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

2.    What you need to know before you use „Montelukast Gedeon Richter” 4/5 mg

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

4.    Possible side effects

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

6.    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.

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.

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.

•    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

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:.

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, Gyomroi ut 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; Montelukast Apotex comprimes

a croquer 4/5 mg; Montelukast Apotex 5 mg Kautabletten France    Montelukast Gedeon Richter 4/5 mg, comprime a croquer

Germany    Montelukast Gedeon Richter 4/5 mg Kautabletten

Hungary    Montelukast Gedeon Richter 4/5 mg ragotabletta

Italy    Montelukast Gedeon Richter 4/5 mg compresse masticabili

United Kingdom Montelukast Gedeon Richter 4/5 mg chewable tablets

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

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