MONTELUKAST PENSA 4 mg CHEWABLE TABLETS

Introduction

Leaflet: information for the user

Montelukast Pensa 4 mg chewable tablets EFG

Read the entire leaflet carefully before your child starts taking this medication, 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 medication has been prescribed to your child only, and you should not give it to others, even if they have the same symptoms as your child, as it may harm them.
• If your child experiences side effects, consult your child's doctor or pharmacist. Even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Montelukast Pensa and what is it used for
2. What you need to know before your child starts taking Montelukast Pensa
3. How to take Montelukast Pensa
4. Possible side effects
5. Storage of Montelukast Pensa
6. Package contents and additional information

1. What is Montelukast Pensa and what is it 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 prevent asthma symptoms during the day and night.

• Montelukast Pensa is used for treatment in patients between 2 and 5 years of age who are not adequately controlled with their medication and need additional treatment.
• Montelukast Pensa 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 have shown that they are unable to use inhaled corticosteroids.
• Montelukast Pensa also helps prevent exercise-induced narrowing of the airways in patients 2 years of age and older.

Depending on your child's symptoms and the severity of their asthma, your child's doctor will determine how to use Montelukast Pensa.

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 diseases.
• Airways that are sensitive and react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• Swelling (inflammation) of the inner layer of the airways.

Asthma symptoms include: Coughing, wheezing, and chest congestion.

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

Do not use Montelukast Pensa:

Warnings and precautions

Consult 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 attack occurs, follow the instructions given by your child's doctor. Always have your child's rescue inhaler medication for asthma attacks.
• It is essential that your child uses all asthma medications prescribed by the doctor. Montelukast Pensa should not replace other asthma medications prescribed by the doctor 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 of arms or legs, worsening of lung symptoms, and/or skin rash, they should consult your child's doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your child's asthma.
• Patients should be aware that several neuropsychiatric events have been reported with Montelukast Pensa (e.g., changes in behavior and mood-related events) in adults, adolescents, and children (see section 4). If you develop these symptoms while taking Montelukast Pensa, you should consult your doctor.

Children

For children between 2 and 5 years of age, Montelukast Pensa 4 mg chewable tablets are available.

For children between 6 and 14 years of age, Montelukast Pensa 5 mg chewable tablets are available.

Taking Montelukast Pensa with other medications

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

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

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

• 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 meals; it should be taken at least 1 hour before or 2 hours after meals.

Pregnancy, breastfeeding, and fertility

This subsection is not applicable to Montelukast Pensa 4 mg chewable tablets, as its use is indicated in children between 2 and 5 years of age. However, the following information is important for the active ingredient, montelukast.

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

Use during pregnancy

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

Use during breastfeeding

It is unknown whether Montelukast Pensa appears in breast milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking Montelukast Pensa.

Driving and using machines

This subsection is not applicable to Montelukast Pensa 4 mg chewable tablets, as its use is indicated in children between 2 and 5 years of age. However, the following information is important for the active ingredient, montelukast.

Montelukast Pensa is not expected to affect your ability to drive a car or operate machines. However, individual responses to the medication may vary. Certain side effects (such as dizziness and drowsiness) that have been reported very rarely with Montelukast Pensa may affect the patient's ability to drive or operate machines.

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

3. How to take Montelukast Pensa

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

• Your child should only take one Montelukast Pensa tablet once a day, as prescribed by the doctor.
• It should be taken even when your child does not have symptoms or when they have an acute asthma attack.
• It should be taken orally.

Use in children from 2 to 5 years of age:

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

If your child is taking Montelukast Pensa, ensure that they do not take any other product containing the same active ingredient, montelukast.

Use in children

For children between 2 and 5 years of age, Montelukast Pensa 4 mg chewable tablets are available.

For children between 6 and 14 years of age, 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 help from your child's doctor immediately.

In most cases of overdose, no side effects were reported. The symptoms that occurred most frequently reported in overdose in adults and children were abdominal pain, drowsiness, thirst, 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 ingested.

If you forget to give Montelukast Pensa to your child

Try to give Montelukast Pensa as prescribed. However, if your child forgets a dose, simply resume the usual routine of one tablet once a day. Do not give a double dose to make up for forgotten doses.

If your child stops taking Montelukast Pensa

Montelukast Pensa can only treat your child's asthma if they continue taking it. It is essential that they continue taking Montelukast Pensa for the time prescribed by the doctor. It will help control your child's asthma.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone experiences them.

In clinical trials conducted with montelukast 4 mg chewable tablets, the side effects related to the administration of montelukast and reported most frequently (occurring in at least 1 in 100 patients and 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 side effects were reported:

• headache

These side effects were generally mild and occurred with a higher frequency in patients treated with montelukast than with placebo (a pill that does not contain medication).

The frequency of possible side effects, indicated 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 medication has been marketed, the following side effects have been reported:

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

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

Reporting side effects:

If your child experiences any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Montelukast Pensa

Keep this medication out of sight and reach of children.

This medication does not require any special storage temperature.

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

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Montelukast Pensa

The active ingredient 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 flavor (maltodextrin, modified cornstarch, artificial flavors, triacetin, benzyl alcohol).

Appearance of the product and package contents

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

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

Not all 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 medication is authorized in the Member States of the European Economic Area 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 last revision of this leaflet: August 2019

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