Package Insert: Information for the User

Montelukast Aurovitas Spain 4 mg Granule EFG

Read this package insert carefully before giving this medication to your child, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for your child, and should not be given to others who have the same symptoms as your child, as it may harm them.
• If your child experiences any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Contents of the package and additional information

What isMontelukast Aurovitas Spain

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

How it worksMontelukast Aurovitas Spain

Leukotrienes produce 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 medication to treat your child's asthma and prevent asthma symptoms during the day and night.

• Montelukast Aurovitas Spain is used to treat 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 who have demonstrated that they are unable to use inhaled corticosteroids.
• Montelukast Aurovitas Spain also helps prevent airway constriction caused by exercise in patients 2 years of age and older.

Depending on the symptoms and severity of your child's asthma, your 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.
• Sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.
• Inflammation (swelling) of the inner layer of the airways.

Asthma symptoms include: Coughing, wheezing, and congestion in the chest.

Inform your child's doctor about any allergy or medical condition 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 components of this medication (listed in section 6).

Warnings and precautions

Consult your child's doctor or pharmacist before giving Montelukast Aurovitas Spain to your child:

• If your child's asthma or breathing worsens, inform your child's doctor immediately.
• Montelukast Aurovitas Spain oral is not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions given by your child's doctor. Always have your child's rescue inhaler medication for asthma attacks.
• It is essential that your child uses all medications for asthma prescribed by their doctor. Montelukast Aurovitas Spain should not be used in place of other asthma medications prescribed by your child's doctor.
• If your child is being treated with asthma medications, be aware that if your child develops a combination of symptoms such as flu-like illness, tingling or numbness in arms or legs, worsening respiratory symptoms, and/or skin rash, they should consult their doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they make their asthma worse.

Children and adolescents

Do not give this medication to children under 6 months of age.

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

Other medications and Montelukast Aurovitas Spain

Inform your child's doctor or pharmacist if your child istaking, hastakenrecentlyor may have to take any other medication, including those purchased without a prescription.

Some medications may affect the functioning of montelukast, or montelukast may affect the functioning of other medications your child is using.

Before taking Montelukast Aurovitas Spain, inform your doctor if your child is taking the following medications:

• Phenobarbital (used for the treatment of epilepsy).
• Phenytoin (used for the treatment of epilepsy).
• Rifampicin (used for the treatment of tuberculosis and some other infections).

Taking Montelukast Aurovitas Spain with food and drinks

This medication can be taken regardless of meal times.

Pregnancy and breastfeeding

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

Driving and operating machines

This subsection does not apply to Montelukast Aurovitas Spain 4 mg granule, as its use is indicated in children between 6 months and 5 years of age, however, the following information is important for the active ingredient, montelukast.

Montelukast is not expected to affect your ability to drive a car or operate machines. However, individual responses to the medication 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 machines.

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

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

For children aged 6 months to 5 years:

The recommended dose is one packet of Montelukast Aurovitas Spain 4 mg granule by oral route every night.

If your child is taking Montelukast Aurovitas Spain, make sure they do not take any other medication that contains the same active ingredient, montelukast.

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

This medication is taken orally.

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

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

• Mix the entire content of Montelukast Aurovitas Spain granule in a spoonful of cold or room-temperature soft food, taking care to observe that the full dose is mixed with the food.
• Make sure to administer the entire spoonful to the child immediately (within 15 minutes). IMPORTANT: Never store any leftovers of the food/granule mixture for later use.
• Montelukast Aurovitas Spain granule is not intended to dissolve in liquids. However, your child may take liquids after swallowing Montelukast Aurovitas Spain granule.
• Montelukast Aurovitas Spain granule can be taken regardless of meal times.

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

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

If you forgot 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 packet per day.

Do not give a double dose to compensate for the missed doses.

If your child interrupts treatment with Montelukast Aurovitas Spain

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

If you have any other doubts about the use of this medication, ask your child's doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

In clinical trials conducted with Montelukast Aurovitas Spain 4 mg granule, 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.
• Skin with itching or scaly skin.
• 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:

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).

Severe 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 require urgent medical treatment.

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

• Allergic reactions that include swelling of the face, lips, tongue, and/or throat that may cause difficulty breathing or swallowing.
• Behavioral and mood 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 respiratory symptoms and/or skin rash (Churg-Strauss syndrome) (see section 2).
• Low platelet count.
• Behavioral and mood changes: hallucinations, disorientation, suicidal thoughts and actions.
• Pulmonary edema.
• Severe skin reactions (erythema multiforme) that may 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.
• Skin rash.
• Fever.
• Elevated liver enzymes.

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

• Behavioral and mood changes: sleep disturbances, including nightmares, sleep problems, somnambulism, irritability, anxiety, restlessness.
• Dizziness, drowsiness, tingling/numbness.
• Nosebleeds.
• Dry mouth, indigestion.
• Bruising, itching, urticaria.
• Muscle or joint pain, muscle cramps.
• Bedwetting (in children).
• Weakness/fatigue, discomfort, swelling.

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

• Behavioral and mood changes: attention disturbances, memory disturbances, uncontrolled muscle movements.

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

• Red, painful bumps under the skin that more frequently appear on the face (erythema nodosum).
• Behavioral and mood changes: obsessive-compulsive symptoms, stuttering.

Reporting of side effects

If your child experiences any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the blister pack. The first two numbers indicate the month; the last four numbers indicate the year. The expiration date is the last day of the month indicated.

No requires special storage conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Montelukast Aurovitas Spain

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

Appearance of the product and content of the packaging

The granules of Montelukast Aurovitas Spain 4 mg are a white to yellowish granulate.

Packaging of 28 sachets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

Generis Farmacêutica, S.A.

Rua Joao de Deus, 19

2700-487 Amadora

Portugal

Last review date of this leaflet: April 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)