MONTELUKAST KERN PHARMA 5 mg CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

Montelukast KERN PHARMA 5 mg Chewable Tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, 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 pass it on to others, even if their symptoms are the same, as it may harm them.
• If you think any of the side effects that your child is getting are serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Contents of the pack:

1. What Montelukast Kern Pharma is and what it is used for
2. Before taking Montelukast Kern Pharma
3. How to take Montelukast Kern Pharma
4. Possible side effects
5. Storage of 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 the symptoms of asthma 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 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 between 6 and 14 years of age who have not recently taken oral corticosteroids for the treatment of their asthma and have demonstrated that they are unable to use inhaled corticosteroids.
• Montelukast also helps prevent airway narrowing caused by exercise.

Depending on the symptoms and severity of your asthma or 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 diseases.
• airways that are sensitive and react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• swelling (inflammation) of the inner layer of the airways.

The symptoms of asthma include: Cough, wheezing, and chest congestion.

2. BEFORE TAKING MONTELUKAST KERN PHARMA

Tell your doctor about any allergy or medical problem that 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 ingredients of Montelukast Kern Pharma (see 6. FURTHER INFORMATION).

Be careful with Montelukast Kern Pharma

• If your asthma or breathing or your child's asthma or breathing worsen, tell your doctor immediately.
• Oral montelukast is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions that your doctor has given you or your child. Always have your child's rescue inhaler medication for asthma attacks.
• It is essential that you or your child use all asthma medications prescribed by your doctor. Montelukast should not be used instead of other asthma medications that your doctor has prescribed 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 lung 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 non-steroidal anti-inflammatory medications or NSAIDs) if they worsen your asthma.

Use in children

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

For children from 6 to 14 years of age, 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.

Tell your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

Before taking Montelukast, tell your doctor if you or your child are taking the following medications:

• 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 drinks

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 plan to become pregnant should consult their doctor before taking Montelukast. Your doctor will assess whether you can take montelukast during this period.

Use during breastfeeding

It is not known whether montelukast appears in breast milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking Montelukast Kern Pharma.

Driving and using machines

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 side effects (such as dizziness and drowsiness) 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 ingredients of Montelukast Kern Pharma

Montelukast Kern Pharma chewable tablets contain aspartame, a source of phenylalanine. If your child has phenylketonuria (a rare, inherited disorder of metabolism), you should note that each 5 mg chewable tablet contains phenylalanine (equivalent to 0.842 mg of phenylalanine in each 5 mg chewable tablet).

3. HOW TO TAKE MONTELUKAST KERN PHARMA

• 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 you or your child have an acute asthma attack.
• Always take montelukast as your doctor has told you. Consult your child's doctor or pharmacist if you have any doubts.
• It should be taken orally.

For children from 6 to 14 years of age:

One 5 mg chewable tablet should be taken daily in the evening. Montelukast should not be taken with meals; it should be taken at least 1 hour before or 2 hours after meals.

If you or your child are taking Montelukast Kern Pharma, make sure that neither you nor your child take any other medication that contains the same active ingredient, montelukast.

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

Ask your doctor for help immediately.

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

If you or your child forget to take Montelukast Kern Pharma

Try to take Montelukast Kern Pharma as prescribed. However, if you or your child forget a dose, just resume your usual routine of one tablet once a day.

Do not take a double dose to make up for forgotten 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 that you continue taking montelukast for as long as your doctor prescribes it. 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.

4. Possible side effects

Like all medicines, Montelukast Kern Pharma can cause side effects, although not everybody gets them.

In clinical trials 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 with a higher frequency in patients treated with montelukast than with placebo (a pill that does not contain medication).

Additionally, since the medication has been marketed, the following side effects have been reported:

• upper respiratory infection
• increased risk of bleeding
• allergic reactions including skin rash, swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing
• behavioral and mood-related changes [sleep disturbances, including nightmares, hallucinations, irritability, feeling anxious, restlessness, excitement including aggressive or hostile behavior, tremor, depression, sleep problems, sleepwalking, suicidal thoughts and actions (in very rare cases)]
• dizziness, drowsiness, tingling/numbness, seizures
• palpitations
• nosebleeds
• diarrhea, dry mouth, indigestion, nausea, vomiting
• hepatitis (inflammation of the liver)
• bruises, 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 lung symptoms, and/or skin rash (Churg-Strauss syndrome) have been reported. You should immediately inform your doctor if you have one or more of these symptoms.

Ask your doctor or pharmacist for more information about side effects. If you think any of the side effects that you are getting are serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. Storage of MONTELUKAST KERN PHARMA

• Keep out of the reach and sight of children.
• Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. FURTHER INFORMATION

Composition of Montelukast Kern Pharma

• The active ingredient is montelukast. Each 5 mg chewable tablet contains 5.19 mg of montelukast sodium, which corresponds to 5 mg of montelukast.
• The other ingredients are: mannitol, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl cellulose, red iron oxide, cherry flavor, aspartame (E 951), and magnesium stearate.

Appearance of the product and pack contents

Montelukast Kern Pharma 5 mg chewable tablets are pink, round, and biconvex. They are presented in blister packs of 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 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/