Leaflet: information for the user

Monkasta 4 mg chewable tablets EFG

For children from 2 to 5 years

montelukast

Read this leaflet carefully before giving this medicine to your child, as 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 only for your child, and should not be given to other people, 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.

1. What is Monkasta and what it is used for

2. What you need to know before your child takes Monkasta

3. How to take Monkasta

4. Possible side effects

5. Storage of Monkasta

6. Contents of the pack and additional information

What is Montelukast

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

Leukotrienes.

How Montelukast 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

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

• Montelukast is used for the treatment of patients between 2 and 5 years of age who are not adequately controlled with their medication and require 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 the treatment of their asthma and who have demonstrated an inability to use inhaled corticosteroids.
• Montelukast also helps prevent airway constriction 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 conditions.
• 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 chest congestion.

Inform your child's doctor about any allergy or medical condition your child has now or has had.

Do not give Monkasta to your child

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

Warnings and precautions

Consult your doctor or pharmacist before starting to give Monkasta to your child.

• If your child's asthma or breathing worsens, inform your doctor immediately.
• Monkasta oral is not indicated for treating acute asthma attacks. If an attack occurs, follow the instructions your doctor has given to your child. Always have your child's rescue inhaler medication on hand for asthma attacks.
• It is essential that your child takes all prescribed asthma medications. Monkasta 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, you should consult your 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.

Monkasta with other medications

Inform your doctor or pharmacist if your child is using, has used recently, or may need to use any other medication, including those purchased without a prescription.

Some medications may affect the functioning of Monkasta, or Monkasta may affect the functioning of other medications being used.

Before taking Monkasta, inform your 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).

Monkasta with food and drinksand beverages

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

Pregnancy and breastfeeding

This subsection is not applicable to Monkasta 4 mg chewable tablets, as its use is

indicated in children between 2 and 5 years of age.

Driving and operating machinery

This subsection is not applicable to Monkasta 4 mg chewable tablets, as its use is

indicated in children between 2 and 5 years of age, however, the following information is important for the active ingredient, montelukast.

Monkasta is not expected to affect your child's ability to drive a car or operate machinery. However, individual responses to the medication may vary. Certain adverse effects (such as dizziness and drowsiness) reported with Monkasta may affect the patient's ability to drive or operate machinery.

Monkasta contains aspartame and sodium

This medication contains 1.2 mg of aspartame in each chewable tablet.The aspartame contains a source of phenylalanine that may be harmful to your child in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

This medication contains less than 1 mmol of sodium (23 mg) per chewable tablet, which is essentially “sodium-free.”

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

• This medication should be administered to children under the supervision of an adult. For children who have difficulty taking a chewable tablet, an oral granule formulation is available.

• Your child should only take one Monkasta chewable tablet once a day as prescribed by their doctor.
• It should be taken even when you or your child do not have symptoms or when having an acute asthma attack.

Use in children aged 2 to 5 years:

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

If your child is taking Monkasta, ensure they do not take any other medication containing the same active ingredient, montelukast.

This medication should be taken orally.

The tablets should be chewed before swallowing.

Monkasta 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 Monkasta than they should

Seek help from your child's doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 652 04 20, indicating the medication and the amount ingested.

In most cases of overdose, no adverse effects were reported. The symptoms reported that occurred most frequently in overdose in children and adults were abdominal pain, drowsiness, drowsiness, headache, vomiting, and hyperactivity.

If you forgot to give Monkasta to your child

Try to give Monkasta as prescribed. However, if your child forgets a dose, limit yourself to resuming the usual regimen of one chewable tablet once a day.

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

If your child interrupts treatment with Monkasta

Monkasta 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 their doctor prescribes. 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 medicine may cause side effects, although not everyone will experience them.

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

• sedation.

Additionally, the following side effect was reported in clinical trials with montelukast 10 mg

film-coated tabletsand 5 mg chewable tablets:

• headache.

These side effects were generally mild and occurred more frequently in

patients treated with montelukast than with placebo (a tablet that does not contain the active ingredient).

Severe side effects

Talk to your child's doctor immediatelyif you notice any of the following side effects, which may be severe, and for which your child may need urgent medical treatment.

Rare: the following 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: agitation, including aggressive or hostile behavior, depression,
• seizures.

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

• increased tendency to bleed,
• 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 in blood,
• behavioral 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 have been reported while the drug has been marketed

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, 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

• behavioral and mood changes: attention alteration, memory alteration, 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 elbows (erythema nodosum),
• behavioral and mood changes: obsessive-compulsive symptoms,
• stuttering.

Reporting of side effects

If you 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: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

container after CAD. The expiration date is the last day of the month indicated.

Keep in the original container to protect it from light.

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and

medicines you no longer need at the SIGRE drop-off point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Monkasta

• The active ingredient is montelukast.

Each chewable tablet contains 4 mg of montelukast (as montelukast sodium).

• The other components are mannitol (E421), microcrystalline cellulose, sodium croscarmellose, hydroxypropyl cellulose, aspartame (E951), red iron oxide (E172), black cherry flavor (also contains triacetin (E1518)) and magnesium stearate (see section 2 “Monkasta 4 mg contains aspartame and sodium”).

Appearance of the product and contents of the pack

The tablets are pink, speckled, round, slightly biconvex, with bevelled edges and engraved with “4” on one face.

Available in boxes of 7, 10, 14, 20, 28, 30, 49, 50, 56, 84, 90, 98, 100, 140 or 200 chewable tablets in blisters.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Responsible for manufacturing

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27772 Cuxhaven, Germany

KRKA-POLSKA Sp. z o.o., ul. Równolegla 5, 02-235 Warsaw, Poland

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

KRKA Pharmaceutical, S.L., C/ Anabel Segura 10, Pta. Baja, Office 1, 28108 Alcobendas, Madrid, Spain

This medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Last review date of this leaflet: February 2024

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