Montelukast Aurovitas Spain 4 mg granules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Montelukast Aurovitas Spain 4 mg granules for oral suspension EFG

Read the entire leaflet carefully before giving this medicine to your child, 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 your child only, and you should not give it to other people, even if they have the same symptoms as your child, since it could harm them.
• If your child experiences any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Montelukast Aurovitas Spain is and what it is 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. How to store Montelukast Aurovitas Spain

Pack contents and additional information

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

What Montelukast Aurovitas Spain is

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

How Montelukast Aurovitas Spain works

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

When Montelukast Aurovitas Spain should be used

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

• Montelukast Aurovitas Spain is used for the treatment of patients aged 6 months to 5 years who are not adequately controlled with their current medication and require additional treatment.
• Montelukast Aurovitas Spain is also used as an alternative to inhaled corticosteroids in patients aged 2 to 5 years who have not recently taken oral corticosteroids for the treatment of their asthma and who have demonstrated inability to use inhaled corticosteroids.
• Montelukast Aurovitas Spain also helps prevent exercise-induced narrowing of the airways in patients aged 2 years and older.

Depending on your child's symptoms and the severity of their asthma, your doctor will determine how Montelukast Aurovitas Spain should be used.

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.

Asthma symptoms include: cough, wheezing, and chest tightness.

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

Inform your doctor of any allergies or medical conditions your child currently has or has had in the past.

Do not give Montelukast Aurovitas Spain to your child:

• if he or she is allergic to montelukast or to 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 your doctor immediately.
• Montelukast Aurovitas Spain oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for your child. Always keep your child's rescue inhaled medication available for asthma attacks.
• It is important that your child uses all asthma medications prescribed by the doctor. Montelukast Aurovitas Spain must not be used instead of other asthma medications prescribed by your child's doctor.
• If your child is being treated with asthma medications, you should be aware that if your child develops a combination of symptoms such as flu-like illness, tingling or numbness of arms or legs, worsening of pulmonary symptoms, and/or skin rash, you must consult your child's doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they cause worsening of asthma.

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 depending on the age range.

Other medicines and Montelukast Aurovitas Spain

Inform your child's doctor or pharmacist if your child is taking, has recently taken, or might need to 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 taking work.

Before taking Montelukast Aurovitas Spain, inform the 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 drink

This medicine may be taken regardless of meal times.

Pregnancy and breastfeeding

This section does not apply to Montelukast Aurovitas Spain 4 mg granules, as it is indicated for use in children aged 6 months to 5 years.

Driving and using machines

This section does not apply to Montelukast Aurovitas Spain 4 mg granules, as it is indicated for use in children aged 6 months to 5 years. However, the following information is important regarding the active substance, montelukast.

Montelukast is not expected to affect your ability to drive a car or operate machinery. However, individual responses to the medicine may vary. Certain adverse effects (such as dizziness and somnolence) reported with Montelukast Aurovitas Spain may affect the patient's ability to drive or operate machinery.

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

3. How to take Montelukast Aurovitas Spain

Follow exactly the instructions for administering this medicine as given by your child's doctor or pharmacist. If you are unsure, consult your child's doctor or pharmacist again.

• This medicine should be administered to children under the supervision of an adult.
• Your child should take Montelukast Aurovitas Spain every night.
• It should be taken even when your child has no symptoms or during an acute asthma attack.

For children aged 6 months to 5 years:

The recommended dose is one sachet of Montelukast Aurovitas Spain 4 mg oral granules once daily at night.

If your child is taking Montelukast Aurovitas Spain, make sure they do not take any other medication containing 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 may be administered:

• directly into the mouth;

• or mixed with one spoonful of soft food at cold or room temperature (e.g., apple sauce, ice cream, carrots and rice).

• Mix the entire contents of the Montelukast Aurovitas Spain granules sachet with one spoonful of cold or room-temperature soft food, taking care to ensure the full dose is mixed with the food.

• Make sure to administer the entire spoonful of the food/granule mixture to the child immediately (within 15 minutes). IMPORTANT: Never store any leftover mixture of food/granules for later use.

• Montelukast Aurovitas Spain granules are not intended to be dissolved in liquids. However, your child may drink liquids after swallowing the granules.

• Montelukast Aurovitas Spain granules may be taken regardless of meal times.

If your child takes more Montelukast Aurovitas Spain than they should

Seek immediate help from your child's doctor.

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.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 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, simply resume the usual regimen of one sachet once daily.

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

If your child stops treatment with Montelukast Aurovitas Spain

Montelukast Aurovitas Spain can only treat your child's asthma if treatment is continued. It is important that your child continues taking this medicine for the duration prescribed by the doctor. It will help control your child's asthma.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

In clinical trials conducted with Montelukast Aurovitas Spain 4 mg granules, the adverse effects related to administration of the medicine and reported most frequently (may affect up to 1 in 10 people) were:

• Diarrhea.
• Hyperactivity.
• Asthma.
• Itchy or scaly skin.
• Skin rash.

Additionally, the following adverse 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 adverse effects were generally mild and occurred more frequently in patients treated with montelukast than with placebo (a pill containing no active medicine).

Serious adverse effects

Contact your doctor immediately if you notice any of the following adverse effects in your child, as they may be serious and your child 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: excitation 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 in 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) which may occur without warning.
• Inflammation of the liver (hepatitis).

Other adverse effects reported during post-marketing surveillance 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.
• 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, 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):

• 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, most commonly appearing on the shins (erythema nodosum).
• Changes in behaviour and mood: obsessive-compulsive symptoms, stuttering.

Reporting of adverse effects

If your child experiences any adverse effect, consult 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 Aurovitas Spain

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

Do not use this medicine after the expiry date stated on the carton and sachet. The first two digits indicate the month, and the last four digits indicate the year. The expiry date refers to the last day of the specified month.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE Point in your pharmacy. 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 Aurovitas Spain

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

Appearance of the medicinal product and contents of the pack

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

Packs containing 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 the most recent review of this leaflet: April 2024

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