Montelukast Pensa 4 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast Pensa 4 mg Chewable Tablets EFG

Read this entire leaflet carefully before your child starts taking this medicine, as it contains important information.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your child's doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not give it to others, even if they have the same symptoms as your child, as it may harm them.
• If your child experiences any adverse effects, consult your child's doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Montelukast Pensa is and what it is used for
2. What you need to know before your child takes Montelukast Pensa
3. How to take Montelukast Pensa
4. Possible adverse effects
5. How to store Montelukast Pensa
6. Contents of the pack and other information

1. What Montelukast Pensa is and what it is used for

Montelukast Pensa is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, Montelukast Pensa improves asthma symptoms and helps control asthma.

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

• Montelukast Pensa is used for treatment in patients aged 2 to 5 years who are not adequately controlled with their current medication and require additional treatment.
• Montelukast Pensa is also used as an alternative treatment to inhaled corticosteroids in patients aged 2 to 5 years who have not recently taken oral corticosteroids for the treatment of their asthma and who have been shown to be unable to use inhaled corticosteroids.
• Montelukast Pensa 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 child's doctor will determine how Montelukast Pensa 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: Cough, wheezing, and chest tightness.

2. What you need to know before your child starts taking Montelukast Pensa

Do not use Montelukast Pensa:

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

Warnings and precautions

Talk to your child's doctor or pharmacist before starting to use montelukast.

• If your child's asthma or breathing worsens, inform your child's doctor immediately.
• Montelukast Pensa is not indicated for the treatment of acute asthma attacks. If an asthma attack occurs, follow the instructions given by your child's doctor. 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. Montelukast Pensa should not replace other asthma medications prescribed for your child.
• Any patient being treated with asthma medications should be aware that if your child 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 must consult your child's doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your child's asthma.
• Various neuropsychiatric events (for example, behavior- and mood-related changes, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If such symptoms develop while taking montelukast, you must contact your doctor.

Children

For children aged 2 to 5 years, Montelukast Pensa 4 mg chewable tablets are available.

For children aged 6 to 14 years, Montelukast Pensa 5 mg chewable tablets are available.

Taking Montelukast Pensa with other medicines

Inform your child's doctor or pharmacist if your child is taking, has recently taken, or might need to take any other medicines.

Some medicines may affect how Montelukast Pensa works, or Montelukast Pensa may affect how other medicines work.

Before taking Montelukast Pensa, inform the 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 Montelukast Pensa with food, drinks and alcohol

Montelukast Pensa should not be taken with food; it should be taken at least 1 hour before or 2 hours after eating.

Pregnancy, breastfeeding and fertility

This section does not apply to Montelukast Pensa 4 mg chewable tablets, as they are indicated for use in children aged 2 to 5 years. However, the following information is important regarding the active substance, montelukast.

Use during pregnancy

Your doctor will assess whether you can take Montelukast Pensa during pregnancy.

Use during breastfeeding

It is unknown whether Montelukast Pensa passes into breast milk. If you are breastfeeding or planning to breastfeed, you should consult your doctor before taking Montelukast Pensa.

Driving and using machines

This section does not apply to Montelukast Pensa 4 mg chewable tablets, as they are indicated for use in children aged 2 to 5 years. However, the following information is important regarding the active substance, montelukast.

Montelukast Pensa 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), which have been reported very rarely with Montelukast Pensa, may affect a patient's ability to drive or operate machinery.

Montelukast Pensa contains aspartame, a source of phenylalanine. This medicine may be harmful to people with phenylketonuria.

3. How to take Montelukast Pensa

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

• Your child should take only one Montelukast Pensa tablet once daily, as prescribed by the doctor.
• It should be taken even when your child has no symptoms or during an acute asthma attack.
• It must be taken orally.

Use in children aged 2 to 5 years:

One 4 mg chewable tablet should be taken daily at night. Montelukast Pensa 4 mg chewable tablets should not be taken with food; it should be taken at least 1 hour before or 2 hours after eating.

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

Use in children

For children aged 2 to 5 years, Montelukast Pensa 4 mg chewable tablets are available.

For children aged 6 to 14 years, Montelukast Pensa 5 mg chewable tablets are available.

Montelukast Pensa 4 mg chewable tablets are not recommended for children under 2 years of age.

If your child takes more Montelukast Pensa 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, 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 medication and the amount ingested.

If you forget to give Montelukast Pensa to your child

Try to give Montelukast Pensa as prescribed. However, if your child misses a dose, simply resume the usual regimen of one tablet once daily. Do not give a double dose to make up for missed doses.

If your child stops taking Montelukast Pensa

Montelukast Pensa can only treat your child's asthma if they continue taking it. It is important that they continue taking Montelukast Pensa 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 experiences them.

In clinical trials with montelukast 4 mg chewable tablets, the adverse effects related to montelukast administration and reported most frequently (occurring in at least 1 in 100 patients and in less than 1 in 10 patients treated) were:

• abdominal pain
• thirst

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

• headache

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

The frequency of possible adverse effects listed below is defined using the following convention:

• Very common (affects at least 1 in 10 patients)
• Common (affects between 1 and 10 in 100 patients)
• Uncommon (affects between 1 and 10 in 1,000 patients)
• Rare (affects between 1 and 10 in 10,000 patients)
• Very rare (affects less than 1 in 10,000 patients)

Additionally, since the medicine has been marketed, the following adverse effects have been reported:

• upper respiratory tract infection (Very common)
• increased tendency to bleeding (Rare)
• allergic reactions including swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (Uncommon)
• changes in behavior and mood [sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, anxious feelings, restlessness, excitement including aggressive behavior or hostility, depression (Uncommon); tremor (Rare); hallucinations, disorientation, suicidal thoughts and actions, stuttering (Very rare)]
• dizziness, drowsiness, tingling/numbness, seizures (Uncommon)
• palpitations (Rare)
• nosebleeds (Uncommon)
• diarrhea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon)
• hepatitis (inflammation of the liver) (Very rare)
• skin rash (Common); bruising, itching, urticaria (Uncommon); painful red lumps under the skin, most commonly appearing on the shins (erythema nodosum), severe skin reactions (erythema multiforme) which may occur without warning (Very rare)
• joint or muscle pain, muscle cramps (Uncommon)
• fever (Common); fatigue, malaise, swelling (Uncommon)

In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flu-like illness, tingling or numbness in the arms and legs, worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) have been reported. You must inform your doctor immediately if you or your child experience one or more of these symptoms.

Reporting of adverse effects:

If your child experiences any adverse effect, consult 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 Montelukast Pensa

Keep this medicine out of the sight and reach of children.

This medicine does not require any special storage temperature.

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

Do not use this medicine after the expiry date stated on the container. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Montelukast Pensa

The active substance is montelukast. Each tablet contains 4 mg of montelukast (as sodium salt).

The other components are: microcrystalline cellulose, mannitol (E-421), sodium croscarmellose, aspartame (E-951), red iron oxide (E-172), magnesium stearate (E-572), cherry flavour (maltodextrin, modified food starch (waxy corn), artificial flavours, triacetin, benzyl alcohol).

Appearance of the product and contents of the pack

The 4 mg chewable tablets are pink, biconvex, and have the code M4 engraved on one side.

The chewable tablets are available in packs containing blisters of 14, 28, and 98 chewable tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Kymos, S.L.

Ronda de Can Fatjó, 7B (Parque Tecnológico del Vallès)

08290 Cerdanyola del Vallès (Barcelona)

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

PT: Montelucaste Pensa, 4 mg, chewable tablets

ES: Montelukast Pensa 4 mg chewable tablets EFG

IT: Montelukast Pensa 4 mg chewable tablets

Date of the most recent review of this leaflet: November 2025

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/