Leaflet: information for the user

Monkasta 5 mg chewable tablets EFG

For children from 6 to 14 years old}

montelukast

Read this leaflet carefully before you or your child start taking this medicine,because it contains important information for you or your child.

• 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 you or your child and should not be given to others, even if they have the same symptoms as you or your child, as it may harm them.
• If you or your child experience 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 starting to take 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 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 asthma and prevent asthma symptoms during the day and night.

• Montelukast is used for the treatment of pediatric patients aged 6 to 14 years 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 aged 6 to 14 years who have not recently taken oral corticosteroids for the treatment of their asthma and have demonstrated an inability to use inhaled corticosteroids.
• Montelukast also helps prevent airway constriction caused by exercise.

Depending on symptoms and the severity of asthma or that of your child, 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 of the inner layer of the airways.

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

Inform your doctor of any allergy or medical condition you or your child have now or have had.

Do not take Monkasta.

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

Warnings and precautions

Consult your doctor or pharmacist before you or your child start taking Monkasta:

• If your asthma or your child's asthma 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 you or your child.Always have your child's rescue inhaler for asthma attacks nearby.
• It is essential that you or your child take all asthma medications prescribed by your doctor. Monkasta should not be used in place of other asthma medications prescribed by your doctor.
• Any patient treated with asthma medications 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 respiratory symptoms, and/or skin rash, they should consult their doctor.
• You or your child should not take acetylsalicylic acid (aspirin) or nonsteroidal anti-inflammatory drugs (also known as NSAIDs) if they make your asthma worse.

Children and adolescents

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

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

Taking Monkasta with other medications

Inform your doctor or pharmacist if you or your child are taking, have taken recently, or may need to take 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 you are using.

Before taking Monkasta, inform your doctor if you or your child are taking the following medications:

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

Taking Monkasta with food

Monkasta 5 mg chewable tablets should not be taken with meals; it should be taken at least 1 hour before or 2 hours after meals.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Your doctor will evaluate whether you can take Monkasta during this period.

Breastfeeding

The safety of Monkasta in breastfeeding women is unknown. If you are breastfeeding or intend to breastfeed, consult your doctor before taking Monkasta.

Driving and operating machinery

Monkasta 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) reported with Monkasta may affect the patient's ability to drive or operate machinery.

Monkasta contains aspartame and sodium

This medication contains 1.5 mg of aspartame in each chewable tablet.

Aspartame contains a source of phenylalanine that may be harmful to you or your child if they have 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."

Always take this medication exactly as your doctor or pharmacist has instructed. Consult your doctor or pharmacist if you have any doubts.

• You or your child should only take one Monkasta chewable tablet once a day, as prescribed by your doctor.
• Take it even when you or your child do not have symptoms or when you have an acute asthma attack.

Use in children aged 6 to 14 years

The recommended dose is one 5 mg chewable tablet at night.

If you or your child are taking Monkasta, make sure neither your child nor you take any other medication that contains the same active ingredient, montelukast.

This medication should be taken orally.

The tablets should be chewed before swallowing.

Monkasta 5 mg chewable tablets should not be taken with meals; it should be taken at least 1 hour before or 2 hours after eating.

If you or your child take more Monkasta than you should

Seek immediate help from your doctor.

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 take or give Monkasta to your child

Try to take/give Monkasta as prescribed. However, if you or your child forget a dose, simply resume the usual regimen of one chewable tablet once a day.

Do not take/double a dose to compensate for missed doses.

If you or your child interrupt treatment with Monkasta

Monkasta can only treat your or your child's asthma if you continue to take it. It is essential to continue taking Monkasta for the time your doctor prescribes. It will help control your or your child's asthma.

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

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

In clinical trials conducted with Monkasta 5 mg chewable tablets, the side effects related to the administration of the medicine and reported most frequently (may affect 1 in 10 patients), were:

• headache.

Additionally, the following side effect was reported in clinical trials with montelukast 10 mg film-coated tablets:

abdominal pain.

These side effects were generally mild and occurred more frequently in patients treated with montelukast than with placebo (a tablet that does not contain medicine).

Severe side effects

Talk to your doctor or 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: 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: agitation, including aggressive or hostile behavior, depression,
• seizures.

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

• increased tendency to bleed,
• 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 in blood,
• 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 have been reported while the medicine 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

• 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 disturbance, memory disturbance, 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),
• behavior and mood changes: obsessive-compulsive symptoms,
• stuttering.

Reporting of side effects

If you or your child 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 packaging after CAD. The expiration date is the last day of the month indicated.

Keep in the original packaging to protect it from light.

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

medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and the medicines you no longer need. By doing so, you will help protect the environment.

Composition of Monkasta

• The active principle is montelukast.

Each chewable tablet contains 5 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 5 mg contains aspartame and sodium”).

Appearance of the product and contents of the package

The tablets are pink, speckled, round, slightly biconvex, with beveled edges and engraved with “5” 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, 27472 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 Farmacéutica, S.L., C/ Anabel Segura 10, Pta. Baja, Oficina 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/”