Montelukast Alter 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MONTELUKAST ALTER 10 mg film-coated tablets EFG

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

• 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 could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents:

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

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

MONTELUKAST ALTER 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 ALTER 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 ALTER to treat asthma and to 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 whose asthma is not adequately controlled with their current medication and who require additional treatment.
• MONTELUKAST ALTER also helps prevent narrowing of the airways caused by exercise.
• In those asthmatic patients for whom MONTELUKAST ALTER is indicated 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 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.

Symptoms of asthma include: coughing, 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 include: stuffy nose, runny nose, itchy nose; sneezing; watery, swollen, red, and itchy eyes.

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

Tell your doctor about any allergies or medical conditions you currently have or have had in the past.

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

Talk to 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 to you by your doctor. Always have your rescue inhaled medication available for asthma attacks.

• It is important 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 a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening of pulmonary symptoms, and/or skin rash should prompt a consultation with their doctor.

• You should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they worsen your asthma.

• Patients should be aware that various neuropsychiatric events have been reported with montelukast (e.g., changes in behavior and mood-related events) in adults, adolescents, and children (see section 4). If you or your child develops 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 formulations of this medicine are available depending on the age range.

Other medicines and MONTELUKAST ALTER

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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, 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)
• gemfibrozil (used for the treatment of elevated plasma lipid levels)

Taking MONTELUKAST ALTER with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

It is unknown whether MONTELUKAST ALTER passes into breast milk. If you are breastfeeding or planning to breastfeed, you should consult your doctor before taking MONTELUKAST ALTER.

Driving and using machines

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

MONTELUKAST ALTER contains lactose and sodium

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult him 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 for Montelukast Alter provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

• You should take only one tablet of MONTELUKAST ALTER once daily, as prescribed by your doctor.
• It should be taken even when you do not have symptoms or during an acute asthma attack.

For adults and adolescents aged 15 years and older:

The recommended dose is one 10 mg tablet daily, taken in the evening.

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

This medicine is taken orally.

You may take MONTELUKAST ALTER with or without food.

If you take more MONTELUKAST ALTER than you should

If you have taken more Montelukast Alter than you should, consult your doctor or pharmacist immediately. 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, somnolence, thirst, headache, vomiting, and hyperactivity.

Contact your doctor, pharmacist immediately, or call the Toxicology Information Service at 91.562.04.20, indicating the medicine and the amount taken. It is recommended to bring the medicine package and the package leaflet to the healthcare professional.

If you forget to take MONTELUKAST ALTER

Try to take MONTELUKAST ALTER as prescribed. However, if you miss a dose, simply resume your regular schedule of one tablet once daily.

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

If you stop taking MONTELUKAST ALTER

MONTELUKAST ALTER can only treat your asthma if you continue taking it. It is important that you continue taking MONTELUKAST ALTER for as long as your doctor prescribes it. 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 ALTER may cause adverse effects, although not everyone experiences them.

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

• abdominal pain
• headache

These adverse effects were generally mild and occurred with similar frequency in patients treated with MONTELUKAST ALTER or with placebo (a tablet that does not contain any active ingredient).

Serious adverse effects

Consult your doctor immediately if you experience any of the following adverse 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, which may cause difficulty breathing or swallowing
• changes in behaviour and mood: agitation including aggressive behaviour or hostility, depression
• seizures

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

• increased tendency to 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 pulmonary symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2)
• low platelet count
• changes in behaviour and mood: 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 adverse effects reported during the medicine's marketing

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

• upper respiratory tract infection

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

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

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

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

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

• changes in behaviour and mood: attention disturbance, memory disturbance, uncontrolled muscle movements

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

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the blister pack after EXP. The first two digits indicate the month; the last four digits indicate the year. The expiry date refers to the last day of the month indicated.

• No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information.

Composition of MONTELUKAST ALTER

• The active substance is montelukast. Each tablet contains 10 mg of montelukast.
• The other components 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 in colour.

They are presented in packs of 28 tablets.

Marketing Authorisation 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 most recent revision of this leaflet: March 2025

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