Monkasta 4 mg chewable tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Monkasta 4 mg chewable tablets EFG

For children from 2 to 5 years of age

montelukast

Read the entire leaflet carefully before you start giving this medicine to your child, because 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 for your child only, and you should not give it to others, even if they 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 these are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Monkasta is 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. How to store Monkasta
6. Contents of the pack and other information

1. What Monkasta is and what it is 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 your child's asthma and to prevent asthma symptoms during the day and night.

• Monkasta is used for the treatment of patients aged 2 to 5 years who are not adequately controlled with their current medication and require additional treatment.

• Monkasta is also used as an alternative treatment to inhaled corticosteroids in patients aged 2 to 5 years who have not recently taken oral corticosteroids for the treatment of their asthma and who have been shown to be unable to use inhaled corticosteroids.

• Monkasta also helps prevent exercise-induced narrowing of the airways in patients aged 2 years and older.

Depending on your child's symptoms and the severity of their asthma, your doctor will determine how Monkasta should be used.

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 triggers.

• sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or exercise.

• swelling (inflammation) of the inner lining of the airways.

Asthma symptoms include: cough, wheezing, and chest tightness.

2. What you need to know before starting Monkasta for your child

Inform your doctor of any allergies or medical conditions your child currently has or has had in the past.

Do not give Monkasta to your child

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to give Monkasta to your child

• If your child's asthma or breathing worsens, inform your doctor immediately.
• Oral Monkasta is not indicated for the treatment of acute asthma attacks. If an asthma attack occurs, follow the instructions your doctor has given your child. Always keep your child’s rescue inhaler medication with you for asthma attacks.
• It is important that your child takes all asthma medications prescribed by their doctor. Monkasta should not be used instead 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 in arms or legs, worsening of pulmonary symptoms, and/or skin rash, you should consult your doctor.
• Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if these worsen their asthma.

Children and adolescents

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

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

Taking Monkasta with other medicines

Inform your doctor or pharmacist if your child is taking, has recently taken, or might need to take any other medicines, including those obtained without a prescription.

Some medicines may affect how Monkasta works, or Monkasta may affect how other medicines work.

Before taking Monkasta, inform your doctor if your child is taking any of the following medicines:

• phenobarbital (used for the treatment of epilepsy),
• phenytoin (used for the treatment of epilepsy),
• rifampicin (used for the treatment of tuberculosis and certain other infections).

Taking Monkasta with food and drinks

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

Pregnancy and breastfeeding

This section does not apply to Monkasta 4 mg chewable tablets, as its use is

indicated in children aged between 2 and 5 years.

Driving and using machines

This section does not apply to Monkasta 4 mg chewable tablets, as its use is

indicated in children aged between 2 and 5 years. However, the following information is relevant for the active substance, montelukast.

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

Monkasta contains aspartame and sodium

This medicine contains 1.2 mg of aspartame per chewable tablet. Aspartame is a source of phenylalanine, which may be harmful to your child if they have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot 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

Follow exactly the administration instructions for this medicine given by your child's doctor or pharmacist. If you are unsure, consult your child's doctor or pharmacist again.

• This medicine 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 take only one Monkasta chewable tablet once daily, as prescribed by the doctor.

• It must be taken even when you or your child do not have symptoms or during 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, make sure they do not take any other medicine containing the same active substance, montelukast.

This medicine is for oral use.

The tablets must be chewed before swallowing.

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

If your child takes more Monkasta than they should

Seek immediate help from your child's doctor.

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

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

If you forget to give Monkasta to your child

Try to give Monkasta as prescribed. However, if your child misses a dose, simply resume the usual regimen of one chewable tablet once daily.

Do not give a double dose to make up for missed doses.

If your child stops treatment with Monkasta

Monkasta can only treat your child's asthma if treatment is continued.

It is important that your child continues to take this medicine for as long as prescribed by the doctor. It will help control your child's asthma.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• abdominal pain,
• thirst.

Additionally, the following adverse effect was reported in clinical trials with montelukast 10 mg film-coated tablets and 5 mg chewable tablets:

• headache.

These adverse effects were generally mild and occurred more frequently in patients treated with montelukast than with placebo (a pill containing no active ingredient).

Serious adverse effects

Speak to your child's doctor immediately if you notice any of the following side effects, which may be serious and for which your child may require urgent medical treatment.

Uncommon: may affect up to 1 in 100 people

• allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty breathing or swallowing,
• changes related to behavior and mood: 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

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

Other adverse effects reported after 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,
• rash,
• fever,
• elevated liver enzymes.

Uncommon: may affect up to 1 in 100 people

• changes related to behavior and mood: sleep disturbances, including nightmares, sleep problems, sleepwalking, irritability, feeling anxious, restlessness,
• dizziness, somnolence, tingling/numbness,
• nosebleed,
• dry mouth, indigestion,
• bruising, itching, urticaria,
• joint or muscle pain, muscle cramps,
• bedwetting in children,
• weakness/tiredness, malaise, swelling.

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

• changes related to behavior and mood: attention disturbance, memory impairment, uncontrolled muscle movements.

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

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse 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 stated on the blister and on the
package after EXP. The expiry date refers to the last day of the month indicated.

Keep in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Monkasta

• The active substance 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 flavour (also contains glyceryl triacetate (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, mottled, round, slightly biconvex, with bevelled edges and engraved with “4” on one side.

Available in packs 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. Równoległa 5, 02-235 Warsaw, Poland

You can request further information regarding this medicinal product 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 medicinal product is authorized in the European Economic Area Member States and in the United Kingdom (Northern Ireland) under the following names:

Date of the last revision of this leaflet: February 2024

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