Montelukast 4mg Chewable Tablets
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MONTELUKAST 4 mg CHEWABLE TABLETS
For children from 2 to 5 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, please ask your doctor or 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 or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Montelukast 4 mg Chewable Tablet is and what it is used for
2. What you need to know before you take Montelukast 4 mg Chewable Tablets
3. How to take Montelukast 4 mg Chewable Tablets
4. Possible side effects
5. How to store Montelukast 4 mg Chewable Tablets
6. Contents of the pack and other information
1. What Montelukast 4 mg Chewable Tablet is and what it is used for
Montelukast 4 mg Chewable Tablet is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in your lungs. By blocking leukotrienes, Montelukast 4 mg Chewable Tablet improves asthma symptoms and helps control asthma.
Your doctor has prescribed Montelukast 4 mg Chewable Tablets to treat your child's asthma, preventing asthma symptoms during the day and night.
• Montelukast 4 mg Chewable Tablet is used for the treatment of 2 to 5 year old patients who are not adequately controlled on their medication and need additional therapy.
• Montelukast 4 mg Chewable Tablet may also be used as an alternative treatment to inhaled corticosteroids for
2 to 5 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 4 mg Chewable Tablet also helps prevent the narrowing of airways triggered by exercise for patients
2 years of age and older.
Your doctor will determine how Montelukast 4 mg Chewable Tablets 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 you take Montelukast 4 mg Chewable Tablets
Tell your doctor about any medical problems or allergies your child has now or has had.
Do not give Montelukast 4 mg Chewable Tablets to your child if he/she
• is allergic to montelukast or any of the other ingredients of this medicine (listed in section 6.1).
Warnings and precautions
• If your child's asthma or breathing gets worse, tell your doctor immediately.
• Oral Montelukast 4 mg Chewable Tablet 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 child's inhaled rescue medicine for asthma attacks with you.
• It is important that your child take all asthma medications prescribed by your doctor. Montelukast 4 mg Chewable 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 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.
• Your child should not take acetyl-salicylic acid (aspirin) or anti-inflammatory medicines (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they make his/her asthma worse.
Use in children
For children 2 to 5 years old, Montelukast 4 mg Chewable Tablet is available.
For children 6 to 14 years old, Montelukast 5 mg Chewable Tablet is available.
Other medicines and Montelukast 4 mg Chewable Tablets
Some medicines may affect how Montelukast 4 mg Chewable Tablet works, or Montelukast 4 mg Chewable Tablet 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 the following medicines before starting Montelukast 4 mg Chewable Tablets:
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
Montelukast 4 mg Chewable Tablets with food and drink
Montelukast 4 mg Chewable Tablet 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 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 Montelukast 4 mg Chewable Tablets. Your doctor will assess whether you can take Montelukast 4 mg Chewable Tablets during this time.
Use in breast-feeding
It is not known if Montelukast 4 mg Chewable Tablet appears in breast milk. You should consult your doctor before taking Montelukast 4 mg Chewable Tablets if you are breast-feeding or intend to breast-feed.
Driving and using machines
This subsection is not applicable for 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.
Montelukast 4 mg Chewable Tablet 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.
Important information about some of the ingredients of Montelukast 4 mg Chewable Tablets
Montelukast 4 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 4 mg Chewable Tablet contains phenylalanine (equivalent to 1.12 mg phenylalanine per chewable tablet).
3. How to take Montelukast 4 mg Chewable Tablets
• This medicine is to be given to a child under adult supervision.
• Your child should take only one tablet of Montelukast 4 mg once a day as prescribed by your doctor.
• It should be taken even when your child has no symptoms or he/she has an acute asthma attack.
• Always have your child take this medicine exactly as your doctor has told you. 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 4 mg chewable tablet daily to be taken in the evening. Montelukast 4 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 your child is taking Montelukast 4 mg Chewable Tablets, be sure that he/she does not take any other products that contain the same active ingredient, montelukast.
If your child takes more Montelukast 4 mg Chewable Tablet 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 4 mg Chewable Tablets to your child
Try to take Montelukast 4 mg Chewable Tablets as prescribed. However, if 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 your child stops taking Montelukast 4 mg Chewable Tablets
Montelukast 4 mg Chewable Tablet can treat your child's asthma only if he/she continues to take it.
It is important for your child to continue taking Montelukast 4 mg Chewable 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, Montelukast 4 mg Chewable Tablets can cause side effects, although not everybody gets them.
If your child gets any of the following symptoms you should stop taking Montelukast 4 mg Chewable Tablets and see your doctor immediately:
Uncommon (may affect up to 1 in 100 people)
• Severe allergic reaction (called anaphylaxis) that may include difficulty in breathing, dizziness and collapse.
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)
• Hepatitis (inflammation of the liver), liver problems (hepatic eosinophilic infiltration)
• 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
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 your child gets one or more of these symptoms.
In clinical studies with Montelukast 4 mg Chewable 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 Montelukast chewable tablets were:
• abdominal pain
• thirst
Additionally, the following side effect was reported in clinical studies with Montelukast 10 mg film-coated tablets:
• headache
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
• Nausea
• Vomiting
• Rash
• Raised liver enzymes
• 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
• 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
• Disturbance in attention
• Memory impairment
• Tremor
• Palpitations
Very rare (may affect up to 1 in 10,000 people)
• Hallucinations (seeing, feeling or hearing things that are not there), disorientation
• Suicidal thoughts and actions
Reporting of side effects
If you get any side effect, talk to your doctor, pharmacist or nurse. This includes any 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 4 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 of medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Montelukast 4 mg Chewable Tablet contains
• The active substance is montelukast. Each tablet contains montelukast sodium which corresponds to 4mg of montelukast.
• The other ingredient(s) are:
Mannitol, granular Cellulose, Microcrystalline Croscarmellose sodium Magnesium stearate Sodium Laurilsulfate Silica, Colloidal Anhydrous Aspartame (E 951)
Cherry flavour (Maize maltodextrin, Benzyl alcohol E 1519, Triethyl citrate E 1505)
What Montelukast 4 mg Chewable Tablet looks like and contents of the pack
Montelukast 4 mg Chewable Tablets are white to off-white coloured, oval, biconvex tablets debossed with “M" on one side and “MS1" on other side.
Tablets are available in the following pack types and sizes: Aluminium/Aluminium blisters in pack 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 HDPE bottles with white opaque PP cap containing absorbent cotton and a desiccant canister 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, UK
This leaflet was last revised in November 2013.
346880
Code No.: MH/DRUGS/25/NKD/89