Instructions Symbicort Turbuhaler inhalation powder dosed 320 mcg/dose + 9 mcg/dose turbuhaler 60 doses
Composition
active ingredients: 1 inhalation (1 dose) contains: 320 mcg of micronized budesonide;
9.0 mcg formoterol fumarate dihydrate;
excipient: lactose monohydrate.
Dosage form
Inhalation powder, metered.
Main physicochemical properties:
Inhaler: red rotating dispenser. Braille code is 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.
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 mechanisms of action of both compounds are discussed below.
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 action is at least 12 hours after a single dose.
Clinical efficacy and safety
Bronchial asthma
Clinical trials in adult patients have shown that adding formoterol to budesonide improved asthma symptoms and 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 better than that of budesonide alone. All treatment groups used short-acting β2-adrenergic agonists as needed. There was no evidence of a decrease in the anti-asthmatic 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.
COPD
Two 12-month studies evaluated the effects of the drug on lung function and exacerbation rate (as measured by the number of courses of oral steroids and/or antibiotics and/or hospitalizations) in patients with moderate to severe COPD. The inclusion criterion for both studies was a pre-bronchodilator FEV1 < 50% predicted. The median post-bronchodilator FEV1 at study entry was 42% predicted.
The mean number of exacerbations per year (as defined above) was significantly reduced in the budesonide/formoterol group compared with formoterol monotherapy or placebo (mean rate 1.4 compared with 1.8–1.9 in the placebo/formoterol group). The mean number of days of oral corticosteroids/patient over 12 months was slightly reduced in the budesonide/formoterol group (7–8 days/patient/year compared with 11–12 and 9–12 days in the placebo and formoterol groups, respectively). Regarding changes in lung function parameters such as FEV1, treatment with budesonide/formoterol was not more effective than treatment with formoterol alone.
Pharmacokinetics
Absorption
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.
The pharmacokinetics of the respective substances were similar after administration of budesonide and formoterol as monodrugs and as part of a fixed-dose combination. After administration of the combination product, the AUC of budesonide, absorption rate and maximum plasma concentration were slightly higher. The maximum plasma concentration of formoterol after administration of the fixed-dose 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 dry 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 formoterol dose undergoes hepatic metabolism and is subsequently excreted by the kidneys. After inhalation, 8–13% of the administered formoterol dose 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 approximately 4 hours.
The pharmacokinetics of budesonide or formoterol in children and 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
Bronchial asthma
Symbicort Turbuhaler, 320 mcg/9.0 mcg, is prescribed to adults and children aged 12 years and over for the regular treatment of bronchial asthma when combination therapy (inhaled corticosteroid and long-acting β2-adrenoceptor agonist) is appropriate:
if their condition is not adequately controlled with inhaled corticosteroids and short-acting β2-adrenergic agonists used as needed, or
if their condition is adequately controlled with inhaled corticosteroids and long-acting β2-adrenergic agonists.
Chronic obstructive pulmonary disease (COPD)
Symbicort Turbuhaler is indicated for the symptomatic treatment of adult patients aged 18 years and older with COPD with a forced expiratory volume in 1 second (FEV1) < 70% predicted normal (after bronchodilator use) and a history of exacerbations despite regular bronchodilator therapy.
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 concentrations 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.
No interactions of budesonide and formoterol with any other drugs used to treat bronchial asthma have been observed.
Children: Drug interaction studies have only been conducted in adults.
Application features
If treatment needs to be discontinued, it is recommended to gradually reduce the dose rather than abruptly discontinue therapy.
The patient should consult a doctor if he considers the treatment ineffective or when the maximum recommended daily dose of Symbicort Turbuhaler has been exceeded (see section "Method of administration and dosage"). More frequent use of immediate-release bronchodilators indicates a deterioration in the patient's condition and the need to review the treatment of bronchial asthma. Sudden and progressive deterioration in control of bronchial asthma or COPD is potentially life-threatening, so the patient should undergo an urgent 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 if a bacterial infection is present.
The patient should be advised to always carry a rescue inhaler.
Patients should be reminded to continue their maintenance use of Symbicort Turbuhaler as prescribed, even if they are asymptomatic.
Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Symbicort Turbohaler. It is important that the patient is reviewed regularly. 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.
Serious adverse reactions related to bronchial asthma or exacerbation of the disease may occur during the period of use of Symbicort Turbuhaler. Patients should continue treatment and consult a doctor if symptoms of bronchial asthma do not go away or worsen after starting therapy with Symbicort Turbuhaler.
There are no clinical trial data on the use of Symbicort Turbuhaler in patients with COPD with a pre-bronchodilator FEV1 > 50% predicted normal and a post-bronchodilator FEV1 < 70% predicted normal (see section 5.1).
Systemic effects may occur with all inhaled corticosteroids, particularly at high doses and during prolonged treatment. The likelihood of such effects is much lower with inhaled corticosteroids than with oral corticosteroids. 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).
The possible effect on bone mineral density should be considered, especially in patients taking high doses for long periods of time, which is an additional risk factor for osteoporosis. 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 effect of Symbicort Turbuhaler at higher doses.
If there is reason to believe that adrenal function has been impaired on previous systemic steroid therapy, caution should be exercised when transferring patients to Symbicort Turbuhaler.
The benefits of inhaled budesonide therapy generally minimize the need for oral steroids, but patients who have previously been on oral steroids for a significant period of time may still be at risk of adrenal insufficiency. Recovery from oral steroid withdrawal may take a significant amount of time, and therefore patients who have previously been on oral steroids and are transferred to inhaled budesonide may remain at risk for adrenal insufficiency for a significant period of time. In such circumstances, the function of the hypothalamic-pituitary-adrenal axis should be monitored regularly.
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 steroids should be considered during periods of stress (e.g., 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 may be somewhat vague but may include anorexia, abdominal pain, weight loss, fatigue, headache, nausea, vomiting, decreased level of consciousness, convulsions, hypotension, and hypoglycemia.
Treatment with additional systemic steroids or inhaled budesonide should not be abruptly discontinued.
When switching from oral steroid therapy to Symbicort Turbuhaler, there will generally be a lower systemic exposure to steroids and this may lead to the development of allergy or arthritic symptoms such as rhinitis, eczema and muscle and joint pain. If these conditions develop, specific treatment should be initiated. Insufficient glucocorticosteroid effect should generally be suspected if symptoms such as increased fatigue, headache, nausea and vomiting occur in rare cases. In such cases, a temporary increase in the dose of oral glucocorticosteroids is sometimes necessary.
To reduce the risk of oropharyngeal candidiasis (see section "Adverse reactions"), the patient should be instructed to rinse the mouth with water after each maintenance dose.
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 medicinal products should be as long as possible.
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 cardiac diseases such as ischemic heart disease, tachyarrhythmia or severe heart failure.
The drug should be used with caution in patients with prolonged QTc interval. Formoterol may cause prolongation of the QTc interval.
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 when using various immediate-acting bronchodilators, 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 a complication such as hypokalemia. 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.
Pneumonia in patients with COPD
An increased incidence of pneumonia, including pneumonia requiring hospitalization, has been observed in patients with COPD receiving inhaled corticosteroids. There is some evidence of an increased risk of pneumonia with increasing steroid doses, but this has not been demonstrated reliably in all studies.
There is no convincing clinical evidence of differences in the magnitude of the risk of pneumonia between inhaled corticosteroid medications.
Physicians should remain alert to the possible development of pneumonia in patients with COPD, as the clinical features of such infections overlap with symptoms of COPD exacerbation.
Risk factors for developing pneumonia in patients with COPD include smoking, older age, low body mass index (BMI), and severe COPD.
Children
It is recommended that children who are taking inhaled corticosteroids for a long time should have their growth monitored regularly. 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 symptoms is maintained, if possible. The benefits of using corticosteroids should be carefully weighed against the potential risk of growth retardation. It may also be appropriate to refer the patient to a paediatric respiratory specialist.
Given the limited data from long-term studies of glucocorticoid treatment, it can be assumed that most children and adolescents treated with inhaled budesonide will eventually achieve normal adult growth. However, an initial, small and transient reduction in growth rate (approximately 1 cm) has been observed. This delay is usually observed in 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 effects of this combination on embryo-fetal development in rats did not reveal any evidence of any additive effect when the combination was used.
There are no adequate data from the use of formoterol in pregnant women. In animal reproduction studies, formoterol caused adverse effects at very high systemic doses.
Data from approximately 2000 pregnancies have not revealed any increased teratogenic risk associated with inhaled budesonide. Animal studies have shown that glucocorticosteroids can cause birth defects. However, these findings are probably not considered relevant for humans 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 benefits of treatment outweigh the potential risks. The lowest effective dose of budesonide should be used to provide adequate control of asthma symptoms.
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 effects of budesonide on fertility. In animal reproductive studies with formoterol, a slightly reduced level of fertility was observed in male rats at high systemic exposure.
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
Bronchial asthma
Symbicort Turbohaler is not prescribed for the initial treatment of bronchial asthma. The doses of the components of the drug Symbicort Turbohaler 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 combination of doses that differ from those available in the combination inhaler, appropriate doses of β2-adrenoceptor agonists and/or corticosteroids in separate inhalers should be prescribed.
Recommended doses
Adults (aged 18 years and over): 1 inhalation twice daily. Some patients may require up to 2 inhalations twice daily.
Adolescents (ages 12–17): 1 inhalation twice daily.
Patients should be re-examined regularly by their prescribing physician to ensure that the dose of Symbicort Turbuhaler remains optimal. The dose should be gradually reduced to the lowest dose that effectively controls symptoms. Once long-term control of symptoms is achieved with the lowest recommended dose, symptoms should be controlled with inhaled corticosteroids alone.
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, up to the use of Symbicort Turbuhaler once a day, in cases where, in the opinion of the physician, the patient requires maintenance therapy with a long-acting bronchodilator.
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 6 years of age and older: A lower strength formulation (80 mcg/4.5 mcg/dose) is available for use in children 6–11 years of age.
Children under 6 years of age: As only limited data are available, Symbicort Turbohaler is not recommended for use in children under 6 years of age.
Symbicort Turbohaler, 320 mcg/9.0 mcg, should only be used for maintenance therapy. For maintenance therapy and symptom relief with Symbicort Turbohaler, lower strengths (160 mcg/4.5 mcg/dose and 80 mcg/4.5 mcg/dose) are available.
COPD
Recommended doses
Adults: 1 inhalation twice daily.
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 exposure to the drug can be expected in patients with severe cirrhosis of the liver.
Method of application
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
To take your dose, 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.
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 Turbuhaler are left in the inhaler. The dose counter in a filled inhaler starts at 60.
The indicator shows an interval of 10 doses. Therefore, it does not show every dose.
When the indicator window turns red, it means that there are approximately 20 doses left in the inhaler. When there are 10 doses left 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.
Note
The dispenser will spin and click even when the Symbicort Turbohaler inhaler is empty.
The sound you hear when you shake your Symbicort Turbohaler inhaler is caused by the desiccant, not the medicine. Therefore, this sound will not help you determine how much medicine is left in the inhaler.
If more than one dose is mistakenly loaded into the Symbicort Turbohaler inhaler, only one dose will be delivered to the lungs when inhaled. However, the dose indicator will register the total number of doses delivered.
In case of overdose
The medicine should be taken according to the instructions or recommendations of the doctor. Do not exceed the prescribed dose without consulting a doctor.
The most common symptoms that may occur in case of an overdose of Symbicort Turbuhaler are tremor, headache or rapid heartbeat.
In case of missed inhalation
If an inhalation is missed, it should be taken as soon as possible, as mentioned above. However, if it is almost time for the next inhalation, the missed dose should not be taken.
You should not take a double dose to make up for a missed one.
If you have any further questions about the use of this medicine, please ask your doctor or pharmacist.
The inhaler is activated by inspiratory flow, which means that when the patient inhales through the nozzle, the active ingredients will enter the respiratory tract along with the inhaled air.
Note
It is important to instruct the patient:
follow the instructions for medical use;
inhale strongly and deeply through the nozzle to ensure the optimal dose reaches the lungs;
never exhale through the nozzle;
after use, close the inhaler with the Symbicort Turbuhaler medicine with a cap;
After inhaling the maintenance dose, rinse your mouth with water to minimize the risk of oral candidiasis. In case of oral candidiasis, rinse your mouth with water also after using the drug if necessary.
The patient may not taste or feel the medicine Symbicort Turbuhaler when using the inhaler due to the small dose inhaled.
Children: Symbicort Turbohaler is not recommended for use in children under 6 years of age. A lower strength formulation (80 mcg/4.5 mcg/dose) is available for use in children aged 6–11 years.
Overdose
Overdose of formoterol is likely to lead to effects typical of β2-adrenergic agonists: tremor, headache, palpitations. In isolated cases, tachycardia, hyperglycemia, hypokalemia, QTc prolongation, arrhythmia, nausea have been reported.
