Patient leaflet - Montelukast 4 mg sugar free chewable tablets
1. What Montelukast Chewable is and what it is used for What Montelukast Chewable is
Montelukast Chewable is a leukotriene receptor antagonist that blocks substances called leukotrienes.
How Montelukast Chewable works
Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Montelukast Chewable improves asthma symptoms and helps control asthma.
When Montelukast Chewable should be used
Your doctor has prescribed Montelukast Chewable to treat your child’s asthma, preventing asthma symptoms during the day and night.
Montelukast Chewable 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 Chewable 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 Chewable also helps prevent the
narrowing of airways triggered by exercise for patients 2 years of age and older.
Your doctor will determine how Montelukast Chewable 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 Chewable
Tell your doctor about any medical problems or allergies your child has now or has had.
Do not give Montelukast Chewable 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 Chewable to your child.
If your child’s asthma or breathing gets worse, tell
your doctor immediately.
Oral Montelukast Chewable 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 Chewable 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) have been reported in adults, adolescents and children with Montelukast (see section 4).
If your child develops such symptoms while taking
Montelukast, you should consult your child’s doctor.
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 Chewable
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
Chewable works, or Montelukast Chewable may
affect how your child’s other medicines work. Tell your doctor if your child is taking the following
medicines before starting Montelukast Chewable: • phenobarbital (used for treatment of epilepsy) • phenytoin (used for treatment of epilepsy) • rifampicin (used to treat tuberculosis and some
other infections)
Montelukast Chewable with food and drink
Montelukast 4mg Sugar Free 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
4mg Sugar Free 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
4mg Sugar Free 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 Chewable 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 Chewable may affect some patients’
ability to drive or operate machinery.
Montelukast 4mg Sugar Free Chewable Tablets contain aspartame, a source of phenylalanine and sodium
If your child has phenylketonuria (a rare, hereditary
disorder of the metabolism) you should take into
account that each 4 mg chewable tablet contains
phenylalanine (equivalent to 0.674 mg
phenylalanine per 4 mg chewable tablet). This medicine contains less than 1 mmol sodium (23
mg) per tablet, that is to say essentially ‘sodium-
free’.
3. How to take Montelukast Chewable
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 Chewable 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 Chewable, be
sure that he/she does not take any other medicines
that contain the same active ingredient, montelukast. This medicine is for oral use.
The tablets are to be chewed before swallowing. Montelukast 4 mg Sugar Free 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 Chewable 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 Chewable to your child
Try to give Montelukast Chewable 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 Chewable
Montelukast Chewable can treat your child’s asthma
only if he/she continues taking it.
It is important for your child to continue taking
Montelukast Chewable 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 4mg Sugar Free Chewable Tablets, the most commonly reported side effects (may affect up to 1 in 10 people) thought to be related to Montelukast Chewable 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 the Yellow Card Scheme at: 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 Chewable
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 blister after EXP. The first two numbers indicate the month; the last four numbers indicate the year. The expiry date refers to the last date of that month.
Store in the original package in order to protect
from light and moisture.
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 Chewable contains
The active substance is montelukast. Each chewable tablet contains montelukast sodium which corresponds to 4 mg of montelukast. • The other ingredients are:
Mannitol (E421), microcrystalline cellulose, hyprolose (E463), red ferric oxide (E172), croscarmellose sodium, cherry flavour, aspartame (E951), and magnesium stearate.
What Montelukast Chewable looks like and contents of the pack
Montelukast 4mg Sugar Free Chewable Tablets are light pink to pink coloured, speckled, oval, biconvex shaped, chewable tablets, debossed with ‘I’ on one side and ‘112’ on the other side.
This medicine is available in Alu-Alu blister packs of 28 tablets.
Not all pack sizes may be marketed.
This leaflet was last revised in September 2025.
To listen to or request a copy of this leaflet in Braille, large print or audio please call, 01293827819 (UK only) Please be ready to give the following information:
Product name
Montelukast 4mg Sugar Free Chewable Tablets
Reference number
PL 49565/0125
Marketing Authorisation Holder:
Rudipharm Limited
Unit 6, Salbrook Road Industrial Estate
Salbrook Road, Redhill, Surrey, RH1 5GJ, UK
Manufacturer:
Rudipharm Limited
Oak House, Reeds Crescent,
Watford, WD24 4QP, UK
Montelukast chewable Tablets 4mg - PIL Montelukast Tablets 4mg
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