MONTELUKAST ALTER 4 mg CHEWABLE TABLETS

Introduction

Patient Information Leaflet

Montelukast Alter 4 mg

chewable tablets EFG

Contents of the pack:

1. What is Montelukast Alter and what is it used for
2. What you need to know before your child takes Montelukast Alter
3. How to take Montelukast Alter
4. Possible side effects
5. Storage of Montelukast Alter
6. Contents of the pack and further information

1. What is Montelukast Alter and what is it used for

What is Montelukast Alter

Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes.

How it worksMontelukast Alter

Leukotrienes cause narrowing and swelling of the airways in the lungs. By blocking leukotrienes, montelukast 4 mg improves asthma symptoms and helps control asthma.

When to useMontelukast Alter

Your doctor has prescribed montelukast 4 mg to treat your child's asthma and prevent asthma symptoms during the day and night.

• Montelukast is used to treat patients between 2 and 5 years of age who are not adequately controlled with their medication and need additional treatment.
• Montelukast is also used as an alternative treatment to inhaled corticosteroids in patients between 2 and 5 years of age who have not recently taken oral corticosteroids for their asthma and have shown that they are unable to use inhaled corticosteroids.
• Montelukast also helps prevent narrowing of the airways caused by exercise in patients 2 years of age and older.

Depending on your child's symptoms and the severity of their asthma, your doctor will determine how to use montelukast.

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.

Asthma symptoms include: coughing, wheezing, and chest congestion.

2. What you need to know before your child takes Montelukast Alter

Tell your doctor about any allergy or medical problem your child has now or has had.

Do not giveMontelukast Alterto your child

• if your child is allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before giving montelukast 4 mg to your child.

• If your child's asthma or breathing worsens, tell your doctor immediately.
• Montelukast oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions your doctor has given your child. Always have your child's rescue inhaler medication for asthma attacks.
• It is essential that your child uses all asthma medications prescribed by their doctor. Montelukast should not be used instead of other asthma medications prescribed by your child's doctor.
• If your child is being treated with asthma medications, 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.
• Your child should not take aspirin or non-steroidal anti-inflammatory drugs (also known as non-steroidal anti-inflammatory medications or NSAIDs) if they make their asthma worse.

Children and other adolescents

Do not give this medicine to children under 2 years of age.

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

Other medicines and Montelukast Alter

Tell your doctor or pharmacist if your child is taking, has recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines may affect the way montelukast 4 mg works, or montelukast 4 mg may affect the way other medicines work that your child is using.

Before taking montelukast, tell your doctor if your child is taking the following medicines:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)

Taking Montelukast Alterwith food and drinks

Montelukast 4 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after food.

Pregnancy and breastfeeding

This subsection is not applicable to montelukast 4 mg chewable tablets, as their use is indicated in children between 2 and 5 years of age.

Driving and using machines

This subsection is not applicable to montelukast 4 mg chewable tablets, as their use is indicated in children between 2 and 5 years of age. However, the following information is important for the active substance, montelukast.

Montelukast is not expected to affect your child's 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 may affect your child's ability to drive or operate machinery.

Montelukast Alter4 mgchewable tablets contain aspartame and sodium

This medicine contains 2.40 mg of aspartame in each tablet.

Aspartame is a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

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

3. How to take Montelukast Alter

Follow exactly the administration instructions of this medicine indicated by your doctor or pharmacist for your child. In case of doubt, consult your child's doctor or pharmacist again.

• This medicine should be administered to children under adult supervision. For children who have problems taking a chewable tablet, an oral granule formulation is available.
• Your child should only take one montelukast chewable tablet once a day, as prescribed by their doctor.
• It should be taken even when your child does not have symptoms or when they have an acute asthma attack.

For children from2 to5 years of age:

The recommended dose is one 4 mg chewable tablet daily in the evening.

If your child is taking montelukast, make sure they do not take any other medicine that contains the same active substance, montelukast.

This medicine is taken orally.

The tablets should be chewed before swallowing.

Montelukast 4 mg chewable tablets should not be taken with food; they should be taken at least 1 hour before or 2 hours after food.

If your child takes moreMontelukast Alterthan they should

Seek help from your child's doctor immediately.

In most cases of overdose, no side 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.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to take the packaging and the leaflet of the medicine to the healthcare professional.

If you forget to giveMontelukast Alterto your child

Try to give montelukast 4 mg as prescribed. However, if your child forgets a dose, just resume the usual intake of one tablet once a day.

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

If your child stops takingMontelukast Alter

Montelukast can only treat your child's asthma if they continue taking it.

It is essential that your child continues taking montelukast for the time their doctor prescribes it. It will help control your child's asthma.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In clinical trials with montelukast 4 mg chewable tablets, the side effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:

• abdominal pain
• thirst

Additionally, the following side effects were reported in clinical trials with montelukast 10 mg film-coated tablets and 5 mg chewable tablets:

• headache

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

Serious side effects

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

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

• allergic reactions that include swelling of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing;
• changes related to behavior and mood: 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
• changes related to behavior and mood: hallucinations, disorientation, suicidal thoughts and actions
• inflammation (inflammation) of the lungs
• severe skin reactions (erythema multiforme) that can 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):

• changes related to behavior and mood: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness
• dizziness, drowsiness, tingling/numbness
• nosebleeds
• dry mouth, indigestion
• bruises, 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):

• changes related to behavior and mood: 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)
• changes related to behavior and mood: obsessive-compulsive symptoms, stuttering

Reporting of side effects

If your child experiences any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: 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 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.
• Store in the original packaging to protect from light and moisture.
• Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE Collection Point (or any other pharmaceutical waste collection system) at your pharmacy. If you have any further questions, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Montelukast Alter:

• The active substance is montelukast. Each tablet contains montelukast sodium equivalent to 4 mg of montelukast.
• The other ingredients are: mannitol, microcrystalline cellulose, hydroxypropylcellulose, red iron oxide (E 172), sodium croscarmellose, strawberry flavor, aspartame (E 951), and magnesium stearate.

Appearance of the product and contents of the pack

The 4 mg chewable tablets are pink, oval, biconvex, and have the inscription "4" on one side.

They are available in packs of 28 tablets.

Marketing authorization holder

Laboratorios Alter, S.A.

C/ Mateo Inurria, 30

28036 Madrid-Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí, Barcelona

Spain

This leaflet was approved in:March 2025

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