EPHYRA 10 mg. 28 tablets

What is EPHYRA 10 mg tablets is and what it is used
EPHYRA10 mg film-coated tablet is a leukotriene receptor antagonist that blocks substances called leukotrienes. They cause narrowing and swelling of airways in the lungs and also cause symptoms of asthma. By blocking leukotrienes, Montelukast 10 mg film-coated tablets improves asthma symptoms, helps control asthma and helps to improve the symptoms of seasonal allergies (also known as seasonal allergic rhinitis or hay fever).
Your doctor has prescribed EPHYRA 10 mg film-coated tablets to treat your asthma to prevent asthma symptoms during the day and night.
EPHYRA 10 mg film-coated tablets are used to treat patients aged 15 and over in which medicated asthma control was not adequate and need additional therapy.
For patients with asthma and seasonal allergies, Montelukast 10 mg film-coated tablets and treat your seasonal allergy symptoms.
Air 10 mg tablets helps prevent symptoms of asthma during exercise in patients and over 15 years of age.

What is asthma?
Asthma is a long-term illness.

Asthma includes:
difficulty breathing due to narrowing of the airways. This narrowing of airways worsens and improves depending on various conditions;
sensitivity of the airways to many factors such as cigarette smoke, pollen, cold air or exercise;
swelling (inflammation) in the course of the respiratory tract.
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 pollen found in the air by trees, grasses and weeds. Typical symptoms of seasonal allergies include: stuffy, runny, itchy nose, wheezing; watery, swollen, red and itchy eyes.

2. What you need to know before taking Montelukast 10 mg film-coated tablets
Do not take Montelukast 10 mg film-coated tablets:
if you are allergic to the active substance montelukast sodium or any of the other ingredients of this medicine (listed in section 6).
Warning and Precautions
Talk to your doctor or pharmacist before taking Montelukast 10 mg film-coated tablets.
It is important EPHYRA 10 mg film-coated tablets to be taken daily in the evening, exactly as prescribed by your doctor, even when you do not get symptoms or an asthma attack;
Oral tablets of 10 mg Montelukast are not intended to treat a sudden attack of breathlessness. They will not help in this situation and should never be used for such purpose. If an asthma attack, you should carefully follow given to you by your doctor. Of particular importance is always to have the drugs needed to tackle such attacks. Always keep with you inhaled rescue medicine for asthma for your child;
If you need inhaled (β-agonist more often than usual, you should consult your doctor as soon as possible;
It is important to use all prescribed by your doctor asthma medications as directed. Montelukast 10 mg film-coated tablets does not replace steroid medications (whether inhaled or oral), which you may already use;
Patients with aspirin asthma taking Montelukast 10 mg film-coated tablets should continue to avoid taking aspirin or other NSAIDs;
If you are taking antiasthmatic medications, including montelukast may receive a combination of symptoms such as flu-like feeling, shortness of breath, tingling and / or rash - you should consult with your doctor.
Montelukast 10 mg film-coated tablets are not recommended for use in children and adolescents under 15 years of age.

Other medicines and EPHYRA 10 mg film-coated tablets
Montelukast 10 mg film-coated tablets can be used together with other medicines that you may already be taking for asthma. However, some medications may interact with Montelukast 10 mg film-coated tablets or Montelukast 10 mg film-coated tablets can change their action.

Tell your doctor or pharmacist if you are taking, you have recently taken or might take any other medicines. This is particularly important if these other drugs are:
phenobarbital (used for the treatment of epilepsy);
phenytoin (used for the treatment of epilepsy);
rifampicin (used to treat tuberculosis and some other infections).
Montelukast 10 mg film-coated tablets with food and drink
Montelukast 10 mg film-coated tablets can be taken in the evening with or without food.

Pregnancy, lactation and fertility
Pregnancy: pregnant women, women planning pregnancy or think they might be pregnant should consult their doctor before taking Montelukast 10 mg film-coated tablets.
Breast-feeding is not known whether Montelukast 10 mg film-coated tablets are located in the stern. Physicians should counsel breastfeeding women and women who plan to breastfeed before taking Montelukast 10 mg film-coated tablets.

Ask your doctor or pharmacist before taking any medicine.

Driving and using machines
Not expected Montelukast 10 mg film-coated tablets to change your ability to drive or operate machinery. However, individual response to the drug may vary. For montelukast reported some side effects (such as dizziness and drowsiness) that can change some patients' ability to drive or operate machinery.

Montelukast 10 mg film-coated tablets contain lactose
Montelukast 10 mg film-coated tablets contain lactose. If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take EPHYRA 10 mg film-coated tablets
Always take this medicine exactly as you have been told your doctor or pharmacist, even if you do not get symptoms or an asthma attack. If you're not sure, ask your doctor or pharmacist.
The recommended dose for adults and adolescents aged 15 and over is one 10 mg tablet daily in the evening.
Air 10 mg tablets should not be used concomitantly with other medicinal products containing the same active ingredient montelukast.

If you take a large dose of EPHYRA 10 mg film-coated tablets required
It is important not to take too many tablets. If you take too many tablets, or you think a child has swallowed any of the tablets, contact the nearest hospital or emergency room or call your doctor for advice. Symptoms of overdose include abdominal pain, drowsiness, thirst, vomiting and hyperactivity disorder (uncontrolled movements).
Take this leaflet and other tablets with you to show the doctor.

If you forget to take EPHYRA 10 mg film-coated tablets
If you forget to take a tablet, just proceed to the next as usual. Do not take a double dose to make up the missed dose.

If you stop taking Montelukast 10 mg film-coated tablets
It is important to continue taking Montelukast 10 mg film-coated tablets regardless of the presence or absence of symptoms for so long as your doctor prescribes to help control your asthma. Air 10 mg tablets can treat asthma only with continued use.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

For children aged 2 to 5 years is available Montelukast 4 mg chewable tablets.
For children aged 2 to 5 years who have a problem with taking the chewable form is available from 4 mg granules.
For children aged 6 to 14 years is available Montelukast 5 mg chewable tablets.

4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

In clinical studies with montelukast, the most commonly reported side effects (may affect up to 1 in 10 people), mentally linked to montelukast:
abdominal pain;
headache.
Additionally, post-marketing drug, these side effects have been reported:

Very common (may affect more than 1 in 10 people):
infections of the upper respiratory tract.
Common (may affect up to 1 in 10 people):
diarrhea, nausea, vomiting;
fever;
rash;
increased liver enzymes.
Uncommon (may affect up to 1 in 100 people):
allergic reactions including rash, swelling of face, lips, tongue and / or throat that may cause difficulty in breathing or swallowing;
changes in behavior and related mood changes, unusual dreams, including nightmares, trouble sleeping, walking in his sleep, irritability, anxiety, restlessness, agitation including aggressive behavior or hostility, depression, dizziness, drowsiness, numbness and tingling / belief seizures;
nosebleeds;
dry mouth, indigestion;
bruising, itching, hives;
joint or muscle pain, muscle cramps;
weakness, fatigue, malaise, swelling - due to fluid retention.
Rare (may affect up to 1 in 1,000 people):
increased bleeding;
behavioral and related mood changes tremor;
palpitations.
Very rare (may affect up to 1 in 10,000 people):
hallucinations, disorientation, thoughts and suicide attempts;
hepatitis (inflammation of liver);
intense red lumps under the skin, most often on the lower legs (erythema nodosum), severe skin reactions (erythema multiforme), which can occur suddenly;
hepatic eosinophilic infiltration.
In asthmatic patients treated with montelukast have been reported rare cases of a combination of flu-like symptoms numbness or tingling in the arms and legs, worsening of pulmonary symptoms and / or rash (syndrome Churg-Straus). If you receive one or more of these symptoms, you should call your doctor immediately.
For more information about side effects, ask your doctor or pharmacist.

5. How to store EPHYRA 10 mg film-coated tablets
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of that month.
No special storage conditions. Keep the blisters in the outer carton to protect from light.