Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - bretaris

Document Subject

Generated Narrative: MedicinalProductDefinition mp54a021f4e4e92ada183e2df4eec44f64

identifier: http://ema.europa.eu/identifier/EU/1/12/781/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Bretaris Genuair 322 micrograms inhalation powder

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

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-54a021f4e4e92ada183e2df4eec44f64

identifier: http://ema.europa.eu/identifier/EU/1/12/781/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - bretaris

Attesters

Instructions for Use

What is in this leaflet:

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

What Bretaris Genuair is The active ingredient of Bretaris Genuair is aclidinium bromide, which belongs to a group of medicines called bronchodilators. Bronchodilators relax airways and help keep bronchioles open. Bretaris 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 Bretaris Genuair is used for Bretaris 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 Bretaris 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 Bretaris 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 Bretaris 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.

Bretaris 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 Bretaris 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 Bretaris 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 Bretaris Genuair is not for use in children or adolescents below 18 years of age.

Other medicines and Bretaris 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 Bretaris 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 Bretaris Genuair if you are pregnant or are breast-feeding unless your doctor tells you so.

Driving and using machines Bretaris 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.

Bretaris 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 Bretaris Genuair last for 12 hours; therefore, you should try to use your Bretaris 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 Bretaris 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 Bretaris Genuair, contact your doctor or pharmacist.

You can use Bretaris Genuair any time before or after food or drink.

If you use more Bretaris Genuair than you should If you think you may have used more Bretaris Genuair than you should, contact your doctor or pharmacist.

If you forget to use Bretaris Genuair If you forget a dose of Bretaris 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 Bretaris 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 Bretaris 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 Bretaris 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 Bretaris 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 Bretaris Genuair contains lactose ).

What Bretaris Genuair looks like and contents of the pack Bretaris 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. T l/Tel: 80013Lietuva
UAB BERLIN CHEMIE MENARINI BALTIC
Tel: +370 52 691

• / . E
  .: +359 2 454 09 Luxembourg/Luxemburg
  Covis Pharma Europe B.V. T l/Tel: 80024 esk republika
  Berlin-Chemie/A.Menarini Ceska republika s.r.o.
  Tel: +420 267 199 Magyarorsz g
  Berlin-Chemie/A. Menarini Kft.
  Tel.: +36 1799 7Danmark
  Covis Pharma Europe B.V. Tlf: 80711Malta
  Covis Pharma Europe B.V. Tel: 80065Deutschland
  Berlin-Chemie AG
  Tel: +49 (0) 30 67Covis Pharma Europe B.V. Tel: +49 (0) 3031196Nederland
  Covis Pharma Europe B.V.
  Tel: 08000270Eesti
  O Berlin-Chemie Menarini Eesti
  Tel: +372 667 5Norge
  Covis Pharma Europe B.V.
  Tlf: 80031
  MENARINI HELLAS AE
  : +30 210 8316111- sterreich
  A. Menarini Pharma GmbH Tel: +43 1 879 95 85-0

Espa a
Laboratorios Menarini S.A.
Tel: +34-93 462 88 Polska
Covis Pharma Europe B.V.
Tel.: 0800919France
MENARINI France
T l: +33 (0)1 45 60 77 Portugal
A. Menarini Portugal Farmac utica, S.A.
Tel: +351 210 935 Hrvatska
Berlin-Chemie Menarini Hrvatska d.o.o.
Tel: + 385 1 4821 Rom nia
Berlin-Chemie A.Menarini S.R.L.
Tel: +40 21 232 34 Ireland
Covis Pharma Europe B.V.
Tel: 1800937Slovenija
Berlin-Chemie / A. Menarini Distribution Ljubljana d.o.o. Tel: +386 01 300 2 sland
Covis Pharma Europe B.V.
S mi: 8007Slovensk republika
Berlin-Chemie / A. Menarini Distribution Slovakia s.r.o. Tel: +421 2 544 30 Italia
Laboratori Guidotti S.p.A.
Tel: +39- 050 971Suomi/Finland
Covis Pharma Europe B.V. Puh/Tel: 0800413
Covis Pharma Europe B.V. : 80091Sverige
Covis Pharma Europe B.V. Tel: 0200898Latvija
SIA Berlin-Chemie/Menarini Baltic
Tel: +371 67103United Kingdom (Northern Ireland) Covis Pharma Europe B.V. Tel: 08004334This leaflet was last revised in <{month YYYY}>.

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