MONTELUKAST ALTER 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

MONTELUKAST ALTER 10 mg film-coated tablets EFG

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

• 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 you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is MONTELUKAST ALTER and what is it used for
2. What you need to know before you take MONTELUKAST ALTER
3. How to take MONTELUKAST ALTER
4. Possible side effects
5. Storage of MONTELUKAST ALTER
6. Contents of the pack and other information

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

MONTELUKAST ALTER is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of the airways in your lungs and can also cause allergy symptoms. By blocking leukotrienes, MONTELUKAST ALTER improves asthma symptoms, helps control asthma, and improves symptoms of seasonal allergies (also known as hay fever or 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 exercise-induced narrowing of the airways.
• In patients with asthma who are indicated for MONTELUKAST ALTER for asthma, MONTELUKAST ALTER 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 ALTER.

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: Coughing, wheezing, and chest congestion.

What are seasonal allergies?

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

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

Tell your doctor about any allergy or medical problem you have now or have had.

Do not take MONTELUKAST ALTER if you

• are allergic (hypersensitive) to montelukast or any of the other ingredients 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 the treatment of 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 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 lung symptoms, and/or skin rash, they should consult their doctor.

• Do not take aspirin or non-steroidal anti-inflammatory drugs (also known as non-steroidal anti-inflammatory medications or NSAIDs) if they worsen your asthma.

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

Children and adolescents

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

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

Other medicines and MONTELUKAST ALTER

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

Some medicines may affect the way MONTELUKAST ALTER works, or MONTELUKAST ALTER may affect the way other medicines work.

Before taking MONTELUKAST ALTER, tell your doctor if you are taking the following medicines:

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

Taking MONTELUKAST ALTER with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

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

Breastfeeding

It is not known whether MONTELUKAST ALTER appears in breast milk. If you are breastfeeding or plan to breastfeed, consult your doctor before taking MONTELUKAST ALTER.

Driving and using machines

MONTELUKAST ALTER is not expected to affect your ability to drive a car or operate machinery. However, individual responses to the medicine may vary. Certain side effects (such as dizziness and drowsiness) that have been reported very rarely with MONTELUKAST ALTER may affect the patient's ability to drive or operate machinery.

MONTELUKAST ALTER contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

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

3. How to take MONTELUKAST ALTER

Follow exactly the administration instructions of 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.
• It should be taken 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 in the evening.

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

This medicine 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 occurred most frequently reported in overdose in adults and children were abdominal pain, drowsiness, thirst, headache, vomiting, and hyperactivity.

Consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91.562.04.20, indicating the medicine and the amount taken. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to take MONTELUKAST ALTER

Try to take MONTELUKAST ALTER as prescribed. However, if you forget a dose, just resume your regular schedule of one tablet once a day.

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

If you stop taking MONTELUKAST ALTER

MONTELUKAST ALTER may only treat your asthma if you continue to take it. It is essential that you continue to take MONTELUKAST ALTER for the time your doctor prescribes it. It will help control your asthma.

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

4. Possible side effects

Like all medicines, MONTELUKAST ALTER can cause side effects, although not everybody gets them.

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

• abdominal pain
• headache

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

Serious side effects

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

Uncommon (may affect up to 1 in 100 people):

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

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

• increased risk of bleeding
• tremor
• palpitations

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

• 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) (see section 2)
• low platelet count
• mood-related 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 medicine

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

• upper respiratory infection

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

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

Uncommon (may affect up to 1 in 100 people):

• mood-related changes: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, tingling/numbness
• nosebleeds
• dry mouth, indigestion
• bruising, itching, hives
• joint or muscle pain, muscle cramps
• bedwetting (in children)
• weakness/tiredness, malaise, swelling

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

• mood-related changes: attention disturbance, memory disturbance, uncontrolled muscle movements

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

• red, painful lumps under the skin that most frequently appear on the shins (erythema nodosum)
• mood-related changes: obsessive-compulsive symptoms, stuttering

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of MONTELUKAST ALTER

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

• Do not use this medicine after the expiry date which is stated on the blister after EXP. The first two numbers indicate the month; the last four numbers indicate the year. The expiry date is the last day of the month indicated.

• No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of MONTELUKAST ALTER

• The active ingredient is montelukast. Each tablet contains 10 mg of montelukast.
• The other ingredients are: Core:lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, hydroxypropylcellulose, and magnesium stearate. Coating:Opadry White.

Appearance of the product and contents of the pack

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

They are available in packs of 28 tablets.

Marketing authorization holder and manufacturer

Laboratorios ALTER, S.A.

Mateo Inurria, 30

28036 Madrid

or

Laboratorios Alter, S.A.

C/ Zeus, 6 Polígono Industrial R2

28880, Meco (Madrid)

Spain

Date of the last revision of this leaflet: March 2025

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es