PATIENT INFORMATION LEAFLET

MONTIUKAST ASTHMAPHARMA 10 mg film-coated tablets

Montelukast sodium

Read this leaflet carefully before your child starts taking the medicine.

• 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 and should not be given to others, even if they have the same symptoms as your child, as it may harm them.
• If you consider any of the side effects you experience to be serious or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

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

• Montelukast is used for the treatment of patients who are not adequately controlled with their medication and need additional treatment.
• Montelukast also helps prevent airway constriction caused by exercise.
• In asthmatic patients for whom Montelukast is indicated for asthma, Montelukast may also provide symptomatic relief of seasonal allergic rhinitis.

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

What is asthma?

Asthma is a chronic disease.

Asthma includes:

• Difficulty breathing due to bronchospasm. This bronchospasm worsens and improves in response to various conditions.
• Respiratory 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 respiratory 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: nasal congestion, runny nose, sneezing; itchy nose; watery, swollen, red, and itchy eyes.

Inform your doctor about any allergy or medical condition you have now or have had.

Do not take MONTELUKAST ASTHMAPHARMA if youare allergic (hypersensitive) to montelukast or to any of the other components of Montelukast (see 6).

Be especially careful with MONTELUKAST ASTHMAPHARMA

• If your asthma or breathing worsens, inform your doctor immediately
• Montelukast 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.
• It is essential that you or your child use all asthma medications prescribed by your doctor. Montelukast should not replace other asthma medications prescribed by your doctor.
• Any patient whodoctor. Montelukast should not replace other asthma medications prescribed by your doctor.
• Should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.
• Several neuropsychiatric events (e.g., changes in behavior and mood, depression, and suicidal tendencies) have been reported in patients of all ages (see section 4). If you develop these symptoms while taking Montelukast, contact your doctor.

Use in children

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

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

Use of other medications

Some medications may affect the functioning of Montelukast, or Montelukast may affect the functioning of other medications you are using.

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription.

Before taking Montelukast, 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 ASTHMAPHARMA with food and beverages

Montelukast 10 mg can be taken with or without food.

Pregnancy and breastfeeding

Use during pregnancy

Women who are pregnant or intend to become pregnant should consult their doctor before taking Montelukast. Your doctor will evaluate whether you can take Montelukast during this period.

Use during breastfeeding

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

Driving and operating machinery

Montelukast 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 may affect the patient's ability to drive or operate machinery.

Important information about some components of MONTELUKAST ASTHMAPHARMA

The film-coated tablets of Montelukast 10 mg contain lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medication.

• You should only take one Montelukast Asthmapharma tablet once a day, as prescribed by your doctor.

• You should take it even when you don't have symptoms or when you have an acute asthma attack.

• Take Montelukast Asthmapharma as directed by your doctor. Consult your doctor or pharmacist if you have any doubts.

• It should be taken orally.

For adults 15 years of age and older:

Take one 10 mg tablet daily at night. Montelukast Asthmapharma 10 mg can be taken with or without food.

Make sure you are not taking any other product that contains the same active ingredient, montelukast, while taking Montelukast.

If you take more Montelukast Asthmapharma than you should:

In most cases of overdose, no adverse effects were reported. The most frequently reported symptoms in adults and children who experienced an overdose were abdominal pain, drowsiness, dizziness, 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 Asthmapharma:

Try to take Montelukast as directed. However, if you forget a dose, simply resume your usual regimen of one tablet once a day.

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

If you interrupt treatment with Montelukast Asthmapharma:

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

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

Like all medications, Montelukast can produce side effects, although not everyone will experience them.

In clinical trials conducted with Montelukast 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 than with placebo (a tablet that does not contain medication).

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

• Upper respiratory tract infection

• Increased risk of bleeding

• Allergic reactions that include skin rash, swelling of the face, lips, tongue, and/orthroat that can cause difficulty breathing or swallowing

• Behavioral and mood changes [sleep disturbances, including nightmares, hallucinations, irritability, anxiety, restlessness, excitement including aggressive or hostile behavior, tremors, depression, sleep problems, somnambulism, thoughts, and suicidal actions (in very rare cases)]

• Dizziness, drowsiness, tingling/numbness, seizures

• Palpitations

• Nasal bleeding

• Diarrhea, dry mouth, indigestion, nausea, vomiting

• Hepatitis (liver inflammation)

• Hematomas, itching, urticaria, painful red lumps under the skin that more frequently appear on the skin (erythema nodosum)

• Muscle or joint pain, muscle cramps

• Fatigue, discomfort, swelling, fever

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. Rare cases (may affect up to 1 in 10,000 people) of stuttering have also been reported.

Ask your doctor or pharmacist for more information about side effects. If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, report it to your doctor or pharmacist.

• Keep out of reach and sight of children.

• Do not use this medicine after the date represented by the six numbers after CAD that appears on the blister. The first two numbers indicate the month; the last four numbers indicate the year. The expiration date is the last day of the month indicated.

• Store in the original packaging.

• Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you do not need. This will help protect the environment.

Composition of MONTELUKAST ASTHMAPHARMA

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, sodium croscarmellose, hydroxypropyl cellulose, magnesium stearate.

Coating: polyvinyl alcohol, titanium dioxide (E-171), talc, yellow iron oxide (E-172), lecithin, xanthan gum, red iron oxide (E-172), and black iron oxide (E-172)

Appearance of the product and contents of the package

The 10 mg tablets are beige, round, biconvex, and film-coated.

Blister packs in packages of: 7, 10, 14, 20, 28, 30, 50, 56, 84, 90, 98, 100, 140, and 200 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

FARMALIDER S.A.

c/ Aragoneses 15-

28108 Alcobendas (Madrid)

Spain

Responsible manufacturers

PHARMATEN, S.A.

6 Dervenakion Street

Pallini 15351 –Athens

Greece

or

PHARMATEN INTERNATIONAL, S.A.

Sapes Industrial Park Block 5

69300 Rodopi

Greece

or

FARMALIDER S.A.

c/ Aragoneses 15-

28108 Alcobendas (Madrid)

Spain

This leaflet was approved in March 2025