Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pulmozyme 2500 U/ 2.5ml, nebuliser solution
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Dornase alfa may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Pulmozyme contains a medicine called dornase alfa. It is a man-made version of a protein found in your body called 'DNase'. Pulmozyme is used for people with cystic fibrosis. It helps by breaking down the thick mucus found in lungs. This helps lungs of people with cystic fibrosis to work better. Pulmozyme is breathed in (inhaled) using something called a 'nebuliser' (see Section 3: How to use Pulmozyme). As well as using Pulmozyme you will normally keep taking the other medicines you use for cystic fibrosis (see 'Other medicines and Pulmozyme' in section 2). 2.
What you need to know before you take it
e Pulmozyme
Do not use Pulmozyme: • if you are allergic (hypersensitive) to dornase alfa or any of the other ingredients in Pulmozyme (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before using Pulmozyme. Children Pulmozyme is not recommended for use by children under 5 years of age. Check with your doctor or pharmacist before using Pulmozyme if it has been prescribed for a child under 5 years of age.
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Other medicines and Pulmozyme Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Pulmozyme may affect the way some medicines work. Also some other medicines may affect the way Pulmozyme works. You can carry on using your usual treatments for cystic fibrosis when you are using Pulmozyme (such as antibiotics, pancreatic enzymes, bronchodilators and painkillers). If you are not sure about this, talk to your doctor or pharmacist before using Pulmozyme. Pregnancy and breast-feeding Do not use Pulmozyme if you are pregnant, trying to get pregnant or breast-feeding, unless your doctor has told you to. Driving and using machines Pulmozyme is not likely to affect you being able to drive or use any tools or machines. 3.
How to use Pulmozyme
Always use Pulmozyme exactly as your doctor has told you. Pulmozyme is breathed in (inhaled) using a nebuliser (see 'Which nebuliser to use'). You should check with your doctor if you are not sure. Keep having your standard chest physiotherapy when you are using Pulmozyme. People 5 years of age and over
- You should use Pulmozyme every day.
- The recommended dose is one ampoule every day, inhaled using your nebuliser.
- If you are over 21, your doctor may tell you to use one ampoule twice a day. People under 5 years of age
- Pulmozyme is not recommended in children under 5 years of age. Which nebuliser to use: Use a nebuliser such as:
- Hudson T Up-draft II/Pulmo-Aide, Airlife Misty/Pulmo-Aide, customised Respirgard/PulmoAide, or AcornII/Pulmo-Aide.
- Pulmozyme may also be used with a reusable nebuliser system, such as the Pari LL/Inhalierboy, Pari LC/Inhalierboy or Master, Aiolos/2 Aiolos, Side Stream/CR50 or MobilAire or Porta-Neb.
- The Pari eFlow Rapid nebuliser, a general purpose electronic vibrating membrane nebuliser may be used. The Pari eFlow Rapid nebuliser should be cleaned according to manufacturer's instructions. In addition it is recommended to use the Pari EasyCare cleaning accessory after every seventh use.
- Ultrasonic nebulisers must not be used, as they may stop Pulmozyme from working properly. Please read carefully and follow the manufacturers' instructions for use of each nebuliser. Talk to your doctor as they will be able to tell you which nebulisers can be used with Pulmozyme.
How to take it
Pulmozyme with the nebuliser When getting your nebuliser ready for use with Pulmozyme, please remember these important points:
- Do not mix Pulmozyme with any other liquids or medicines in the nebuliser.
- Do not use any left over Pulmozyme, this should always be thrown away.
- If you have a 're-usable' nebuliser, remember to clean it after use. The makers of the nebuliser will be able to give you the best advice on how to clean their equipment after using Pulmozyme.
- If someone else uses your Pulmozyme by mistake, they should talk to a doctor straight away. 2 uk-pil-pulmozyme-clean-251213-neb-sol
To use your nebuliser
- Make sure that the nebuliser is clean.
- Snap the top off one Pulmozyme ampoule.
- Pour the contents into the nebuliser chamber.
- Follow the nebuliser instructions and inhale the Pulmozyme straight away. If you use more Pulmozyme than you should If you use more Pulmozyme than you should, talk to a doctor straight away. If you forget to use Pulmozyme
- If you forget to take a dose, take it as soon as you remember.
- If it is nearly time for the next dose, skip the missed dose.
- Do not take a double dose to make up for a forgotten dose. If you stop using Pulmozyme If you stop using Pulmozyme your chest symptoms may get worse. Talk to your doctor if you would like 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, Pulmozyme can cause side effects, although not everyone will get them. Side effects from Pulmozyme are rare. They affect less than 1 in 1000 people.
Possible side effects
include:
- Chest pain.
- Fever.
- Upset stomach (indigestion).
- Changes to your voice including hoarseness or loss of voice.
- Sore throat.
- Difficulty breathing.
- A runny or blocked nose and sneezing (rhinitis).
- Irritation of your eye (conjunctivitis). The signs include redness and itchiness of the eye and a discharge from the eye.
- Skin rash, which may be lumpy and itchy (hives).
- When you start your treatment, your lung function may get worse and you may produce more mucus than normal. This usually gets better with time. If any of the side effects become serious or troublesome, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Reporting of side effects If you get 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine. United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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5.
How to store it
Pulmozyme
- Pulmozyme ampoules must be stored in a refrigerator (2°C to 8°C) in the original carton, to protect them from light.
- You can still use an ampoule if it has been left out of the refrigerator for only a short time at a higher temperature (only left out once 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 Pulmozyme after the expiry date (EXP) which is printed on the pack. The expiry date refers to the last day of that month.
- Do not throw away any left over ampoules via wastewater or household waste. Instead, return them to your pharmacist so that they can be disposed of carefully. These measures will help protect the environment. Only keep them if your doctor tells you to. 6.
Content of the pack and other information
What Pulmozyme contains • •
The active ingredient in Pulmozyme 2500 U/2.5 ml Nebuliser Solution is dornase alfa. This is also known as recombinant human deoxyribonuclease 1 or rhDNase. Each 2.5 ml (millilitres) of liquid medicine contains 2500 Units (or 2.5 milligrams) of dornase alfa. Other ingredients are sodium chloride, calcium chloride dihydrate and water for injections
What Pulmozyme looks like and contents of the pack Pulmozyme Nebuliser Solution is provided in clear plastic ampoules. The ampoules contain 2.5 ml of liquid medicine. The medicine is clear and colourless to slightly yellowish. Pulmozyme is supplied in cartons containing either 6 or 30 ampoules. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Roche Products Limited 6 Falcon Way, Shire Park Welwyn Garden City AL7 1TW United Kingdom
This leaflet was last revised in November 2025.
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Frequently asked questions about Pulmozyme 2500 U/ 2.5ml, nebuliser solution
How do I take Pulmozyme 2500 U/ 2.5ml, nebuliser solution?
Pulmozyme 2500 U/ 2.5ml, nebuliser solution comes as inhaler containing 2.5ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Pulmozyme 2500 U/ 2.5ml, nebuliser solution?
The active substance in Pulmozyme 2500 U/ 2.5ml, nebuliser solution is dornase alfa.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Pulmozyme 2500 U/ 2.5ml, nebuliser solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Pulmozyme 2500 U/ 2.5ml, nebuliser solution without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: dornase alfa
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Management of cystic fibrosis patients with a forced vital capacity (FVC) of greater than 40% of predicted and over 5 years of age to improve pulmonary function.
4.2. Posology and method of administration
Posology
2.5 mg (corresponding to 2500 U) deoxyribonuclease l by inhalation once daily.
Some patients over the age of 21 years may benefit from twice daily dosage.
Most patients gain optimal benefit from regular daily use of Pulmozyme. In studies in which Pulmozyme was given in an intermittent regimen, improvement in pulmonary function was lost on cessation of therapy. Patients should therefore be advised to take their medication every day without a break.
Patients should continue their regular medical care, including their standard regimen of chest physiotherapy.
Administration can be safely continued in patients who experience exacerbation of respiratory tract infection.
Safety and efficacy have not yet been established in patients with forced vital capacity less than 40% of predicted.
Paediatric population
Safety and efficacy have not yet been established in patients under the age of 5 years.
Method of administration
Inhale the content of one ampoule (2.5 ml of solution) undiluted using a recommended nebuliser system (see section 6.6).
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Traceability of PULMOZYME: In order to improve the traceability of Pulmozyme the trade name of the administered dornase alfa and the batch number should be clearly recorded in the patient file.
4.5. Interaction with other medicinal products and other forms of interaction
Pulmozyme can be effectively and safely used in conjunction with standard cystic fibrosis therapies such as antibiotics, bronchodilators, pancreatic enzymes, vitamins, inhaled and systemic corticosteroids, and analgesics.
4.6. Pregnancy and lactation
Pregnancy
The safety of dornase alfa has not been established in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, or embryofoetal development (see section 5.3). Caution should be exercised when prescribing dornase alfa to pregnant women.
Breastfeeding
When dornase alfa is administered to humans according to the dosage recommendation, there is minimal systemic absorption; therefore no measurable concentrations of dornase alfa would be expected in human milk. Nevertheless, caution should be exercised when dornase alfa is administered to a breast-feeding woman (see section 5.3).
4.7. Effects on ability to drive and use machines
Pulmozyme has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
The adverse event data reflect the clinical trial and post-marketing experience of using Pulmozyme at the recommended dose regimen.
Adverse reactions attributed to Pulmozyme are rare (< 1/1000). In most cases, the adverse reactions are mild and transient in nature and do not require alterations in Pulmozyme dosing.
Eye disorders:
Conjunctivitis.
Respiratory, thoracic and mediastinal disorders:
Dysphonia, dyspnea, pharyngitis, laryngitis, rhinitis (all non-infectious).
Gastrointestinal disorders:
Dyspepsia.
Skin and subcutaneous tissue disorders:
Rash, urticaria.
General disorders:
Chest pain (pleuritic/non-cardiac), pyrexia.
Investigations:
Pulmonary function tests decreased.
Patients who experience adverse events common to cystic fibrosis can, in general, safely continue administration of Pulmozyme as evidenced by the high percentage of patients completing clinical trials with Pulmozyme.
In clinical trials, few patients experienced adverse events resulting in permanent discontinuation from dornase alfa, and the discontinuation rate was observed to be similar between placebo (2%) and dornase alfa (3%).
Upon initiation of dornase alfa therapy, as with any aerosol, pulmonary function may decline and expectoration of sputum may increase.
Less than 5% of patients treated with dornase alfa have developed antibodies to dornase alpha and none of these patients have developed IgE antibodies to dornase alfa. Improvement in pulmonary function tests has still occurred even after the development of antibodies to dornase alfa.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard
4.9. Overdose
The effect of Pulmozyme overdosage has not been established.
In clinical studies, cystic fibrosis patients have inhaled up to 20 mg Pulmozyme twice daily (16 times the recommended daily dose) for up to 6 days and 10 mg twice daily (8 times the recommended dose) intermittently (2 weeks on/2 weeks off drug) for 168 days. Six adult non-cystic fibrosis patients received a single intravenous dose of 125 µg/kg of dornase alfa, followed 7 days later by 125 µg/kg subcutaneously for two consecutive 5-day periods, without either neutralising antibodies to DNase or any change in serum antibodies against double-stranded DNA being detected. All of these doses were well tolerated.
Systemic toxicity of Pulmozyme has not been observed and is not expected due to the poor absorption and short serum half-life of dornase alfa. Systemic treatment of overdose is therefore unlikely to be necessary (see section 5.2).
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- PulmozymeDornasum alfa · inhaler / nebuliser
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Pulmozyme 2500 U/ 2.5ml, nebuliser solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.