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MONTELUKAST GEDEON RICHTER 4MG CHEWABLE TABLETS

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Package leaflet: Information for the user
„Montelukast Gedeon Richter” 4 mg chewable tablets for children from 2 to 5 years
„Montelukast Gedeon Richter” 5 mg chewable tablets for children from 6 to 14 years
montelukast
Read all of this leaflet carefully before giving your child 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, 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.
2.
3.
4.
5.
6.

What „Montelukast Gedeon Richter” 4/5 mg is and what it is used for
What you need to know before you use „Montelukast Gedeon Richter” 4/5 mg
How to use „Montelukast Gedeon Richter” 4/5 mg
Possible side effects
How to store „Montelukast Gedeon Richter” 4/5 mg
Contents of the pack and other information

1.

What „Montelukast Gedeon Richter” 4/5 mg is and what it is used for

The active ingredient of this medicine is called montelukast 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 Gedeon Richter” 4/5 mg improves
asthma symptoms and helps control asthma.
„Montelukast Gedeon Richter” tablets are used in the treatment of children with asthma,
preventing asthma symptoms during night and day as follows:

For patients who are not adequately controlled on their existing medication and need
additional therapy.

It may also be used as an alternative treatment to inhaled corticosteroids for patients who have
not recently taken oral corticosteroids for their asthma and have shown that they are unable to
use inhaled corticosteroids.

To help prevent the narrowing of airways triggered by exercise.

Your doctor will determine how „Montelukast Gedeon Richter” chewable tablets should be
used depending on the symptoms and severity of your child’s asthma.
„Montelukast Gedeon Richter” 5 mg chewable tablet for in children 6-14 years of age.
„Montelukast Gedeon Richter” 4 mg chewable tablet for in children 2-5 of age.
ABOUT ASTHMA
Asthma is a long term disease. It cannot be cured, only controlled.
Asthma includes:

Difficulty breathing because of narrowed airways. This narrowing worsens in response to
various conditions.

Swelling (inflammation) in the lining of airways. When this occurs, the symptoms of asthma
become worse and it becomes difficult to breathe.

Sensitive airways that react to many things, such as cigarette smoke, pollen, cold air, or
excercise.

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Symptoms of asthma include:
Coughing, wheezing and chest tightness.

2.

what you need to know before you use „Montelukast Gedeon Richter” 4/5 mg

Tell your doctor about any medical problems or allergies your child has now or has had.
Do not use „Montelukast Gedeon Richter” 4/5 mg:
if 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 before using „Montelukast Gedeon Richter” 4/5 mg.
Take special care with „Montelukast Gedeon Richter” 4/5 mg
Tell your doctor or pharmacist if your child has any other medical conditions, and especially if you
notice any of the following :

if during treatment with „Montelukast Gedeon Richter” the asthma symptoms get worse, you
should contact your doctor immediately.

„Montelukast Gedeon Richter” 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 take all asthma medications prescribed by your doctor.
“Montelukast Gedeon Richter” 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 Gedeon Richter” 4/5 mg
Some medicines may affect how „Montelukast Gedeon Richter” works, or „Montelukast Gedeon
Richter” 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.
„Montelukast Gedeon Richter” is normally used with other medicines for asthma.
Do not stop or change the dose of any medicine without first checking with your doctor.
In particular, tell your doctor if your child is taking the following medicines before starting:

phenobarbital (used for treatment of epilepsy),

phenytoin (used for treatment of epilepsy),

rifampicin (used to treat tuberculosis and some other infections).
„Montelukast Gedeon Richter” 4/5 mg with food and drink


„Montelukast Gedeon Richter” should not be taken immediately with food, they should be
taken at least 1 hour before or 2 hours after food.

2

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
As this medicine is for children up to the age of 14, pregnancy and breast-feeding are unlikely
occurences. 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 Gedeon Richter”. Your doctor will assess whether you can take “Montelukast Gedeon
Richter” during this time.
Use in breast-feeding
It is not known if „Montelukast Gedeon Richter” appears in breast milk. You should consult your
doctor before taking “Montelukast Gedeon Richter” if you are breast-feeding or intend to breast-feed.
Driving and using machines
As this medicine is for children up to the age of 14, driving and using machinery is unlikely. In adults
„Montelukast Gedeon Richter” is not expected to affect their ability to drive a car or operate
machinery. However, the following information is relevant to the active ingredient, montelukast.
„Montelukast Gedeon Richter” 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 Gedeon Richter” may affect some
patients' ability to drive or operate machinery.
„Montelukast Gedeon Richter” 4/5 mg contains aspartame
„Montelukast Gedeon Richter” 5 mg chewable tablet contains 1.5 mg aspartame. Contains a source of
phenylalanine. May be harmful for people with phenylketonuria (a rare inherited disease requiring a
special diet). You should take into account that each „Montelukast Gedeon Richter” 5 mg chewable
tablet contains phenylalanine (equivalent to 0.842 mg phenylalanine per 5 mg chewable tablet).
„Montelukast Gedeon Richter” 4 mg chewable tablet contains 1.2 mg aspartame. Contains a source of
phenylalanine. May be harmful for people with phenylketonuria (a rare inherited disease requiring a
special diet). You should take into account that each „Montelukast Gedeon Richter” 4 mg chewable
tablet contains phenylalanine (equivalent to 0.674 mg phenylalanine per 4 mg chewable tablet).

3.

How to use „Montelukast Gedeon Richter” 4/5 mg

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if
you are not sure.






This medicinal product is to be given to a child under adult supervision. For children who have
problems consuming a chewable tablet this medicine cannot be given.
Your child should take only one tablet of „Montelukast Gedeon Richter” 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 Gedeon Richter” 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.

Safety and efficacy of 4 mg chewable tablets have not been established in the paediatric population
below 2 years of age.


The usual dose for children of 6-14 years is one 5 mg chewable tablet to be taken once a day in
the evening.

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The usual dose for children of 2-5 years is one 4 mg chewable tablet to be taken once a day in
the evening.
Tablets should not be taken immediately with food; it should be taken either one hour before, or
two hours after food and should be chewed.
If your child is taking SINGULAIR Paediatric, be sure that he/she does not take any other
medicines that contain the same active ingredient, montelukast.

For children 2 to 5 years old, „Montelukast Gedeon Richter” 4 mg chewable tablets are available.
For children 6 to 14 years old, „Montelukast Gedeon Richter” 5 mg chewable tablets are available.
The „Montelukast Gedeon Richter” 4 mg chewable tablet is not recommended below 2 years of age.
If your child takes more „Montelukast Gedeon Richter” 4/5 mg than he/she should
Contact your child’s doctor immediately for advice.
There is no side effects reported in the majority of overdose reports. The most frequent symptoms
reported with overdose in adults and children included abdominal pain, sleepiness, thirst, headache,
vomiting, and hyperactivity.
If your child forgets to take „Montelukast Gedeon Richter” 4/5 mg
Try to give “Montelukast Gedeon Richter” as prescribed. However, if your child misses a dose, just
resume the usual schedule one tablet once daily. Do not give a double dose to make up for a forgotten
dose.
If your child stops taking „Montelukast Gedeon Richter” 4/5 mg
“Montelukast Gedeon Richter” can treat your child’s asthma only if your child continues taking it.
It is important to continue taking „Montelukast Gedeon Richter” 4/5 mg for as long as your doctor
prescribes it. This will help maintain control of your child's asthma.
If you have any further questions on the use of this product, ask your child’s doctor or pharmacist.

4.

Possible side effects

Like all medicines „Montelukast Gedeon Richter” 4/5 mg can cause side effects, although not
everybody gets them.
Allergic reactions have been reprted including swelling of the face, lips, tongue, and/or throat which
may cause difficulty in breathing or swallowing. It is vital that your child stops taking
„Montelukast Gedeon Richter” chewable tablets and that medical attention is sought
immediately if your child experiences an allergic reaction.
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.
The most frequently reported side effects (occurring in at least 1 of 100 and less than 1 of 10
paediatric patients treated) in clinical studies with „Montelukast Gedeon Richter” 4/5 mg in children
were:

abdominal pain

thirst
Additionally, the following side effect was reported in clinical studies with 10 mg film-coated tablets
and 5 mg chewable tablets:

headache

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These were usually mild and occurred at a greater frequency in patients treated with „Montelukast
Gedeon Richter” than placebo (a pill containing no medication).
The frequency of possible side effects listed below is defined using the following convention:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect more than 1 in 100 people)
Rare (may affect more than 1 in 1,000 people)
Very rare (may affect more than 1 in 10,000 people)
Additionally, while the medicine has been on the market, the following side effects have been
reported:
Very common:

upper respiratory infection
Common:

diarrhoea, nausea, vomiting

rash

fever
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

dizziness, drowsiness, pins and needles/numbness, seizure

nosebleed

dry mouth, indigestion

bruising, itching, hives

joint or muscle pain, muscle cramps

weakness/tiredness, feeling unwell, swelling
Rare:

increased bleeding tendency

tremor, disturbance in attention, memory impairment

palpitations
Very rare:

hallucinations, disorientation, suicidal thoughts and actions

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
Ask your doctor or pharmacist for more information about side effects.
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
Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store „Montelukast Gedeon Richter” 4/5 mg

Keep out of the reach and sight of children.
Do not use “Montelukast Gedeon Richter” after the expiry date which is stated on the carton after
EXP:.

5

The expiry date refers to the last day of that month.
Store below 25°C.
Store in the original package in order to protect from moisture and light.
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.

Contents of the pack and other information

What „Montelukast Gedeon Richter” contains
The active substance is montelukast.
Each chewable tablet contains 4/5 mg of montelukast equivalent to 4.16/5.20 mg of montelukast
sodium.
The other ingredients are:
Mannitol, cellulose, microcrystalline, hydroxypropyl cellulose, yellow iron oxide (E172),
croscarmellose sodium, cherry flavour powder (maltodextrin, starch modified), aspartame (E951),
magnesium stearate (E572).
What „Montelukast Gedeon Richter” looks like and contents of the pack
5 mg chewable tablet:
cream, round, biconvex chewable tablet with R14 embossing on one side
Blister: OPA-Al-PVC/Al blister
Pack sizes: 20, 28, 30, 50, 56, 84, 98 and 100 tablets.
Not all pack sizes may be marketed.
4 mg chewable tablet:
cream, lenticular, biconvex chewable tablet with R13 embossing on one side
Blister: OPA-Al-PVC/Al blister
Pack sizes: 20, 28, 30, 50, 56 and 84 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Gedeon Richter Plc.
1103 Budapest, Gyömrői út 19-21
Hungary
Manufacturer
GEDEON RICHTER POLSKA Sp. z o.o.
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland
This medicinal product is authorised in the Member States of the EEA under the
following names:
Belgium
Montelukast Apotex 4/5 mg kauwtabletten; Montélukast Apotex comprimés
à croquer 4/5 mg; Montelukast Apotex 5 mg Kautabletten
France
Montelukast Gedeon Richter 4/5 mg, comprimé à croquer
Germany
Montelukast Gedeon Richter 4/5 mg Kautabletten
Hungary
Montelukast Gedeon Richter 4/5 mg rágótabletta
Italy
Montelukast Gedeon Richter 4/5 mg compresse masticabili
United Kingdom Montelukast Gedeon Richter 4/5 mg chewable tablets

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This leaflet was last revised in {12/2013}.

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Expand Transcript

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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