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PACKAGE LEAFLET: INFORMATION FOR THE USER

Montelukast 5 mg chewable tablets

Montelukast

For children from 6 to 14 years

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 Montelukast to treat asthma, preventing your asthma symptoms during the day and night.

•    Montelukast 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 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 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?

Astha 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, oor exercise.

•    Swelling (inflammation)in the lining of the airways

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

2. BEFORE YOU TAKE Montelukast

Tell your doctor about any medical problems or allergies you or your child has now or has had.

Do not take Montelukast if you or your child

•    is allergic (hypersensitive) to Montelukast or any of the other ingredients of Montelukast (see 6. Further information).

Take special care with Montelukast

•    If your or 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 you or 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 you or 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.

•    You or your child should not take aspirin or anti-inflammatory medicines (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.

Use in children

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.

Montelukast chewable tablets in children less than 2 years 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 you or your child is taking or has recently taken other medicines, including those obtained without a prescription.

Tell your doctor if you or 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)

Taking Montelukast with food and drink

Montelukast 5 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

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 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.

Important information about some of the ingredients of Montelukast

Montelukast chewable tablets contain aspartame.

Contains a source of phenylalanine. May be harmful for people with phenylketonuria. If you or your child has phenylketonuria you should take into account that each Montelukast 5 mg chewable tablet contains phenylalanine (equivalent to 0.168 mg phenylalanine per 5 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 ofMontelukast 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

For children 6 to 14 years of age:

One Montelukast 5 mg chewable tablet daily to be taken in the evening. Montelukast 5 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 you or your child is taking Montelukast, be sure that you or your child does not take any other products that contain the same active ingredient, montelukast.

If you or your child takes more Montelukast than you 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 take Montelukast or give Montelukast to your child

Try to give Montelukast as prescribed. However, if you or your child misses a dose, just resume the usual schedule of one tablet once daily.

Do not take a double dose to make up for a forgotten dose.

If you or your child stops taking Montelukast

Montelukast can treat you or your child’s asthma only if you or 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 or 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.

In clinical studies with Montelukast 5 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:

•    headache

Additionally, the following side effect was reported in clinical studies with Montelukast 10 mg film-coated 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 drug has been on the market, the following have been reported:

•    increased bleeding tendency

•    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)

•    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.

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 you or your child gets one or more of these symptoms.

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 day 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

•    Montelukast 5 mg chewable tablet contains montelukast sodium which corresponds to 5 mg of montelukast.

•    The other ingredients are: Mannitol, microcrystalline cellulose, hyprolose (E 463), red iron 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 5 mg chewable tablets are pink, round, biconvex.

In packs of: 14 and 28 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Pharmathen S.A., 6 Dervenakion str., Pallini Attiki, 15351 Greece Tel: +30 210 6664300