PATIENT INFORMATION LEAFLET

Montelukast MABO 10 mg Film-Coated Tablets

Read this leaflet carefully before you start taking 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 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, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

• Even if you have no complaints, you should see your doctor regularly.

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

2. What you need to know before you take 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 additional information

Montelukast MABO is a leukotriene receptor antagonist that blocks certain substances called leukotrienes. Leukotrienes produce 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 seasonal allergy symptoms (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 require additional treatment.

?Montelukast MABO also helps prevent airway constriction caused by exercise.

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

Depending on symptoms and the severity of asthma, your doctor will determine how to 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 and react to many things, such as cigarette smoke, pollen, or cold air, or exercise.

??inflammation of the inner layer of the airways.

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

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. Typical symptoms of seasonal allergies may include: a stuffy nose, runny nose, itchy nose; sneezing; watery, swollen, red, and itchy eyes.

Do not takeMontelukast MABOif

• you are allergic (hypersensitive) to Montelukast or to 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 treating acute asthma attacks. If an attack occurs, follow the instructions given by your doctor. Always have your rescue inhaler medication for asthma attacks available.
• It is essential that you or your child use all the 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, numbness or tingling of arms or legs, worsening of 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.

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 way Montelukast MABO works, or Montelukast MABO may affect the way other medicines work that you areusing.

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

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

??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 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, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Use in pregnancy

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

Use in breastfeeding

It is unknown whether Montelukast MABO appears in breast milk. If you are breastfeeding or intend to breastfeed, consult your doctor before taking Montelukast MABO.

Driving and operating 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 adverse effects (such as dizziness and somnolence) that have been reported 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 with them before taking this medicine.

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

Use in adults and adolescents 15 years of age and older

It should be taken daily one 10 mg tablet at night. 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 medication that contains the same active ingredient, Montelukast.

• You should only take one Montelukast MABO 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.
• Take Montelukast MABO always as your doctor has indicated. Consult your doctor or pharmacist if you have any doubts.
• 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 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 Toxicological Information Service, Tel. 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Montelukast MABO

Try to take Montelukast MABO as prescribed. However, if you forget a dose, limit yourself to resuming the 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 MABO

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

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

Like all medicines, Montelukast MABO can cause side effects, although not everyone will experience them.

In clinical trials conducted with Montelukast MABO 10 mg film-coated tablets, the side effects related to the administration of the medication 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 tablet that does not contain medication).

The frequency of possible side effects, indicated 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 peoplepeople
• Very rare: may affect less than 1 in 10,000 people

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

??upper respiratory tract infection(Very common)

??increased risk of bleedingage(Rare)

??allergic reactions that include skin rash, facial swelling, lips, tongue, and/or throat that may cause difficulty breathing or swallowing(Uncommon)

??behavioral and mood changes [sleep changes, including nightmares, sleep problems, sleepwalking, irritability, anxiety, restlessness, excitement including aggressive or hostile behavior, depression(Uncommon);shakiness(Rare); hallucinations, suicidal thoughts and actions(Very rare)]

??dizziness, drowsiness, tingling/numbness, convulsions(Uncommon)

??palpitations(Rare)

??nasal bleeding(Uncommon)

??diarrhea, nausea, vomiting(Common);dry mouth, indigestion(Uncommon)

??hepatitis (inflammation of the liver)(Very rare)

??hematomas, itching, urticaria(Uncommon); red, painful bumps under the skin that more frequently appear on the face (erythema nodosum)(Very rare)

??joint or muscle pain, muscle cramps(Uncommon)

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

??stammering(Very rare)

In patients with asthma treated with Montelukast, rare cases of a combination of symptoms such as flu-like illness, tingling 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 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 do not appear in this prospectus.

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

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

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

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 ofMontelukast MABO

• The active ingredient is Montelukast. Each tablet contains Montelukast sodium corresponding to 10 mg of Montelukast.
• The other components 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 content of the container

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

The containers contain 28 film-coated tablets.

Holder of the Marketing Authorization

MABO-FARMA S.A.

Calle Rejas 2, planta 1

28821 Coslada

Madrid España

Responsible for manufacturing

Meditrial Internationals Ltd.

Iztok Distr.

119A Tsarigradsko shose blvd.

1784 Sofia

Bulgaria

Date of the last review of this leaflet: March 2024

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