322 micrograms inhaled powder
aclidinium (aclidinium bromide)
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 group of medicines called bronchodilators. Bronchodilators help relax the airways and help keep the bronchioles open. Eklira Genuair is a dry powder inhaler that uses your breathing to deliver the medicine directly to your lungs. This makes it easier for patients with chronic obstructive pulmonary disease (COPD) to breathe.
What Eklira Genuair is used for
Eklira Genuair is used to help open the airways and relieve the symptoms of COPD, a serious and long-lasting lung disease characterized by difficulty breathing. Regular use of Eklira Genuair can help you when you have ongoing shortness of breath associated with your illness. Eklira Genuair helps you minimize the impact of the disease on your daily life and reduce the number of worsening periods (worsening of your COPD symptoms 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 any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Eklira Genuair.
- if you have recently had heart problems
- if you see a halo around lights or color images ( glaucoma )
- if you have an enlarged prostate, problems urinating, or a blockage in the bladder.
Eklira Genuair is used for maintenance treatment and should not be used to treat a sudden attack of shortness of breath or wheezing. If your COPD symptoms (shortness of breath, wheezing, coughing) do not get better or worse, you should contact and consult your doctor as soon as possible.
Dry mouth, which has been observed with medicines similar to Eklira Genuair, can be associated with caries if you use the medicine for a long time. Therefore, be careful with oral hygiene.
Stop taking Eklira Genuair and seek medical attention immediately:
- if you get pressure over your chest, cough, have wheezing, or become short of breath right after taking the medicine. This may be a sign of a condition called bronchospasm.
Children and young people
Eklira Genuair must not be used by children or adolescents under 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.
Tell your doctor if you have taken or are taking similar medicines for breathing problems, e.g. medicines containing tiotropium or ipratropium. Ask your doctor or pharmacist if you are unsure. The use of Eklira Genuair with these medicines is not recommended.
Pregnancy and breastfeeding
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 breast-feeding unless your doctor tells you to.
Driving and using machines
Eklira Genuair has no or negligible effect on the ability to drive and use machines. This medicine may cause headaches or blurred vision. Do not drive or use machines until the headache has disappeared and 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 medicine.
3. How to use Eklira Genuair
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is one inhalation twice daily, in the morning and the 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 enough medicine in your body to help you breathe easier throughout the day and night. It also helps you remember to use it.
The recommended dose can be used in elderly patients and patients with renal or hepatic impairment. No dose adjustments are needed.
COPD is a long-term disease and therefore it is recommended that Eklira Genuair be used every day, twice daily, and not only when you experience breathing problems or other symptoms of COPD.
How to use the medicine
This medicine is intended for inhalation.
See the Instructions for Use for instructions on using the Genuair inhaler. Contact your doctor or pharmacist if you are not sure how to use Eklira Genuair.
You can use Eklira Genuair at any time before or after food or drink.
If you take more Eklira Genuair then you should
If you happen to take a larger dose of Eklira Genuair than you were told to, contact your doctor or pharmacist.
If you forget to use Eklira Genuair
If you miss a dose of Eklira Genuair, inhale one 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 a forgotten dose.
If you stop using Eklira Genuair
This medicine is intended for long-term use. If you want to stop treatment, talk to your doctor first, as your symptoms may get worse.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions are rare but may occur (may affect up to 1 in 1,000 people). Stop using the medicine and contact your doctor immediately if you get swelling of the face, throat, lips, or tongue (with or without difficulty breathing or swallowing), dizziness or fainting, faster pulse, or if you get a severe itchy rash on the skin ( hives ) because this may be a symptom of an allergic reaction.
The following side effects may occur while using Eklira Genuair:
Common: affects 1 in 10 people
- Headache
- Sinusitis ( sinusitis )
- Common cold ( nasopharyngitis )
- Cough
- Diarrhea
Uncommon: affects 1 in 100 people
- Dry mouth
- Hoarseness ( dysphonia )
- Faster heartbeat ( tachycardia )
- Difficulty emptying the bladder ( urine retention )
- Dimsyn
- Rash
- Skin itching
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 expiration date is the last day of the specified month.
Store the inhaler inside the bag until the period of use begins.
Use within 90 days after opening the bag.
Do not use this medicine if you notice that the packaging is damaged or shows signs of tampering.
After taking the last dose, the inhaler should be discarded. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is aclidinium bromide. Each delivered dose contains 375 micrograms of aclidinium bromide corresponding to 322 micrograms of aclidinium.
- The other ingredients are lactose monohydrates (see section 2 “Eklira Genuair contains lactose”).
What the medicine looks like and the contents of the pack
Eklira Genuair is a white or almost white powder.
The Genuair inhaler unit is white with a built-in dose indicator and a green dose knob.
The nozzle is covered with a removable, green lid. It is delivered in a plastic bag.
Pack sizes available:
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.
Manufacturer
Industrias Pharmacéuticas Almirall, SL
Ctra. Nacional II, Km. 593
08740 Sant Andreu de la Barca, Barcelona
Spain
Contact the representative of the marketing authorization holder to find out more about this medicine:
| Belgium / Belgique / BelgienAstraZeneca SA / NVTel: +32 2 370 48 11 | LithuaniaUAB AstraZeneca LietuvaTel: +370 5 2660550 |
| BulgariaAstrology Bulgaria BODYTel: +359 (2) 44 55 000 | Luxembourg / LuxemburgAstraZeneca SA / NVTel: +32 2 370 48 11 |
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| DenmarkAstraZeneca A / S Tel: +45 43 66 64 62 | MaltaAssociated Drug Co. Ltd.Tel: +356 2277 8000 |
| GermanyAstraZeneca GmbH Tel: +49 41 03 7080 | The NetherlandsAstraZeneca BV Tel: +31 79 363 2222 |
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| GreeceAstraZeneca AE :Ηλ: +30 2 106871500 | AustriaAstraZeneca Österreich GmbH Tel: +43 1 711 31 0 |
| SpainAstraZeneca Pharmacéutica Spain, SA Tel: +34 91 301 91 00 | PolandAstraZeneca Pharma Poland Sp. z ooTel .: +48 22 245 73 00 |
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| Ireland. Menarini Pharmaceuticals Ireland LtdTel: +353 1 284 6744 | SloveniaAstraZeneca UK LimitedTel: +386 1 51 35 600 |
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