Montelukast Kern Pharma 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast KERN PHARMA 10 mg film-coated tablets EFG

Read the entire leaflet carefully before you start 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 you and must not be given to other people, even if they have the same symptoms, as it may harm them.

• 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, 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 and can also cause allergy symptoms. By blocking leukotrienes, montelukast improves asthma symptoms, helps control asthma, and improves symptoms of seasonal allergies (also known as hay fever or seasonal allergic rhinitis).

Your doctor has prescribed Montelukast Kern Pharma to treat your asthma and to prevent asthma symptoms during the day and night.

• Montelukast is used for the treatment of patients whose asthma is not adequately controlled with their current medication and who require additional therapy.
• Montelukast also helps prevent airway narrowing caused by exercise.
• In those asthmatic patients for whom montelukast is indicated for asthma, montelukast may also provide symptomatic relief of seasonal allergic rhinitis.

Depending on your symptoms and the severity of your asthma, your doctor will determine how you should use Montelukast Kern Pharma.

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.

What are seasonal allergies?

Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic response often caused by airborne pollen from trees, grass, and weeds. Symptoms of seasonal allergies typically may include: nasal congestion, runny nose, itchy nose; sneezing; watery, swollen, red, and itchy eyes.

2. BEFORE TAKING MONTELUKAST KERN PHARMA

Inform your doctor of any allergies or medical conditions you currently have or have previously had.

Do not take Montelukast Kern Pharma if you

• are 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 worsens, inform your doctor immediately.
• Oral montelukast is not indicated for the treatment of acute asthma attacks. If an asthma attack occurs, follow the instructions given by your doctor. Always keep your rescue inhaled medication for asthma attacks on hand.
• It is important that you or your child use all asthma medications prescribed by your doctor. Montelukast Kern Pharma should not replace other asthma medications prescribed by your doctor.
• 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 should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

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 how Montelukast works, or Montelukast may affect how other medicines you are taking work.

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Before taking Montelukast Kern Pharma, inform your doctor if you are taking 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 Kern Pharma may be taken with or without food.

Pregnancy and breastfeeding

Use during pregnancy

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

Use during breastfeeding

It is unknown whether montelukast is excreted in breast milk. If you are breastfeeding or planning 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 medicine may vary. Certain adverse reactions (such as dizziness and drowsiness), which have been reported very 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

Montelukast Kern Pharma film-coated tablets contain lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. HOW TO TAKE MONTELUKAST KERN PHARMA

• You should take only one Montelukast Kern Pharma tablet once a day, as prescribed by your doctor.
• It should be taken even when you do not have symptoms or during an acute asthma attack.
• Always take Montelukast Kern Pharma exactly as your doctor has instructed. Consult your doctor or pharmacist if you have any doubts.
• It should be taken orally.

For adults aged 15 years and older:

One 10 mg tablet should be taken daily at night. Montelukast may be taken with or without food.

If you are taking Montelukast, make sure you do not take any other medication containing the same active substance, montelukast.

If you take more Montelukast Kern Pharma than you should

Seek immediate medical help.

In most cases of overdose, 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 take Montelukast Kern Pharma

Try to take Montelukast as prescribed. However, if you miss a dose, simply resume your usual regimen of one tablet once daily.

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

If you stop taking Montelukast Kern Pharma

Montelukast can only control your asthma if you continue taking it. It is important to continue taking montelukast for the duration prescribed by your doctor. It will help control your asthma.

If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Montelukast Kern Pharma may produce adverse effects, although not everyone experiences them.

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

• abdominal pain
• headache

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

In addition, 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, which may cause difficulty breathing or swallowing
• changes in behavior and mood [sleep disturbances, including nightmares, hallucinations, irritability, anxious feelings, restlessness, agitation including aggressive behavior or hostility, 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)
• bruising, itching, hives, painful red lumps under the skin most commonly appearing 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 in arms and legs, worsening of pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) have been reported. You must inform your doctor immediately if you experience one or more of these symptoms.

Ask your doctor or pharmacist for more information about adverse effects. If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform 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 stated on the packaging following EXP. The expiry date refers to the last day of the month indicated.
• Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Montelukast Kern Pharma

• The active substance is montelukast. Each film-coated tablet contains 10.4 mg of montelukast sodium, equivalent to 10 mg of montelukast.
• The other components are: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hydroxypropyl cellulose, magnesium stearate and Opadry AMB TAN.

Appearance of the medicinal product and contents of the pack

Montelukast Kern Pharma 10 mg film-coated tablets are round, beige, biconvex tablets.

They are supplied in packs containing 28 tablets.

Marketing Authorization Holder

KERN PHARMA, S.L.

Venus, 72 - Polígono Ind. Colón II

08228 Terrassa (Barcelona)

Spain

Manufacturer

PHARMATHEN S.A.

Dervenakion 6

Pallini 15351

Attikis (Greece)

This summary of product characteristics 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/