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Active substance: MONTELUKAST SODIUM

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Package leaflet: Information for the user
Montelukast 10 mg tablets
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

What Montelukast tablets are and what they are used for
What you need to know before you take Montelukast tablets
How to take Montelukast tablets
Possible side effects
How to store Montelukast tablets
Contents of the pack and other information


What Montelukast tablets are and what they are used for

The full name of your medicine is Montelukast 10 mg tablets (referred to as Montelukast
tablets in the rest of this leaflet).
Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes.
Leukotrienes cause narrowing and swelling of airways in your lungs and also cause allergy
symptoms. By blocking leukotrienes, Montelukast tablets improve asthma symptoms, help
control asthma and improve seasonal allergy symptoms (also known as hay fever or seasonal
allergic rhinitis).
Your doctor has prescribed Montelukast tablets to treat asthma, preventing asthma symptoms
during the day and night.

Montelukast tablets are used for the treatment of patients who are not adequately
controlled on their medication and need additional therapy.
Montelukast tablets also help prevent the narrowing of airways triggered by exercise.
In those asthmatic patients in whom Montelukast tablets are indicated in asthma,
Montelukast tablets can also provide symptomatic relief of seasonal allergic rhinitis.

Your doctor will determine how Montelukast tablets should be used depending on the
symptoms and severity of your 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
swelling (inflammation) in the lining of the 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.

What you need to know before you take Montelukast tablets

Do not take Montelukast tablets
if you are 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 tablets

If your asthma or breathing gets worse, tell your doctor immediately.

Montelukast tablets are not meant to treat acute asthma attacks. If an attack occurs,
follow the instructions your doctor has given for you. Always have your inhaled rescue
medicine for asthma attacks with you.

It is important that you take all asthma medications prescribed by your doctor.
Montelukast tablets should not be used instead of other asthma medications your doctor
has prescribed for you.

Any patient on anti-asthma medicines should be aware that if you develop a
combination of symptoms such as a flu-like illness, pins and needles or numbness of
arms or legs, worsening of pulmonary (lung) symptoms, and/or rash, you should consult
your doctor.

You should not take acetyl-salicylic acid (aspirin) or anti-inflammatory medicines (also
known as non-steroidal anti-inflammatory drugs or NSAIDs) if they make your asthma
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 tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
Some medicines may affect how Montelukast tablets work, or Montelukast tablets may affect
how other medicines work.
Tell your doctor if you are taking the following medicines before starting Montelukast 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 tablets with food and drink
Montelukast tablets may be taken with or without food.
Pregnancy, breast-feeding and fertility
Women who are pregnant or intend to become pregnant should consult their doctor before
taking Montelukast tablets. Your doctor will assess whether you can take Montelukast tablets
during this time.
It is not known if Montelukast appears in breast milk. You should consult your doctor before
taking Montelukast tablets if you are breast-feeding or intend to breast-feed.
Driving and using machines
Montelukast tablets are 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 tablets may affect some
patient’s ability to drive or operate machinery.
Montelukast tablets contains aspartame
Montelukast tablets contain aspartame, a source of phenylalanine. May be harmful for
patients with phenylketonuria. If you have phenylketonuria (a rare, hereditary disorder of the
metabolism), you should take into account that each 10 mg tablet contains phenylalanine
(equivalent to 0.421 mg phenylalanine per 10 mg tablet).


How to take Montelukast tablets

Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.

You should take only one Montelukast tablet once a day as prescribed by your doctor.
It should be taken even when you have no symptoms or have an acute asthma attack.
To be taken by mouth. The tablet should be swallowed with a sufficient amount of fluid
(e.g. with a glass of water).

For adults 15 years of age and older:
One 10 mg tablet to be taken daily in the evening. Montelukast 10 mg tablets may be taken
with or without food.
If you are taking Montelukast tablets, be sure that you do not take any other products that
contain the same active ingredient, montelukast.
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.
If you take more Montelukast 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 tablets
Try to take Montelukast tablets as prescribed. However, if you miss 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 stop taking Montelukast tablets
Montelukast tablets can treat your asthma only if you continue taking them.
It is important to continue taking Montelukast tablets for as long as your doctor prescribes.
They will help control your asthma.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following serious side effects that have been reported with montelukast,
stop taking Montelukast tablets and contact a doctor immediately:
- sudden wheezing, swelling of lips, tongue and throat or body, rash, fainting or difficulties to
swallow (severe allergic reaction). This side effect is uncommon (may affect up to 1 in 100
- flu-like illness, pins and needles or numbness of arms and legs, worsening of pulmonary
symptoms and/or rash (Churg-Strauss syndrome). This side effect is very rare (may affect up to 1
in 10,000 people).

In clinical studies the most commonly (may affect up to 1 in 10 people) reported side effects

abdominal pain

These were usually mild and occurred at a greater frequency in patients treated with
montelukast than placebo (a pill containing no medication).
Additionally, while montelukast has been on the market, the following have been reported:
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
 rash
 fever
 elevated levels of serum transaminases (ALT, AST)
Uncommon side effects (may affect up to 1 in 100):

behaviour and mood related changes such as dream abnormalities, including nightmares, trouble
sleeping, sleepwalking, irritability, feeling anxious, restlessness, agitation including aggressive
behaviour or hostility, depression, increased motor activity (difficulty to stand still)
dizziness, drowsiness, pins and needles/numbness, seizure
dry mouth, indigestion
bruising, itching, hives
joint or muscle pain, muscle cramps
weakness/tiredness, feeling unwell, swelling

Rare side effects (may affect up to 1 in 1,000 people):
 increased bleeding tendency
 tremor
 palpitations
 swelling under the skin
Very rare side effects (may affect up to 1 in 10,000 people):
 hepatic problems (hepatic eosinophilic infiltration)
 hallucinations, disorientation, suicidal thoughts and actions
 hepatitis (inflammation of the liver)
 tender red lumps under the skin most commonly on your shins (erythema nodosum), severe skin
reactions (erythema multiforme) that may occure 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: By reporting side effects you can help provide
more information on the safety of this medicine.

How to store Montelukast tablets

Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after
EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special temperature storage conditions. Store in
the original package in order to protect from light and moisture
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer required. These measures will help to protect the


Contents of the pack and other information

What Montelukast tablets contain

The active substance is montelukast. Each tablet contains 10.4 mg montelukast sodium
which corresponds to 10 mg of montelukast.
The other ingredients are: mannitol (E421), cellulose microcrystalline, croscarmellose
sodium, magnesium stearate, aspartame (E951), cherry flavour (Firmenich CHERRY
501027 AP0551), irion oxide yellow (E172), iron oxide red (E172)

What Montelukast tablets looks like and contents of the pack
Montelukast 10 mg tablets are light brown coloured, round biconvex shaped, uncoated tablet,
with breakline on both sides.
Tablets are packed into Alu/Alu blisters. The blisters are packed into cartons.
Pack sizes of: 28, 56, 98 tablets
Marketing Authorisation Holder and Manufacturer
Orion Corporation
Orionintie 1
FI-02200 Espoo
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Heumann Pharma GmbH & Co. Generica KG
Südwestpark 50
90449 Nürnberg

This leaflet was last revised in 06/2015

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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.