Package Leaflet: Information for the User

Montelukast Aurovitas 4 mg Chewable Tablets EFG

Read this 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 only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2.What you need to know before you start taking Montelukast Aurovitas

3.How to take Montelukast Aurovitas

4.Possible side effects

5.Storage of Montelukast Aurovitas

6.Contents of the pack and additional information

What is Montelukast Aurovitas

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

How Montelukast Aurovitas works

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

When to use Montelukast Aurovitas

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

• Montelukast Aurovitas is used for the treatment of patients between 2 and 5 years of age who are not adequately controlled with their medication and need additional treatment.
• Montelukast Aurovitas 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 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.

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 situations.
• Sensitive airways that 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 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 to your child

• if they are allergic to montelukast or to 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 to your child:

• If your child's asthma or breathing worsens, inform your child's doctor immediately.
• Montelukast Aurovitas 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 asthma medications prescribed by their doctor. Montelukast Aurovitas 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 they develop a combination of symptoms such as flu-like illness, tingling or numbness of arms or legs, worsening of 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 worsen their asthma.

Children and adolescents

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

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

Other medications andMontelukast Aurovitas

Inform your child's doctor or pharmacist if your child is taking, has recently taken, or may need 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, inform your child's doctor if your child is taking the following medications:

• phenobarbital (used for epilepsy treatment)
• phenytoin (used for epilepsy treatment)
• rifampicin (used for tuberculosis and some other infections treatment)

Administration ofMontelukast Aurovitaswith food, beverages, and alcohol

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

Pregnancy, breastfeeding, and fertility

This subsection is not applicable to Montelukast Aurovitas chewable tablets, as its use is indicated in children aged 2 to 5 years.

Driving and operating machinery

This subsection is not applicable toMontelukast Aurovitas4 mg chewable tablets, as its use is indicated in children aged 2 to 5 years, 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 machinery. However, individual responses to the medication may vary. Certain adverse effects (such as dizziness and somnolence) that have been reported rarely with montelukast may affect the patient's ability to drive or operate machinery.

MontelukastAurovitascontains aspartame

This medication may be harmful to individuals with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

Each Montelukast Aurovitas 4 mg chewable tablet contains an aspartame content equivalent to 0.674 mg of phenylalanine.

MontelukastAurovitascontains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

• This medication should be administered to children under the supervision of an adult.
• Your child should only take one Montelukast Aurovitas tablet once a day, as prescribed by your child's doctor.
• It should be taken even when your child does not have symptoms or when having an acute asthma attack.

For children aged 2 to 5 years:

The recommended dose is one chewable 4 mg tablet daily at night.

Ensure your child does not take any other medication containing the same active ingredient, montelukast.

This medication is taken orally.

The tablets should be chewed before swallowing.

Montelukast Aurovitas 4 mg chewable tablets should not be taken with meals; it should be taken at least 1 hour before or 2 hours after eating.

If your child takes more Montelukast Aurovitas than they should:

Seek immediate help from your child's doctor.

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, drowsiness, 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 medication and the amount ingested.

If you forgot to give Montelukast Aurovitas to your child:

Try to give Montelukast Aurovitas as prescribed. However, if you forget to give your child a dose, simply resume the usual regimen of one tablet once a day.

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

If your child interrupts treatment with Montelukast Aurovitas:

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

It is essential that your child continues taking Montelukast Aurovitas for the time prescribed by their doctor. It will help control your child's asthma.

If you have any other questions about using this medication, ask your child's doctor or pharmacist.

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

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

• abdominal pain
• fatigue

In addition, the following side effect was 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 more frequently in patients treated with montelukast than with placebo (a pill that does not contain a medicine).

Severe side effects

Consult your doctor immediatelyif you notice any of the following side effects, as they 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 may cause difficulty breathing or swallowing,
• behavior 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,
• tremors,
• 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,
• behavior and mood changes: hallucinations, disorientation, suicidal thoughts and actions,
• lung inflammation,
• severe skin reactions (erythema multiforme) that may occur without warning,
• inflammation of the liver (hepatitis).

Other side effects reported during the marketing of the drug

Very common:may affect more than 1 in 10 people

• upper respiratory tract infections.

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

• behavior and mood changes: sleep disturbances, including nightmares, sleep problems, somnambulism, irritability, anxiety, restlessness,
• dizziness, somnolence, tingling/numbness,
• nasal bleeding,
• dry mouth, indigestion,
• bruising, itching, urticaria,
• joint or muscle pain, muscle cramps,
• bedwetting (in children),
• weakness/fatigue, discomfort, swelling.

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

• behavior and mood changes: attention alteration, memory alteration, uncontrolled muscle movements.

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

-red, painful lumps under the skin that more frequently appear on the skin (erythema nodosum).

-behavior and mood changes: obsessive-compulsive symptoms, stuttering.

Reporting of side effects

Ifyou experience 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 blister pack and on the box after CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

Store in the original packaging to protect it from light and moisture.

Medications should not be disposed of through drains or in the trash. Deposit empty containers and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Montelukast Aurovitas

• The active ingredient is montelukast. Each chewable tablet contains montelukast sodium, equivalent to 4mg of montelukast.
• The other components are: mannitol (E 421), microcrystalline cellulose, hydroxypropylcellulose at 2% (6 to 10 mPa.s), sodium croscarmellose, iron oxide red (E 172), aspartame (E 951), artificial cherry aroma (with its flavoring ingredients and modified cornstarch) and magnesium stearate (E 572).

Appearance of the product and contents of the package

Chewable tablets

Uncoated pink tablets, speckled, biconvex, oval, and marked with “X” on one face and “52” on the other face of the tablet.

Montelukast Aurovitas chewable tablets are available in PVC/polyamide/aluminum foil/PVC – aluminum foil blisters and high-density polyethylene (PEAD) bottles with a polypropylene closure containing silica gel desiccant.

Presentations

Blister packs: 7, 10, 14, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 140, and 200 chewable tablets.

High-density polyethylene (PEAD) bottles: 30, 90, and 500 chewable tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far,

Birzebbugia, BBG 3000.

Malta

This medicine is authorized in the member states of the European Economic Area with the following names:

FranceMontelukast Aurobindo 4 mg, chewable tablet

GermanyMontelukast Aurobindo 4 mg Kautabletten

ItalyMontelukast Pharma Italia 4 mg Compressa masticabile

PolandMontelukast Aurobindo

SpainMontelukast Aurovitas4 mg chewable tablets EFG

Last review date of this leaflet:February 2024

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