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

(Montelukast)

For children from 6 to 14 years of age

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. See section4.

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 5mg chewable tablets (referred to as Montelukast in the rest of this leaflet).

Montelukast Paediatric 5mg 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, rnontelukast 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 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 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 antiinflammatory 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 4mg chewable tablets are available.

For children 6 to 14 years old, Montelukast Paediatric 5mg 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 and drink

Montelukast Paediatric 5mg chewable tablets should not be taken immediately with food; it should be taken at least 1 hour before or 2 hours after food. (See also section 3. How to take Montelukast)

Pregnancy, breast-feeding and fertility

Use in Pregnancy

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 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 breastfeed.

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 patient’s ability to drive or operate machinery. Montelukast contains Aspartame Montelukast chewable tablets contain aspartame, a source of phenylalanine. May be harmful for people 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 5mg chewable tablets contains phenylalanine

SAME SIZE ARTWORK 130 x 420 mm Front

(equivalent to 0.674mg phenylalanine per 5mg chewable tablets).

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

The tablets are to be chewed before swallowing. 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 Montelukast 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 chlld

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 5mg chewable tablets, the most commonly reported side effects (occurring in more than 1 in 10 people) thought to be related to Montelukast were:

•    headache

Additionally, the following side effect was reported in clinical studies with Montelukast 10mg 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 (may affect more than 1 in 10 people)

•    upper respiratory infection Common (may affect more than 1 in 10 people)

•    diarrhoea, nausea, vomiting

•    fever

•    rash

Uncommon (may affect up to 1 in 100 people)

•    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 (may affect up to 1 in 1000 people)

•    increased bleeding tendency

•    palpitations

•    tremor, disturbance in attention, memory impairment

Very rare (may affect up to 1 in 10,000 people)

•    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)

•    swelling of the lungs

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 Yellowcard 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 (EXP). 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 throw away any medicines via waste water 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 5.2mg montelukast sodium, which corresponds to 5mg montelukast.

•    The other ingredients are: Mannitol (E421), microcrystalline cellulose, red ferric oxide (E172), croscarmellose sodium, cherry flavour, aspartame (E951), and magnesium stearate, hydroxypropyl cellulose (E463).

What Montelukast look like and contents of the pack Chewable tablets

Montelukast chewable tablets are Pink coloured, round, bi-convex, diameter 9.6mm, tablets, debossed with ‘BL 5’ on one side and plain on other side.

Blister pack: Aluminium/Aluminium Blister

Pack size: 28, 30 tablets.

Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer:

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

Telephone: 0044(0)1442200922 Fax:    0044(0)1442873717

Email:    info@bristol-labs.co.uk

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

To request a copy of this leaflet in Braille, large print or audio, please contact the licence holder at the address (or telephone, fax, email) above.

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