Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - duaklir

Document Subject

Generated Narrative: MedicinalProductDefinition mp90e75941fbec0604a5aef8f6392abdfd

identifier: http://ema.europa.eu/identifier/EU/1/14/964/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Duaklir Genuair 340 micrograms /12 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-90e75941fbec0604a5aef8f6392abdfd

identifier: http://ema.europa.eu/identifier/EU/1/14/964/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - duaklir

Attesters

Instructions for Use

What is in this leaflet

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

What Duaklir Genuair is This medicine contains two active ingredients called aclidinium and formoterol fumarate dihydrate. Both belong to a group of medicines called bronchodilators. Bronchodilators relax the muscles in your airways, which allows the airways to open more widely and helps you to breathe more easily. The Genuair inhaler delivers the active ingredients directly into your lungs as you breathe in.

What Duaklir Genuair is used for Duaklir Genuair is used for adult patients who have breathing difficulties due to a lung disease called chronic obstructive pulmonary disease (COPD), in which the airways and air sacs in the lungs become damaged or blocked. By opening the airways, the medicine helps relieve symptoms such as shortness of breath. Taking Duaklir Genuair regularly will reduce the effects of COPD on your everyday life.

Do not use Duaklir Genuair:

• if you are allergic to aclidinium, formoterol fumarate dihydrate or to the other ingredient of this medicine (listed in section 6).

Warnings and precautions Talk to your doctor, pharmacist or nurse before using Duaklir Genuair, if you have any of the following conditions/symptoms:

• If you have asthma. This medicine should not be used for the treatment of asthma.
• If you have heart problems.
• If you have epilepsy.
• If you have thyroid gland problems (thyrotoxicosis).
• If you have a tumour in one of your adrenal glands (phaeochromocytoma).
• If you have difficulty passing urine or problems due to an enlarged prostate.
• If you have an eye condition called narrow angle glaucoma, which results in high pressure in the eye.

Stop taking Duaklir Genuair and seek medical help immediately if you experience any of the following:

• If you get sudden tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine. See section 4. Duaklir Genuair is used as a maintenance (long-term) treatment for COPD. You should not use this medicine to treat a sudden attack of breathlessness or wheezing.

If your usual COPD symptoms (breathlessness, wheezing, cough) do not improve or get worse while you are using Duaklir Genuair you should continue to use it, but go to see your doctor as soon as possible because you may need another medicine.

If you see halos around lights or coloured images, have eye pain or discomfort or suffer temporary blurring of vision, go to see your doctor for advice as soon as possible.

Dry mouth has been observed with medicines like Duaklir Genuair. In the long-term, dry mouth can be associated with tooth decay, so it is important to pay attention to oral hygiene.

Children and adolescents Duaklir Genuair is not for use in children or adolescents below 18 years of age.

Other medicines and Duaklir Genuair Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you use Duaklir Genuair with some other medicines, the effect of Duaklir Genuair or the other medicines may be altered.

Tell your doctor or pharmacist if you are taking:

• Any medicines that may be similar to Duaklir Genuair to treat breathing difficulties.
• Medicines that lower the amount of potassium in your blood. These include: * corticosteroids that you take by mouth (such as prednisolone), * diuretics (such as furosemide or hydrochlorothiazide), * certain medicines used to treat breathing conditions (such as theophylline).
• Medicines called beta blockers that may be used to treat high blood pressure or other heart problems (such as atenolol or propranolol) or to treat glaucoma (such as timolol).
• Medicines which can cause a type of change in the electrical activity of the heart known as QT interval prolongation (observed in an electrocardiogram). These include medicines for the treatment of: * depression (such as monoamine oxidase inhibitors or tricyclic antidepressants), * bacterial infections (such as erythromycin, clarithromycin, telithromycin), * allergic reactions (anti-histamines).

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, nurse or pharmacist for advice before using this medicine. You should not use Duaklir Genuair if you are pregnant or are breast-feeding unless your doctor tells you to do so.

Driving and using machines Duaklir Genuair is unlikely to affect your ability to drive or use machines. In some patients, this medicine may cause blurred vision or dizziness. If you are affected by either of these side effects, do not drive or use machines until the dizziness has cleared or your vision has returned to normal.

Duaklir Genuair contains lactose This medicine 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.

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 in the morning and one inhalation in the evening.
• You can use Duaklir Genuair anytime before or after food or drink.
• The effects of Duaklir Genuair last for 12 hours; therefore, you should try to use Duaklir Genuair at the same time each morning and evening as this will ensure that there is always enough medicine in your body to help you breathe more easily throughout the day and night. Taking your medicine at regular times 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 in these patients.
• Duaklir Genuair is for inhalation use.
• Instructions for use: Refer to the Instructions for Use at the end of this leaflet for instructions on how to use the Genuair inhaler. If you are not sure of how to use Duaklir Genuair, contact your doctor or pharmacist.

COPD is a long-term disease; therefore, Duaklir Genuair is for long-term use. The medicine must be used every day, twice a day and not only when breathing problems or other symptoms of COPD are experienced.

If you use more Duaklir Genuair than you should If you think you may have used more Duaklir Genuair than you should, you are more likely to experience some of its side effects, such as blurred vision, dry mouth, feeling sick, shaking/tremor, headache, palpitations or an increase in blood pressure, therefore you must immediately contact your doctor or go to the nearest emergency unit. Show the packaging of Duaklir Genuair. Medical attention may be needed.

If you forget to use Duaklir Genuair If you forget a dose of Duaklir Genuair, just take it as soon as possible and take your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop using Duaklir 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.

Stop using the medicine and contact your doctor immediately if you:

• develop swelling of the face, throat, lips or tongue (with or without difficulty breathing or swallowing), severe itchy bumps on the skin (hives) as these may be symptoms of an allergic reaction. Frequency of this reaction cannot be estimated from the available data.

• develop tightness of the chest, coughing, wheezing or breathlessness immediately after using the medicine. These may be signs of a condition called paradoxical bronchospasm , which is an excessive and prolonged contraction of the airway muscles immediately following treatment with a bronchodilator. This reaction may rarely occur (may affect up to 1 in 1,000 people).

Some side effects may be serious: if you get any of these side effects, tell your doctor immediately.

Uncommon (may affect up to 1 in 100 people)

• Muscle weakness, twitching and/or abnormal heart rhythm, as these may be signs of a decrease in the amount of potassium in your blood
• Tiredness, increased thirst and/or a need to pass urine more frequently than usual, as these may be signs of an increase in the amount of sugar in your blood
• Palpitations, as these may be a sign of an unusually fast heart beat or an abnormal heart rhythm

Rare (may affect up to 1 in 1,000 people)

• Sudden difficulty in breathing or swallowing, swelling of the tongue, throat, lips or face, skin rash and/or itching - these may be signs of an allergic reaction

Other side effects which may occur while using Duaklir Genuair:

Common (may affect up to 1 in 10 people)

• Combination of sore throat and runny nose these may be signs of nasopharyngitis
• Headache
• Painful and/or frequent urination these may be signs of a urinary tract infection
• Cough
• Diarrhoea
• A blocked, runny or stuffy nose and/or pain or a feeling of pressure in the cheeks or forehead
  these may be symptoms of sinusitis
• Dizziness
• Muscle cramps
• Nausea (feeling sick)
• Difficulty sleeping
• Dry mouth
• Muscle pain
• Abscess (infection) in the tissues at the base of a tooth
• Increased blood levels of a protein found in muscle called creatine phosphokinase
• Shaking/tremor
• Anxiety

Uncommon

• Fast heart beat (tachycardia)
• Chest pain or tightness in the chest (angina pectoris)
• Blurred vision
• Changes in the sound of the voice (dysphonia)
• Difficulty passing urine or a feeling that your bladder has not completely emptied (urinary retention)
• An abnormal heart trace (QT interval prolongation) potentially leading to an abnormal heart rhythm
• Distorted sense of taste (dysgeusia)
• Throat irritation
• Inflammation of the mouth (stomatitis)
• Increased blood pressure
• Agitation
• 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, carton and inhaler bag after EXP . The expiry date refers to the last day of that month.

This medicine does not require any special temperature storage conditions.

Keep the Genuair inhaler protected inside the sealed bag until the administration period starts.

To be used within 60 days of opening the bag.

Do not use Duaklir 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 household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Duaklir Genuair contains

• The active substances are aclidinium and formoterol fumarate dihydrate. Each delivered dose (the dose leaving the mouthpiece) contains 396 micrograms aclidinium bromide equivalent to 340 micrograms of aclidinium and 11.8 micrograms of formoterol fumarate dihydrate.
• The other ingredient is lactose monohydrate (see end of section 2 under Duaklir Genuair contains lactose for more information).

What Duaklir Genuair looks like and contents of the pack Duaklir Genuair is a white or almost white inhalation powder. The Genuair inhaler is a white device fitted with an integral dose indicator and an orange dosage button. The mouthpiece is covered with a removable orange protective cap. It is supplied in a sealed protective aluminium bag containing a desiccant sachet. After removing the inhaler from the bag, the bag and desiccant sachet should be thrown away.

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 Covis Pharma Europe B.V.
Tel: 1800937Slovenija 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

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