Ephyra 4 mg. 30 sachets

WHAT EPHYRA AND WHAT IT IS USED
EPHYRA granules is a leukotriene receptor antagonist that blocks substances called leukotrienes. They cause narrowing and swelling of airways in your lungs. By blocking leukotrienes, EPHYRA granule improves asthma symptoms and helps to better control the disease.

Your doctor has prescribed Montelukast granule to treat your child's asthma, preventing the onset of asthma symptoms during the day and night.
Montelukast granules are used to treat patients aged 6 months to 5 years, at which control of asthma is not adequate and require additional treatment;
Additionally, Montelukast granules can be used as an alternative treatment to inhaled corticosteroids for children aged from 2 to 5 years of age who have not received soon corticosteroid orally for the treatment of asthma and have shown that they are not capable of using inhaled corticosteroids ;
Air pellets helps to prevent symptoms of asthma, which are unlocked by exercise in patients and over 2 years of age.
Your doctor will determine how to use Ether granules depending on the symptoms and severity of your child's asthma.
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.

2. BEFORE TAKE EPHYRA
Tell your doctor about any medical problems or allergies your child has been or there.

Do not give Montelukast granule your child if:
It is allergic (hypersensitive) to the active substance or any of the other ingredients of Montelukast granule (see. 6 Further information).
Take special care with Montelukast granule:
If your asthma or breathing your child gets worse, inform your doctor immediately;
Ether oral granules are not intended to treat a sudden attack of breathlessness. If an asthma attack, you should follow the given instructions from your doctor for your child. Always carry your inhaler your child needed to curb such attacks;
It is important that your child take all medications prescribed by the doctor for asthma. Air granules should not be used instead of other asthma medications that your doctor has prescribed for your child;
If your child is taking antiasthmatic drugs, note that if he / she develops a combination of symptoms such as flu-like illness, tingling and numbness of the arms or legs, worsening of pulmonary symptoms and / or rash, you should consult with your doctor;
Your child should not take acetylsalicylic acid (aspirin) or anti-inflammatory drugs (also known as nonsteroidal anti-inflammatory drugs or NSAIDs) if they worsen his / her asthma.
Taking other medicines
Some medicines can affect the action of Ether Ether granules or pellets can affect the way other medicines that you give to your child.

Please tell your doctor or pharmacist if your child is taking or have recently taken any other medicines, including medicines obtained without a prescription.
Tell your doctor if your child is taking the following medicines before starting to take Montelukast granule:
phenobarbital (used for the treatment of epilepsy);
phenytoin (used for the treatment of epilepsy);
rifampicin (used to treat tuberculosis and some other infections).
Taking Montelukast granules with food and drink
Air granules can be taken regardless of meals.

Pregnancy and lactation
This section is not applicable for terrestrial granules as the medicinal product for use in children aged 6 months to 5 years old, but the information below applies to the active substance montelukast.

Use during pregnancy:
Pregnant women and those who plan to become pregnant should consult their doctor before taking montelukast. Your doctor will decide whether it is appropriate to take montelukast during this period.

Lactation
It is not known whether montelukast passes into breast milk. You should consult your doctor before taking montelukast if you are breastfeeding or plan to breastfeed.

Driving and using machines
This section is not applicable for terrestrial granules as the medicinal product for use in children aged 6 months to 5 years old, but the information below applies to the active substance montelukast.
Montelukast significantly altered the ability to drive and use machines. However, individual responses to medication may vary. Some 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.

3. HOW TO TAKE EPHYRA
This medicine should not be given to children only under adult supervision. Your child should take Montelukast granule every night;
The drug should be taken even when your child has no symptoms or he / she has an acute asthma attack;
Always give Montelukast granule your child exactly as prescribed by your doctor. If you're not sure, check with your doctor or pharmacist your child;
To be taken orally.
For children aged 6 months to 5 years
One sachet Montelukast 4 mg granules orally every night.
If your child is taking Montelukast granule, make sure that it does not take any other products containing the same active ingredient, montelukast.
For children aged 6 months to 2 years is available Montelukast 4 mg granules.
For children aged 2 to 5 years is offered Montelukast 4 mg chewable tablets and Montelukast 4 mg granules. Montelukast 4 mg granules are not recommended for children under 6 months of age.

How should you give Ether granules to your child?
Do not open the sachet advance.
Air granules can be given either:
directly into the mouth;
OR mixed with a spoonful of cold or room temperature soft food (eg, applesauce, ice cream, carrots and rice);
Mix the entire contents of Montelukast granule spoon in cold or room temperature soft food, taking care that the entire dose is mixed with food;
Make sure your child has swallowed the entire quantity of granules / mixture of food and granules immediately (within 15 minutes). IMPORTANT: Never store the mixture of granules / food for later;
Montelukast granules are not intended to be dissolved in a liquid. However, your child may take liquids after swallowing pellets Ether;
Air granules can be taken at any time regardless of the timing of meals.
If your child has taken a larger dose of Montelukast granule necessary
Immediately call your child's doctor for advice.
In the majority of cases of overdose, were not received reports of adverse reactions. The most commonly observed symptoms of overdose in adults and children included abdominal pain, sleepiness, thirst, headache, vomiting and hyperactivity.

If you forget to give Montelukast granule your child
Try to give Montelukast granule as prescribed. However, if your child misses a dose, just carry on as usual intake of one sachet daily.
Do not give a double dose to make up the missed dose.

If your child stops taking EPHYRA granule
Air granules can treat your child's asthma only if he / she accepts them continuously.
It is important for the child to continue taking Montelukast granule so long as the doctor has prescribed for your child. This will help control your child's asthma.

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

4. POSSIBLE SIDE EFFECTS
Like all medicines, ethereal granules can cause side effects, although not everybody gets them.

For a description of the frequency of adverse reactions following terms are used:
Very common: affects more than 1 user in 10;
Common: affects 1 to 10 users in 100;
Uncommon: affects 1 to 10 users in 1000;
rare: affects 1 to 10 users in 10,000;
very rare: affects less than 1 user in 10 000;
not known, estimates of frequency can not be made from the available data.
In clinical studies, montelukast 4 mg granules, the most commonly reported adverse reactions (occurring in at least 1 out of 100 patients and less than 1 in 10 pediatric patients), which are deemed to have been associated with montelukast were :
diarrhea;
hyperactivity;
asthma;
dry and itchy skin;
rash.
Moreover, in clinical studies with montelukast 10 mg tablets or montelukast 5 mg or 4 mg chewable tablets were obtained following adverse reactions:
abdominal pain;
headache;
thirst.
These were usually mild and occurred more frequently in patients treated with montelukast than in patients treated with placebo (tablet containing no drug).

Additional post-marketing drug market have been reported:
infections of the upper respiratory tract (very common);
increased bleeding tendency (rare);
allergic reactions including rash, swelling of face, lips, tongue and / or throat that may cause difficulty breathing or swallowing (Uncommon)
changes in behavior and mood [changes in sleep, including nightmares, sleep disorders, somnambulism, irritability, feeling anxious, restlessness, agitation including aggressive behavior or hostility, depression (Uncommon) tremor (Rare) hallucinations, thoughts and suicide attempts (very rare)];
dizziness, drowsiness, tingling / numbness, seizures (Uncommon)
palpitations (rare);
nosebleeds (Uncommon)
diarrhea, nausea, vomiting (common); dry mouth, indigestion (Uncommon)
hepatitis (liver inflammation) (very rare);
bruising, itching, rash (uncommon); sensitive red spots under the skin, most often around the tibia (erythema nodosum) (very rare);
pain in the muscles or joints, stiff muscles (Uncommon)
fever (common); fatigue, malaise, sweating (Uncommon).
In asthmatic patients treated with montelukast, very rare cases has been reported for a combination of symptoms such as flu-like syndrome, tingling or numbness in the arms and legs, worsening of pulmonary symptoms and / or rash (syndrome Churg-Strauss). If your child experiences any of these symptoms, you should call your doctor immediately.

For more information about side effects, ask your doctor or pharmacist.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist your child.

5. HOW TO STORE EPHYRA
Keep out of reach of children.
Do not use this medicine after the expiry date stated on the sachet after 'EXP'. The first two digits indicate the month; the last four digits indicate the year. The expiry date refers to the last day of that month.
Store in the original container to protect from light and moisture.
Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. What EPHYRA granule:
The active ingredient is montelukast. Each sachet of granules contains montelukast sodium equivalent to 4 mg of montelukast.
The other ingredients are mannitol, hydroxypropylcellulose, sodium lauryl sulfate and magnesium stearate.

How does Ether granules and contents of the pack
Montelukast 4 mg granules are white to off-white granules.
Cartons of 7, 20, 28,30 and 98 sachets.
Not all pack sizes may be marketed.