Montelukast 4 Mg Chewable Tablets
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Package leaflet: information for the user
Montelukast 4 mg Chewable Tablets
For children from 2 to 5 years Montelukast
Read all of this leaflet carefully before your
child 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 or pharmacist or nurse.
• This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child's.
• If any of the side effects, talk to your doctor or 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 chewable tablet 4 mg is and what it is used for
2. What you need to know before you take Montelukast chewable tablet 4 mg
3. How to take Montelukast chewable tablet 4 mg
4. Possible side effects
5. How to store Montelukast chewable tablet 4 mg
6. Contents of the pack and other information
1. What Montelukast chewable tablet 4 mg is and what it is used for
Your doctor has prescribed, Montelukast chewable tablet to treat your child's asthma, preventing asthma symptoms during the day and night.
• Montelukast 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 chewable tablet 4 mg 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 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 chewable tablet should be used depending on the symptoms and severity of your child's asthma.
Montelukast 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 chewable tablet improves asthma symptoms and helps control asthma.
What is asthma?
Asthma is a long-term disease.
Asthma includes:
• difficulty in 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 chewable tablet 4 mg
Tell your doctor about any medical problems or
allergies your child has now or has had.
Do not give montelukast chewable tablet 4 mg
• if your child is allergic (hypersensitive) to montelukast, or any of the other ingredients of montelukast chewable tablet (see 6. Contents of the pack and other information).
Warnings and precautions
• Please tell your doctor immediately if your child's asthma or breathing gets worse.
• Oral montelukast 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 chewable tablet 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 your child 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 non-steroidal anti-inflammatory drugs or NSAIDs) if they make your child's asthma
Other medicines and Montelukast chewable tablet 4 mg
Some medicines may affect how montelukast chewable tablet works, or montelukast chewable tablet may affect how 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 chewable tablet:
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
Montelukast chewable tablet 4 mg with food and drink
Montelukast 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 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 Montelukast chewable tablets. Your doctor will assess whether you can take Montelukast chewable tablet during this time.
Use in breast-feeding It is not known if montelukast is excreted in human milk. You should consult your doctor before taking Montelukast chewable tablets 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.
Montelukast 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 chewable tablets may affect some patients' ability to drive or operate machinery.
Montelukast chewable tablet contains aspartame
Montelukast chewable tablet contains aspartame, a source of phenylalanine. It may be harmful for your children with phenylketonuria. If your child has phenylketonuria (a rare, hereditary disorder of the metabolism) you should take into account that each Montelukast chewable tablet contains phenylalanine (equivalent to 0.674 mg phenylalanine per 4 mg chewable tablet).
3. How to take Montelukast chewable tablet 4 mg
• This medicine is to be given to a child under adult supervision.
• Your child should take only one tablet of Montelukast chewable tablet once a day as prescribed by your doctor.
• It should be taken even when your child has no symptoms or if your child has an acute asthma attack.
• Always have your child take Montelukast chewable tablet as your child's doctor has told you. You should check with your child's doctor or pharmacist if you are not sure.
• To be taken by mouth.
One Montelukast chewable tablets daily to be taken in the evening. Montelukast chewable tablets 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 chewable tablets, be sure that your child does not take any other medicines that contain the same active ingredient, montelukast.
Other available strength/pharmaceutical forms:
5 mg chewable tablets are available for children 6 to 14 years old.
4 mg chewable tablets are available for children 2 to 5 years old. The Montelukast chewable tablets 4 mg is not recommended below 2 years of age.
If your child takes more montelukast chewable tablet 4 mg 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 chewable tablet 4 mg to your child
Try to give Montelukast chewable tablets 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.
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If your child stops taking montelukast chewable tablet 4 mg
Montelukast chewable tablets can treat your child's asthma only if your child continues taking it.
It is important to continue taking Montelukast 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 chewable tablets can cause side effects, although not everybody gets them.
The following terms are used to describe how often side effects have been reported.
very common: affects more than 1 user in 10 common:affects 1 to 10 users in 100 uncommon:affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: Frequency cannot be estimated from the available data
In clinical studies with Montelukast chewable tablets, the most commonly reported side effects thought to be related to Montelukast chewable tablets were:
For 4mg:
• abdominal pain
• thirst
For 5mg:
• 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:
• upper respiratory infection (very common)
• increased bleeding tendency (Rare)
• allergic reactions including rash, swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing (Uncommon)
• behaviour and mood related changes [dream abnormalities, including nightmares, hallucinations, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, tremor, depression, trouble sleeping, sleep walking, suicidal thoughts and actions (Very rare)]
• dizziness, drowsiness, pins and needles/numbness, seizure (Uncommon)
• palpitations (Rare)
• nose bleeding (Uncommon)
• diarrhoea, nausea, vomiting (Common); dry mouth, indigestion, (Uncommon)
• hepatitis (inflammation of the liver) (Very rare)
• Rash (Common); bruising, itching, hives (Uncommon); tender red lumps under the skin most commonly on your shins (erythema nodosum),severe skin reactions (erythema multiforme) that may occur without warning (Very rare)
• joint or muscle pain, muscle cramps (Uncommon)
• Fever (Common); tiredness, feeling unwell, swelling, (Uncommon)
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.
Ask your doctor or pharmacist for more information about side effects. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your child's doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. By reporting side effects you can help provide more information on the safety of this medicine.
For UK - You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
For Malta- ADR Reporting The Medicines Authority Post-Licensing Directorate 203 Level 3, Rue D'Argens GZR-1368 Gzira
Website: www.medicinesauthority.gov.mt e-mail: postlicensing.medicinesauthority@gov.mt
6. Contents of the pack and other information
What Montelukast chewable tablets 4 mg contains
• The active substance is montelukast. Each tablet contains montelukast sodium which corresponds to 4 mg of montelukast.
• The other ingredients are: mannitol(E421) (SD 200), cellulose, microcrystalline (PH 112), croscarmellose sodium, cherry flavour (501027 AP0551), iron oxide red(E172), aspartame (E951), magnesium stearate
What Montelukast chewable tablets 4 mg looks like and contents of the pack
Pink colored, mottled, oval, biconvex tablet, debossed “M4” on one side and plain on other side.
Packaged in OPA-Al-PVC/Al blister.
Pack sizes: 7, 10, 14, 20, 28, 30, 50, 56, 98, 100, 140 and 200 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex HA1 4HF, United Kingdom
Manufacturer
Accord Healthcare Limited,
Sage House, 319 Pinner Road,
North Harrow, Middlesex HA1 4HF, United Kingdom
or
Cemelog-BRS Ltd.,
H-2040 Budaors, Vasut u. 13,
Hungary
This leaflet was last revised in 02/2014
5. How to store Montelukast chewable tablet 4 mg
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
• Do not store above 30°C. 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 to protect the environment.