Package Insert: Information for the User

Montelukast KERN PHARMA 5 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 asthma and prevent asthma symptoms during the day and night.

• Montelukast is used to treat 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 asthma treatment and 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, 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.
• 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 Kern Pharma if you or your child

• are 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 asthma or your child's 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 you or your child. Always have your child's rescue inhaler medication available for asthma attacks.
• 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, tingling or numbness 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.

Use in children

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.

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 purchased 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 Kern Pharma with food and beverages

Montelukast should not be taken with meals; it 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 safety of montelukast in breastfeeding women is unknown. If you are breastfeeding or intend to breastfeed, you should consult your doctor before taking Montelukast Kern Pharma.

Driving and operating machinery

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 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 metabolic disorder), you should be aware that each 5 mg chewable tablet contains phenylalanine (equivalent to 0.842 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.
• It should be taken 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 child's doctor or pharmacist if you have any doubts.
• It should be taken orally.

For children aged 6 to 14 years:

A daily chewable tablet of 5 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 you or your child are taking Montelukast Kern Pharma, make sure neither you nor your child take any other medication containing the same active ingredient, montelukast.

If you or your child take more Montelukast Kern Pharma than you should:

Seek immediate help from your doctor.

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.

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

Try to take Montelukast Kern Pharma 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 missed doses.

If you or your child stop taking Montelukast Kern Pharma:

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

In clinical trials conducted with montelukast 5 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:

• headache

Additionally, 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).

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
• hepatitis (inflammation of the liver)
• bruising, itching, urticaria, painful red lumps under the skin that more frequently appear on the skin (erythema nodosum)
• joint or muscle pain, muscle cramps
• fatigue, discomfort, 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 you have 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 leaflet, report it to your doctor or pharmacist.

• Keep out of reach and sight of children.
• Do not use this medicine after the expiration date shown 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.

Composition of Montelukast Kern Pharma

• The active ingredient is montelukast. Each chewable tablet of 5 mg contains 5.19 mg of montelukast sodium, which corresponds to 5 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.

Appearance of the product and contents of the package

The chewable tablets of Montelukast Kern Pharma 5 mg are pink, round, biconvex. They are presented in blister packaging in a package of 28 tablets.

Holder of the marketing authorization

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/