Montelukast 4 Mg Chewable Tablets
PACKAGE LEAFLET
Package leaflet: Information for the user
Montelukast 4 mg chewable tablets
Montelukast
For children from 2 to 5 years
Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for him/her.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for your child only. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child’s.
• If you get any side effects talk to your doctor or pharmacist. his includes any possible side effects not listed in this leaflet, See section 4.
• What is inn 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
Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in your lungs. By blocking leukotrienes, Montelukast improves asthma symptoms and helps control asthma.
Your doctor has prescribed Montelukast to treat asthma, preventing your 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.
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 the asthma include: Coughing, wheezing and chest tightness.
2. What you need to know before you take Montelukast
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 precautionsIf 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 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.
• 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 pulmonary symptoms, and/or rash, you should consult your doctor.
• Your child should not take aspirin or anti-inflammatory medicines (also known as non-steroidal antiinflammatory drugs or NSAIDs) if they make her/his asthma worse.
Children and adolescentsFor children 2 to 5 years old, Montelukast 4 mg chewable tablets are available.
For children 6 to 14 years old, Montelukast 5 mg chewable tablets are available. Safety and effectiveness of
Montelukast 4 mg chewable tablets in children less than 2 years old have not been established.
Other medicines and Montelukast
Some medicines may affect how Montelukast works, or Montelukast may affect how other medicines work.
Tell your doctor or pharmacist if your child is taking or has recently taken or might take any other medicines.
Tell your doctor if your child is taking the following medicines before starting Montelukast Pharmathen:
• 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)
Taking Montelukast with food and drink
Montelukast 4 mg chewable tablets should not be taken immediately with food; it should be taken at least 1 hour before or two hours after food.
Pregnancy and Breast-feeding
This subsection is not applicable for the Montelukast 4 mg chewable tablets since it is 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
Limited data concerning the exposed pregnancies do not suggest a causal relationship between Montelukast and malformations (i.e. limb defects) that have been rarely reported in worldwide post marketing experience.
Women who are pregnant or breast-feeding, think they may be pregnant or are planning to have a baby should consult their doctor before takingthis 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 consult your doctor before taking Montelukast 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 it is 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 chewable tablets contain aspartame.
Contains a source of phenylalanine. May be harmful for people with phenylketonuria. If your child has the genetic disorder phenylketonuria you should take into account that each Montelukast 4 mg chewable tablet contains phenylalanine (equivalent to 0.135 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 ofMontelukast 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 Montelukast as your doctor has told you. You should check with your doctor or pharmacist if you are not sure
• To be taken by mouth.
For children 2 to 5 years of age:
One Montelukast 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 two hours after food. If your child is taking Montelukast Pharmathen, be sure that your child does not take any other products that contain the same active ingredient, Montelukast.
If your child takes more Montelukast than he/she should
Contact your doctor immediately for advice.
There were no side effects reported in the majority of overdosage reports. The most frequently occurring symptoms reported with overdosage 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 your child continues to take it. It is important 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 product, 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 (in more than 1 in 100, or less than 1 in 10 treated patients) reported side effects thought to be related to Montelukast were:
• abdominal pain
• thirst
Additionally, the following side effect was reported in clinical studies with Montelukast 10 mg film-coated 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 drug has been on the market, the following have been reported:
• upper respiratory infection (Very common)
• increased bleeding tendency (Rare)
• allergic reactions including 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, disorientation suicidal thoughts and actions (Very rare)
• dizziness, drowsiness, pins and needles/numbness, seizure(Uncommon)
• palpitations(Rare)
• nosebleed(Uncommon)^ dry mouth, indigestion(Uncommon) diarrhea, nausea, vomiting(Common)
• 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)
• weakness/tiredness, feeling unwell, swelling (Uncommon);, fever (Common)..
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.
Reporting of side effects
If you get 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
5. How to store Montelukast
• Keep out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last date of that month.
• 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 tothrow away medicines you no longer useThese measures will help to protect the environment.
6. Contents of the pack and other information
What Montelukast contains
• The active substance is: Montelukast
Montelukast 4 mg chewable tablet contains Montelukast sodium which corresponds to 4 mg of Montelukast.
• The other ingredients are: Mannitol, microcrystalline cellulose, hyprolose (E 463), red ferric oxide (E 172), croscarmellose sodium, cherry flavour (consisting of: maltodexrin, arabic gum, anisaldehyde, benzaldehyde, cinnamaldehyde, vanillin, heliotropin, ionons), aspartame (E951), and magnesium stearate.
What Montelukast looks like and contents of the pack
Montelukast 4 mg chewable tablets are pink, oval, biconvex.
In packs of: 10, 14, 28, tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pharmathen S.A,, 6 Dervenakion street, Pallini Attiki, 15351 Greece Manufacturer:
Pharmathen S.A,, 6 Dervenakion street, Pallini Attiki, 15351 Greece
Distributed by:
Aspire Pharma Limited
Antrobus House Business Centre
18 College Street
Petersfield
Hampshire
GU31 4AD
United Kingdom
This medicinal product is authorized in the Member States of the EEA under the following names:
UK/H/2159/01-02/DC:
United Kingdom
Bulgaria
Cyprus
Greece
Italy
Montelukast 4 mg chewable tablets Alvokast 4 mg chewable tablets Apilone 4mg Apilone
Poland
Romania
Monterast 4mg compresse masticabili Zapetin
Montelukast Alvogen 4 mg comprimate masticabile
This leaflet was last revised in 12/2013