Montelukast Kern Pharma 5 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast KERN PHARMA 5 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 questions, ask your doctor or pharmacist.
• This medicine 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 think any of the side effects your child experiences are serious, 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 taking 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 MONTELUKAST KERN PHARMA is and what it is 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 asthma and to prevent asthma symptoms during the day and night.

• Montelukast is used for the treatment of patients who are not adequately controlled with their current medication and require additional therapy.
• Montelukast is also used as an alternative 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 inability to use inhaled corticosteroids.
• Montelukast also helps prevent exercise-induced narrowing of the airways.

Depending on the symptoms and severity of your asthma or your child's 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.

Asthma symptoms include: cough, wheezing, and chest tightness.

2. BEFORE TAKING MONTELUKAST KERN PHARMA

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

Do not take Montelukast Kern Pharma if you or your child

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

Take special care with Montelukast Kern Pharma

• If your asthma or breathing, or your child's, 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 you or your child. Always keep your child's inhaled rescue medication for asthma attacks on hand.
• It is important that you or your child use all asthma medications prescribed by your doctor. Montelukast should not be used instead 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 in arms or legs, worsening of pulmonary symptoms, and/or skin rash, they should consult their doctor.
• You or your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they cause your asthma to worsen.

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 medicines

Some medicines may affect the way montelukast works, or montelukast may affect the way other medicines you are taking work.

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Before taking Montelukast, inform your doctor if you or your child are taking any of the following medicines:

• phenobarbital (used for the treatment of epilepsy)
• phenytoin (used for the treatment of epilepsy)
• rifampicin (used for the treatment of tuberculosis and certain other infections)

Taking Montelukast Kern Pharma with food and drink

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

Pregnancy and breastfeeding

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 this period.

Use during breastfeeding

It is unknown whether montelukast passes into breast milk. If you are breastfeeding or intend 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 medicine may vary. Certain adverse reactions (such as dizziness and somnolence), which have been reported very rarely with montelukast, may 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 5 mg chewable tablet contains phenylalanine (equivalent to 0.842 mg of phenylalanine per 5 mg chewable tablet).

3. HOW TO TAKE MONTELUKAST KERN PHARMA

• You or your child should take only one montelukast tablet once daily, as prescribed by your doctor.
• It should be taken even when you or your child do not have symptoms or during an acute asthma attack.
• Always take montelukast exactly as directed by your doctor. Consult your child's doctor or pharmacist if you have any doubts.
• It must be taken orally.

For children aged 6 to 14 years:

One 5 mg chewable tablet should be taken daily in the evening. Montelukast should not be taken with food; 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 that neither you nor your child take any other medication containing the same active substance, montelukast.

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

Seek immediate medical help.

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 or your child forget to take Montelukast Kern Pharma or forget to give it to your child

Try to take Montelukast Kern Pharma as prescribed. However, if you or your child miss a dose, simply resume your regular schedule of one tablet daily.

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

If you or your child stop taking Montelukast Kern Pharma

Montelukast Kern Pharma will only control your asthma or your child's asthma if you or your child continue taking it.

It is important 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 further questions about the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

In clinical trials with montelukast 5 mg, the side 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:

• 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 in those treated with placebo (a tablet containing no active ingredient).

Furthermore, since the medicine has been marketed, the following side 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 which may cause difficulty in breathing or swallowing
• changes in behaviour and mood [sleep disturbances, including nightmares, hallucinations, irritability, anxious feelings, restlessness, agitation including aggressive behaviour or hostility, tremor, depression, sleep problems, sleepwalking, suicidal thoughts and actions (in very rare cases)]
• dizziness, drowsiness, tingling/numbness, seizures
• palpitations
• nosebleeds
• diarrhoea, dry mouth, indigestion, nausea, vomiting
• hepatitis (inflammation of the liver)
• bruising, itching, hives, painful red lumps under the skin which most commonly appear on the shins (erythema nodosum)
• joint or muscle pain, muscle cramps
• tiredness, 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 in arms and legs, worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) have been reported. You should contact your doctor immediately if you experience one or more of these symptoms.

Ask your doctor or pharmacist for further information about side effects. If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.

5. Storage of MONTELUKAST KERN PHARMA

• Keep out of the reach and sight of children.
• Do not use this medication 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 or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Montelukast Kern Pharma

• The active substance is montelukast. Each 5 mg chewable tablet contains 5.19 mg of montelukast sodium, equivalent to 5 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 product and contents of the packaging

Montelukast Kern Pharma 5 mg chewable tablets are pink, round, biconvex tablets. They are presented in blisters within a pack 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/