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MONTELUKAST CINFA 10MG FILM-COATED TABLETS

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Package leaflet: Information for the user
montelukast cinfa 10 mg film-coated tablets
Montelukast
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, please 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.

What is in this leaflet:
1. What montelukast cinfa is and what it is used for
2. What you need to know before you take montelukast cinfa
3. How to take montelukast cinfa
4. Possible side effects
5. How to store montelukast cinfa
6. Contents of the pack and other information
1. What montelukast cinfa is and what it is used for
montelukast cinfa is a leukotriene receptor antagonist that blocks substances called leukotrienes.
Leukotrienes cause narrowing and swelling of airways in the lungs and also cause allergy
symptoms. By blocking leukotrienes, montelukast 10 mg 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 cinfa to treat asthma, preventing your asthma symptoms
during the day and night.
• montelukast cinfa is used for the treatment of patients who are not adequately controlled on their
medication and need additional therapy.
• montelukast cinfa also helps prevent the narrowing of airways triggered by exercise.
• In those asthmatic patients in whom montelukast cinfa is indicated in asthma, montelukast cinfa
can also provide symptomatic relief of seasonal allergic rhinitis.
Your doctor will determine how montelukast cinfa 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.

2. What you need to know before you take montelukast cinfa
Tell your doctor about any medical problems or allergies you have now or have had.
If you have been told by your doctor that you have an intolerance to some sugars, contact your
doctor before taking this medicinal product.
Do not take montelukast cinfa
• if you are allergic (hypersensitive) to montelukast or any of the other ingredients of montelukast
cinfa (see 6.1 For further information).
Warnings and precautions
• Talk to your doctor or pharmacist before taking montelukast cinfa.
• If your asthma or breathing gets worse, tell your doctor immediately.
• Oral montelukast cinfa 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 cinfa 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 acetyl-salicylic acid (aspirin) or anti-inflammatory medicines (also known as
non-steroidal anti-inflammatory drugs or NSAIDs) if they make your asthma worse.
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 cinfa
Some medicines may affect how montelukast cinfa works, or montelukast cinfa may affect how
other medicines work.
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other
medicines.
Tell your doctor if you are taking the following medicines before starting montelukast cinfa:
• phenobarbital (used for treatment of epilepsy)
• phenytoin (used for treatment of epilepsy)
• rifampicin (used to treat tuberculosis and some other infections)
Montelukast cinfa with food and drink
montelukast cinfa 10 mg 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 cinfa. Your doctor will assess whether you can take montelukast cinfa during this time.
Use in breast-feeding
It is not known if montelukast cinfa appears in breast milk. You should consult your doctor before
taking montelukast cinfa if you are breast-feeding or intend to breast-feed.
Driving and using machines
montelukast cinfa 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 cinfa may affect some patients’
ability to drive or operate machinery.
Montelukast cinfa contains
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 montelukast cinfa
• You should take only one tablet of montelukast cinfa 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 cinfa 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 cinfa 10 mg may be taken with or without food.
If you are taking montelukast cinfa, be sure that you do not take any other products that contain the
same active ingredient, montelukast.
If you take more montelukast cinfa 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 cinfa
Try to take montelukast cinfa 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 cinfa
montelukast cinfa can treat your asthma only if you continue to take it.
It is important to continue taking montelukast cinfa 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

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical studies with montelukast cinfa 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 cinfa were:
• Abdominal pain.
• Headache.
These were usually mild and occurred at a greater frequency in patients treated with montelukast
cinfa than placebo (a pill containing no medication).
Additionally, while the medicine has been on the market, the following have been reported:
• 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,
irritability, feeling anxious, restlessness, agitation including aggressive behaviour or hostility,
tremor, depression, trouble sleeping, sleep walking, 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 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 cinfa
• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated 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.
• Do not store above 30ºC.
• Store in the original package in order to protect from light and moisture.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how
to throw away medicines no longer use. These measures will help to protect the environment.
6. Further information
6. Contents of the pack and other information

What montelukast cinfa contains
• The active substance is: montelukast. Each tablet contains montelukast sodium which corresponds
to 10 mg of montelukast.
• The other ingredients are: Microcrystalline cellulose, Lactose monohydrate, Sodium starch
glycolate, Low-substituted Hydroxypropyl-cellulose (E-463), Hydroxypropylcellulose and
Magnesium stearate.
Film coating:
Hypromellose, Macrogol 6000, Titanium dioxide (E 171), Talc, Red and yellow iron oxide (E
172).
What montelukast cinfa looks like and contents of the pack
montelukast cinfa 10 mg film-coated tablets are Cream-colored rounded biconvex and engraved
film-coated tablets.

Blisters in packages of 1, 14, 20,28, 30, 50, 84 and 100 tablets.
Not all pack sizes will be marketed
Marketing Authorisation Holder
LABORATORIOS CINFA, S.A.
Ctra. Olaz-Chipi, 10.
31620 Huarte-Pamplona (Navarra) Spain.
Manufacturers
LABORATORIOS CINFA, S.A.
C/ Olaz-Chipi, 10. Polígono Industrial Areta.
31620 Huarte-Pamplona (Navarra) España.
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6
28760 Tres Cantos – Madrid (ESPAÑA)

This package leaflet was last revised in February 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.

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