Montelukast Pensa 5 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast Pensa 5 mg chewable tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist. This includes any adverse 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 taking 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 doctor has prescribed Montelukast Pensa to treat asthma and to prevent daytime and nighttime asthma symptoms.

• Montelukast Pensa is used for the treatment of patients aged between 6 and 14 years who are not adequately controlled with their current medication and require additional treatment.
• Montelukast Pensa is also used as an alternative to inhaled corticosteroids in patients aged between 6 and 14 years who have not recently taken oral corticosteroids for the treatment of their asthma and who have demonstrated inability to use inhaled corticosteroids.
• Montelukast Pensa 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 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: coughing, wheezing, and chest tightness.

2. What you need to know before taking Montelukast Pensa

Do not take Montelukast Pensa:

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

Warnings and precautions

Talk to your doctor or pharmacist before taking montelukast.

• If your asthma or breathing, or that of your child, worsens, inform your doctor immediately.
• Montelukast Pensa is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given to you by your doctor for you or your child. Always keep your inhaled rescue medication for asthma attacks.
• It is important that you or your child use all asthma medications prescribed by your doctor. Montelukast Pensa should not replace other asthma medications prescribed 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 they worsen your asthma.
• Various neuropsychiatric events (for example, behavior- and mood-related changes, depression, and suicidal thoughts) have been reported in patients of all ages treated with montelukast (see section 4). If you develop such symptoms 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 doctor or pharmacist if you or your child are taking, have 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 you are taking work.

Before taking Montelukast Pensa, 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 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

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

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

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 somnolence), 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 use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

• You or your child should take only one Montelukast Pensa 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.
• It should be taken orally.

Use in children aged 6 to 14 years:

One 5 mg chewable tablet should be taken daily at night. Montelukast Pensa 5 mg chewable tablets should not be taken with food; it should be taken at least 1 hour before or 2 hours after meals.

If you or your child are taking Montelukast Pensa, make sure that neither you nor your child 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.

If you take more Montelukast Pensa 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 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Montelukast Pensa

Try to take Montelukast Pensa as prescribed. However, if you or your child miss a dose, simply resume your regular schedule of one tablet daily. Do not take a double dose to make up for a missed dose.

If you stop taking Montelukast Pensa

Montelukast Pensa can only control your child's or your own asthma if you or your child continue taking it. It is important to continue taking Montelukast Pensa for as long as your doctor has prescribed 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 may cause adverse effects, although not everyone experiences them.

In clinical trials with montelukast 4 mg chewable tablets, the adverse effects related to the administration of montelukast and reported most frequently (occurring in at least 1 in 100 patients and in fewer 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 in those treated with placebo (a tablet containing no active drug).

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 1 to 10 in 100 patients)
• Uncommon (affects 1 to 10 in 1,000 patients)
• Rare (affects 1 to 10 in 10,000 patients)
• Very rare (affects fewer 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 that may cause difficulty breathing or swallowing (Uncommon)
• changes in behaviour and mood [sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, anxious feelings, restlessness, excitement including aggressive behaviour or hostility, depression (Uncommon); tremor (Rare); hallucinations, disorientation, suicidal thoughts and actions, stuttering (Very rare)]
• dizziness, somnolence, tingling/numbness, seizures (Uncommon)
• palpitations (Rare)
• nasal bleeding (Uncommon)
• diarrhoea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon)
• hepatitis (inflammation of the liver) (Very rare)
• 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 arms and legs, worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) have been reported. You should inform your doctor immediately if you experience one or more of these symptoms.

Reporting of adverse effects:

If you 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 should not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. 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 5 mg of montelukast (as sodium salt).

The other components are: microcrystalline cellulose, mannitol (E-421), sodium croscarmellose, aspartame (E-951), iron oxide red (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 5 mg chewable tablets are pink, biconvex tablets with the code M5 engraved on one side.

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

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 authorised in the European Economic Area member states under the following names:

PT: Montelucaste Pensa, 5 mg, chewable tablets

ES: Montelukast Pensa 5 mg chewable tablets EFG

IT: Montelukast Pensa 5 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/