MONTELUKAST SODIUM 4MG ORAL GRANULES

Active substance: MONTELUKAST SODIUM

View full screen / Print PDF » Download PDF ⇩

Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

SZ00000LT000

Montelukast Sodium 4 mg Oral Granules

Montelukast

For children 6 months to 5 years of age

Read all of this leaflet carefully before your child starts 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, please 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 childʼs.
• If your child gets any side effects, talk to your childʼs doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.

What is in this leaflet:
1. What Montelukast is and what it is used
for
2. What you need to know before
Montelukast is taken
3. How to take Montelukast
4. Possible side effects
5. How to store Montelukast
6. Contents of the pack and other
information

1

What Montelukast is and
what it is used for

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 childʼs asthma, preventing asthma
symptoms during the day and night.
• Montelukast is used for the treatment of
6 months to 5 year old patients who are
not adequately controlled on their
medication and need additional therapy.
• Montelukast 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.
• Montelukast also helps prevent the
narrowing of airways triggered by exercise
for patients 2 years of age and older.
Your doctor will determine how Montelukast
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 Montelukast is taken

Tell your doctor about any medical problems
or allergies your child has now or has had.
Do not give Montelukast to your child:
• if he/she is allergic (hypersensitive) 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:

• If your childʼs asthma or breathing gets
worse, tell your doctor immediately.
• Oral Montelukast 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
childʼs inhaled rescue medicine for asthma
attacks with you.
• It is important that your child take all
asthma medications prescribed by your
doctor. Montelukast 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
(acetyl-salicylic acid) or anti-inflammatory
medicines (also known as non-steroidal
anti-inflammatory drugs or NSAIDs) if they
make his/her asthma worse.
Other medicines and Montelukast:
Some medicines may affect how
Montelukast works, or Montelukast may
affect how your child's other medicines work.
Tell your doctor or pharmacist if your child is
taking, has recently taken or might take any
other medicines, including those obtained
without a prescription.

Tell your doctor if your child is taking the
following medicines before starting
Montelukast:
• phenobarbital (used for treatment of
epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and
some other infections)
Montelukast with food and drink
Montelukast can be taken with or without
food.

Pregnancy and breast-feeding:
This subsection is not applicable for
Montelukast since they are intended for use
in children 6 months 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 Montelukast. Your doctor will
assess whether you can take Montelukast
during this time.
Use in breast-feeding
It is not known if Montelukast appears in
breast milk. You should consult your doctor
before taking Montelukast if you are
breast-feeding or intend to breast-feed.

Driving and using machines:
This subsection is not applicable for
Montelukast since they are intended for use
in children 6 months 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 very rarely with Montelukast may
affect some patientsʼ ability to drive or
operate machinery.

3

How to take Montelukast

• This medicine is to be given to a child
under adult supervision. Your child should
take Montelukast every evening.
• It should be taken even when your child
has no symptoms or if he/she has an
acute asthma attack.
• Always have your child take this medicine
exactly as your doctor has told you. Check
with your childʼs doctor or pharmacist if
you are not sure.
• To be taken by mouth
The usual dose is:

For children 6 months to 5 years of age:
One sachet of Montelukast 4 mg Oral
Granules to be taken by mouth each
evening.
If your child is taking Montelukast, be sure
that your child does not take any other
products that contain the same active
ingredient, montelukast.
For children 6 months to 2 years old,
Montelukast granules are available.

For children 2 to 5 years old, Montelukast
4 mg chewable tablets and Montelukast
granules are available.

Montelukast granules are not recommended
for children below 6 months of age.

How should I give Montelukast to my
child?
• Do not open the sachet until ready to use.
• Montelukast can be given either:
- directly in the mouth;
- OR mixed with a spoonful of cold or
room temperature soft food (for
example, applesauce, ice cream,
carrots and rice).
• Mix all of the contents of Montelukast Oral
Granules into a spoonful of cold or room
temperature soft food, taking care to see
that the entire dose is mixed with the food.

Continued on the next page >>

• Be sure the child is given the entire
spoonful of the granule/food mixture
immediately (within 15 minutes).
IMPORTANT: Never store any
granule/food mixture for use at a later
time.
• Montelukast Oral Granules are not
intended to be dissolved in liquid.
However, your child may take liquids after
swallowing Montelukast.
• Montelukast can be taken without regard
to the timing of food intake.

If your child takes more Montelukast than
he/she should:
Contact your childʼs 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 give Montelukast to your
child:
Try to give Montelukast as prescribed.
However, if your child misses a dose, just
resume the usual schedule of one sachet
once daily.

Do not give a double dose to make up for a
forgotten dose.

If your child stops taking Montelukast:
Montelukast can treat your childʼs 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 childʼs
asthma.
If you have any further questions on the use
of this medicine, ask your childʼs doctor or
pharmacist.

4

Possible side effects

Like all medicines, this medicine can cause
side effects, although not everybody gets
them.

In clinical studies with Montelukast, the most
commonly reported side effects (may affect
up to 1 in 10 people) thought to be related to
Montelukast were:
• diarrhoea
• hyperactivity
• asthma
• scaly and itchy skin
• rash
Additionally, the following side effects were
reported in clinical studies with either
montelukast 10 mg film-coated tablets, 5 mg
or 4 mg chewable tablets:
• abdominal pain
• headache
• thirst
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:
Talk to a doctor straight away if you
notice any of the following serious side
effects - you may need urgent medical
treatment:

Uncommon side effects (may affect up to 1
in 100 people):
• allergic reactions including rash, swelling
of the face, lips, tongue, and/or throat
which may cause difficulty in breathing or
swallowing

Very rare side effects (may affect up to 1 in
10,000 people):
• suicidal thoughts and actions. Warning
signs are e.g. talking about suicide,
withdrawing from social contact and
wanting to be left alone or feeling trapped
or hopeless about a situation
• yellowing of the skin and eyes, unusual
tiredness or fever, dark coloured urine
caused by inflammation of the liver
(hepatitis)
• a combination of symptoms such as
flu-like illness, pins and needles or
numbness of arms and legs, worsening of
pulmonary symptoms and/or rash
(Churg-Strauss syndrome) have been
reported. You must tell your doctor right
away if your child gets one or more of
these symptoms.
• severe skin reactions (erythema
multiforme) that may occur without
warning.
Other possible side effects








walking, irritability, feeling anxious,
restlessness, agitation including
aggressive behaviour or hostility,
depression)
dizziness, drowsiness, pins and
needles/numbness, seizure
nosebleed
dry mouth, indigestion
bruising, itching, hives
joint or muscle pain, muscle cramps
tiredness, feeling unwell, swelling

Rare side effects (may affect up to 1 in 1,000
people):
• increased bleeding tendency
• tremor
• palpitations
Very rare side effects (may affect up to 1 in
10,000 people):
• hallucinations
• tender red lumps under the skin most
commonly on your shins (erythema
nodosum)

Ask your doctor or pharmacist for more
information about side effects. If your child
gets any side effects, talk to your childʼs
doctor or pharmacist. This includes any
possible side effects not listed in this leaflet.

5

How to store Montelukast

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 label carton and
the sachet 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
to protect the environment.

6

Contents of the pack and
other information

What Montelukast Sodium 4 mg Oral
Granules contains
• The active substance is: montelukast.
Each sachet of granules contains
montelukast sodium which corresponds to
4 mg of montelukast.
• The other ingredients are: mannitol,
hydroxypropyl cellulose and magnesium
stearate.
What Montelukast Sodium 4 mg Oral
Granules looks like and contents of the
pack
Montelukast Oral Granules are white to off
white granules.
Montelukast Oral Granules are packed in
PET/ Al/ PE sachets.

Available in packs of 7, 10, 14, 20, 28, 30
and 100 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.

Manufacturer
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1, 39179 Barleben,
Germany or
Salutas Pharma GmbH,
Dieselstrasse 5, 70839 Gerlingen,
Germany or
Lek Pharmaceuticals d.d.,
Verovškova 57, 1526 Ljubljana,
Slovenia or

Lek S.A.,
Domaniewska 50 C, 02-672 Warszawa,
Poland or

S.C. Sandoz,
S.R.L. Livezeni Street no 7A, Targu Mures,
Romania or
Lek Pharmaceuticals d.d.,
Trimlini 2D, 9220 Lendava,
Slovenia or

LEK S.A.,
ul. Podlipie 16, I 95-01 0 Strykow,
Poland.

This leaflet was last revised in 10/2012.

Very common side effects (may affect more
than 1 in 10 people):
• upper respiratory infection
Common side effects (may affect up to 1 in
10 people):
• diarrhoea, nausea, vomiting
• abnormal liver function test results
• rash
• fever

Uncommon side effects (may affect up to 1
in 100 people):
• behaviour and mood related changes
(dream abnormalities, including
nightmares, trouble sleeping, sleep

SZ00000LT000

Expand view ⇕

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.

Hide
(web1)