Enurev Breezhaler 44 micrograms powder for inhalation

Introduction

Package Leaflet: Information for the User

Enurev Breezhaler 44 micrograms inhalation powder (hard capsule)

glycopyrronium

(as glycopyrronium bromide)

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.

Contents of the pack

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

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

What is Enurev Breezhaler

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

What Enurev Breezhaler is used for

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

In COPD, the muscles around the airways contract, making it difficult to breathe. This medicine blocks the contraction of these muscles in the lungs, making it easier for air to enter and leave the lungs.

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

2. What you need to know before you use 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

Talk to your doctor before you start using Enurev Breezhaler, if you have:

• kidney problems.
• a known eye condition called narrow-angle glaucoma.
• difficulty urinating.

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

• if you notice chest tightness, coughing, wheezing, or difficulty breathing immediately after using Enurev Breezhaler (signs of bronchospasm).
• if you have difficulty breathing or swallowing, swelling of the tongue, lips, or face, rash, itching, and hives (signs of an allergic reaction).
• if you notice pain or discomfort in the eyes, blurred vision, halos, or colored images in association 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 shortness of breath or wheezing.

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 using, have recently used, or might use any other medicines. These include medicines similar to Enurev Breezhaler used for your lung disease, such as ipratropium, oxitropium, or tiotropium (also known as anticholinergics).

No specific side effects have been reported when Enurev Breezhaler is used 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., prednisolone).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

No data are available on the use of this medicine in pregnant women, and it is not known 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 use machines.

Enurev Breezhaler contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

3. How to use Enurev Breezhaler

Follow exactly the instructions for using this medicine given by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist again.

How much Enurev Breezhaler to use

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

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

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

Elderly

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 use it.

You can inhale this medicine at any time before or after food or drink.

How to inhale Enurev Breezhaler

• In this pack, you will find an inhaler and capsules (in blisters) that contain the medicine in powder form for inhalation. Use the capsules only with the inhaler provided in this pack (Enurev Breezhaler inhaler). The capsules should be kept in the blister until you need to use them.
• Do not push the capsule through the foil.
• When starting a new pack, use the new Enurev Breezhaler inhaler provided in the pack.
• Discard the inhaler from each pack once you have used all the capsules.
• Do not swallow the capsules.
• For more information on how to use the inhaler, 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 uses your capsules accidentally, tell your doctor immediately or go to the nearest emergency room. Show the pack of Enurev Breezhaler. Medical attention may be needed.

If you forget to use Enurev Breezhaler

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

How long to continue treatment with Enurev Breezhaler

• Continue using your treatment with this medicine for as long as your doctor tells you.
• COPD is a long-term disease, and you should use this medicine every day and not just when you have breathing problems or other symptoms of COPD.

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

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.

Some side effects may be serious but are rare

(may affect up to 1 in 100 people)

• Irregular heartbeat
• High blood sugar levels (hyperglycemia: typical symptoms include excessive thirst or hunger and frequent urination)
• 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 side effects, tell your doctor immediately.

Some side effects may be serious but the frequency is not known

(cannot be estimated from the available data)

• Difficulty breathing with wheezing or coughing (signs of paradoxical bronchospasm)

Some side effects are common

(may affect up to 1 in 10 people)

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

Some side effects are uncommon

(may affect up to 1 in 100 people)

• Difficulty or pain when urinating
• Painful or frequent urination
• Palpitations
• Rash
• Numbness
• Coughing with phlegm
• Tooth decay
• 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 upset after meals
• Sore throat
• Tiredness
• Weakness
• Itching
• Voice changes (hoarseness)
• Nausea
• Vomiting

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. 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. Storing Enurev Breezhaler

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 carton and blister after ‘EXP’. The expiry date is the last day of the month stated.

Do not store above 25°C.

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

The inhaler from each pack should be discarded once you have used all the capsules.

Do not use this medicine if you notice the pack is damaged or shows signs of deterioration.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Enurev Breezhaler

• The active ingredient 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 ingredients of the powder for inhalation are lactose monohydrate and magnesium stearate.

Appearance of Enurev Breezhaler and Package Contents

The hard capsules of Enurev Breezhaler 44 micrograms powder for inhalation are transparent and orange in color 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 it.

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

The following package sizes are available:

Packages containing 6x1, 10 x 1, 12 x 1 or 30 x 1 hard capsules, along with an inhaler.

Multiple package containing 90 (3 packages of 30 x 1) hard capsules and 3 inhalers.

Multiple package containing 96 (4 packages of 24 x 1) hard capsules and 4 inhalers.

Multiple package containing 150 (15 packages of 10 x 1) hard capsules and 15 inhalers.

Multiple package containing 150 (25 packages of 6 x 1) hard capsules and 25 inhalers.

Only some package 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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Date of Last Revision 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 Enurev Breezhaler Inhaler

Read the Instructions for Usecompletely before using Enurev Breezhaler