Patient leaflet - Montelukast 4 mg chewable tablets
1. What Montelukast is and what it is used for What Montelukast is
Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How Montelukast works
Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, montelukast improves asthma symptoms and helps control asthma.
When Montelukast should be used
Your doctor has prescribed montelukast to treat your child’s asthma, preventing asthma symptoms during the day and night.
Montelukast is used for the treatment of 2 to 5 year old patients who are not
adequately controlled on their medication and need additional therapy. · Montelukast may also be used as an alternative treatment to inhaled
corticosteroids for 2 to 5 year old patients who have not recently taken oral corticosteroids for their asthma and have shown that they are unable to use inhaled corticosteroids.
Montelukast also helps prevent the narrowing of airways triggered by exercise for
patients 2 years of age and older.
Your doctor will determine how montelukast should be used depending on the symptoms and severity of your child’s asthma.
What is asthma?
Asthma is a long-term disease.
Asthma includes:
difficulty breathing because of narrowed airways. This narrowing of airways
worsens and improves in response to various conditions.
sensitive airways that react to many things, such as cigarette smoke, pollen, cold
air, or exercise.
- swelling (inflammation) in the lining of the airways.
Symptoms of asthma include: Coughing, wheezing, and chest tightness.
2. What you need to know before your child takes Montelukast
Tell your doctor about any medical problems or allergies your child has now or has had.
Do not give Montelukast to your child
- if he/she is allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before you give montelukast to your child. · If your child’s asthma or breathing gets worse, tell your doctor immediately. · Oral montelukast is not meant to treat acute asthma attacks. If an attack occurs,
follow the instructions your doctor has given you for your child. Always have your child’s inhaled rescue medicine for asthma attacks with you. · It is important that your child take all asthma medications prescribed by your
doctor. montelukast should not be used instead of other asthma medications your doctor has prescribed for your child.
- If your child is on anti-asthma medicines, be aware that if he/she develops a combination of symptoms such as flu-like illness, pins and needles or numbness of arms or legs, worsening of pulmonary symptoms, and/or rash, you should consult your doctor.
- Your child should not take acetyl-salicylic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make his/her asthma worse.
Patients should be aware that various neuropsychiatric events (for example behaviour and mood-related changes, depression and suicidality) have been reported in patients of all ages treated with montelukast (see section 4). There have also been reports of these symptoms continuing after treatment is stopped. If you develop such symptoms while taking montelukast or if these symptoms do not resolve after montelukast is stopped, you should contact your prescriber.
Children and adolescents
Do not give this medicine to children less than 2 years of age.
There are different form(s) of this medicine available for paediatric patients under 18 years of age based on age range.
Other medicines and Montelukast
Tell your doctor or pharmacist if your child is taking or has recently been given or might be given any other medicines including those obtained without a prescription.
Some medicines may affect how montelukast works, or montelukast may affect how your child’s other medicines work.
Tell your doctor if your child is taking the following medicines before starting Montelukast:
- phenobarbital (used for treatment of epilepsy)
- phenytoin (used for treatment of epilepsy)
- rifampicin (used to treat tuberculosis and some other infections)
Montelukast with food and drink
Montelukast 4 mg chewable tablets should not be taken immediately with food; they should be taken at least 1 hour before or 2 hours after food.
Pregnancy and breast-feeding
This subsection is not applicable for the montelukast 4 mg chewable tablets since they are intended for use in children 2 to 5 years of age.
Driving and using machines
This subsection is not applicable for the montelukast 4 mg chewable tablets since they are intended for use in children 2 to 5 years of age, however the following information is relevant to the active ingredient, montelukast.
Montelukast is not expected to affect your ability to drive a car or operate machinery. However, individual responses to medication may vary. Certain side effects (such as dizziness and drowsiness) that have been reported with montelukast may affect some patients’ ability to drive or operate machinery.
Montelukast 4 mg chewable tablets contain aspartame and sodium
This medicine contains 1.2 mg aspartame in each 4 mg chewable tablet which is equivalent to 0.674 mg phenylalanine. Aspartame is a source of phenylalanine. It may be harmful if your child has phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Montelukast
Always have your child take this medicine exactly as your doctor or pharmacist has told you. Check with your child’s doctor or pharmacist if you are not sure. · This medicine is to be given to a child under adult supervision. For children who have problems consuming a chewable tablet, an oral granule formulation is available.
- Your child should take only one chewable tablet of montelukast once a day as prescribed by your doctor.
- It should be taken even when your child has no symptoms or if he/she has an acute asthma attack.
For children 2 to 5 years of age:
The recommended dose is one 4 mg chewable tablet daily to be taken in the evening.
If your child is taking Montelukast, be sure that he/she does not take any other medicines that contain the same active ingredient, montelukast.
UK (Unit-V) Montelukast 4 mg chewable tablets Leaflet
Supersede: 2098054
This medicine is for oral use.
The tablets are to be chewed before swallowing.
Montelukast 4 mg chewable tablets should not be taken immediately with food; it should be taken at least 1 hour before or 2 hours after food.
If your child takes more Montelukast than he/she should
Contact your child’s doctor immediately for advice.
There were no side effects reported in the majority of overdose reports. The most frequently occurring symptoms reported with overdose in adults and children included abdominal pain, sleepiness, thirst, headache, vomiting, and hyperactivity.
If you forget to give Montelukast to your child
Try to give montelukast as prescribed. However, if your child misses a dose, just resume the usual schedule of one chewable tablet once daily. Do not give a double dose to make up for a forgotten dose.
If your child stops taking Montelukast
Montelukast can treat your child’s asthma only if he/she continues taking it. It is important for your child to continue taking Montelukast for as long as your doctor prescribes. It will help control your child’s asthma.
If you have any further questions on the use of this medicine, ask your child’s doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical studies with montelukast 4 mg chewable tablets, the most commonly reported side effects (may affect up to 1 in 10 people) thought to be related to montelukast were:
- abdominal pain
- thirst
Additionally, the following side effect was reported in clinical studies with montelukast 10 mg film-coated tablets and 5 mg chewable tablets: · headache
These were usually mild and occurred at a greater frequency in patients treated with montelukast than placebo (a pill containing no medication).
Serious side effects
Talk with your doctor immediately if you notice any of the following side effects with your child, which may be serious, and for which your child may need urgent medical treatment.
Uncommon: the following may affect 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
behaviour and mood related changes: agitation including aggressive behaviour or
hostility, depression
- seizure
Rare: the following may affect up to 1 in 1,000 people
- increased bleeding tendency
- tremor
- palpitations
Very rare: the following may affect up to 1 in 10,000 people
combination of symptoms such as flu-like illness, pins and needles or numbness
of arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome) (see section 2)
- low blood platelet count
behaviour and mood related changes: hallucinations, disorientation, suicidal
thoughts and actions
- swelling (inflammation) of the lungs
- severe skin reactions (erythema multiforme) that may occur without warning · inflammation of the liver (hepatitis)
Other side effects while the medicine has been on the market
Very common: the following may affect more than 1 in 10 people · upper respiratory infection
Common: the following may affect up to 1 in 10 people
diarrhoea, nausea, vomiting
- rash
- fever
- elevated liver enzymes
Uncommon: the following may affect up to 1 in 100 people
- behaviour and mood related changes: dream abnormalities, including nightmares, trouble sleeping, sleepwalking, irritability, feeling anxious, 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, feeling unwell, swelling
Rare: the following may affect up to 1 in 1,000 people
- behaviour and mood related changes: disturbance in attention, memory impairment, uncontrolled muscle movements
Very rare: the following may affect up to 1 in 10,000 people
tender red lumps under the skin, most commonly on your shins
(erythema nodosum)
- behaviour and mood related changes: obsessive-compulsive symptoms, stuttering
Reporting of side effects
If your child gets any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Montelukast
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 carton and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 Montelukast contains
The active substance is montelukast.
One chewable tablet contains montelukast sodium, which is equivalent to 4 mg montelukast.
The other ingredients are: Mannitol, croscarmellose sodium, hydroxypropyl cellulose, ferric oxide, cellulose, microcrystalline, aspartame, ART Cherry flavour containing Flavoring ingredients and modified food starch and magnesium stearate
What Montelukast looks like and contents of the pack
Light pink to pink coloured, speckled, oval, biconvex shaped, chewable tablets, debossed with ‘I’ on one side and ‘112’ on the other side.
Dimensions: 10.9 mm x 7.8 mm
Montelukast is available in blister pack containing 28 chewable tablets.
Marketing Authorisation Holder and Manufacturer
Amarox Limited
Congress House, 14 Lyon Road
Harrow, HA1 2EN
United Kingdom
This leaflet was last revised in 07/2026.
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