PATIENT INFORMATION LEAFLET

Montelukast ASTHMAPHARMA 5 mg chewable tablets EFG

Montelukast sodium

Read this leaflet carefully before you or your child start 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 you or your child and should not be given to others, even if they have the same symptoms as you or your child, as it may harm them.
• If you consider that any of the side effects you experience 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 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 is also used as an alternative treatment to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for the treatment of their asthma and who have demonstrated an inability to use inhaled corticosteroids.

• Montelukast also helps prevent airway constriction caused by exercise.

The use of Montelukast will depend on your symptoms and the severity of your asthma or your child's asthma.

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.

• Sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.

• Inflammation of the inner lining of the airways.

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

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

Do not take MONTELUKAST ASTHMAPHARMA if you or your child

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

Be especially careful with MONTELUKAST ASTHMAPHARMA

• If your asthma or breathing or 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 your doctor has given you or your child. Always have your rescue inhaler medication for asthma attacks available.

• It is essential that you or your child use all medications for asthma prescribed by your doctor. Montelukast should not be used in place of other asthma medications prescribed by your doctor for you or your child.

• 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.

• You or your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.

• Several neuropsychiatric events (e.g., changes in behavior and mood-related, 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 4 mg chewable tablets are available.

For children aged 6 to 14 years, Montelukast 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 or your child are using or have recently used other medications, including those obtained without a prescription.

Before taking Montelukast, inform your doctor if you or your child 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 5 mg chewable tablets should not be taken with meals; they should be taken at least 1 hour before or 2 hours after meals.

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 presence of Montelukast in breast milk 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 very 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), be aware that each 5 mg chewable tablet of Montelukast contains phenylalanine (equivalent to 0.168 mg of phenylalanine in each 5 mg chewable tablet).

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

• Take it even when you or your child do not have symptoms or when having an acute asthma attack.

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

• It should be taken orally.

For children aged 6 to 14 years:

Take one chewable tablet of 5 mg daily at night. Montelukast should not be taken with meals; it should be taken at least 1 hour before or 2 hours after eating.

If you or your child are taking Montelukast Asthmapharma, ensure that neither you nor your child take any other product containing the same active ingredient, montelukast.

If you or your child take more Montelukast Asthmapharma 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, drowsiness, 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 forgot to take Montelukast Asthmapharma or forgot to give Montelukast Asthmapharma to your child:

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

Do not take a double dose to compensate for the missed doses.

If you or your child interrupt treatment with Montelukast Asthmapharma:

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

If you have any other questions about the use of 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 5 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:

• Headache

In addition, the following side effects were reported in clinical trials with Montelukast 10 mg film-coated tablets:

• Abdominal pain

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/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

• Hepatitis (liver inflammation)

• Bruising, 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 pulmonary 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 leaflet, 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. This tablet contains montelukast sodium corresponding to 5 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 5 mg are pink, round, biconvex, packaged in blister of PA/ALL/PVC-Aluminum in packages of: 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140, and 200 tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

FARMALIDER S.A.

c/ Aragoneses 15-

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

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