Pulmozyme 2.500 U/2.5 ml solution for inhalation by nebulizer

Package leaflet: Information for the user

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 instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist.

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

Contents of the leaflet

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

1. What Pulmozyme is and what it is used for

Pulmozyme is a medicine containing dornase alfa, which is a humanized version of a protein naturally found in our body called “DNase”.

Pulmozyme is indicated in the treatment of cystic fibrosis to help dissolve the thick mucus secretions that develop in the lungs of 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 taking other medications you are using for the treatment of cystic fibrosis (see “Use of Pulmozyme with other medicines” in section 2).

2. What you need to know before using Pulmozyme

Do not use Pulmozyme:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting to use 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.

Use of Pulmozyme with other medicines

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

Standard treatments for cystic fibrosis (such as antibiotics, pancreatic enzymes, bronchodilators, and analgesics) may continue to be used alongside Pulmozyme. If you are unsure, consult your doctor or pharmacist before using Pulmozyme.

Pregnancy and breastfeeding

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

Driving and using machines

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

3. How to use Pulmozyme

Follow exactly the instructions given by your doctor for using this medicine. Pulmozyme is inhaled using a nebulizer (see section “Which nebulizer to use”). If in doubt, consult your doctor again.

Continue your chest physiotherapy treatment while using Pulmozyme.

Adults and children aged 5 years and older

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

Children under 5 years of age

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

Which nebulizer to use:

• Use a nebulizer such as:

• Hudson T Up-draft II/Pulmo-Aide, Airlife Misty/Pulmo-Aide, customized Respirgard/Pulmo-Aide, or AcornII/Pulmo-Aide.

• Pulmozyme can also be used with a reusable nebulizing system such as Pari LL/Inhalierboy, Pari LC/Inhalierboy or Master, Aiolos/2 Aiolos, Side Stream/CR50 or MobilAire or Porta-Neb.

• The Pari eFlow Rapid nebulizer, a general-use electronic nebulizer using vibrating membrane technology, may be used. The Pari eFlow Rapid nebulizer must 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 must not be used with Pulmozyme, as they may cause Pulmozyme to become ineffective.

Carefully read and follow the manufacturer’s instructions for the use of each nebulizer.

Talk to your doctor, as he or she may advise you which nebulizers can be used with Pulmozyme.

How to use Pulmozyme with a nebulizer:

Once your nebulizer is ready for use with Pulmozyme, please keep the following points in mind:

• Do not mix Pulmozyme with other liquids or medications in the nebulizer.
• Do not use any leftover portion; these 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 regarding the use and maintenance of these devices.
• If someone accidentally uses Pulmozyme, contact your doctor immediately.

To use the nebulizer

• Make sure the nebulizer is clean before use.
• Break off the top of a Pulmozyme vial.
• Pour the entire contents of the vial 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 the next dose is due soon, skip the missed dose.
• Do not take a double dose to make up for a missed dose.

If you stop treatment with Pulmozyme

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them. The adverse effects of Pulmozyme are rare. These affect less than 1 in 1,000 people.

These adverse effects include:

• Chest pain.

• Fever.

• Digestive disorders (indigestion).

• Voice changes including hoarseness or loss of voice.

• Sore throat.

• Difficulty breathing.

• Runny or stuffy nose and sneezing (rhinitis).

• Eye irritation (conjunctivitis). These signs include redness, itching, and fluid discharge.

• Skin rash which may include itchy lumps (hives).

• At the beginning of treatment with dornase alfa, lung function may decrease and mucus secretions may increase. This usually improves over time.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, consult your doctor or pharmacist.

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 Spanish System of Pharmacovigilance for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pulmozyme

• Pulmozyme vials should be stored in a refrigerator (between 2°C and 8°C), in the original packaging, to protect from light.
• The vial may still be used if it has been kept outside the refrigerator for a short period of time and exposed to high temperatures (provided this is the first time the vial has been removed from refrigeration and for no longer than 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 stated on the packaging following (EXP). The expiration date refers to the last day of the month indicated. Do not discard leftover vial contents; return them to your pharmacy for proper disposal. Only retain any remaining liquid if your doctor specifically instructs you to do so.
• Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point in your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pulmozyme

• The active substance is dornase alfa. It is also known as deoxyribonuclease 1 or rhDNase. Each 2.5 ml (millilitres) of solution contain 2,500 Units (or 2.5 milligrams) of dornase alfa.

• The other components are sodium chloride, calcium chloride dihydrate, and water for injections.

Appearance of the product and contents of the container

Pulmozyme for inhalation solution for nebulizer is supplied in clear plastic ampoules. The ampoules contain 2.5 ml of solution. The solution is clear, colourless to slightly yellowish.

Pulmozyme is available in cardboard packs containing 6 or 30 ampoules. Only certain pack sizes may be marketed.

Marketing Authorisation 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 last approved in November 2015

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