Instruction for use: Foradil Combi

Active substance: Budesonide + Formoterol

ATX Code R03AK07 Budesonide + Formoterol

Pharmacotherapeutic group:

Bronchodilator combination means (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

Composition

Capsules with powder for inhalation set

Formoterol capsules 1 caps.

active substance:

Formoterol fumarate dihydrate 12 mg

excipient: lactose monohydrate - 25 mg

capsule shell: gelatin, 100% - 49 mg

Budesonide capsules 1 caps.

active substance:

budesonide 200 mcg

400 mcg

Excipients: lactose monohydrate - 24.77 / 24.54 mg

capsule shell

cap: iron oxide red (E172) - 0.086 / 0.12%, m / m; titanium dioxide (E171) - 2 / 2.46% m / m; Black iron oxide (E172) - 0 / 0.075% w / w; carmine dye (Ponceau 4R) - 0 / 0.04% m / m; water - 15 / 14.5% m / m; gelatin - 83 / 82.8% m / m

Housing: Water - 14.5 / 14.5%, m / m; Gelatin - 85.5 / 85.5% m / m

Pharmacological Properties
Pharmachologic effect

anti-inflammatory, bronchodilatory, antiallergic.

pharmacodynamics

anti-inflammatory, bronchodilatory, antiallergic, immunosuppressive, glucocorticoid, beta 2-agonists.

Dosing and Administration

Inhalation, only with the help of a special device - Aerolayzera that comes in the package. Formoterol and budesonide are intended for inhalation application - preparations are capsules with powder for inhalation.

Formoterol and budesonide should be prescribed individually, the lowest effective dose.

Upon reaching the control of asthma symptoms during therapy with formoterol is necessary to consider the possibility of gradually reducing the dose. Reducing formoterol dose is carried out under regular medical supervision.

Against the backdrop of worsening asthma not treated formoterol or change the dose of the drug. Formoterol should not be used for the relief of acute asthma attacks.

When carrying out treatment using an inhalation device must be progressively select the dose to doses sufficient to maintain therapeutic effect.

Budesonide + formoterol

Preliminary inhalation of β-adrenomimetic dilates the bronchi, improves the flow of budesonide in the airways and enhances its therapeutic effect, so the maintenance treatment of asthma and COPD is conducted in the following sequence:

- Inhalation of formoterol;

- Inhalation of budesonide.

Adults

1. The dose of formoterol for regular maintenance therapy - 12-24 mcg (contents of 1-2 capsules.) 2 times a day.

Do not exceed the maximum recommended dose for adults of the drug (48 mg / day).

Given that the maximum daily dose of formoterol is 48 mg, if necessary, in addition can be used 12-24 mg / day for the relief of asthma symptoms. If you need to use additional doses of the drug ceases to be episodic (eg becoming more often than two days per week), the patient should consult a physician for consideration of treatment change, because this may indicate a worsening of the disease course.

2. Minimum dose of budesonide per capsule is 200 mg. It should not be prescribed the drug, if you want to use a single dose of less than 200 micrograms. In adult patients with asthma mild treatment is initiated with a minimum effective dose of 200 mg / day. Supportive budesonide dose for adults - 400-800 mg / day in 2 divided doses (200-400 mg 2 times a day).

During exacerbation of asthma during the transfer of the patient with the use of dosage forms GCS oral to inhaled or dose reduction of dosage forms GCS for oral budesonide can be administered at a dose of 1600 mg / day in 2-4 reception.

Children ≥6 years old

1. The dose of formoterol for regular maintenance therapy is 12 mg 2 times a day. The maximum recommended dose - 24 mg / day.

2. In the absence of clinical experience on use in children under 6 years of budesonide should not be administered to patients in this age group.

Treatment of children with bronchial mild asthma should start with a dose of 200 mg / day.

budesonide dose for regular maintenance therapy is 100-200 mg 2 times a day. If necessary, the dose of budesonide may be increased to a maximum of - 800 mg / day.

Special patient groups

Impaired renal function. No data on the need to correct the dose in patients with impaired renal function. Based on pharmacokinetic budesonide when used inside unlikely that such patients the systemic exposure of the drug can vary clinically significant.

Abnormal liver function. No data on the need to correct the dose in patients with impaired hepatic function, however, budesonide derived primarily by the liver. In connection with this drug should be used with caution in patients with impaired liver function severe. Patients with impaired liver function mild or moderate severity unlikely to significantly change the impact of the drug, taking into account the pharmacokinetic parameters for budesonide when administered.

Elderly patients (over 65 years). No Information about the necessity of correction dose in patients over 65 years.

Instructions for inhalation

To ensure proper use of the drug the nurse or doctor should teach the patient proper technique of using an inhaler; clarify that the use capsules with powder for inhalation should be only through Aerolayzera; warn the patient that the capsules are intended for inhalation use only and are not intended to be swallowed. In children and adolescents inhaled budesonide and formoterol should be under adult supervision. Make sure that the child is correctly performing the inhalation technique.

It is important to warn the patient that the destruction of small pieces of gelatinous capsules of gelatin as a result of inhalation can get into the mouth or throat. In order to reduce this phenomenon to a minimum, do not pierce the capsule 1 once more.

To take out a capsule from the blister pack immediately before application (see. Also instructions for use Aerolayzera).

Rinse the mouth with water after inhalation of budesonide can prevent irritation of the mouth and throat, as well as reduce the risk of systemic adverse events.

There are anecdotal reports of accidental ingestion of capsules of the drug entirely. Most of these cases are not associated with the development of adverse events. A nurse or doctor should teach the patient proper technique of the drug, especially after the inhalation of the patient is not breathing comes improvement.

Instructions for use Aerolayzera

1. It is necessary to remove the cap from Aerolayzera.

2. It is hard to keep Aerolayzer the base and turn the mouthpiece in the direction of the arrow.

3. Place the capsule in a cell located at the base Aerolayzera (it has a capsule shape). Keep in mind that removing the capsule from the blister pack should be immediately prior to inhalation.

4. Turn the mouthpiece should be closed Aerolayzer.

5. Hold Aerolayzer strictly vertical position, 1 time should push before the end of the blue buttons on the sides. Then let them go.

Note. At this stage, by puncturing it may break the capsule, so that small pieces can fall into the gelatin, mouth or throat. Since gelatin is edible, it will not cause any harm. To the capsule is not completely destroyed, it should meet the following requirements: not to pierce the capsule more than 1 times; to comply with the storage rules; removing the capsule from the blister until immediately prior to inhalation.

6. It is necessary to make a full exhalation.

7. It is necessary to take the mouthpiece into your mouth and gently tilt the head back. Tightly wrapped around the mouthpiece with his lips, even to make a quick, deep breath as much as possible. It must be a characteristic rattling sound generated by the rotation of the capsule and powder spraying. If there is no characteristic sound, it should be open Aerolayzer and see what happened to the capsule. Maybe she's stuck in a cell. In this case, you need to carefully remove the capsule. In no event should not attempt to release the capsule by repeated taps on the sides of Aerolayzera button.

8. If the characteristic sound originated by inhalation, you need to hold your breath as long as possible. At the same time, it should remove the mouthpiece out of his mouth. Then exhale. Open Aerolayzer and see not stayed there in a capsule powder. If the capsule remained powder, re-do the steps described in paragraphs 6-8.

9. After the inhalation procedure, you must open the Aerolayzer, remove the empty capsule, close mouthpiece and Aerolayzer cap.

Care Arolayzerom: to remove the powder residue should be wiped with a mouthpiece and a cell with a dry cloth. You can also use a soft brush.

release Form

Capsules with powder for inhalation set. On 10 caps. formoterol 12 mcg in blister. On 10 caps. budesonide 200 mcg or 400 in the blister. On 6 bl. capsules with formoterol and 6 bl. capsules with budesonide with the device for inhalation (Aerolayzer) in a carton box.

Conditions of supply of pharmacies

On prescription.

Storage product

In a dry place at a temperature no higher than 25 ° C.

Keep out of the reach of children.

Shelf-life

2 years.

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