Package leaflet: Information for the user montelukast cinfa 10 mg film-coated tablets

Montelukast

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

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 30°C.

•    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. 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. Poligono Industrial Areta. 31620 Huarte-Pamplona (Navarra) Espana.

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos - Madrid (ESPANA)

This package leaflet was last revised in February 2012