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MONTELUKAST RANBAXY 5 MG CHEWABLE TABLETS

Active substance(s): MONTELUKAST SODIUM

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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 5 mg chewable tablets are
and what they are used for
2. What you need to know before you take
Montelukast 5 mg chewable tablets
3. How to take Montelukast 5 mg chewable
tablets
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
are and what they are used for
Montelukast 5 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
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 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.
 This medicine also helps prevent the
narrowing of airways triggered by exercise.
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 5 mg chewable tablets
Tell your doctor about any medical problems or
allergies you or your child has now or has had.
Do not take Montelukast 5 mg chewable
tablets if you or 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 doctor or pharmacist before taking
Montelukast 5 mg chewable tablets
 If you or 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 or your

child. Always have your inhaled rescue
medicine for asthma attacks with you.
 It is important that you or 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 you or your child.
 Any patient on anti-asthma medicines should
be aware that if you develop 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.
 You or your child should not take aspirin
(acetylsalicylic acid) or anti-inflammatory
medicines (also known as non-steroidal antiinflammatory drugs or NSAIDs) if they make
your 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.
Other medicines and Montelukast 5 mg
chewable tablets
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
Some medicines may affect how Montelukast 5
mg chewable tablets work, or Montelukast 5 mg
chewable tablets may affect how other
medicines work.
Tell your doctor if you or your child is taking the
following medicines before starting Montelukast
5mg 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 5 mg chewable tablets with food
and drink
These tablets 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
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.
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 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
Montelukast 5 mg chewable tablets 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 this tablet contains phenylalanine
(equivalent to 0.842 mg phenylalanine per 5 mg
chewable tablet).
3. How to take Montelukast 5 mg chewable
tablets
Always take this medicine exactly as your doctor
or pharmacist has told you. Check with your

[5105625] - LIT. MONTELUKAST 5MG CHEWABLE TABS,
MARKET : UK, SIZE : 140X400MM,
RLL-DWS: 05.12.13vs, 09.10.13vs, 08.10.13VS (98482)

For children 6 to 14 years of age:
One Montelukast 5 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 you or your child is taking this medicine, be
sure that you or your child does not take any
other products that contain the same active
ingredient, montelukast.
If you or your child takes more Montelukast 5
mg chewable tablets than you should
Contact your 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 take Montelukast 5 mg
chewable tablets or give Montelukast 5 mg
chewable tablets to your child
Try to take this medicine as prescribed.
However, if you or your child misses a dose, just
resume the usual schedule of one tablet once
daily.
Do not take a double dose to make up for a
forgotten dose.
If you or your child stops taking Montelukast
5 mg chewable tablets
This medicine can treat you or your child's
asthma only if you or your child continues to take
it.
It is important to continue taking these tablets for
as long as your doctor prescribes. It will help
control you or your child's asthma.
If you have any further questions on the use of
this medicine, ask your 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 you experience any of the following, stop
taking 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 5 mg
chewable tablets, the commonly reported side
effects (occurring in at least 1 of 100 patients
and less than 1of 10 paediatric patients treated)
thought to be related to these medicines were:
 headache
Additionally, the following side effect was
reported in clinical studies with Montelukast 10
mg film coated tablets:
 abdominal pain
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 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 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 5 mg chewable tablets
contain
The active substance is montelukast. Each
tablet contains montelukast sodium which
corresponds to 5 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 5 mg chewable tablets
look like and contents of the pack
Montelukast 5 mg chewable tablets are Pink to
red coloured, mottled, round, biconvex tablet
with "MT5"debossed on one side and plain on
the other side.
Blisters in packages of 28, 30 or 50 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Ranbaxy UK Ltd
Building 4 Chiswick Park,
566 Chiswick High Road
London, W4 5YE
United Kingdom
Manufacturers:
Ranbaxy Ireland Ltd
Spafield, Cork Road
Cashel
Co. Tipperary
Ireland
Terapia SA
124 Fabricii Street
400 632 ClujNapoca
Romania
This leaflet was last revised in December 2013.
5105625

doctor or pharmacist if you are not sure.
 You or your child should take only one tablet of
Montelukast 5 mg chewable tablets once a
day as prescribed by your doctor.
 It should be taken even when you or your child
has no symptoms or has an acute asthma
attack.
 To be taken by mouth

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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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