Instructions Symbicort Turbuhaler inhalation powder dosed 80 mcg/dose + 4.5 mcg/dose turbuhaler 60 doses
Composition
active ingredients: 1 inhalation (1 dose) contains: 80 mcg of micronized budesonide;
4.5 mcg formoterol fumarate dihydrate;
excipient: lactose monohydrate.
Dosage form
Inhalation powder, metered.
Main physicochemical properties:
Inhaler (60 doses): Red rotating dispenser. Braille code embossed on the rotating dispenser. White cap. There are five ribs inside the cap.
The number 60 is visible in the dosage indicator window. The nozzle has four rods and can rotate.
Contents: white to off-white content, mainly in the form of rounded granules.
Inhaler (120 doses): red rotating dispenser. Braille code is embossed on the rotating dispenser. White cap. There are five ribs inside the cap.
The number 120 is visible in the dosage indicator window. The nozzle has four rods and can rotate.
Contents: white to off-white content, mainly in the form of rounded granules.
Pharmacotherapeutic group
Adrenergic agents in combination with corticosteroids or other drugs, except anticholinergics. Formoterol and budesonide.
ATX code R03A K07.
Pharmacological properties
Pharmacodynamics.
Mechanisms of action and pharmacodynamic effects
Symbicort Turbuhaler contains formoterol and budesonide, which have different mechanisms of action and exhibit an additive effect in reducing the frequency of exacerbations of bronchial asthma. The specific properties of budesonide and formoterol allow the combination to be used for maintenance therapy and symptom relief or for maintenance therapy of bronchial asthma.
Budesonide
Budesonide is a glucocorticosteroid that, when inhaled, exerts a dose-dependent anti-inflammatory effect in the airways, leading to a reduction in symptoms and a decrease in the frequency of exacerbations of bronchial asthma. Inhaled budesonide causes fewer adverse reactions than systemic corticosteroids. The exact mechanism responsible for the anti-inflammatory effect of glucocorticosteroids is unknown.
Formoterol
Formoterol is a selective β2-adrenergic agonist that, when inhaled, produces rapid and long-lasting relaxation of bronchial smooth muscle in patients with reversible airway obstruction. The bronchodilator effect is dose-dependent, with onset of action within 1–3 minutes. The duration of effect after a single dose is at least 12 hours.
Clinical efficacy and safety
Clinical efficacy of budesonide/formoterol maintenance therapy
Clinical studies in adult patients showed that adding formoterol to budesonide relieved asthma symptoms and improved lung function and reduced the frequency of exacerbations.
In two 12-week studies, the effect of the fixed combination of budesonide/formoterol on lung function was similar to that of the free combination of budesonide and formoterol and was superior to budesonide alone. All treatment groups used short-acting β2-adrenergic agonists as needed. There was no evidence of a loss of antiasthmatic effect over time.
Two 12-week studies were conducted in paediatric patients in which 265 subjects aged 6-11 years were treated with maintenance doses of budesonide/formoterol (2 inhalations of 80 mcg/4.5 mcg/inhalation twice daily) and a short-acting β2-adrenergic agonist as needed. In both studies, improvements in lung function were observed and the treatment was well tolerated compared with the corresponding dose of budesonide alone.
Clinical efficacy of maintenance therapy and the use of budesonide/formoterol for symptom relief
The use of budesonide/formoterol for maintenance therapy and for symptom relief provided a statistically and clinically significant reduction in the frequency of severe asthma exacerbations compared with all other therapies.
Comparable efficacy and safety in adolescents and adults were demonstrated in 6 double-blind studies, including 5 of the above studies and one additional study using a higher maintenance dose of two inhalations of 160/4.5 mcg twice daily. The estimates were based on data from a total of 14,385 asthma patients, of whom 1,847 were adolescents. The number of adolescent patients who used more than 8 inhalations of the drug on at least one day as part of the maintenance and reliever therapy of budesonide/formoterol was limited and this use was infrequent.
In studies involving patients seeking medical attention for acute asthma symptoms, budesonide/formoterol provided rapid and effective relief of bronchospasm symptoms similar to salbutamol and formoterol.
Pharmacokinetics.
The fixed-dose combination of budesonide and formoterol and the respective monoproducts were bioequivalent with respect to systemic exposures of budesonide and formoterol. However, a small increase in cortisol suppression was observed with the fixed-dose combination compared to the single agents. The difference was considered not to be clinically significant with respect to safety.
There was no evidence of a pharmacokinetic interaction between budesonide and formoterol.
The pharmacokinetics of the respective substances were similar after administration of budesonide and formoterol as monodrugs or as part of a fixed-dose combination. After administration of the fixed combination, the AUC of budesonide was slightly higher, the absorption rate and maximum plasma concentration were slightly higher than when administered separately. The maximum plasma concentration of formoterol after administration of the fixed combination was similar to that after administration of the monodrug. Inhaled budesonide is rapidly absorbed; plasma concentrations reach a maximum within 30 minutes after inhalation. In studies, the mean pulmonary deposition of budesonide after inhalation via a powder inhaler ranged from 32% to 44% of the delivered dose. The systemic bioavailability is approximately 49% of the delivered dose. In children aged 6–16 years, pulmonary deposition varies in the same range as in adults at the same doses. Corresponding plasma concentrations have not been determined.
Inhaled formoterol is rapidly absorbed; plasma concentrations peak within 10 minutes after inhalation. In studies, mean pulmonary deposition of formoterol after inhalation via a dry powder inhaler ranged from 28% to 49% of the delivered dose. Systemic bioavailability is approximately 61% of the delivered dose.
Distribution and metabolism
Approximately 50% of formoterol and 90% of budesonide are bound to plasma proteins. The volume of distribution of formoterol is approximately 4 l/kg, of budesonide – 3 l/kg. Formoterol is inactivated by conjugation reactions (active O-demethylated and deformylated metabolites are formed, but they are present mainly in the form of inactivated conjugates). Budesonide undergoes significant (approximately 90%) biotransformation during the first pass through the liver with the formation of metabolites with low glucocorticosteroid activity. The glucocorticosteroid activity of the main metabolites, 6-β-hydroxy-budesonide and 16-α-hydroxy-prednisolone, does not exceed 1% of the similar activity of budesonide. There are no signs of metabolic interaction or substitution reactions between formoterol and budesonide.
Breeding
The majority of the dose of formoterol undergoes hepatic metabolism and is subsequently excreted by the kidneys. After inhalation, 8-13% of the delivered dose of formoterol is excreted unchanged in the urine. Formoterol has a high systemic clearance (approximately 1.4 l/min), its terminal half-life is on average 17 hours.
Budesonide is metabolized mainly by the enzyme CYP3A4. Budesonide metabolites are excreted in the urine in unchanged or conjugated form. Only a small amount of unchanged budesonide is detected in the urine. Budesonide has a high systemic clearance (approximately 1.2 l/min), and its plasma half-life after intravenous administration is on average 4 hours.
The pharmacokinetics of formoterol in children have not been studied. The pharmacokinetics of budesonide and formoterol in patients with renal insufficiency are unknown. In patients with liver disease, blood exposure to budesonide and formoterol may be increased.
Linearity/nonlinearity
Systemic exposure to budesonide and formoterol is linearly correlated with the applied dose.
Indication
Symbicort Turbuhaler, 80 mcg/4.5 mcg, is indicated for use in adults, adolescents and children aged 6 years and over.
Symbicort Turbuhaler is prescribed for the regular treatment of bronchial asthma when combination therapy (inhaled corticosteroid and long-acting β2-agonist) is appropriate:
patients whose condition is not adequately controlled with inhaled corticosteroids and short-acting β2-agonists used as needed, or
patients adequately controlled with inhaled corticosteroids and long-acting β2-agonists.
Symbicort Turbuhaler (80 mcg/4.5 mcg/dose) is not suitable for the treatment of patients with severe bronchial asthma.
Contraindication
Hypersensitivity to the active substances or excipients listed in the "Composition" section (lactose, which contains small amounts of milk proteins).
Interaction with other medicinal products and other types of interactions
Pharmacokinetic interactions.
The potent CYP3A4 inhibitor ketoconazole, administered at a dose of 200 mg once daily, increased the plasma concentration of oral budesonide (3 mg as a single dose) by an average of 6-fold when administered concomitantly. When ketoconazole was administered 12 hours after budesonide, the concentration of budesonide increased by an average of 3-fold, indicating that separating the drugs with a certain interval may reduce the increase in plasma concentration of budesonide. Limited data on this interaction with high doses of inhaled budesonide indicate that when itraconazole 200 mg once daily was administered concomitantly with inhaled budesonide (1000 μg as a single dose), plasma levels of budesonide may be markedly increased (on average by four-fold).
Pharmacodynamic interactions
Beta-blockers may weaken or inhibit the effect of formoterol. Therefore, Symbicort Turbohaler should not be used together with beta-blockers (including eye drops) unless there are compelling reasons for this.
Concomitant use of quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine), and tricyclic antidepressants may prolong the QTc interval and increase the risk of ventricular arrhythmias.
In addition, L-dopa, L-thyroxine, oxytocin, and alcohol may impair the cardiac tolerance of β2-sympathomimetics.
Concomitant use of monoamine oxidase inhibitors, including drugs with similar properties such as furazolidone and procarbazine, may provoke hypertensive reactions.
Patients receiving concomitant anesthesia with halogenated hydrocarbons are at increased risk of developing arrhythmias.
Concomitant use of other β-adrenergic or anticholinergic drugs may have a potentially additive bronchodilator effect.
Hypokalemia may increase the susceptibility to arrhythmias in patients taking digitalis glycosides.
Hypokalemia may occur as a result of β2-agonist therapy and may be potentiated by concomitant use of xanthine derivatives, corticosteroids and diuretics (see section "Special warnings and precautions for use").
No interactions of budesonide and formoterol with any other drugs used to treat bronchial asthma have been observed.
Children
Interaction studies have only been conducted in adult patients.
Application features
If treatment needs to be discontinued, it is recommended to gradually reduce the dose rather than abruptly discontinue therapy.
If, in the opinion of the patient, the treatment is ineffective or the maximum recommended daily dose of Symbicort Turbuhaler has been exceeded, a doctor should be consulted (see section "Method of administration and dosage"). Sudden and progressive deterioration in control of bronchial asthma is potentially life-threatening, so the patient should urgently undergo a medical examination. In such cases, the need for increased corticosteroid therapy should be considered, for example, by prescribing a course of oral corticosteroids or antibiotic treatment in the presence of a bacterial infection.
The patient should be advised to always carry a "reliever" inhaler: either Symbicort Turbohaler (for patients using Symbicort Turbohaler as maintenance therapy and for symptom relief), or a separate fast-acting bronchodilator (for patients using Symbicort Turbohaler as maintenance therapy only).
Patients should be reminded to continue their maintenance treatment with Symbicort Turbohaler as prescribed, even if they are asymptomatic. The prophylactic use of Symbicort Turbohaler, e.g. before exercise, has not been studied. Symbicort Turbohaler reliever inhalers should only be used when asthma symptoms occur and are not intended for regular prophylactic use, e.g. before exercise. For this purpose, the use of a separate rapid-acting bronchodilator should be considered.
Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Symbicort Turbohaler. It is important that patients are re-evaluated during dose reduction. The lowest effective dose of Symbicort Turbohaler should be used (see section 4.2).
Patients should not start taking Symbicort Turbuhaler during an exacerbation, acute or significant worsening of bronchial asthma.
As with any inhalation therapy, paradoxical bronchospasm may occur with immediate worsening of wheezing and dyspnoea after dosing. If a patient develops paradoxical bronchospasm, Symbicort Turbohaler should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary. Paradoxical bronchospasm, which should be treated immediately, is managed with rapid-acting inhaled bronchodilators (see section 4.8).
Systemic effects may occur with the use of any inhaled corticosteroid, particularly at high doses and during prolonged treatment. The likelihood of such effects is much lower with inhaled forms of corticosteroids than with oral forms. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density, cataracts and glaucoma and, less commonly, psychological or behavioural changes, including psychomotor hyperactivity, sleep disturbances, anxiety, depression or aggression (particularly in children) (see section 4.8).
In long-term studies of inhaled budesonide at an average daily dose of 400 micrograms (metered dose) in children or 800 micrograms (metered dose) in adults, no significant effect on bone mineral density was observed. There is no information on the effects of Symbicort Turbuhaler at higher doses.
If there is reason to believe that adrenal function has been impaired on the background of previous systemic steroid therapy, precautions should be taken when transferring patients to treatment with Symbicort Turbuhaler.
The benefits of inhaled budesonide therapy generally minimize the need for oral steroids, but patients who have previously used oral steroids may still be at risk of adrenal insufficiency for a long time. Recovery from oral steroids may take a long time, so patients who have previously used oral corticosteroids and are transferred to inhaled budesonide may remain at risk for adrenal insufficiency for a long time. In such cases, regular monitoring of the hypothalamic-pituitary-adrenal axis is necessary.
Prolonged treatment with high doses of inhaled corticosteroids, especially at doses higher than recommended, may also lead to clinically significant suppression of adrenal function. Therefore, additional systemic corticosteroids should be considered during periods of stress, such as during severe infectious diseases or elective surgery. Rapid reduction of steroid doses may precipitate acute adrenal crisis. Symptoms and signs that may occur during acute adrenal crisis are not always clear-cut but may include anorexia, abdominal pain, weight loss, fatigue, headache, nausea, vomiting, decreased level of consciousness, convulsions, hypotension and hypoglycaemia.
Treatment with additional systemic steroids or inhaled budesonide should not be abruptly discontinued.
When switching from oral steroid therapy to Symbicort Turbuhaler, there will usually be a lower systemic exposure to steroids and this may lead to the development of allergy or arthritis symptoms such as rhinitis, eczema and muscle and joint pain. If these conditions develop, specific treatment should be initiated. Usually, an insufficient effect of glucocorticosteroids can be suspected if symptoms such as fatigue, headache, nausea and vomiting occur, although this is rare. In such cases, it may be necessary to temporarily increase the dose of oral glucocorticosteroids.
To reduce the risk of oropharyngeal candidiasis (see section 4.8), the patient should be instructed to rinse their mouth with water after each maintenance dose. If oropharyngeal candidiasis is present, the mouth should be rinsed with water after inhalation of the medicinal product as needed.
Concomitant use of itraconazole, ritonavir or other potent CYP3A4 inhibitors should be avoided (see section 4.5). If this is not possible, the time interval between the use of the interacting drugs should be as long as possible. Symbicort Turbohaler is not recommended for use in patients taking potent CYP3A4 inhibitors for maintenance therapy and relief of symptoms.
Symbicort Turbuhaler should be used with caution in patients with thyrotoxicosis, pheochromocytoma, diabetes mellitus, untreated hypokalemia, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe arterial hypertension, aneurysm or other severe cardiovascular diseases such as ischemic heart disease, tachyarrhythmia or severe heart failure.
The need for and dose of inhaled corticosteroids should be reviewed in patients with active or inactive pulmonary tuberculosis, fungal or viral respiratory tract infections.
When using β2-adrenergic agonists in high doses, the development of potentially serious hypokalemia is possible. With simultaneous treatment with β2-adrenergic agonists and drugs that can cause hypokalemia or enhance the hypokalemic effect (for example, xanthine derivatives, steroids and diuretics), the hypokalemic effect of β2-adrenergic agonists may be enhanced. Particular caution should be exercised in patients with unstable bronchial asthma, requiring frequent use of bronchodilators to relieve symptoms, as well as in acute severe bronchial asthma, since the risk of hypokalemia is increased against the background of hypoxia and other conditions that increase the likelihood of developing such a complication. In such cases, it is recommended to monitor serum potassium levels.
As with other β2-adrenergic agonists, additional monitoring of blood glucose levels is required in patients with diabetes.
Visual disturbances may occur with systemic and topical corticosteroids. If a patient presents with symptoms such as blurred vision or other visual disturbances, an ophthalmologist should be consulted to evaluate possible causes, which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy (CSR), which have been reported following systemic or topical corticosteroid use.
Symbicort Turbuhaler contains lactose monohydrate (< 1 mg/inhalation). This amount is not usually a problem for patients who are lactose intolerant. This excipient contains small amounts of milk proteins which may cause allergic reactions.
Children
It is recommended that children who are receiving long-term inhaled corticosteroids be monitored regularly for growth. If growth is slowed, the therapy should be reviewed with the aim of reducing the dose of inhaled corticosteroid to the lowest dose at which effective control of asthma is maintained, if possible. The benefits of corticosteroids should be carefully weighed against the potential risks of growth retardation. Referral to a paediatric respiratory specialist may also be considered.
Limited data from long-term studies suggest that most children and adolescents treated with inhaled budesonide eventually achieve normal adult growth. However, an initial, small and transient reduction in growth rate (approximately 1 cm) has been observed. This usually occurs within the first year of treatment.
Use during pregnancy or breastfeeding
Pregnancy
There are no clinical data on the use of Symbicort Turbuhaler or concomitant therapy with formoterol and budesonide during pregnancy. Data obtained during a study of the effect of the drug on embryofoetal development in rats did not reveal any additional effect when using this combination. Experience with the use of formoterol in pregnant women is limited. In animal reproduction studies, formoterol caused adverse effects at very high concentrations of the drug in the systemic circulation. Data obtained during approximately 2000 pregnancies did not reveal any increased teratogenic risk associated with the use of inhaled budesonide. Animal studies have shown that glucocorticosteroids can cause developmental disorders. However, these data are probably not considered relevant for humans when using the drug at recommended doses.
Animal studies have also shown that high-dose glucocorticoid use during pregnancy increased the risk of intrauterine growth retardation, cardiovascular disease in adult animals, and resulted in permanent changes in glucocorticoid receptor density, metabolism, and neurotransmitter profiles at doses below teratogenic doses.
During pregnancy, Symbicort Turbuhaler should only be used if the benefit to the mother outweighs the potential risk to the fetus/child. The lowest effective dose of budesonide should be used to provide adequate control of bronchial asthma.
Breast-feeding
Budesonide passes into breast milk. However, when the drug is taken in therapeutic doses, no effects on the infant are expected. It is not known whether formoterol passes into human breast milk.
In rats, small amounts of formoterol have been detected in breast milk. The use of Symbicort Turbohaler in breast-feeding women should only be considered if the expected benefit to the mother outweighs any possible risk to the child.
Fertility
There are no data on the potential effect of budesonide on fertility. In animal reproductive studies, a slightly reduced level of fertility was observed in male rats at high systemic drug concentrations.
Ability to influence reaction speed when driving vehicles or other mechanisms
Symbicort Turbohaler has no or negligible influence on the ability to drive and use machines.
Method of administration and doses
The route of administration is inhalation.
Dosage
Symbicort Turbuhaler is not prescribed for the initial treatment of bronchial asthma.
The doses of the components of the drug Symbicort Turbuhaler are selected individually and should be adjusted according to the severity of the disease. This should be taken into account not only at the beginning of the use of combination drugs, but also when adjusting the maintenance dose. If the patient requires a dose combination that differs from that available in the combination inhaler, appropriate doses of β2-adrenoceptor agonists and/or corticosteroids should be prescribed in separate inhalers.
The dose should be gradually reduced to the lowest dose that effectively controls symptoms. Patients should be re-examined regularly by their prescriber to ensure that the dose of Symbicort Turbuhaler remains optimal. Once long-term control of symptoms is achieved with the lowest recommended dose, symptoms should be controlled with an inhaled corticosteroid alone.
There are two options for using the drug Symbicort Turbuhaler.
A. For maintenance therapy: Symbicort Turbohaler is used for regular maintenance therapy in combination with a separate rapid-acting bronchodilator used as needed as a reliever.
B. For maintenance therapy and relief of symptoms: Symbicort Turbuhaler is used for regular maintenance therapy and, as needed, for relief of symptoms.
A. Use of Symbicort Turbuhaler for maintenance therapy.
Patients should be advised to always carry a separate rapid-acting bronchodilator for symptom relief at all times.
Recommended doses
Adults (aged 18 years and over): 1–2 inhalations twice daily. Some patients may require up to 4 inhalations twice daily.
Adolescents (ages 12–17): 1–2 inhalations twice daily.
Children (age 6 years and older): 2 inhalations twice daily.
Usually, after achieving control of the symptoms of the disease with twice-daily use of the drug, the dose is titrated to the lowest effective dose, including the use of Symbicort Turbuhaler once daily, in cases where, in the opinion of the physician, the patient requires combined maintenance therapy with a long-acting bronchodilator and an inhaled corticosteroid.
More frequent use of an additional rapid-acting bronchodilator indicates a worsening of the patient's condition and the need to review asthma treatment.
Children under 6 years of age: Symbicort Turbohaler is not recommended for use in children under 6 years of age.
B. Use of Symbicort Turbuhaler for maintenance therapy and relief of symptoms.
Patients should take a daily maintenance dose of Symbicort Turbohaler and use Symbicort Turbohaler as needed to relieve symptoms. Patients should be advised to always carry Symbicort Turbohaler for emergency relief. The use of Symbicort Turbohaler for maintenance and relief of symptoms should be considered in particular in patients:
with insufficiently controlled bronchial asthma, who often need medications to relieve symptoms;
with exacerbations of bronchial asthma in the past that required medical intervention.
Patients who use Symbicort Turbuhaler as needed and frequently and in large quantities should be closely monitored for dose-related adverse reactions.
Recommended doses
Adults and adolescents (12 years of age and older): The recommended maintenance dose is 2 inhalations per day – 1 inhalation in the morning and evening or 2 inhalations in the morning or evening only. If necessary, if symptoms occur, use 1 additional inhalation. If symptoms do not disappear after a few minutes, an additional inhalation should be taken. In any individual case, no more than 6 inhalations should be taken.
A total daily dose of more than 8 inhalations is not usually required; however, for a limited period, the total daily dose may be up to 12 inhalations. Patients who use more than 8 inhalations per day are strongly advised to consult a doctor. They should be re-evaluated and their maintenance therapy reviewed.
Children under 12 years of age: Symbicort Turbuhaler is not recommended for use in children for maintenance therapy and relief of symptoms.
General information
Special patient groups
There are no special dosage requirements for elderly patients. There are no data on the use of Symbicort Turbuhaler in patients with impaired renal or hepatic function. Since budesonide and formoterol are eliminated primarily by hepatic metabolism, increased plasma concentrations of the drug can be expected in patients with severe cirrhosis of the liver.
Instructions for the correct use of the drug Symbicort Turbuhaler
Preparing a new inhaler with the drug Symbicort Turbuhaler for use
Before first use, a new Symbicort Turbohaler inhaler must be primed as follows:
Unscrew and remove the cap. You may hear a rattling sound.
Hold the Symbicort Turbuhaler inhaler vertically with the red dispenser facing down.
Turn the red dispenser all the way in one direction, then all the way in the other direction (it doesn't matter which way you turn it first). You should hear a click.
Turn the red dispenser in both directions again.
The Symbicort Turbuhaler inhaler is now ready for use.
How to do inhalation
Each time you take a dose, you must follow the instructions below.
1. Unscrew and remove the cap. You may hear a rattling sound.
2. Hold the inhaler with the Symbicort Turbuhaler medicine vertically with the red dispenser facing down.
3. When filling the inhaler with a dose, do not hold it by the nozzle. To fill the inhaler with a dose, you need to turn the dispenser all the way in one direction (either direction) and then in the other. You should hear a click. The Symbicort Turbohaler inhaler is filled and ready to use. The inhaler should only be filled before inhalation.
4. Without bringing the inhaler to your mouth, exhale calmly (as much as is comfortable). Do not exhale through the inhaler mouthpiece.
5. Carefully place the mouthpiece between your teeth, purse your lips, and inhale as deeply and forcefully as possible through your mouth. Do not chew or clench the mouthpiece with your teeth.
6. Remove the inhaler from your mouth. Exhale slowly.
The amount of medicine inhaled is very small. This means that you may not be able to taste the medicine after inhalation. As long as you follow the instructions, you can be sure that you have taken your dose and that the medicine has reached your lungs.
7. If another inhalation is required, repeat steps 2–6.
8. Close the cap tightly after using the inhaler.
9. After daily morning and/or evening inhalations, rinse your mouth with water without swallowing it.
Do not attempt to remove or unscrew the mouthpiece. It is attached to the Symbicort Turbohaler inhaler and should not be removed. Do not use the inhaler if it is damaged or if the mouthpiece has come off.
As with other inhalers, caregivers should ensure that children prescribed Symbicort Turbuhaler use their inhalers according to the instructions above.
Cleaning the Symbicort Turbuhaler inhaler
The outer surface of the nozzle should be wiped with a dry cloth once a week. Do not use water or other liquids.
When to use a new inhaler
The dose indicator shows how many doses (inhalations) of Symbicort Turbohaler are left in the inhaler. The dose counter in a filled inhaler starts at 60 or 120.
The indicator shows an interval of 10 doses. Therefore, it does not show every dose.
The appearance of red in the indicator window means that there are approximately 20 doses left in the inhaler. When 10 doses remain in the inhaler, the dose indicator window turns completely red. When the “0” mark in the red window reaches the center of the indicator window, the inhaler should be replaced with a new one (Fig. 5).
Note
The dispenser will spin and click even when the Symbicort Turbohaler inhaler is empty.
The sound you hear when you shake the Symbicort Turbo inhaler
