Monkasta

Leaflet accompanying the packaging: patient information

Monkasta, 5 mg, chewable tablets

For children aged 6 to 14 years

Montelukast

Read the leaflet carefully before giving the medicine to the child, as it contains important information for the patient.

• 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 a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient or child experiences any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Monkasta and what is it used for
• 2. Important information before taking 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 is Monkasta and what is it used for

What is Monkasta

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

How Monkasta works

Leukotrienes cause narrowing and swelling of the airways. By blocking the action of leukotrienes, Monkasta relieves asthma symptoms and helps control asthma.

When to use Monkasta

The doctor has prescribed Monkasta for the treatment of asthma, to prevent asthma symptoms from occurring during the day and at night.

• Monkasta is used to treat children and adolescents aged 6 to 14 years who have not achieved adequate asthma control with their current medications and require additional treatment.
• Monkasta may also be used as an alternative to inhaled corticosteroids in patients aged 6 to 14 years who have not recently taken oral corticosteroids for asthma and are unable to use inhaled corticosteroids.
• Monkasta also helps prevent narrowing of the airways caused by physical exertion.

The doctor will determine how to take Monkasta based on the patient's or child's symptoms and the severity of their asthma.

What is asthma?

Asthma is a chronic disease.

In asthma, the following occur:

• breathing difficulties due to narrowing of the airways, which worsens and improves in response to various factors.
• airway hypersensitivity, which reacts to many factors, such as cigarette smoke, plant pollen, cold air, or physical exertion.
• swelling (inflammation) of the lining of the airways.

Asthma symptoms include: coughing, wheezing, and a feeling of tightness in the chest.

2. Important information before taking Monkasta

Tell your doctor about any health problems or allergies that the patient or child has now or has had in the past.

When not to use Monkasta

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

Warnings and precautions

Before starting to take or give Monkasta to a child, consult a doctor or pharmacist:

• If the patient's or child's asthma worsens or they experience breathing difficulties, tell your doctor immediately.
• Monkasta taken orally is not intended for the treatment of acute asthma attacks. If an attack occurs, follow the doctor's instructions. Always carry a rescue inhaler with you in case of an asthma attack.
• It is essential to give the patient or child all asthma medications prescribed by the doctor. Do not use Monkasta, 5 mg, chewable tablets as a replacement for other asthma medications prescribed by the doctor.
• Remember to consult a doctor if the patient taking asthma medications experiences a set of symptoms such as flu-like symptoms, tingling or numbness of the hands or feet, worsening of respiratory symptoms, and/or rash.
• Do not give the patient or child aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) if they worsen their asthma symptoms.

Various neuropsychiatric events (such as changes in behavior and mood, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If the patient experiences such symptoms while taking montelukast, consult a doctor.

During treatment with montelukast, consult a doctor if such symptoms occur.

Children and adolescents

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

For children and adolescents under 18 years of age, other forms of this medicine are available, suitable for the patient's age.

Other medicines and Monkasta

Tell your doctor or pharmacist about all medicines the patient or child is taking now or has taken recently, including those obtained without a prescription.

Some medicines may affect the action of Monkasta or Monkasta may affect the action of other medicines.

Before taking Monkasta, tell your doctor if the patient or child is taking:

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

Monkasta with food and drink

Do not take Monkasta, 5 mg, chewable tablets with food; take the medicine at least 1 hour before or 2 hours after food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, consult a doctor or pharmacist before taking Monkasta.

Pregnancy

The doctor will assess whether Monkasta can be taken during this period.

Breastfeeding

It is not known whether Monkasta passes into breast milk. If a woman is breastfeeding or plans to breastfeed, consult a doctor before taking Monkasta.

Driving and using machines

Do not expect Monkasta to affect the ability to drive or use machines. However, individual reactions to the medicine may vary. Some side effects (such as dizziness and drowsiness) reported during treatment with montelukast may affect the ability to drive or use machines in some patients.

Monkasta contains aspartame and sodium

This medicine contains 1.5 mg of aspartame in each chewable tablet. Aspartame is a source of phenylalanine. It may be harmful if the patient or child has phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to its improper elimination.

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

3. How to take Monkasta

Always take this medicine exactly as the doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

• Give the child only one Monkasta tablet once a day, as instructed by the doctor.
• Take the medicine even when the patient or child does not have asthma symptoms, and also when an acute asthma attack occurs.

Use in children aged 6 to 14 years

The recommended dose is one 5 mg chewable tablet, taken once daily, in the evening.

If the child is taking this medicine, ensure they do not take other medicines containing the same active substance, montelukast.

This medicine is for oral use only.

Chew the tablets before swallowing.

Do not take Monkasta, 5 mg, chewable tablets with food; take the medicine at least 1 hour before or 2 hours after food.

Overdose of Monkasta

In order to get advice, contact a doctor immediately.

In most cases of overdose, no side effects have been observed.

The most commonly reported symptoms of overdose in adults and children are: stomach pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

Missed dose of Monkasta

Try to take Monkasta as instructed by the doctor. However, if a dose is missed, return to the usual dosing schedule - one chewable tablet once daily.

Do not take a double dose to make up for a missed dose.

Stopping treatment with Monkasta

Monkasta is effective in treating asthma only when taken regularly.

It is essential to continue taking the medicine as long as the doctor has prescribed. This will help keep the asthma under control.

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

4. Possible side effects

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

During clinical trials with montelukast, 5 mg, chewable tablets, the most commonly reported side effect (which may occur in up to 1 in 10 people) considered to be related to montelukast was:

• headache.

In addition, in clinical trials with montelukast, 10 mg, film-coated tablets, the following were reported:

• stomach pain.

These symptoms were usually mild and occurred more frequently in patients treated with montelukast than in patients taking a placebo (a tablet that does not contain any medicine).

Severe side effects

Contact a doctor immediatelyif any of the following side effects occur, which may be severe and require immediate medical attention.

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 in behavior and mood: 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 set of symptoms such as flu-like symptoms, tingling or numbness of the hands and feet, worsening of respiratory symptoms, and/or rash (Churg-Strauss syndrome) (see section 2),
• decreased platelet count,
• changes in behavior and mood: hallucinations, disorientation, suicidal thoughts and attempts,
• inflammation (inflammation) of the lungs,
• severe skin reactions (erythema multiforme), which may occur without prior symptoms,
• hepatitis.

Other side effects reported after the medicine was marketed

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,
• rash,
• fever,
• increased liver enzyme levels.

Uncommon: may affect up to 1 in 100 people

• changes in behavior and mood: unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness,
• dizziness, drowsiness, tingling and numbness,
• nosebleeds,
• dry mouth, indigestion,
• bruising, itching, hives,
• muscle or joint pain, muscle cramps,
• bedwetting in children,
• weakness and/or fatigue, malaise, swelling.

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

• changes in behavior and mood: attention disorders, memory disorders, uncontrolled movements.

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

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

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the contact details below.

Side effects can also be reported to the regulatory authority.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 carton after EXP. The expiry date refers to the last day of that month.

Store in the original package to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Monkasta contains

• The active substance is montelukast. Each chewable tablet contains 5 mg of montelukast (as montelukast sodium).
• The other ingredients are mannitol (E 421), microcrystalline cellulose, sodium croscarmellose, hydroxypropyl cellulose, aspartame (E 951), red iron oxide (E 172), cherry flavor (also containing triacetin (E 1518)), and magnesium stearate. See section 2 "Monkasta contains aspartame and sodium".

What Monkasta looks like and contents of the pack

Pink, mottled, round, slightly biconvex tablets, with beveled edges and the inscription "5" on one side.

Packaging: 28 and 90 chewable tablets in blisters, in a cardboard box.

Marketing Authorisation 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

KRKA-POLSKA Sp. z o.o., ul. Równoległa 5, 02-235 Warszawa, Poland

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

To obtain more detailed information on the names of the medicine in other EU Member States and the UK (Northern Ireland), contact the local representative of the Marketing Authorisation Holder:

KRKA-POLSKA Sp. z o.o.

ul. Równoległa 5

02-235 Warszawa

Tel. 22 57 37 500

Date of last revision of the leaflet:07.02.2024