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Active substance: MONTELUKAST SODIUM

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Montelukast 10 mg tablets
For adolescents and adults from 15 years
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 is and what it is used for
2. Before you take Montelukast
3. How to take Montelukast
4. Possible side effects
5. How to store Montelukast
6. Further information
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 improves asthma
symptoms, helps control asthma and improves seasonal allergy symptoms (also
known as hay fever or seasonal allergic rhinitis).
Your doctor has prescribed Montelukast to treat asthma, preventing asthma symptoms
during the day and night.
- Montelukast is used for the treatment of patients who are not adequately controlled
on their medication and need additional therapy.
- Montelukast also helps prevent the narrowing of airways triggered by exercise.
- In those asthmatic patients in whom Montelukast is indicated in asthma,
Montelukast can also provide symptomatic relief of seasonal allergic rhinitis.
Your doctor will determine how Montelukast 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 exercise.
- 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.
Tell your doctor about any medical problems or allergies you have now or have had.
Do not take Montelukast if you are
- allergic (hypersensitive) to montelukast or any of the other ingredients of
Montelukast (see section 6. Further information).
Take special care with Montelukast
If your asthma or breathing gets worse, tell your doctor immediately.
Montelukast is 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 or your child take all asthma medications prescribed by
your doctor. 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 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 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 works, or Montelukast may affect how
other medicines work. Please tell your doctor or pharmacist if you are taking or have
recently taken other medicines, including those obtained without a prescription. Tell
your doctor if you are 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)

Taking Montelukast with food and drink
Montelukast may be taken with or without food.
Pregnancy and breast-feeding
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
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 patients’ ability to drive or operate machinery.
Important information about some of the ingredients of Montelukast
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).


You should take only one tablet of Montelukast once a day as prescribed by your
It should be taken even when you have no symptoms or have an acute asthma
Always take Montelukast as your doctor has told you. You should check with
your doctor or pharmacist if you are not sure.
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 may be taken
with or without food.
If you are taking Montelukast, be sure that you do not take any other products that
contain the same active ingredient, montelukast.
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 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
Try to take Montelukast 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
Montelukast can treat your asthma only if you continue taking 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 product, ask your doctor or
Like all medicines, Montelukast can cause side effects, although not everybody gets
The frequency of possible side effects listed below is defined using the following
Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)
Rare (affects 1 to 10 users 10,000)
Very rare (affects less than 1 user in 10,000)
Not known (frequency cannot be estimated from the available data)
Common side effects:
In clinical studies the following side effects were reported:
- 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).
Additionally, while montelukast has been on the market, the following have been
• upper respiratory infection
• increased bleeding tendency
• allergic reactions including rash, swelling of the face, lips, tongue, and/or throat
which may cause difficulty in breathing or swallowing
• behaviour and mood related changes [dream abnormalities, including nightmares,
hallucinations, sleepwalking, irritability, feeling anxious, restlessness, agitation
including aggressive behaviour or hostility, tremor, depression, trouble sleeping,
suicidal thoughts and actions (in very rare cases)]
• dizziness, drowsiness, pins and needles/numbness, seizure

• palpitations
• nosebleed
• 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.
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
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.
Keep out of the reach and sight of children.
Do not use Montelukast 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
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help
to protect the environment.
What Montelukast contains

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 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:
UK/H/2392/001/DC 10, 14, 20, 28, 50, 56, 98, 100 tablets
UK/H/3718/001/DC 28, 56, 98 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Orion Corporation
Orionintie 1
FI-02200 Espoo
This medicinal product is authorised in the Member States of the EEA under the
following names:
UK – 10mg Montelukast tablets
This leaflet was last approved in {07/2012 }

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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.