Patient Leaflet Updated 22-Jan-2024 | Dr. Reddy's Laboratories (UK) Ltd
Montelukast 4mg Chewable Tablets
Montelukast 4 mg Chewable Tablets
Montelukast
For children from 2 to 5 years
1. What Montelukast is and what it is used for
2. What you need to know before taking Montelukast
3. How to take Montelukast
4. Possible side effects
5. How to store Montelukast
6. Contents of the pack and other information
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.
Your doctor will determine how Montelukast should be used depending on the symptoms and severity of your child's asthma.
Asthma is a long-term disease.
Asthma includes:
Symptoms of asthma include: Coughing, wheezing, and chest tightness.
Tell your doctor about any medical problems or allergies your child has now or has had.
Talk to your doctor or pharmacist before you give Montelukast to your child
Various neuropsychiatric events (for example behaviour and mood-related changes, depression and suicidality) have been reported in patients of all ages treated with montelukast (see section 4). If you develop such symptoms while taking montelukast, you should contact your doctor.
Do not give this medicine to children less than 2 years of age.
There are different form(s) of this medicine available for paediatric patients under 18 years of age based on age range.
Tell your doctor or pharmacist if your child is taking, or has recently been given or might be given any other medicines, including those obtained without a prescription.
Some medicines may affect how montelukast works, or montelukast may affect how your child’s other medicines work.
Tell your doctor if your child is taking the following medicines before starting Montelukast:
Montelukast should not be taken immediately with food; they should be taken at least 1 hour before or 2 hours after food.
This subsection is not applicable for Montelukast since they are intended for use in children 2 to 5 years of age.
This subsection is not applicable for Montelukast 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 with montelukast may affect some patients’ ability to drive or operate machinery.
If your child has phenylketonuria (a rare, hereditary disorder of the metabolism) you should take into account that each Montelukast chewable tablet contains phenylalanine (equivalent to 0.674 mg phenylalanine per 4 mg chewable tablet).
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.
The recommended dose is one Montelukast chewable tablet daily to be taken in the evening.
If your child is taking Montelukast 4 mg chewable tablets, be sure that he/she does not take any other medicines that contain the same active ingredient, montelukast.
This medicine is for oral use.
The tablets are to be chewed before swallowing.
Montelukast should not be taken immediately with food; it should be taken at least 1 hour before or 2 hours after food.
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.
Try to give Montelukast as prescribed. However, if your child misses a dose, just resume the usual schedule of one chewable tablet once daily.
Do not give a double dose to make up for a forgotten dose.
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 child’s doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical studies with montelukast 4mg 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:
Additionally, the following side effect was reported in clinical studies with Montelukast 10 mg film-coated tablets and 5 mg chewable tablets:
These were usually mild and occurred at a greater frequency in patients treated with montelukast than placebo (a pill containing no medication).
Talk with your doctor immediately if you notice any of the following side effects, which may be serious, and for which you may need urgent medical treatment.
Uncommon: the following may affect up to 1 in 100 people
Rare: the following may affect up to 1 in 1,000 people
Very rare: the following may affect up to 1 in 10,000 people
Very common: the following may affect more than 1 in 10 people
Common: the following may affect up to 1 in 10 people
Uncommon: the following may affect up to 1 in 100 people
Rare: the following may affect up to 1 in 1,000 people
Very rare: the following may affect up to 1 in 10,000 people
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 website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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 blister and carton 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 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.
The active substance is montelukast. Each chewable tablet contains montelukast sodium which corresponds to 4 mg of montelukast.
The other ingredients are: mannitol (E 421), hydroxypropylcellulose (E 463), croscarmellose sodium (E 468), iron oxide, red (E 172), cherry flavour (contains modified food starch), aspartame (E 951), cellulose, microcrystalline (E 460), magnesium stearate (E 572).
Light pink to pink coloured, speckled, oval shaped, biconvex tablets debossed with ‘MTS’ on one side and ‘4’ on the other side.
Blister in pack sizes of: 14, 20, 28, 50, 100 chewable tablets. Not all pack sizes will be marketed.
This leaflet was last updated in 01/2024.
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