Abbreviated Prescribing Information
Symbicort

Presentation: Budesonide/Formoterol Turbuhaler. Indications: In adults and adolescents (12 years and older), for the treatment of asthma, to achieve overall asthma control, including the relief of symptoms and the reduction of the risk of exacerbations. Symptomatic treatment of moderate to severe COPD in adults. Dosage: Asthma 1) Symbicort anti-inflammatory reliever therapy (patients with mild disease) 160/4.5 mcg Turbuhaler Adult & Adolescent ≥ 12yr: 1 inhalations 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. 2) Symbicort maintenance and reliever therapy Adult & Adolescent ≥ 12yr: Patients should take 1 inhalation of Symbicort Turbuhaler 160/4.5 mcg 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. Recommend maintenance dose is 1 inhalation b.d. and some may need 2 inhalations b.d. 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. 3) Symbicort maintenance therapy 160/4.5 mcg Turbuhaler Adult & Adolescent ≥ 12yr: 1-2 inhalations b.d. Max daily dose is 4 inhalations. COPD 160/4.5 mcg Turbuhaler Adult: 2 inhalations b.d. Max daily dose is 4 inhalations. Contraindications: Hypersensitivity to budesonide, formoterol or lactose. Precautions: Should be used for the shortest duration of time required to achieve control of asthma symptoms. Should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications. Not be used to initiate treatment with inhaled steroids in patients being transferred from oral steroids. It is recommended that the maintenance dose be tapered when long-term treatment is discontinued. Potential systemic effects of ICS, HPA axis suppression and adrenal insufficiency, bone density, growth, visual disturbance, infections/tuberculosis, sensitivity to sympathomimetic amines, cardiovascular disorders, hypokalaemia, diabetes, pneumonia, lactose, pregnancy & lactation. Not recommended for children below 12 years of age. Incidence of candidiasis can be minimized by having patients rinse their mouth out with water after inhaling their maintenance dose. Interactions: CYP3A4 inhibitors, beta-receptor blocking agents, other sympathomimetic agents, Xanthine derivatives, mineralocorticosteroids and diuretics, Monoamine oxidase inhibitors, tricyclic antidepressants, quinidine, disopyramide, procainamide, phenothiazines and antihistamines. Undesirable effects: Palpitations, Candida infections in the oropharynx, headache, tremor, mild irritation in the throat, coughing, hoarseness. Full local prescribing information is available upon request. API.HK.SYM.0221.

HK-10000 19/02/2024