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MONTELUKAST RANBAXY 4 MG CHEWABLE TABLETS

Active substance(s): MONTELUKAST SODIUM / MONTELUKAST SODIUM / MONTELUKAST SODIUM

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Package leaflet: Information for the user
Refl. Blue
Montelukast 4 mg chewable tablets
Montelukast
Read all of this leaflet carefully before you start 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
- 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 4 mg chewable tablets are and what they are used for
2. What you need to know before you take Montelukast 4 mg chewable tablets
3. How to take Montelukast 4 mg chewable tablets
4. Possible side effects
5. How to store Montelukast 4 mg chewable tablets
6. Contents of the pack and other information
1. What Montelukast 4 mg chewable tablets are and what they are used for
Montelukast 4 mg chewable tablets are a leukotriene receptor antagonist that blocks substances
called leukotrienes.
Leukotrienes cause narrowing and swelling of airways in your lungs. By blocking leukotrienes,
this medicine improves asthma symptoms and helps control asthma.
Your doctor has prescribed this medicine to treat your child's asthma, preventing asthma
symptoms during the day and night.




This medicine is used for the treatment of 2 to 5 year old patients who are not adequately
controlled on their medication and need additional therapy.
This medicine 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.
This medicine also helps prevent the narrowing of airways triggered by exercise for
patients 2 years of age and older.

Your doctor will determine how these 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.

2. What you need to know before you take Montelukast 4 mg chewable tablets
Tell your doctor about any medical problems or allergies your child has now or has had.
Do not give Montelukast 4 mg chewable tablets 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 precautions
Talk to your doctor or pharmacist before giving Montelukast 4 mg chewable tablets









If your child's asthma or breathing gets worse, tell your doctor immediately.
This oral medicine 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 child's
inhaled rescue medicine for asthma attacks with you.
It is important that your child take all asthma medications prescribed by your doctor.
This medicine should not be used instead of other asthma medications your 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 doctor.
Your child should not take aspirin (acetylsalicylic acid) or anti-inflammatory medicines
(also known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make his/her
asthma worse.

Children and adolescents
For 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.
The 4 mg chewable tablets are not recommended in children below 2 years of age.
Other medicines and Montelukast 4 mg chewable tablets
Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other
medicines.
Some medicines may affect how Montelukast 4 mg chewable tablets work, or Montelukast 4 mg
chewable tablets may affect how your child's other medicines work.

Tell your doctor if your child is taking the following medicines before starting Montelukast 4 mg
chewable 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 4 mg chewable tablets with food and drink
These tablets should not be taken immediately with food; they should be taken atleast 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 they are
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
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 tablet during this time.
Use in breast-feeding
It is not known if this medicine appears in breast milk. You should consult your doctor before
taking this tablet, 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 they are
intended for use in children 2 to 5 years of age; however the following information is relevant to
the active ingredient, montelukast.
This medicine 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 this medicine may affect some patients' ability to
drive or operate machinery.
Montelukast 4 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 0.674 mg phenylalanine per 4 mg chewable tablet).
3. How to take Montelukast 4 mg chewable tablets
Always give this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
• 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 of Montelukast 4 mg chewable tablets 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.
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. This tablet should not be
taken immediately with food; it should be taken at least 1 hour before or 2 hours after food.
If your child is taking this medicine, be sure that he/she does not take any other medicines that
contain the same active ingredient, montelukast.
If your child takes more Montelukast 4 mg chewable tablets than he/she should
Contact your child's doctor immediately for advice. There were no side effects reported in the
majority of over dose reports. The most frequently occurring symptoms reported with over dose
in adults and children included abdominal pain, sleepiness, thirst, headache, vomiting, and
hyperactivity.
If you forget to give Montelukast 4 mg chewable tablets to your child
Try to give this medicine 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 4 mg chewable tablets
This medicine can treat your child's asthma only if your child continues taking it.
It is important for your child to continue taking these tablets 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.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
If your child experiences any of the following, stop giving the medicine and tell your doctor
immediately or go to the casualty department of your nearest hospital.
• Allergic reactions: If your child have allergic reactions, stop having this medicine and
see a doctor straight away. You may need urgent medical treatment. The signs may
include rashes, swelling of the face, lips, tongue, and/or throat which may cause difficulty
in breathing or swallowing.
• Behaviour and mood related changes: Suicidal thoughts and actions.
• Churg-Strauss syndrome: Symptoms include flu-like illness, pins and needles or
numbness of arms and legs, worsening of pulmonary symptoms and/or rash.

Other side effects
In clinical studies with Montelukast 4 mg chewable tablets, the commonly reported side effects
(occurring in at least 1 of 100 patients and less than 1in 10 paediatric patients treated) thought to
be related to this medicine 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).
Very common: may affect more than 1 in 10 people
• upper respiratory infection
Common: may affect up to 1 in 10 people
• diarrhea, nausea, vomiting
• changes in liver function test
• rash
• fever
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, seizure
• nose bleed
• 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
• tremor
• palpitations
Very rare: may affect up to 1 in 10,000 people
• hallucinations, disorientation
• hepatitis (inflammation of the liver)



tender red lumps under the skin most commonly on your shins (erythema nodosum),
severe skin reaction (erythema multiforme) that may occur without warning

Reporting of side effects
If your child gets any side effects, talk to your child's 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 4 mg chewable tablets
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the date which is stated on the 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.
6. Contents of the pack and other information
What Montelukast 4 mg chewable tablets contain



The active substance is montelukast. Each tablet contains montelukast sodium which
corresponds to 4 mg of montelukast.
The other ingredients are: Mannitol, microcrystalline cellulose, low substituted
hydroxypropyl cellulose, red iron oxide (E172), croscarmellose sodium, cherry flavour
(Flavourings, Maize Maltodextrin, Moisture), aspartame (E951), magnesium stearate.

What Montelukast 4 mg chewable tablets look like and contents of the pack
Montelukast 4 mg chewable tablets are Pink to red coloured, mottled, oval shaped, biconvex
tablet with“MT4” debossed on one side and plain on the otherside.
Blisters in package of 28 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Ranbaxy (UK) Limited
5th floor, Hyde Park, Hayes 3
11 Millington Road
Hayes, UB3 4AZ
United Kingdom

Manufacturers:
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
The Netherlands
Terapia SA
124 Fabricii Street
400 632 ClujNapoca
Romania
This leaflet was last revised in August 2016.

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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