Patient leaflet - Montelukast 5 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 asthma, preventing your asthma symptoms during the day and night.
Montelukast Chewable is used for the treatment
of paediatric patients 6 to 14 years of age 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 6 to 14 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. Your doctor will determine how Montelukast Chewable should be used depending on the symptoms and severity of your or 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 you take Montelukast Chewable
Tell your doctor about any medical problems or allergies you or your child has now or has had.
Do not take Montelukast Chewable
if you or your child 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 or your child take Montelukast Chewable.
If you or 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 or your child. Always have your inhaled rescue medicine for asthma attacks with you.
It is important that you or 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 you or your child.
Any patient on anti-asthma medicines should be
aware that if you develop 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.
You or 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 your 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 you or your child develop such
symptoms while taking Montelukast, you should
consult your doctor.
Children and adolescents
Do not give this medicine to children less than 6
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 you or your child
are taking or have recently taken or might take any
other medicines including those obtained without a
prescription.
Some medicines may affect how Montelukast
Chewable works, or Montelukast Chewable may
affect how other medicines work.
Tell your doctor if you or 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 5 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.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking
Montelukast Chewable.
Pregnancy
Your doctor will assess whether you can take
Montelukast Chewable during this time. Breast-feeding
It is not known if Montelukast Chewable appears in
breast milk. You should consult your doctor before
taking Montelukast Chewable if you are
breast-feeding or intend to breast-feed.
Driving and using machines
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 5 mg Sugar Free Chewable Tablets contain aspartame, a source of phenylalanine and sodium
If you or your child has phenylketonuria (a rare,
hereditary disorder of the metabolism) you should
take into account that each 5 mg chewable tablet
contains phenylalanine (equivalent to 0.842 mg
phenylalanine per 5 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 take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
You or 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 you or your child
has no symptoms or has an acute asthma attack.
For children 6 to 14 years of age:
The recommended dose is one 5 mg chewable tablet
daily to be taken in the evening.
If you or your child are taking Montelukast
Chewable, be sure that you or your child do not take
any other products that contain the same active
ingredient, montelukast.
This medicine is for oral use.
The tablets are to be chewed before swallowing. Montelukast 5 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 you or your child takes more Montelukast
Chewable than you should
Contact your 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 take Montelukast Chewable or give Montelukast Chewable to your child
Try to take Montelukast Chewable as prescribed.
However, if you or your child misses a dose, just
resume the usual schedule of one chewable tablet
once daily.
Do not take a double dose to make up for a forgotten
dose.
If you or your child stops taking Montelukast
Chewable
Montelukast Chewable can treat you or your child’s
asthma only if you or your child continues to take it. It is important to continue taking Montelukast
Chewable for as long as your doctor prescribes. It
will help control you or your child’s asthma.
If you have any further questions on the use of this medicine, ask your 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 5 mg 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: • headache
Additionally, the following side effect was reported in clinical studies with Montelukast 10 mg film- coated tablets:
- abdominal pain
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, which may be serious, and for which you or 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 you or your child get 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 5 mg of montelukast. • The other ingredients are:
Mannitol (E 421), microcrystalline cellulose, hyprolose (E 463), red ferric oxide (E 172), croscarmellose sodium, cherry flavour, aspartame (E 951), and magnesium stearate
What Montelukast Chewable looks like and contents of the pack
Montelukast 5 mg Sugar Free Chewable tablets are light pink to pink coloured, speckled, round, biconvex shaped, chewable tablets, debossed with ‘I’ on one side and ‘113’ 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.
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
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 5 mg Sugar Free Chewable Tablets
Reference number
PL 49565/0126
Montelukast chewable Tablets 5mg - PIL Montelukast Tablets 5mg
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