Package Leaflet: Information for the user Montelukast Paediatric 5 mg chewable tablets

For children from 6 to 14 years Montelukast

Read all of this leaflet carefully before you start taking 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, pharmacist or nurse.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours or your child's.

•    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

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

The full name of this medicine is Montelukast Paediatric 5 mg chewable tablets (referred to as Montelukast in the rest of this leaflet).

Montelukast Paediatric 5 mg chewable tablets contains the active substance 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 improve asthma symptoms and helps control asthma.

Your or your child's doctor has prescribed Montelukast to treat asthma, preventing your or your child's asthma symptoms during the day and night.

•    Montelukast is used for the treatment of 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 to14 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 or your child's doctor will determine how Montelukast should be used depending on the symptoms and severity of your or 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 you take Montelukast Do not take Montelukast

•    If you are or 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 or your child's doctor, pharmacist or nurse before taking or giving him/her Montelukast.

•    If you or your child's asthma or breathing gets worse, tell your doctor immediately.

•    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 takes all asthma medications prescribed by your or your child's doctor. Montelukast should not be used instead of other asthma medications your or your child's doctor has prescribed.

•    If you or your child is on anti-asthma medicines, be aware that if you or he/she develops a combination of symptoms such as flu like illness, pins and needles or numbness of arms or legs, worsening of pulmonary (lung) symptoms, and/or rash, you should consult your or your child's doctor.

•    You or 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 your or his/her asthma worse.

Children

For children 2 to 5 years old, Montelukast Paediatric 4 mg chewable tablets are available.

For children 6 to 14 years old, Montelukast Paediatric 5 mg chewable tablets are available.

Other medicines and Montelukast

Tell your or your child's doctor or pharmacist if you or your child are taking, have recently taken or might take other medicines.

Some medicines may affect how Montelukast works, or Montelukast may affect how other medicines work.

It is especially important to tell your or your child's doctor if you or your child are 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) Montelukast with food

Montelukast Paediatric 5 mg chewable tablets should not be taken at the same time as food; They should be taken at least 1 hour before or 2 hours after food. (See also section 3. How to take Montelukast)

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have baby, ask your doctor for advice before taking this medicine. Your doctor will assess whether you can take montelukast during this time.

It is not known if Montelukast appears in breast milk. If you are breast-feeding or intend to breast-feed, tell your doctor.

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.

Montelukast contains Aspartame

Montelukast chewable tablets contain aspartame, a source of phenylalanine. May be harmful for patients with phenylketonuria. If you or your child have phenylketonuria (a rare, hereditary disorder of the metabolism) you should take into account that each Montelukast Paediatric 5 mg chewable tablets contains phenylalanine (equivalent to 0.674 mg phenylalanine per 5 mg chewable tablets).

Size : W-230mm x H-350mm

3.    How to take Montelukast

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

•    You or 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.

•    To be taken by mouth. The tablet can be chewed or swallowed. If swallowed it should be taken with a sufficient amount of fluid (e.g. with a glass of water).

Use in children 6 to 14 years of age

One Montelukast Paediatric 5 mg chewable tablets daily, to be taken in the evening. Montelukast Paediatric 5 mg chewable tablets should not be taken at the same time as food; it should be taken at least 1 hour before or 2 hours after food.

If you or your child is taking Montelukast, be sure that you or he/she does not take any other products that contain the same active ingredient, montelukast.

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

Try to take 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 stop taking Montelukast

Montelukast can treat your or your child's asthma only if you or he/she continues taking 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 medicine, ask your doctor or pharmacist, or nurse.

4.    Possible side effects

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

In clinical studies with Montelukast Paediatric 5 mg chewable tablets, the most commonly reported side effects (occurring in at least 1 of 100 patients and less than 1 of 10 patients treated) 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 medicine has been on the market, the following side effects have been reported:

Very common (occurs in more than 1 patients in 10)

•    upper respiratory infection Common (occurs in 1 to 10 users in 100)

•    diarrhoea, nausea, vomiting

•    fever

Uncommon (occurs in 1 to 10 users in 1,000)

•    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 such as 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, seizures

•    nosebleed

•    dry mouth, indigestion

•    bruising, itching, hives

•    joint or muscle pain, muscle cramps

•    tiredness, feeling unwell, swelling Rare (occurs in 1 to 10 users in 10,000)

•    increased bleeding tendency

•    palpitations

•    tremor

Very rare (occurs in less than 1 user in 10,000)

•    hallucinations, suicidal thoughts and actions, confusion hallucinations, suicidal thoughts and actions, confusion

•    hepatitis (inflammation of the liver)

•    severe skin reactions (erythema multiforme) that may occur without warning

•    tender red lumps under the skin most commonly on your shins (erythema nodosum)

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.

Reporting of side effects

If you get any side effects, talk to your 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 side effects you can help provide more information on the safety of this medicine.

5.    How to store Montelukast

•    Keep this medicine out of the sight and reach of children.

•    Do not use this medicine after the expiry date which is stated on the carton and blister after EXR The expiry date refers to the last day of that month.

•    This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light and moisture.

•    Do not use this medicine if you notice if pack is damaged or shows signs of tampering.

•    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. Each tablet contains 5.2 mg montelukast sodium, which corresponds to 5 mg montelukast.

•    The other ingredients are:

Mannitol (E421), microcrystalline cellulose, red ferric oxide (E 172), croscarmellose sodium, cherry flavour, aspartame (E951), and magnesium stearate, hydroxy propyl cellulose (E463),

What Montelukast look like and contents of the pack

Chewable tablets

Montelukast chewable tablets are pink coloured, round, bi-convex tablets, debossed with “AUM102” on one side and plain on other side.

Blister pack: Aluminium/Aluminium Blister Pack size: 30 tablets.

Marketing Authorisation Holder and Manufacturer:

Bristol Laboratories Limited

Unit 3, Canalside, Northbridge Road, Berkharmsted, Hertfordshire, HP4 1 EG, United Kingdom.

Telephone:    0044 (0) 1442 200922

Fax:    0044 (0) 1442 873717

Email: info@bristol-labs.co.uk

Montelukast Paediatric 5mg chewable Tablets; PL 17907/0476 This leaflet was last revised in 01/2015.

Size : W-230mm x H-350mm