor for yourself or for your child. Always have your rescue inhaled medication available for asthma attacks.
• It is important 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 in 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 medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if these worsen your asthma.

Do not give this medicine to children under 6 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 you or your child are taking, have 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 work.

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

• phenobarbital (used for the treatment of epilepsy)
• phenytoin (used for the treatment of epilepsy)
• rifampicin (used for the treatment of tuberculosis and certain other infections)

Taking Pluralais with food and drink

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

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning 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 passes into breast milk. If you are breastfeeding or planning 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 adverse effects (such as dizziness and drowsiness) reported with Pluralais may affect a patient's ability to drive or operate machinery.

Pluralais 5 mg chewable tablets contain aspartame and sodium**

This medicine contains 3.0 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine which may be harmful if phenylketonuria (PKU) is present, 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, i.e., essentially "sodium-free".

3. How to take Pluralais

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

• You or your child should take only one 5 mg chewable tablet once daily, as prescribed by your doctor.
• It should be taken even when you or your child do not have symptoms or during an acute asthma attack.

For children aged 6 to 14 years:

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

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

This medicine is taken by mouth.

The tablets must 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 meals.

If you or your child take more Pluralais than you should

Seek medical help immediately.

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, somnolence, thirst, headache, vomiting, and hyperactivity.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet 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 miss a dose, simply resume the usual regimen of one tablet once daily.

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

If you or your child stop taking Pluralais

Pluralais will only help control your asthma or your child's asthma if you or your child continue taking it. It is important to keep 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 further questions about the use of this medicine, ask your 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 5 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:

• headache

In addition, the following adverse effects were reported in clinical trials with montelukast 10 mg film-coated tablets:

• abdominal pain

These adverse effects were generally mild and occurred more frequently in patients treated with montelukast tablets than with placebo (a tablet containing no active ingredient).

Serious adverse effects

Contact your doctor immediately if you notice any of the following adverse effects, which may be serious and may require urgent medical treatment for you or your child.

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: excitation including aggressive behaviour or hostility, depression
• seizures

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

• increased tendency to bleed
• 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
• severe 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, feeling anxious, restlessness
• dizziness, somnolence, tingling/numbness
• nosebleeds
• dry mouth, indigestion
• bruising, itching, urticaria
• joint or muscle pain, muscle cramps
• bed-wetting (in children)
• weakness/tiredness, malaise, swelling

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

• changes in behaviour 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, most commonly appearing on the shins (erythema nodosum)
• changes in behaviour and mood: obsessive-compulsive symptoms, stuttering

Reporting of adverse effects

If you or your child experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 month indicated.
• Store in the original packaging to protect from light and moisture.
• Medicines must not be disposed of via wastewater or in household waste. Dispose of unused medicines and their containers at the SIGRE collection point (or any other medicine waste collection system) at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Pluralais 5 mg:

• The active substance is: montelukast. Each tablet contains montelukast sodium equivalent to 5 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 5 mg chewable tablets are pink, round, biconvex, and marked with the number "5" on one side.

Packaged 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 the most recent revision of this leaflet: March 2025

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