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MONTELUKAST GEDEON RICHTER 10MG FILM-COATED TABLETS

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Package leaflet: Information for the user
10 mg film coated tablets
montelukast
Read all of this leaflet carefully before taking this medicine because it contains important
information for you.
Keep this leaflet. You may need to read it again. 10 mg film
coated tablets will be referred to as throughout this leaflet.
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 possible 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.
2.
3.
4.
5.
6.

What is and what it is used for
What you need to know before you take
How to take
Possible side effects
How to store
Contents of the pack and other information

1.

What is and what it is used for

The active ingredient of this medicine is called montelukast. It blocks naturally occurring compounds in
the lungs called leukotrienes. These compounds cause narrowing and swelling of the airways and
inflammation in the lungs which can lead to asthma symptoms such as cough and wheeze. By blocking
leukotrienes, improves asthma symptoms, helps control asthma and
improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis).
Your doctor has prescribed to treat asthma, preventing your asthma
symptoms during the day and night.
is used for the treatment of patients who are not adequately
controlled on their medication and need additional therapy.
also helps prevent the narrowing of airways triggered by
exercise.
In those asthmatic patients in whom is indicated in asthma,
can also provide symptomatic relief of seasonal allergic rhinitis.
Your doctor will determine how should be used depending on the
symptoms and severity of your asthma.
What is asthma?
Asthma is a long term disease.
Characteristics of asthma include:
- 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

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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 use

Do not take
if you are allergic to montelukast or any of the other ingredients of this medicine (listed in section
6).
Warnings and precautions
Talk to your doctor before taking .
If you have now or have ever had any medical problems or allergies.
If your asthma or breathing get 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 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 aspirin or anti-inflammatory medicines (also known as non-steroidal antiinflammatory drugs or NSAIDs) if they make your asthma worse.
Montelukast should not be substituted for inhaled or oral corticosteroids.
Children and adolescents
10 mg film-coated tablets are not recommended for use in children
and adolescents under the age of 15. 5 mg chewable tablets are available for paediatric patients 6 to 14
years of age. 4 mg chewable tablets are available for children 2 to 5 years of age.
Other medicines and
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Some medicines may affect how works, or Richter> may affect how other medicines work.
Tell your doctor if you are taking the following medicines before starting Richter>:
phenobarbital (used for treatment of epilepsy)
phenytoin (used for treatment of epilepsy)
rifampicin (used to treat tuberculosis and some other infections)
gemfibrozil (used for the treatment of high lipid levels in plasma)
any other products that contain the same active ingredient, montelukast.
with food and drink
Montelukast 10 mg may be taken with or without food.
Pregnancy and breast-feeding
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.

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Women who are pregnant or intend to become pregnant should consult their doctor before taking
. Your doctor will assess whether you can take Richter> during this time.
It is not known if appears in breast milk. You should consult your
doctor before taking if you are breast-feeding or intend to breast-feed.
Driving and using machines
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 may
affect some patients’ ability to drive or operate machinery.
contains lactose
10 mg 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.

3.

How to take

Always use 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 tablet of once a day as prescribed by your
doctor.
It should be taken even when you have no symptoms or have an acute asthma attack.
For adults and adolescents aged 15 years and older:
One 10 mg tablet to be taken by mouthdaily in the evening. 10 mg may
be taken with or without food.
Use in children and adolescents
10 mg film-coated are available for adults and adolescents 15 years of age and older.
5 mg chewable tablets are available for paediatric patients 6 to 14 years of age.
4 mg chewable tablets are available for children 2 to 5 years of age.
If you are taking , be sure that you do not take any other products that
contain the same active ingredient, montelukast.
If you take more 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
Try to take 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
can treat your asthma only if you continue to take it.
It is important to continue taking for as long as your doctor prescribes.
It will help control your asthma.

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If you have any further questions on the use of this product, 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 (occurring in 1 or
more of 100 patients and less than 1 of 10 patients treated) 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).
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 more than 1 in 100 people)
Rare (may affect more than 1 in 1000 people)

Very rare (may affect more than 1 in 10,000 people)
Additionally, while the medicine has been on the market, the following have been reported:
Very common:
upper respiratory infection
Common:
nausea, vomiting, diarrhoea
rash
fever
Uncommon:
allergic reactions including 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, trouble
sleeping, sleep walking], irritability, feeling anxious, restlessness, agitation including aggressive
behaviour or hostility, depression
dizziness, drowsiness, pins and needles/numbness, seizure
joint or muscle pain, muscle cramps
dry mouth, indigestion
nosebleed
bruising, itching, hives
weakness/tiredness, feeling unwell, swelling
Rare:
tremor, disturbance in attention, memory impairment
palpitations
increased bleeding tendency
Very rare:
hallucinations, disorientation, suicidal thoughts and actions
hepatitis (inflammation of the liver)
tender red lumps under the skin most commonly on the shins (erythema nodosum), severe skin
reactions (erythema multiforme) that may occur without warning
In asthmatic patients treated with montelukast, very rare cases of a combination of symptoms

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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 the national reporting system
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.
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

Keep out of the reach and sight of children.
Do not use “Montelukast Gedeon Richter” after the expiry date which is stated on the carton and the
blister after EXP:.
The expiry date refers to the last day of that month.
Store below 25°C. Store in the original package in order to protect from moisture and light.
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.

Contents of the pack and other information

What contains
The active substance is montelukast.
Each film-coated tablet contains 10 mg of montelukast equivalent to 10.4 mg montelukast sodium.
The other ingredients are:
Lactose monohydrate, cellulose microcrystalline , hydroxypropylcellulose, croscarmellose sodium,
magnesium stearate (E572).
Coat (Opadry Yellow 20B32427): hypromellose, hydroxypropylcellulose, titanium dioxide (E171),
macrogol 400, iron oxide yellow (E172)

What looks like and contents of the pack
Yellow, round, biconvex, with “R15” engraving on one side.
Blister: OPA-Al-PVC/Al blister
Pack sizes: 20x, 28x, 30x, 50x, 98x, 100x tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Gedeon Richter Plc.
1103 Budapest, Gyömrői út 19-21
Hungary
Manufacturer
GEDEON RICHTER POLSKA Sp. z o.o.
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Poland

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This medicinal product is authorised in the Member States of the EEA under the following
names:
Belgium: Montelukast Apotex
France: Montelukast Gedeon Richter
Germany: Montelukast Gedeon Richter
Hungary: Montelukast Gedeon Richter
Italy: Montelukast Gedeon Richter
United Kingdom: Montelukast Gedeon Richter
This leaflet was last revised in {12/2013}.

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Expand Transcript

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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