MONKASTA 5 mg CHEWABLE TABLETS

Introduction

Package Leaflet: Information for the User

Monkasta 5 mg Chewable Tablets EFG

For Children from 6 to 14 Years

montelukast

Read all of 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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you or your child only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours or your child's.
• If you or your child experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Monkasta and what is it used for
2. What you need to know before taking Monkasta
3. How to take Monkasta
4. Possible side effects
5. Storage of Monkasta
6. Contents of the pack and further information

1. What is Monkasta and what is it used for

What is Monkasta

Monkasta is a leukotriene receptor antagonist that blocks substances called leukotrienes.

How Monkasta works

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

When Monkasta should be used

Your doctor has prescribed Monkasta to treat asthma and prevent asthma symptoms during the day and night.

• Monkasta is used for the treatment of pediatric patients between 6 and 14 years of age who are not adequately controlled with their medication and need additional treatment.
• Monkasta is also used as an alternative treatment to inhaled corticosteroids in patients between 6 and 14 years of age who have not recently taken oral corticosteroids for the treatment of their asthma and have demonstrated that they are unable to use inhaled corticosteroids.
• Monkasta also helps prevent narrowing of the airways caused by exercise.

Depending on the symptoms and severity of your or your child's asthma, your doctor will determine how to use Monkasta.

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.
• • airways that are sensitive and 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 chest congestion.

2. What you need to know before taking Monkasta

Tell your doctor about any allergy or medical problem that you or your child have now or have had.

Do not take Monkasta

• if you or your child are allergic to montelukast sodium or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

• If your or your child's asthma or breathing worsens, inform your doctor immediately.
• Monkasta oral is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor to you or your child. Always have your asthma rescue medication with you.
• It is essential that you or your child take all asthma medications prescribed by your doctor. Monkasta should not be used instead of other asthma medications prescribed by your doctor for you or your child.
• 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 lung symptoms, and/or skin rash, they should consult their doctor.
• You or your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medications (also known as non-steroidal anti-inflammatory medications or NSAIDs) if they worsen your or your child's asthma.

Children and adolescents

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

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

Taking Monkasta with other medicines

Tell your doctor or pharmacist if you or your child are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.

Some medicines may affect the way Monkasta works, or Monkasta may affect the way other medicines work.

Before taking Monkasta, tell your doctor if you or your child are taking the following medicines:

• phenobarbital (used to treat epilepsy)
• phenytoin (used to treat epilepsy)
• rifampicin (used to treat tuberculosis and some other infections).

Taking Monkasta with food

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

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

Breastfeeding

It is not known whether Monkasta appears in breast milk. If you are breastfeeding or plan to breastfeed, you should consult your doctor before taking Monkasta.

Driving and using machines

Monkasta is not expected to affect your ability to drive a car or operate machines. However, individual responses to the medicine may vary. Certain side effects (such as dizziness and drowsiness) that have been reported with Monkasta may affect the patient's ability to drive or operate machines.

Monkasta contains aspartame and sodium

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

Aspartame is a source of phenylalanine, which may be harmful to you or your child if you or your child have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

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

3. How to take Monkasta

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are not sure.

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

Use in children between 6 and 14 years of age

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

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

This medicine should be taken orally.

The tablets should be chewed before swallowing.

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

If you or your child take more Monkasta than you should

Seek immediate medical attention from your doctor.

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

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

If you or your child forget to take Monkasta

Try to take Monkasta as prescribed. However, if you or your child forget a dose, just resume your usual routine of one chewable tablet once a day.

Do not take a double dose to make up for forgotten doses.

If you or your child stop taking Monkasta

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

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In clinical trials with Monkasta 5 mg chewable tablets, the side effects related to the administration of the medicine and reported most frequently (may affect up to 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 with a higher frequency in patients treated with montelukast than with placebo (a pill that does not contain medicine).

Serious side effects

Talk to your doctor or your child's doctor immediatelyif you notice any of the following side effects, which may be serious and for which your child may need 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 can cause difficulty breathing or swallowing,
• mood-related changes: agitation, including aggressive behavior 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

• a combination of symptoms such as flu-like illness, tingling or numbness of arms and legs, worsening of lung symptoms, and/or skin rash (Churg-Strauss syndrome) (see Section 2),
• low platelet count in blood,
• mood-related changes: hallucinations, disorientation, suicidal thoughts and actions,
• swelling (inflammation) of the lungs,
• severe skin reactions (erythema multiforme) that can occur without warning,
• inflammation of the liver (hepatitis).

Other side effects have been reported while the medicine has been on the market

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

• mood-related changes: 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

• mood-related changes: attention disturbance, memory disturbance, uncontrolled muscle movements.

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

• painful red lumps under the skin, which most often appear on the shins (erythema nodosum),
• mood-related changes: obsessive-compulsive symptoms,
• stuttering.

Reporting of side effects

If you or your child experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Monkasta

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

Do not use this medicine after the expiry date which is stated on the blister and on the carton after EXP. The expiry date refers to the last day of the month shown.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. This will help protect the environment.

6. Contents of the pack and further information

Composition of Monkasta

• The active substance is montelukast.

Each chewable tablet contains 5 mg of montelukast (as montelukast sodium).

• The other ingredients are mannitol (E421), microcrystalline cellulose, sodium croscarmellose, hydroxypropyl cellulose, aspartame (E951), red iron oxide (E172), black cherry flavor (also contains glycerol triacetate (E1518)), and magnesium stearate (see section 2 "Monkasta 5 mg contains aspartame and sodium").

Appearance of the product and pack contents

The tablets are pink, speckled, round, slightly biconvex, with bisected edges and engraved with "5" on one side.

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

Manufacturer

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 obtain further information about this medicine from the 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:

Date of last revision of this leaflet: February 2024

“Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/”