MONTELUKAST 10 MG FILM-COATED TABLETS

Active substance: MONTELUKAST SODIUM

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Montelukast 10mg film-coated tablets
Montelukast
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, please 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

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 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 your 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 the 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. 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 (hypersensitive) to montelukast or any of the other ingredients of Montelukast (see 6. Further information).
Take special care with Montelukast
• If your 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.
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. Montelukast should not be substituted for 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 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-salicilic acid (aspirin) or anti-inflammatory medicines (also known as non-steroidal anti-inflammatory drugs or
NSAIDs) if they make your asthma worse.
• If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Use in children
Montelukast 10mg film-coated tablets are not recommended for use in children and adolescents under the age of 15.
For children 2 to 5 years old, Montelukast 4mg chewable tablets are available.
For children 6 to 14 years old, Montelukast 5mg 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 10mg 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 10mg film-coated tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.
Montelukast contains soya oil. If you are allergic to soya or peanut, do not use this medicinal product.

3. How to take Montelukast
• You should take only one tablet of Montelukast once a day as prescribed by your doctor.
• It should be taken even when you have no symptoms or have an acute asthma attack.
• 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
For adults 15 years of age and older:
One 10 mg tablet to be taken daily in the evening. Montelukast 10mg 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.
If you take more Montelukast than you should
Contact your doctor immediately for advice.
There were no side effects reported in the majority of overdosage reports. The most frequently occurring symptoms reported with overdosage
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 give a double dose to make up for a forgotten dose.
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 product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Montelukast can cause side effects, although not everybody gets them.
In clinical studies with Montelukast 10mg film-coated tablets, the most commonly (in more than 1 in 100, or less than 1 in 10 treated patients)
reported side effects 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).
Additionally, while the drug has been on the market, the following have been reported:
• increased bleeding tendency, epistaxis
• 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, irritation, feeling anxious, restlessness,
agitation including aggressive behaviour, 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
• 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 symptoms.
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
• 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 wastewater 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 contains
• The active substance is: montelukast
Each tablet contains 10.4mg montelukast sodium which corresponds to 10mg of montelukast.
• The other ingredients are:
Tablet core: Microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, hydroxypropyl cellulose and magnesium stearate.
Film coating: Polyvinyl alcohol, titanium dioxide, talc, iron oxide red, iron oxide black, iron oxide yellow, lecithin and xanthan gum.
What Montelukast looks like and contents of the pack
Montelukast 10mg tablets are beige, round, biconvex, film-coated tablets.
In packs of: 10, 14, 28, tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Pharmathen SA
6 Dervenakion street
Pallini Attiki, 15351
Greece
Distributed by:
Aspire Pharma Limited
Antrobus House Business Centre
18 College Street
Petersfield
Hampshire
GU31 4AD
United Kingdom
This leaflet was last revised in 03/2012

1010088/P1.3

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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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