Monkasta

Package leaflet: Information for the patient

Monkasta, 4 mg, chewable tablets
For children aged 2 to 5 years
Montelukastum
Please read this leaflet carefully before administering the medicine to your child, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If your child experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Monkasta is and what it is used for
2. Important information before administering Monkasta to your child
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, which 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 Monkasta should be used
Your doctor has recommended Monkasta for the treatment of asthma in your child to prevent asthma symptoms during the day and at night.

• Monkasta is used in the treatment of patients aged 2 to 5 years who have not achieved adequate asthma control with previously used medications and require additional therapy.
• Monkasta may also be used instead of inhaled corticosteroids in patients aged 2 to 5 years who have not recently taken oral corticosteroids for asthma and who are unable to use inhaled corticosteroids.
• Monkasta also helps prevent exercise-induced narrowing of the airways in patients aged 2 years and older.

Your doctor will determine how to use Monkasta based on your child's symptoms and the severity of asthma.

What is asthma?
Asthma is a chronic disease.
In asthma, the following occur:

• Breathing difficulties caused by narrowing of the airways. This narrowing worsens and improves in response to various triggers.
• Increased sensitivity of the airways, which react to many factors such as cigarette smoke, pollen, cold air, or physical exertion.
• Swelling (inflammation) of the lining of the airways. Asthma symptoms include coughing, wheezing, and chest tightness.

2. Important information before using Monkasta medicine in children

Inform the doctor about any health problems or allergies the child currently has or has had in the past.

When not to use Monkasta medicine

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

Warnings and precautions
Before starting to give the child Monkasta medicine, consult a doctor or pharmacist:

• If the child's asthma worsens or if the child has difficulty breathing, inform the doctor immediately.
• Monkasta medicine taken orally is not intended for the treatment of acute asthma attacks. If such an attack occurs in the child, follow the doctor's instructions. Always keep a reliever inhaler available for immediate use in case of an asthma attack in the child.
• It is important to give the child all anti-asthma medicines prescribed by the doctor. Monkasta medicine should not be used as a substitute for other anti-asthma medicines prescribed for the child by the doctor.
• Remember to consult the doctor if the child taking anti-asthma medicines develops a cluster of symptoms such as flu-like symptoms, tingling or numbness in hands or feet, worsening of lung symptoms and/or rash.
• Do not give the child acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (also known as NSAIDs), if they worsen the child's asthma symptoms.

Various neuropsychiatric events (for example, changes in behavior and mood, depression, and suicidal tendencies) have been reported in patients of all ages treated with montelukast (see section 4). If such symptoms occur in a patient during treatment with montelukast, consult a doctor.

Children and adolescents
This medicine should not be given to children under 2 years of age.
Other formulations of this medicine, appropriate for the patient's age, are available for children and adolescents under 18 years of age.

Other medicines and Monkasta medicine
Tell the doctor or pharmacist about all medicines currently or recently given to the child, as well as any other medicines, including those available without a prescription.
Some medicines may affect the action of Monkasta medicine, or Monkasta medicine may affect the action of other medicines.
Before starting to use Monkasta medicine, tell the doctor if the child is taking any of the following medicines:

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

Monkasta medicine with food and drink
Monkasta 4 mg chewable tablets should not be taken during meals; the medicine should be taken at least one hour before a meal or two hours after a meal.

Pregnancy and breastfeeding
This section does not apply to Monkasta 4 mg chewable tablets, as they are intended for use in children aged 2 to 5 years.

Driving and operating machinery
This section does not apply to Monkasta 4 mg chewable tablets, as they are intended for use in children aged 2 to 5 years. However, the following information is relevant regarding the active substance of the medicine, montelukast.
Monkasta medicine is not expected to affect the ability to drive or operate machinery. However, individual responses to the medicine may vary. Some adverse reactions (such as dizziness and drowsiness) reported during use of Monkasta medicine may affect the ability to drive or operate machinery in some patients.

Monkasta contains aspartame and sodium
This medicine contains 1.2 mg of aspartame in each chewable tablet. Aspartame is a source of phenylalanine. It may be harmful if the child has phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to improper excretion.
This medicine contains less than 1 mmol (23 mg) of sodium per chewable tablet, meaning the medicine is considered "sodium-free".

3. How to take Monkasta

This medicine should always be taken exactly as directed by the child's doctor or pharmacist. If in doubt,
consult the child's doctor or pharmacist.

• This medicine should be given to the child under the supervision of an adult. For children who have difficulty taking chewable tablets, a granule formulation is available.
• The child should be given only one Monkasta chewable tablet once daily, as directed by the doctor.
• This medicine should be taken even when the child does not have asthma symptoms, and also during an acute asthma attack.

Use in children aged 2 to 5 years
The recommended dose is one 4 mg chewable tablet taken once daily in the evening.
If the child is taking this medicine, ensure that they are not taking other medicines containing the same active substance, montelukast.
This medicine is intended for oral use.
The tablets should be chewed before swallowing.
Monkasta 4 mg chewable tablets should not be taken with food; they should be taken 1 hour before or 2 hours after a meal.

Taking more Monkasta than recommended
Seek immediate advice from the child's doctor.
In most cases of overdose, no adverse effects have been observed.
The most commonly reported symptoms of overdose in adults and children include: abdominal pain, drowsiness, excessive thirst, headache, vomiting, and hyperactivity.

If a dose of Monkasta is missed
Try to give Monkasta as directed by the doctor. However, if the child misses a dose, return to the usual dosing schedule—one chewable tablet once daily.
Do not give a double dose to make up for a missed dose.

Stopping Monkasta
Monkasta is effective in treating the child's asthma only when taken regularly.
It is important to continue giving the medicine to the child for as long as directed by the doctor. This will help keep asthma under control.
If there are any further questions about the use of this medicine, consult the child's doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
In clinical trials with montelukast 4 mg chewable tablets, the most commonly reported adverse effects (which may occur in up to 1 in 10 people), considered to be related to montelukast, were:

• abdominal pain,
• excessive thirst.

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

• headache.

These symptoms were usually mild and occurred more frequently in patients treated with montelukast than in patients receiving placebo (a tablet containing no active ingredient).

Serious adverse effects
Contact your doctor immediately if any of the following adverse effects occur, as they may be serious and may require immediate medical attention.

Uncommon: may occur in up to 1 in 100 people

• allergic reactions, including swelling of the face, lips, tongue, and (or) throat, which may cause difficulty in breathing or swallowing,
• changes in behaviour and mood: agitation, including aggressive behaviour or hostility, depression,
• seizures.

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

• increased tendency to bleed,
• tremor,
• palpitations.

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

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

Other adverse effects reported after marketing of the medicine
Very common: may occur in more than 1 in 10 people

• upper respiratory tract infections.

Common: may occur in up to 1 in 10 people

• diarrhoea, nausea, vomiting,
• rash,
• fever,
• increased liver enzyme levels.

Uncommon: may occur in up to 1 in 100 people

• changes in behaviour and mood: unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling anxious, restlessness,
• dizziness, drowsiness, tingling and numbness,
• nosebleeds,
• dry mouth, dyspepsia,
• bruising, itching, urticaria,
• muscle or joint pain, muscle cramps,
• nocturnal enuresis in children,
• weakness and (or) fatigue, malaise, oedema.

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

• changes in behaviour and mood: attention disorders, memory disturbances, uncontrolled muscle movements.

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

• tender, red nodules under the skin, usually appearing on the shins (erythema nodosum),
• changes in behaviour and mood: obsessive-compulsive symptoms,
• stuttering.

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Effects of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 4921 301
Fax: +48 22 4921 309
Website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Monkasta

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and carton following EXP.
The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such 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 4 mg of montelukast (in the form of montelukast sodium).
• The other ingredients are mannitol (E 421), microcrystalline cellulose, sodium croscarmellose, hydroxypropylcellulose, aspartame (E 951), iron oxide red (E 172), cherry flavour (also containing triacetin (E 1518)) and magnesium stearate. See section 2 "Monkasta contains aspartam and sodium".

What Monkasta looks like and contents of the pack
Pink, marbled, round, slightly biconvex tablets with bevelled edges and engraved with "4" on one side.
Pack: 28 and 90 chewable tablets in blister packs, contained in a cardboard box.

Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturers
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
KRKA-POLSKA Sp. z o.o., Równoległa 5, 02-235 Warsaw, Poland
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For further information on the names under which the medicinal product is registered in the other European Economic Area and United Kingdom (Northern Ireland) countries, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5
02-235 Warsaw
Tel. 22 57 37 500