Instruction for use: Seretide Multidisk

Active substance Salmeterol + Fluticasone

ATX Code R03AK06 Salmeterol + Fluticasone

Pharmacotherapeutic group:

Bronchodilator agent (beta2-agonists selective glucocorticosteroid + local) [beta-adrenergic agonist in combination]

The nosological classification (ICD-10)

J44 Other chronic obstructive pulmonary disease

Allergic bronchitis, Bronchitis asthma, Asthmatic bronchitis, wheeze bronchitis, Bronchitis is an obstructive, bronchi disease, Shortness of sputum in acute and chronic respiratory diseases, Cough in inflammatory diseases of the lung and bronchus, Reversible airflow obstruction, Reversible obstructive airway disease, Obstructive bronchitis disease, Obstructive lung disease, Obstructive bronchitis, Spastic bronchitis, Chronic lung disease, Chronic nonspecific lung diseases, Chronic obstructive pulmonary disease, Chronic obstructive bronchitis, Chronic obstructive airway disease, Chronic obstructive pulmonary disease, Restrictive lung pathology

J45 Asthma

Asthma physical effort, status asthmaticus, Bronchial asthma, Asthma lung flow, Bronchial asthma with obstruction of sputum discharge, Bronchial asthma heavy currents, Bronchial asthma physical effort, hypersecretory asthma, Hormone-dependent form of bronchial asthma, Relief of asthma attacks in bronchial asthma, Non-allergic asthma, nocturnal asthma, Exacerbation of asthma, Asthma attacks, Endogenous forms of asthma, Night asthma, Cough with bronchial asthma

Structure and Composition

Aerosol for inhalation dose 1 dose

salmeterol xinafoate 36.3 g

(Expressed in salmeterol 25 mcg)

fluticasone propionate 50 mcg/ 125 mcg/ 250 mcg

Excipients: 1,1,1,2-tetrafluoroethane - 75 mg

aluminum inhaler doses of 120 (complete with a dosing device); in a cardboard box 1 inhaler.

Seretid® Multidisk®

The powder for inhalation dose 1 dose

salmeterol xinafoate 72.5 g

(Expressed in salmeterol 50 mcg)

fluticasone propionate (micronized) 100 mg/ 250 mcg/ 500 mcg

Excipients: lactose monohydrate - 12.5 mg

in a round plastic inhaler 1 blister with 28 or 60 cells; In the paper cartons 1 inhaler.

The drug forms

Aerosol for inhalation dose Seretid®: inhaler - aluminum with a concave bottom, sealed with a metering valve; the inner surface of the inhaler and the valve must not have any visible defects.

Content inhaler - suspension of white or nearly white.

The powder for inhalation dose Seretid® Multidisk®: inhaler - round plastic device 2 shades of purple (dark purple and light purple) color with a diameter of about 8.5 cm and a height of about 3 cm, with dose counter, showing 28 or 60 doses.

Content inhaler - powder white or nearly white

pharmachologic effect

anti-inflammatory, bronchodilatory, antiasthmatic, glucocorticoid, beta-agonists

pharmacodynamics

Preparations Seretid® and Seretid® Multidisk - combined preparations contain salmeterol and fluticasone propionate which have different mechanisms of action. Salmeterol prevents bronchospasm, fluticasone propionate improves lung function and prevents exacerbations. The formulations may be an alternative for patients who receive both an agonist β2-adrenergic receptors and inhaled corticosteroids.

Salmeterol - is a selective long-acting (12 h) β2-adrenoceptor agonist having a long side chain which binds to the outer domain of the receptor.

The pharmacological properties of salmeterol offer protection against histamine-induced bronchoconstriction and longer lasting bronchodilation (lasting at least 12 hours) than the β2-adrenergic receptor agonists, short-acting. Home bronchodilator effect - for 10-20 minutes. Salmeterol is a potent and long-acting inhibitor release from human pulmonary mast cells of tissue mediators such as histamine, LT and PG D2.

Salmeterol inhibits the early and late phase response to inhaled allergen; the latter takes over 30 hours after administration of one dose, i.e. while when bronchodilator effect is no longer present. A single administration of salmeterol attenuates bronchial hyper-responsiveness of the tree. This indicates that the addition bronchodilator salmeterol activity has an additional effect, the clinical significance is not completely established. This mechanism of action differs from the anti-inflammatory effect of GCS. At therapeutic doses of salmeterol no effect on the CCC.

Fluticasone propionate belongs to the group of corticosteroids for topical use and has a pronounced anti-inflammatory and antiallergic effect when inhaled at recommended doses in the lungs, resulting in reduction of clinical symptoms and reducing exacerbations diseases accompanied by airway obstruction. Restores the patient's response to bronchodilators by reducing the frequency of their use. Action fluticasone propionate is not accompanied by side effects typical of systemic corticosteroids.

With prolonged use of inhaled fluticasone propionate at recommended doses, the maximum daily secretion of adrenal hormones remained in the normal range in both adults and children. After the transfer of patients treated with other inhaled corticosteroids, to receive fluticasone propionate daily secretion of adrenal hormones is gradually improving, in spite of the previous and current periodic use of oral steroids. This indicates a recovery of adrenal function on the background of the use of inhaled fluticasone propionate. With prolonged use of fluticasone propionate backup function of the adrenal cortex also remained within normal limits, as evidenced by an increase in the normal production of cortisol in response to appropriate stimulation (please note that the reduction in residual adrenal reserve, caused by previous therapy can be maintained for a long time).

A study of 318 adult patients with persistent asthma showed that when using double doses Seretid® Seretid® Multidisk and 14 days (regardless of the dose of the components in the formulation) is a slight increase in the frequency of adverse events associated with the action of β- adrenomimetic (tremor - 1 patient (1%) 0 patients - at the usual dose, palpitations - 6 patients (6%), 1 patient (<1%) - at the usual dose, convulsions - 6 patients (6%), 1 patients (<1%) - with the usual dose), and the frequency of adverse events associated with the action of inhaled corticosteroid remains the same (e.g. oral candidiasis - 6 patients (6%), 16 patients (8%) - with the usual dose ; hoarseness - 2 patients (2%), 4 patients (2%) - with the usual dose) compared to the conventional treatment regimen. Thus, twice the dose of the drug can be used in cases where patients require additional short (14 days) rate of corticosteroid therapy.

Pharmacokinetics

When coupled with inhaled salmeterol and fluticasone propionate did not affect the pharmacokinetics of each other so that the pharmacokinetic characteristics of each component drugs Seretid® and Seretid® Multidisk can be considered separately.

Even though a very low concentration of salmeterol and fluticasone propionate in the plasma, one can not exclude the interaction with other substrates and inhibitors CYPZA4 isoenzyme.

Salmeterol: acts locally in the lung tissue, so its content in the plasma was not correlated with the therapeutic effect. Data on the pharmacokinetics of its very limited due to technical problems: inhalation therapeutic doses its Cmax in plasma is extremely low (200 pg / ml and below). After repeated inhalation of salmeterol xinafoate in the blood can be detected gidroksinaftoevuyu acid, Css which make up about 10 pg / ml. These concentration 1000 times lower than the equilibrium levels observed in toxicity studies.

Fluticasone propionate: Absolute bioavailability of inhaled fluticasone propionate in healthy individuals varies depending on the inhaler (using salmeterol / fluticasone propionate using a metered aerosol for inhalation, it is 5.3% of the nominal dose). Patients with bronchial asthma and COPD have lower concentrations of fluticasone propionate in plasma. Systemic absorption occurs mainly through the lungs, and at first it faster, but then slows down.

Some inhaled dose may be swallowed, but this part is making a minimal contribution to the systemic absorption of the drug due to the low solubility in water and because of its first-pass metabolism. The bioavailability from the gastrointestinal tract is less than 1%. As the inhalation dose observed linear increase in the concentration of fluticasone propionate in plasma. Distribution fluticasone propionate is characterized by rapid clearance from the plasma (1 150 ml / min), a large Vss (approximately 300 L) and the end T1 / 2 of approximately 8 hours. Fluticasone propionate has a relatively high degree of binding to plasma proteins (91%). It is rapidly eliminated from the blood, mainly as a result of metabolism by the action of the isoenzyme CYP3A4 metabolite to inactive carboxyl.

Renal clearance of fluticasone propionate unmodified negligible (<0.2%) as a metabolite in the urine output of less than 5% of the dose. Care must be taken while the application of known inhibitors CYPZA4 and fluticasone propionate, because these situations may increase the content of the latter in plasma.

Displayed through the gastrointestinal tract, mainly in the form of a hydroxylated metabolite.

Indications

treatment of asthma in patients, which shows the combination therapy β2-adrenoceptor agonists and long-acting inhaled corticosteroid:

- In patients with poor control of the disease against a background of continuing monotherapy with inhaled corticosteroids with occasional use of β2-adrenomimetic short-acting;

- In patients with adequate control of the disease on therapy with an inhaled corticosteroid and a β2-adrenoceptor agonists of long action;

- As a starting maintenance therapy in patients with persistent asthma (daily occurrence of symptoms, daily use of tools for the rapid relief of symptoms) in the presence of indications for corticosteroids to achieve control of the disease;

maintenance therapy in COPD patients with the value of the forced inspiratory volume (FEV1) <60% of predicted values (up to inhaled bronchodilator) and a history of repeated exacerbations in whose disease severe symptoms persist despite regular bronchodilator therapy.

Contraindications

Hypersensitivity to the drug;

Children under 4 years old.

Precautions: pulmonary tuberculosis, fungal, viral or bacterial respiratory infections, hyperthyroidism, pheochromocytoma, diabetes, uncontrolled hypokalemia, idiopathic hypertrophic subaortic stenosis, uncontrolled hypertension, arrhythmia, prolongation of the QT interval on an electrocardiogram, coronary artery disease, hypoxia of different genesis, cataracts, glaucoma, hypothyroidism, osteoporosis, pregnancy, lactation.

Pregnancy and breast-feeding

Pregnant and lactating women prescribed the drug only if the expected benefit to the mother outweighs any possible risk to the fetus or child.

Side effects

Preparations Seretid® and Seretid® Multidisk contain salmeterol and fluticasone propionate, and therefore it is expected that the drugs can cause side effects that are typical of these components. There is no evidence that the simultaneous administration of salmeterol and fluticasone propionate causing additional side effects.

May cause paradoxical bronchospasm. In this case, you should immediately apply a short-inhaled bronchodilator, stop the drug and start, if indicated alternative therapy.

Salmeterol: describe such pharmacological side effects of beta2-adrenergic agonist, as tremor, palpitations and headache, hypokalemia, which tend to be transient and diminish with continued therapy salmeterol.

In sensitive patients may experience arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles).

There have been reports of arthralgia, nervousness, abdominal pain, nausea, vomiting and hypersensitivity reactions, including skin rash, peripheral edema, and angioedema.

Cases of irritation of the mucous membranes of the oropharynx, changes in sense of taste (dysgeusia).

Published reports of the development of painful muscle spasms and very rare cases of hyperglycemia.

Fluticasone propionate: some patients may appear rough, or hoarseness and candidiasis (thrush) of the mouth and pharynx.

Described cutaneous hypersensitivity reactions. There were also reports of hypersensitivity reactions manifested as angioedema (mainly facial swelling and oropharynx), respiratory disorders (mainly shortness of breath and / or bronchospasm) and anaphylactic reactions.

The severity and frequency, and candidiasis voice roughening is minimized by rinsing the mouth with water after inhalation. Symptomatic candidiasis can be treated with topical antifungal drugs, continuing therapy or drugs Seretid® Seretid® Multidisk.

Very rarely it reported an alarm occurs, sleep disorders and behavioral disorders, including hyperactivity and irritability (predominantly in children); hyperglycemia.

It is theoretically possible development of systemic reactions, including Cushing's syndrome or Cushingoid symptoms, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma.

With prolonged use, doses of the combination of salmeterol with fluticasone propionate, which exceed the permitted doses, possibly a significant inhibition of the function of the adrenal cortex. There are very rare reports of acute adrenal crisis, which occurred mostly in children treated with higher than permitted, the dose of the combination (several months or years) for a long time; symptoms of adrenal crisis include hypoglycemia, accompanied by a decrease in the level of consciousness and / or convulsions.

Interaction

Because of the risk of bronchospasm should avoid simultaneous use of selective and nonselective .beta.-blockers except when they are essential to the patient.

In normal situations inhalation fluticasone propionate its accompanied by low concentrations in plasma due to an intensive metabolism in the "first" pass and high systemic clearance influenced CYP3A4 cytochrome P450 in the gut and liver. This clinically relevant interactions involving fluticasone propionate are unlikely.

Investigation of drug interactions has shown that ritonavir (a highly active inhibitor of CYP3A4) may cause a sharp increase in the concentration of fluticasone propionate in plasma, resulting in significantly reduced serum cortisol concentrations.

There are reports of clinically significant drug interactions in patients who received both fluticasone propionate and ritonavir. These interactions cause side effects such as Cushing's syndrome and adrenal suppression. Given this, you should avoid simultaneous use of fluticasone propionate and ritonavir, unless the potential benefit to the patient outweighs the risk of systemic side effects of corticosteroids.

Other inhibitors of CYP3A4 produce negligible (erythromycin) and minor (ketoconazole) increased content of fluticasone propionate in plasma, in which almost no decrease in serum cortisol concentrations. Despite this, it is advisable to be careful while applying fluticasone propionate and potent inhibitors of CYP3A4 (e.g. ketoconazole), since under such combinations do not exclude the probability of increasing the concentration of fluticasone propionate in plasma.

Xanthine derivatives, corticosteroids and diuretics increase the risk of hypokalemia (especially in patients with acute exacerbation of bronchial asthma, during hypoxia).

MAO inhibitors and tricyclic antidepressants increase the risk of side effects from the CCC.

Compatible with kromoglitsievoy acid.

Dosing and Administration

For optimal effect, the drug should be used regularly, even in the absence of clinical symptoms of asthma and COPD. Determination of the duration of therapy and dose change is possible only on doctor's advice. The patient should be given a form of release of the drug or Seretid® Seretid® Multidisk which contains a dose of fluticasone propionate, the corresponding severity of the disease.

If the patient fails to achieve adequate control of the disease with inhaled corticosteroids alone, a combination therapy for transition salmeterol and fluticasone propionate in an equivalent dose of corticosteroid may lead to better control of asthma. Those patients in whom monotherapy with an inhaled corticosteroid provides adequate control of asthma, inhalation therapy switching to a combination of salmeterol with fluticasone propionate can afford to reduce the dose of corticosteroid without loss of asthma control.

Seretid®

Inhalation is intended only for inhalation.

Recommended dose

Adults and children 12 years and older: 2 inhalations (25 micrograms of salmeterol and 50 micrograms fluticasone propionate) 2 times daily or 2 inhalations (25 micrograms salmeterol and 125 mcg fluticasone propionate) 2 times a day, or 2 inhalations (25 micrograms of salmeterol and 250 micrograms of fluticasone propionate), 2 times a day.

Children 4 years and older: 2 inhalations (25 micrograms of salmeterol and 50 micrograms fluticasone propionate) 2 times a day.

There is currently no data on the use Seretide® drug in children up to 4 years.

Seretide® dose should be reduced to the lowest dose that provides effective control of symptoms. If symptoms control provides the drug Seretid® 2 times a day, a dose reduction to the minimum effective may include a single dose of the drug per day.

COPD

For adult patients, the maximum recommended dose - 2 inhalations (25 micrograms salmeterol and 250 mcg fluticasone propionate) 2 times a day.

Special patient groups

There is no need to reduce the dose in elderly patients and in patients with impaired renal or hepatic function.

Seretide® Multidisk

Inhalation is intended only for inhalation.

Recommended dose

Adults and children 12 years and older: 1 inhalation (50 mcg salmeterol and 100 mcg fluticasone propionate) 2 times a day, or 1 inhalation (50 mcg salmeterol and 250 mcg fluticasone propionate) 2 times a day, or 1 inhalation (50 mcg salmeterol and 500 micrograms of fluticasone propionate), 2 times a day.

In adults over 18 years by doubling the dose during treatment of any form of release of the drug Seretide® Multidisk for up to 14 days is maintained the same safety and tolerability as the regular use of this combination for 1 inhalation 2 times a day. The dose can be double in cases where patients require additional short term (up to 14 days) inhaled corticosteroid therapy, as described in some guidelines for treatment of bronchial asthma.

Children 4 years and older: 1 inhalation (50 mcg salmeterol and 100 mcg fluticasone propionate) 2 times a day.

There is currently no data on the use of the drug Seretide® Multidisk in children up to 4 years.

COPD

For adult patients, the maximum recommended dose is 1 inhalation (50 mcg salmeterol and 500 mcg fluticasone propionate) 2 times a day.

Special patient groups

There is no need to reduce the dose in elderly patients and in patients with impaired renal or hepatic function.

Seretide®

Instructions for use of the inhaler

Testing the inhaler: Before the first use of an inhaler or if the inhaler has not been used a week or longer, you must remove the cap from the mouthpiece, gently squeezing the cap on the sides, shake the inhaler well and release 1 jet in the air to make sure it works.

Using inhaler

1. Remove the cap from the mouthpiece, gently squeezing the cap on the sides.

2. Inspect the interior and exterior of the inhaler including the mouthpiece for the detection of loose parts.

3. Shake the inhaler to make sure that any loose parts are removed and that the contents of the inhaler are uniformly mixed.

4. Take the inhaler between the thumb and the other four fingers upright upside down, with the thumb should be placed on the basis of a mouthpiece.

5. Exhale as deeply as possible, then place the mouthpiece in your mouth between your teeth, having closed his lips around it, but not biting.

6. Immediately after the start of inhalation through the mouth, press the top of the inhaler to carry out spraying Seretide® drug, while continuing to breathe deeply and slowly.

7. Holding my breath, take the inhaler from the mouth and remove your finger from the top of the inhaler. Continue to hold your breath for as long as possible.

8. For the implementation of the second spray should keep the inhaler upright and approximately 30 to repeat steps 3-7.

9. After using the inhaler need to rinse your mouth with water and then spit it out.

10. Close the mouthpiece cover by pressing and clicks into position.

The preparation can also be applied through a spacer (e.g. Volyumatik).

Attention! Perform steps 4, 5 and 6, you can not rush. It should begin to breathe in as slowly as possible just before pressing the inhaler valve. In the first few times it is recommended to practice before the mirror. If you see "mist" coming from the top of the inhaler or from the corners of the mouth, then you should start again from step 2.

If your doctor has given other instructions on the use of the inhaler, it is necessary to strictly observe them. You should contact your doctor if you have difficulty using an inhaler.

Applying an inhaler in children

Young children can not themselves use an inhaler, and they need to help adults. It is necessary to wait for the child to exhale and bring the inhaler at the onset of inhalation. It is necessary to practice in the use of the inhaler with the child. Older children and adults with weak hands should hold the inhaler with both hands. In this case both index fingers should be placed at the top of the inhaler and both thumbs - on the basis of lower die. Children drug is administered via an inhaler through a spacer with face mask (eg Bebihaler).

Cleaning the inhaler: inhaler should be cleaned at least 1 time per week. Remove the protective cap from the mouthpiece. Do not remove the metal canister from the plastic casing. Dry with a cloth or a cotton swab, wipe the mouthpiece inside and outside and a plastic casing - outside. Close the mouthpiece protective cap.

Do not immerse the metal canister into water.

Seretide® Multidisk

Instructions for use of the inhale

inhaler device

Multidisk closed (Fig. 1)

Multidisk open (Fig. 2)

The inhaler has an indicator which is carried out after inhalation indicates the number of remaining doses. Numbers are in descending order from 60 to 0. The numbers 0 to 5 are red, warning of the fact that only a few doses remain in the inhaler. The appearance of the window the number 0 means that the inhaler is empty and is not suitable for further use.

Using inhaler

For inhalation, perform 4 successive steps:

1) open the inhaler;

2) press the lever,

3) to inhale a dose of the drug;

4) close the inhaler;

5) Rinse mouth with water.

1. Open inhaler

It is necessary to keep the body with one hand, placing the thumb of the other hand in a special recess. To open the inhaler, press your thumb away from you all the way until a click is heard.

2. Press the lever

It is necessary to keep the inhaler mouthpiece to face. The inhaler can keep the right or left hand. Push the lever away from you all the way until a click is heard. Now, the inhaler is ready for use. After pressing the lever opened another box of powder for inhalation. The number of doses remaining is reduced, which is indicated in the display window. It is only to press the lever before the inhalation, otherwise it will lead to a waste of the drug.

3. Inject a dose of the drug

It should keep the inhaler at some distance away from your mouth and take a deep breath without effort.

Remember, you can never do exhale into the inhaler!

It is necessary to firmly grasp the die lips. Make a slow, deep breath through your mouth (not through the nose).

Remove the inhaler from the mouth.

Hold your breath for about 10 seconds or longer, as much as possible.

Make a slow exhalation. You can not do exhale into the inhaler.

4. Close the inhaler

In order to close the inhaler, it is necessary to place the thumb in a special groove and press in toward you until it stops, until you hear a click. The lever automatically returns to its original position.

5. should rinse your mouth with water and spit it out after use of the drug.

Cleaning the inhaler: after using the inhaler mouthpiece should be cleaned with a dry cloth.

Overdose

Symptoms for both objective and subjective symptoms of salmeterol overdose are tremor, headache and tachycardia. Inhalation of fluticasone propionate doses higher than recommended may cause temporary suppression of the hypothalamic-pituitary-adrenal system. it does not usually require the adoption of any emergency measures, since in most cases normal adrenal function is recovered in a few days.

Prolonged inhalation of excessive doses of the drug Seretide® and Seretide® Multidisk may be significant adrenal suppression. In the literature, there are rare reports of acute adrenal crisis, which occurs mostly in children treated with excessively high doses (several months or years) for a long time; acute adrenal crisis manifested hypoglycemia accompanied by confusion and / or convulsions. Situations that can serve as a triggering factor of acute adrenal crisis, include trauma, surgery, infection or rapid dose reduction is part of the preparations of fluticasone propionate.

Treatment: antidotes are cardioselective β-blockers. In cases where it is necessary to cancel the preparations Seretide® and Seretide® Multidisk due to an overdose of being a part of salmeterol, the patient should be assigned to the appropriate replacement corticosteroids.

Patients should be aware that you should not take drugs Seretide® and Seretide® Multidisk at doses higher than recommended. Important is regular evaluation of the effectiveness of therapy and dose reduction to the minimum effective, ie, so, which provides effective control of symptoms.

In chronic overdose recommended control reserve of adrenocortical function.

special instructions

Treatment of asthma is recommended gradually, controlling the patient's clinical response to treatment and lung function. The patient must be taught how to use the inhaler.

Preparations Seretide® and Seretide® Multidisk are not intended to relieve acute symptoms, since in such cases should be applied rapidly and short-inhaled bronchodilator (eg salbutamol). Patients should be informed of that they have always had a drug on hand for relief of acute symptoms.

Salmeterol / fluticasone propionate can be used for the initial maintenance therapy in patients with persistent asthma patients (daily occurrence of symptoms or daily use of cupping) in the presence of indications for corticosteroids and in determining their approximate dosage.

More frequent use of short-acting bronchodilators to relieve symptoms indicates deterioration of disease control, and in such situations the patient should consult a doctor.

A sudden and increasing deterioration in control of bronchospastic syndrome is a potential threat to life, and in such situations the patient should also seek medical attention. It is possible that the doctor will prescribe a higher dose of corticosteroids. If your dose Seretide® and Seretide® Multidisk does not provide adequate control of the disease, the patient should also consult a doctor, who may prescribe extra corticosteroids, and if the aggravation caused by an infection, then antibiotics.

Because of the risk of acute treatment with drugs Seretide® and Seretide® Multidisk can not abruptly stop, the dose should be reduced gradually under medical supervision.

Any inhaled corticosteroids may cause systemic effects, especially with prolonged use at high doses; It should be noted, however, that the probability of occurrence of such symptoms are much lower than in the treatment of oral corticosteroids. Possible systemic effects include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. Considering the above, the dose of inhaled corticosteroids should be titrated to the minimum, ensuring the maintenance of effective control.

In emergency and planned situations that can cause stress, you should always keep in mind the possibility of adrenal suppression and be ready to use corticosteroids.

If resuscitation or surgical procedures require a degree of adrenal insufficiency.

It is recommended to regularly measure the growth of children who receive prolonged treatment with inhaled corticosteroids.

Some patients may be more sensitive to the effects of inhaled corticosteroids than most patients.

In view of the possibility of adrenal suppression patients transferred from oral corticosteroids to inhalation of fluticasone propionate therapy should be treated with extreme caution and regular monitoring of their function of the adrenal cortex. When transferring patients receiving systemic corticosteroids allergic reactions may occur on inhalation therapy (eg allergic rhinitis, eczema), which previously suppressed by systemic GCS. In such situations, it is recommended to carry out symptomatic treatment with antihistamines and / or topical preparations, including SCS for local use.

After initiation of treatment with inhaled fluticasone propionate systemic corticosteroids should be lifted gradually, and such patients should carry a special card that contains an indication of the possible need for additional administration of SCS in stressful situations.

In patients with acute exacerbation of asthma, hypoxia necessary to control the concentration of K + in plasma.

There are very rare reports of increased blood glucose levels, and this should be remembered by assigning a combination of salmeterol with fluticasone propionate in patients with diabetes mellitus.

Conditions of supply of pharmacies

On prescription.

Storage conditions

At temperatures below 30 ° C. Do not freeze, do not expose to direct sunlight.

Keep out of the reach of children.

The shelf life

2 years.

Do not use beyond the expiration date printed on the package.