PULMOZYME 2,500 U/2.5 ml SOLUTION FOR NEBULIZER INHALATION

Introduction

Package Leaflet: Information for the User

Pulmozyme 2,500 U/2.5 ml Solution for Inhalation by Nebulizer

Dornase alfa

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

Follow exactly the administration instructions of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Pulmozyme and what is it used for
2. What you need to know before you start using Pulmozyme
3. How to use Pulmozyme
4. Possible side effects
5. Storage of Pulmozyme
6. Package Contents and Further Information

1. What is Pulmozyme and what is it used for

Pulmozyme is a medicine that contains dornase alfa, which is a humanized version of the protein found in our body called "DNase".

Pulmozyme is indicated for the treatment of cystic fibrosis to help dissolve the viscous secretions produced in the lungs in adults and children over 5 years of age. Pulmozyme is inhaled using a nebulizer (see section 3: How to use Pulmozyme). During treatment with Pulmozyme, you can usually continue with other medications you are using for the treatment of cystic fibrosis (see "Using Pulmozyme with other medications" in section 2).

2. What you need to know before you start using Pulmozyme

Do not use Pulmozyme:

• If you are allergic to dornase alfa or to any of the other components of this medicine (listed in section 6).

Warnings and Precautions

Talk to your doctor or pharmacist before you start using Pulmozyme.

Children

Pulmozyme is not recommended for use in children under 5 years of age. Before using Pulmozyme, confirm with your doctor or pharmacist if it has been prescribed for a child under 5 years of age.

Using Pulmozyme with other medications

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medications. This includes medications you buy without a prescription and herbal medicines. Pulmozyme may affect the way other medications work, and other medications may affect how Pulmozyme works.

Usual treatments for cystic fibrosis (such as antibiotics, pancreatic enzymes, bronchodilators, and pain relievers) can be continued with Pulmozyme. If you are unsure, talk to your doctor or pharmacist before using Pulmozyme.

Pregnancy and Breastfeeding

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

Driving and Using Machines

Pulmozyme is unlikely to affect your ability to drive or use machines.

3. How to use Pulmozyme

Follow exactly the administration instructions of this medicine as indicated by your doctor. Pulmozyme is inhaled using a nebulizer (see section "Which Nebulizer to Use"). If you are unsure, consult your doctor again.

Continue with your chest physiotherapy treatment while using Pulmozyme.

Adults and Children Over 5 Years

• Use Pulmozyme once a day.
• The recommended dose is one ampoule per day, for inhalation using the nebulizer.
• If you are over 21 years of age, your doctor may instruct you to use one ampoule twice a day.

Children Under 5 Years

Pulmozyme is not recommended for children under 5 years of age.

Which Nebulizer to Use:

• Use a nebulizer such as:

• The Hudson T Up-draft II/Pulmo-Aide, the Airlife Misty/Pulmo-Aide, the Respirgard/Pulmo-Aide customized, or the AcornII/Pulmo-Aide.
• Pulmozyme can also be used with a reusable nebulizer system, such as the Pari LL/Inhalierboy, the Pari LC/Inhalierboy or Master, Aiolos/2 Aiolos, the Side Stream/CR50, or MobilAire or Porta-Neb.
• The Pari eFlow Rapid nebulizer, a general-purpose electronic nebulizer using vibrating membrane technology, can be used. The Pari eFlow Rapid nebulizer should be cleaned according to the manufacturer's instructions. Additionally, it is recommended to use the Pari EasyCare cleaning accessory after every seven uses.
• Ultrasonic nebulizers cannot be usedwith Pulmozyme because they may cause Pulmozyme not to work properly.

Read carefully and follow the manufacturer's instructions for the use of each nebulizer.

Talk to your doctor, as they may instruct you on which nebulizers can be used with Pulmozyme.

How to Use Pulmozyme with a Nebulizer:

When you have the nebulizer ready to be used with Pulmozyme, please note the following points:

• Do not mix Pulmozyme with other liquids or medications in the nebulizer.
• Do not use any leftover portions; these should always be discarded.
• If your nebulizer is reusable, remember to clean it after use. Follow the manufacturer's instructions for the compressor and nebulizer for the use and maintenance of these devices.
• If someone uses Pulmozyme by mistake, contact your doctor immediately.

To Use the Nebulizer

• Make sure the nebulizer is clean before using it.
• Break the top of a Pulmozyme ampoule.
• Pour the complete contents of the ampoule into the nebulizer chamber.
• Follow the nebulizer's instructions for use and inhale Pulmozyme immediately.

If You Use More Pulmozyme Than You Should

If you use more Pulmozyme than you should, inform your doctor immediately.

If You Forget to Use Pulmozyme

• If you forget to take a dose, take it as soon as you remember.
• If it is almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for missed doses.

If You Stop Using Pulmozyme

If you stop using Pulmozyme, your chest symptoms may worsen. Contact your doctor if you want to stop using Pulmozyme.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The side effects of Pulmozyme are rare. They affect less than 1 in 1,000 people.

These side effects include:

• Chest pain.
• Fever.
• Digestive disorders (indigestion).
• Voice disorders, including hoarseness or loss of voice.
• Sore throat.
• Difficulty breathing.
• Runny nose or stuffy nose and sneezing (rhinitis).
• Eye irritation (conjunctivitis). These signs include redness, itching, and discharge.
• Skin rash that may have nodules and cause itching (hives).

• At the start of treatment with dornase alfa, lung function may decrease, as well as an increase in mucous secretions. This usually improves over time.

If you think any of the side effects you are experiencing are serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting 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 through the Spanish Medicines Agency's website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pulmozyme

• Pulmozyme ampoules should be stored in the refrigerator (between 2°C and 8°C), in the original packaging, to protect it from light.
• The ampoule can be used even if it has been out of the refrigerator for a short period and exposed to high temperatures (provided it is the first time the ampoule is left out of the refrigerator and for a maximum of 24 hours at temperatures up to 30°C).
• 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 packaging after (EXP). The expiry date is the last day of the month stated. Do not throw away any leftover ampoules; take them to your pharmacist for disposal. Only keep leftover liquid if your doctor tells you to.
• Medicines should not be disposed of via wastewater or household waste. Take the packaging and any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Further Information

Composition of Pulmozyme

• The active ingredient is dornase alfa. It is also known as deoxyribonuclease 1 or rhDnase. Each 2.5 ml (milliliters) of solution contains 2,500 Units (or 2.5 milligrams) of dornase alfa.

• The other ingredients are sodium chloride, calcium chloride dihydrate, and water for injection.

Appearance of the Product and Package Contents

Pulmozyme solution for inhalation by nebulizer is presented in transparent plastic ampoules. The ampoules contain 2.5 ml of solution. The solution is clear, colorless to slightly yellowish.

Pulmozyme is available in cardboard packages containing 6 or 30 ampoules. Not all pack sizes may be marketed.

Marketing Authorization Holder

Roche Farma, S.A.

C/ Ribera del Loira, nº 50,

28042 Madrid

Manufacturer

Roche Pharma AG

Emil-Barell-St. 1

D-79639 Grenzach-Wyhlen

This leaflet was approved in November 2015

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.gob.es/