Symbicort Rapihaler, aerosol 80 mcg+4, 5 mcg/dose 120 doses

Indications

80/4.5 mcg/dose

160/4.5 mcg/dose

Active ingredient

Composition

Each dose delivered contains:

How to take, the dosage

For inhaled use.

80/4.5 µg/dose

Symbicort® is not indicated for the initial treatment of bronchial asthma.

The dosage of Symbicort® is adjusted individually and according to the severity of the disease. This must be taken into account not only when starting treatment with the combination drugs, but also when changing the maintenance dose of the drug.

Patients must have ongoing monitoring by their physician to ensure that the dose of Symbicort® Turbukhaler® is appropriately adjusted.

Symbicort® Turbuhaler® can be used according to different approaches to therapy:

B. Symbicort® Turbuhaler® as maintenance therapy and for relief of attacks/symptoms with anti-inflammatory effects.

C. Symbicort® Turbuhaler® as maintenance therapy (fixed dose).

Interaction

Special Instructions

Dosing instructions

If bronchial asthma symptoms can be controlled, the dose of Symbicort® Turbukhaler® may be gradually reduced, and it is important to monitor the patient’s condition continuously. The lowest effective dose of Symbicort® Turbuhaler® should be prescribed (see section “Dosage and administration”).

. Patients are advised to have emergency medications or Symbicort® Turbuhaler® (for patients with bronchial asthma using Symbicort® Turbuhaler® for relief of attacks/symptoms with anti-inflammatory action – therapy A or B) or short-acting beta2-adrenomimetics (for all patients using Symbicort® Turbuhaler® for maintenance therapy only – therapy C) on hand at all times.

When using Symbicort® as maintenance therapy, the patient should be reminded of the need for regular maintenance doses of the drug according to the therapy chosen, even when there are no symptoms of the disease.

Patients should be instructed to rinse their mouth with water after inhaling maintenance doses to prevent the risk of oral candidiasis and pharyngeal candidiasis. It is also necessary to rinse the mouth with water after inhalation on demand if oral and pharyngeal candidiasis develops.

It is recommended that the maintenance dose of the drug be gradually reduced before discontinuing treatment, and abrupt withdrawal of treatment is not recommended. Inhaled glucocorticosteroids should not be completely withdrawn unless temporary withdrawal is necessary to confirm a diagnosis of bronchial asthma.

Symbicort® Turbukhaler® 80/4.5 mcg/dose is not indicated for patients with mild to severe bronchial asthma.

Enhancement of symptoms

An exacerbation and development of serious adverse events associated with bronchial asthma may occur during therapy with Symbicort® Turbuhaler®. Patients should continue treatment, but should seek medical attention if bronchial asthma symptoms are not controlled or if their condition worsens after starting therapy.

If therapy is not effective enough or the maximum recommended doses of Symbicort® are exceeded, the therapy should be reconsidered. Unexpected and progressive worsening of bronchial asthma or COPD symptom control is a potentially life-threatening condition and requires urgent medical intervention. In this situation, consideration should be given to increasing the dose of glucocorticosteroids, such as prescribing a course of oral glucocorticosteroids, or antibiotic treatment if infection has set in. In severe exacerbations, monotherapy with a combination inhaled glucocorticosteroid and a long-acting beta2-adrenomimetic is insufficient.

Transfer from oral therapy

. If there is reason to believe that adrenal function has been impaired on prior systemic glucocorticosteroid therapy, precautions should be taken when transferring patients to Symbicort® treatment.

The benefits of inhaled budesonide therapy generally minimize the need for oral glucocorticosteroids, but patients who discontinue oral glucocorticosteroid therapy may have long-term impaired adrenal function. Patients who in the past have required urgent high-dose glucocorticosteroids or have received long-term treatment with high-dose inhaled glucocorticosteroids may also be at risk. Additional glucocorticosteroids should be considered in times of stress or surgery.

Associates

Symbicort® Turbuhaler® contains lactose (< 1 mg/inhalation). Usually this amount does not cause problems in patients with lactose intolerance.

Cautions for Certain Conditions

Precaution should be taken when treating patients with prolonged QT-s interval. Taking formoterol may cause prolongation of the QTc-interval.

In co-administration of beta2-adrenomimetics with drugs that may cause or exacerbate hypokalemic effects, such as xanthine derivatives, steroids, or diuretics, the hypokalemic effects of beta2-adrenomimetics may be enhanced. Special precautions should be observed in patients with unstable bronchial asthma who use short-acting bronchodilators to relieve attacks, in exacerbation of severe bronchial asthma, since the risk of hypokalemia increases against hypoxia and in other conditions, when the possibility of hypokalemic effect increases. In such cases it is recommended to monitor serum potassium content.

The blood glucose concentration in patients with diabetes mellitus should be monitored during treatment.

The necessity of use and dose of inhaled glucocorticosteroid should be reconsidered in patients with active or inactive pulmonary tuberculosis, fungal, viral or bacterial respiratory infections.

Systemic action

Systemic action can occur with any inhaled glucocorticosteroid, especially when using high doses over a long period of time. Systemic effects are less likely to occur with inhaled therapy than with oral glucocorticosteroids. Possible systemic effects include suppression of adrenal function, growth retardation in children and adolescents, decreased bone mineral density, cataracts and glaucoma.

Because of the potential effect of inhaled glucocorticosteroids on bone mineral density, special attention should be paid to patients taking high doses of the drug over a long period of time with risk factors for osteoporosis. Studies of long-term use of inhaled budesonide in children at an average daily dose of 400 mcg (measured dose) or in adults at a daily dose of 800 mcg (measured dose) showed no significant effect on bone mineral density. There are no data regarding the effect of high doses of Symbicort® Turbukhaler® on bone mineral density.

Paradoxical bronchospasm

As with any other inhalation therapy, paradoxical bronchospasm may occur with immediate increased wheezing after administration of the drug dose. Therefore Simbicort® should be discontinued, the therapy should be reconsidered, and alternative therapy should be prescribed if necessary.

Population of pediatric patients

The growth of children receiving long-term inhaled glucocorticosteroid therapy should be monitored regularly. If growth retardation is established, therapy should be revised to reduce the dose of inhaled glucocorticosteroid. The ratio of the benefit of glucocorticosteroid therapy to the possible risk of growth retardation should be carefully evaluated. It is recommended that a pediatric pulmonologist be consulted when choosing therapy.

Based on limited research data on long-term glucocorticosteroid use, most children and adolescents receiving inhaled budesonide therapy will eventually achieve growth rates normal for adults. However, minor short-term growth retardation has been reported, mostly in the first year of treatment.

Population of patients with COPD

The data from clinical studies of Simbicort® Turbuhaler® in patients with COPD with prebronchodilator SPH1 > 50% of proper and post-bronchodilatation BEP1 < 70% of proper are not available (see Pharmacodynamics section).

Clinical studies and meta-analyses have shown that the use of inhaled glucocorticosteroids in COPD maintenance therapy can lead to an increased risk of pneumonia. Physicians should be aware of the possibility of pneumonia in patients with COPD, because clinical signs of pneumonia and exacerbations often coincide.

Influence on ability to drive vehicles, mechanisms Simbicort® Turbukhaler® has no effect on the ability to drive vehicles and mechanisms. May affect the ability to drive and operate vehicles if side effects develop.

Synopsis

Contraindications

Side effects

An increase in the incidence of adverse reactions has not been observed with budesonide and formoterol. The most common adverse reactions associated with the use of the drug are adverse events pharmacologically expected for b2-adrenomimetics, such as tremor and palpitations; symptoms are usually of moderate severity and resolve on their own after a few days of treatment.

The adverse reactions associated with the use of budesonide or formoterol are listed below by organ system class and frequency of occurrence. The frequency of reactions is graded as follows: very common (≥1/10), common (≥1/100, < 1/10), infrequent (≥1/1000, < 1/100), rare (≥1/10000, < 1/1000), very rare (< 1/10000).

Infections and invasions: frequently – candidiasis of mucous membrane of the mouth and throat, pneumonia (in patients with COPD)

Intestinal system disorders: frequently – immediate and delayed-type hypersensitivity reactions (e.g., dermatitis, exanthema, urticaria, skin itching, angioedema, anaphylactic reaction)

Metabolism and nutrition disorders: frequently – hypokalemia; very rarely – hyperglycemia, signs or symptoms of systemic effects of glucocorticosteroids (including adrenal hypofunction)

Mental disorders: infrequent – psychomotor agitation, anxiety, sleep disorders; very rare – depression, behavioral disorders (mainly in children)

Nervous system disorders: frequent – headache, tremor; infrequent – dizziness; very rare – taste disorders

Cardiovascular disorders: frequent – palpitations; infrequent – tachycardia; rare – arrhythmia (e.g., atrial fibrillation, supraventricular tachycardia, extrasystole); very rare – angina pectoris, blood pressure fluctuations

Relatory system, chest and mediastinal organ disorders: often – cough, hoarseness of voice, mild irritation of the pharyngeal mucosa; rarely – bronchospasm

Gastrointestinal tract disorders: infrequently – nausea

Skin and subcutaneous tissue disorders: infrequently – bruising

Skeletal, muscular and connective tissue disorders: infrequent – muscle cramps

Systemic effects of inhaled glucocorticosteroids may occur when high doses are used for prolonged periods of time.

The use of b2-adrenomimetics may increase blood levels of insulin, free fatty acids, glycerol and ketone bodies.

Overdose

Pregnancy use

Similarities