Leaflet: information for the user

MONTELUKAST ALTER 10 mg film-coated tablets

Read this leaflet carefully before you start taking the medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine 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 experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet (see section 4).

1. What MONTELUKAST ALTER is and what it is used for

2. What you need to know before starting to take MONTELUKAST ALTER

3. How to take MONTELUKAST ALTER

4. Possible side effects

5. Storage of MONTELUKAST ALTER

6. Contents of the pack and additional information

MONTELUKAST ALTER 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 ALTER 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 ALTER to treat asthma and prevent asthma symptoms during the day and night.

• MONTELUKAST ALTER is used for the treatment of adults and adolescents 15 years of age and older who are not adequately controlled with their medication and need additional treatment.
• MONTELUKAST ALTER also helps prevent airway constriction caused by exercise.
• In patients with asthma for whom MONTELUKAST ALTER is indicated, MONTELUKAST ALTER may also provide symptomatic relief of seasonal allergic rhinitis.

The dosage of MONTELUKAST ALTER will depend on your symptoms and the severity of your asthma, as determined by your doctor.

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, itchy nose; sneezing; watery, swollen, red, and itchy eyes.

Inform your doctor of any allergy or medical condition you have now or have had.

Do not take MONTELUKAST ALTER if you

• Are allergic (hypersensitive) to montelukast or to any of the other components of MONTELUKAST ALTER (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take MONTELUKAST ALTER

• If your asthma or breathing worsens, inform your doctor immediately.

• MONTELUKAST ALTER 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 available.

• It is essential that you or your child use all medications for asthma prescribed by your doctor. MONTELUKAST ALTER 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 of 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.

• Patients should be aware that several neuropsychiatric events have been reported with montelukast (e.g., behavioral changes and mood-related changes) in adults, adolescents, and children (see section 4). If you or your child develop these symptoms while taking montelukast, consult your doctor or your child's doctor.

Children and adolescents

Do not give this medication to children under 15 years of age.

For pediatric patients under 18 years of age, other presentations of this medication are available based on age range.

Other medications and MONTELUKAST ALTER

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

Some medications may affect the functioning of MONTELUKAST ALTER, or MONTELUKAST ALTER may affect the functioning of other medications you are using.

Before taking MONTELUKAST ALTER, inform your doctor if you are taking the following medications:

• phenobarbital (used for epilepsy treatment)
• phenytoin (used for epilepsy treatment)
• rifampicin (used for tuberculosis and some other infections treatment)
• gemfibrozil (used for high plasma lipid levels treatment)

Taking MONTELUKAST ALTER with food and beverages

MONTELUKAST ALTER 10 mg can be taken with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Your doctor will evaluate whether you can take MONTELUKAST ALTER during this period.

Breastfeeding

The presence of MONTELUKAST ALTER in breast milk is unknown. If you are breastfeeding or intend to breastfeed, consult your doctor before taking MONTELUKAST ALTER.

Driving and operating machinery

MONTELUKAST ALTER 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 drowsiness) that have been reported rarely with MONTELUKAST ALTER may affect the patient's ability to drive or operate machinery.

MONTELUKAST ALTER contains lactose and sodium

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially "sodium-free."

Follow exactly the administration instructions for Montelukast Alter indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

• You should only take one MONTELUKAST ALTER 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.

For adults and adolescents 15 years of age and older:

The recommended dose is one 10 mg tablet daily at night.

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

This medication is taken orally.

You can take MONTELUKAST ALTER with or without food.

If you take more MONTELUKAST ALTER than you should

If you have taken Montelukast Alter more than you should, consult your doctor or pharmacist immediately. In most cases of overdose, no adverse effects were reported. The symptoms that were most frequently reported in overdose cases in adults and children were abdominal pain, drowsiness, drowsiness, headache, vomiting, and hyperactivity.

Consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forgot to take MONTELUKAST ALTER

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

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with MONTELUKAST ALTER

MONTELUKAST ALTER can only treat your asthma if you continue to take it. It is essential that you continue taking MONTELUKAST ALTER 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 medicines, MONTELUKAST ALTER can cause side effects, although not everyone will experience them.

In clinical trials conducted with MONTELUKAST ALTER 10 mg film-coated tablets, the side effects related to the administration of the drug and reported most frequently (in more than 1 in 10 people), were:

• abdominal pain
• headache

These side effects were generally mild and occurred more frequently in patients treated with MONTELUKAST ALTER or with a placebo (a pill that does not contain a medicine).

Severe side effects

Consult your doctor immediatelyif you notice any of the following side effects, which may be severe and may require urgent medical treatment.

Not common (may affect up to 1 in 100 people):

• allergic reactions that include swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing
• behavior and mood changes: excitement including aggressive or hostile behavior, depression
• seizures

Rare (may affect up to 1 in 1,000 people):

• increased risk of bleeding
• tremors
• palpitations

Very rare (may affect up to 1 in 10,000 people):

• 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) (see section 2)
• low platelet count
• behavior and mood changes: hallucinations, disorientation, suicidal thoughts and actions
• swelling (inflammation) of the lungs
• severe skin reactions (erythema multiforme) that may occur without warning
• inflammation of the liver (hepatitis)

Other side effects reported during the marketing of the drug

Very common (may affect more than 1 in 10 people):

• upper respiratory tract infection

Common (may affect up to 1 in 10 people):

• diarrhea, nausea, vomiting
• skin rash
• fever
• enzymes elevated in the liver

Not common (may affect up to 1 in 100 people):

• behavior and mood changes: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, anxiety, restlessness
• dizziness, somnolence, tingling/numbness
• nasal bleeding
• dry mouth, indigestion
• bruising, itching, urticaria
• joint or muscle pain, muscle cramps
• bedwetting (in children)
• weakness/fatigue, malaise, swelling

Rare (may affect up to 1 in 1,000 people):

• behavior and mood changes: attention alteration, memory alteration, uncontrolled muscle movements

Very rare (may affect up to 1 in 10,000 people):

• red, painful lumps under the skin that more frequently appear on the face (erythema nodosum)
• behavior and mood changes: obsessive-compulsive symptoms, stuttering

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.

• Do not use this medication after the expiration date that appears on the blister pack after CAD. The first two numbers indicate the month; the last four numbers indicate the year. The expiration date is the last day of the month indicated.

• No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of MONTELUKAST ALTER

Appearance of the product and contents of the packaging

Montelukast Alter 10 mg are film-coated, round, and white tablets.

They are presented in packs of 28 tablets.

Holder of the marketing authorization and responsible manufacturer

Laboratorios ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

or

Laboratorios Alter, S.A.

C/ Zeus, 6 Industrial Park R2

28880, Meco (Madrid)

Spain

Last review date of this leaflet: March 2025

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es