Montelukast 5mg Chewable Tablets
Package leaflet: Information for the patient
Montelukast 5 mg Chewable Tablets
For children 6 to 14 years old
Read all of this leaflet carefully before you start giving/ 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 or your child 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 or your child gets any side effects, talk to your
doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4._
What is in this leaflet
1. What Montelukast 5 mg Chewable Tablet is and what it is used for
2. What you need to know before you give/take Montelukast 5 mg Chewable Tablets
3. How to take Montelukast 5 mg Chewable Tablets
4. Possible side effects
5. How to store Montelukast 5 mg Chewable Tablets
6. Contents of the pack and other information
1. What Montelukast 5 mg Chewable Tablet is and what it is used for
Montelukast 5 mg Chewable Tablet contains montelukast, which is a leukotriene receptor antagonist that blocks substances called leukotrienes.
Leukotrienes cause narrowing and swelling of airways in your lungs. By blocking leukotrienes, Montelukast 5 mg Chewable Tablet improves asthma symptoms and helps control asthma.
Your doctor has prescribed Montelukast 5 mg Chewable Tablet to treat asthma, preventing your or your child's asthma symptoms during the day and night.
• Montelukast 5 mg Chewable Tablet is used for the treatment of patients who are not adequately controlled on their medication and need additional therapy.
• Montelukast 5 mg Chewable Tablet 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 5 mg Chewable Tablet also helps prevent the narrowing of airways triggered by exercise.
Your doctor will determine how Montelukast 5 mg Chewable Tablets should be used depending on the symptoms and severity of you 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 give/take Montelukast 5 mg Chewable Tablets
Tell your doctor about any medical problems or allergies you or your child has now or has had.
Do not give or take Montelukast 5 mg Chewable Tablets if you or your child:
• is allergic to montelukast or any of the other ingredients of this medicine (listed in section 6.1).
Warnings and precautions
• If you or your child's asthma or breathing gets worse, tell your doctor immediately.
• Montelukast 5 mg Chewable Tablet is not meant to treat acute asthma attacks. If an attack occurs, follow the instructions your doctor has given you for you or your child. Always have your or your child's inhaled rescue medicine for asthma attacks with you. Talk to your doctor if you or your child needs more inhaled rescue medicine than usual for the acute asthma attacks.
• It is important that you or your child take all asthma medications prescribed by your doctor. Montelukast 5 mg Chewable Tablets 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 lung (pulmonary) symptoms, and/or rash, you should consult your 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 asthma worse.
Children and adolescents
For children 2 to 5 years old, Montelukast 4 mg Chewable Tablet may be available.
For children 6 to 14 years old, Montelukast 5 mg Chewable Tablet may be available.
Other medicines and Montelukast 5 mg Chewable Tablets
Some medicines may affect how Montelukast 5 mg Chewable Tablet works, or Montelukast 5 mg Chewable Tablet may affect how other medicines work.
Tell your doctor or pharmacist if you or your child are taking, have recently taken or might take other medicines, including those obtained without a prescription.
Tell your doctor if you or your child are taking the following medicines before starting Montelukast 5 mg Chewable Tablets:
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
• gemfibrozil (used for the treatment of high lipid levels in plasma)
Pregnancy and breast-feeding
Use in pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 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 talk to your doctor before taking Montelukast 5 mg Chewable Tablets 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 tablets may affect some patients' ability to drive or operate machinery.
Montelukast 5 mg Chewable Tablets contain aspartame
Montelukast 5 mg Chewable Tablets contain aspartame, a source of phenylalanine. If your child has phenylketonuria (a rare, hereditary disorder of the metabolism) you should take into account that each Montelukast 5 mg Chewable Tablet contains phenylalanine (equivalent to 1.12 mg phenylalanine per chewable tablet).
3. How to take Montelukast 5 mg Chewable Tablets
Always give this medicine to your child, or take yourself, 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 5 mg once a day as prescribed by your doctor.
• It should be taken even when you or your child has no symptoms or has an acute asthma attack.
• To be taken by mouth
For children 6 to 14 years of age:
The recommended dose is one 5 mg chewable tablet daily to be taken in the evening. Montelukast 5 mg Chewable Tablet should not be taken immediately with food; it should be taken at least 1 hour before or 2 hours after food.
If you or your child is taking Montelukast 5 mg Chewable Tablets, 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 5 mg Chewable Tablet than you should
Contact your 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, being sick (vomiting), and hyperactivity.
If you forget to take Montelukast 5 mg Chewable Tablets or give Montelukast 5 mg Chewable Tablets to your child
Try to take Montelukast 5 mg Chewable Tablets 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 5 mg Chewable Tablets
Montelukast 5 mg Chewable Tablet 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 5 mg Chewable Tablets 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you or your child get any of the following side effects you or your child should stop taking this medicine and see your doctor immediately or go to the nearest hospital casualty department straight away:
Uncommon (may affect up to 1 in 100 people)
• Severe allergic reaction (called anaphylaxis) that may include difficulty in breathing, dizziness and collapse.
• Seizure (fits)
Rare (may affect up to 1 in 1,000 people)
• Swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
Very rare (may affect up to 1 in 10,000 people)
• Yellowing of the skin or eyes which may be caused by hepatitis (inflammation of the liver) or liver problems (hepatic eosinophilic infiltration)
• Suicidal thoughts and actions
• Chest pain with a dry cough, fever, shortness of breath and wheezing due to an inflammation of the lungs caused by an increase in the numbers of a type of white blood cell (pulmonary eosinophilia)
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 lung (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.
In clinical studies with montelukast 5 mg chewable tablets, the most commonly reported side effects (occurring in up to 1 in 10 children) thought to be related to montelukast chewable tablets 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 tablets 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 10 people)
• Diarrhoea
• Feeling sick (nausea)
• Being sick (vomiting)
• Rash
• Raised liver enzymes, which show up in test results
• Fever
Uncommon (may affect up to 1 in 100 people)
• Behaviour and mood related changes e.g. dream abnormalities, including nightmares, trouble sleeping, sleep walking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression, shaking (tremor)
• Dizziness, drowsiness
• Pins and needles, numbness
• 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
• Disturbance in attention
• Memory impairment
• Fast or irregular heartbeats (Palpitations)
Very rare (may affect up to 1 in 10,000 people)
• Hallucinations (seeing, feeling or hearing things that are not there), disorientation
• Tender red lumps under the skin most commonly on your shins (erythema nodosum)
• Skin rash, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) called erythema multiforme
Reporting of side effects
If you or your child gets 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 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 5 mg Chewable Tablets
• 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 or bottle or blister after "EXP". The expiry date refers to the last day of that month.
• Bottles: Once open use within 100 days.
• 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 throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Montelukast 5 mg Chewable Tablet contains
• The active substance is montelukast. Each tablet contains montelukast sodium which corresponds to 5 mg
of montelukast.
• The other ingredient(s) are:
Mannitol, granular Cellulose, microcrystalline Croscarmellose, sodium Magnesium stearate Sodium laurilsulfate Silica, colloidal anhydrous
Aspartame (E 951) (see section 2 "Montelukast 5 mg Chewable Tablets contain aspartame")
Cherry flavour (maize maltodextrin, benzyl alcohol E 1519, triethyl citrate E 1505)
What Montelukast 5 mg Chewable Tablet looks like and contents of the pack
Montelukast 5 mg Chewable Tablets are white to off-white coloured, round, tablet with sides that curves outwards marked with "M" on one side and "MS2" on other side.
Tablets are available in the following pack types and sizes: Blister packs in sizes of 7, 10, 14, 20, 28, 30, 50, 56, 98, 100,
112 or 200 tablets or in perforated unit dose blisters of 28 x 1.
White plastic bottles with white non see-though plastic cap containing absorbent cotton and a desiccant canister (do not eat the desiccant) in pack sizes of 28, 56, 100, 112, 200 & 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Mylan, Potters Bar, Hertfordshire EN6 1TL, United Kingdom
Manufacturer:
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Mylan Hungary Kft, H-2900 Komarom, Mylan utca 1, Hungary
Generics [UK] Limited, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
This leaflet was last revised in September 2015.
613861
Code No.: MH/DRUGS/25/NKD/89