Product Overview

Product Name: GSK Trelegy Ellipta 200 mcg / 62.5 mcg / 25 mcg Inhalation Powder

Brand: GSK (GlaxoSmithKline)
Product Range: Trelegy Ellipta
Dosage Form: Dry Powder Inhaler (DPI)
Strength: 200 mcg / 62.5 mcg / 25 mcg per inhalation (labelled strength)
Pack Size: 30 Doses
Packaging: 1 Ellipta Inhaler
Country of Origin: UK (as supplied; verify manufacturing and regulatory details on the physical pack)
Administration: Oral inhalation
Prescription Status: Prescription-only medicine (POM, subject to local regulations)

Product Description

GSK Trelegy Ellipta is a prescription combination inhaler containing three active ingredients that work together to help manage long-term respiratory conditions.

It combines an inhaled corticosteroid with two long-acting bronchodilators. This triple-action formulation is designed to reduce airway inflammation, relax airway muscles and help maintain open airways.

The 200/62.5/25 mcg formulation contains:

• Fluticasone Furoate 200 mcg: An inhaled corticosteroid (ICS) that helps reduce inflammation and swelling in the airways.
• Umeclidinium 62.5 mcg: A long-acting muscarinic antagonist (LAMA) that helps relax airway muscles and widen the airways.
• Vilanterol 25 mcg: A long-acting beta-2 agonist (LABA) that helps relax airway muscles and improve airflow.

The Ellipta inhaler is designed to deliver a pre-measured dose through a simple breath-activated inhalation mechanism.

Key Features

• Three active respiratory medicines combined in one inhaler.
• Combines corticosteroid and two long-acting bronchodilators.
• Designed for regular maintenance treatment of asthma where the prescribed strength is appropriate.
• Helps reduce airway inflammation.
• Helps relax and widen the airways.
• Convenient once-daily maintenance regimen when prescribed according to the applicable product information.
• Easy-to-use Ellipta dry powder inhaler.
• 30 pre-measured doses per inhaler.

Benefits and Functions

1. Helps Control Airway Inflammation

Fluticasone furoate helps reduce inflammation in the airways, an important factor in asthma.

2. Helps Keep Airways Open

Umeclidinium and vilanterol work through different mechanisms to relax airway muscles and improve airflow.

3. Triple-Action Respiratory Support

The three active ingredients provide complementary anti-inflammatory and bronchodilator effects.

4. Supports Long-Term Asthma Management

When prescribed appropriately and used regularly, the medicine helps maintain asthma control.

5. Convenient Inhaler Format

The Ellipta device provides pre-measured inhalation doses, making regular treatment more convenient.

Indications and Uses

The 200/62.5/25 mcg strength is intended for maintenance treatment of asthma in eligible adult patients under the applicable prescribing information.

It may be prescribed for adults:

• Whose asthma is not adequately controlled with other combination maintenance treatments.
• Who require a higher inhaled corticosteroid dose alongside long-acting bronchodilators.
• Who need combined anti-inflammatory and bronchodilator maintenance therapy.

Important: This 200 mcg strength should not be presented as a COPD treatment. The commonly authorised UK COPD presentation is Trelegy Ellipta 92/55/22 mcg delivered dose. The exact indication must be checked against the registration and leaflet for the supplied 200-strength pack.

Active Ingredients and Their Functions

How to Use

Use Trelegy Ellipta exactly as prescribed by a qualified healthcare professional.

General Ellipta inhaler instructions:

1. Open the inhaler cover by sliding it down until it clicks.
2. Breathe out gently, away from the mouthpiece.
3. Place the mouthpiece between your lips and close your lips firmly around it.
4. Take one long, steady, deep breath through the inhaler.
5. Remove the inhaler and hold your breath for approximately 3–4 seconds, or as long as comfortable.
6. Breathe out slowly.
7. Close the inhaler cover.
8. Rinse your mouth with water and spit it out. Do not swallow the water.

Important usage instructions:

• Do not breathe out into the inhaler.
• Open the cover only when you are ready to take a dose.
• Opening and closing the cover without inhaling can waste a dose.
• Follow the instructions supplied with the specific inhaler.

Important Safety Information

Trelegy Ellipta is not a rescue inhaler.

• It must not be used to treat sudden asthma attacks or acute breathing difficulties.
• Keep your prescribed quick-relief inhaler available.
• Do not exceed the prescribed dose.
• Do not stop treatment without consulting your doctor.
• Seek urgent medical attention if you experience severe breathing difficulty.

Possible Side Effects

Some possible side effects include:

• Headache.
• Cough.
• Hoarseness or voice changes.
• Oral thrush (fungal infection in the mouth).
• Upper respiratory tract infections.
• Throat irritation.

Serious potential adverse effects include pneumonia, allergic reactions, cardiovascular effects, glaucoma, urinary retention and paradoxical bronchospasm.

Seek medical advice if you experience unusual or persistent symptoms.

Precautions

Consult your doctor before using this medicine if you have:

• Heart disease or irregular heartbeat.
• High blood pressure.
• Glaucoma.
• Urinary retention or prostate problems.
• Diabetes.
• Thyroid disorders.
• Liver problems.
• A history of recurrent respiratory infections.

Patients with severe milk-protein allergy should also check the product's excipients and contraindications before use.

Drug Interactions

Inform your doctor or pharmacist if you are taking any other medicines, particularly:

• Other inhaled or oral corticosteroids.
• Other long-acting bronchodilators.
• Anticholinergic medicines.
• Beta-blockers.
• Certain antifungal medicines, such as ketoconazole.
• Certain antibiotics, such as clarithromycin.
• Some antidepressants, including tricyclic antidepressants.

These medicines may increase the risk of side effects or affect how Trelegy works.

Storage Instructions

• Store according to the temperature and storage instructions on the original packaging.
• Keep the inhaler in its original sealed foil tray until first use.
• Once the foil tray is opened, use the inhaler within 6 weeks, unless its specific packaging states otherwise.
• Keep away from excessive heat and moisture.
• Keep out of reach of children.
• Do not use after the expiry date.

Product Specifications

Who Should Not Use This Medicine Without Medical Advice?

• Individuals with an allergy to any active ingredient or excipient.
• People experiencing an acute asthma attack.
• Patients with significant cardiovascular conditions.
• Patients with severe milk-protein allergy.
• Children and adolescents, unless specifically authorised by the applicable product information.

Pregnant or breastfeeding individuals should consult their healthcare professional before use.

Frequently Asked Questions (FAQ)

Q1. What is GSK Trelegy Ellipta used for?

It is a triple-combination maintenance inhaler used to help manage asthma in eligible adults when prescribed at the appropriate strength.

Q2. What are the three active ingredients?

Fluticasone Furoate, Umeclidinium and Vilanterol.

Q3. How many doses are included?

This pack contains one inhaler with 30 pre-measured doses.

Q4. Is Trelegy Ellipta a steroid inhaler?

Yes. It contains Fluticasone Furoate, an inhaled corticosteroid, together with two long-acting bronchodilators.

Q5. Can it be used during a sudden asthma attack?

No. It is a maintenance medicine, not a rescue inhaler. A prescribed quick-relief inhaler should be used for sudden asthma symptoms.

Q6. Is Trelegy Ellipta suitable for COPD?

The 200/62.5/25 mcg strength should not be marketed for COPD. The UK COPD presentation is a different strength.

Q7. Should I rinse my mouth after using it?

Yes. Rinse your mouth with water and spit it out after each inhalation to help reduce the risk of oral thrush.

Q8. Can I use it without a prescription?

No. It is a prescription medicine and should only be used under appropriate medical supervision.