Package Insert: Information for the User

Montelukast KERN PHARMA 10 mg Film-Coated Tablets

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 you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing are 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 and can also cause allergy symptoms. By blocking leukotrienes, montelukast improves asthma symptoms, helps control asthma, and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).

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 also helps prevent airway constriction caused by exercise.
• In asthmatic patients for whom montelukast is indicated for asthma, montelukast may also provide symptomatic relief of seasonal allergic rhinitis.

Depending on symptoms and the severity of your asthma, your doctor will determine how to 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 conditions.
• Sensitive airways that react to many things, such as cigarette smoke, pollen, or cold air, or exercise.
• Inflammation of the inner layer of the airways.

Asthma symptoms include: Coughing, wheezing, and congestion in the chest.

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. Typical symptoms of seasonal allergies may include: Stuffy nose, runny nose, sneezing; itchy nose; watery, red, itchy, and swollen eyes.

Inform your doctor about any allergy or medical condition you have now or have 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 6. ADDITIONAL INFORMATION).

Be especially careful with Montelukast Kern Pharma

• If your asthma or 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. Always have your rescue inhaler medication for asthma attacks.
• It is essential 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 of arms or legs, worsening respiratory symptoms, and/or skin rash, they should consult their doctor.
• Do not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal 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 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 Kern Pharma, inform your doctor if you 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 Kern Pharma can be taken with or without food.

Pregnancy and breastfeeding

Use during pregnancy

Women who are pregnant or intend to become pregnant should consult their doctor before taking Montelukast Kern Pharma. 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, 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 rarely reported with montelukast may affect the patient's ability to drive or operate machinery.

Important information about some of the components of Montelukast Kern Pharma

The film-coated tablets of Montelukast Kern Pharma contain lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medication.

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

For adults 15 years of age and older:

Take one 10 mg tablet daily at night. Montelukast can be taken with or without food.

If you are taking Montelukast, make sure you do not take any other medication that contains the same active ingredient, montelukast.

If you take more Montelukast Kern Pharma than you should

Seek help from your doctor immediately.

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

If you forget to take Montelukast Kern Pharma

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

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

If you interrupt treatment with Montelukast Kern Pharma

Montelukast can only treat your asthma if you continue to take it. It is essential that you continue to take montelukast for the time your doctor prescribes. It will help control your asthma.

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

Like all medications, Montelukast Kern Pharma may produce adverse effects, although not everyone will experience them.

In clinical trials conducted with montelukast, the adverse 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:

• abdominal pain
• headache

These adverse effects were generally mild and occurred more frequently in patients treated with montelukast than with placebo (a pill that does not contain medication).

In addition, since the medication has been marketed, the following adverse 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 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 are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, report it to your doctor or pharmacist.

• Keep out of reach and sight of children.
• Do not use this medicine after the expiration date that appears 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.Deposit the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. If in doubtask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Montelukast Kern Pharma

• The active ingredient is montelukast. Each film-coated tablet contains 10.4 mg of montelukast sodium, which corresponds 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 product and contents of the package

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

They are presented in a package of 28 tablets.

Holder of the marketing authorization

KERN PHARMA, S.L.

Venus, 72 - Industrial Park Colón II

08228 Terrassa (Barcelona)

Spain

Responsible for manufacturing

PHARMATHEN S.A.

Dervenakion 6

Pallini 15351

Attikis (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/