Patient leaflet - Eklira Genuair 322 micrograms inhalation powder
1. What Eklira Genuair is and what it is used for
What Eklira Genuair is
The active ingredient of Eklira Genuair is aclidinium bromide, which belongs to
a group of medicines called bronchodilators. Bronchodilators relax airways and
help keep bronchioles open. Eklira Genuair is a dry powder inhaler that uses
your breath to deliver the medicine directly into your lungs. This makes it easier
for chronic obstructive pulmonary disease (COPD) patients to breathe.
What Eklira Genuair is used for
Eklira Genuair is indicated to help open the airways and relieve symptoms of
COPD, a serious, long-term lung disease characterised by breathing difficulties.
Regular use of Eklira Genuair can help you when you have ongoing shortness of
breath related to your disease to help you minimise the effects of the disease
on your everyday life and reduce the number of flare-ups (the worsening of your
COPD symptoms for several days).
2. What you need to know before you use Eklira Genuair
Do not use Eklira Genuair
- if you are allergic to aclidinium bromide or any of the other ingredients of this
medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Eklira Genuair:
- if you have heart problems.
- if you see halos around lights or coloured images (glaucoma).
- if you have an enlarged prostate, problems passing urine, or a blockage in
your bladder.
3. How to use Eklira Genuair
Always use this medicine exactly as your doctor or pharmacist has told you.
Check with your doctor or pharmacist if you are not sure.
The recommended dose is one inhalation twice a day in the morning and evening.
The effects of Eklira Genuair last for 12 hours; therefore, you should try to use
your Eklira Genuair inhaler at the same time every morning and evening. This
ensures that there is always enough medicine in your body to help you breathe
more easily throughout the day and night. It will also help you to remember to
use it.
The recommended dose can be used for elderly patients and for patients with
kidney or liver problems. No dose adjustments are necessary.
COPD is a long-term disease; therefore, it is recommended that Eklira Genuair
is used every day, twice a day and not only when breathing problems or other
symptoms of COPD are experienced.
Driving and using machines
Eklira Genuair may have minor influence on the ability to drive and use
machines. This medicine may cause headache, dizziness or blurred vision. If
you are affected by any of these side effects do not drive or use machinery until
the headache has cleared, the feeling of dizziness has passed and your vision
has returned to normal.
Eklira Genuair contains lactose
If you have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
Children and adolescents
Eklira Genuair is not for use in children or adolescents below 18 years of age.
Other medicines and Eklira Genuair
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines.
Inform your doctor if you have been or are using similar medicines for breathing
problems, such as medicines containing tiotropium, ipratropium. Ask your
doctor or pharmacist if you are not sure. The use of Eklira Genuair with these
medicines is not recommended.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are
planning to have a baby, ask your doctor or pharmacist for advice before taking
this medicine. You should not use Eklira Genuair if you are pregnant or are
breast-feeding unless your doctor tells you so.
Eklira Genuair is indicated for maintenance treatment and should not be
used to treat a sudden attack of breathlessness or wheezing. If your COPD
symptoms (breathlessness, wheezing, cough) do not improve or get worse you
should contact your doctor for advice as soon as possible.
Dry mouth, which has been observed with medicines like Eklira Genuair, may
after using your medicine for a long time, be associated with tooth decay.
Therefore, please remember to pay attention to oral hygiene.
Stop taking Eklira Genuair and seek medical help immediately:
- if you get tightness of the chest, coughing, wheezing or breathlessness
immediately after using the medicine. These may be signs of a condition
called bronchospasm.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
Allergic reactions may rarely occur (may affect up to 1 in 1,000 people). Stop using
the medicine and contact your doctor immediately if you develop swelling of your
face, throat, lips or tongue (with or without difficulty breathing or swallowing),
dizziness or fainting, faster heart rate or if you get raised severely itchy bumps on
your skin (hives) as these may be symptoms of an allergic reaction.
If you stop using Eklira Genuair
This medicine is for long-term use. If you want to stop treatment, first talk to
your doctor, as your symptoms may worsen.
If you have any further questions on the use of this medicine, ask your doctor,
pharmacist or nurse.
Route of administration
The medicine is for inhalation use.
Refer to Instructions for Use for instructions on how to use the Genuair inhaler. If
you are not sure of how to use Eklira Genuair, contact your doctor or
pharmacist.
You can use Eklira Genuair any time before or after food or drink.
If you use more Eklira Genuair than you should
If you think you may have used more Eklira Genuair than you should, contact
your doctor or pharmacist.
If you forget to use Eklira Genuair
If you forget a dose of Eklira Genuair, inhale the dose as soon as you remember.
However, if it is nearly time for your next dose, skip the missed dose.
Do not take a double dose to make up for a forgotten dose.
5. How to store Eklira Genuair
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the inhaler
label and carton after “EXP”. The expiry date refers to the last day that month.
Keep the inhaler inside the pouch until the administration period starts.
To be used within 90 days of opening the pouch.
Do not use the Eklira Genuair if you notice that the pack is damaged or shows
signs of tampering.
After you have taken the last dose, the inhaler has to be disposed of. Do not
throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures
will help protect the environment.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. You can also report side effects
directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search
for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side
effects you can help provide more information on the safety of this medicine.
Common: may affect up to
1 in 10 people
- Headache
- Inflammation of the sinuses
(sinusitis)
- Common cold (nasopharyngitis)
- Cough
- Diarrhoea
- Nausea
Uncommon: may affect up to
1 in 100 people
- Dizziness
- Dry mouth
- Inflammation of the mouth (stomatitis)
- Hoarseness (dysphonia)
- Faster heart beat (tachycardia)
- Sensation of heart beating (palpitations)
- Abnormal or irregular heartbeat (cardiac
arrhythmias)
- Difficulty passing urine (urinary retention)
- Blurred vision
- Rash
Itching of the skin 14
The following side effects may occur whilst using Eklira Genuair:
6. Contents of the pack and other information
What Eklira Genuair contains
- The active substance is aclidinium bromide. Each delivered dose contains
375 micrograms aclidinium bromide equivalent to 322 micrograms of
aclidinium.
- The other ingredient is lactose monohydrate (refer to Section 2 “Eklira
Genuair contains lactose”).
What Eklira Genuair looks like and contents of the pack
Eklira Genuair is a white or almost white powder.
The Genuair inhaler device is white coloured with an integral dose indicator
and a green dosage button. The mouthpiece is covered with a removable green
protective cap. It is supplied in a plastic pouch.
