SYMBICORT 160 / 4.5UG / DOSE INHALER 120 DOSES

** Symbicort® Turbuhaler (budesonide / formoterol) 160/4.5 microg/inhalation. Inhalation powder 120 doses.

** 1 dose (1 inhalation) contains:

160 mcg budesonide,

4.5 mcg formoterol fumarate dihydrate and

approx. 730 mcg lactose monohydrate

** Therapeutic Indications:

# Asthma:

– Regular treatment of asthma where use of a combination (inhaled corticosteroid and long acting beta2-agonist) is appropriate.

– patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting beta2-agonists or

– patients already adequately controlled on both inhaled corticosteroids and long-acting beta2-agonists.

# COPD: Symptomatic treatment of patients with severe COPD (FEV1< 50% predicted normal) and a history of exacerbations, who have significant symptoms despite regular therapy with long-acting bronchodilators.

** Psology and method of administration:

# Asthma:

A- Symbicort maintenance therapy: Symbicort is taken as regular maintenance treatment with a separate rapid-acting bronchodilator as rescue.

$ 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 inhalation twice daily.

– Children (6 years and older): A lower strength is available for children 6-11 years.

B- Symbicort maintenance and reliever therapy: Symbicort is taken as regular maintenance treatment and as needed in response to symptoms.

$ Recommended doses:

– Adults (18 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. For some patients a maintenance dose of 2 inhalations twice daily may be appropriate. 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 and adolescents under 18 years: Symbicort maintenace and reliever therapy is not recommended for children and adolescents.

# COPD:

$ Recommended doses:

Adults: 2 inhalations twice daily.

** To be taken as directed by the physician.

** N.B.: Replace the cover properly after use.

** Do not store above 30 degrees C. Keep the container tightly closed.

Keep all medicines away from children.

** Manufactured by: AstraZeneca Sweden

Packed by: AstraZeneca – Egypt

SYMBICORT® is a Trade Mark of AstraZeneca group of companies.