Enurev Breezhaler 44 micrograms powder for inhalation

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Enurev Breezhaler 44 micrograms inhalation powder (hard capsule)

glycopyrronium
(as glycopyrronium bromide)

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Enurev Breezhaler is and what it is used for

What Enurev Breezhaler is

This medicine contains an active substance called glycopyrronium bromide, which belongs to a class of medicines known as bronchodilators.

What Enurev Breezhaler is used for

This medicine is used to make breathing easier in adult patients who have difficulty breathing due to a lung disease called chronic obstructive pulmonary disease (COPD).

In COPD, the muscles surrounding the airways contract, making it difficult to breathe. This medicine blocks the contraction of these muscles in the lungs, thereby facilitating the flow of air in and out of the lungs.

If you use this medicine once daily, it will help reduce the impact of COPD on your daily life.

2. What you need to know before using Enurev Breezhaler

Do not use Enurev Breezhaler

• if you are allergic to glycopyrronium bromide or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor before starting to use Enurev Breezhaler if you have any of the following conditions:

• if you have kidney problems.
• if you have a known eye disorder called narrow-angle glaucoma.
• if you have difficulty urinating.

During treatment with Enurev Breezhaler, stop using this medicine and contact your doctor immediately:

• if you experience chest tightness, cough, wheezing, or breathing difficulty immediately after using Enurev Breezhaler (signs of bronchospasm).
• if you have difficulty breathing or swallowing, swelling of the tongue, lips or face, rash, itching, or hives (signs of an allergic reaction).
• if you experience eye pain or discomfort, transient blurred vision, visual halos, or colored images along with eye redness. These may be signs of an acute attack of narrow-angle glaucoma.

Enurev Breezhaler is used as a maintenance treatment for your COPD. Do not use this medicine to treat a sudden attack of breathlessness (difficulty breathing) or wheezing (whistling sounds when breathing).

Children and adolescents

Do not give this medicine to children or adolescents under 18 years of age.

Other medicines and Enurev Breezhaler

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines similar to Enurev Breezhaler used for your lung disease, such as ipratropium, oxitropium, or tiotropium (also known as anticholinergics).

No specific adverse effects have been reported when Enurev Breezhaler has been administered together with other medicines used to treat COPD, such as rescue inhalers (e.g. salbutamol), methylxanthines (e.g. theophylline), and/or oral and inhaled steroids (e.g. prednisolona).

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

There are no data available on the use of this medicine in pregnant women, and it is unknown whether the active substance of this medicine passes into breast milk.

Driving and using machines

This medicine is unlikely to affect your ability to drive or operate machinery.

Enurev Breezhaler contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to use Enurev Breezhaler

Follow exactly the instructions for the use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Amount of Enurev Breezhaler you should use

The usual dose is to inhale the contents of one capsule each day.

You only need to inhale the medicine once a day, as the effect of this medicine lasts for 24 hours.

Do not use more than the dose indicated by your doctor.

Elderly patients

If you are 75 years of age or older, you can use this medicine at the same dose as other adults.

When to inhale Enurev Breezhaler

Use this medicine at the same time each day. This will help you remember to take it.

You may inhale this medicine at any time before or after eating or drinking.

How to inhale Enurev Breezhaler

• In this package, you will find a device and capsules (in blisters) containing the medicine as powder for inhalation. Use the capsules only with the device provided in this package (Enurev Breezhaler device). The capsules should remain in the blister until you are ready to use them.
• Do not push the capsule through the foil.
• When starting a new package, use the new Enurev Breezhaler device provided in the package.
• Discard the device from each package once all capsules have been used.
• Do not swallow the capsules.
• For more information on how to use the device, please read the instructions at the end of this leaflet.

If you use more Enurev Breezhaler than you should

If you have inhaled too much of this medicine or if someone accidentally uses your capsules, inform your doctor immediately or go to the nearest emergency department. Show the Enurev Breezhaler package. Medical attention may be required.

If you forget to use Enurev Breezhaler

If you forget to inhale a dose, inhale it as soon as possible. However, do not inhale two doses on the same day. Then inhale the next dose at your usual time.

How long you should continue your treatment with Enurev Breezhaler

• Continue your treatment with this medicine for as long as your doctor tells you to.
• COPD is a long-term condition and you must use this medicine every day, not only when you have breathing problems or other COPD symptoms.

Consult your doctor or pharmacist if you have any questions about how long you should continue your treatment with this medicine.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Some adverse effects may be serious but are uncommon

(may affect up to 1 in 100 patients)

• Irregular heartbeat
• High blood sugar level (hyperglycaemia: typical symptoms include excessive thirst or hunger and frequent urination)
• Skin rash, itching, hives, difficulty breathing or swallowing, dizziness (possible signs of an allergic reaction)
• Swelling, mainly of the tongue, lips, face or throat (possible signs of angioedema)

If you experience any of these adverse effects, inform your doctor immediately.

Some adverse effects may be serious but their frequency is unknown

(frequency cannot be estimated from the available data)

• Difficulty breathing with wheezing (whistling sounds when breathing) or cough (signs of paradoxical bronchospasm)

Some adverse effects are common

(may affect up to 1 in 10 patients)

• Dry mouth
• Difficulty sleeping
• Runny or stuffy nose, sneezing, sore throat
• Diarrhoea or abdominal pain
• Musculoskeletal pain

Some adverse effects are uncommon

(may affect up to 1 in 100 patients)

• Difficulty and pain when urinating
• Painful and frequent urination
• Palpitations
• Skin rash
• Loss of sensation
• Cough with sputum
• Dental caries
• Feeling of pain or pressure in the cheeks and forehead
• Nosebleeds
• Pain in arms or legs
• Pain in the muscles, bones or joints of the chest
• Stomach discomfort after meals
• Sore throat
• Fatigue
• Weakness
• Itching
• Voice alteration (hoarseness)
• Nausea
• Vomiting

Some patients aged over 75 years experienced headache (commonly) and urinary tract infection (commonly).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Enurev Breezhaler

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after «CAD»/«EXP». The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Keep the capsules in the original blister pack to protect them from moisture. Remove them from the blister pack just before use.

The inhaler from each package should be discarded once all capsules have been used.

Do not use this medicine if the packaging is damaged or shows signs of deterioration.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Enurev Breezhaler

• The active substance is glycopyrronium bromide. Each capsule contains 63 micrograms of glycopyrronium bromide (equivalent to 50 micrograms of glycopyrronium). The delivered dose (the dose released by the inhaler mouthpiece) is equivalent to 44 micrograms of glycopyrronium.
• The other components of the inhalation powder are lactose monohydrate and magnesium stearate.

Appearance of Enurev Breezhaler and contents of the pack

Enurev Breezhaler 44 microgram hard capsules for inhalation powder are transparent and orange-coloured and contain a white powder. They have the product code «GPL50» printed in black above a black line and the company logo () printed in black below the same line.

Each pack contains a device known as an inhaler, together with capsules in blisters. Each blister strip contains 6 or 10 hard capsules.

The following pack sizes are available:

Packs containing 6x1, 10x1, 12x1 or 30x1 hard capsules, together with one inhaler.

Multiple pack containing 90 (3 packs of 30x1) hard capsules and 3 inhalers.

Multiple pack containing 96 (4 packs of 24x1) hard capsules and 4 inhalers.

Multiple pack containing 150 (15 packs of 10x1) hard capsules and 15 inhalers.

Multiple pack containing 150 (25 packs of 6x1) hard capsules and 25 inhalers.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer

Novartis Farmacéutica SA
Gran Via de les Corts Catalanes, 764
08013 Barcelona
Spain

Novartis Pharma GmbH
Roonstraße 25
D-90429 Nuremberg
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

Instructions for use of the Enurev Breezhaler inhaler

Read the complete Instructions for Use before using Enurev Breezhaler