Budesonide 100 mcg + Formoterol fumarate dihydrate 6 mcg per rotacap (inhalation capsule)

Maintenance treatment of asthma, Maintenance treatment of COPD (chronic obstructive pulmonary disease) to reduce symptoms and prevent exacerbations

Budesonide is an inhaled corticosteroid that reduces airway inflammation, swelling and mucus production. Formoterol is a long-acting beta2-agonist (LABA) that relaxes bronchial smooth muscle to keep airways open for easier breathing. Together they improve long-term symptom control and reduce flare-ups.

For inhalation use only with a compatible rotahaler/rotacap inhaler device; do not swallow the capsule. Use exactly as prescribed, usually 1 rotacap inhalation once or twice daily at the same time each day. Rinse mouth and gargle with water after each use and spit out to reduce risk of oral thrush.

Throat irritation, hoarseness, cough, headache, oral thrush (candidiasis), dry mouth, tremor, palpitations, nausea

Not for relief of sudden breathing attacks; keep a quick-relief inhaler (e.g., salbutamol) available. Use with caution in patients with heart rhythm disorders, ischemic heart disease, hypertension, hyperthyroidism, diabetes, seizures, glaucoma, tuberculosis or untreated infections. Inhaled steroids may cause oral thrush, pneumonia risk in COPD, and rarely systemic steroid effects (adrenal suppression, decreased bone mineral density, cataract/glaucoma) with long-term/high doses; use the lowest effective dose. Seek medical help if breathing worsens, you need rescue inhaler more often, or signs of allergic reaction occur.

Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir/cobicistat) may increase budesonide levels; other beta-agonists may increase side effects; beta-blockers may reduce bronchodilation; diuretics/xanthines/corticosteroids may increase risk of hypokalemia; MAO inhibitors/tricyclic antidepressants may increase cardiovascular effects; QT-prolonging drugs may increase arrhythmia risk

Store below 25°C in a cool, dry place, protected from moisture and direct light. Keep capsules in original blister until use. Keep out of reach of children.

Budamate 100 Rotacaps, Forair 100 Rotacaps, Symbicort 100/6 Turbuhaler, Duolin Rotacaps (alternative bronchodilator class), Budecort respules (budesonide only; not equivalent)