MONTELUKAST MABO 10 mg FILM-COATED TABLETS

Introduction

PATIENT INFORMATION LEAFLET

Montelukast MABO 10 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it

contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, do not pass it on to others

even if they have the same symptoms as 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.

Contents of the pack:

1. What is Montelukast MABO 10 mg and what is it used for
2. What you need to know before taking Montelukast MABO 10 mg
3. How to take Montelukast MABO 10 mg
4. Possible side effects
5. Storage of Montelukast MABO 10 mg
6. Contents of the pack and further information

1. What is Montelukast MABO 10 mg and what is it used for

Montelukast MABO is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in the lungs and can also cause allergy symptoms. By blocking leukotrienes, Montelukast MABO 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 MABO to treat asthma and prevent asthma symptoms during the day and night.

Montelukast MABO is used for the treatment of patients who are not adequately controlled with their medication and need additional treatment.

Montelukast MABO also helps prevent airway narrowing caused by exercise.

In asthmatic patients for whom Montelukast MABO is indicated for asthma, Montelukast MABO may also provide symptomatic relief of seasonal allergic rhinitis.

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

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 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: coughing, wheezing, and chest congestion.

What are seasonal allergies?

Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic response often caused by airborne pollen from trees, grass, and weeds. Symptoms of seasonal allergies typically include: congested nose, runny nose; sneezing; itchy, watery, swollen, red, and stinging eyes.

2. What you need to know before taking Montelukast MABO 10 mg

Do not takeMontelukast MABOif

• you are allergic (hypersensitive) to Montelukast or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• If your asthma or breathing worsens, inform your doctor immediately.
• Montelukast MABO oral 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 inhalation medication for asthma attacks.
• It is essential that you or your child use all asthma medications prescribed by your doctor. Montelukast MABO 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.

Use in children

For children aged 2 to 5 years, Montelukast MABO 4 mg chewable tablets are available.

For children aged 6 to 14 years, Montelukast MABO 5 mg chewable tablets are available.

Taking Montelukast MABO with other medicines

Some medicines may affect the functioning of Montelukast MABO, or Montelukast MABO may affect the functioning of other medicines you are taking.

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Before taking Montelukast MABO, tell your doctor if you are taking the following medicines:

fenobarbital (used to treat epilepsy)

phenytoin (used to treat epilepsy)

rifampicin (used to treat tuberculosis and some other infections)

Taking Montelukast MABO with food and drinks

Montelukast MABO 10 mg can be taken with or without food.

Pregnancy and breastfeeding

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

Use during pregnancy

Your doctor will assess whether you can take Montelukast MABO during this period.

Use during breastfeeding

It is not known whether Montelukast MABO appears in breast milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking Montelukast MABO.

Driving and using machines

Montelukast MABO is not expected to affect your ability to drive a car or operate machines. However, individual responses to the medicine may vary. Certain side effects (such as dizziness and drowsiness) that have been reported very rarely with Montelukast MABO may affect the patient's ability to drive or operate machines.

Montelukast MABO 10 mg contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Montelukast MABO 10 mg

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Use in adults and adolescents 15 years of age and older

One 10 mg tablet should be taken daily in the evening. Montelukast MABO 10 mg can be taken with or without food.

If you are taking Montelukast MABO, make sure you do not take any other medicine that contains the same active ingredient, Montelukast.

• You should only take one Montelukast MABO 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.
• Always take Montelukast MABO as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
• It should be taken orally.

If you take more Montelukast MABO than you should

In most cases of overdose, no adverse effects were reported. The symptoms that occurred most frequently reported 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, Tel. 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Montelukast MABO

Try to take Montelukast MABO as prescribed. However, if you miss a dose, just resume your regular schedule of one tablet once a day.

Do not take a double dose to make up for missed doses.

If you stop taking Montelukast MABO

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

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

4. Possible side effects

Like all medicines, Montelukast MABO can cause side effects, although not everybody gets them.

In clinical trials conducted with Montelukast MABO 10 mg film-coated tablets, the side effects related to the administration of the medicine and reported most frequently (occurring in at least 1 in 100 patients and less than 1 in 10 patients treated) were:

• abdominal pain
• headache

These side effects were generally mild and occurred more frequently in patients treated with Montelukast MABO than with placebo (a pill that does not contain medicine).

The frequency of possible side effects, listed below, is defined using the following convention:

• Very common: may affect more than 1 in 10 people
• Common: may affect between 1 and 10 in 100 people
• Uncommon: may affect between 1 and 10 in 1,000 people
• Rare: may affect between 1 and 10 in 10,000 people
• Very rare: may affect less than 1 in 10,000 people

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

upper respiratory infection (Very common)

increased risk of bleeding (Rare)

allergic reactions including skin rash, swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing (Uncommon)

behavior-related changes and mood changes [sleep disturbances, including nightmares, sleep problems, somnambulism, irritability, feeling anxious, restlessness, excitement including aggressive or hostile behavior, depression (Uncommon);tremor (Rare); hallucinations, suicidal thoughts and actions (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)

bruising, itching, urticaria (Uncommon); red, painful bumps under the skin that most frequently appear on the shins (erythema nodosum) (Very rare)

joint or muscle pain, muscle cramps (Uncommon)

fever (Common);fatigue, malaise, swelling (Uncommon)

stuttering (Very rare)

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.

Ask your doctor or pharmacist for more information about side effects.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

5. Storage of Montelukast MABO 10 mg

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and further information

Composition ofMontelukast MABO

• The active substance is Montelukast. Each tablet contains Montelukast sodium equivalent to 10 mg of Montelukast.
• The other ingredients are: Core:microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropylcellulose (E-463), sodium croscarmellose, magnesium stearate. Coating:Opadry orange 03B23378 (hypromellose (E-464), hydroxypropylcellulose (E-463), titanium dioxide (E-171), yellow iron oxide (E-172), red iron oxide (E-172), black iron oxide (E-172), and polyethylene glycol).

Appearance of the product and contents of the pack

Montelukast MABO 10 mg film-coated tablets are beige, square, biconvex, marked with MOK 10 on one side and PHD 741 on the other.

The packs contain 28 film-coated tablets

Marketing authorization holder

MABO-FARMA S.A.

Calle Vía de los Poblados 3,

Edificio 6, 28033, Madrid,

Spain.

Manufacturer

Meditrial Internationals Ltd.

Iztok Distr.

119A Tsarigradsko shose blvd.

1784 Sofia

Bulgaria

Date of the last revision of this leaflet: March 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/