Product Information:

FORMIGET 400/12 mcg Capsules contain a fixed-dose combination of:

1. Budesonide 400 mcg – an inhaled corticosteroid (ICS) that reduces airway inflammation
2. Formoterol Fumarate 12 mcg – a long-acting beta₂-adrenergic agonist (LABA) that provides sustained bronchodilation

This high-strength formulation is intended for the maintenance treatment of moderate to severe asthma and chronic obstructive pulmonary disease (COPD) in adults and adolescents. The capsules are designed for use with a compatible dry powder inhaler (DPI) device and are for oral inhalation only—not for oral ingestion.

Uses of (FORMIGET 400/12 MCG CAPSULES):

1. Maintenance therapy in severe persistent asthma not controlled with lower ICS/LABA doses
2. Management of moderate to severe COPD with frequent exacerbations
3. Patients requiring intensified anti-inflammatory and bronchodilator therapy
4. Step-up treatment when symptoms persist despite standard-dose combination therapy

Key Benefits of (FORMIGET 400/12 MCG CAPSULES):

1. Enhanced anti-inflammatory effect (higher budesonide dose)
2. Potent and rapid bronchodilation (formoterol acts within 1–3 minutes, lasts up to 12 hours)
3. Reduces risk of severe exacerbations and hospitalizations
4. Improves lung function, exercise tolerance, and quality of life
5. Once- or twice-daily dosing for convenience

How To Use (FORMIGET 400/12 MCG CAPSULES):

1. For inhalation only using a compatible dry powder inhaler (e.g., Turbuhaler-type device).
2. Do not swallow the capsule.
3. Typical dosage:
4. Asthma: 1 capsule twice daily (morning and evening)
5. COPD: 1 capsule twice daily
6. Insert capsule into the inhaler, pierce it, and inhale deeply and forcefully through the mouthpiece.
7. Rinse mouth thoroughly with water after each use to prevent oral thrush and hoarseness.

When Not to Use (FORMIGET 400/12 MCG CAPSULES):

Do not use if you have:

1. Hypersensitivity to budesonide, formoterol, or any excipients
2. Acute asthma attack, status asthmaticus, or acute bronchospasm (not a rescue medication)
3. Severe milk protein allergy (some DPI devices contain lactose)
4. Uncontrolled cardiac arrhythmias or severe cardiovascular disease (use with extreme caution)

Side Effects of (FORMIGET 400/12 MCG CAPSULES):

Common: Headache, tremor, palpitations, throat irritation, hoarseness, oral candidiasis (thrush), cough.

Rare: Tachycardia, muscle cramps, hypokalemia, adrenal suppression (with prolonged high-dose use).

Serious (rare):

1. Paradoxical bronchospasm (worsening breathing after use)
2. Pneumonia (especially in COPD patients—symptoms: fever, increased sputum, chest pain)
3. Glaucoma, cataracts, or reduced bone mineral density with long-term use
4. Discontinue and seek immediate help if breathing worsens suddenly after inhalation.

Dosage: (FORMIGET 400/12 MCG CAPSULES):

1. Adults & adolescents (≥12 years): 1 capsule twice daily
2. Maximum: 2 capsules per day (do not exceed)
3. Not for children under 12 years
4. LABAs must always be used with an ICS—never as monotherapy in asthma

Who It’s For (FORMIGET 400/12 MCG CAPSULES):

Adults and adolescents with severe asthma or advanced COPD requiring high-dose maintenance therapy. Not for mild disease, intermittent symptoms, or acute attacks.

Warnings & Precautions:

1. Not a rescue inhaler—use short-acting beta-agonists (e.g., salbutamol) for acute symptoms
2. Monitor COPD patients for pneumonia
3. Long-term high-dose ICS may suppress adrenal function or affect growth in adolescents
4. Avoid abrupt discontinuation—taper under medical supervision
5. Inform surgeon/dentist before procedures (adrenal suppression risk)

Drug Interactions:

1. Beta-blockers: May block bronchodilator effect and provoke bronchospasm
2. Diuretics, theophylline: Increased risk of hypokalemia
3. Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): May increase budesonide levels
4. Always inform your doctor about all medications.

Additional Information:

Store below 30°C in a dry place, protected from light and moisture. Keep capsules in original blister until use. Discard unused capsules after opening the blister. Available by prescription in Pakistan.