MONTELUKAST 4 mg Oral Solution/Suspension

Contents of the leaflet

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

Introduction

Package Leaflet: Information for the User

Montelukast Aurovitas Spain 4 mg Granules

Read all of this leaflet carefully before giving this medicine to your child, 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 your child only. Do not give it to others, even if they have the same symptoms as your child, as it may harm them.
• If your child experiences any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Montelukast Aurovitas Spain and what is it used for
2. What you need to know before your child takes Montelukast Aurovitas Spain
3. How to take Montelukast Aurovitas Spain
4. Possible side effects
5. Storage of Montelukast Aurovitas Spain

Contents of the pack and further information

1. What is Montelukast Aurovitas Spain and what is it used for

What isMontelukast Aurovitas Spain

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

How it worksMontelukast Aurovitas Spain

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

When to useMontelukast Aurovitas Spain

Your doctor has prescribed this medicine to treat your child's asthma and prevent asthma symptoms during the day and night.

• Montelukast Aurovitas Spain is used for the treatment of patients between 6 months and 5 years of age who are not adequately controlled with their medication and need additional treatment.
• Montelukast Aurovitas Spain 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 the treatment of their asthma and have demonstrated that they are unable to use inhaled corticosteroids.
• Montelukast Aurovitas Spain 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, their doctor will determine how to use Montelukast Aurovitas Spain.

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 Aurovitas Spain

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

Do not give Montelukast Aurovitas Spain to your child:

• if they are 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 Aurovitas Spain to your child:

• If your child's asthma or breathing worsens, inform their doctor immediately.
• Montelukast Aurovitas Spain oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor for 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 Aurovitas Spain should not be used in place of other asthma medications prescribed by their doctor.
• If your child is being treated with asthma medications, they 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.
• 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 adolescents

Do not give this medicine to children under 6 months 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 Aurovitas Spain

Tell your child's 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 how montelukast works, or montelukast may affect how other medicines your child is using work.

Before taking Montelukast Aurovitas Spain, 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 Aurovitas Spain with food and drinks

This medicine can be taken with or without food.

Pregnancy and breastfeeding

This subsection is not applicable to Montelukast Aurovitas Spain 4 mg granules, as its use is indicated in children between 6 months and 5 years of age.

Driving and using machines

This subsection is not applicable to Montelukast Aurovitas Spain 4 mg granules, as its use is indicated in children between 6 months 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 with Montelukast Aurovitas Spain may affect your child's ability to drive or operate machinery.

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

3. How to take Montelukast Aurovitas Spain

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

• This medicine should be administered to children under adult supervision.
• Your child should take Montelukast Aurovitas Spain every night.
• It should be taken even when your child does not have symptoms or when they have an acute asthma attack.

For children from 6 months to 5 years of age:

The recommended dose is one sachet of Montelukast Aurovitas Spain 4 mg granules orally every night.

If your child is taking Montelukast Aurovitas Spain, ensure they do not take any other medicine that contains the same active substance, montelukast.

How should I give Montelukast Aurovitas Spain granules to my child?

This medicine is taken orally.

• Do not open the sachet until the time of use.
• Montelukast Aurovitas Spain granules can be administered:

• directly into the mouth;
• or mixed with a spoonful of soft cold or room temperature food (e.g., apple sauce, ice cream, carrots, and rice).

• Mix the entire contents of Montelukast Aurovitas Spain granules in a spoonful of soft cold or room temperature food, taking care to observe that the full dose is mixed with the food.
• Ensure the entire spoonful of the food/granule mixture is given to the child immediately (within 15 minutes). IMPORTANT: Never save any leftover food/granule mixture for later use.
• Montelukast Aurovitas Spain granules are not intended to be dissolved in liquids. However, your child can drink liquids after swallowing Montelukast Aurovitas Spain granules.
• Montelukast Aurovitas Spain granules can be taken with or without food.

If your child takes more Montelukast Aurovitas Spain than they should

Seek help from your child's doctor 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to give Montelukast Aurovitas Spain to your child

Try to give Montelukast Aurovitas Spain as prescribed. However, if you forget to give a dose to your child, just resume the regular schedule of one sachet once a day.

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

If your child stops taking Montelukast Aurovitas Spain

Montelukast Aurovitas Spain may only treat your child's asthma if they continue taking it. It is essential that your child continues taking this medicine for the time their doctor prescribes it. It will help control your child's asthma.

If you have any other questions about the use of this medicine, 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 conducted with Montelukast Aurovitas Spain 4 mg granules, the side effects related to the administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:

• Diarrhea.
• Hyperactivity.
• Asthma.
• Itchy or scaly skin.
• Rash.

Additionally, the following side effects were reported in clinical trials with Montelukast Aurovitas Spain 10 mg film-coated tablets and Montelukast Aurovitas Spain 5 mg or 4 mg chewable tablets:

• Abdominal pain.
• Headache.
• Thirst.

These side effects were generally mild and occurred more frequently in patients treated with montelukast 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, as they may be serious and your child may need 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 can cause difficulty breathing or swallowing.
• Behavior and 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):

• A 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.
• Behavior and mood-related changes: hallucinations, disorientation, suicidal thoughts and actions.
• Inflammation (inflammation) of the lungs.
• Severe skin reactions (erythema multiforme) that can occur without warning.
• Liver inflammation (hepatitis).

Other side effects reported during the marketing of the medicine:

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.
• Rash.
• Fever.
• Elevated liver enzymes.

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

• Behavior and 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):

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

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

• Painful red lumps under the skin that most frequently appear on the shins (erythema nodosum).
• Behavior and mood-related changes: 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 Medicines and Healthcare Products Agency (AEMPS) website (http://www.aemps.gob.es/). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Montelukast Aurovitas Spain

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 carton and sachet. 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. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE collection point. 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 Aurovitas Spain

• The active substance is montelukast. Each sachet of granules contains montelukast sodium equivalent to 4 mg of montelukast.
• The other ingredients (excipients) are: mannitol, hypromellose (low substituted), and magnesium stearate.

Appearance of the product and pack contents

Montelukast Aurovitas Spain 4 mg granules are a white to yellow granule.

Pack sizes: 28 sachets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Generis Farmacêutica, S.A.

Rua Joao de Deus, 19

2700-487 Amadora

Portugal

Date of last revision of this leaflet: April 2024

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