Leaflet SYMBICORT 160mcg / 4.5mcg / dose pressurised inhalation suspension

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
Glaucoma warning

Use caution if you have glaucoma or increased eye pressure.

Hyperglycemia
Hyperglycemia

This medicine may increase blood sugar.

Immunosuppression / infection risk
Immunosuppression / infection risk

This medicine may increase the risk of infections.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Cardiac risk / QT prolongation / arrhythmias
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.

SYMBICORT 160mcg/4.5mcg/dose pressurised inhalation suspension ASTRAZENECA, budesonide+formoterol

General data about SYMBICORT 160mcg / 4.5mcg / dose

  • Substance: budesonide + formoterol
  • Date of latest medicines list: 01-06-2026
  • Product code: W62789001
  • Concentration: 160mcg / 4.5mcg / dose
  • Pharmaceutical form: pressurised inhalation suspension
  • Quantity: 1
  • Product type: Original
  • Price: 149.54 RON
  • 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 (AZDP) - FRANTA
  • Holder: ASTRAZENECA AB - SUEDIA
  • Number: 13866/2021/01
  • 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

Compensation lists for SYMBICORT 160mcg / 4.5mcg / dose AstraZeneca

B - Sublist B with 50% discount from the reference price

Price

Copayment

Patient

149.54 RON

64.27 RON

85.27 RON