Package Leaflet:Information for the User

Montelukast 5 mg Chewable Tablets EFG

Read this leaflet carefully before you start to take this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, do not give it to others even if they have similar symptoms to you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist. Even if they are not listed in this leaflet. 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 and helps control asthma.

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

• Montelukast Pensa is used for treatment in patients between 6 and 14 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 6 and 14 years of age who have not taken oral corticosteroids recently for asthma treatment and have shown that they are unable to use inhaled corticosteroids.
• Montelukast Pensa also helps prevent airway narrowing caused by exercise.

Depending on symptoms and the severity of your asthma or your child's 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 takeMontelukastThink:

• If you or your child is allergic to montelukast or to any of the other components of this medication (including those listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take montelukast.

• If your asthma or breathing or your child's 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 for you or for your child. Always have your rescue inhaler medication for asthma attacks available.
• It is essential that you or your child use all asthma medications prescribed by your doctor. Montelukast Pensa should not replace other asthma medications prescribed by your doctor 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 of arms or legs, worsening of respiratory symptoms, and/or skin rash, they should consult their doctor.
• You or your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.
• 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 or your child 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 or your child 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 should not be taken with meals; 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 intend 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 presence of Montelukast Pensa in breast milk is unknown. If you are breastfeeding or intend 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 aspartame,a source of phenylalanine. This medication may be harmful to individuals with phenylketonuria.

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

Use in children aged 6 to 14 years:

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

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 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 overdose cases in adults and children 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 Toxicology 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 or your child forget a dose, simply resume the usual regimen of one tablet once a day. Do not take a double dose to compensate for missed doses.

If you interrupt treatment with Montelukast Pensa

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

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

Like all medicines, this medicine may 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); tremor(Rare); hallucinations, disorientation, suicidal thoughts and actions, stuttering(Very rare)]
• dizziness, somnolence, paresthesia, convulsions(Uncommon)
• palpitations(Rare)
• epistaxis(Uncommon)
• diarrhea, nausea, vomiting(Common); dry mouth, indigestion(Uncommon)
• hepatitis (inflammation of the liver)(Very rare)
• skin rash(Common); hematomas, pruritus, urticaria(Uncommon); red painful bumps under the skin that more frequently appear on the acne (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 respiratory 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 prospectus. You can also report them directly through theSpanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

This medication does not require any special storage temperature.

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 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 chewable 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 flavor (maltodextrin, modified food starch (corn syrup), artificial flavors, triacetin, benzyl alcohol).

Appearance of the product and contents of the packaging

The 5 mg chewable tablets are pink and biconvex with the code M5 engraved on one face.

The chewable tablets are presented in packaging containing 14, 28, and 98 chewable tablets.

Only some package sizes may be marketed.

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, 5 mg, chewable tablets

ES:Montelukast Pensa 5 mg chewable tablets EFG

IT:Montelukast Pensa 5 mg chewable tablets

Last review date of this leaflet: August 2019

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/