PATIENT INFORMATION LEAFLET

Montelukast ASTHMAPHARMA 4 mg chewable tablets EFG

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, consult your doctor or pharmacist.
• This medicine has been prescribed for your child 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 that any of the side effects you are experiencing are 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 narrowing and swelling of the airways in the lungs. By blocking leukotrienes, Montelukast improves asthma symptoms and helps control asthma.

Your doctor has prescribed Montelukast to treat your child's asthma and prevent asthma symptoms during the day and night.

• Montelukast is used for the treatment of patients between 2 and 5 years of age who are not adequately controlled with their medication and need additional treatment.

• Montelukast is also used as an alternative treatment to inhaled corticosteroids in patients between 2 and 5 years of age who have not recently taken oral corticosteroids for the treatment of their asthma and who have demonstrated that they are unable to use inhaled corticosteroids.

• Montelukast also helps prevent airway constriction caused by exercise in patients 2 years of age and older.

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

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, cold air, or exercise.

• Swelling (inflammation) of the inner layer of the airways.

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

Inform your child's doctor about any allergy or medical condition your child has now or has had.

Do not give MONTELUKAST ASTHMAPHARMA to your child if

• He is allergic (hypersensitive) to montelukast or to any of the other components of Montelukast (see section 6).

Be especially careful with MONTELUKAST ASTHMAPHARMA

• If your child's 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 for your child. Always have your child's rescue inhaler medication available for asthma attacks.

• It is important that your child uses all the asthma medications prescribed by your doctor.

Montelukast should not be used in place of other asthma medications prescribed by your doctor for your child.

• If your child is being treated with asthma medications, be aware that if he develops a combination of symptoms such as flu-like illness, tingling or numbness of arms or legs, worsening of respiratory symptoms, and/or skin rash, he should consult his doctor.

• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they worsen his asthma.

• Several neuropsychiatric events (e.g., changes in behavior and mood-related changes, depression, and suicidal tendencies) have been reported in patients of all ages (see section 4). If he develops these symptoms while taking Montelukast, he should contact his doctor.

Use of other medications

Some medications may affect the functioning of Montelukast ASTHMAPHARMA, or Montelukast ASTHMAPHARMA may affect the functioning of other medications your child is using.

Inform your doctor or pharmacist if your child is using or has recently used other medications, including those obtained without a prescription.

Before taking Montelukast, inform your doctor if your child is 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 ASTHMAPHARMA 4 mg chewable tablets should not be taken with meals; it should be taken at least 1 hour before or 2 hours after meals.

Pregnancy and breastfeeding

This subsection does not apply to Montelukast 4 mg chewable tablets, as its use is indicated in children aged 2 to 5 years, however, the following information is important for the active ingredient, montelukast.

Use during pregnancy

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

Use during breastfeeding

The passage of Montelukast into breast milk is unknown. If you are breastfeeding or intend to breastfeed, you should consult your doctor before taking Montelukast.

Driving and operating machinery

This subsection does not apply to Montelukast 4 mg chewable tablets, as its use is indicated in children aged 2 to 5 years, however, the following information is important for the active ingredient, montelukast.

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 of the components of MONTELUKAST ASTHMAPHARMA

This medication may be harmful to individuals with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

If your child has phenylketonuria (a rare hereditary metabolic disorder), note that each 4 mg chewable tablet of Montelukast contains phenylalanine (equivalent to 0.135 mg of phenylalanine in each 4 mg chewable tablet).

• This medication should be administered to children under the supervision of an adult.

• Your child should only take one Montelukast tablet once a day, as prescribed by their doctor.

• It should be taken even when your child does not have symptoms or when they have an acute asthma attack.

• Make sure your child takes Montelukast as instructed by their doctor. Consult with your child's doctor or pharmacist if you have any doubts.

• It should be taken orally

For children aged 2 to 5 years:

A daily chewable tablet of 4 mg should be taken at night. Montelukast should not be taken with meals; it should be taken at least 1 hour before or 2 hours after eating.

If your child is taking Montelukast Asthmapharma, make sure they do not take any other medication that contains the same active ingredient, montelukast.

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. The 4 mg chewable tablet of Montelukast Asthmapharma is not recommended for children under 2 years of age.

If your child takes more Montelukast Asthmapharma than they 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to give Montelukast Asthmapharma to your child:

Try to give Montelukast as prescribed. However, if your child forgets a dose, simply resume the usual regimen of one tablet once a day.

Do not give a double dose to compensate for missed doses.

If your child interrupts treatment with Montelukast Asthmapharma:

Montelukast can only treat your child's asthma if they continue to take it.

It is essential that your child continues to take Montelukast for the duration prescribed by their doctor.

This will help control your child's asthma.

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

Like all medications, Montelukast can produce 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 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
• Thirst

Additionally, the following side effects were reported in clinical trials with Montelukast 10 mg film-coated tablets and 5 mg chewable tablets:

• 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 medication).

Additionally, 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/or throat that may 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, suicidal thoughts and actions (in very rare cases)]

• Dizziness, drowsiness, tingling/numbness, seizures

• Palpitations

• Nasal bleeding

• Diarrhea, dry mouth, indigestion, nausea, vomiting

• Heptatitis (inflammation of the liver)

• Ecchymoses, pruritus, urticaria, painful red nodules 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 your child has 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 side effects not mentioned in this prospectus, report them to your doctor or pharmacist.

• Keep out of the reach and sight of children.

• Do not use this medicine after the date represented by the six numbers following 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 no longer need. This will help protect the environment.

Composition of MONTELUKAST ASTHMAPHARMA

• The active ingredient is montelukast. Each tablet contains montelukast sodium equivalent to 4 mg of montelukast.

• The other components are:

Manitol, microcrystalline cellulose, sodium croscarmellose, L-hydroxypropyl cellulose, iron oxide red (E172), cherry aroma, aspartame (E 951), magnesium stearate.

Appearance of the product and contents of the package

The chewable tablets of Montelukast ASTHMAPHARMA 4 mg are pink, oval, biconvex, packaged in PA/ALL/PVC-Aluminum blisters in packages of: 7, 10, 14, 20, 28, 30, 50, 56, 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