MONTELUKAST PENSA 10 mg FILM-COATED TABLETS

Introduction

Leaflet: information for the user

Montelukast Pensa 10 mg film-coated tablets EFG

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, 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 side effects, consult your 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 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 produce 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 asthma and prevent asthma symptoms during the day and night.

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

Depending on the symptoms and 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 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.

The symptoms of asthma include: Cough, wheezing, and chest congestion.

2. What you need to know before taking Montelukast Pensa

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 the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor. Always carry 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 of arms or legs, worsening of lung symptoms, and/or skin rash, they should consult their doctor.
• You should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.
• Patients should be aware that several neuropsychiatric events have been reported with Montelukast Pensa (such as 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 from 2 to 5 years of age, Montelukast Pensa 4 mg chewable tablets are available.

For children from 6 to 14 years of age, 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 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 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 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

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

3. How to take Montelukast Pensa

Follow the administration instructions of this medication exactly 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.
• It should be taken 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, in the evening. 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 from 2 to 5 years of age, Montelukast Pensa 4 mg chewable tablets are available.

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

If you take more Montelukast Pensa than you should

Seek help from your doctor immediately.

In most cases of overdose, no side effects were reported. The symptoms that occurred most frequently 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 take Montelukast Pensa

Try to take Montelukast Pensa as prescribed. However, if you forget a dose, just resume your regular schedule of one tablet once a day. Do not take a double dose to make up for forgotten doses.

If you stop treatment with Montelukast Pensa

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets 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 (affecting at least 1 in 10 patients)
• Common (affecting between 1 and 10 in 100 patients)
• Uncommon (affecting between 1 and 10 in 1,000 patients)
• Rare (affecting between 1 and 10 in 10,000 patients)
• Very rare (affecting 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 that can cause difficulty breathing or swallowing (Uncommon)
• mood-related events [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, and 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, urticaria (Uncommon); painful red lumps under the skin that 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 asthmatic patients 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 have one or more of these symptoms.

Reporting side effects:

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's online system: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Montelukast Pensa

Keep this medication out of the 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 stated 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 pharmacy's SIGRE collection point. If you have any doubts, 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 10 mg of montelukast (as sodium salt).

The other ingredients are:

• Core:Microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, 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 package contents

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

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