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

Alvokast is a medicine containing the active substance montelukast and belongs to the group of leukotriene receptor antagonists. Leukotrienes are substances that cause narrowing and swelling of the airways in the lungs; by blocking their action, Alvokast improves asthma symptoms and helps keep asthma under long-term control.

In Serbia, Alvokast is authorised in three forms intended for different age groups: 4 mg chewable tablets (children aged 2 to 5 years), 5 mg chewable tablets (children aged 6 to 14 years) and 10 mg film-coated tablets (adults and adolescents aged 15 years and older). Dosing and other details below are given separately for each form.

What is Alvokast (montelukast) used for and how should it be taken by children and adults?

Key facts about the medicine

What is Alvokast used for?

Alvokast is used to treat asthma, as it prevents asthma symptoms during the day and night. The approved uses depend on the strength:

Your doctor will decide how Alvokast should be used depending on the symptoms and severity of asthma.

How is it used and dosed?

The medicine is taken once a day, in the evening, every day – both when there are no symptoms and during worsening. Do not take other medicines containing montelukast at the same time.

This is the dosing stated in the package leaflet and is not an individual recommendation – always follow your doctor's instructions.

Special patient groups

• Children under 2 years: the 4 mg chewable tablets must not be used; montelukast 4 mg granules (a different medicine) exist for children aged 6 months to 5 years.
• Children aged 2 to 5 years: only the 4 mg strength is used; for children who cannot chew tablets the doctor may prescribe granules.
• Children aged 6 to 14 years: the 5 mg strength is used.
• Adults and adolescents aged 15 and older: the 10 mg film-coated tablet is used; the safety and efficacy of the 10 mg tablet in children under 15 have not been established.

Contraindications – when the medicine must not be used

Alvokast must not be taken in case of allergy (hypersensitivity) to montelukast or to any of the excipients.

• The 10 mg film-coated tablets contain lecithin – the medicine must not be used in people allergic to peanut or soya.

Precautions and warnings

• If asthma symptoms or breathing get worse, contact your doctor immediately.
• The medicine is not for an acute asthma attack – during an attack use the fast-acting inhaled reliever (inhaled β-agonist) as instructed by your doctor.
• Do not stop or replace your other asthma medicines without your doctor's advice.
• If a combination of flu-like symptoms, pins and needles or numbness of the arms or legs, worsening of lung symptoms and/or rash occurs, contact your doctor (possible Churg-Strauss syndrome).
• Do not take acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs) if they make your asthma worse.
• Watch for possible changes in mood and behaviour (neuropsychiatric events) in children and adults and inform your doctor if they occur.
• The chewable tablets contain aspartame (4 mg: 0.24 mg; 5 mg: 0.30 mg per tablet) – may be harmful for people with phenylketonuria.
• The 10 mg film-coated tablets contain lactose – if you have an intolerance to some sugars, consult your doctor.

Interactions with other medicines, food and drink

Tell your doctor or pharmacist about all medicines you are taking. It is especially important if you take:

• phenobarbital or phenytoin (medicines for epilepsy);
• rifampicin (a medicine for tuberculosis and some other infections);
• gemfibrozil (a medicine for high blood fats) – listed in the leaflet of the 10 mg film-coated tablets.

The 10 mg film-coated tablets can be taken with or without food, while the chewable tablets are taken at least 1 hour before or 2 hours after a meal.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, are planning a pregnancy or are breastfeeding, ask your doctor for advice before taking the medicine. Your doctor will assess whether you may use Alvokast during pregnancy. It is not known whether montelukast passes into breast milk, so you should consult your doctor before use while breastfeeding.

Driving and using machines

Alvokast is not expected to affect the ability to drive or use machines. However, dizziness and drowsiness may occur in some people and may affect these abilities.

Possible side effects

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

• Common in clinical trials: abdominal pain and headache (with the 4 mg chewable tablets also thirst); usually mild.
• Very common (reported after marketing): upper respiratory tract infections.
• Common: diarrhoea, nausea, vomiting, rash, fever, raised liver enzymes.
• Uncommon: nightmares and other sleep disorders, sleepwalking, irritability, anxiety, restlessness; dizziness, drowsiness, pins and needles/numbness; nosebleed; dry mouth, indigestion; bruising, itching, hives; joint or muscle pain, muscle cramps; bedwetting in children; weakness, tiredness, swelling.
• Serious (uncommon): allergic reactions with swelling of the face, lips, tongue or throat; agitation including aggressive or hostile behaviour, depression; seizures.
• Rare: increased bleeding tendency, palpitations, tremor, disturbance in attention and memory.
• Very rare: Churg-Strauss syndrome, low platelet count, hallucinations, disorientation, suicidal thoughts and actions, inflammation of the lungs, erythema multiforme, hepatitis, erythema nodosum, obsessive-compulsive symptoms, stuttering.

Report any suspected side effect to your doctor, pharmacist or the Serbian Medicines Agency (ALIMS).

Overdose, missed dose and stopping treatment

• Overdose: contact your doctor immediately. In most reported cases there were no side effects; the most frequently reported symptoms were abdominal pain, drowsiness, thirst, headache, vomiting and hyperactivity.
• Missed dose: continue with the usual schedule of one tablet a day; do not take a double dose to make up for a missed one.
• Stopping treatment: Alvokast only works if taken regularly – take it for as long as your doctor has prescribed, even when you have no symptoms.

Related information

Read more about allergies, their symptoms and treatment in the article Allergy – what it is, when it occurs, what the symptoms are and how it is treated.

For inhalation therapy prescribed by your doctor, see also the category Inhalers – products in this category do not replace the medicine prescribed for you.

Composition, packaging and manufacturer

• Active substance: montelukast (as montelukast sodium) – 4 mg, 5 mg or 10 mg per tablet.
• Excipients of the chewable tablets (4 mg and 5 mg): mannitol (E421), microcrystalline cellulose, croscarmellose sodium, hydroxypropylcellulose (E463), aspartame (E951), red iron oxide (E172), magnesium stearate, cherry flavour.
• Excipients of the 10 mg film-coated tablets: core – lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hydroxypropylcellulose, magnesium stearate; coating – polyvinyl alcohol, titanium dioxide (E171), talc, iron oxides (E172), lecithin, xanthan gum.
• Appearance: 4 mg – pink oval tablets; 5 mg – pink round tablets; 10 mg – beige round biconvex film-coated tablets.
• Pack: 28 tablets in blisters (4 × 7 chewable tablets or 2 × 14 film-coated tablets).
• Marketing authorisation holder: ZENTIVA PHARMA D.O.O., Milentija Popovića 5v, Belgrade – New Belgrade. Manufacturer: PHARMATHEN SA, Dervenakion 6, Pallini, Attiki, Greece.
• Authorisations: 10 mg – 515-01-03134-21-001 of 11.05.2022; 4 mg – 515-01-05169-21-001 of 27.10.2022; 5 mg – 515-01-05170-21-001 of 27.10.2022.

Storage

• The medicine does not require any special storage conditions.
• Keep out of the sight and reach of children.
• Do not use after the expiry date stated on the pack.

Frequently asked questions

Does Alvokast help during an asthma attack?

No. Alvokast is not intended for treating an acute asthma attack. During an attack the fast-acting inhaled reliever prescribed by your doctor is used, while Alvokast is taken every day to control the disease.

Which strength of Alvokast does a child use?

Children aged 2 to 5 use the 4 mg chewable tablets, children aged 6 to 14 the 5 mg chewable tablets, and adolescents from 15 years and adults the 10 mg film-coated tablets. The strengths are not interchangeable.

When is Alvokast taken – before or after food?

Once a day in the evening. The chewable tablets are taken at least 1 hour before or 2 hours after a meal, and the 10 mg film-coated tablets with or without food.

Can Alvokast affect mood and sleep?

Yes, sleep disorders and nightmares, irritability and agitation, and less often depression, aggressive behaviour and suicidal thoughts are listed as possible side effects. Any such change should be reported to the doctor.

Sources

• ALIMS – Package leaflet ALVOKAST® 4 mg chewable tablet (October 2022, in Serbian)
• ALIMS – Summary of Product Characteristics ALVOKAST® 4 mg chewable tablet (in Serbian)
• ALIMS – Package leaflet ALVOKAST® 5 mg chewable tablet (October 2022, in Serbian)
• ALIMS – Summary of Product Characteristics ALVOKAST® 5 mg chewable tablet (in Serbian)
• ALIMS – Package leaflet ALVOKAST® 10 mg film-coated tablets (May 2022, in Serbian)
• ALIMS – Summary of Product Characteristics ALVOKAST® 10 mg film-coated tablets (in Serbian)

Date sources were checked: 24.10.2026.