Montelukast Pensalab 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast Pensa 10 mg film-coated tablets EFG

Read the entire package 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 other people, 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 package 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, helps control asthma, and improves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

Your doctor has prescribed Montelukast Pensa to treat your asthma and to prevent asthma symptoms during both day and night.

• Montelukast Pensa is used for the treatment of adults and adolescents aged 15 years and older who are not adequately controlled with their current medication and require additional treatment.
• In those asthmatic patients for whom Montelukast Pensa is indicated for asthma, Montelukast Pensa may also provide symptomatic relief of seasonal allergic rhinitis.
• Montelukast Pensa also helps prevent airway narrowing triggered by exercise.

Depending on your symptoms and the severity of your asthma, your doctor will determine how you should 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 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.

Symptoms of asthma include: Cough, wheezing, and chest tightness.

2. What you need to know before taking Montelukast Pensa

Do not take Montelukast Pensa:

• If you 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 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 by your doctor. Always have your rescue inhaled medication available for asthma attacks.
• It is important that you use all asthma medications prescribed by your doctor. Montelukast Pensa should not replace other asthma medications prescribed by your doctor.
• 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 must consult their doctor.
• You should not take acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (also known as NSAIDs) if they worsen your asthma.
• Various neuropsychiatric events (for example, behavioral 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

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

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

Taking Montelukast Pensa with other medicines

Inform your doctor or pharmacist if you 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 work.

Before taking Montelukast Pensa, inform your doctor if you are 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 may be taken with or without food.

Pregnancy, breast-feeding and fertility

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.

Use during pregnancy

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

Use during breast-feeding

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

Montelukast Pensa contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Montelukast Pensa

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

• You should take only one tablet of Montelukast Pensa once daily, as prescribed by your doctor.
• It should be taken even when you have no symptoms or during an acute asthma attack.
• It must be taken by oral route.

Use in adults aged 15 years and older:

One 10 mg film-coated tablet of Montelukast Pensa should be taken daily at night. Montelukast Pensa 10 mg film-coated tablets can be taken with or without food.

If you are taking Montelukast Pensa, make sure you do not take any other medication 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 immediate help from your 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, drowsiness, 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, indicating the medicine and the amount ingested.

If you forget to take Montelukast Pensa

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

If you stop taking Montelukast Pensa

Montelukast Pensa will only treat your asthma if you continue taking it. It is important that you continue taking Montelukast Pensa for the duration prescribed by your doctor. It will help control your 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 everybody gets 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 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 tablet 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 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 less than 1 in 10,000 patients)

In addition, 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 in 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, and stuttering (Very rare)]
• dizziness, somnolence, tingling/numbness, seizures (Uncommon)
• palpitations (Rare)
• nosebleeds (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 must 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, talk to 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 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 or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. 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 10 mg of montelukast (as sodium salt).

The other components are:

• Core: Microcrystalline cellulose, monohydrate lactose, sodium croscarmellose, magnesium stearate (E-572).
• Coating: Partially hydrolyzed polyvinyl alcohol, talc, titanium dioxide (E-171), macrogol/PEG3350, yellow iron oxide (E-172), red iron oxide (E-172).

Appearance of the product and contents of the pack

The 10 mg film-coated tablets are peach-colored, biconvex, with the code M10 engraved on one side.

The film-coated tablets are available in packs containing 14, 28, and 98 film-coated tablets in blister packs.

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 Member States of the European Economic Area under the following names:

PT: Montelucaste Pensa, 10 mg, film-coated tablets

ES: Montelukast Pensa 10 mg film-coated tablets EFG

IT: Montelukast Pensa 10 mg film-coated 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/