Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
Symbicort Turbohaler is indicated in adults, adolescents, and children aged 6 years and older.
Symbicort Turbohaler is indicated in the regular treatment of asthma where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:
or
Note: Symbicort Turbohaler (100 micrograms/6 micrograms/inhalation) is not appropriate in patients with severe asthma.
Route of administration: For inhalation use.
Symbicort Turbohaler is not intended for the initial management of asthma. The dosage of the components of Symbicort 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 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 there are two treatment approaches:
A. Symbicort maintenance therapy: Symbicort is taken as regular maintenance treatment with a separate rapid-acting bronchodilator as rescue.
B. Symbicort maintenance and reliever therapy: Symbicort is taken as regular maintenance treatment and as needed in response to symptoms.
Patients should be advised to have their separate rapid-acting bronchodilator available for rescue use at all times.
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 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 is not recommended for children younger than 6 years.
Patients take a daily maintenance dose of Symbicort and in addition take Symbicort as needed in response to symptoms. Patients should be advised to always have Symbicort available for rescue use.
Symbicort maintenance and reliever therapy should especially be considered for patients with:
Close monitoring for dose-related adverse effects is needed in patients who frequently take high numbers of Symbicort as-needed inhalations.
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.
There are no special dosing requirements for elderly patients. There are no data available for use of Symbicort in patients with hepatic or renal impairment. As budesonide and formoterol are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver cirrhosis.
The inhaler 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
The patient may not taste or feel any medication when using Symbicort Turbohaler Inhaler due to the small amount of drug dispensed.
An overdose of formoterol would likely lead to effects that are typical for β2 adrenoceptor agonists: tremor, headache, palpitations. Symptoms reported from isolated cases are tachycardia, hyperglycaemia, hypokalaemia, prolonged QTc-interval, arrhythmia, nausea and vomiting. Supportive and symptomatic treatment may be indicated. A dose of 90 micrograms administered during three hours in patients with acute bronchial obstruction raised no safety concerns.
Acute overdosage with budesonide, even in excessive doses, is not expected to be a clinical problem. When used chronically in excessive doses, systemic glucocorticosteroid effects, such as hypercorticism and adrenal suppression, may appear.
If Symbicort therapy has to be withdrawn due to overdose of the formoterol component of the drug, provision of appropriate inhaled corticosteroid therapy must be considered.
3 years.
This medicinal product does not require any special storage conditions.
Symbicort Turbohaler is an inspiratory flow-driven, multidose powder inhaler. The inhaler is white with a red turning grip. The inhaler is made of different plastic materials (PP, PC, HDPE, LDPE, LLDPE, PBT). In each secondary package there are 1, 2, 3, 10 or 18 inhaler(s) containing 60 (or 120) doses.
Not all pack-sizes may be marketed.
No special requirements.
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