Monkasta 10 mg film-coated tablets and 4 mg / 5 mg chewable tablets – montelukast for asthma

Monkasta contains montelukast, a leukotriene receptor antagonist (ATC R03DC03). Leukotrienes cause narrowing and swelling of the airways; by blocking their action, Monkasta improves asthma symptoms and helps keep asthma under control.

The medicine is registered in three age-adapted forms: 10 mg film-coated tablets (adults and adolescents from 15 years), 5 mg chewable tablets (children aged 6 to 14) and 4 mg chewable tablets (children aged 2 to 5). Monkasta is taken every day, long-term, and is not used to stop an acute asthma attack.

What is Monkasta used for and how is it taken correctly?

Key facts about the medicine

What is Monkasta used for?

• Add-on asthma treatment in patients whose asthma is not adequately controlled with their current medicines (10 mg: from 15 years; 5 mg: 6–14 years; 4 mg: 2–5 years).
• Alternative to low-dose inhaled corticosteroids in children aged 2 to 14 (chewable tablets) who have not recently used oral corticosteroids and have shown that they cannot use inhaled corticosteroids.
• Prevention of exercise-induced narrowing of the airways.
• In patients from 15 years for whom it is indicated for asthma, the 10 mg film-coated tablets may also relieve symptoms of seasonal allergic rhinitis (hay fever).

How is Monkasta taken and dosed?

• The medicine is taken every day – both when there are no symptoms and during worsening of asthma.
• Do not take other medicines containing montelukast at the same time.
• The strengths are not interchangeable: for children from 6 months to 2 years, 4 mg granules (a different medicine) are intended.

Special patient groups

• Children: 10 mg film-coated tablets are not given to children under 15; 5 mg tablets are not given to children under 6, and 4 mg tablets not to children under 2.
• Phenylketonuria: the chewable tablets contain aspartame (a source of phenylalanine).
• Sugar intolerance: the 10 mg film-coated tablets contain lactose.

Contraindications – when the medicine must not be used

• hypersensitivity to montelukast or any of the excipients.

Warnings and precautions

• If asthma symptoms or breathing get worse, tell your doctor immediately.
• Contact a doctor immediately if flu-like symptoms, pins and needles or numbness in the arms or legs, worsening of lung symptoms and/or rash occur (possible Churg-Strauss syndrome).
• Do not take acetylsalicylic acid or other NSAIDs if they make your asthma worse.
• Neuropsychiatric changes are possible in adults, adolescents and children – watch behaviour and mood and inform the doctor of any changes.

Interactions with other medicines, food and drink

• Tell your doctor if you take phenobarbital, phenytoin (epilepsy), rifampicin (tuberculosis) or gemfibrozil (blood lipids) – they may affect the medicine.
• Do not combine with other medicines containing montelukast.
• Food: 10 mg film-coated tablets can be taken with or without food; chewable tablets are taken at least 1 hour before or 2 hours after food.

Pregnancy and breast-feeding

• Pregnancy: the doctor will assess whether you may take the medicine during pregnancy.
• Breast-feeding: it is not known whether montelukast passes into breast milk – talk to your doctor before taking it.

Driving and using machines

• Monkasta is not expected to affect the ability to drive, but dizziness and drowsiness in some patients may affect driving and using machines.

Possible side effects

Most common in clinical trials (up to 1 in 10): abdominal pain, headache; in children aged 2 to 5 also increased thirst.

Very common after marketing: upper respiratory tract infections. Common: diarrhoea, nausea, vomiting, rash, fever, raised liver enzymes.

Uncommon: sleep disorders and nightmares, sleepwalking, irritability, anxiety, restlessness, agitation and aggression, depression, dizziness, drowsiness, pins and needles, nosebleeds, dry mouth, indigestion, bruising, itching, muscle and joint pain, bed-wetting in children, tiredness, swelling, allergic reactions with swelling of the face, lips, tongue and throat, seizures.

Rare and very rare: increased bleeding tendency, tremor, palpitations, disturbed attention and memory, hallucinations, disorientation, suicidal thoughts and behaviour, obsessive-compulsive symptoms, stuttering, Churg-Strauss syndrome, low platelets, lung inflammation, erythema multiforme, erythema nodosum, hepatitis.

Overdose, missed dose and stopping treatment

• Overdose: contact a doctor immediately. Most reports involved no side effects; the most frequently reported were abdominal pain, drowsiness, thirst, headache, vomiting and hyperactivity.
• Missed dose: continue with one tablet a day on the usual schedule; do not take a double dose.
• Stopping treatment: the medicine only works when taken continuously – continue for as long as your doctor has prescribed.

Related information

Asthma is a long-term disease triggered by factors such as tobacco smoke, pollen, cold air or physical exertion; avoiding triggers and regular medical check-ups are part of treatment. Always read the leaflet supplied with the medicine.

For additional care and support with allergy symptoms (e.g. hay fever), see also the Anti-allergy preparations category – products in this category do not replace the medicine you have been prescribed.

Composition, pack and manufacturer

• Active substance: montelukast – 10 mg (10.4 mg montelukast sodium) per film-coated tablet; 5 mg (5.20 mg montelukast sodium) or 4 mg (4.16 mg montelukast sodium) per chewable tablet.
• Excipients – 10 mg film-coated tablet: cellactose (lactose monohydrate; cellulose), microcrystalline cellulose, croscarmellose sodium, magnesium stearate; coating: hypromellose, titanium dioxide (E171), talc, propylene glycol, yellow and red iron oxide (E172).
• Excipients – 4 mg and 5 mg chewable tablets: mannitol (E421), aspartame (E951), microcrystalline cellulose, croscarmellose sodium, hydroxypropylcellulose, magnesium stearate, red iron oxide (E172), black cherry flavour.
• Appearance: 10 mg – round apricot-coloured film-coated tablets; 5 mg and 4 mg – pink marbled tablets marked “5” or “4”.
• Pack: 4 blisters of 7 tablets (28 tablets) for each strength.
• Marketing authorisation holder: Krka-Farma d.o.o. Belgrade. Manufacturers: Krka d.d., Novo Mesto, Slovenia; Krka Polska Sp. z o.o., Warsaw, Poland.
• Authorisations: 515-01-01305-20-003 of 20.08.2021 (10 mg); 515-01-03624-20-001 (5 mg) and 515-01-03623-20-001 (4 mg) of 01.03.2022.

Storage

• Store in the original package to protect from light; the medicine does not require any special temperature storage conditions.
• Keep out of the sight and reach of children; do not use after the expiry date.

Frequently asked questions

Which strength of Monkasta is for my child?

According to the leaflet: children aged 2 to 5 – 4 mg chewable tablet; children aged 6 to 14 – 5 mg chewable tablet; from 15 years – 10 mg film-coated tablet. The strength is always decided by the doctor.

Can Monkasta stop an asthma attack?

No. Monkasta is taken regularly to control asthma. For an attack, use the quick-relief inhaler prescribed by your doctor.

Should the chewable tablet be given with a meal?

No. The 4 mg and 5 mg chewable tablets are taken at least 1 hour before or 2 hours after food, while the 10 mg film-coated tablets can be taken regardless of meals.

Which side effects need special attention?

Changes in behaviour and mood (aggression, depression, sleep disorders, suicidal thoughts) and a combination of flu-like symptoms with numbness of the limbs and rash – in these cases contact a doctor immediately.

Sources

• ALIMS – Package leaflet Monkasta 10 mg film-coated tablets (PIL, Serbian, 08/2021)
• ALIMS – Summary of product characteristics Monkasta 10 mg (SmPC, Serbian)
• ALIMS – Package leaflet Monkasta 5 mg chewable tablets (PIL, Serbian, 03/2022)
• ALIMS – Summary of product characteristics Monkasta 5 mg (SmPC, Serbian)
• ALIMS – Package leaflet Monkasta 4 mg chewable tablets (PIL, Serbian, 03/2022)
• ALIMS – Summary of product characteristics Monkasta 4 mg (SmPC, Serbian)

Date sources were checked: 25.10.2026.