Leaflet SYMBICORT 80mcg / 2.25mcg / dose pressurised inhalation suspension

Product code:
W66886001
Quantity:
1
Indicated for:
asthma; chronic obstructive pulmonary disease
Route of administration:
inhalation
Substance:
budesonide + formoterol (glucocorticoid + beta-2 adrenergic agonist)
ATC
R03AK07 — Respiratory system | Adrenergics, inhalants | Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics

Precautions:

Glaucoma warning

Use caution if you have glaucoma or increased eye pressure.

Hyperglycemia

This medicine may increase blood sugar.

Immunosuppression / infection risk

This medicine may increase the risk of infections.

Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning

Use during pregnancy only on medical advice.

Cardiac risk / QT prolongation / arrhythmias

This medicine may increase the risk of heart rhythm disturbances.

The combination of budesonide and formoterol is used to treat asthma and chronic obstructive pulmonary disease (COPD). It combines a corticosteroid (budesonide) with a long-acting bronchodilator (formoterol), providing both inflammation control and airway relaxation.

Budesonide reduces airway inflammation, preventing asthma symptoms such as wheezing, coughing, and breathing difficulties. Formoterol acts quickly and long-term to relax airway muscles, making breathing easier and preventing asthma attacks.

This combination is used both as maintenance therapy and, in some cases, for the relief of acute symptoms. It is recommended for patients who require both long-term inflammation control and an effective bronchodilator.

Side effects may include dry mouth, throat irritation, hoarseness, tremors, or palpitations. In rare cases, severe allergic reactions, oral fungal infections (thrush), or worsening respiratory symptoms may occur. It is important for patients to rinse their mouth after using the inhaler to prevent oral infections.

Patients should strictly follow their doctor’s instructions regarding inhaler use. It is essential not to exceed the prescribed dose and to use the medication as part of the treatment plan to prevent asthma or COPD exacerbations.

General data about SYMBICORT 80mcg / 2.25mcg / dose

Substance:
budesonide + formoterol
Date of latest medicines list:
01-10-2020
Product code:
W66886001
Concentration:
80mcg / 2.25mcg / dose
Pharmaceutical form:
pressurised inhalation suspension
Quantity:
1
Product type:
Original
Prescription status:
P-6L — Medicines dispensed with a medical prescription that is not retained by the pharmacy and may be renewed; the prescription may be used for 6 months from the date of issue.

Marketing authorisation

Manufacturer:
ASTRAZENECA DUNKERQUE PRODUCTION - FRANTA
Holder:
ASTRAZENECA AB - SUEDIA
Number:
13369/2020/01
Shelf life:
2 years-after packing for marketing;after the first opening a dispozitivului-3 months

Pharmaceutical forms available for budesonide + formoterol

Concentrations available for budesonide + formoterol

  • 160mcg/4.5mcg
  • 160mcg/4.5mcg/dose
  • 320mcg/9mcg
  • 320mcg/9mcg/dose
  • 80mcg/2.25mcg/dose
  • 80mcg/4.5mcg/dose