Formisonide-native - instructions for use, doses, side effects, contraindications

Active substanceBudesonide + FormoterolBudesonide + Formoterol

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Formisonide®-native

powder d / inhal.

NATIVA, LLC Russia

Dosage form: & nbspPinhalation powder dosed.

Composition:

Per one capsule:

Active substance:	80 μg + 4.5 μg	160 μg + 4.5 μg	320 μg + 9 μg
Budesonide	80 μg	160 μg	320 μg
Formoterol fumarate dihydrate	4.5 μg	4.5 μg	9 μg
Excipients:
Sodium benzoate	0.02 mg	0.02 mg	0.02 mg
Lactose Monohydrate	up to 12.0 mg	up to 12.0 mg	up to 12.0 mg
Capsule:
Caramel dye	1,4388%	-	-
Dye of chlorophyllin-copper sodium and potassium	-	-	0,2%
Hypromellose	up to 100%	100%	up to 100%

Description:

Dosage of 80 mcg + 4.5 mcg: hard capsules No. 3, transparent, light brown in color. Dosage 160 mcg + 4.5 mcg: hard capsules № 3, transparent, colorless, with a slightly yellowish tinge.

Dosage of 320 μg + 9 μg: hard capsules number 3, transparent, green.

The contents of capsules are white or almost white powder.

Pharmacotherapeutic group:bronchodilating agent combined (beta2-adrenomimetic selective + glucocorticosteroid local)

ATX: & nbsp

R.03.A.K.07 Formoterol and budesonide

Pharmacodynamics:

Formisonide®-native - combined preparation, contains formoterol and budesonide, which have different mechanisms of action and have an additive effect on the severity of symptoms of bronchial asthma (BA), improving lung function and reducing the frequency of exacerbations of bronchial asthma and chronic obstructive pulmonary disease (COPD).

The special properties of budesonide and formoterol make it possible to use their combination in the treatment of bronchial asthma at the same time as maintenance therapy and for relief of seizures, or as maintenance therapy.

Budesonide - Glucocorticosteroid (GCS), after inhalation in the recommended doses has a rapid (within a few hours) and a dose-dependent anti-inflammatory effect on the respiratory tract, reducing the severity of symptoms and the frequency of exacerbations of bronchial asthma. With the appointment of inhaled budesonide, there is a lower incidence of serious adverse effects than with systemic GCS. Budesonide reduces the severity of the edema of the bronchial mucosa, the production of mucus, the formation of sputum and hyperreactivity of the respiratory tract.The exact mechanism of the anti-inflammatory effect of GCS is unknown.

Formoterol - selective β₂-adrenomimetic (selective agonist β₂- adrenergic receptors), causes rapid and prolonged relaxation of the smooth muscles of the bronchi in patients with reversible airway obstruction.

The bronchodilator effect is dose-dependent, occurs within 1-3 minutes after inhalation and persists for at least 12 hours after taking a single dose.

Effect of the drug Formisonide®-native on lung function corresponds to the action of a combination of mono preparations budesonide and formoterol and exceeds the action of one budesonide.

Pharmacokinetics:

Pharmacokinetic parameters for the relevant substances are comparable after administration of budesonide and formoterol in the form of monopreparations and in combination. For budesonide, when administered as a combination preparation, the area under the concentration-time curve (AUC) a little more, the absorption of the drug is faster and the maximum concentration in the blood plasma is higher.

For formoterol, when administered in a combination preparation, the maximum concentration in the blood plasma coincides with that for a mono drug.

32-44% of the dose of inhaled budesonide precipitates in the lungs, where it is rapidly absorbed and reaches its maximum concentration (C_mOh) in 20-30 minutes. Systemic bioavailability is approximately 39-49% of the delivered dose. The cumulation index for budesonide (when taking 2 inhalations 2 times a day) is 1.32.

After taking budesonide inside, peak C_mOh in plasma occurs after 1-2 hours. Absolute systemic bioavailability - 6-13% of the inhaled dose.

28-49% of the dose of inhaled formoterol precipitates in the lungs, where it is quickly absorbed and reaches its maximum concentration 5-10 minutes after the inhalation. Systemic bioavailability is about 61% of the delivered dose. The cumulation index for formoterol (when administered 2 inhalations 2 times a day) is 1.77.

Distribution

Budesonide almost does not bind to corticosteroid-binding globulin. Binding to plasma proteins is constant for budesonide in the concentration range (1-100 nmol / L) for both recommended doses and exceeded, and is approximately 90%.

The volume of budesonide distribution is about 3 l / kg.

Budesonide penetrates into breast milk.

Formoterol: in the entire concentration range of 10-500 nmol / L, binding to plasma proteins for RR and SS enantiomers of formoterol - 46% and 58%, respectively, on average - 50%.

The volume of distribution is formoterol - 4 l / kg.

Metabolism

Budesonide is subjected to intensive biotransformation (about 90%) with a "first pass" through the liver with the formation of metabolites with low glucocorticosteroid activity. Metabolism budesonide is carried out mainly with the participation of isoenzyme CYP3A4. Glucocorticosteroid activity of the main metabolites - 6-β-hydroxybuddesonide and 16-α-hydroxy-prednisolone - does not exceed 1% similar activity of budesonide.

Formoterol metabolized mainly in the liver with the participation of enzymes CYP2D6 and CYP2C by conjugation with the formation of active O-demethylated metabolites, mainly inactivated conjugates. Secondary metabolism involves the destruction of the molecule and sulfate conjugation.

There is no evidence for the interaction of metabolites or substitution reactions between budesonide and formoterol.

Excretion

Budesonide is excreted in urine and feces in the form of conjugates and only in a small amount - unchanged. Budesonide has a high system clearance (approximately 1.2 l / min). The half-life (T₁_/₂) budesonide is from 2 to 3.6 hours.

Formoterol: after inhalation, 8-13% of the delivered dose of formoterol is excreted unchanged in urine (62%) and feces (24%). Formoterol has a high system clearance (approximately 1.4 l / min). The half-life (T₁_/₂) is an average of 17 hours.

Pharmacokinetics in special clinical cases

The pharmacokinetics of formoterol in patients with renal insufficiency have not been studied. The concentration of budesonide and formoterol in blood plasma can be increased in patients with liver disease.

Indications:

- Bronchial asthma, as maintenance therapy and for the management of seizures (insufficiently controlled by the use of inhaled glucocorticosteroids and β₂-adrenomimetics of short-acting as therapy on demand, or adequately controlled by inhaled GCS and β₂long-acting adrenomimetics);

- chronic obstructive pulmonary disease (symptomatic therapy in patients with severe COPD with FEV₁ <50% of the estimated calculated level and with repeated exacerbations in the anamnesis, in the presence of severe symptoms of the disease, despite the therapy with long-acting bronchodilators).

Contraindications:

- Hypersensitivity to budesonide, formoterol or any other auxiliary component of the drug;

- intolerance to galactose, deficiency of lactase or glucose-galactose malabsorption;

- age to 18 years.

Carefully:

Caution should be applied Formisonide®-native patients with pulmonary tuberculosis (active and inactive form), with fungal, viral or bacterial infections of the respiratory system, thyrotoxicosis, hypothyroidism, pheochromocytoma, diabetes mellitus, ketoacidosis, uncontrolled hypokalemia, idiopathic hypertrophic subaortal stenosis, severe arterial hypertension, aneurysm of any site or other severe cardiovascular diseases (ischemic heart disease, tachyarrhythmia or severe heart failure), lengthening QTc-Interval (taking formoterol may cause lengthening QTc-interval), cirrhosis of the liver, cataract, glaucoma, convulsive disorders, allergy to lactose and milk protein in the anamnesis (since it is possible to partially swallow the drug during inhalation).

Pregnancy and lactation:

There are no clinical data on the use of the drug Formisonide®-native or combined use of budesonide and formoterol in pregnancy.

Pregnancy

During pregnancy Formisonide®-native should be used only in those cases when the benefit of using the drug exceeds the potential risk to the fetus. The lowest effective dose of budesonide needed to maintain adequate control of asthma symptoms should be used.

Lactation

Inhalable budesonide is excreted in breast milk, however, when applied in therapeutic doses, no effect on the child was noted. It is not known whether the formoterol into the breast milk of women, so Formisonide®-native may be prescribed during breastfeeding only if the expected benefit to the mother is greater than any possible risk to the child.

Dosing and Administration:

Selection of the dose of active substances that make up the drug Formisonide®-native, is carried out individually and depending on the severity of the disease. This need to be taken into account not only at the beginning of treatment with combined preparations, but also when the dose of the drug is changed.

Bronchial asthma

Formisonide®-native It is not intended for the initial treatment of bronchial asthma of intermittent and mild persistent treatment.

In the event that individual patients require a different combination of doses of active substances than in the preparation Formisonide®-Nashv, should be assigned separately to β2- adrenomimetics and / or GCS in separate inhalers.

Patients should visit the doctor regularly to monitor the optimal dose of the drug Formisonide®-native. The dose should be reduced to the lowest, against which the optimal control of symptoms of bronchial asthma remains. After achieving bronchial asthma control when taking the drug 2 times a day, it is recommended to titrate the dose to the minimum effective, up to reception 1 inhalations per day, in cases where, in the opinion of the physician, the patient needs supportive therapy in combination with a long-acting bronchodilator. At the next stage, when complete control is achieved, it is possible to try the appointment of monotherapy with inhaled glucocorticosteroids.

There are two approaches to the appointment of therapy of bronchial asthma with the drug Formisonide®-native:

A. As maintenance therapy: Formisonide®-native is prescribed for continuous maintenance therapy in combination with a single β₂short-acting adrenomimetic for relief of attacks;

B. As maintenance therapy and for relief of seizures: Formisonide®-native is prescribed for both constant maintenance therapy, and on demand when symptoms appear.

As maintenance therapy: appoint in combination with a separate β₂-adrenomimetikom short-acting for relief of attacks. The patient should always have a separate inhaler with him β₂-adrenomimetikom short-acting for relief of attacks.

Formmisone®-native 80 μg + 4.5 μg and 160 μg + 4.5 μg

The drug is prescribed for 1-2 inhalations 2 times a day. If necessary, it is possible to increase the dose to 4 inhalations 2 times a day.

Formmisone®-native 320 μg + 9 μg

The drug is prescribed for 1 inhalation 2 times a day. If necessary, an increase in the dose up to 2 inhalations 2 times a day.

Increased frequency of application 02-adrenomimetics of short action is an indicator of the deterioration of general control over the disease and requires revision of anti-asthmatic therapy.

As maintenance therapy and for the relief of attacks the drug is especially indicated for patients with insufficient control of bronchial asthma and the need for frequent use of drugs to stop seizures; with indications in an anamnesis of exacerbations of bronchial asthma requiring medical intervention. The patient must be kept with him at all times Formisonide®-native for relief of attacks.

It is necessary to carefully monitor the occurrence of dose-dependent side effects in patients who use a large number of inhalations to stop seizures.

Formmisone®-native 80 μg + 4.5 μg and 160 μg + 4.5 μg

The recommended dose is 2 inhalations per day: 1 inhalation in the morning and in the evening, or 2 inhalations once a day only in the morning or only in the evening. Some patients may receive a maintenance dose of the drug Formisonide®-native 160 mcg + 4.5 mcg 2 inhalations 2 times a day. If symptoms of bronchial asthma occur, 1 additional inhalation is necessary. With a further increase in symptoms within a few minutes, another 1 additional inhalation is prescribed, but no more than 6 inhalations for stopping 1 attack.

Usually, no more than 8 inhalations per day are required, but you can increase the number of inhalations to 12 per day for a short time. In patients who use more than 8 inhalations per day, a review of therapy is recommended.

Chronic obstructive pulmonary disease

Formmisone®-native 160 μg + 4.5 μg

Recommended dose: 2 inhalations 2 times a day.

Formmisone®-native 320 μg + 9 μg

Recommended dose: 1 inhalation 2 times a day.

Special patient groups

No data on drug use Formisonide®-native patients with hepatic insufficiency.

As budesonide and formoterol are derived mainly by the kidneys with the participation of hepatic metabolism, then in patients with severe cirrhosis of the liver, a slowing down of the drug release rate can be expected.

There is no need for a special dose selection for elderly patients.

Instructions for the use of inhaler "Inhaler CDM®"

In order to ensure the correct use of the drug, apply Formisonide®-native It is only possible with the device "Inhaler CDM®. "Capsules are for inhalation use only and are not intended for ingestion.

Remove the capsule from the cell pack immediately before use.

Instruments for the use of an inhaler Inhaler CDM®"

Inhaler CDM® "is a single-dose inhaler that allows you to dose and inhale the drug in very small doses. Formisonide®-native falls into the patient's airway along with the air streams when performing an active breath through the mouthpiece. Inhaler CDM® "is very easy to use.When using it, follow the step-by-step instructions below:

Step 1.

Remove the transparent cap from the device "Inhaler CDM® ", as shown in Figure 1.

Step 2.

Hold the device firmly with one hand, with the index finger and the thumb of the other hand, open the capsule compartment, as shown in Fig. 2. To do this, press the index finger on "PUSH" in the moving part of the inhaler "Inhaler CDM® ", moving the compartment in the opposite direction.

Step 3.

Hold the device with one hand, insert the capsule with the drug into the compartment of the compartment (Figure 3).

Step 4.

Make sure that the capsule is correctly inserted into the socket (Figure 4).

Step 5.

Holding "Inhaler CDM® "in the vertical position, close the compartment by pressing the thumb in the opposite direction until it stops, until a click is heard (Fig. 5).

Step 6.

Hold the device "Inhaler CDM® "is strictly vertical (Fig. 6).

Step 7.

Bring the device into operation, as shown in Fig. 7. To do this, press firmly onto the mouthpiece so that the arrow on the body disappears from the bottom of the device to the top line. Then release the mouthpiece to return it to its original position. Thus, you will pierce the capsule, opening access to the drug in the lumen of the mouthpiece.

Attention: Due to the destruction of the gelatin capsule, small pieces of gelatin can be inhaled into the mouth or throat. In order to reduce this phenomenon to a minimum, do not pierce the capsule more than 1 time.

Step 8.

Attention: exhale before inhalation (Fig. 8). Do not exhale through the mouthpiece!

Step 9.

Carefully squeeze the mouthpiece device "Inhaler CDM® "with your teeth, tightly grasp it with your lips and take a deep and strong breath through your mouth (Figure 9) .You will hear a vibrating sound inside the capsule compartment, released by the capsule as you rotate and disperse the drug.

Attention: the mouthpiece can not be chewed and squeezed strongly with your teeth!

Do not press on the mouthpiece when inhaled. This can block the movement of the capsule.Hold your breath for about 10 seconds or longer, as far as possible.

Remove the inhaler from the mouth. Make a slow exhalation. Then breathe normally. Repeat steps 8-9 again, to ensure that the dose of the drug is inhaled.

Step 10.

After the inhalation, open the capsule compartment (Figure 2), remove the empty capsule and then close it, as shown in Fig. 5.

Attention:

When carrying out inhalation try not to cover the holes, located on the sides of the mouthpiece. This can interfere with the free movement of air within the inhaler, thereby reducing the dispersion of the contents of the capsule.

Always close tight after use "Inhaler FROMDM® cap, this will keep the mouthpiece clean.

Regularly (once a week), you should clean the mouthpiece from the outside with a dry cloth.

Side effects:

Against the background of co-administration of budesonide and formoterol, there was no increase in incidence of adverse reactions.

Undesired reactions are distributed according to the frequency of occurrence. The following criteria were used to estimate the frequency: very often (> 1/10), often (from 1/100 to 1/10), infrequently (from 1/1000 to 1/100), rarely (from 1/10000 to 1/1000), very rarely (<1 / 10000), (including individual messages).

Infectious and parasitic diseases: often - nasopharyngitis, nasal congestion, sinusitis, upper respiratory tract infections, bronchitis, oropharyngeal candidiasis (candidiasis of mouth and throat mucosa).

Immune system disorders: rarely - Anaphylactic reactions, including angioedema (edema of Quincke); bronchospasm, including paradoxical.

Disorders from the endocrine system: rarely - hypokalemia; rarely - hyperglycemia, symptoms of systemic glucocorticosteroid effects (including hypocorticism, hypercorticism.

Disorders of the psyche: infrequently - psychomotor agitation, anxiety, anxiety, dizziness, sleep disturbances; rarely - Depression, behavioral disorders, aggressive behavior, nervousness, taste disorders.

Disorders from the central nervous system: often - headache.

Disturbances on the part of the organ of sight: rarely - Cataract, glaucoma (with prolonged use of high doses), increased intraocular pressure.

Heart Disease: often - a feeling of palpitations; infrequently - tachycardia; rarely - arrhythmias, including atrial fibrillation, supraventricular tachycardia, extrasystole; rarely - angina pectoris, atrial and ventricular tachyarrhythmia.

Vascular disorders: rarely - changes in blood pressure (arterial hypotension, arterial hypertension).

Disturbances from the respiratory system, chest and mediastinal organs: often - irritation in the throat, coughing, hoarseness of the voice; rarely - dysphonia, (disappearing after discontinuing therapy or reducing the dose of the drug).

Disorders from the gastrointestinal tract: often - discomfort in the stomach, rarely - vomiting, rarely - nausea, dysphagia (violation of swallowing).

Disturbances from the skin and subcutaneous tissues: infrequently - bruising, rarely - hives, itching, dermatitis, rash, rarely - face redness.

Disturbances from musculoskeletal and connective tissue: often - tremor, infrequently - muscle cramps; rarely - osteoporosis (reduction of bone mineral density), back pain.

The systemic effect of inhaled glucocorticosteroids can be observed when taking the drug in high doses for a long time.

The use of β₂-adrenomimetikov can lead to an increase in the blood levels of insulin, free fatty acids, glycerol, ketone derivatives.

If any of the side effects listed in the manual are aggravated or you notice any other manifestations not listed in the instructions, inform the doctor about it.

Overdose:

Symptoms: in acute overdose of budesonide, which is part of the drug Formisonide®-native, no clinically significant symptoms are expected. With chronic administration of budesonide in excessive doses, the systemic effect of SCS may be manifested.

In case of an overdose of formoterol, tremors, nervousness, insomnia, headache, dizziness, palpitations, tachycardia, angina pectoris, changes in blood pressure, metabolic acidosis, in some cases - hyperglycemia, hypokalemia, lengthening of the interval QT_C, arrhythmias, nausea, increased nervous excitability, muscle spasms.

Treatment: Supportive and symptomatic treatment is indicated.

Interaction:

With the simultaneous intake of ketoconazole at a dose of 200 mg once a day and budesonide at a dose of 3 mg, the concentration of budesonide in plasma increases by an average of 6 times.When taking ketoconazole 12 hours after taking budesonide, the concentration of the latter in the plasma increases on average by 3 times. Information on this interaction with budesonide with inhalation administration is not available, but a noticeable increase in the concentration of budesonide in the blood plasma should be expected.

Not recommended drug administration Formisonide®-native as maintenance therapy and for relieving seizures in patients receiving potent inhibitors of CYP3A4 (for example, itraconazole, ketoconazole, nelfinavir, amiodarone, clarithromycin), since there is no data for recommendations for dose selection, the above combination of drugs should be avoided. If it is impossible to avoid using a combination of these drugs, then the intervals between their methods should be maximized. You should also consider the possibility of reducing the dose of budesonide.

Formisonide®-native should not be prescribed simultaneously with β-blockers (including eye drops), since they can weaken or inhibit the action of formoterol, in addition to forced cases.

With the simultaneous use of the drug Formisonide®-native and quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), monoamine oxidase (MAO) inhibitors and tricyclic antidepressants, an interval may be longer QT_C and an increased risk of ventricular arrhythmias.

Levodopa, levothyroxine sodium, oxytocin and ethanol can reduce the tolerance of the heart muscle to β₂-adrenomimetics.

With the simultaneous administration of the drug Formisonide®-native monoamine oxidase inhibitors (MAO), as well as drugs with similar properties (furazolidone, procarbazine), it is possible to increase blood pressure.

When anesthetized with preparations of halogenated hydrocarbons against the background of the drug Formisonide®-native there is an increased risk of arrhythmia in patients.

With simultaneous reception of the drug Formisonide®-native and other β-adrenomimetic agonists, the side effect of formoterol may be increased.

Hypokalemic action of β₂-adrenomimetics can be enhanced with simultaneous administration of xanthine derivatives, mineral derivatives of GCS and diuretics.Hypokalemia increases the predisposition to the development of arrhythmias in patients taking cardiac glycosides.

Methandienone, estrogens strengthen the action of budesonide.

No interaction of budesonide with other medications used to treat bronchial asthma was noted.

Special instructions:

It is recommended to gradually reduce the dose of the drug before discontinuing treatment and it is not recommended to abruptly cancel treatment.

Dosages 80 + 4.5 μg / dose and 320 + 9 μg / dose They are not intended for the treatment of patients with severe bronchial asthma.

Formisonide®-native It is not intended for initial selection of therapy at the first stages of treatment of bronchial asthma and COPD.

If the therapy is inadequate or if the maximum recommended doses of the drug are exceeded Formisonide®-native it is necessary to revise the tactics of treatment.

An increase in the frequency of bronchodilators as an emergency medicine indicates a worsening of the course of the underlying disease and is the basis for reviewing the tactics of treating bronchial asthma.

An unexpected and progressive deterioration in the management of symptoms of bronchial asthma or COPD is potentially life threatening and requires urgent medical intervention.In this situation, one should consider the possibility of increasing the dose of GCS, that is, the administration of a course of oral GCS or treatment with antibiotics in case of infection.

Patients should always have emergency medication with them: Formisonide®-native (for patients with bronchial asthma using Formisonide®-native for maintenance therapy and for relief of seizures) or β₂short-acting adrenomimetics (for patients using Formisonide®-only for maintenance therapy).

It should be explained to the patient the need for regular intake of a maintenance dose of the drug Formisonide®-native in accordance with the selected therapy, even in those cases where there are no symptoms of the disease.

Inhalation of the drug Formmisonide®-native (80 + 4.5 μg / dose and 160 + 4.5 μg / dose) for relief of seizures should be performed only in the event of symptoms, but the use of the drug is not indicated for regular preventive use, i.e. before exercise. In such cases, the use of an individual β₂-adrenomimetics of short action.

If the symptoms of bronchial asthma are amenable to control,You can gradually reduce the dose of the drug Formisonide®-native, it is important to constantly monitor the condition of patients. The lowest effective dose should be given (see section "Dosage and Administration").

Treatment with drug Formisonide®-native Do not start in the period of exacerbation of bronchial asthma.

As with any other inhalation drug, a paradoxical bronchospasm may occur with an immediate increase in wheezing after taking a dose of the drug Formisonide®-native. In this case, discontinue drug therapy Formisonide®-native, to review the tactics of treatment and, if necessary, prescribe an alternative therapy.

When taking any inhaled glucocorticosteroids, especially when taking high doses of drugs for a long period of time, a systemic effect may occur. The manifestation of systemic action is less likely in inhalation therapy than with oral GCS. Possible systemic effects include suppression of adrenal function, reduction of bone mineral density, cataract and glaucoma.

Because of the potential effect of inhaled glucocorticosteroids on the bone mineral density, special attention should be paid to patients taking the drug at high doses for a long time with the presence of risk factors for osteoporosis. Studies of long-term use of inhaled budesonide in adults at a daily dose of 800 micrograms (metered dose) did not show a significant effect on bone mineral density. There is no data on the effect of high doses of the drug on the bone mineral density.

If there is reason to believe that, against the backdrop of previous systemic therapy of GCS, adrenal function has been disrupted, precautions should be taken when transferring patients to Formisonide®-native.

Inhaled therapy with budesonide usually minimizes the need for oral glucocorticosteroids, but patients who stop oral GCS therapy may have a long history of adrenal insufficiency. Patients who in the past needed urgent high-dose GCS or received long-term treatment with high-dose inhaled glucocorticosteroids may also be at this risk group.One should remember about the possibility of residual disturbance of adrenal function in such patients in extreme cases and any situations that can cause stress (including during surgical interventions). In such situations it is necessary to provide adequate treatment for SCS. Depending on the degree of adrenal insufficiency, specialist consultation may be required before the recommended procedures are performed.

Possible development of candidal infection of the oral cavity. To reduce the risk, patients are advised to rinse the mouth thoroughly with water after each inhalation of the drug. With the development of candidal infection of the oral cavity, it is possible to perform local antifungal therapy without stopping the treatment with the Formisonide®-native drug.

Special precautions should be taken in patients with unstable bronchial asthma who use β₂-adrenomimetiki short-acting, to relieve attacks with exacerbation of severe bronchial asthma, tk. the risk of hypokalemia increases with hypoxia and other conditions, when the likelihood of developing symptoms of hypokalemic action increases.In such cases it is recommended to monitor the potassium content in the blood serum.

During the treatment period it is necessary to control the concentration of glucose in the blood in patients with diabetes mellitus.

The use of formoterol in a dose exceeding 54 mcg / day (over 12 inhalations Formisonide®-native in doses of 80 + 4.5 μg or 160 + 4.5 μg or more than 6 inhalations in a dose of 320 + 9 μg) can lead to positive results of doping tests.

Features of the drug during its cancellation

Because of the risk of developing an exacerbation, sudden discontinuation of the drug should be avoided Formisonide®-native, the dose of the drug should be reduced gradually under the supervision of a doctor.

Effect on the ability to drive transp. cf. and fur:

In the case of development of such adverse reactions as tremor or muscle cramps, with the use of the drug Formisonide®-native should refrain from driving vehicles and controlling mechanisms, as well as from engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:Pinhalation powder dosed, 160 mcg + 4.5 mcg / dose, 320 μg + 9 μg / dose, 80 μg + 4.5 μg / dose.

Packaging:

10 capsules per circuit cell packaging made of aluminum foil and laminated aluminum foil.

For 3, 6 or 12 contour packagings together with the device for inhalation or without it, the instructions for use are placed in a cardboard box.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-003487