What is it used for?

• Chronic obstructive pulmonary disease (COPD).
• This inhaler is used regularly on a twice daily basis to help keep the airways open.

How does it work?

• Eklira Genuair inhaler contains the active ingredient aclidinium bromide, which is a type of medicine known as an antimuscarinic or anticholinergic bronchodilator. It works by opening the airways to make it easier to breathe.
• Aclidinium works in the lungs, where it blocks receptors called muscarinic receptors that are found on the muscle surrounding the airways. A natural chemical called acetylcholine normally acts on these receptors, causing the muscle in the airways to contract and the airways to narrow.
• In chronic obstructive lung diseases (COPD), such as chronic bronchitis or emphysema, the airways are narrowed, and this makes breathing in and out difficult.
• Aclidinium blocks the muscarinc receptors in the lungs and therefore stops the action of acetylcholine on them. This allows the muscle around the airways to relax and the airways to open. This makes it easier for people with COPD to breathe.
• Aclidinium is taken using an inhaler device called a Genuair inhaler. Inhaling the medicine allows it to act directly in the lungs where it is needed most. It also reduces the potential for side effects in other parts of the body, as the amount absorbed into the blood through the lungs is lower than if it is taken by mouth.
• Aclidinium should not be used to relieve an attack of breathing difficulty. Instead, it should be used regularly each day to keep the airways open and help prevent breathing difficulties. The medicine works over 12 hours so it is taken twice a day - morning and evening.

How do I use it?

• Follow the instructions provided with your Eklira Genuair inhaler carefully. These describe in detail how to use the inhaler correctly. Talk to your doctor, pharmacist or nurse if you are unsure how to use the device, or have any problems using it.
• To use the inhaler there are two steps you need to follow after removing the cap. Firstly, you must press and release the green button, then breathe out completely without holding the inhaler to your mouth. The second step is to place your lips tightly around the mouthpiece and inhale strongly and deeply through the inhaler. It is important that you do not keep the green button on the inhaler pressed down while you are breathing in your dose.
• The usual dose of Eklira is one dose to be inhaled twice a day - morning and evening. The effects of one dose last for 12 hours, so it is best to try and use the inhaler at about the same time in the morning and evening. This will help you to breathe more easily during the day and night.
• If you forget to take a dose take it as soon as you remember, unless it is nearly time for your next dose. If this is the case, leave out the forgotten dose and just take your next dose as usual. Do not take a double dose to make up for a missed dose.
• Do not exceed the recommended dose of this medicine.
• The Eklira Genuair inhaler should only be cleaned with dry tissue or paper towel. Water should not be used to clean the inhaler as this can damage the medicine in the inhaler.

Warning!

• Inhalers may cause an unexpected increase in wheezing (paradoxical bronchospasm) straight after using them. If this happens, stop using the inhaler immediately and consult your doctor. The medicine should be stopped and an alternative treatment found.
• Eklira should not be used to relieve an attack of breathing difficulty. Instead, it should be used regularly each morning and evening to keep the airways open and help prevent breathing difficulties.
• This medicine can cause a dry mouth, which may increase the risk of tooth decay with long-term use of the medicine. It is therefore important to practise good oral hygiene and visit your dentist regularly for check-ups.

Use with caution in

Closed angle glaucoma.

• People who have difficulty passing urine, for example men with an enlarged prostate gland (prostatic hypertrophy) or people with an obstruction of the bladder.
• People who have had a heart attack during the previous six months.
• People with unstable angina.
• People with irregular heartbeats (arrhythmias) that have been diagnosed within the previous three months.
• People who have had to go into to hospital for moderate to severe heart failure in the last 12 months

Not to be used in

• People who are allergic to atropine or similar medicines, eg ipratropium, tiotropium or oxitropium.
• Children and adolescents under 18 years of age.
• Eklira inhaler contains lactose and should not be used by people with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.
• This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• The safety of this medicine in pregnancy has not been established. It should therefore be used with caution during pregnancy, and only if the benefits to the mother outweigh any risks to the unborn baby. Seek medical advice from your doctor.
• It is not known if this medicine passes into breast milk after inhalation. You should seek medical advice from your doctor before breastfeeding while using this medicine.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Common

• Headache.
• Inflammation of the nose and throat, causing a blocked or runny nose and sore throat (nasopharyngitis).
• Inflammation of the sinuses (sinusitis).
• Cough.
• Diarrhoea.

Uncommon 

• Difficulty passing urine (urinary retention).
• Increased heart rate (tachycardia).
• Blurred vision.
• Dry mouth.
• Hoarseness.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before using any new medicines while using this one, to make sure that the combination is safe.

The manufacturer of this medicine has not performed any studies to confirm whether it can affect other medicines. However, it has been used safely with the following medicines for COPD:

• aminophylline
• corticosteroids taken by mouth, eg prednisolone, or by inhaler, eg beclometasone, budesonide.
• sympathomimetic bronchodilators, such as salbutamol and terbutaline
• theophylline.

This medicine has not been studied in combination with other anticholinergic medicines such as those below, and these are therefore not recommended while you are using this medicine:

• glycopyrronium
• ipratropium
• oxitropium
• tiotropium.

If you experience a dry mouth as a side effect of this medicine you may find that medicines that are designed to dissolve and be absorbed from under the tongue, eg sublingual glyceryl trinitrate (GTN) tablets for angina, become less effective. This is because the tablets do not dissolve properly in a dry mouth. To resolve this, drink a mouthful of water before taking sublingual tablets.

References:

https://www.evidence.nhs.uk/formulary/bnf/current/3-respiratory-system/31-bronchodilators/312-antimuscarinic-bronchodilators/aclidinium-bromide/eklira-genuair

http://www.netdoctor.co.uk/medicines/lungs/a8820/eklira-aclidinium/

http://www.medicines.ie/medicine/15968/SPC/Eklira+Genuair+322+micrograms+inhalation+powder/#MACHINEOPS

https://www.medicines.org.uk/emc/medicine/26994

http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002211/WC500132661.pdf

https://patient.info/medicine/aclidinium-inhaler-eklira