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Active substance(s): MONTELUKAST SODIUM

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Package leaflet: Information for the patient
Montelukast 1 A Pharma 5 mg Chewable Tablets
Read all of this leaflet carefully before your child starts taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, please ask your doctor or pharmacist.

This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as your child’s.

If your child gets any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
What is in this leaflet
1. What Montelukast is and what it is used for
2. What you need to know before Montelukast is taken
3. How to take Montelukast
4. Possible side effects
5. How to store Montelukast
6. Contents of the pack and other information


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

Montelukast 5 mg is used for the treatment of 6 to 14 year old patients who are not adequately controlled
on their medication and need additional therapy.
Montelukast 5 mg 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 5 mg also helps prevent the narrowing of airways triggered by exercise.

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.



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 (hypersensitive) 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 taking Montelukast:

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 takes 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.

Other medicines and Montelukast
Some medicines may affect how Montelukast works, or Montelukast may affect how your child’s other
medicines work.
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines,
including those obtained without a prescription.
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 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 Montelukast since they are intended for use in children 6 to 14 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
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 very rarely with montelukast may affect some patients’ ability to drive or operate machinery.
Montelukast contains:

aspartame, which contains a source of phenylalanine. This may be harmful for people with
phenylketonuria (a rare, hereditary disorder of the metabolism).

 phenylalanine (equivalent to 0. 674 mg phenylalanine per 5 mg chewable tablet).


Allura Red (E129). This may cause allergic reactions.

Your child should take only one 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.
Always have your child take this medicine exactly as your doctor has told you. Check with your child’s
doctor or pharmacist if you are not sure.
To be taken by mouth

The usual dose is:
For children 6 to 14 years of age:
One 5 mg chewable tablet daily to be taken in the evening. Montelukast should not be taken immediately
with food; it should be taken at least 1 hour before or 2 hours after food.
If your child is taking Montelukast, be sure that he/she does not take any other medicines that contain the
same active ingredient, montelukast.
Montelukast is not recommended below 6 years of age.
Different strengths and dosage forms may be available for the other age groups:
4 mg chewable tablets are available for children 2 to 5 years of age.

10 mg tablets are available for adults and adolescents 15 years of age and older.
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 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.

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

In clinical studies with 5 mg chewable tablets and 10 mg film-coated tablets, the most commonly
reported side effects (may affect up to 1 in 10 people) thought to be related to montelukast were:

Additionally, the following side effect was reported in clinical studies with 10 mg filmcoated 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:
Very common side effects (may affect more than 1 in 10 people):
upper respiratory infection

Common side effects (may affect up to 1 in 10 people):
diarrhoea, nausea, vomiting
abnormal liver function test results

Uncommon side effects (may affect up to 1 in 100 people):
allergic reactions including rash, swelling of the face, lips, tongue, and/or throat which may cause
difficulty in breathing or swallowing

behaviour and mood related changes (dream abnormalities including nightmares, trouble sleeping, sleep
walking, irritability, feeling anxious, restlessness, agitation including aggressive behavior or hostility,

dizziness, drowsiness, pins and needles/numbness, seizure


dry mouth, indigestion

bruising, itching, hives

joint or muscle pain, muscle cramps

tiredness, feeling unwell, swelling

Rare side effects (may affect up to 1 in 1,000 people):

increased bleeding tendency


Very rare side effects (may affect up to 1 in 10,000 people):

inflammation of the liver (hepatitis)

hallucinations, suicidal thoughts and actions
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.
tender red lumps under the skin most commonly on your shins (erythema nodosum)
severe skin reactions (erythema multiforme) that may occur without warning

Ask your doctor or pharmacist for more information about side effects. If your child gets any side effects,
talk to your child’s doctor or pharmacist. This includes any possible side effects not listed in this leaflet.



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. The expiry date refers to the last
day 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 to protect the environment.


What Montelukast contains

The active substance is montelukast.
Each tablet contains 5 mg montelukast as montelukast sodium.

The other ingredients are:
Mannitol (E421), cellulose microcrystalline, hydroxypropylcellulose (E 463), iron oxide, red (E 172),
croscarmellose sodium, flavour (Cherry Flavour AP0551, Cherry Durarome TD0990B [contains Allura
Red, E129]), aspartame (E 951) and magnesium stearate.

What Montelukast looks like and contents of the pack
5 mg Montelukast chewable tablets are pink to slightly speckled pink, round with ‘5’ encoded on one side
Montelukast is available in packs of:
7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 140, 200 chewable tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching

Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen, Germany
Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia
Lek Pharmaceuticals d.d., Trimlini 2 D, 9220 Lendava, Slovenia
LEK S.A., Ul. Podlipie 16 C, 95 010 Strykow, Poland
LEK S.A., Ul. Domaniewska 50, 02-672 Warszawa, Poland
S.C. Sandoz S.R.L., Str. Livezeni nr. 7A, 540472 Targu-Mures, Romania
This leaflet was last approved in 04/2012


V004: CDS update


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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.