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MONTELUKAST 4 mg CHEWABLE TABLETS

For children from 2 to 5 years of age Montelukast

What is in this leaflet:

1.    What Montelukast is and what it is used for

2.    What you need to know before your child takes Montelukast

3.    How to take Montelukast

4.    Possible side effects

5.    How to store Montelukast

6.    Content 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 the lungs. By blocking leukotrienes, Montelukast improves asthma symptoms and helps to control asthma.

Your doctor has prescribed this medicine to treat your child’s asthma, preventing asthma symptoms during the day and night.

-    This medicine is used for the treatment of children from 2 to 5 years of age 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 children from 2 to 5 years of age 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 for children from

2 years of age and older.

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. What you need to know before your child takes 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 in this medicine (see 6. FURTHER INFORMATION).

Warnings and precautions

Take special care with Montelukast

-    If your child’s asthma or breathing gets worse, tell your doctor immediately.

-    These oral tablets are 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 medicines prescribed by your doctor.

These tablets 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 different symptoms such as flu-like illness, pins and needles or numbness of arms or legs, worsening of pulmonary symptoms, and/or rash occur, you should consult your doctor.

-    Your child should not take aspirin (acetyl-salicylic acid) or other anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make his/her asthma worse.

Other medicines and Montelukast

Some medicines may affect how your tablets work, or these tablets may affect how your child’s 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 or has recently taken one of 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)

Montelukast with food and drink

These tablets should not be taken immediately with food; they should be taken at least 1 hour before or 2 hours after food.

Pregnancy and breast-feeding

This subsection is not applicable for the Montelukast 4 mg chewable tablets since they are 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

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 they are intended for use in children 2 to 5 years of age, however the following information is relevant to the active ingredient, montelukast.

This medicine is not expected to affect your ability to drive 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 these tablets may affect some patients' ability to drive or operate machinery.

Important information about some of the ingredients of Montelukast

These tablets contain aspartame, a source of phenylalanine. May be harmful for children with phenylketonuria.

If your child has phenylketonuria (a rare, hereditary disorder of the metabolism) you should take into account that each 4 mg chewable tablet contains phenylalanine (equivalent to 0.898 mg phenylalanine per 4mg chewable tablet)

3. HOW TO TAKE MONTELUKAST

- This medicine is to be given to a child under adult supervision.

-    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 the tablets 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.

For children 2 to 5 years of age:

One Montelukast 4 mg chewable tablet daily to be taken in the evening. The tablet should not be taken immediately with food; it should be taken at least 1 hour before or 2 hours after food.

If your child is taking this medicine, 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 4 mg chewable tablets are available.

For children 6 to 14 years old, Montelukast 5 mg chewable tablets are available. The Montelukast 4 mg chewable tablet is not recommended below 2 years of age.

If your child takes more Montelukast than he/she should

Contact your child’s doctor immediately for advice.

There were no side effects reported in the majority of overdose reports. The most frequently occurring symptoms reported with overdose 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 he/ she continues taking it.

It is important for your child to continue taking the tablets 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 child’s doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines this medicine can cause side effects, although not everybody gets them.

Seek immediate medical advice if your child experiences allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing (Uncommon).

Tell your doctor right away if you notice any behaviour and mood related changes such as:

Uncommon (may affect up to 1 in 100 people) dream abnormalities, including nightmares, trouble sleeping, sleepwalking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression.

Rare (may affect up to 1 in 1,000 people)

tremor, disturbance in attention, memory impairment.

Very rare (may affect up to 1 in 10,000 people) hallucinations, disorientation, suicidal thoughts and actions.

In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as flulike 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.

In clinical studies with these tablets, the most commonly reported side effects (occurring in at least 1 of 100 patients and less than 1 of 10 paediatric patients treated) thought to be related to the medicine were:

-    abdominal pain

-    thirst

Additionally, the following side effect was reported commonly in clinical studies with the 10 mg film-coated tablets and the 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 medicine 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 100 people):

-    diarrhoea, nausea, vomiting; rash; fever

Uncommon (may affect up to 1 in 100 people):

-    dizziness, drowsiness, pins and needles/numbness, seizure

-    nosebleed

-    dry mouth, indigestion

-    bruising, itching, hives

-    joint or muscle pain, muscle cramps

-    tiredness, feeling unwell, swelling

Rare (may affect up to 1 in 1,000 people):

-    increased bleeding tendency

-    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

Reporting of side effects

If your child gets any side effects, talk to your child's doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting the side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE MONTELUKAST

-    Keep out of sight and reach of children.

-    Do not use this medicine after the date shown by the six numbers following <EXP> on the blister. The first two numbers indicate the month; the last four numbers indicate the year. This medicine expires at the end of the month shown.

-    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 dispose of medicines no longer required. These measures will help protect the environment.

6. CONTENT OF THE PACK AND OTHER INFORMATION

What Montelukast contains

-    The active substance is montelukast. Each tablet contains montelukast sodium which corresponds to 4 mg of montelukast.

-    The other ingredients are:

Mannitol, microcrystalline cellulose, low-substituted hydroxypropyl-cellulose (E463), red ferric oxide (E172), croscarmellose sodium, cherry flavour (E1518-glyceryl triacetate; E1450-sodium octenylsuc-cinate), aspartame (E951), and magnesium stearate.

What Montelukast looks like and content of the pack

Montelukast 4 mg chewable tablets are pink, oval and biconvex with MOK 4 engraved on one side and PHD471 on the other.

Packaged in oPA/ Al/ PVC/ aluminium blisters packed in cardboard boxes.

Pack sizes of 14, 20, 28, 30, 50, 98 and 100 chewable tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Dexcel®-Pharma Ltd., 7 Sopwith Way, Drayton Fields, Daventry, Northamptonshire, NN11 8pB, Uk.

Manufacturer

MC Pharma AD

35, Zemliane Str., 1618 Sofia, Bulgaria

This medicinal product is authorised in the Member States of the EEA under the following names:

United Kingdom: Montelukast 4 mg chewable tablets This leaflet was last revised in December 2013