MONTELUKAST 4 MG CHEWABLE TABLETS

Active substance: MONTELUKAST SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Montelukast 4mg chewable tablets
Montelukast
For children from 2 to 5 years old
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, please 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:
• 1. What Montelukast is and what it is used for
• 2. Before you take Montelukast
• 3. How to take Montelukast
• 4. Possible side effects
• 5. How to store Montelukast
• 6. Further information

1. What Montelukast is and what it is used for
Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of
airways in your lungs. By blocking leukotrienes, Montelukast improves asthma symptoms and helps control asthma.
Your doctor has prescribed this medicine to treat asthma, preventing your asthma symptoms during the day and night.
• This medicine is used for the treatment of 2 to 5 year old patients who are not adequately controlled on their medication and
need additional therapy.
• This medicine 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.
• This medicine also helps prevent the narrowing of airways triggered by exercise.
Your doctor will determine how this medicine 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. Before you take 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 (hypersensitive) to Montelukast or any of the other ingredients of this medicine (see 6. Further information).
Take special care with 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 inhaled rescue medicine for asthma attacks with you.
• It is important that your child takes all asthma medications prescribed by your doctor. This medicine should not be used instead of other
asthma medications your doctor has prescribed for 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.
• Your child should not take aspirin or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they
make her/his asthma worse.
Use in children
For children 2 to 5 years old, Montelukast 4mg chewable tablets are available.
For children 6 to 14 years old, Montelukast 5mg chewable tablets are available.
Safety and effectiveness of these tablets in children less than 2 years old have not been established.
Taking other medicines
Some medicines may affect how Montelukast works, or Montelukast may affect how 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 this medicine:
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
Taking Montelukast with food and drink
This medicine should not be taken immediately with food; it should be taken at least 1 hour before or two hours after food.
Pregnancy and Breast-feeding
This subsection is not applicable for the this medicine since it is intended for use in children 2 to 5 years of age;
however the following information is relevant to the active ingredient, Montelukast.
Use in pregnancy
Limited data concerning the exposed pregnancies do not suggest a causal relationship between this medicine and malformations
(i.e. limb defects) that have been rarely reported in worldwide post marketing experience.
Women who are pregnant or intend to become pregnant should consult their doctor before taking this medicine. Your doctor will assess
whether you can take this medicine during this time.
Use in breast-feeding
It is not known if Montelukast appears in breast milk. You should consult your doctor before taking this medicine if you are breast-feeding
or intend to breast-feed.
Driving and using machines
This subsection is not applicable for the Montelukast 4 mg chewable tablets since it is 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 very rarely with Montelukast may affect some patients’ ability
to drive or operate machinery.
Important information about some of the ingredients of Montelukast
These tablets contain aspartame.
Contains a source of phenylalanine. May be harmful for people with phenylketonuria. If your child has the genetic disorder phenylketonuria
you should take into account that each 4mg chewable tablet contains phenylalanine (equivalent to 0.135mg phenylalanine per 4mg
chewable tablet).

3. How to take Montelukast
• 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 tablet of this medicine 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 as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
• To be taken by mouth.
For children 2 to 5 years of age:
One 4mg chewable tablet daily to be taken in the evening. This medicine should not be taken immediately with food; it should be taken at least 1
hour before or two hours after food.
If your child is taking this medicine, be sure that your child does not take any other products that contain the same active ingredient, Montelukast.
If your child takes more Montelukast than he/she should
Contact your doctor immediately for advice.
There were no side effects reported in the majority of overdosage reports. The most frequently occurring symptoms reported with overdosage
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 this medicine 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
This medicine can treat your child’s asthma only if your child continues to take it. It is important to continue taking this medicine 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 doctor or pharmacist.

4. Possible side effects
Like all medicines, Montelukast can cause side effects, although not everybody gets them.
You should contact your doctor immediately if your child experiences:
• 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, hallucinations, irritability, feeling anxious, restlessness,
agitation including aggressive behaviour, tremor, depression, trouble sleeping, suicidal thoughts and actions [in very rare cases])
• 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).
You must tell your doctor straight away if your child gets one or more of these symptoms.
In clinical studies with Montelukast 4mg chewable tablets, the most commonly (in more than 1 in 100, or less than 1 in 10 treated patients)
reported side effects thought to be related to this medicine were:
• abdominal pain
• thirst
Additionally, the following side effect was reported in clinical studies with Montelukast 10mg film-coated tablets and 5mg 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).
Additionally, while the drug has been on the market, the following have been reported:
• increased bleeding tendency
• dizziness, drowsiness, pins and needles/numbness, seizure
• palpitations
• nosebleed
• diarrhoea, dry mouth, indigestion, nausea, vomiting
• hepatitis
• bruising, itching, hives, tender red lumps under the skin most commonly on your shins (erythema nodosum),
• joint or muscle pain, muscle cramps
• tiredness, feeling unwell, swelling, fever.
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 doctor or pharmacist.

5. How to store Montelukast
• Keep out of the reach and sight of children.
• Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last date of that 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.

6. Further information
What Montelukast contains
• The active substance is: Montelukast
This medicine contains Montelukast sodium which corresponds to 4mg of Montelukast.
• The other ingredients are: Mannitol, microcrystalline cellulose, hyprolose (E 463), red ferric oxide (E 172), croscarmellose sodium, cherry
flavour (consisting of: maltodexrin, arabic gum, anisaldehyde, benzaldehyde, cinnamaldehyde, vanillin, heliotropin, ionons), aspartame
(E951), and magnesium stearate.
What Montelukast looks like and contents of the pack
Montelukast 4mg chewable tablets are pink, oval, biconvex tablets.
In packs of: 10, 14, 28, tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Pharmathen SA
6 Dervenakion street,
Pallini Attiki, 15351
Greece
Distributed by:
Aspire Pharma Limited
Antrobus House Business Centre
18 College Street
Petersfield
Hampshire, GU31 4AD
United Kingdom
This leaflet was last revised in 10/2012

1010089/P1.5

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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.

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