MONTELUKAST RANBAXY 5 MG CHEWABLE TABLETS

Active substance: MONTELUKAST SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Montelukast
5 mg chewable tablets
Montelukast

Read all of this leaflet carefully before you
start taking this medicine.
- 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.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as
yours.
- If any of the side effects gets serious, or if you
notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Montelukast 5 mg chewable tablets
are and what they are used for
2. 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. Further information
1. W H A T M O N T E L U K A S T 5 M G
CHEWABLE TABLETS ARE AND WHAT
THEYARE 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. 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 (hypersensitive) to montelukast or
any of the other ingredients of Montelukast 5
mg chewable tablets (see 6. Further
information).
Take special care with 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
anti-inflammatory drugs or NSAIDs) if they
make your asthma worse.

Use in children
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.
Taking 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.
Please tell your doctor or pharmacist if you or
your child is taking or has recently taken other
medicines, including those obtained without a
prescription.
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)
Taking 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 and breast-feeding
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 very
rarely with Montelukast 5 mg chewable tablets
may affect some patient’s ability to drive or
operate machinery.
Important information about some of the
ingredients of Montelukast 5 mg chewable
tablets
Montelukast 5 mg chewable tablets contain
aspartame, 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





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.
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 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.

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:
• upper respiratory infection
• increased bleeding tendency
• dizziness, drowsiness, pins and
needles/numbness,
• seizure
• palpitations
• nose bleed
• diarrhoea, dry mouth, indigestion, nausea,
vomiting
• hepatitis (inflammation of the liver)
• bruising, itching, hives, tender red lumps
under the skin most commonly on your
shins (erythema nodosum),
• joint or muscle pain, muscle cramps
• tiredness, feeling unwell, swelling, fever
Ask your doctor or pharmacist for more
information about side effects. If any of the side
effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your
doctor or pharmacist.
5. HOW TO STORE MONTELUKAST 5 MG
CHEWABLE TABLETS

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.

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

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. You
must tell your doctor right away if your child gets
one or more of these symptoms.
• 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:
The symptoms include dream
abnormalities, including nightmares,
hallucinations, irritability, feeling anxious,
restlessness, agitation including aggressive
behaviour or hostility, tremor, depression,
trouble sleeping, sleep walking,suicidal
thoughts and actions (in very rare cases)
· Churg-Strauss syndrome: Symptoms
include flu-like illness, pins and needles or
numbness of arms and legs, worsening of
pulmonary symptoms and/or rash (in very
rare cases).
In clinical studies with Montelukast 5 mg
chewable tablets, the most 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



Keep out of the reach and sight of children.
Do not use this medicine after the date
shown by the six numbers following EXP on
the blister. The first two numbers indicate
the month; the last four numbers indicate
the year. This medicine expires at the end of
the month shown.
Store in the original package in order to
protect from light and moisture.
Medicines should not be disposed of via
waste water or household waste. Ask your
pharmacist how to dispose of medicines no
longer required. These measures will help
to protect the environment.

6. FURTHER INFORMATION

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.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Ranbaxy UK Ltd
Building 4 Chiswick Park,
566 Chiswick High road
London W4 5YE
UK
Manufacturers:
Ranbaxy Ireland Ltd.
Spafield, Cork Road
Cashel
Co. Tipperary
Ireland
Terapia SA
124 Fabricii Street
400 632 Cluj Napoca
Romania
This leaflet was last approved in August
2012.

Point Size : 9.3 Pt.

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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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