Monkasta

Package leaflet: Information for the patient

Monkasta, 5 mg, chewable and chewable tablets
For children aged 6 to 14 years
Montelukastum
Please read this leaflet carefully before administering the medicine to your child, as it contains important information.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, 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 identical.
• If any adverse reactions occur in the patient or child, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Monkasta is and what it is 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 Monkasta is and what it is used for

What Monkasta is
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 Monkasta should be used
Your doctor has recommended Monkasta for the treatment of asthma to prevent daytime and nighttime asthma symptoms.

• Monkasta is used in the treatment of children and adolescents aged 6 to 14 years whose asthma is not adequately controlled with previously used medications and who require additional treatment.
• Monkasta may also be used instead of inhaled corticosteroids in patients aged 6 to 14 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.

Your doctor will determine how to use Monkasta based on the symptoms and severity of asthma in the patient or child.
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.
• Airway sensitivity, where the airways react to many factors such as cigarette smoke, pollen, cold air, or physical exertion.
• Swelling (inflammation) of the mucous lining of the airways.

Asthma symptoms include coughing, wheezing, and chest tightness.

2. Important information before using Monkasta

Tell your doctor about any medical conditions and allergies currently present or experienced in the past by the patient or child.
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 treatment or giving the child Monkasta, consult a doctor or pharmacist:

• If asthma symptoms worsen or breathing difficulties occur, inform the 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 keep a reliever inhaler available for immediate use in case of an asthma attack in the patient or child.
• It is important to give the patient or child all anti-asthma medicines prescribed by the doctor. Monkasta 5 mg chewable tablets must not be used as a substitute for other anti-asthma medicines prescribed for the patient or child.
• Remember to consult a doctor if the patient taking anti-asthma medicines develops a group of symptoms such as flu-like symptoms, tingling or numbness in hands or feet, worsening of lung symptoms and/or rash.
• Do not give acetylsalicylic acid (aspirin) or non-steroidal anti-inflammatory drugs (also known as NSAIDs) to the patient or child if these worsen asthma symptoms.

Various neuropsychiatric events (e.g. changes in behaviour and mood, depression, and suicidal thoughts) have been reported in patients of all ages treated with montelukast (see section 4). If such symptoms occur in the patient while taking montelukast, consult a doctor.
Children and adolescents
This medicine must not be given to children under 6 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
Tell your doctor or pharmacist about all medicines currently or recently taken by the patient or child, and about any other medicines, including those available without a prescription.
Some medicines may affect the action of Monkasta, or Monkasta may affect the action of other medicines.
Before starting Monkasta, tell your doctor if the patient or child is taking any of the following medicines:

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

Monkasta with food and drink
Monkasta 5 mg chewable tablets should not be taken during meals; the medicine should be taken at least 1 hour before or 2 hours after a meal.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
The doctor will decide 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 intends to breastfeed, she should consult her doctor before using Monkasta.
Driving and operating machinery
Monkasta is not expected to affect the ability to drive or operate machinery. However, individual responses to the medicine may vary. Some adverse effects (such as dizziness and drowsiness) reported during treatment with montelukast may affect the ability to drive or operate machinery in some patients.
Monkasta contains aspartame and sodium
This medicine contains 1.5 mg of aspartame per chewable tablet. Aspartame is a source of phenylalanine. It may be harmful if the patient or child has phenylketonuria, a rare inherited disorder in which phenylalanine accumulates in the body due to impaired 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 according to the doctor's or pharmacist's instructions. If in doubt,
consult your doctor or pharmacist.

• Only one Monkasta tablet should be given to the child once daily, as directed by the doctor.
• This medicine should be taken even when the patient or child does not have asthma symptoms, as well as during an acute asthma attack.

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 that they are not taking other medicines containing the same active substance, montelukast.
This medicine is intended for oral use.
Tablets must be chewed before swallowing.
Monkasta 5 mg chewable tablets should not be taken with food; the medicine should be taken at least 1 hour before or 2 hours after a meal.

Taking more Monkasta than recommended
Seek immediate medical advice.
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 you miss a dose of Monkasta
Try to take Monkasta as directed by your 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 Monkasta
Monkasta is effective in treating asthma only when taken regularly.
It is important to continue taking the medicine for as long as your doctor has instructed. This will help keep asthma under control.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
During clinical trials with montelukast 5 mg chewable tablets, the most frequently reported adverse reaction (which may occur in up to 1 in 10 people), considered to be related to montelukast intake, was:

• headache.

Additionally, in clinical trials using montelukast 10 mg coated tablets, the following were reported:

• abdominal pain.

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

Not common: 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 breathing or swallowing,
• changes in behaviour and mood: agitation, including aggressive behaviour or hostile attitude, 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 syndrome of symptoms such as flu-like symptoms, tingling or numbness in hands and feet, worsening respiratory symptoms and (or) rash (Churg-Strauss syndrome) (see section 2),
• decreased platelet count,
• changes in behaviour and mood: hallucinations, disorientation, suicidal thoughts and attempts,
• swelling (inflammation) of the lungs,
• severe skin reactions (erythema multiforme), which may occur without prior warning symptoms,
• hepatitis (inflammation of the liver).

Other adverse reactions reported after marketing authorization

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 enzymes.

Not common: may occur in up to 1 in 100 people

• changes in behaviour and mood: unusual dreams, including nightmares, difficulty sleeping, sleepwalking, irritability, feeling nervous, 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, most commonly on the shins (erythema nodosum),
• changes in behaviour and mood: obsessive-compulsive symptoms,
• stuttering.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this 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 after 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 5 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 aspartame and sodium".

What Monkasta looks like and contents of the pack
Pink, marbled, round, slightly biconvex tablets with bevelled edges and the inscription "5" on one side.
Pack: 28 and 90 chewable tablets in blisters, packed 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., 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 authorised in other European Economic Area (EEA) countries and the United Kingdom (Northern Ireland), 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