Active substance: MONTELUKAST SODIUM

View full screen / Print PDF » Download PDF ⇩

Version 1
Draft 2

Montelukast 4 mg granules
For children from 6 months to 5 years of age
Read all of this leaflet carefully before your child starts taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for your child. Do not pass it on to others. It may harm them,
even if their symptoms are the same as your child’s.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

In this leaflet:
What Montelukast granules are and what they are used for
Before Montelukast granules are taken
How to take Montelukast granules
Possible side effects
How to store Montelukast granules
Further information



Montelukast granules are a leukotriene receptor antagonist that blocks substances called leukotrienes.
Leukotrienes cause narrowing and swelling of airways in your lungs. By blocking leukotrienes,
Montelukast granules improve asthma symptoms and help control asthma.
Your doctor has prescribed Montelukast granules to treat your child’s asthma, preventing asthma
symptoms during the day and night.

Montelukast granules are used for the treatment of 6 months to 5 year old patients who are not
adequately controlled on their medication and need additional therapy.
Montelukast granules 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 granules also help prevent the narrowing of airways triggered by exercise for
patients 2 years of age and older.

Your doctor will determine how Montelukast granules 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.

Version 1
Draft 2



Tell your doctor about any medical problems or allergies your child has now or has had.
Do NOT give Montelukast granules to your child if he/she
is allergic (hypersensitive) to montelukast sodium or any of the other ingredients of Montelukast
granules (see 6. Further information)
Take special care with Montelukast granules
If your child’s asthma or breathing gets worse, tell your doctor immediately.
Oral Montelukast granules are 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 granules 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.
Taking other medicines
Some medicines may affect how Montelukast granules work, or Montelukast granules may affect how
your child's other medicines work.
Please tell your doctor or pharmacist if your child is taking or has recently taken other medicines,
including those obtained without a prescription.
Tell your doctor if your child is taking the following medicines before starting Montelukast granules:
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
Taking Montelukast granules with food and drink
Montelukast granules can be taken without regard to the timing of food intake.
Pregnancy and breast-feeding
This subsection is not applicable for Montelukast 4 mg granules since they are intended for use in
children 6 months to 5 years of age, however the following information is relevant to the active
ingredient, montelukast.
Use in pregnancy
Women who are pregnant or intend to become pregnant should consult their doctor before taking
montelukast. Your doctor will assess whether you can take montelukast during this time.
Use in breast-feeding
It is not known if montelukast appears in breast milk. You should consult your doctor before taking
montelukast if you are breast-feeding or intend to breast-feed.
Driving and using machines

Version 1
Draft 2

This subsection is not applicable for Montelukast 4 mg granules since they are intended for use in
children 6 months to 5 years of age, however the following information is relevant to the active
ingredient, montelukast.
Montelukast has minor influence on the ability to drive and use machines. However, individual
responses to medication may vary. Certain side effects (such as dizziness and drowsiness) that have
been reported very rarely with montelukast may affect some patients’ ability to drive or operate



This medicine is to be given to a child under adult supervision. Your child should take
Montelukast granules every evening.
It should be taken even when your child has no symptoms or if he/she has an acute asthma
Always have your child take Montelukast granules as your doctor has told you. You should
check with your child’s doctor or pharmacist if you are not sure.
To be taken by mouth

For children 6 months to 5 years of age:
One sachet of Montelukast 4 mg granules to be taken by mouth each evening.
If your child is taking Montelukast granules, be sure that your child does not take any other products
that contain the same active ingredient, montelukast.
For children 6 months to 2 years old, Montelukast 4 mg granules are available.
For children 2 to 5 years old, Montelukast 4 mg chewable tablets and Montelukast 4 mg granules are
available. The Montelukast 4 mg granules formulation is not recommended below 6 months of age.
How should I give Montelukast 4 mg granules to my child?

Do not open the sachet until ready to use.

Montelukast granules can be given either:
directly in the mouth;
OR mixed with a spoonful of cold or room temperature soft food (for example,
applesauce, ice cream, carrots and rice).

Mix all of the contents of the Montelukast granules into a spoonful of cold or room temperature
soft food, taking care to see that the entire dose is mixed with the food.

Be sure the child is given the entire spoonful of the granule/food mixture immediately (within
15 minutes). IMPORTANT: Never store any granule/food mixture for use at a later time.

Montelukast granules are not intended to be dissolved in liquid. However, your child may take
liquids after swallowing the Montelukast granules.

Montelukast granules can be taken without regard to the timing of food intake.

If your child takes more Montelukast granules than he/she should
Contact your child’s doctor immediately for advice.

Version 1
Draft 2

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 granules to your child
Try to give Montelukast granules as prescribed. However, if your child misses a dose, just resume the
usual schedule of one sachet once daily.
Do not give a double dose to make up for a forgotten dose.
If your child stops taking Montelukast granules
Montelukast granules can treat your child’s asthma only if he/she continues taking it.
It is important for your child to continue taking Montelukast granules 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 product, ask your child’s doctor or pharmacist.



Like all medicines, Montelukast granules can cause side effects, although not everybody gets them.
The following terms are used to describe how often side effects have been reported:
very common:
very rare:
not known:

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
frequency cannot be estimated from the available data

In clinical studies with montelukast 4 mg granules, the most commonly reported side effects (occurring
in at least 1 of 100 patients and less than 1 of 10 paediatric patients treated) thought to be related to
montelukast were:




scaly and itchy skin

Additionally, the following side effects were reported in clinical studies with either montelukast 10 mg
film-coated tablets or montelukast 5 mg or 4 mg chewable 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).
Additionally, while the medicine has been on the market, the following have been reported:

upper respiratory infection (Very common)

increased bleeding tendency (Rare)

Version 1
Draft 2

allergic reactions including rash, swelling of face, lips, tongue, and/or throat which may cause
difficulty in breathing or swallowing (Uncommon)
behaviour and mood related changes [dream abnormalities, including nightmares, trouble
sleeping, sleep walking, irritability, feeling anxious, restlessness, agitation including aggressive
behaviour or hostility, depression (Uncommon); tremor (Rare); hallucinations, suicidal thoughts
and actions (Very rare)]
dizziness, drowsiness, pins and needles/numbness, seizure (Uncommon)
palpitations (Rare)
nosebleed (Uncommon)
diarrhoea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon)
hepatitis (inflammation of the liver) (Very rare)
bruising, itching, hives (Uncommon); tender red lumps under the skin most commonly on your
shins (erythema nodosum) (Very rare)
joint or muscle pain, muscle cramps (Uncommon)
fever (Common); tiredness, feeling unwell, swelling (Uncommon)

In asthmatic patients treated with montelukast, very rare cases of a 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) have been reported. You must tell your doctor right away if
your child gets one or more of these symptoms.
Ask your doctor or pharmacist for more information about side effects. If any of the side effects gets
serious, or if you notice any side effects not listed in this leaflet, please tell your child’s doctor or



Keep out of the reach and sight of children.
Do not use this medicine after the date shown on the sachet after EXP. The first two numbers indicate
the month; the last four numbers indicate the year. This medicine expires at the end of the month
Store in the original package in order to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.



What Montelukast granules contain
The active substance is montelukast. Each sachet of granules contains montelukast sodium
which corresponds to 4 mg montelukast.
The other ingredients are mannitol, hydroxypropyl cellulose, sodium laurilsulfate and
magnesium stearate
What Montelukast granules look like and contents of the pack
Montelukast 4 mg granules are white to off-white granules.
Cartons of 7, 10 20, 2 x 28, 28 and 30 sachets.
Not all pack sizes may be marketed.

Version 1
Draft 2

Marketing Authorisation Holder
Teva UK Limited, Eastbourne, BN22 9AG, UK
TEVA Pharmaceutical Works Private Limited Company, Pallagi út 13, 4042, Debrecen,Hungary
TEVA Pharmaceutical Works Private Limited Company, H-2100 Gödöllő, Táncsics Mihály út 82,
Teva UK Limited, Eastbourne, BN22 9AG, UK
Pharmachemie B.V., Swensweg 5, 2031 GA Haarlem, The Netherlands
TEVA Santé, Rue Bellocier, 89100 Sens, France
Teva Operations Sp. z.o.o, Ul. Sienkeiwicza 25, 99-300 Kutno, Poland
TEVA PHARMA S.L.U., C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza,Spain
Teva Operations Sp. z.o.o, ul. Mogilska 80., 31-546, Krakow, Poland
Teva Czech Industries s.r.o., Ostravska 29, c.p. 305, 74770 Opava-Komarov,Czech Republic
Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany

This leaflet was last revised in 01/2013.
PL 00289/1676

*Only the actual site of batch release will appear on the printed version of the leaflet

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.