Montelukast 5 Mg Chewable Tablets
TEVA UK Ref: 231-30-70023-D LEA MONTELUKAST 5MG CHEWABLE TAB TUK Version: 1 04 November 2015
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Pharma code 355
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m Montelukast Chewable 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 Chewable Tablets improve asthma symptoms and help control asthma.
Your doctor has prescribed Montelukast Chewable Tablets to treat your child's asthma, preventing asthma symptoms during day and night.
• Montelukast Chewable Tablets are used for the treatment of patients 6 to 14 years of age who are not adequately controlled on their asthma medications and need additional therapy.
• Montelukast Chewable Tablets may also be used as an alternative treatment to inhaled corticosteroids for 6 to 14 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 5 mg CHEWABLE TABLETS For children 6 to 14 years of age
Package leaflet: Information for the user
Read all of this leaflet carefully before your child starts taking this medicine because it contains important information.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for your child. 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 of the side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Montelukast Chewable Tablets are and what they are used for
2. What you need to know before you take Montelukast Chewable Tablets
3. How to take Montelukast Chewable Tablets
4. Possible side effects
5. How to store Montelukast Chewable Tablets
6. Contents of the pack and other information
1 What Montelukast Chewable Tablets are and what they are used for
• Montelukast Chewable Tablets, in patients 6 to 14 years of age, also helps prevent asthma symptoms which are triggered by exercise.
attack readily accessible at all times. Always have your child's inhaled rescue medicine for asthma attacks with you.
If your child needs to use their beta-agonist inhaler more often than usual, you should consult your child's doctor as soon as possible.
It is important that your child takes all the asthma medication prescribed by the doctor as intended. Montelukast Chewable Tablets should not replace steroid medications (whether inhaled or taken by mouth) that your child may already be using.
If your child has phenylketonuria you should note that Montelukast Chewable Tablets contain aspartame, which is a source of phenylalanine. The phenylalanine in the tablets may be harmful to people with phenylketonuria.
A rare condition has been seen in a very small number of patients taking asthma medications, including montelukast. If you experience a combination of any of the following symptoms, particularly if they are persistent and worsening, seek medical attention immediately: flu-like illness, increasing breathlessness, pins and needles or numbness of limbs, and/or rash.
Use in infants and toddlers: Montelukast Chewable Tablets are not recommended for use in children under two years of age.
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.
Use in infants and toddlers: Montelukast Teva Chewable Tablets are not recommended for use in children under two years of age.
Other medicines and Montelukast Chewable Tablets
Montelukast Chewable Tablets may be used together with other medicines your child may be taking for asthma. However, some medicines can interfere with Montelukast Chewable Tablets, or Montelukast Chewable Tablets may affect how your child's other medicines work.
Tell your doctor or pharmacist if your child is taking or has recently taken or might take any other medicines, including those medicines obtained without a prescription. This is particularly important if the other medicine is:
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some other infections).
Montelukast Chewable Tablets with food and drink
If Montelukast Chewable tablets are taken together with food they should be taken in the evening 1 hour before or 2 hours after food.
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Your doctor will determine how Montelukast 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.
©What you need to know before you take Montelukast Chewable Tablets
Tell your doctor about any medical problems or allergies your child has now or has had.
Do not give Montelukast Chewable Tablets if:
• your child is allergic (hypersensitive) to montelukast sodium or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before giving Montelukast Teva Chewable Tablets to your child.
• If your child's asthma or breathing gets worse, tell your doctor immediately.
• Oral Montelukast Chewable Tablets is NOT intended for the treatment of a sudden attack of breathlessness. It will not help your child in this situation and should never be used for this purpose. If an attack occurs, the instructions that the doctor has given should be followed exactly. It is very important to have the medication needed for such an
Pregnancy, breast-feeding and fertility
This subsection is not applicable for Montelukast Chewable tablets since they are intended for use in children 6 to 14 years of age, however the following information is relevant to the active ingredient, montelukast.
Pregnancy
Female patients who are pregnant, intend to become pregnant or think they might be pregnant should consult their doctor before taking Montelukast Chewable Tablets.
Breast- feeding
It is not known whether Montelukast Chewable Tablets is present in human breast-milk. The doctor should be consulted before Montelukast Chewable Tablets are taken, if you are already breast-feeding or intending to breast-feed a baby.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
This subsection is not applicable for Montelukast Chewable tablets since they are intended for use in children 6 to 14 years of age, however the following information is relevant to the active ingredient, montelukast.
In adults, Montelukast Chewable Tablets are not expected to affect their 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:
Montelukast Chewable Tablets contain aspartame, a source of phenylalanine. May be harmful for people with phenylketonuria.
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3 How to take Montelukast Chewable Tablets
Always ensure that your child takes Montelukast Chewable Tablets as instructed by your doctor, even when your child has no symptoms, or if your child experiences an asthma attack. Check with your doctor or pharmacist if you are not sure.
The recommended dose for children aged 6 to 14 years is one Montelukast 5 mg Chewable Tablet daily in the evening and taken by mouth.
If Montelukast Chewable Tablets use is associated with food, the tablets should be taken 1 hour before or two hours after food.
The safety and effectiveness of Montelukast 5mg Chewable Tablets in children younger than 2 years old have not been established.
For children 2 to5 years old, 4 mg Chewable Tablets are available.
For children 2 to 5 years of age , that have difficulty having the Chewable tablet, a 4mg granule formulation is available. For patients 15 years of age and older Montelukast Teva 10 mg Film-coated Tablets are available.
Montelukast Chewable Tablets should not be used together with other products that contain the same active ingredient, montelukast.
If your child takes more Montelukast Chewable Tablets than he/she should
If your child (or someone else) swallows a lot of the tablets all together, contact your nearest hospital casualty department or your doctor immediately. An overdose is likely to cause abdominal pain, sleepiness, thirst, headache, vomiting, and hyperactivity (involuntary movement). Please take this leaflet, any remaining tablets and the container with you to the hospital or doctor so that they know which tablets were consumed.
If you forget to give Montelukast Chewable Tablets to your child
If your child misses a dose, just carry on with the next one as usual. Do not give a double dose to make up for a forgotten dose.
If your child stops taking Montelukast Chewable Tablets
It is important to continue taking Montelukast Chewable Tablets in the presence or absence of symptoms, for as long as your child's doctor prescribes it, in order to help maintain control of your child's asthma. Montelukast Chewable Tablets can help control your asthma only with continued use.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If your child experiences the following side effects you should contact your doctor or go to the hospital immediately:
In clinical studies with montelukast, the most commonly reported side effects (may affect upto 1 of 10 people) thought to be related to montelukast were:
• headache
• abdominal pain
• thirst
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 has been reported:
The other side effects that have been experienced by some patients taking Montelukast are:
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
• fever
• rash
• increased liver enzymes Uncommon (affects 1 to 10 users in 1,000)
• allergic reactions including swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing
• behaviour and mood related changes [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
• weakness/tiredness, feeling unwell, swelling
Rare (may affect up to 1 in 1000 people)
• increased bleeding tendency
• tremor
• palpitations
• swelling beneath the skin
• swelling beneath the skin
Very rare (may affect up to 1 in 10,000 people)
• hallucinations, disorientation, suicidal thoughts and actions
• hepatitis (inflammation of the liver)
• tender red lumps under the skin most commonly on your shins (erythema nodosum), severe skin reactions (erythema multiforme) that may occur without warning.
• hepatic eosininophilic infiltration
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 you get one or more of these symptoms.
Ask your doctor or pharmacist for more information about side effects.
Reporting of side effects
If you get 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 medicine.
How to store Montelukast Chewable Tablets
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Keep blister in the outer carton in order to protect from light.
Do not use this medicine after the expiry date that is stated on the blister and carton. The expiry date refers to the last day of that month
Do not use this medicine if you notice visible signs of deterioration.
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 Chewable Tablets contain:
• the active ingredient is montelukast sodium equivalent to 5mg montelukast
• the other ingredients include: mannitol (E421), sodium laurilsulfate, hydroxypropyl cellulose, Red iron oxide (E172), Flav.cherry PHS-143671: maltodextrins (maize) and starch modified E1450 (Waxy maize), aspartame (E951), sodium starch glycolate Type A, magnesium stearate
What Montelukast Chewable Tablets looks like and contents of the pack
Montelukast 5 mg Chewable Tablets are mottled pink, square shaped tablet, debossed with "93" on one side and "7425" on the other side of the tablet.
Montelukast 5 mg Chewable Tablets are available in packs of 7, 14, 15, 20, 28, 30, 50, 56, 60, 90, 98 and 100 tablets and calendar packs of 7, 14, 28, 56 and 98 tablets.
Aluminium - Aluminium blister packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG, United Kingdom .
This leaflet was last revised in October 2015
PL 00289/1118
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TEVA UK LIMITED