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MONTELUKAST 10MG FILM-COATED TABLETS

Active substance(s): MONTELUKAST / MONTELUKAST SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER



Montelukast 10 mg film-coated tablets
For adults and adolescents from 15 years
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 is and what it is used for
2. What you need to know before you take
Montelukast
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

The active ingredient in Montelukast 10 mg tablets
is montelukast, which is a leukotriene receptor
antagonist. It blocks naturally occurring chemicals in
the lungs called leukotrienes which cause narrowing
of the airways and inflammation in the lungs, which
can lead to asthma symptoms. Leukotrienes also
contribute to the symptoms of allergy. Blocking
leukotrienes reduces the symptoms of seasonal
allergy (also known as seasonal allergic rhinitis or
hay fever).
Montelukast is used for the treatment of adult
patients and adolescents, aged 15 years and older
with asthma, who are not adequately controlled on
their asthma medications and need additional
therapy. For patients with asthma and seasonal
allergies, Montelukast also treats your seasonal
allergy symptoms.
Montelukast also helps prevent asthma symptoms in
adult patients and adolescents, aged 15 years and
older, which are triggered by exercise.
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, or cold air, or exercise.
• swelling (inflammation) in the lining of airways.
Symptoms of asthma include: Coughing,
wheezing, and chest tightness.
What are seasonal allergies?
Seasonal allergies (also known as hay fever or
seasonal allergic rhinitis) are an allergic response
often caused by airborne pollens from trees, grasses
and weeds. The symptoms of seasonal allergies
typically may include: stuffy, runny, itchy nose;
sneezing; watery, swollen, red, itchy eyes.

2. WHAT you need to know before
you take Montelukast
Tell your doctor about any medical problems or
allergies you have now or have had.
Do not take Montelukast:
• if you are allergic to montelukast or any of the
other ingredients of this medicine (listed in
section 6).

Warnings and precautions
It is important that you take the medicine as
prescribed by the doctor, even if you have no
symptoms or if you experience an asthma attack.

Oral Montelukast is NOT intended for the treatment
of a sudden attack of breathlessness. It will not help
you in this situation and should never be used for
this purpose. If an attack occurs, the instructions
that the doctor has given should be followed exactly.
It is very important to have the medication needed
for such an attack readily accessible at all times.
If you need to use your beta-agonist inhaler (also
known as a bronchodilator or reliever inhaler) more
often than usual, you should consult your doctor as
soon as possible.
Montelukast should not replace steroid medications
(whether inhaled or taken by mouth) that you may be
already using.
Patients with aspirin-sensitive asthma taking
Montelukast must continue to avoid taking aspirin or
other non-steroidal anti-inflammatory drugs.
A rare condition has been seen in a very small
number of patients taking asthma medications,
including montelukast, although montelukast has not
been shown to cause it. Seek medical attention
immediately if you experience a combination of any
of the following symptoms, particularly if they are
persistent or worsening:
• flu-like illness,
• increasing breathlessness,
• pins and needles or numbness of limbs, and/or
• rash.
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.
Other medicines and Montelukast
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. In
particular, tell your doctor if you are taking
phenobarbital or phenytoin (used for treatment of
epilepsy), rifampicin (used to treat tuberculosis and
some other infections) or gemfibrozil (used for
treatment of high lipid levels in plasma) because
they may affect the efficacy of Montelukast.
Montelukast may be used together with other
medicines that you may be taking for asthma.
Taking Montelukast with food
You may take the medicine with or without food.
Pregnancy and breast-feeding
Pregnancy
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.
Breast-feeding
It is not known whether montelukast is present in
human breast-milk. You should consult your doctor
before taking Montelukast if you are breast-feeding
a baby, or intend to breast-feed.
Driving and using machines
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 that have been reported very rarely with
Montelukast may affect some patients’ ability to drive
or operate machinery.
Montelukast contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor
before taking this medicine.

3. How to take Montelukast
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
Take Montelukast once a day by mouth in the evening,
with or without food, as instructed by your doctor.
The usual dose for adults and adolescents aged 15
years upwards is one 10 mg tablet daily.
It is important to continue taking Montelukast in the
presence or absence of symptoms, for as long as your
doctor prescribes it, in order to help maintain control
of your asthma. Montelukast can treat asthma only
with continued use.
Montelukast tablets should not be used together with
other products that contain the same active
ingredient, montelukast.
Use in children
Montelukast 10 mg tablets are not recommended for
use in children under 15 years of age.
If you take more Montelukast than you should
If you have taken more Montelukast than you should,
contact your doctor or pharmacist immediately.

behaviour or hostility, depression (Uncommon);
tremor (Rare); hallucination, disorientation, suicidal
thoughts and actions (Very rare)]
• dizziness, drowsiness, pins and needles/numbness,
seizure (Uncommon)
• palpitations (Rare)
• nosebleed (Uncommon)
• diarrhoea, nausea, vomiting (Common); dry mouth,
indigestion (Uncommon)
• hepatitis (inflammation of the liver) (Very rare)
• rash (Common); bruising, itching, hives (Uncommon);
tender red lumps under the skin most commonly on
your shins (erythema nodosum), severe skin reaction
(erythema multiforme), which may occur without
warning (Very rare)
• joint or muscle pain, muscle cramps (Uncommon)
• fever (Common); tiredness, feeling unwell, swelling
(Uncommon).
In asthmatic patients treated with montelukast, very
rare cases of 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 you get one or more
of these symptoms.
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 Yellow Card Scheme Website: www.mhra.
gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this
medicine.

In most cases, no side effects have been reported.
The most common symptoms that were reported
included the following: thirst, sleepiness, headache,
hyperactivity and abdominal pain.

5. HOW TO STORE Montelukast

If you forget to take Montelukast
If you forget to take a tablet, just carry on with the
next one as usual. Do not take an extra tablet to make
up, just resume the usual schedule of one tablet,
once daily.

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.

If you stop taking Montelukast
Montelukast can treat your asthma only if you
continue to take it.
It is important to continue taking Montelukast for as
long as your doctor prescribes. It will help control your
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.
In clinical studies with montelukast 10 mg film-coated
tablets, the most commonly reported side effects
(occurring in at least 1 of 100 patients and less than 1
of 10 patients treated) thought to be related to
montelukast were:
• abdominal pain
• headache
These were usually mild and occurred at a greater
frequency in patients treated with Montelukast than
placebo (a pill containing no medication).
The frequency of possible side effects listed below is
defined using the following convention:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Very rare: may affect up to 1 in 10,000 people
Additionally, while the medicine has been on the
market, the following have been reported:
• upper respiratory infection (very common)
• increased bleeding tendency (rare)
• allergic reactions including swelling of the face, lips,
tongue, and/or throat which may cause difficulty in
breathing or swallowing (uncommon)
• behaviour and mood related changes [dream
abnormalities, including nightmares, trouble
sleeping, sleep walking, irritability, feeling anxious,
restlessness, agitation including aggressive

Keep this medicine out of the sight and reach of
children.

Store in the original package in order to protect from
light.
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. FURTHER INFORMATION
What Montelukast contains
• The active substance is montelukast. Each

film-coated tablet contains 10 mg montelukast (as
montelukast sodium).
• The other ingredients are lactose monohydrate,
powdered cellulose, microcrystalline cellulose,
croscarmellose sodium and magnesium stearate in
the tablet core, and hypromellose, titanium dioxide
(E171), talc, propylene glycol, red iron oxide (E172)
and yellow iron oxide (E172) in the film coating.
What Montelukast looks like and contents of the
pack
The film-coated tablets are apricot-coloured, round,
slightly biconvex, with bevelled edges.
Boxes of 7, 10, 14, 20, 28, 30, 49, 50, 56, 84, 90,
98, 100, 140 or 200 film-coated tablets in blisters are
available.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501
Novo mesto, Slovenia
Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501
Novo mesto, Slovenia
KRKA Polska Sp. z o.o., ul. Równoległa 5, 02-235
Warsaw, Poland
TAD Pharma GmbH, Heinz-Lohmann-Straße 5,
27472 Cuxhaven, Germany
Distributed by:
Consilient Health (UK) Ltd, No.1 Church Road,
Richmond upon Thames, Surrey. TW9 2QE.
This leaflet was last revised 08/2014

P0295

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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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