Montelukast 4mg Chewable Tablets
Package leaflet: Information for the patient Montelukast 4 mg chewable tablets
montelukast
Read all of this leaflet carefully before your child starts 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 your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your child’s.
• If your child gets any side effects, talk to your child’s 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 Montelukast is taken
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
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 improves asthma symptoms and helps control asthma.
Your doctor has prescribed Montelukast to treat your child’s asthma, preventing asthma symptoms during the day and night.
• Montelukast 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 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 also helps prevent the narrowing of airways triggered by exercise for patients 2 years of age and older.
Your doctor will determine how Montelukast 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 Montelukast is taken
Tell your doctor about any medical problems or allergies your child has now or has had.
Do not give Montelukast to your child if he/she
• Is allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before Montelukast is taken
• If your or your child’s asthma or breathing gets worse, tell your doctor immediately.
• Oral 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 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 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 non-steroidal anti-inflammatory drugs or NSAIDs) if they make his/her asthma worse.
Other medicines and Montelukast
Some medicines may affect how Montelukast works, or Montelukast may affect how your
child’s other medicines work.
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any
other medicines.
Tell your doctor if your child is 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)
Montelukast with food and drink
Montelukast 4 mg chewable tablets 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, think they may be pregnant or are planning to have a baby, should ask their doctor for advice before taking this medicine. Their doctor will assess whether they can take Montelukast during this time.
Use in breast-feeding
It is not known if Montelukast appears in breast milk. Women who are breast-feeding or intend to breast-feed, should ask their doctor for advice before taking this medicince.
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 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 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 4-mg chewable tablet contains phenylalanine (equivalent to 0.67 mg phenylalanine per 4 mg chewable tablet).
3. How to take Montelukast
• This medicine is to be given to a child under adult supervision. For children who have problems consuming a chewable tablet, an oral granule formulation is available.
• 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.
• Always have your child take this medicine exactly as your doctor or pharmacist 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:
The recommended dose is one 4 mg chewable tablet daily to be taken in the evening. Montelukast 4 mg 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, be sure that he/she does not take any other medicines that contain the same active ingredient, montelukast.
For children 2 to 5 years old, Montelukast 4 mg chewable tablets and 4mg granules are available.
For children 6 to 14 years old Montelukast 5 mg chewable tablets are available. The Montelukast 4 mg chewable tablet is not recommended below 2 years of age.
If your child takes more Montelukast 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 to your child
Try to give Montelukast 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.
If your child stops taking Montelukast
Montelukast can treat your child’s asthma only if he/she continues taking it.
It is important for your child to continue taking Montelukast 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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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 were:
• abdominal pain
• thirst
Additionally, the following side effect was reported in clinical studies with Montelukast 10 mg filmcoated tablets and 5 mg chewable tablets:
• headache
These were usually mild and occurred at a greater frequency in patients treated with Montelukast than placebo (a pill containing no medication).
The frequency of possible side effects listed below is defined using the following convention: Very common (affects at least 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)
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, trouble sleeping, sleep walking, irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility, depression (Uncommon); tremor (Rare); hallucinations, suicidal thoughts and actions (Very rare)]
• Dizziness, drowsiness, pins and needles/numbness, seizure (Uncommon)
• Palpitations (Rare)
• Nosebleed (Uncommon)
• Diarrhoea, nausea, vomiting (Common); dry mouth, indigestion (Uncommon)
• Hepatitis (inflammation of the liver) (Very rare)
• Bruising, itching, hives (Uncommon); tender red lumps under the skin most commonly on your shins (erythema nodosum) (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 your child gets any side effects, talk to your child’s doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.
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 EXP. The expiry date refers to the last day of that month.
• 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 4 mg chewable tablets contain
• The active substance is montelukast. Each Montelukast 4 mg tablet contains montelukast sodium which corresponds to 4 mg of montelukast.
• The other ingredients are: microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, lactose monohydrate, iron oxide red (E172), mannitol, silarom cherry flavour, aspartame, magnesium stearate.
What Montelukast 4 mg chewable tablets look like and contents of the pack
4 mg Montelukast chewable tablets are pink, mottled, oval, biconvex tablets with M4
engraved on one side.
Blisters in packages of:
7. 10, 14, 20, 28, 30, 49, 50, 56, 98, 100, 140 and 200 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aptil Pharma Limited
9th Floor, CP House
97-107 Uxbridge Road, Ealing
London
W5 5TL
Manufacturer:
Actavis Ltd
BLB 016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta