Prospect: information for the user

Pulmozyme 2.500 U/2.5 ml solution for inhalation by nebulizer

Dornasa alfa

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.

1. What isPulmozymeand for what it is used

2. What you need to know before starting to usePulmozyme

3. How to usePulmozyme

4. Possible adverse effects

5. Conservation ofPulmozyme

6. Contents of the package and additional information

Pulmozyme is a medication 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 break down thick secretions that form in the lungs in adults and children over 5 years old. Pulmozyme is inhaled using a nebulizer (see section 3: How to use Pulmozyme). During treatment with Pulmozyme, you will normally be able to continue using other medications you are taking for the treatment of cystic fibrosis (see “Using Pulmozyme with other medications” in section 2).

Do not use Pulmozyme:

-If you are allergic to dornase alfa or to any of the other components of this medication (including those listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Pulmozyme.

Children

Pulmozyme is not recommended for 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

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes medications you buy without a prescription and herbal medications. Pulmozyme may alter the mechanism of action of other medications, as well as other medications may alter the functioning of Pulmozyme.

Usual treatments for cystic fibrosis (such as antibiotics, pancreatic enzymes, bronchodilators, and pain relievers) may continue to be used in conjunction with Pulmozyme. If you are unsure,consult your doctor or pharmacist before using Pulmozyme.

Pregnancy and breastfeeding

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

Driving and operating machinery

Pulmozyme is unlikely to affect your ability to drive or operate machinery.

Follow exactly the administration instructions of this medication as indicated by your doctor.Pulmozyme is inhaled using a nebulizer (see section “Which nebulizer to use”). If in doubt, consult your doctor again.

Continue with your chest physical therapy treatment while using Pulmozyme.

Adults and children 5 years or older

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

Children under 5 years

Pulmozyme is not recommended for children under 5 years.

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-use electronic nebulizer that uses vibrating membrane technology, can be used. The Pari eFlow Rapid nebulizer must be cleaned according to the manufacturer's instructions. It is also recommended to use the Pari EasyCare cleaning accessory after every seven uses.
• Ultrasonic nebulizers cannot be usedwith Pulmozyme as they may cause Pulmozyme to not work properly.

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

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

How to use Pulmozyme with 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, they must 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 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 one Pulmozyme vial.
• Pour the entire contents of the vial into the nebulizer chamber.
• Follow the nebulizer usage instructions 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 your next dose is near, skip the missed dose.
• Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Pulmozyme

If you interrupt treatment with Pulmozyme, your chest symptoms may worsen. Contact your doctor if you want to interrupt treatment with Pulmozyme.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them. Adverse effects of Pulmozyme are rare. These affect fewer than 1 in 1,000 people.

These adverse effects include:

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

• At the beginning of treatment with dornase alfa, lung function may decrease, as well as increase mucous secretions. This generally improves over time.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, consult your doctor or pharmacist.

Reporting 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 prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

• Pulmozyme ampoules should be stored in a 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 outside the refrigerator for a brief period of time and exposed to high temperatures (as long as it is the first time the ampoule has been left outside the refrigerator and for a maximum of 24 hours at temperatures up to 30°C).
• Keep this medication out of sightand out of the reach of children.
• Do not use this medication after the expiration date that appears on the packaging after (CAD). The expiration date is the last day of the month indicated. Do not dispose of any leftover ampoules, take them to your pharmacy so they can take care of their disposal. Only conserve the remaining liquid if your doctor tells you to.
• Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE pointof the pharmacy. Please ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

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 components are sodium chloride, calcium chloride dihydrate, and water for injection preparations.

Appearance of the product and contents of the packaging

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

Pulmozyme is available in carton packaging containing 6 or 30 ampoules.Only some packaging sizes may be marketed

Marketing authorization holder

Roche Farma, S.A.

C/ Ribera del Loira, nº 50,

28042 Madrid

Responsible for manufacturing

Roche Pharma AG

Emil-Barell-St. 1

D-79639 Grenzach-Wyhlen

This leaflet was approved in November 2015

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