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MONTELUKAST 4 MG CHEWABLE TABLETS

Active substance(s): MONTELUKAST SODIUM / MONTELUKAST SODIUM / MONTELUKAST SODIUM

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PACKAGE LEAFLET

Package leaflet: Information for the user
[MONTELUKAST] 4 mg chewable tablets
Montelukast

For children from 2 to 5 years
Read all of this leaflet carefully before your child starts taking this medicine because it contains
important information for him/her.

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 symptoms are the same as your child’s.

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet:

1. What [Montelukast] is and what it is used for

2. What you need to know before you take [Montelukast]

3. How to take [Montelukast]

4. Possible side effects

5. How to store [Montelukast]

6. Contents of the pack and other 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 [Montelukast] to treat asthma, preventing your asthma symptoms during the day
and night.
 [Montelukast] 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] 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] 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 the asthma include: Coughing,wheezing and chest tightness.

2. What you need to know 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 to Montelukast or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
 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 take all asthma medications prescribed by your doctor. [Montelukast]
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 antiinflammatory drugs or NSAIDs) if they make her/his asthma worse.
Children and adolescents
For children 2 to 5 years old, [Montelukast] 4 mg chewable tablets are available.
For children 6 to 14 years old, [Montelukast] 5 mg chewable tablets are available. Safety and effectiveness of
[Montelukast] 4 mg chewable tablets in children less than 2 years old have not been established.
Other medicines and [Montelukast]
Some medicines may affect how [Montelukast] works, or [Montelukast] may affect how other medicines
work.
Tell your doctor or pharmacist if your child is taking or has recently taken or might take any other medicines.
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)
 gemfibrozil (used for treatment of high lipid levels in plasma)
Taking [Montelukast] with food and drink
[Montelukast] 4 mg chewable tablets 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 [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.
Use in pregnancy
Limited data concerning the exposed pregnancies do not suggest a causal relationship between montelukast
and malformations (i.e. limb defects) that have been rarely reported in worldwide post marketing experience.
Women who are pregnant or breast-feeding, think they may be pregnant or are planning to have a baby,
should consult their doctor before taking this medicine. 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
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.
[Montelukast] chewable 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 [Montelukast] 4 mg chewable tablet
contains phenylalanine (equivalent to 0.135 mg phenylalanine per 4 mg 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[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 [Montelukast] 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 [Montelukast] 4 mg chewable tablet daily to be taken in the evening. [Montelukast] 4 mg chewable
tablets 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 [Montelukast], 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 [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 your child continues to take it. It is important 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 product, 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] 4 mg 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 [Montelukast] 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).
Additionally, while the drug has been on the market, the following have been reported:
Very common (may affect more than 1 in 10 people)
 upper respiratory infection

Common (may affect up to 1 in 10 people)




diarrhea, nausea, vomiting
rash
fever

Uncommon (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 (dream abnormalities, including nightmares, trouble sleeping, sleep
walking, irritation, feeling anxious, restlessness, agitation including aggressive behaviour or hostility,
depression)
 dizziness, drowsiness, pins and needles/numbness, seizure
 nosebleed
 bruising, itching, hives
 dry mouth, indigestion
 joint or muscle pain, muscle cramps
 weakness/tiredness, feeling unwell, swelling
Rare (may affect up to 1 in 1,000 people)
 increase bleeding tendency
 tremor
 palpitations
Very rare (may affect up to 1 in 10,000 people)
 hepatitis (inflammation of the liver)
 tender red lumps under the skin most commonly on your shins(erythema nodosum), severe skin reactions
(erythema multiforme) that may occur without warning
 hallucinations, disorientation, suicidal thoughts and actions
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.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix
V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store [Montelukast]



Keep 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 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 to protect the environment.

6. Contents of the pack and other information
What [Montelukast] contains
 The active substance is: montelukast
[Montelukast] 4 mg chewable tablet contains montelukast sodium which corresponds to 4 mg 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] 4 mg chewable tablets are pink, oval, biconvex.
In packs of: 7, 10, 14, 20, 28, 30, 50, 56, 84, 90 and 98 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
<[To be completed nationally]>
{Name and address}
<{tel}>
<{fax}>
<{e-mail}>
Manufacturer:
Pharmathen S.A,, 6 Dervenakion street, Pallini Attiki, 15351 Greece
Tel.: +30 210 6664300
Fax: +30 210 6666749
E-mail: info@pharmathen.com

This medicinal product is authorized in the Member States of the EEA under the following names:
UK/H/2159/01-02/DC:
United Kingdom
Cyprus

Montelukast 5 mg chewable tablets
Silukast 5mg

Greece
Italy
Romania

Apilone
Monterast 5mg compresse masticabili
Montelukast Alvogen 5 mg comprimate masticabile

UK/H/2686/01-02/DC:
United Kingdom
Italy

Montelukast 5 mg chewable tablets
Montelukast Pharmacare

UK/H/2688/01-02/DC:
United Kingdom
Belgium
Italy
Luxembourg

Montelukast 5 mg chewable tablets
Montelukast Mylan 5 mg kauwtabletten
MONTELUKAST DOC 5 mg compresse masticabili
Montelukast Mylan 5 mg comprimes a croquer

UK/H/2690/01-02/DC:
United Kingdom
Italy
Poland

Montelukast 5mg chewable tablets
FILKAST 5mg
Alvokast

UK/H/2692/01-02/DC:
United Kingdom
Germany
Iceland

Montelukast 5 mg chewable tablets
Montelukast Aurus 5 mg Kautabletten, For children from 2 to 5 years
Montelukast Portfarma 5mg

This leaflet was last revised in {MM/YYYY}

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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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