Montelukast 4mg Chewable Tablets
Montelukast 4mg chewable Tablets
For children 2 to 5 years of age
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, please ask your child's 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. See section 4.
• The full name of this medicine is Montelukast 4mg chewable Tablets but within the leaflet it will be referred to as Montelukast tablets
What is in this leaflet: j What Montelukast tablets are and what they are used for
^ What you need to know before your child takes Montelukast tablets ^ How to take Montelukast tablets Possible side effects How to store Montelukast tablets Contents of the pack and other information
j What Montelukast tablets are and what they are used for
Montelukast tablets are a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Montelukast tablets improve asthma symptoms and help control asthma.
Your child's doctor has prescribed Montelukast tablets to treat your child's asthma, preventing asthma symptoms during the day and night.
• Montelukast tablets are used for the treatment of 2 to 5 year old patients who are not adequately controlled on their medication and need additional therapy.
• Montelukast tablets 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 tablets also help prevent the narrowing of airways triggered by exercise for patients 2 years of age and older.
Your child's doctor will determine how Montelukast tablets should be used depending on the symptoms and severity of your child's asthma.
^ What you need to know before your child takes Montelukast tablets
Tell your child's doctor about any medical problems or allergies your child has now or has had.
Do not use Montelukast tablets:
• if your child is allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your child's doctor, pharmacist or nurse before using Montelukast tablets
• If your child's asthma or breathing gets worse, tell your child's doctor immediately.
• Oral Montelukast tablets are not meant to treat acute asthma attacks. If an attack occurs, follow the instructions your child's doctor has given you. Always have your child have his/her inhaled rescue medicine for asthma attacks with him/her.
• It is important that your child takes all asthma medications prescribed by your child's doctor. Montelukast tablets should not be used instead of other asthma medications your child's 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 child's doctor.
• Your child should not take acetyl-salicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs) if they make his/her asthma worse.
Other medicines and Montelukast tablets
Some medicines may affect how Montelukast tablets work, or Montelukast tablets may affect how your child's other medicines work.
Tell your child's doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
Tell your child's doctor if your child is taking the following medicines before starting Montelukast 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 treatment of high lipid levels in plasma)
Montelukast tablets with food and drink
Montelukast tablets should not be taken immediately with food; they should be taken at least one hour before or two hours after food.
Pregnancy and breast-feeding
This subsection is not applicable for the Montelukast 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.
Pregnancy
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Breastfeeding
It is not known if Montelukast tablets appears in breast milk. You should consult your doctor before taking Montelukast tablets if you are breast-feeding or intend to breast-feed. Your doctor will assess whether you can take Montelukast tablets during this time.
Driving and using machines
This subsection is not applicable for the Montelukast 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 tablets are 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 tablets contain aspartame, a source of phenylalanine (an amino acid). May be harmful for people with phenylketonuria (a genetic disorder affecting the metabolism).
Montelukast tablets contain lactose. If you have been told by your child's doctor that he/she has an intolerance to some sugars, contact your child's doctor before having him/her take this medicinal product.
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How to take Montelukast tablets
• Always use this medicine exactly as your child's doctor has told you. Check with your child's doctor or pharmacist if you are not sure.
• This medicine is to be given to a child under adult supervision.
• the recommended dose is one tablet of Montelukast once a day as prescribed by his/her doctor.
• It should be taken even when your child has no symptoms or if he/she has an acute asthma attack.
• To be taken by mouth
For children 2 to 5 years of age
One Montelukast tablet daily to be taken in the
evening. Montelukast tablets should not be taken
immediately with food; it should be taken at least one
hour before or two hours after food.
If your child is taking Montelukast tablets, be sure that he/she does not take any other medicines that contain the same active ingredient, montelukast.
For other age groups
For other age groups, other strengths and
pharmaceutical forms of montelukast may be available.
The Montelukast tablet is not recommended below 2 years of age.
If your child takes more Montelukast tablets 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 tablets to your child
Try to give Montelukast 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.
If your child stops taking Montelukast tablets
Montelukast tablets can treat your child's asthma only if your child continues taking it.
It is important for your child to continue taking Montelukast tablets for as long as your child's doctor prescribes. It will help control your child's asthma.
If you have any further questions on the use of this medicine, ask your child's doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following serious side effects that have been reported with montelukast, stop giving Montelukast tablets to your child and contact a doctor immediately:
• Sudden wheezing, swelling of lips, tongue and throat or body, rash, fainting or difficulties to swallow (severe allergic reaction). This side effect is uncommon (may affect up to 1 in 100 people).
• Flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome). This side effect is very rare (may affect up to 1 in 10,000 people).
• Suicidal thoughts and actions. This side effect is very rare (may affect up to 1 in 10,000 people).
• Severe skin reactions (erythema multiforme) that may occur without warning. This side effect is very rare (may affect up to 1 in 10,000 people).
The following side effects have also been reported with montelukast:
Very common: may affect more than 1 in 10 people
• Colds (upper respiratory infection)
Common: may affect up to 1 in 10 people
• Headache
• Abdominal pain
• Thirst
• Diarrhoea, nausea, vomiting
• Rash
• Fever
• Asthma
• Hyperactivity
• Red, itchy skin (eczema)
• Increased amounts of certain substances in the blood (transaminases)
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Uncommon: may affect up to 1 in 100 people
• 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, seizures (fits)
• 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
• Shaking
• Feeling your hearbeat (palpitations)
• Swelling of the skin
Very rare: may affect up to 1 in 10,000 people
• Hallucinations, confusion
• Hepatitis (inflammation of the liver), liver problems (hepatic eosinophilic infiltration)
• Tender red lumps under the skin most commonly on your shins (erythema nodosum)
Reporting of side effects
If your child gets any side effects, talk to your doctor, pharmacist or nurse. 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.
How to store Montelukast 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 and blister after EXP. The expiry date refers to the last day of that month.
• Store in the original package in order to protect from light and moisture.
• Do not store above 30°C.
• 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.
^ Contents of the pack and other information
What Montelukast tablets contain
• The active substance is montelukast. Each chewable tablet contains montelukast sodium which corresponds to 4mg of montelukast.
• The other ingredients (excipients) are: microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, lactose monohydrate, iron oxide red (E172), mannitol, silarom cherry flavour (nature-identical flavouring substances, flavouring preparations, natural flavouring substances, maltodextrin (potato), gum arabic (acacia) (E414), triacetin (E1518), ethyl maltol, maltol, alpha-tocopherol (E307)), aspartame (E951), magnesium stearate.
What Montelukast tablets look like and contents of the pack
Montelukast 4mg chewable tablets are pink, mottled, oval, biconvex tablets with M4 engraved on one side.
Blisters in packages of:
28 chewable tablets
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegi 76-78,
220 Hafnarfjordur Iceland
Manufacturer
Actavis Ltd
BLB016, Bulebel Industrial Estate,
Zejtun ZTN 3000 Malta
This leaflet was last revised in July 2014.
If you would like a leaflet with larger text, please contact 01271 311257.
actavis
Actavis, Barnstaple, EX32 8NS, UK