Abbreviated Prescribing Information
Symbicort

Presentation: Budesonide/Formoterol Turbuhaler. Indications: 80/4.5 mcg Turbuhaler Regular treatment of asthma in adults, adolescents and children ≥6 years where use of an ICS/LABA combination is appropriate; not appropriate in severe asthma. 160/4.5 mcg Turbuhaler 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 with FEV₁ ≤50% predicted normal (despite long-acting bronchodilator) and/or a history of recurrent exacerbation. 320/9 mcg Turbuhaler Regular treatment of asthma in adults and adolescents 12–17 yr where use of a combination (ICS and LABA) is appropriate. Symptomatic treatment of COPD in adults with FEV₁ <70% predicted normal (post-bronchodilator) and an exacerbation history despite regular bronchodilator therapy. Dosage: Asthma 1) Symbicort anti-inflammatory reliever therapy (patients with mild disease) 160/4.5 mcg Turbuhaler Adult & Adolescent ≥ 12yr: 1 inhalation 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 80/4.5 mcg & 160/4.5 mcg Adult & Adolescent ≥ 12yr: Patients should take 1 inhalation of Symbicort Turbuhaler 80/4.5 mcg or 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.Recommended maintenance dose is 1 inhalation b.d. or as 2 inhalations in either the morning or evening For some patients taking 160/4.5 mcg, 2 inhalations b.d. may be appropriate. 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 80/4.5 mcg Adult ≥18 yr: 1–2 inhalations b.d.; some patients may require up to a maximum of 4 inhalations b.d. Adolescent 12–17 yr: 1–2 inhalations b.d.Children 6–11 yr: 2 inhalations b.d. 160/4.5 mcg Turbuhaler Adult & Adolescent ≥ 12yr: 1-2 inhalations b.d..Max daily dose is 4 inhalations. 320/9 mcg Turbuhaler Adult ≥18yr: 1 inhalation b.d.; some patients may require up to a maximum of 2 inhalations b.d. Adolescent 12–17yr: 1 inhalation b.d. Symbicort 320/9 mcg should be used as maintenance therapy only. Lower strengths are available for the MART regimen. COPD 160/4.5 mcg Turbuhaler Adult: 2 inhalations b.d.. Max daily dose is 4 inhalations. 320/9 mcg Turbuhaler Adult: 1 inhalation b.d. Contraindications: Hypersensitivity to the active substance(s) or to any of theexcipients (lactose, which contains small amounts of milk proteins). 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 (160/4.5 mcg & 320/9 mcg), pregnancy & lactation. Not recommended for children below 6 years of age (80/4.5 mcg) or below 12 years of age (160/4.5 mcg and 320/9 mcg).Incidence of candidiasis can be minimized by having patients rinse their mouth out with water after inhaling their maintenance dose. Interactions: CYP3A4 inhibitors (MART not recommended in patients using potent 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-13388 20/09/2026