Aerosol for inhalations (dosed) "Fliksotid™ Evohaler™" is applied to preventive treatment of bronchial asthma:

• adult:
  • slight asthma: patients who need periodic symptomatic treatment by bronchodilators daily;
  • moderate asthma: patients with unstable asthma or with aggravation of symptoms against the background of the existing preventive therapy or therapy only bronchodilators;
  • heavy asthma: patients with heavy chronic asthma and the patients dependent on system corticosteroids for adequate control of symptoms (after the beginning of application of an inhalation flutikazon of propionate many such patients will be able significantly to reduce or to refuse completely oral administration of corticosteroids);
• children: preventive antiasthmatic treatment including in case it is not reached control of asthma symptoms against the background of already carried out treatment by other antiasthmatic medicines.

Structure

Active ingredient - a flutikazona propionate (one dose supports a flutikazon of propionate of 125 mkg).

Excipient - HFA 134a propellant.

Contraindication

Hypersensitivity to any component of medicine.

Route of administration Drug is intended to

by

only for inhalation application through a mouth.

to Patients, it is difficult for them to synchronize breath with pressing the valve, recommends to use a spacer (the device for simplification of administration of inhalation medicines).

should inform

Patients what inhalation fliksotid should be applied to prevention of a disease regularly, even in the period of lack of attacks of asthma. The beginning of therapeutic action is observed in 4-7 days.

in case of reduction of efficiency of bronchodilators of short action or need of their frequent application to the patient should see a doctor.

Doctor has to mean

that the flutikazona propionate is effective in the dose making a half of a dose of other inhalation corticosteroids. For example, 100 mkg of a flutikazon of propionate are approximately equivalent to 200 mkg of a dose of beclomethasone of Dipropionas (that contains freon) or a budesonid.

Initial dose has to correspond to severity of a disease. The dosage can be raised to achievement of control or is reduced to a minimal effective dose which allows to establish effective control behind a disease.

Adults and children are more senior than 16 years: 100-1000 mkg 2 times a day, usually on two inhalations 2 times a day.

more than 500 mkg 2 times a day can be appointed by

Due to the risk of emergence of system dosage effects only to adult patients at heavy bronchial asthma when improvement of pulmonary functions and/or control of symptoms, or reduction of application of oral corticosteroids is expected.

Typical initial dose for adults. For patients with slight asthma the typical initial dose makes 100 mkg 2 times a day. In moderately severe moderate asthma and heavy persistent asthma the initial dose can make from 250 to 500 mkg 2 times a day. In case of need it is possible to appoint doses more than 1000 mkg 2 times a day. Only the specialist in treatment of patients with asthma can appoint such doses.

Dosage should be reduced to a minimal effective dose which allows to establish effective control behind a disease.

Typical initial dose for children of 4 years: 50-100 mkg 2 times a day.

asthma is well controlled by

At many children at application of doses on 50-100 mkg 2 times a day.

to Children for whom this dose is insufficient improvement can be reached by

by increase in a dose up to 200 mkg 2 times a day. The maximum dose for children makes 200 mkg 2 times a day.

Dosage should be reduced to a minimal effective dose which allows to establish effective control behind a disease.

Use of doses more than 1000 mkg (500 mkg 2 times a day) should be carried out by

through a spacer for reduction of side reactions from a mouth and a throat.

Pregnant

Experience of application during pregnancy for people is limited to

Feature of application

. At the solution of a question of prescribing of medicine during this period it is necessary to weigh the expected advantage for mother and potential risk for a fruit. Results of a retrospective epidemiological research did not reveal the increased risk of big congenital malformations after exposure of a flutikazon of propionate during the first trimester of pregnancy in comparison with other inhalation corticosteroids.

to

it is not established Now whether the flutikazona propionate gets into breast milk, however, proceeding from a pharmacological profile of medicine, it is improbable. It is possible to use medicament during feeding by a breast only when the expected advantage for mother exceeds potential risk for a fruit.

Children

to Apply

to children aged from 4 years.

Drivers

Any influence on speed of response at control of motor transport or other mechanisms is improbable

.

Overdose

At use of the medicine "Fliksotid™ Evohaler™" in the doses exceeding recommended can arise sharp overdose that is shown in temporary suppression of function of adrenal glands. It does not demand emergency aid as function of bark of adrenal glands is restored in several days that is confirmed by measurement of level of cortisol in blood plasma.

by

However at application of the doses exceeding recommended the significant oppression of function of adrenal glands can be observed for a long time. There were single messages about sharp adrenal crises which arose at children who were treated above the recommended dose (usually 1000 mkg and above) for a long time (several months or years). The symptoms observed at the same time included a hypopotassemia and consequences of a loss of consciousness and/or convulsion. The injury, surgical intervention, infections or a sharp dose decline belong to situations which can provoke sharp adrenal crisis.

therapy can be continued by

in case of overdose in the doses necessary for control of asthma symptoms. Patients who are treated by doses above, than are recommended, have to be under special observation of the doctor, and the medicine dose for them should be reduced gradually.

Side effects

Infection and invasion: very often - candidiasis of a mouth and throat; often - at patients with HOBL the development of pneumonia is possible.

Respiratory system and thorax: often - hoarseness of a voice.

Skin and hypodermic fabrics: often - bruises.

Storage conditions

to Store

at a temperature not above 30 °C, out of children's reach. Not to freeze. To protect from influence of direct sunshine.

Right after use to close a mouthpiece a cap, carefully pressing it before emergence of click.

Expiration date - 2 years.