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Route of administration: For inhalation use.
General Information: If patients take Symbicort Turbuhaler as an anti-inflammatory reliever (either alone or in combination with maintenance therapy) physicians should discuss allergen exposure and exercise patterns with the patients and take these into consideration when recommending the dose frequency for asthma treatment.
If patients take Symbicort Turbuhaler as a maintenance therapy, they should be instructed that Symbicort Turbuhaler must be used even when asymptomatic for optimal benefit.
Special patient populations: Renal impairment: There are no data available for use of Symbicort Turbuhaler in patients with renal impairment.
Hepatic impairment: There are no data available for use of Symbicort Turbuhaler in patients with hepatic impairment. As budesonide and formoterol are primarily eliminated via hepatic metabolism an increased systemic availability can be expected in patients with severe liver disease.
Use in the elderly: There are no special dosing requirements for elderly patients.
Use in paediatric patients: Symbicort Turbuhaler is not recommended for children below 12 years of age.
Posology: Asthma: 80/4.5 mcg: Symbicort Turbuhaler 80/4.5 μg/dose is not intended for the initial management of asthma.
The dosage of the components of Symbicort Turbuhaler 80/4.5 μg/dose is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated but also when the maintenance dose is adjusted. If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of β2 adrenoceptor agonists and/or corticosteroids by individual inhalers should be prescribed.
The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Patients should be regularly reassessed by their prescriber/health care provider so that the dosage of Symbicort Turbuhaler 80/4.5 μg/dose remains optimal. When long-term control of symptoms is maintained with the lowest recommended dosage, then the next step could include a test of inhaled corticosteroid alone.
For Symbicort Turbuhaler 80/4.5 μg/dose there are two treatment approaches: A. Symbicort maintenance therapy: Symbicort Turbuhaler 80/4.5 μg/dose is taken as regular maintenance treatment with a separate rapid-acting bronchodilator as rescue; B. Symbicort maintenance and reliever therapy: Symbicort Turbuhaler 80/4.5 μg/dose is taken as regular maintenance treatment and as needed in response to symptoms.
A. Symbicort maintenance therapy: Patients should be advised to have their separate rapid-acting bronchodilator available for rescue use at all times.
Recommended doses: Adults (18 years and older): 1-2 inhalations twice daily. Some patients may require up to a maximum of 4 inhalations twice daily.
Adolescents (12-17 years): 1-2 inhalations twice daily.
Children (6 years and older): 2 inhalations twice daily.
In usual practice when control of symptoms is achieved with the twice daily regimen, titration to the lowest effective dose could include Symbicort Turbuhaler 80/4.5 μg/dose given once daily, when in the opinion of the prescriber, a long-acting bronchodilator in combination with an inhaled corticosteroid would be required to maintain control.
Increasing use of a separate rapid acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy.
Children under 6 years: As only limited data are available, Symbicort Turbuhaler 80/4.5 μg/dose is not recommended for children younger than 6 years.
B. Symbicort maintenance and reliever therapy: Patients take a daily maintenance dose of Symbicort Turbuhaler 80/4.5 μg/dose and in addition take Symbicort Turbuhaler 80/4.5 μg/dose as needed in response to symptoms. Patients should be advised to always have Symbicort Turbuhaler 80/4.5 μg/dose available for rescue use.
Symbicort maintenance and reliever therapy should especially be considered for patients with: inadequate asthma control and in frequent need of reliever medication; asthma exacerbations in the past requiring medical intervention.
Close monitoring for dose-related adverse effects is needed in patients who frequently take high numbers of Symbicort Turbuhaler 80/4.5 μg/dose as-needed inhalations.
Recommended doses: Adults and adolescents (12 years and older): The recommended maintenance dose is 2 inhalations per day, given either as one inhalation in the morning and evening or as 2 inhalations in either the morning or evening. Patients should take 1 additional inhalation as needed in response to symptoms. If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 6 inhalations should be taken on any single occasion.
A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up to 12 inhalations could be used for a limited period. Patients using more than 8 inhalations daily should be strongly recommended to seek medical advice. They should be reassessed and their maintenance therapy should be reconsidered.
Children under 12 years: Symbicort maintenance and reliever therapy is not recommended for children.
160/4.5 mcg: Symbicort Turbuhaler can be used according to different treatment approaches: A. Symbicort anti-inflammatory reliever therapy (patients with mild disease); B. Symbicort anti-inflammatory reliever plus maintenance therapy; C. Symbicort maintenance therapy (fixed dose).
Symbicort anti-inflammatory reliever therapy (patients with mild disease): Symbicort Turbuhaler 160/4.5 μg/dose is taken as needed for the relief of asthma symptoms when they occur, and as a preventative treatment of symptoms in those circumstances recognised by the patient to precipitate an asthma attack. Patients should be advised to always have Symbicort Turbuhaler 160/4.5 μg/dose available for relief of symptoms.
Adults and adolescents (12 years and older): Patients should take 1 inhalation of Symbicort Turbuhaler 160/4.5 μg/dose as needed in response to symptoms. If symptoms persist after a few minutes, 1 additional inhalation should be taken. No more than 6 inhalations should be taken on any single occasion.
A total daily dose of more than 8 inhalations is normally not needed, however a total daily dose of up to 12 inhalations can be used temporarily. If the patient experiences a 3-day period of deteriorating symptoms after taking additional as needed inhalations, the patient should be reassessed for alternative explanations of persisting symptoms.
Symbicort anti-inflammatory reliever plus maintenance therapy: When maintenance treatment with a combination of inhaled corticosteroid (ICS) and long acting β2 agonist (LABA) is required, patients take Symbicort anti-inflammatory reliever therapy and in addition take a daily maintenance dose of Symbicort Turbuhaler. The as-needed inhalations provide both rapid relief of symptoms and improved overall asthma control. Patients should be advised to have Symbicort Turbuhaler available for relief of symptoms at all times.
Adults and adolescents (12 years and older): Patients should take 1 inhalation of Symbicort Turbuhaler 160/4.5 μg/dose as needed in response to symptoms to control asthma. If symptoms persist after a few minutes, 1 additional inhalation should be taken. No more than 6 inhalations should be taken on any single occasion.
Patients also take the recommended maintenance dose of Symbicort Turbuhaler 160/4.5 μg/dose, which is 2 inhalations per day, given as either 1 inhalation in the morning and evening or as 2 inhalations in either the morning or evening. For some patients, a maintenance dose of Symbicort Turbuhaler 160/4.5 μg/dose 2 inhalations twice daily may be appropriate. The maintenance dose should be titrated to the lowest dose at which effective control of asthma is maintained.
A total daily dose of more than 8 inhalations is normally not needed, however a total daily dose of up to 12 inhalations can be used temporarily. If the patient experiences a 3-day period of deteriorating symptoms after taking the appropriate maintenance therapy and additional as needed inhalations, the patient should be reassessed for alternative explanations of persisting symptoms.
Symbicort maintenance therapy (fixed dose): When maintenance treatment with a combination of ICS and LABA is required, Symbicort Turbuhaler is taken as a fixed daily dose treatment, with a separate short-acting bronchodilator for relief of symptoms. Patients should be advised to have their separate short-acting bronchodilator available for relief of symptoms at all times.
Increasing use of short-acting bronchodilators indicates a worsening of the underlying condition and warrants reassessment of the asthma therapy. The dosage of Symbicort Turbuhaler should be individualised according to disease severity. When control of asthma has been achieved, the maintenance dose should be titrated to the lowest dose at which effective asthma control is maintained.
Adults and adolescents (12 years and older): 1 or 2 inhalations of Symbicort Turbuhaler 160/4.5 μg/dose twice daily. The maximum recommended daily maintenance dose is 4 inhalations.
320/9 mcg: Symbicort Turbuhaler 320/9 μg/dose is not intended for the initial management of asthma. The dosage of the components of Symbicort Turbuhaler 320/9 μg/dose is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated but also when the maintenance dose is adjusted. If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of β2 adrenoceptor agonists and/or corticosteroids by individual inhalers should be prescribed.
Recommended doses: Adults (18 years and older): 1 inhalation twice daily. Some patients may require up to a maximum of 2 inhalations twice daily.
Adolescents (12-17 years): 1 inhalation twice daily.
Patients should be regularly reassessed by their prescriber/health care provider, so that the dosage of Symbicort Turbuhaler 320/9 μg/dose remains optimal. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. When long-term control of symptoms is maintained with the lowest recommended dosage, then the next step could include a test of inhaled corticosteroid alone.
In usual practice when control of symptoms is achieved with the twice daily regimen, titration to the lowest effective dose could include Symbicort Turbuhaler 320/9 μg/dose given once daily, when in the opinion of the prescriber, a long-acting bronchodilator would be required to maintain control.
Increasing use of a separate rapid-acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy.
Children (6 years and older): A lower strength of Symbicort Turbuhaler is available for children aged from 6 to 11 years.
Children under 6 years: As only limited data are available, Symbicort Turbuhaler is not recommended to be used in children who are younger than 6 years.
Symbicort 320 microgrmas/9 micrograms/inhalation should be used as Symbicort maintenance therapy only. Lower strengths are available for the Symbicort maintenance and reliever therapy regimen (160 micrograms/4.5 micrograms/inhalation and 80 micrograms/4.5 micrograms/inhalation).
COPD: 160/4.5 mcg: Adults: 2 inhalations of Symbicort Turbuhaler 160/4.5 μg/dose twice daily. The maximum recommended daily dose is 4 inhalations.
320/9 mcg: Recommended doses: Adults: 1 inhalation twice daily.
Instruction for correct use of Symbicort Turbuhaler: Turbuhaler is inspiratory flow-driven which means that, when the patient inhales through the mouthpiece, the substance will follow the inspired air into the airways.
NOTE: It is important to instruct the patient to: Check the expiry date; Carefully read the instructions for use in the patient information leaflet that are provided with each pack of Symbicort Turbuhaler; Breathe in forcefully and deeply through the mouthpiece to ensure that an optimal dose is delivered to the lungs; Never to breathe out through the mouthpiece; Replace the cover of Symbicort Turbuhaler after use; Rinse their mouth out with water after inhaling the maintenance dose to minimise the risk of oropharyngeal thrush.
The patient may not taste or feel any medication when using Symbicort Turbuhaler due to the small amount of drug delivered.
