Formatide 12/400 Capsule

Inhaled corticosteroid + fast-onset long-acting bronchodilator (LABA) for:

• Asthma: regular maintenance, and as maintenance and reliever therapy (MART) or as-needed reliever in mild asthma (where approved)
• COPD with frequent exacerbations

Asthma — adults and adolescents 12+ (dry powder 160/4.5 or 200/6, or inhaler 160/4.5 mcg):

• Maintenance: 1–2 inhalations twice daily (max 4 inhalations twice daily of 160/4.5).
• MART: 1–2 inhalations daily (or 1 twice daily) as maintenance, plus 1 extra inhalation as needed for symptoms (max 6 at one time; usually not more than 8–12 per day).
• As-needed only (mild asthma, adolescents/adults): 1 inhalation as needed.

Children 6–11 years: 80/4.5 mcg, 2 inhalations twice daily (MART not recommended in some guidance).

COPD: 160/4.5 mcg, 2 inhalations twice daily (or 320/9 one inhalation twice daily).

• Rinse mouth after maintenance doses.
• If you need more than usual, your asthma is worsening — see a doctor.

• Allergy to budesonide, formoterol or lactose (dry powder contains milk protein traces)

Common: oral thrush, hoarse voice, throat irritation, cough, headache, tremor, palpitations.

Less common: muscle cramps, fast heartbeat, anxiety, sleep problems, bruising, nausea.

COPD: increased risk of pneumonia.

Rare / high doses long-term: low potassium, high blood sugar, adrenal suppression, reduced growth in children, cataract, glaucoma, paradoxical bronchospasm, irregular heartbeat.

• Do not stop suddenly.
• Heart disease, irregular heartbeat, overactive thyroid, diabetes, low potassium, TB: caution.
• Monitor growth in children on long-term use.

May be used in pregnancy and breastfeeding (budesonide has the most pregnancy data among inhaled steroids) — uncontrolled asthma is riskier.

• Ritonavir, cobicistat, ketoconazole, itraconazole (raise budesonide — avoid)
• Beta-blockers including eye drops (reduce effect, bronchospasm)
• Diuretics, theophylline, steroids (low potassium)
• QT-prolonging drugs, MAO inhibitors, tricyclics (heart effects)

Formoterol: tremor, headache, palpitations, fast heartbeat, low potassium, high sugar. Seek medical advice.

Store below 30°C with the cap closed, dry. Inhaler: protect from heat; do not puncture.