Eklira Genuair (Aclidinium Bromide)

What Is Eklira Genuair and What Is It Used For?

Eklira Genuair belongs to a group of medicines called bronchodilators. The active substance, aclidinium bromide, is classified as a long-acting muscarinic antagonist (LAMA). It works by blocking the action of acetylcholine on muscarinic receptors (specifically M3 receptors) in the smooth muscle of the airways. This causes the airway muscles to relax, which widens the bronchioles and makes it easier to breathe.

The Genuair device is a specially designed dry powder inhaler that uses the patient's own breathing effort to deliver the medication directly to the lungs. This targeted delivery ensures that the active substance reaches the airways efficiently, while minimising systemic exposure. Aclidinium bromide is rapidly broken down in the bloodstream into inactive metabolites, which contributes to its favourable safety profile with low rates of systemic anticholinergic side effects.

Eklira Genuair is indicated for the maintenance treatment of chronic obstructive pulmonary disease (COPD), a serious, progressive lung disease characterised by persistent airflow limitation. COPD encompasses conditions such as chronic bronchitis and emphysema. Regular use of Eklira Genuair can help to reduce ongoing breathlessness associated with the disease, improve exercise tolerance, and decrease the frequency of exacerbations (flare-ups of COPD symptoms lasting several days).

It is important to understand that Eklira Genuair is a maintenance medication. It is designed for regular, ongoing use and is not a rescue inhaler. It should not be used to treat sudden episodes of acute breathlessness or wheezing. For acute symptom relief, patients should use a short-acting bronchodilator (such as salbutamol) as prescribed by their healthcare provider.

According to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2024 guidelines, long-acting muscarinic antagonists like aclidinium are recommended as a first-line maintenance therapy option for patients with COPD who experience persistent symptoms despite appropriate use of short-acting bronchodilators. Clinical trials have demonstrated that aclidinium bromide significantly improves lung function (as measured by FEV1), reduces symptom burden, and improves health-related quality of life compared to placebo.

What Should You Know Before Taking Eklira Genuair?

Contraindications

You should not use Eklira Genuair if you have a known allergy (hypersensitivity) to aclidinium bromide or to any of the other ingredients in the product, including lactose monohydrate. Allergic reactions, although rare, can include swelling of the face, throat, lips or tongue, difficulty breathing or swallowing, dizziness, fainting, rapid heartbeat, or severe hives (urticaria). If you experience any of these symptoms, stop using the inhaler immediately and seek emergency medical attention.

Eklira Genuair is approved only for adult patients and must not be used by children or adolescents under 18 years of age, as safety and efficacy have not been established in this population.

Warnings and Precautions

Before starting treatment with Eklira Genuair, inform your doctor if you have any of the following conditions, as special monitoring or dose adjustments may be necessary:

• Heart problems: Anticholinergic medications can occasionally affect heart rate and rhythm. Patients with unstable cardiovascular conditions, recent myocardial infarction, or arrhythmias should be closely monitored.
• Narrow-angle glaucoma: Aclidinium may worsen this condition. Seek medical attention promptly if you notice eye pain, blurred vision, visual halos, or coloured images around lights.
• Prostatic hyperplasia or bladder-neck obstruction: Anticholinergic drugs can cause urinary retention. If you have difficulty urinating or an enlarged prostate, discuss this with your doctor before starting treatment.

Long-term use of anticholinergic inhalers may be associated with dry mouth, which can increase the risk of dental caries (tooth decay) over time. Maintain good oral hygiene practices, including regular brushing, flossing, and dental check-ups, while using this medication.

Pregnancy and Breastfeeding

There is limited clinical data on the use of aclidinium bromide during pregnancy. Animal studies have not shown direct harmful effects on fertility or foetal development, but as a precaution, Eklira Genuair should not be used during pregnancy unless your doctor considers the potential benefit to outweigh the possible risk to the foetus.

It is not known whether aclidinium bromide or its metabolites are excreted in human breast milk. A decision must be made by your healthcare provider as to whether to discontinue breastfeeding or to discontinue the medication, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the mother.

If you are pregnant, planning to become pregnant, or breastfeeding, always consult your doctor or pharmacist before using this medicine.

Driving and Operating Machinery

Eklira Genuair has no or negligible effect on the ability to drive and use machines at the recommended dose. However, headache and blurred vision have been reported as uncommon side effects. If you experience these symptoms, avoid driving or operating machinery until they have resolved.

How Does Eklira Genuair Interact with Other Drugs?

Drug interactions with aclidinium bromide are relatively few because the drug is rapidly hydrolysed in the bloodstream and has low systemic bioavailability. Nevertheless, certain combinations should be avoided or used with caution. Always inform your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including over-the-counter products and herbal supplements.

Anticholinergic Interactions

The most important interaction to be aware of is with other anticholinergic (muscarinic antagonist) medicines. Using Eklira Genuair concurrently with other long-acting or short-acting anticholinergic inhalers is not recommended, as this can lead to an additive anticholinergic effect, increasing the risk of side effects such as dry mouth, urinary retention, constipation, tachycardia, and blurred vision without providing additional therapeutic benefit.

Other Medication Considerations

In clinical pharmacokinetic studies, aclidinium bromide has not shown clinically relevant interactions with commonly used medications, including cardiovascular drugs, antibiotics, or diabetes medications. The rapid plasma hydrolysis of aclidinium means that its potential for systemic drug-drug interactions is low.

However, patients taking multiple anticholinergic medications for other conditions (such as certain bladder medications, antispasmodics, or some antihistamines) should discuss the cumulative anticholinergic burden with their doctor, as additive side effects may occur even from non-inhaled anticholinergic drugs.

What Is the Correct Dosage of Eklira Genuair?

Always use Eklira Genuair exactly as your doctor or pharmacist has instructed. If you are unsure, check with your healthcare provider. COPD is a chronic condition, and Eklira Genuair is intended for long-term, regular use – not only when you experience symptoms.

Adults

Elderly Patients

Renal and Hepatic Impairment

Children and Adolescents

How to Use the Genuair Inhaler

The Genuair inhaler has a unique colour-coded feedback system that confirms when a dose has been correctly prepared and successfully inhaled. Follow these steps carefully:

1. Remove the cap: Squeeze the arrows on each side of the protective cap and pull it off. Check that the mouthpiece is clear and unobstructed.
2. Check the control window: It should be red, indicating the device is ready to be loaded.
3. Load the dose: Hold the inhaler horizontally with the mouthpiece facing you and the green button pointing upwards. Press the green button all the way down. The control window will change from red to green. Release the button.
4. Exhale: Hold the inhaler away from your mouth and breathe out fully. Never exhale into the inhaler.
5. Inhale: Keep your head upright, place the mouthpiece between your lips and seal them tightly. Take a strong, deep breath through your mouth. Continue inhaling as long as possible.
6. Hold your breath: Remove the inhaler from your mouth and hold your breath for as long as comfortable.
7. Verify: Check the control window – it should now be red again, confirming successful inhalation.
8. Replace the cap: Put the protective cap back on after each use to keep out dust and debris.

Missed Dose

If you forget to take a dose, inhale it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten one.

Overdose

If you accidentally take more Eklira Genuair than prescribed, contact your doctor or pharmacist. High doses of anticholinergic medications may cause symptoms such as dry mouth, blurred vision, tachycardia, urinary retention, and constipation. Treatment is symptomatic and supportive.

What Are the Side Effects of Eklira Genuair?

Like all medicines, Eklira Genuair can cause side effects, although not everybody gets them. Most side effects are mild to moderate in severity and tend to diminish with continued use. The following side effects have been reported in clinical trials and post-marketing surveillance:

The anticholinergic mechanism of aclidinium bromide means that some side effects are class-related. Dry mouth, urinary retention, and blurred vision are typical anticholinergic effects, but they occur less frequently with aclidinium than with some other agents in this class, likely due to its rapid hydrolysis and low systemic exposure.

Clinical trials comparing aclidinium bromide to placebo showed that the overall incidence of adverse events was similar between the two groups, and discontinuation rates due to side effects were low. Most side effects resolved without the need for dose adjustment or treatment discontinuation.

If you experience any side effects, including any not listed above, talk to your doctor, pharmacist, or nurse. You can also report suspected side effects to your national pharmacovigilance authority to help monitor the benefit-risk balance of medicines.

How Should You Store Eklira Genuair?

Proper storage of Eklira Genuair is essential to ensure the medication remains effective and safe to use throughout its shelf life. Follow these storage guidelines carefully:

• Before first use: Keep the inhaler inside its original sealed aluminium pouch until you are ready to start using it. The pouch protects the dry powder from moisture, which could affect its performance.
• After opening the pouch: Use the inhaler within 90 days of opening the sealed pouch. Write the date of opening on the inhaler or its packaging to help you keep track.
• Temperature: Store at room temperature (below 25°C / 77°F). Do not expose the inhaler to extreme heat, direct sunlight, or freezing temperatures.
• Keep dry: Protect the inhaler from moisture. Do not store it in the bathroom.
• Keep out of reach of children: Store the inhaler out of sight and reach of children at all times.
• Expiry date: Do not use Eklira Genuair after the expiry date stated on the inhaler label and carton ("EXP"). The expiry date refers to the last day of that month.
• Damaged packaging: Do not use the inhaler if you notice that the packaging is damaged or shows signs of tampering.

After you have taken the last dose, the inhaler should be disposed of responsibly. Do not throw it in household waste or flush it down the drain. Return used inhalers to your pharmacy for proper disposal. This protects the environment and ensures that residual medication is handled safely.

What Does Eklira Genuair Contain?

Understanding the composition of your medication can help you identify potential allergens and make informed decisions about your treatment.

Active Ingredient

The active substance is aclidinium bromide. Each delivered dose contains 375 micrograms of aclidinium bromide, which is equivalent to 322 micrograms of aclidinium (the active moiety). Aclidinium bromide is a synthetic quaternary ammonium compound that acts as a competitive, reversible antagonist at muscarinic acetylcholine receptors, with particular selectivity for the M3 receptor subtype found in airway smooth muscle.

Excipients

The only excipient (inactive ingredient) in Eklira Genuair is lactose monohydrate. Lactose serves as a carrier for the active powder, ensuring that the drug is delivered consistently and efficiently with each inhalation. The amount of lactose in each dose is very small.

Physical Appearance

The inhalation powder is white or almost white in appearance. The Genuair inhaler device is white with a built-in dose indicator and a green dosing button. The mouthpiece is covered with a removable green protective cap. The inhaler is supplied inside a sealed plastic pouch.

Available Pack Sizes

Eklira Genuair is available in the following pack sizes:

• Carton containing 1 inhaler with 30 doses
• Carton containing 1 inhaler with 60 doses
• Carton containing 3 inhalers with 60 doses each

Not all pack sizes may be marketed in your country.

Marketing Authorisation Holder

The marketing authorisation holder is Covis Pharma Europe B.V., based in Amsterdam, the Netherlands. The product is manufactured by Industrias Farmacéuticas Almirall, S.L. in Barcelona, Spain. In some markets, aclidinium bromide is marketed under the brand name Tudorza Pressair.