Simbikort Turbukhaler of 80 mkg (160 mkg)

General characteristics. Structure:

Each delivered dose (the dose leaving a mouthpiece) contains in quality of active agents: the budesonid micronized 80 mkg and a formoterol of a fumarat of a dihydrate of 4,5 mkg; or the budesonid micronized 160 mkg and a formoterol of a fumarat of a dihydrate of 4,5 mkg.
Excipients: lactoses monohydrate of 810 mkg or 730 mkg.
Description
Inhaler: the rotating doser of red color on which Braille's code is squeezed out. Cover of white color. In a window of the indicator of dosing the figure "60" or "120" is visible to an inhaler on 60 doses or 120 doses, respectively. The mouthpiece can rotate.
Contents: granules from white till almost white color, preferential rounded shape.

Pharmacological properties:

Pharmacodynamics. Simbikort Turbukhaler contains формотерол and будесонид which have different mechanisms of action and show the additive effect concerning decrease in frequency of exacerbations of bronchial asthma.

Budesonid. Budesonid, an inhalation glucocorticosteroid, in the recommended doses has antiinflammatory effect in bronchial tubes, reducing expressiveness of symptoms and frequency of exacerbations of bronchial asthma with a smaller frequency of side effects, than when using system glucocorticosteroids. Reduces expressiveness of hypostasis mucous bronchial tubes, products of slime, formation of a phlegm and hyperreactivity of respiratory tracts.

Formoterol. Formoterol - the selection agonist of r2-adrsnsrgichesky receptors which causes relaxation of smooth muscles of bronchial tubes in patients with reversible obstruction of respiratory tracts. Broncholitic action comes quickly, within 1-3 minutes after inhalation and remains within 12 hours after reception of a single dose.

Budesonid + Formoterol. Bronchial asthma Addition of a formoterol to a budesonid reduces expressiveness of symptoms of bronchial asthma, improves function of bronchial tubes and reduces the frequency of exacerbations of a disease.

Simbikort Turbukhaler's action on function of bronchial tubes corresponds to action of a combination of monodrugs of a budesonid and formoterol and exceeds action of one budesonid. Drug has good tolerance.

Simbikort Turbukhaler improves function of bronchial tubes and has good tolerance at children aged from 6 up to 11 years against the background of administration of drug within 12 weeks (two inhalations on 80/4.5 mkg / inhalation twice a day).

The Chronic Obstructive Pulmonary Diseases (COPD) At patients from heavy HOBL against the background of Simbikort Turbukhaler's reception considerable decrease in frequency of exacerbations of a disease in comparison with the patients receiving as therapy only формотерол or placebo was observed (average frequency of aggravations 1.4 but to comparison with 1.8 - 1.9 in group of placebo / формотерол). Distinctions between Simbikort's reception and a formoterola on an indicator of volume of the forced exhalation in the first minute are noted (OFV).

Pharmacokinetics. Absorption. Simbikort Turbukhaler биоэквивалентен to the corresponding monodrugs concerning systemic action of a budesonid and a formoterol. Despite it, small strengthening of suppression of cortisol after Simbikort Turbukhaler's reception in comparison with monodrugs was noted. This distinction does not dig round influence on clinical safety. There are no proofs of pharmacokinetic interaction of a budesonid and a formoterol.

Pharmacokinetic indicators for the corresponding substances are comparable after purpose of a budesonid and a formoterol in the form of monodrugs and as a part of Simbikort Turbukhaler. For a budesonid, at introduction as a part of the combined drug, the area under a curve "concentration time" (AUC) is slightly more, absorption of drug happens quicker and the size of the maximum concentration in a blood plasma is higher.

For a formoterol at introduction as a part of the combined drug the maximum concentration in a blood plasma matches that for monodrug.

Iigaliruyemy будесонид is quickly absorbed and reaches the maximum concentration in plasma in 30 minutes after performing inhalation. The average dose of the budesonid which got into lungs after performing inhalation through Turbukhaler makes 32-44% of the delivered dose. System bioavailability makes about 49% of the delivered dose. At children aged from 6 up to 16 years the average dose of the budesonid which got into lungs after performing inhalation through Turbukhaler does not differ from indicators at adult patients (final concentration of drug in a blood plasma was not defined).

Inhalated формотерол quickly it is absorbed and reaches the maximum concentration in a blood plasma in 10 minutes after performing inhalation. The average dose of the formoterol which got into lungs after performing inhalation through Turbukhaler makes 28-49% of the delivered dose. System bioavailability makes about 61% of the delivered dose.

Distribution and metabolism. About 50% of a formoterol and 90% of a budesonid contact proteins of plasma. Distribution volume for a formoterol makes about 4 l/kg and for a budesonid of 3 l/kg. Formoterol is inactivated by conjugation (are formed active O-demetilirovannye metabolites, generally in the form of the inactivated conjugates). Budesonid is exposed to intensive biotransformation (about 90%) at the first passing through a liver with formation of the metabolites having low glucocorticosteroid activity. Glkyukortikosteroidny activity of the main metabolites 6 - beta гидроксибудесонида and 16-alpha hydroxyprednisolonum - does not exceed 1% of similar activity of a budesonid. There are no proofs of interaction of metabolites or substitution reaction between budesonidy and formoteroly.

The main part of a dose of a formoterol is exposed to metabolism in a liver and then is removed by kidneys. After inhalation of 8-13% of the delivered dose of a formoterol it is removed in not changed view with urine. Formoterol has high system clearance (about 1.4 l/min.); the elimination half-life of drug averages 17 hours.

Budesonid is metabolized preferential with CYP3A4 enzyme participation. Metabolites of a budesonid are removed with urine in not changed look or in the form of conjugates. In urine only the insignificant quantity of not changed budesonid is found. Budesonid has high system clearance (about 1.2 l/min).

The pharmacokinetics of a formoterol at children and at patients with a renal failure is not studied. Concentration of a budesonid and formoterol in a blood plasma can increase at patients with liver diseases.

Indications to use:

Bronchial asthma, as a maintenance therapy and for stopping of attacks (insufficiently controlled by reception of inhalation GKS and beta2-adrenostimulyator of short action as therapy on demand, or adequately controlled by inhalation GKS and beta2-adrenostimulyator of long action).
HOBL (Symptomatic therapy at patients with a heavy chronic obstructive pulmonary disease (OFV <50% of estimated settlement level) and with the repeating aggravations in the anamnesis which have the expressed disease symptoms, despite therapy by bronchodilators of long action).

Route of administration and doses:

Bronchial asthma
Simbikort Turbukhaler is not intended for initial treatment of bronchial asthma of an intermittent and easy persistent current. Selection of a dose of the drugs which are Simbikort's part happens individually and depending on severity of a disease. It needs to be considered not only at an initiation of treatment the combined drugs, but also at change of a maintenance dose of drug.
If certain patients need other combination of doses of active components, than in Simbikort Turbukhaler, it is necessary to appoint pV-of an adrenomimetika and/or glucocorticosteroids in separate inhalers.
The dose should be lowered to the smallest against the background of which optimum control of symptoms of bronchial asthma remains. Patients have to be under constant control of the doctor for adequate selection of a dose Simbikort Turbukhaler. At achievement of complete control over symptoms of bronchial asthma against the background of the minimum recommended drug dose, at the following stage it is possible to try purpose of monotherapy by inhalation glucocorticosteroids.
There are two approaches to purpose of therapy by Simbikort Turbukhaler
A. Simbikort Turbukhaler as a maintenance therapy: Simbikort Turbukhaler is appointed for a constant maintenance therapy in a combination with a separate beta2-adrenostimulyator of short action for stopping of attacks.
V. Simbikort Turbukhaler as a maintenance therapy and for stopping of attacks: Simbikort Turbukhaler is appointed as for a constant maintenance therapy, and on demand at emergence of symptoms.
A. Simbikort Turbukhaler as a maintenance therapy
The patient needs to have constantly at himself a separate inhaler with a beta2-adrenostimulyator of short action for stopping of attacks.
Adults (18 years are also more senior): Simbikort Turbukhaler of 80/4,5 mkg / dose and 160/4,5 mkg / dose: 1 - 2 inhalations twice a day. If necessary increase in a dose up to 4 inhalations twice a day is possible.
Teenagers (12-17 years): Simbikort Turbukhaler of 80/4,5 mkg / dose and 160/4,5 mkg / dose: 1 - 2 inhalations twice a day.
Children are more senior than 6 years: Simbikort Turbukhaler of 80/4,5 mkg / dose: 1 - 2 inhalations twice a day.
After achievement of optimum control over symptoms of bronchial asthma at administration of drug twice a day, it is recommended to titrate a dose to minimum effective, up to administration of drug once a day when, according to the doctor, the patient needs a maintenance therapy in a combination with a bronkhodilyatator of long action.
Increase in frequency of use of beta2-adrenostimulyator of short action is an indicator of deterioration in the general control over a disease and demands review of antiasthmatic therapy.
V. Simbikort Turbukhaler as a maintenance therapy and for stopping of attacks
Simbikort Turbukhaler can be appointed both as a constant maintenance therapy, and as therapy on demand at emergence of attacks. The patient needs to have constantly at himself Simbikort for stopping of attacks.
Simbikort as a maintenance therapy and for stopping of attacks in particular is shown to patients with:
- insufficient control over bronchial asthma and need for frequent use of drugs for stopping of attacks;
- existence in the anamnesis of the exacerbations of bronchial asthma demanding medical intervention.
Careful control of dozozavisimy side effects is required from the patients using a large number of inhalations for stopping of attacks.
Adults (18 years are also more senior): Simbikort Turbukhaler of 80/4,5 mkg / dose and 160/4,5 mkg / dose: the recommended dose for a maintenance therapy 2 inhalations a day, are accepted on 1 inhalation in the morning and in the evening, or 2 inhalations once only in the morning or only in the evening. For some patients the maintenance dose of drug Simbikort Turbukhaler of 160/4,5 mkg / a dose 2 inhalations two times a day can be appointed. At emergence of symptoms purpose of 1 additional inhalation is necessary. At further increase of symptoms within several minutes 1 more additional inhalation, but no more than 6 inhalations for stopping of 1 attack is appointed.
Usually appointment more than 8 inhalations a day is not required, however it is possible to increase number of inhalations to 12 in days by short time. It is recommended to the patients receiving more than 8 inhalations a day to ask for medical care for therapy review.
Children and teenagers up to 18 years: Simbikort Turbukhaler as a maintenance therapy and for stopping of attacks is not recommended to children and teenagers.
HOBL
Adults: 2 inhalations Simbikort Turbukhaler of 160/4,5 mkg / dose twice a day.
Special groups of patients: there is no need for special selection of a dose of drug for patients of advanced age. There are no data on Simbikort's reception by patients with a renal or liver failure. As будесонид and формотерол, mainly, are removed with the participation of hepatic metabolism, at patients with heavy cirrhosis it is possible to expect delay of speed of removal of drug.
Children up to 6 years:
Simbikort Turbukhaler is not recommended to children up to 6 years.
Instructions for the correct use of Turbukhaler:
Mechanism of action of Turbukhaler: at inhalation by the patient through a mouthpiece drug comes to respiratory tracts.
It is necessary to instruct the patient:
- to attentively study the application instruction of Turbukhaler
- to inhale strongly and deeply through a mouthpiece to guarantee hit of an optimum dose of drug in lungs
- never to exhale through a mouthpiece
- to rinse a mouth water after inhalation of maintenance doses for decrease in risk of development of candidiasis of a mucous membrane of an oral cavity and a throat.
It is also necessary to rinse a mouth water after performing inhalations for stopping of symptoms in case of development of candidiasis of a mucous membrane of an oral cavity and a throat.
The patient can not feel taste or not feel drug after Turbukhaler's use that is caused by a small amount of the delivered substance.
APPLICATION INSTRUCTION OF TURBUKHALER
Turbukhaler – the multidose inhaler allowing to dose and inhale drug in very small doses. When you take a breath, powder from Turbukhaler is delivered in lungs. Therefore it is important that you strongly and deeply inhaled through a mouthpiece.
Turbukhaler's training for the first use:
Before the first use of Turbukhaler it needs to be prepared for work.
1. Unscrew and remove a cap.
2. You hold an inhaler vertically red doser down. You do not hold an inhaler for a mouthpiece when you turn the doser. Turn the doser against the stop in one direction, and then also against the stop in an opposite direction. Perform the described procedure twice.
Fig. 2
"click"
Now the inhaler is ready to use, and you should not repeat this procedure of training of Turbukhaler for work before each use. To accept drug, follow the instruction given below.
How to use SIMBIKORT TURBUKHALER
For reception of one dose follow the procedure described below.
1. Unscrew and remove a cap.
2. You hold an inhaler vertically red doser (fig. 2) down. You do not hold an inhaler for a mouthpiece when you turn the doser. To measure a dose, turn the doser against the stop in one direction, and then also against the stop in an opposite direction.
3. Exhale. Do not exhale through a mouthpiece.
4. Carefully place a mouthpiece between teeth, squeeze lips and inhale strongly and deeply through a mouth (fig. 3). Not to chew and not to squeeze a mouthpiece teeth.
Fig. 3
5. Before exhaling, take out an inhaler from a mouth.
6. If inhalation more is required than one dose, repeat steps 2 - 5.
7. Close an inhaler a cap, check that the cap of an inhaler was screwed carefully up.
8. Rinse a mouth water, without swallowing.
IMPORTANT!
Do not try to remove a mouthpiece as it is fixed on an inhaler and does not act. Turbukhaler's mouthpiece rotates, but do not turn it needlessly.
As the amount of the inhaled powder is not enough, you, perhaps, will not feel taste of powder after inhalation.
However, if you followed the instruction, then can be sure that you inhaled (inhalated) a necessary dose of drug.
If you before drug acceptance by mistake repeated the procedure for loading of an inhaler more than once, at inhalation all of you equally receive one dose of drug. While the indicator of doses will show total quantity of the measured doses.
Sound which you hear, stirring up an inhaler, it is made by the draining agent, but not medicine.
How to learn when the inhaler has to be заменен
The indicator of doses (fig. 4) shows approximate quantity of the doses which remained in an inhaler, doses of the filled Turbukhaler are reckoned from the 60th or 120th dose (depending on total quantity of doses of Turbukhaler acquired by you).
Fig. 4
The indicator shows an interval of 10 doses therefore it does not show each measured (loaded) dose.
You can be sure that Turbukhaler delivers a necessary dose of drug even if you do not notice change in a window of the indicator of doses.
Emergence of a red background in a window of the indicator of doses means that in Turbukhalere there were 10 doses of drug. At emergence of figure 0 on a red background in the middle of a window of doses of an inhaler (fig. 5) the inhaler has to be thrown out.
Notice fig. 5 that even when the window of the indicator of doses shows figure 0, the doser continues to turn. However the indicator of doses stops fixing quantity of doses (sticks to move) and in a window of doses of an inhaler there is figure 0.
Cleaning
Regularly (weekly) clear a mouthpiece outside dry fabric.
Do not use water or other liquids for cleaning of a mouthpiece.
Utilization
Be careful with the used inhaler, you remember that in an inhaler there can be a drug quantity.

Features of use:

It is recommended to reduce gradually a drug dose before the termination of treatment and it is not recommended to cancel treatment sharply.
Simbikort (80/4,5 mkg/doza) Turbukhaler is not intended for patients with heavy bronchial asthma.
Simbikort Turbukhaler does not intend for initial selection of therapy at the first stages of treatment of bronchial asthma.
At insufficient efficiency of therapy or exceeding of the maximum recommended Simbikort's doses it is necessary to reconsider treatment tactics. The unexpected and progressing deterioration in control of symptoms of bronchial asthma or HOBL is the state which is potentially menacing for life and demands urgent medical intervention. In this situation it is necessary to consider the possibility of increase in a dose of glucocorticosteroids, i.e. purpose of a course of peroral glucocorticosteroids or treatment by antibiotics in case of accession of an infection. Patients are recommended to have constantly at themselves drugs of acute management, or Simbikort Turbukhaler (for the patients with bronchial asthma using Simbikort Turbukhaler for a maintenance therapy and for stopping of attacks), or beta2-adrenomimetik of short action (for all patients using Simbikort Turbukhaler only for a maintenance therapy).
It is necessary to draw the attention of the patient to need of regular reception of a maintenance dose Simbikort Turbukhaler according to the picked-up therapy, even in cases of lack of symptoms of a disease. Simbikort Turbukhaler's inhalations for stopping of attacks have to be carried out only at emergence of symptoms, but are not shown for regular preventive use, i.e. before an exercise stress. In such cases use of a separate bronkhodilyatator of short action is shown.
If symptoms of bronchial asthma give in to control, it is possible to reduce gradually Simbikort Turbukhaler's dose, at the same time it is important to watch a condition of patients constantly. It is necessary to appoint the smallest effective dose of Simbikort Turbukhaler (see the section "Route of Administration and Doses").
Treatment by Simbikort Turbukhaler should not be begun in the period of an aggravation or considerable deterioration in a course of bronchial asthma.
During therapy by Simbikort Turbukhaler can note aggravations and development of the serious undesirable phenomena connected with bronchial asthma. Patients should continue treatment, but began therapies to ask for medical care in the absence of control over symptoms of bronchial asthma or in case of an aggravation of symptoms later.
As well as at any other inhalation therapy, emergence of a paradoxical bronchospasm with immediate strengthening of rattles after reception of a dose of drug is possible. In this connection, it is necessary to stop therapy by Simbikort, to reconsider tactics of treatment and, if necessary, to appoint alternative therapy.
Systemic action can be shown at reception of any inhalation glucocorticosteroids, especially at reception of high doses of drugs during a long span. Manifestation of systemic action is less probable when performing inhalation therapy, than when using peroral glucocorticosteroids. Suppression of function of adrenal glands, a growth inhibition at children and teenagers, decrease in mineral density of a bone tissue, a cataract and glaucoma belong to possible system effects.
It is regularly recommended to monitorirovat growth of children, it is long receiving glucocorticosteroid therapy in the inhalated form. In case of the established growth inhibition, it is necessary to reconsider therapy for the purpose of a dose decline of the inhalated glucocorticosteroid. It is necessary to estimate carefully a ratio of advantage of glucocorticosteroid therapy to possible risk of a growth inhibition. At the choice of therapy it is recommended to address the children's pulmonologist.
Based on limited these researches about long reception of glucocorticosteroids, it is possible to assume that most of the children and teenagers receiving therapy by an inhalation budesonid will be reached finally normal for adult indicators of growth. At the same time it was reported about an insignificant short-term growth inhibition, generally in the first year of treatment.
Because of potentially possible action of inhalation glucocorticosteroids on the mineral density of a bone tissue it is necessary to pay special attention to the patients accepting high doses of drug during the long period with existence of risk factors of development of osteoporosis. Researches of prolonged use of the inhalated budesonid at children in an average daily dose of 400 mkg (the measured dose) or adults in a daily dose of 800 mkg (the measured dose) did not show noticeable action on the mineral density of a bone tissue. There are no data on action of high doses of Simbikort Turbukhaler on the mineral density of a bone tissue.
If there are bases to believe that against the background of the previous system therapy glucocorticosteroids broke function of adrenal glands, it is necessary to take precautionary measures at transfer of patients into treatment by Simbikort.
Advantages of inhalation therapy budesonidy, as a rule, minimize need of reception of peroral glucocorticosteroids, however at the patients stopping therapy by peroral glucocorticosteroids, insufficient function of adrenal glands can remain for a long time. Patients who in the past needed urgent reception of high doses of glucocorticosteroids or received prolonged treatment by inhalation glucocorticosteroids in a high dose can also be in this risk group. It is necessary to provide additional purpose of glucocorticosteroids in the period of a stress or surgical intervention.
It is recommended to instruct the patient about need to rinse a mouth water after inhalations of maintenance doses for the purpose of prevention of risk of development of candidiasis of a mucous membrane of an oral cavity and a throat. It is also necessary to rinse a mouth water after performing inhalations for stopping of symptoms in case of development of candidiasis of a mucous membrane of an oral cavity and a throat.
It is necessary to observe precautionary measures at treatment of patients with the extended QTS-interval. Reception of a formoterol can cause lengthening of QTS-of an interval.
It is necessary to reconsider need of use and a dose of the inhalated glucocorticosteroid at patients with active or inactive forms of a pulmonary tuberculosis, fungal, viral or bacterial infections of a respiratory organs.
At joint purpose of beta2-adrenomimetik with drugs which can cause or strengthen gipokaliyemichesky effect, for example, xanthine derivatives, steroids or diuretics, strengthening of gipokaliyemichesky effect of beta2-adrenomimetik is possible. It is necessary to observe special precautionary measures at the patients with unstable bronchial asthma applying bronkhodilyatator of short action for removal of attacks at an exacerbation of heavy bronchial asthma as the risk of development of a hypopotassemia increases against the background of a hypoxia and at other states when the probability of manifestation of development of gipokaliyemichesky effect increases. In such cases it is recommended to control the content of potassium in serum.
Reception by patients with acute bronchial obstruction of a formoterol in a dose of 90 mkg within 3 hours is safe. During treatment it is necessary to control concentration of glucose in blood at the patients suffering from a diabetes mellitus.
Simbikort Turbukhaler contains lactose (<1 mg / inhalation). Usually such quantity does not cause problems in patients with a lactose intolerance.
Influence on ability to drive the car or other mechanisms Simbikort Turbukhaler does not exert impact on ability to drive the car and to manage mechanisms. Can exert impact on ability to drive the car and to manage mechanisms in case of development of side effect.

Side effects:

Against the background of joint purpose of two drugs increase in frequency of emergence of side reactions was not noted. The most frequent side reactions connected with administration of drug are such pharmacological expected phenomena, undesirable to beta2-adrenomimetik, as a tremor and a cardiopalmus; symptoms usually have moderate degree of manifestation and pass in several days after an initiation of treatment. During use of a budesonid at HOBL, bruises and pneumonia met frequency of 10% and 6%, respectively, in comparison with 4% and 3% in group with placebo (р <0,001 and р <0,01, respectively).
Frequent                      Central nervous system:       Headache
(> 1/100, <1/10)      Cardiovascular system:       Heartbeat
                                 Musculoskeletal system:           Tremor
                                 Respiratory tracts:                       Candidiases of a mucous membrane
                                                                                      oral cavities and drinks, cough,
                                                                                      voice osiplost, lung
                                                                                      irritation in a throat
Less frequent            Cardiovascular system:      Tachycardia
(> 1/1000, <1/100)     Musculoskeletal system:           Muscular spasms
                                 Central nervous system:      Psychomotor excitement,
                                                                                      concern, nausea,
                                                                                      dizziness, sleep disorders
                                  Skin:                                           Bruises
Rare                        Skin:                                          Dieback, urticaria, itch,
(> 1/10000, <1/1000)                                                     dermatitis, angioedem,
                                                                                      anaphylactic reactions
                                  Respiratory tracts:                      Bronchospasm
                                  Metabolic disturbances:        Hypopotassemia
                                  Cordial and vascular system:     Fibrillation of auricles, supra-
                                                                                      ventrikulyarny tachycardia,
                                                                                      premature ventricular contraction
Very rare              Metabolic disturbances:         Hyperglycemia, signs or symptoms
(<1/10000)                                                                     system glucocorticosteroid
                                                                                      effects (including hypofunction
                                                                                      adrenal glands)
                                  Psychiatric symptoms:        Depression, behavior disorders
                                                                                      (mainly at children)
                                  Central nervous system:     Taste disturbances
                                  Cardiovascular system:      Stenocardia,
                                                                                      fluctuations of arterial pressure

Systemic action of inhalation glucocorticosteroids can meet at reception of high doses for an appreciable length of time.
Use of b2-adrenomimetik can lead to increase in content in blood of insulin, free fatty acids, a glitserol and ketonic derivatives.

Interaction with other medicines:

Reception of 200 mg of a ketokonazol increases concentration in plasma of a peroral budesonid (a single dose of 3 mg) at their joint appointment, on average, by 6 times once a day. At purpose of a ketokonazol in 12 hours after reception of a budesonid, concentration in plasma of the last increased, on average, by 3 times. Information on similar interaction with an inhalation budesonid is absent, however, it is necessary to expect noticeable increase in concentration of drug in a blood plasma. As the doses given for recommendations about selection are absent, it is necessary to avoid the above described combination of drugs. If it is impossible, the time interval between purpose of a ketokonazol and budesonid should be increased as much as possible. Also it is necessary to consider the possibility of a dose decline of a budesonid. Other powerful CYP3A4 inhibitors probably can also increase considerably concentration of a budesonid in plasma. Simbikort's appointment as a maintenance therapy and for stopping of attacks is not recommended to the patients receiving powerful CYP3A4 inhibitors.
Blockers of beta and adrenergic receptors can weaken action of a formoterol. Simbikort it is not necessary to appoint along with beta adrenoblockers (including eye drops), except for forced cases.
Joint appointment of Simbikort Turbukhaler and quinidine, Disopyramidum, procaineamide, fenotiazin, antihistaminic drugs (terfenadin), inhibitors of a monoaminooxidase (MAO) and tricyclic antidepressants can extend an interval of QTc and increase risk of developing of ventricular arrhythmias.
Besides, the levodopa, left thyroxine, oxytocin and alcohol can reduce tolerance of a cardiac muscle to beta2-adrenomimetika.
Joint purpose of MAO inhibitors, and also the drugs having similar properties such as furasolidone and Procarbazinum, can cause increase in arterial pressure. There is an increased risk of development of arrhythmias in patients when carrying out the general anesthesia drugs of the halogenated hydrocarbons.
At joint reception of Simbikort Turbukhaler and other beta and adrenergic medicines strengthening of side effect of a formoterol is possible.
The hypopotassemia which can amplify at the accompanying treatment by xanthine derivatives, mineral derivatives of glucocorticosteroids or diuretics can result from use of beta2-adrenomimetik. The hypopotassemia can increase predisposition to development of arrhythmias in the patients accepting cardiac glycosides.
Interaction of a budesonid with other medicines used for treatment of bronchial asthma was not noted.

Contraindications:

Hypersensitivity to a budesonid, a formoterol or the inhalated lactose.
Children's age up to 6 years.
Lactose intolerance, deficit of lactase or glyukozo-galaktozny malabsorption (see the section "Special Instructions").
With care: a pulmonary tuberculosis (an active or inactive form), fungal, viral or bacterial infections of a respiratory organs, a thyrotoxicosis, a pheochromocytoma, a diabetes mellitus, an uncontrollable hypopotassemia, an idiopathic hypertrophic subaortal stenosis, heavy arterial hypertension, aneurism of any localization or other serious cardiovascular illness (coronary heart disease, a tachyarrhythmia or heart failure of heavy degree), lengthening of an interval of QT (reception of a formoterol can cause lengthening of QTS-of an interval).
Use during pregnancy and feeding by a breast
There are no clinical data on Simbikort's use or sharing of a formoterol and budesonid during pregnancy.
During pregnancy Simbikort it is necessary to use only when the advantage of use of drug exceeds potential risk for a fruit. It is necessary to use the smallest effective dose of a budesonid necessary for maintenance of adequate control of symptoms of bronchial asthma. It is unknown whether gets формотерол or будесонид into breast milk of women. Simbikort can be appointed to the feeding women, only if the expected advantage for mother is more, than any possible risk for the child.

Overdose:

Symptoms of overdose of a formoterol: tremor, headache, tachycardia. It was in some cases reported about development of tachycardia, a hyperglycemia, hypopotassemia, lengthening of a QTS-interval, arrhythmia, nausea and vomiting. The supporting and symptomatic treatment can be appointed.
In case of need Simbikort Turbukhaler's cancellations owing to overdose of the formoterol which is a part of the combined drug it is necessary to consider a question of purpose of the corresponding glucocorticosteroid.
At acute overdose of a budesonid, even in considerable doses, clinically significant effects are not expected. At chronic reception of overdoses systemic action of glucocorticosteroids, such as hypercorticoidism and suppression of function of adrenal glands can be shown.

Storage conditions:

At a temperature below 30 °C, in places unavailable to children. Period of validity 2 years. Not to apply after a period of validity.

Issue conditions:

According to the recipe

Packaging:

Powder for inhalations dosed 80/4,5 mkg / a dose and 160/4,5 mkg / a dose.
On 60 doses and 120 doses in the plastic inhaler with control of the first opening (a protective film with the indication of the place of opening) consisting of the portioning device, a tank for storage of powder, a tank for a desiccant, a mouthpiece and the screw-on cover. Each inhaler is located in a cardboard pack with the application instruction.