Montelukast Kern Pharma 4 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast KERN PHARMA 4 mg chewable tablets EFG

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

• Keep this leaflet as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for your child. Do not give it to others, even if they have the same symptoms, as it may harm them.
• If you think any of the side effects your child experiences is severe, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

1. What Montelukast KERN PHARMA is and what it is used for
2. Before you take Montelukast KERN PHARMA
3. How to take Montelukast KERN PHARMA
4. Possible side effects
5. How to store Montelukast KERN PHARMA
6. Further information

1. What is MONTELUKAST KERN PHARMA and what is it used for?

Montelukast Kern Pharma is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause 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 to prevent asthma symptoms during the day and night.

• Montelukast is used to treat patients aged 2 to 5 years who are not adequately controlled with their current medication and require additional treatment.
• Montelukast is also used as an alternative to inhaled corticosteroids in patients aged 2 to 5 years who have not recently taken oral corticosteroids for their asthma and who have demonstrated inability to use inhaled corticosteroids.
• Montelukast also helps prevent exercise-induced narrowing of the airways in patients aged 2 years and older.

Depending on your child's symptoms and the severity of their asthma, your doctor will determine how Montelukast should be used.

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 triggers.
• sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• swelling (inflammation) of the inner lining of the airways.

Symptoms of asthma include: coughing, wheezing, and chest tightness.

2. BEFORE TAKING MONTELUKAST KERN PHARMA CHEWABLE TABLETS

Inform your doctor of any allergies or medical conditions your child currently has or has had in the past.

Do not give Montelukast Kern Pharma to your child if

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

Take special care with Montelukast Kern Pharma

• If your child's asthma or breathing worsens, inform your doctor immediately.
• Oral montelukast is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for your child. Always keep your child's rescue inhaled medication available for asthma attacks.
• It is important that your child uses all asthma medications prescribed by the doctor. Montelukast should not be used instead 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 or she develops a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening of pulmonary symptoms, and/or skin rash, you should consult your doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they cause worsening of his or her asthma.

Use of other medicines

Some medicines may affect the way Montelukast works, or Montelukast may affect the way other medicines your child is taking work.

Inform your doctor or pharmacist if your child is taking or has recently taken any other medicines, including those obtained without a prescription.

Before taking Montelukast, tell your doctor if your child is taking any of the following medicines:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)

Taking Montelukast Kern Pharma with food and drink

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

Pregnancy and breastfeeding

This section does not apply to Montelukast Kern Pharma 4 mg, as it is indicated for use in children aged 2 to 5 years. However, the following information is relevant for the active substance, montelukast.

Use during pregnancy

Women who are pregnant or planning to become pregnant should consult their doctor before taking Montelukast. Your doctor will assess whether you can take montelukast during pregnancy.

Use during breastfeeding

It is unknown whether montelukast passes into breast milk. If you are breastfeeding or planning to breastfeed, you should consult your doctor before taking Montelukast Kern Pharma.

Driving and using machines

This section does not apply to Montelukast Kern Pharma 4 mg, as it is indicated for use in children aged 2 to 5 years. However, the following information is relevant for the active substance, montelukast.

Montelukast Kern Pharma is not expected to affect the ability to drive a car or operate machinery. However, individual responses to the medicine may vary. Certain adverse reactions (such as dizziness and somnolence), which have been reported very rarely with montelukast, could affect a patient's ability to drive or operate machinery.

Important information about some of the components of Montelukast Kern Pharma

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

3. HOW TO TAKE MONTELUKAST KERN PHARMA

• This medicine should be given to children under the supervision of an adult.
• Your child should take only one montelukast tablet once daily, as prescribed by their doctor.
• It should be taken even when your child has no symptoms or during an acute asthma attack.
• Always ensure your child takes montelukast exactly as directed by their doctor. Consult your child's doctor or pharmacist if you have any doubts.
• This medicine must be taken orally.

For children aged 2 to 5 years:

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

If your child is taking Montelukast Kern Pharma, make sure they do not take any other medication containing the same active substance, 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.

The montelukast chewable tablet is not recommended for children under 2 years of age.

If your child takes more Montelukast Kern Pharma than they should

Seek immediate help from your child's doctor.

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

If you forget to give Montelukast Kern Pharma to your child

Try to give Montelukast Kern Pharma as prescribed. However, if your child misses a dose, simply resume the usual regimen of one tablet once daily.

Do not give a double dose to make up for missed doses.

If your child stops taking Montelukast Kern Pharma

Montelukast Kern Pharma can only treat your child's asthma if treatment is continued.

It is important that your child continues taking montelukast for the duration prescribed by their doctor. It will help control your child's asthma.

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

4. Possible adverse effects

Like all medicines, Montelukast Kern Pharma can cause adverse effects, although not everyone experiences them.

In clinical trials with montelukast 4 mg, the adverse effects related to the administration of the medicine and reported most frequently (occurring in at least 1 in 100 patients and in less than 1 in 10 patients treated) were:

• abdominal pain
• drowsiness

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

• headache

These adverse effects were generally mild and occurred more frequently in patients treated with montelukast than in those treated with placebo (a pill containing no active ingredient).

Furthermore, since the medicine has been marketed, the following adverse effects have been reported:

• upper respiratory tract infection
• increased tendency to bleeding
• allergic reactions including skin rash, swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing
• changes in behavior and mood [sleep disturbances, including nightmares, hallucinations, irritability, anxiety, restlessness, agitation including aggressive behavior or hostility, tremor, depression, sleep problems, sleepwalking, suicidal thoughts and actions (in very rare cases)]
• dizziness, somnolence, tingling/numbness, seizures
• palpitations
• nosebleeds
• diarrhea, dry mouth, indigestion, nausea, vomiting
• hepatitis (inflammation of the liver)
• bruising, itching, hives, painful red lumps under the skin that most frequently appear on the shins (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 asthmatic patients 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 pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) have been reported. You must inform your doctor immediately if your child has one or more of these symptoms.

Ask your doctor or pharmacist for further information about adverse effects. If you consider any of the adverse effects your child experiences to be severe, or if you notice any adverse effect not mentioned in this leaflet, inform your child's doctor or pharmacist.

5. Conservation of MONTELUKAST KERN PHARMA

• Keep out of the reach and sight of children.
• Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.
• Medicines should not be disposed of via wastewater drains or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Montelukast Kern Pharma

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

Appearance of the medicinal product and contents of the pack

Montelukast Kern Pharma 4 mg chewable tablets are pink, oval-shaped, biconvex tablets. They are presented in blister packs containing 28 tablets.

Marketing Authorization Holder

KERN PHARMA, S.L.

Polígono Ind. Colón II

Venus, 72

08228 Terrassa (Barcelona)

Spain

Manufacturer

PHARMATEN S.A.

Dervenakion 6

Pallini 15351

Attica (Greece)

This leaflet was last approved in May 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/