Montelukast 5 Mg Chewable Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
Montelukast 5 mg Chewable Tablets
montelukast
Read all of this leaflet carefully before you start giving this medicine to your child 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.
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 you get any 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 5 mg Chewable Tablets is and what it is used for
2. What you need to know before your child is given Montelukast 5 mg Chewable Tablets
3. How Montelukast 5 mg Chewable Tablets is given
4. Possible side effects
5. How to store Montelukast 5 mg Chewable Tablets
6. Contents of the pack and other information
1. What Montelukast 5 mg Chewable Tablets is and it is used for
Montelukast 5 mg Chewable Tablets is a leukotriene receptor antagonist that blocks the substance called leukotrienes. Leukotrienes can cause the narrowing and swelling of airways in your lungs. By blocking leukotrienes, this medicine improves the symptoms and helps control your asthma.
Your doctor has prescribed Montelukast 5 mg Chewable Tablets to treat your child’s asthma and to help prevent asthma symptoms during the day and night.
This medicine is used in the treatment of children who are not adequately controlled on their medication and need additional therapy.
This medicine also helps to prevent the narrowing of airways triggered by exercise in children aged from 6 to 14 years of age.
This medicine may also be used as an alternative treatment to inhaled corticosteroids for children aged from 6 to 14 years old who have not recently taken oral corticosteroids to relieve asthma and have shown that they are unable to use inhaled corticosteroids.
Your doctor will determine how this medicine should be taken depending on the symptoms and severity of your child’s asthma.
What is asthma?
Asthma is a long-term disease.
Asthma includes:
Difficulty in breathing because of the narrowed airways. The narrowing of airways can worsen and improve 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 tightness in the chest.
What are seasonal allergies?
Seasonal allergies (also known as hay fever or season allergic rhinitis) are an allergic response often caused by airborne pollen from trees, grass and weeds. The symptoms of seasonal allergies may include stuffy, runny and/or itchy nose; sneezing; watery, swollen, red and itchy eyes.
2. What you need to know before your child is given Montelukast 5 mg Chewable Tablets
Please tell your doctor about any medical problems or allergies your child is experiencing now or previously had. Do not give Montelukast 5 mg Chewable Tablets to your child if they:
are allergic to montelukast 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 5 mg Chewable Tablets
If your child’s asthma or breathing gets worse, tell your doctor immediately.
This medicine is not meant to treat acute asthma attacks. If your child has an attack, follow the instructions given to you by your doctor. Always have with you your child’s inhaled rescue medicine for asthma attacks.
It is important that your child is given all asthma medicines as recommended by your doctor. Montelukast 5 mg Chewable Tablets should not be used in place of other asthma medications that your doctor has prescribed for your child.
- Patients on anti-asthma medicines should be aware that if you develop a combination of symptoms such as a flu-like illness, pins and needles or numbness of arms or legs, worsening of chest problems, and/or rash, you should contact your doctor for advice.
- Your child should not be given aspirin or antiinflammatory medicines (also known as non-steroidal anti-inflammatory drugs or NSAIDS) if it makes the asthma worse.
Other medicines and Montelukast 5 mg Chewable Tablets
Tell your doctor or pharmacist if your child is taking, have recently taken or might take any other medicines, including those medicines obtained without a prescription. This is because some medicines may affect how montelukast works, or montelukast can affect how other medicines work.
Please tell your doctor if your child is given any of the following medicines before using Montelukast 5 mg Chewable Tablets:
- Phenobarbital (used for treatment of epilepsy)
- Phenytoin (used for treatment of epilepsy)
- Rifampicin (used to treat tuberculosis and some other infections)
Montelukast 5 mg Chewable Tablets with food and drink
This medicine should not be taken immediately with food; it should be taken at least 1-hour before or 2-hours after food. Pregnancy, breast-feeding and fertility
Pregnancy
Women who are pregnant or intend to become pregnant should consult their doctor before taking this medicine. Your doctor will assess whether you can take this medicine during this time.
Breast-feeding
It is not known if this medicine appears in breast milk. You should consult your doctor before taking this medicine if you are breast feeding or if you intend to breast feed.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Montelukast is not expected to affect your ability to drive or operate machinery. However, individual responses to the 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 5 mg Chewable Tablets contains aspartame
Aspartame is a source of phenylalanine. If your child has phenylketonuria (a rare, hereditary disorder of the metabolism) you should take into account that each tablet contains phenylalanine (equivalent to 1.50 mg/tablet).
3. How Montelukast 5 mg Chewable Tablets is given
This medicine is to be given to a child under the supervision of an adult.
• Your child should take only one tablet of this medicine once a day as prescribed by your doctor.
• It should be taken even when your child has no symptoms or when they are having an acute asthma attack.
Always take this medicine 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 aged 6 to 14 years of age:
One tablet to be taken daily in the evening. This medicine should not be given immediately with food; it should be given at least 1-hour before or 2-hours after food. The tablets are to be chewed before swallowing.
If your child is taking this medicine make sure that your child is not taking other medicines that contain the same active ingredient, montelukast.
For Children aged 2 to 5 years of age:
Montelukast 4 mg Chewable Tablets are also available for children aged from 2-5 years old. This medicine is not recommended for children under the age of 2 years old.
If your child takes more Montelukast 5 mg Chewable Tablets than they should
If your child take more tablets than they should, contact your doctor or pharmacist immediately for advice.
There were no serious 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 (unusually active).
If you forget to give Montelukast 5 mg Chewable Tablets to your child
Try to take this medicine as prescribed by your doctor. However, if you forget to give a dose to your child, just resume the usual schedule of one tablet once daily. Do not give a double dose to make up for a forgotten tablet.
If you stop giving Montelukast 5 mg Chewable Tablets to your child
This medicine can treat your child’s asthma only if your child continues to take it. It is important to continue taking this medicine as recommended by your doctor. It will help control their asthma symptoms.
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 asthmatic patients treated with montelukast, very rare cases of a combination of symptoms such as the following have been reported.
You must tell your doctor right away if your child gets one or more of these symptoms:
- Flu-like illness
- Pins and needles
- Numbness of arms and legs
- Worsening of pulmonary symptoms and/or rash (Churg-Strauss syndrome).
Stop giving your child this medicine and seek medical attention immediately if your child has one or more of these symptoms:
- Rash, swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing and swallowing (allergic reaction).
In clinical studies with Montelukast 5 mg chewable tablets, the most commonly reported side effect (occurring in more than 1 in 100, or less than 1 in 10 treated patients) thought to be related to this medicine was:
• Headache
Additionally, abdominal pain was reported in clinical studies with Montelukast 10 mg film-coated tablets. 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:
Very common side effects (occurring in more than 1 in 10 treated patients):
• upper respiratory infection
Common side effects (occurring in more than 1 to 10 in 100 treated patients):
• diarrhoea
• nausea
• vomiting
• rash
• fever
Uncommon side effects (occurring in more than 1 to 10 in 1,000 treated patients):
• nose bleed
• dry mouth
• indigestion
• bruising
• itching
• hives
• joint and/or muscle pain, muscle cramps
• weakness/tiredness
• feeling unwell
• swelling
• feeling dizzy
• feeling drowsy
• pins and needles/ numbness
• seizure (having a fit)
• allergic reactions including - swelling of the face, lips, tongue, and/or throat which may cause difficulty in breathing or swallowing
• dream abnormalities (including nightmares)
• trouble sleeping
• sleepwalking
• irritability
• feeling anxious
• restlessness
• agitation including aggressive behaviour or hostility
• depression
Rare side effects (occurring in more than 1 to 10 in 10,000 treated patients):
• increased bleeding tendency
• tremor
• disturbance in attention
• palpitations
Very rare side effects (occurring in less than 1 in 10,000 treated patients):
• hallucinations
• disorientation
• suicidal thoughts and actions
• hepatitis (swelling of your liver)
• swelling (inflammation) of the lungs
• tender red lumps under the skin commonly on your shins (erythema nodosum)
• severe skin reactions (erythema multiforme) that may occur without warning
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 medicine.
5. How to store Montelukast 5 mg Chewable 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 after abbreviation “EXP” used for expiry date. The expiry date refers to the last day of that month followed by the last four numbers which indicate the year.
Use within 30 days of opening. Once the pack has been opened write the date of opening on the space provided on the package label and also write the date by when the product should be used.
Store in the original package to protect from moisture. This medicinal product does not require any special temperature storage conditions.
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 5 mg Chewable Tablets contains
- The active substance is montelukast sodium. Each tablet contains montelukast sodium which corresponds to 5 mg of montelukast
- The other ingredients are:
Mannitol [E421], Cellulose microcrystalline. Hydroxypropylcellulose [E463], Croscarmellose sodium, Cherry flavour, Aspartame [E951], Magnesium stearate.
What Montelukast 5 mg Chewable Tablets looks like and contents of the pack
The 5 mg chewable tablets are white to off white, 9.5 mm diameter round, biconvex uncoated tablets, engraved with ‘G’ on one side and ‘391’ on the other side.
The tablets are packed in HDPE containers which includes a desiccant protecting the tablets from moisture. The desiccant should not be swallowed.
Pack sizes: 20, 28, 30, 50 and 100.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited Laxmi House, 2-B Draycott Avenue,
Kenton, Harrow, Middlesex, HA3 0BU,
United Kingdom
Manufacturer
Glenmark Pharmaceuticals s.r.o.
City Tower, Hvezdova 1716/2b, 140 78 Prague 4,
Czech Republic
Glenmark Pharmaceuticals Europe Limited Building 2, Croxley Green Business Park,
Croxley Green, Hertfordshire, WD18 8YA,
United Kingdom Accord Healthcare Limited
Sage House, 319 Pinner Road, Harrow, Middlesex, HA1 4HF, United Kingdom
This leaflet was last revised in 04/2015.