Flomyst-F 5/125

• Asthma: where use of a combination product is appropriate - patients not adequately controlled with inhaled corticosteroids and 'as needed' short-acting β₂-agonist, or patients already adequately controlled on both.
• COPD: where a long-acting β₂-agonist/inhaled corticosteroid is indicated and patients are unable to use other long-acting β₂-agonist/inhaled corticosteroid.

Fluticasone propionate is a synthetic, trifluorinated glucocorticoid with potent anti-inflammatory activity in the lungs when given by inhalation. Fluticasone propionate reduces symptoms and exacerbations of asthma. Formoterol fumarate is a long-acting selective β₂ adrenergic receptor agonist. Inhaled formoterol fumarate acts locally in the lung as a bronchodilator. The onset of bronchodilating effect is rapid, within 1-3 minutes, and the duration of effect is at least 12 hours after a single dose.

Adult Dose (250/10 mcg):

• 2 inhalations (puffs) twice daily - morning and evening.

Adult Dose (50/5 mcg):

• 2 inhalations (puffs) twice daily - morning and evening.

Adult Dose (125/5 mcg):

• 2 inhalations (puffs) twice daily - morning and evening.

Adolescents (12+ years):

• 50/5 mcg or 125/5 mcg - 2 puffs twice daily.

Under 12 years: Not recommended.

* Use as directed by the registered physician

Common Side Effects:

• Nausea
• Vomiting
• Respiratory tract infection
• Fungal infection of mouth
• Sore throat
• Headache
• Hoarseness of voice
• Cough
• Musculoskeletal pain
• Increased heart rate

Use in Pregnancy: May be unsafe during pregnancy. Animal studies have shown harmful effects. Your doctor will weigh the benefits and risks.

Precautions:

• Do not use in acute asthma attacks (fast-acting reliever inhaler needed).
• Seek medical advice if asthma symptoms remain uncontrolled or worsen.
• Paradoxical bronchospasm may occur - use bronchodilator immediately and discontinue.
• Use with caution in tuberculosis, diabetes, hypertension, heart disease.
• Avoid during pregnancy and lactation.

Overdose:

• Formoterol: Angina, hypertension/hypotension, palpitations, tachycardia, arrhythmia, prolonged QTc interval, hypokalemia, hyperglycemia.
• Fluticasone: Temporary suppression of HPA axis function.

Storage: Store in a cool and dry place, protected from light.