Package Insert: Information for the User

Montelukast KERN PHARMA 4 mg Chewable Tablets EFG

Read this package insert carefully before starting to take the medication.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed for your child and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this package insert, inform your doctor or pharmacist.

1. What Montelukast Kern Pharma is and for what it is used

2. Before taking Montelukast Kern Pharma

3. How to take Montelukast Kern Pharma

4. Possible adverse effects

5. Storage of Montelukast Kern Pharma

6. Additional information

Montelukast Kern Pharma 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 Kern Pharma to treat your child's asthma and prevent asthma symptoms during the day and night.

• Montelukast is used to treat 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 asthma treatment and have demonstrated an inability to use inhaled corticosteroids.
• Montelukast also helps prevent airway constriction caused by exercise in patients 2 years of age and older.

The dosage of Montelukast will depend on your child's symptoms and the severity of their asthma, as determined by your doctor.

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, or 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 Kern Pharma to your child if

• he is allergic (hypersensitive) to montelukast or to any of the other components of Montelukast Kern Pharma (see 6. ADDITIONAL INFORMATION).

Be especially careful with Montelukast Kern Pharma

• 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 your doctor has given for your child. Always have your child's rescue inhaler medication available for asthma attacks.
• It is essential that your child uses all medications for asthma 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.

Use of other medications

Some medications may affect the functioning of Montelukast, or Montelukast may affect the functioning of other medications your child is 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 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 Kern Pharma with food and beverages

Montelukast Kern Pharma should not be taken with meals; it should be taken at least 1 hour before or 2 hours after eating.

Pregnancy and breastfeeding

This subsection is not applicable to Montelukast Kern Pharma 4 mg, 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 you can take montelukast 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 Kern Pharma.

Driving and operating machinery

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

Montelukast Kern Pharma 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 Kern Pharma

The chewable tablets of Montelukast Kern Pharma contain aspartame, a source of phenylalanine. If your child has phenylketonuria (a rare hereditary disorder of metabolism), you should be aware that each 4 mg chewable tablet contains phenylalanine (equivalent to 0.674 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.

Make sure your child does not take any other medication that contains the same active ingredient, montelukast.

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

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

Montelukast chewable tablets are not recommended for children under 2 years of age.

If your child takes more Montelukast Kern Pharma than they should:

Seek help from your child's doctor immediately.

In most cases of overdose, no adverse effects were reported. The symptoms that were most frequently reported in adults and children who experienced an overdose were abdominal pain, drowsiness, drowsiness, headache, vomiting, and hyperactivity.

If you forgot to give Montelukast Kern Pharma to your child:

Try to give Montelukast Kern Pharma 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 make up for the missed dose.

If your child stops taking Montelukast Kern Pharma:

Montelukast Kern Pharma 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. It will help control your child's asthma.

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

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

In clinical trials conducted with montelukast 4 mg, 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
• fatigue

In addition, the following side effects were reported in clinical trials with montelukast 10 mg and 5 mg:

• 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/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, tremor, depression, sleep problems, somnambulism, suicidal thoughts and actions (in very rare cases)]
• dizziness, somnolence, paresthesia, seizures
• palpitations
• nasal bleeding
• diarrhea, dry mouth, indigestion, nausea, vomiting
• hepatitis (inflammation of the liver)
• hematomas, pruritus, urticaria, painful red nodules under the skin that more frequently appear on the skin lesions (erythema nodosum)
• joint or muscle pain, muscle cramps
• fatigue, malaise, swelling, fever
• stuttering (very rare - may affect up to 1 in 10,000 people).

In patients with asthma 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 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.

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 expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
• Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Montelukast Kern Pharma Composition

• The active ingredient is montelukast. Each chewable tablet of 4 mg contains 4.15 mg of montelukast sodium, which corresponds to 4 mg of montelukast.
• The other components are: mannitol, microcrystalline cellulose, sodium croscarmellose, hydroxypropyl cellulose, iron oxide red, cherry flavor, aspartame (E 951), and magnesium stearate.

Product Appearance and Packaging Contents

Montelukast Kern Pharma 4 mg chewable tablets are pink, oval, biconvex. They are presented in blister packaging in a 28-tablet container.

Marketing Authorization Holder

KERN PHARMA, S.L.

Polígono Ind. Colón II

Venus, 72

08228 Terrassa (Barcelona)

Spain

Responsible for Manufacturing

PHARMATEN S.A.

Dervenakion 6

Pallini 15351

Attica (Greece)

This leaflet was approved in May 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/