Eklira Genuair 322 micrograms inhalation powder
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Eklira Genuair 322 micrograms powder for inhalation
aclidinium (aclidinium bromide)
Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any side effects, talk to your doctor, pharmacist or nurse, including any possible side effects not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Eklira Genuair is and what it is used for
- What you need to know before using Eklira Genuair
- How to use Eklira Genuair
- Possible side effects
- How to store Eklira Genuair
- Contents of the pack and other information
Instructions for use
1. What Eklira Genuair is and what it is used for
What Eklira Genuair is
The active substance in Eklira Genuair is aclidinium bromide, which belongs to a class of medicines called bronchodilators. Bronchodilators relax the airways and help keep the bronchioles open. Eklira Genuair is a dry powder inhaler that uses your breath to deliver the medicine directly into the lungs. This helps patients with chronic obstructive pulmonary disease (COPD) to breathe more easily.
What Eklira Genuair is used for
Eklira Genuair is indicated to help open the airways and relieve symptoms of COPD, a severe long-term lung disease characterized by difficulty in breathing. Regular use of Eklira Genuair may help when you experience ongoing breathing difficulties due to the disease, helping to minimize the impact of the disease on your daily life and reduce the number of flare-ups (worsening of COPD symptoms lasting for several days).
2. What you need to know before using Eklira Genuair
Do not use Eklira Genuair:
- if you are allergic to aclidinium bromide or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting to use Eklira Genuair:
- if you have heart problems;
- if you see halos around lights or colored images (glaucoma);
- if you have prostate enlargement, problems with urination, or a bladder obstruction.
Eklira Genuair is intended for maintenance treatment and must not be used to treat a sudden attack of breathing difficulty or wheezing. If your COPD symptoms (difficulty breathing, wheezing, or cough) do not improve or worsen, you should consult your doctor as soon as possible.
Dry mouth, which has been observed with medicines like Eklira Genuair, may be associated with dental caries after prolonged use of the medicine. Therefore, remember to maintain good oral hygiene.
Stop using Eklira Genuair and seek immediate medical help if:
- you experience chest tightness, cough, wheezing, or difficulty breathing immediately after using this medicine. These may be signs of a condition called bronchospasm.
Children and adolescents
Eklira Genuair must not be used in children or adolescents under 18 years of age.
Using Eklira Genuair with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Inform your doctor if you have used or are currently using similar medicines for breathing problems, such as medicines containing tiotropium or ipratropium. If in doubt, consult your doctor or pharmacist. The use of Eklira Genuair with these medicines is not recommended.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. You must not use Eklira Genuair during pregnancy or breastfeeding unless your doctor has advised you to do so.
Driving and using machines
The effect of Eklira Genuair on the ability to drive and use machines is minor. This medicine may cause headache, dizziness, or blurred vision. If you experience any of these side effects, do not drive or operate machinery until your headache resolves, dizziness disappears, and your vision returns to normal.
Eklira Genuair contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to use Eklira Genuair
Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is one inhalation twice daily, in the morning and evening.
The effects of Eklira Genuair last for 12 hours; therefore, you should try to use the 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 remember to take it.
The recommended dose can be used in elderly patients and in patients with kidney or liver problems. Dose adjustment is not necessary.
COPD is a long-term condition, therefore it is recommended that Eklira Genuair be used every day, twice daily, and not only when you have breathing difficulties or other COPD symptoms.
Route of administration
This medicine is for inhalation use only.
Refer to the Instructions for Use to learn how to use the Genuair inhaler. If you are unsure about how to use Eklira Genuair, consult your doctor or pharmacist.
You may use Eklira at any time, before or after food or drinks.
If you use more Eklira Genuair than you should
If you think you have used more Eklira Genuair than you should, consult your doctor or pharmacist.
If you forget to use Eklira Genuair
If you miss a dose of Eklira Genuair, inhale the dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
Do not take a double dose to make up for forgotten doses.
If you stop using Eklira Genuair
This medicine is intended for long-term treatment. If you wish to stop treatment, consult your doctor first, as your symptoms may worsen.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.
4. Possible adverse effects
Like all medicines, Eklira Genuair can cause adverse effects, although not everyone experiences them.
Allergic reactions may occur rarely (may affect up to 1 in 1,000 patients). Stop using the medicine and contact your doctor immediately if you experience swelling of the face, throat, lips, or tongue (with or without difficulty breathing or swallowing), dizziness or fainting, rapid heartbeat, or severe swelling with itching of the skin (hives), as these may be symptoms of an allergic reaction.
The following adverse effects may occur when using Eklira Genuair:
Frequent: may affect up to 1 in 10 patients
- Headache
- Inflammation of the sinuses (sinusitis)
- Common cold (nasopharyngitis)
- Cough
- Diarrhea
- Nausea
Uncommon: may affect up to 1 in 100 patients
- Dizziness
- Dry mouth
- Inflammation of the mouth (stomatitis)
- Hoarseness (dysphonia)
- Increased heart rate (tachycardia)
- Sensation of the heart beating strongly (palpitations)
- Abnormal or irregular heartbeat (cardiac arrhythmias)
- Difficulty urinating (urinary retention)
- Blurred vision
- Rash
- Itching of the skin
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Eklira Genuair
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the inhaler label and packaging, following “EXP”. The expiry date refers to the last day of the month indicated.
Keep the Genuair inhaler inside the bag until treatment is started.
Use within 90 days after opening the bag.
Do not use Eklira Genuair if you notice that the packaging is damaged or shows signs of tampering.
Once you have used the last dose, the inhaler must be discarded. Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Eklira Genuair
- The active substance is aclidinium bromide. Each delivered dose contains 375 micrograms of aclidinium bromide, equivalent to 322 micrograms of aclidinium.
- The other component is lactose monohydrate (see section 2, “Eklira Genuair contains lactose”).
Nature and contents of the container
Eklira Genuair is a white or almost white powder.
The Genuair inhaler device is white with an integrated dose indicator and a green dosing button. The mouthpiece is covered by a removable green protective cap. It is supplied in a plastic pouch.
Pack sizes available:
Pack containing 1 inhaler with 30 doses.
Pack containing 1 inhaler with 60 doses.
Pack containing 3 inhalers, each with 60 doses.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Covis Pharma Europe B.V.
Gustav Mahlerplein 2
1082MA Amsterdam
The Netherlands
Manufacturer
Industrias Farmacéuticas Almirall, S.A.
Ctra. de Martorell 41-61
08740 Sant Andreu de la Barca, Barcelona
Spain
More information on this medicinal product is available upon request from the local representative of the Marketing Authorization Holder:
Belgium/Belgium/Belgium Covis Pharma Europe B.V. Tel: 80013067 | Lithuania Covis Pharma Europe B.V. Tel: 880000890 |
| Luxembourg/Luxembourg Covis Pharma Europe B.V. Tel: 80024119 |
Czech Republic Covis Pharma Europe B.V. Tel: 800144474 | Hungary Covis Pharma Europe B.V. Tel.: 0680021540 |
Denmark Zentiva Denmark ApS Tlf: +45 787 68 400 | Malta Covis Pharma Europe B.V. Tel: 80065149 |
Germany Zentiva Pharma GmbH Tel: +49 (0) 800 53 53 010 | Netherlands Covis Pharma Europe B.V. Tel: 08000270008 |
Estonia Covis Pharma Europe B.V Tel: 8000100776 | Norway Zentiva Denmark ApS Tlf: +47 219 66 203 |
Greece Specialty Therapeutics IKE Tel: +30 213 02 33 913 | Austria Covis Pharma Europe B.V. Tel: 0800006573 |
Spain Zentiva Spain S.L.U. Tel: +34 931 815 250 | Poland Covis Pharma Europe B.V. Tel.: 0800919353 |
France Zentiva France Tél: +33 (0) 800 089 219 | Portugal Zentiva Portugal, Lda Tel: +351210601360 |
Croatia Covis Pharma Europe B.V. Tel: 08004300 | Romania Covis Pharma Europe B.V. Tel: 0800410175 |
Ireland Zentiva Denmark ApS Sími: +354 539 0650 | Slovenia Covis Pharma Europe B.V. Tel: 080083003 |
Iceland Zentiva Denmark ApS Sími: +354 539 0650 | Slovakia Covis Pharma Europe B.V. Tel: 0800008203 |
Italy Covis Pharma Europe B.V. Tel: 800168094 | Finland Zentiva Denmark ApS Puh/Tel: +358 942 598 648 |
Cyprus Specialty Therapeutics IKE Tel: +30 213 02 33 913 | Sweden Zentiva Denmark ApS Tel: +46 840 838 822 |
Latvia Covis Pharma Europe B.V. Tel: 80005962 | United Kingdom (Northern Ireland) Zentiva, k.s. Tel: +44 (0) 800 090 2408 |
Date of the last review of this leaflet:
Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Instructions for use
This section contains information on how to use your Genuair inhaler. It is important that you read this information, as Genuair may work differently from inhalers you have used before. If you have any questions about how to use your inhaler, ask your doctor, pharmacist, or nurse for help.
The instructions for use are divided into the following sections:
- Getting started
- Step 1: Prepare your dose
- Step 2: Inhale your medicine
- Additional information
Getting started
Read these instructions for use before starting to use the medicine
Become familiar with the parts of your Genuair inhaler
Before using:
- Before first use, open the sealed bag and remove the inhaler. Dispose of the bag and the desiccant.
- Do not press the orange button until you are ready to inhale a dose.
- Remove the cap by gently pressing the arrows on each side (Figure B).
STEP 1: Prepare your dose
- Check the mouthpiece opening and make sure nothing is blocking it (Figure C).
- Check the control window (it should be red, Figure C).
- Hold the inhaler horizontally with the mouthpiece facing towards you and the orange button on top (Figure D).
- Press the orange button fully downwards to load your dose (Figure E).
When you press the orange button fully down, the control window will change from red to green.
Make sure the orange button is on top. Do not tilt it. |
- Release the orange button (Figure F).
Make sure to release the button so the inhaler can work properly. |
Stop and check:
- Make sure the control window is now green (Figure G).
Your medicine is ready to be inhaled.
Proceed to "STEP 2: Inhale your medicine".
What to do if the control window remains red after pressing the button (Figure H).
The dose is not ready. Go back to “STEP 1 Prepare your dose” and repeat steps 1.1 to 1.6. |
STEP 2: Inhale your medication
Read steps 2.1 to 2.7 completely before use. Do not tilt. |
2.1 Keep the inhaler away from your mouth and breathe out fully. Never exhale into the inhaler (Figure I).
2.2 Keep your head upright, place the mouthpiece between your lips, and close your lips firmly around the mouthpiece (Figure J).
Do not hold the orange button down while inhaling. |
2.3 Take a strong and deep breath in through the mouth. Continue inhaling for as long as possible.
A “click” will let you know that you have inhaled correctly. Continue inhaling for as long as possible after hearing the “click”. Some patients may not hear the “click”. Use the viewing window to ensure that you have inhaled correctly. |
2.4 Remove the inhaler from your mouth.
2.5 Hold your breath for as long as possible.
2.6 Slowly breathe out away from the inhaler.
Some patients may experience a sandy sensation in the mouth or a slightly sweet or bitter taste. Do not inhale an extra dose if you do not notice any taste or do not feel anything after inhaling. |
Stop and check:
2.7 Make sure that the control window is now red (Figure K). This means that you have inhaled your medication correctly.
What to do if the control window remains green after inhaling (Figure L).
This means you have not inhaled your medication correctly. Go back to “STEP 2 Inhale your medication” and repeat steps 2.1 to 2.7. If the control window still does not turn red, you may have forgotten to release the orange button before inhaling, or you may not have inhaled strongly enough. If this happens, try again. Make sure you have released the orange button and that you have breathed out fully. Then take a strong, deep inhalation through the mouthpiece. Please contact your doctor if the control window remains green after several attempts. |
Replace the protective cap on the mouthpiece after each use (Figure M), to prevent contamination of the inhaler with dust or other materials. You must discard your inhaler if you lose the cap.
Additional information:
What should you do if you accidentally load a dose?
Store your inhaler with the protective cap in place until it is time to inhale your medication, then remove the cap and start at step 1.6.
How does the dose indicator work?
- The dose indicator shows the total number of doses remaining in the inhaler (Figure N).
- At first use, each inhaler contains at least 60 or 30 doses, depending on the package size.
- Each time a dose is loaded by pressing the orange button, the dose indicator moves slightly to the next number (50, 40, 30, 20, 10 or 0).
When should you get a new inhaler?
You should get a new inhaler:
- If your inhaler appears damaged or if you lose the cap, or
- When a red striped band appears in the dose indicator, meaning you are approaching the last dose (Figure N), or
- If your inhaler is empty (Figure O).
How can you tell if your inhaler is empty?
When the orange button does not fully return to its upper position and remains stuck in a middle position, you have reached the last dose (Figure O). Even when the orange button is stuck, you can still inhale the final dose. After that, the inhaler cannot be used again and you must start using a new inhaler.
How should you clean the inhaler?
NEVER use water to clean the inhaler, as this could damage your medication.
If you wish to clean your inhaler, simply wipe the outside of the mouthpiece with a dry cloth or paper towel.