Product Information:

VILANTO-UF 100/62.5/25mcg is a triple-combination dry powder inhaler (DPI) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults. It contains three active ingredients in a single capsule, designed for use with a compatible breath-actuated DPI device (e.g., Breezhaler®):

1. Indacaterol Acetate 100mcg – a long-acting beta₂-agonist (LABA) that provides 24-hour bronchodilation
2. Glycopyrronium Bromide 62.5mcg – a long-acting muscarinic antagonist (LAMA) that blocks cholinergic bronchoconstriction
3. Mometasone Furoate 25mcg – an inhaled corticosteroid (ICS) that reduces airway inflammation

This triple therapy (LABA + LAMA + ICS) is indicated for patients with severe COPD and a history of frequent exacerbations despite dual bronchodilator therapy.

⚠️ Important Note:

This product is for inhalation only—capsules must be used with the appropriate DPI device. Do not swallow the capsule.

Uses of (VILANTO-UF 100+62.5+25mcg):

1. Maintenance treatment of severe COPD (FEV₁ <50% predicted)
2. Patients with history of ≥2 moderate or ≥1 severe exacerbation per year
3. Those not adequately controlled on dual therapy (LABA/LAMA or LABA/ICS)

Key Benefits of (VILANTO-UF 100+62.5+25mcg):

1. Triple mechanism: dual bronchodilation + anti-inflammatory action
2. Significantly reduces risk of COPD exacerbations
3. Improves lung function (FEV₁), dyspnea, exercise tolerance, and quality of life
4. Once-daily dosing for consistent 24-hour control

How To Use (VILANTO-UF 100+62.5+25mcg):

1. Open the inhaler device and insert one capsule into the chamber.
2. Close the device and press the piercing button.
3. Breathe out fully (away from the device).
4. Place mouthpiece in mouth, seal lips tightly.
5. Inhale quickly and deeply through the mouthpiece to draw the powder into the lungs.
6. Hold breath for 5–10 seconds, then breathe normally.
7. Discard the empty capsule after use.
8. Dosage: One capsule once daily at the same time each day
9. Not for acute bronchospasm—always carry a rescue inhaler (e.g., salbutamol)

When Not to Use (VILANTO-UF 100+62.5+25mcg):

Do not use if you have:

1. Hypersensitivity to indacaterol, glycopyrronium, mometasone, or any excipients
2. Asthma (triple therapy with ICS/LABA/LAMA is not approved for asthma)
3. Acute COPD exacerbation or respiratory failure
4. Untreated active respiratory infections (e.g., tuberculosis, fungal infection)

Side Effects of (VILANTO-UF 100+62.5+25mcg):

Common:

1. Cough, throat irritation
2. Headache, nasopharyngitis
3. Oral candidiasis (thrush)—rinse mouth after use
4. Dry mouth (due to glycopyrronium)

Less common:

1. Palpitations, tremor (from indacaterol)
2. Hoarseness, dysphonia
3. Pneumonia (increased risk with ICS in COPD)

Serious (rare):

1. Paradoxical bronchospasm—discontinue immediately
2. Acute narrow-angle glaucoma (eye pain, blurred vision)—seek emergency care
3. Urinary retention (in men with BPH—due to anticholinergic effect)
4. Adrenal suppression or cataracts (with long-term ICS use)
5. Seek medical help if breathing worsens, eye pain occurs, or signs of pneumonia (fever, increased sputum) develop.

Dosage: (VILANTO-UF 100+62.5+25mcg):

1. Adults with severe COPD: One capsule once daily
2. Maximum: One capsule per 24 hours
3. Not for children or asthma patients

Who It’s For (VILANTO-UF 100+62.5+25mcg):

Adults with severe, symptomatic COPD and a history of exacerbations who remain uncontrolled on dual bronchodilator therapy and require anti-inflammatory add-on treatment.

Warnings & Precautions:

1. For inhalation only—do not swallow
2. Rinse mouth with water after each use to prevent oral thrush
3. Monitor for pneumonia symptoms (common in COPD patients on ICS)
4. Use caution in patients with glaucoma, prostate enlargement, or cardiac arrhythmias
5. Not a rescue medication—use salbutamol for acute symptoms

Drug Interactions:

1. Strong CYP3A4 inhibitors (ketoconazole): May increase systemic corticosteroid exposure
2. Beta-blockers: May antagonize indacaterol and induce bronchospasm
3. Other anticholinergics: Additive side effects (dry mouth, urinary retention)
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. Do not use after the expiration date. Available by prescription only in Pakistan.