Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - eklira

Document Subject

Generated Narrative: MedicinalProductDefinition mp8a4d23dcb809afdd72ca3100738e1a7e

identifier: http://ema.europa.eu/identifier/EU/1/12/778/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Eklira Genuair 322 micrograms inhalation powder

type: Full name

part

part: nan

type: Invented name part

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part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-8a4d23dcb809afdd72ca3100738e1a7e

identifier: http://ema.europa.eu/identifier/EU/1/12/778/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - eklira

Attesters

Instructions for Use

What is in this leaflet:

1. What Eklira Genuair is and what it is used for
2. What you need to know before you use Eklira Genuair
3. How to use Eklira Genuair
4. Possible side effects
5. How to store Eklira Genuair
6. Contents of the pack and other information

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).

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 had heart problems recently.
• 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.

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.

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.

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.

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.

Route of administration The medicine is for inhalation use.

Refer to the 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.

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.

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.

The following side effects may occur whilst using Eklira Genuair: 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)
• Difficulty passing urine (urinary retention)
• Blurred vision
• Rash
• Itching of the skin

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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 of 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.

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.

Pack sizes supplied: Carton containing 1 inhaler with 30 doses. Carton containing 1 inhaler with 60 doses. Carton containing 3 inhalers each with 60 doses.

Not all pack sizes may be marketed.

Marketing Authorisation Holder Covis Pharma Europe B.V.
Gustav Mahlerplein 2 1082MA Amsterdam The Netherlands

Manufacturer Industrias Farmac uticas Almirall, S.A. Ctra. de Martorell 41-08740 Sant Andreu de la Barca, Barcelona Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Belgi /Belgique/Belgien Covis Pharma Europe B.V. Tel: 80013Lietuva Covis Pharma Europe B.V. Tel: 880000
Covis Pharma Europe B.V. Tel: 008002100Luxembourg/Luxemburg Covis Pharma Europe B.V. Tel: 80024 esk republika Covis Pharma Europe B.V. Tel: 800144Magyarorsz g Covis Pharma Europe B.V. Tel.: 0680021Danmark Zentiva Denmark ApS Tlf: +45 787 68 Malta Covis Pharma Europe B.V. Tel: 80065Deutschland Zentiva Pharma GmbH
Tel: +49 (0) 800 53 53 Nederland Covis Pharma Europe B.V. Tel: 08000270Eesti Covis Pharma Europe B.V
Tel: 8000100Norge Zentiva Denmark ApS Tlf: +47 219 66
Specialty Therapeutics IKE : +30 213 02 33 sterreich Covis Pharma Europe B.V. Tel: 0800006Espa a Zentiva Spain S.L.U. Tel: +34 931 815 Polska Covis Pharma Europe B.V. Tel.: 0800919France Zentiva France T l: +33 (0) 800 089 Portugal Zentiva Portugal, Lda Tel: +351210601Hrvatska Covis Pharma Europe B.V. Tel: 08004Rom nia Covis Pharma Europe B.V. Tel: 0800410Ireland A. Menarini Pharmaceuticals Ireland Ltd
Tel: +353 1 284 6Slovenija Covis Pharma Europe B.V. Tel: 080083 sland Zentiva Denmark ApS S mi: +354 539 0Slovensk republika Covis Pharma Europe B.V. Tel: 0800008Italia Covis Pharma Europe B.V. Tel: 800168Suomi/Finland Zentiva Denmark ApS Puh/Tel: +358 942 598
Specialty Therapeutics IKE : +30 213 02 33 Sverige Zentiva Denmark ApS Tel: +46 840 838 Latvija Covis Pharma Europe B.V. Tel: 80005United Kingdom (Northern Ireland) Zentiva, k.s. Tel: +44 (0) 800 090 2This leaflet was last revised in <{month YYYY}>.

Detailed information on this medicine is available on the European Medicines Agency web site: