Seretid Multidisk 50g / 500g 60 doses for inhalation of metered powder

The operation manual of an inhaler
the Drug Seretid® Multidisk® contains powder for inhalations. The inhaler has the indicator which after the carried-out inhalation shows number of the remained doses.
When you get Seretid® Multidisk® from a cardboard box, your disk will be in the closed position.


The inhaler contains 60 doses of drug in the form of powder and has the indicator which after the carried-out inhalation shows number of the remained doses. Numbers go in the decreasing order from 60 to 0. It is impossible to fill the used doses. Number from 5 to 0 have red color, warning that in an inhaler there were only a few doses. Emergence in a window of figure 0 means that the inhaler is empty and unsuitable for further use.
For performing inhalation perform five consecutive operations:
1. Open an inhaler
2. Press a lever
3. Inhale
medicine 4 dose. Close an inhaler
5. Rinse a mouth

1. Open an inhaler

you Hold the body with one hand, having placed a thumb of other hand in special deepening. To open an inhaler, press a thumb from yourself to an emphasis, you will not hear click yet.

2. Press a lever

you Hold an inhaler a mouthpiece to the person. The inhaler can be held with the right or left hand. Press a lever in the direction from yourself against the stop, yet you will not hear click. Now the inhaler is ready to work.
When you press a lever, the next cell with powder for inhalation is opened, at the same time the number of the remained doses decreases that is specified in an indicator window. Press a lever only before performing inhalation, otherwise it leads to medicine waste.

3. Inhale a medicine dose
Before you begin the procedure, attentively read this section.
You hold an inhaler at some distance from a mouth and make a deep exhalation without effort.
Remember – it is never impossible to do an exhalation in an inhaler!
- densely clasp a mouthpiece with lips. Make a slow and deep breath through a mouth (not through a nose)
- take out an inhaler from a mouth
- hold the breath approximately for 10 seconds or longer as far as you will be able
- make a slow exhalation

4. Close an inhaler
to close an inhaler, place a thumb in special deepening and press in the direction to yourself against the stop, yet you will not hear click. The lever automatically returns to a starting position.
After use of an inhaler the mouthpiece is wiped with dry fabric.

5. Rinse a mouth
After performing inhalation rinse a mouth water and spit out water.

Side effects
are listed below side reactions on each active component of drug – salmeterol and a flutikazona propionate. The profile of side reactions of a combination of these drugs is similar to reactions to each component separately.
Very often ≥ 1 of 10, is frequent ≥ 1 of 100 and & lt, 1 of 10, infrequently ≥ 1 of 1000 and & lt, 1 of 100, is rare ≥ 1 of 10000 and & lt, 1 of 1.000, also lt, 1 of 10000 is very rare.
Very often
- a headache
Often
- candidiasis of a mouth and throat
- pneumonia (at patients with HOBL)
- a voice osiplost, a dysphonia
- muscular spasms, an arthralgia
Infrequently
- irritation of a mucous membrane of a stomatopharynx
- skin allergic reactions
- short wind
- a cataract
- a hyperglycemia
- concern, a sleep disorder
- a tremor
- a cardiopalmus, tachycardia, fibrillation of auricles
- a hematoma
Seldom
- gullet candidiasis
- anaphylactic reactions
- glaucoma
- change of behavior, including superactivity and irritability (especially at children)
- disturbance of a warm rhythm (including supraventricular tachycardia and premature ventricular contraction)
- a Quincke's disease (especially a face edema and stomatopharynxes), a bronchospasm, including paradoxical
- Cushing's syndrome, cushingoid features, oppression of function of adrenal glands, a growth inhibition at children and teenagers, decrease in bone mineral density

of the Contraindication
- hypersensitivity to drug components
- children's age up to 4 years

Medicinal interactions
It is necessary to avoid use of non-selective and selection beta blockers unless they are extremely necessary for the patient.
In usual situations of inhalation of a flutikazon of propionate are followed by its low concentration in plasma owing to intensive metabolism at the first passing and high system clearance under the influence of P450 3A4 cytochrome in intestines and a liver. Thanks to it, clinically significant interactions with participation of a flutikazon of propionate are improbable.
The research of medicinal interactions showed what ritonavir (highly active inhibitor of P450 3A4 cytochrome) can increase considerably concentration of a flutikazon of propionate in blood plasma owing to what concentration of serumal cortisol significantly decrease. Patients who at the same time received a flutikazon propionate and ritonavir have messages about clinically significant medicinal interactions. These interactions caused such side effects as Cushing's syndrome and oppression of function of adrenal glands. Considering told, it is necessary to avoid simultaneous use of a flutikazon of propionate and a ritonavir, except those cases when the potential advantage for the patient exceeds risk of system side effects of GKS.
Other inhibitors of P450 3A4 cytochrome cause insignificant small (erythromycin) and insignificant (ketokonazol) increase in maintenance of a flutikazon propionate in plasma at which concentration of serumal cortisol practically do not decrease. Despite this, it is recommended to be careful at simultaneous use of a flutikazon of propionate and strong inhibitors P450 3A4 cytochrome (for example, a ketokonazola) as such combination can potentially increase system effects of a flutikazon of propionate.
Simultaneous use of a salmeterol and ketokonazol leads to substantial increase of level of a salmeterol in plasma (increase Smakh by 1.4 time and an indicator of AUC – by 15 times) and can lead to lengthening of QT
of an interval.

The special
instructions Drug Seretid® Multidisk® it is not intended for stopping of acute symptoms as in such cases it is necessary to apply fast and short-range inhalation bronchodilator (for example, salbutamol). Patients need to be informed on that they always had near at hand drug for stopping of acute symptoms.
More frequent use of bronchodilators of short action for relief of symptoms demonstrates deterioration in control of a disease, and in such situations the patient has to see a doctor.
The sudden and progressing deterioration in control of a bronkhospastichesky syndrome poses a potential threat of life, and in such situations the patient has to see a doctor immediately. It is possible that the doctor will appoint higher dose of GKS. In cases if the appointed dose of the drug Seretid® Multidisk® does not provide adequate control of a disease, the patient has to see a doctor behind consultation.
Because of danger of development of aggravation patients cannot stop the Multidisk® Seretid® drug treatment sharply with asthma, the dose of drug should be reduced gradually under control of the doctor. At sick HOBL the drug withdrawal can be followed by symptoms of a decompensation and demands observation of the doctor.
Increase in cases of development of pneumonia against the background of reception of Seretid® Multidisk® at patients with HOBL in this connection the attending physician has to be attentive to possible clinical symptoms of manifestation of pneumonia at such patients was revealed.
As well as other inhalation drugs containing corticosteroids, Seretid® Multidisk® patients need to appoint with care with an active or latent pulmonary tuberculosis.
Seretid® Multidisk® should appoint with care to patients with a thyrotoxicosis.
At use of sympathomimetic means, especially in doses, above recommended, increase in systolic pressure and a warm rhythm in this connection patients should be careful when prescribing the drug Seretid® Multidisk® with cardiovascular diseases is possible.
Use of smpatomimetik in doses, above therapeutic, can lead to temporary decrease in level of potassium in blood plasma therefore patients should appoint the drug Seretid® Multidisk® with care with predisposition to decrease in level of potassium in serum.
Any inhalation GKS can cause system effects, especially at prolonged use of high doses, it should be noted, however, that the probability of emergence of such symptoms is much lower, than at treatment by oral GKS. Possible system effects include Cushing's syndrome, cushingoid lines, oppression of function of adrenal glands, a growth inhibition at children and teenagers, decrease in bone mineral density, a cataract and glaucoma therefore it is especially important to titrate a dose of inhalation GKS to the minimum dose which provides maintenance of effective control over disease symptoms.
In the emergency and planned situations capable to cause a stress, it is always necessary to remember a possibility of oppression of adrenal glands and to be ready to use of GKS.
It is regularly recommended to measure growth of the children receiving long-term treatment by inhalation GKS.
Due to a possibility of oppression of adrenal glands, the patients transferred from oral GKS on inhalation therapy of a flutikazon by propionate should be treated with extra care and to regularly control at them function of bark of adrenal glands.
After an initiation of treatment inhalation propionate of a flutikazon, system GKS should be cancelled gradually, and such patients have to have at themselves the special card containing the instruction on the possible need for additional introduction of GKS in stressful situations.
There are very rare messages about increase in level of glucose in blood and therefore patients should appoint with care the drug Seretid® Multidisk® with diabetes.
Patients who at the same time received a flutikazon propionate and ritonavir have messages about clinically significant medicinal interactions. These interactions caused such side effects as Cushing's syndrome and oppression of function of adrenal glands therefore it is necessary to avoid simultaneous use of a flutikazon of propionate and a ritonavir if only, the potential advantage for the patient exceeds risk of system side effects of GKS.
Data of clinical trial of safety of a salmeterol (SMART) added to the carried-out therapy of bronchial asthma in comparison with placebo showed that the frequency of the lethal outcomes caused bronchial asthma was higher in group of a salmeterol. Results of this research showed that patients of African American origin have a risk of development of the serious undesirable phenomena from a respiratory system / a lethal outcome higher, than at other patients. Whether it is unknown, connected with pharmacogenetic or other factors. In this research the influence of simultaneous use of inhalation GKS on risk of the lethal outcome connected with bronchial asthma was not studied.
At a research of interaction of medicines it was revealed that simultaneous use of a system ketokonazol amplifies action of a salmeterol. It can lead to lengthening of an interval of QT. It is necessary to be careful at simultaneous use of strong CYP3A4 inhibitors (for example, a ketokonazola) and a salmeterola.
As well as in a case with other drugs for inhalation introduction, development of a paradoxical bronchospasm with considerable strengthening of an asthma right after introduction of a dose is possible. This state has to be stopped immediately by means of high-speed bronkhodilyatator of short action. The drug Seretid® Multidisk® has to be cancellations immediately, the condition of the patient has to be estimated, and if necessary it is necessary to appoint alternative therapy.
Side reactions of therapy beta-2 by agonists, such as heart consciousness, a tremor and a headache which had passing character and decreased in process of performing regular therapy were revealed.
Special groups of patients
Are not present need to reduce a dose of the drug Seretid® Multidisk® at elderly patients and also at patients with renal failures or a liver. At the moment there are no data on use of the drug Seretid® Multidisk® for children under 4 years.
Pregnancy and the period of a lactation
Use of drug during pregnancy and in the period of a lactation is justified only when the expected advantage for mother exceeds any possible risk for a fruit or the child.
As at inhalation administration of the drug Seretid® Multidisk® in the recommended doses its concentration in plasma is extreme is low, it is supposed that the level of a salmeterol and flutikazon in breast milk is also insignificant, however clinical confirmations to these data do not exist.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
of Special researches it was not carried out, however influence is not supposed.

The overdose
is not recommended to exceed the appointed doses. It is important to accept minimum effective dose for maintenance of control over a disease.
Symptoms: the overdose of a salmeterol is shown by the symptoms characteristic of excessive stimulation of beta2-adrenoceptors: tremor, headache, tachycardia, increase in systolic pressure and hypopotassemia.
Inhalations of a flutikazon of propionate in the doses exceeding recommended can lead to temporary oppression gipotalamo - a hypophysial and adrenal system. This phenomenon does not demand immediate intervention as function of adrenal glands is restored within several days.
Exceeding the recommended doses of the drug Seretid® Multidisk® during the long period can lead to considerable suppression of function of adrenal glands. In literature there are rare messages about acute adrenal crisis which arises mainly at the children receiving excessively high doses of drug for a long time (several months or years), acute adrenal crisis is shown by the hypoglycemia which is followed by confusion of consciousness and/or spasms. The injury, surgical intervention, infections or a fast dose decline of the drug Seretid® Multidisk® of a flutikazon of propionate which is a part belong to situations which can serve as starting factors of acute adrenal crisis.
Treatment: specific antidote does not exist. Patients have to be under observation of the doctor with rendering maintenance therapy.

A form of release and packing
Powder for inhalations of 50 mkg / 100 mkg, 50 mkg / 250 mkg and 50 mkg / 500 mkg, 60 doses.
A round plastic inhaler Multidisk of lilac color of two tones with the indicator of doses. Inside the blister from a foil with 60 evenly located cells, contains in each of which one dose of drug. The inhaler together with the instruction for use in the state and Russian languages is placed in a cardboard box.


To Store storage conditions in the dry place at a temperature not above 30 °C.
To store out of children's reach!

A period of storage
2 years
not to use drug after the expiry date specified on packing

Prescription status
According to the prescription

the Producer
by Glakso Wellk Production, France
(Zone Industrielle n' 2 23, rue Lavoisier, 27000 Evreux, France)

the Packer
Glakso Wellk Production, France
to Develop