Eklira Genuair - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Eklira Genuair 322 micrograms inhalation powder

Aclidinium (aclidinium bromide)

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor, pharmacist or nurse.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

• – If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

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

Instructions for Use

1. What Eklira Genuair is and what it is used for

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, longterm 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).

2. What you need to know before you use 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 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.

3. How to use Eklira Genuair

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.

4. Possible side effects

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.

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 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.

6. Contents of the pack and other information

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

AstraZeneca AB

SE-151 85 Sodertalje

Sweden

Manufacturer

Industrias Farmacéuticas Almirall, S.A.

Ctra. de Martorell 41–61

08740 Sant Andreu de la Barca, Barcelona

Spain

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgiqu­e/Belgien AstraZeneca S.A./N.V. Tel: +32 2 370 48 11	Lietuva UAB AstraZeneca Lietuva Tel: +370 5 2660550
Efc^rapufl AcTpa3eHeKa Etnrapua EOOfl Tea.: +359 (2) 44 55 000	Luxembourg/Lu­xemburg AstraZeneca S.A./N.V. Tél/Tel: +32 2 370 48 11
Česká republika AstraZeneca Czech Republic s.r.o. Tel: +420 222 807 111	Magyarország AstraZeneca Kft. Tel.: +36 1 883 6500
Danmark AstraZeneca A/S Tlf: +45 43 66 64 62	Malta Associated Drug Co. Ltd Tel: +356 2277 8000
Deutschland AstraZeneca GmbH Tel: +49 41 03 7080	Nederland AstraZeneca BV Tel: +31 79 363 2222
Eesti AstraZeneca Tel: +372 6549 600	Norge AstraZeneca AS Tlf: +47 21 00 64 00
EZZáSa AstraZeneca A.E. Tql: +30 2 106871500	Österreich AstraZeneca Österreich GmbH Tel: +43 1 711 31 0
España AstraZeneca Farmacéutica Spain, S.A. Tel: +34 91 301 91 00	Polska AstraZeneca Pharma Poland Sp. z o.o. Tel.: +48 22 245 73 00
France AstraZeneca Tél: +33 1 41 29 40 00	Portugal AstraZeneca Produtos Farmacéuticos, Lda. Tel: +351 21 434 61 00
Hrvatska AstraZeneca d.o.o. Tel: +385 1 4628 000	Romania AstraZeneca Pharma SRL Tel: +40 21 317 60 41
Ireland A. Menarini Pharmaceuticals Ireland Ltd Tel: +353 1 284 6744	Slovenija AstraZeneca UK Limited Tel: +386 1 51 35 600
Ísland Vistor hf. Sími: +354 535 70 00	Slovenská republika AstraZeneca AB, o.z. Tel: +421 2 5737 7777
Italia AstraZeneca S.p.A. Tel: +39 02 9801 1	Suomi/Finland AstraZeneca Oy Puh/Tel: +358 10 23 010
Kúnpog ÄZsKTOJp «EappaKsuuKii At5 Tql: +357 22490305	Sverige AstraZeneca AB Tel: +46 8 553 26 000

United Kingdom (Northern Ireland)

AstraZeneca UK Ltd

Tel: +44 1582 836 836

This leaflet was last revised in <{month YYYY}>.

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

Instructions for Use

This section contains information on how to use your Genuair inhaler. It is important that you read this information as the Genuair may work differently from inhalers you have used previously. If you have any questions about how to use your inhaler, please ask your doctor, pharmacist or nurse for assistance.

The Instructions for Use is 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 you start using the medicine.

Become familiar with the parts of your Genuair inhaler.

Control window indicator

Green = inhaler ready to use

_ Control window

Red = confirms correct inhalation

Mouthpiece

Figure A

Before use:

• a) Before first use, tear open the sealed bag and remove the inhaler. Throw away the bag.

• b) Do not press the green button until you are ready to take a dose.

• c) Pull off the cap by lightly squeezing the arrows marked on each side (Figure B).

Squeeze here and pull

Figure B

STEP 1: Prepare your dose

• 1.1 Look in the opening of the mouthpiece and make sure nothing is blocking it (Figure C).

• 1.2 Look at the control window (should be red, Figure C).

• 1.3 Hold the inhaler horizontally with the mouthpiece facing you and the green button on top (Figure D).

Figure D

• 1.4 Press the green button all the way down to load your dose (Figure E).

When you press the button all the way down, the control window changes from red to green.

Make sure the green button is on top. Do not tilt.

• 1.5 Release the green button (Figure F).

Make sure you release the button so the inhaler can work correctly.

Figure E Figure F

Stop and Check:

• 1.6 Make sure the control window is now green (Figure G).

Your medicine is ready to be inhaled.

Go to ‘STEP 2: Inhale your medicine’.

GREEN

Figure G

What to do if the control window is still red after pressing the button (Figure H).

Figure H

The dose is not prepared. Go back to ‘STEP 1 Prepare your dose’ and repeat steps 1.1 to 1.6.

STEP 2: Inhale your medicine

Read steps 2.1 to 2.7 fully before use. Do not tilt.

• 2.1 Hold the inhaler away from your mouth, and breathe out completely. Never breathe out into the inhaler (Figure I).

Figure I

• 2.2 Hold your head upright, put the mouthpiece between your lips, and close your lips tightly around it (Figure J).

Do not hold the green button down while inhaling.

• 2.3 Take a strong, deep breath through your mouth. Keep breathing in for as long as possible.

A ‘click’ will let you know that you are inhaling correctly. Keep breathing in as long as possible after you hear the ‘click’. Some patients may not hear the ‘click’. Use the control window to ensure you have inhaled correctly.

• 2.4 Take the inhaler out of 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 grainy sensation in their mouth, or a slightly sweet or bitter taste. Do not take an extra dose even if you do not taste or feel anything after inhaling.

Stop and Check:

• 2.7 Make sure the control window is now red (Figure K). This means you have inhaled your medicine correctly.

Figure K

What to do if the control window is still green after inhalation (Figure L).

Figure L

This means you have not inhaled your medicine correctly. Go back to ‘STEP 2 Inhale your medicine’ and repeat steps 2.1 to 2.7.

If the control window still does not change to red, you may have forgotten to release the green button before inhaling, or you may not have inhaled strongly enough. If this happens, try again. Make sure you have released the green button, and you have breathed out completely. Then take a strong, deep breath through the mouthpiece.

Please contact your doctor if the control window is still green after repeated attempts.

Push the protective cap back onto the mouthpiece after each use (Figure M), to prevent contamination of the inhaler with dust or other materials. You should discard your inhaler if you lose the cap.

Figure M

Additional information

What should you do if you accidently prepare a dose?

Store your inhaler with the protective cap in place until it is time to inhale your medicine, 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 left in the inhaler (Figure N).
• On first use, every inhaler contains at least 60 doses, or at least 30 doses, depending on the pack size.
• Each time you load a dose by pressing the green button, the dose indicator moves by a small amount towards 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 to be damaged or if you lose the cap, or
• When a red band appears in the dose indicator, this means you are nearing your last dose (Figure N), or
• If your inhaler is empty (Figure O).