Prospecto:information for the user

Montelukast pensa 10 mg film-coated tablets

Read this prospect carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist. Even if they are not listed in this prospect. See section 4.

Montelukast Pensa is a leukotriene receptor antagonist that blocks certain substances called leukotrienes. Leukotrienes produce narrowing and swelling of the airways in the lungs. By blocking leukotrienes, Montelukast Pensa improves asthma symptoms, helps control asthma, and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).

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

• Montelukast Pensa is used to treat adults and adolescents 15 years of age and older who are not adequately controlled with their medication and need additional treatment.
• In 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 constriction caused by exercise.

Depending on symptoms and the severity of your asthma, your 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 conditions.
• Sensitive airways that react to many things, such as cigarette smoke, pollen, or cold air, or exercise.
• Swelling (inflammation) of the inner layer of the airways.

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

Do not take Montelukast Pensa:

• If you are allergic to montelukast or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take montelukast.

• If your asthma or breathing worsens, inform your doctor immediately.
• Montelukast Pensa is not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions given by your doctor. Always have your rescue inhaler medication for asthma attacks.
• It is essential 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 respiratory symptoms, and/or skin rash, they should consult their doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.
• Patients should be aware that several neuropsychiatric events have been reported with Montelukast Pensa (e.g., changes in behavior and mood-related changes) 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 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 medications

Inform your doctor or pharmacist if you are taking, have 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 you are using.

Before taking Montelukast Pensa, inform your doctor if you are taking the following medications:

• 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 can be taken with or without food.

Pregnancy, breastfeeding, and fertility

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 evaluate whether you can take Montelukast Pensa during pregnancy.

Use during breastfeeding

The safety of Montelukast Pensa in breastfeeding women is unknown. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking Montelukast Pensa.

Driving and operating machinery

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

Montelukast Pensa contains lactose.If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• You should only take one Montelukast Pensa tablet once a day, as prescribed by your doctor.
• You should take it even when you do not have symptoms or when you have an acute asthma attack.
• It should be taken orally.

Use in adults 15 years of age and older:

You should take one Montelukast Pensa 10 mg film-coated tablet 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 that contains the same active ingredient, 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 cases of overdose, no adverse effects were reported. The symptoms that were most frequently reported in adults and children who experienced an overdose were abdominal pain, drowsiness, drowsiness, headache, vomiting, and hyperactivity.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Montelukast Pensa

Try to take Montelukast Pensa as prescribed. However, if you forget a dose, simply resume your usual regimen of one tablet once a day. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Montelukast Pensa

Montelukast Pensa can only treat your asthma if you continue to take it. It is essential that you continue taking Montelukast Pensa for the time your doctor prescribes. It will help control your asthma.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience 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
• sedation

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 tablet that does not contain a medicine).

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)

Furthermore, since the medicine has been marketed, the following side effects have been reported:

• upper respiratory tract infection(Very common)
• increased risk of bleeding(Rare)
• allergic reactions that include swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing(Uncommon)
• behavioral and mood changes [sleep disturbances, including nightmares, sleep problems, somnambulism, irritability, anxiety, restlessness, excitement including aggressive or hostile behavior, depression(Uncommon);shakiness(Rare); hallucinations, disorientation, suicidal thoughts and actions, and stuttering(Very rare)]
• dizziness, somnolence, paresthesia, convulsions(Uncommon)
• palpitations(Rare)
• nasal bleeding(Uncommon)
• diarrhea, nausea, vomiting (Common); dry mouth, indigestion(Uncommon)
• hepatitis (inflammation of the liver)(Very rare)
• skin rash(Common); bruises, pruritus, urticaria(Uncommon); red painful bumps under the skin that more frequently appear on the face (erythema nodosum), severe skin reactions (erythema multiforme) that may occur without warning(Very rare)
• musculoskeletal pain or 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, paresthesia or numbness of arms and legs, worsening of pulmonary symptoms, and/or skin rash (Churg-Strauss syndrome) have been reported. Inform your doctor immediately if you experience one or more of these symptoms.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de medicamentos de Uso Humano:https://www.notificaRAM.es.By reporting side effects, you can contribute to providing more information about the safety of this medicine.

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

This medication does not require any special temperature for conservation.

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

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Montelukast Pensa

The active ingredient is montelukast. Each tablet contains 10 mg of montelukast (as sodium salt).

The other components are:

• Nucleus: Microcrystalline cellulose, lactose monohydrate, 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 packaging

The 10 mg film-coated tablets are orange-colored and biconvex with the code M10 engraved on one face.

The film-coated tablets are presented in packaging containing 14, 28, and 98 film-coated tablets.

Only some packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

Kymos, S.L.

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

08290 Cerdanyola del Vallès (Barcelona)

Spain

This medicine is authorized in the member states of the European Economic Area with 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

Last review date of this leaflet: August 2019

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/