Patient leaflet - Budesonide 1 mg nebuliser suspension
1. WHAT BUDESONIDE NEBULISER SUSPENSION IS AND WHAT IT IS USED FOR
The name of this medicine is Budesonide 0.5 mg or 1 mg nebuliser suspension (called budesonide throughout this leaflet). Budesonide belongs to a group of medicines called ‘corticosteroids’. It works by reducing and preventing swelling and inflammation in your lungs.
- Budesonide nebuliser suspension is used to treat asthma. It is also used to treat croup in infants and children. It is presented in a small plastic container that contains a liquid. The liquid is put into a machine called a nebuliser. This machine turns the medicine into a fine mist which you breathe in through a face mask or mouthpiece.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BUDESONIDE
Do not use Budesonide
- If you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using Budesonide, tell your doctor or pharmacist if you have:
- a lung infection.
- a cold or chest infection.
- liver problems.
Contact your doctor if you experience blurred vision or other visual disturbances.
Other medicines and Budesonide
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Budesonide can affect the way some medicines work and some medicines can have an effect on Budesonide and your doctor may wish to monitor you carefully.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- Steroid medicines.
- Medicines to treat fungal infections (such as itraconazole and ketoconazole).
- HIV medicines (such as ritonavir or cobicistat-containing products).
Pregnancy, breast-feeding and fertility
- If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine - do not use Budesonide unless your doctor tells you to.
- If you get pregnant while using Budesonide, do not stop using budesonide but talk to your doctor immediately.
Driving and using machines
Budesonide is not likely to affect you being able to drive or use any tools or machines.
3. HOW TO USE BUDESONIDE
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The solution must be put into a nebuliser and made into a fine mist before it can be breathed in. It is then inhaled through a face mask or mouthpiece. Instructions for using your nebuliser are given after the section ‘How much to take’.
Note: Do not use an ultrasonic nebuliser with Budesonide.
Your asthma may improve within 2 days. However, it can take up to 4 weeks for the medicine to have its full effect. It is important to use Budesonide every day, even if you have no asthma symptoms at the time.
How much to take
Asthma
Your doctor will tell you how much to take. This will depend on how severe your asthma is. Your doctor may lower your dose as your asthma improves.
The recommended starting dose in adults and children over 12 years is 1 mg to 2 mg (milligrams), twice a day.
- Children under 12 years are usually prescribed lower doses (0.5 mg to 1 mg, twice a day).
Croup
The recommended dose for infants and children is 2 mg a day. This may be given all in one go, or 1 mg may be given followed by another 1 mg 30 minutes later.
Instructions for using Budesonides
- 1. Shake the container before use
- 2. Open the container by unscrewing the flap
- 3.
Place the open end of the container firmly inside the
nebuliser cup. Squeeze slowly to put the liquid in the cup.
- 4.
Use your nebuliser according to the manufacturer’s
instructions and as advised by your doctor.
- 5.
Throw the empty container away. Put the top back on the
nebuliser cup.
- 6. Connect one end of the cup to the face mask or mouthpiece.
- 7. Connect the other end of the cup to the air pump.
- 8. Gently shake the cup.
- 9.
Turn on the nebuliser and breathe in the mist calmly and
deeply using the face mask or mouthpiece. If you are using a face mask, make sure the face mask fits tightly.
- 10.
You will know when your treatment is complete because the
fine mist will stop coming out of your mask or mouthpiece.
- 11.
How long it takes to nebulise all the medicine depends on
the type of equipment you use. It will also depend on the amount of medicine to be used.
- 12.
Rinse your mouth with water. Spit out the water. Do not
swallow it. If you have used a face mask, wash your face as well.
- 13.
After each use, you must wash the nebuliser cup and
mouthpiece (or face mask) in warm soapy water and rinse well. After washing, dry these parts by connecting to the air outlet or the compressor and blow air through them.
Important information about your asthma symptoms
If you feel you are getting breathless or wheezy while using Budesonide, you should continue to use Budesonide but go to see your doctor as soon as possible, as you may need additional treatment.
Contact your doctor immediately if:
- Your breathing is getting worse or you often wake up at night with asthma.
Your chest starts to feel tight in the morning or your chest tightness lasts longer than usual. These signs could mean that your condition is not being properly controlled and you may need different or additional treatment immediately.
If you use more Budesonide than you should
It is important that you take your dose as stated on the pharmacist’s label or as advised by your doctor. You should not increase or decrease your dose without seeking medical advice. If you use more Budesonide than you should, contact your doctor or pharmacist for advice.
If you forget to use Budesonide
If you forget to take a dose, skip the missed dose and take the next dose as usual.
If you have any further questions about 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.
If either of the following happen to you, stop using Budesonide and talk to your doctor immediately:
- Swelling of your face, particularly around your mouth (with possible swelling of the lips, tongue, eyes and ears), rash, itching, contact dermatitis (a skin problem), hives and bronchospasm (tightening of the muscles in the airways which causes wheezing). This may mean that you are having an allergic reaction. This happens rarely, affecting less than 1 in 1,000 people.
- Sudden wheezing after inhaling your medicine. This happens very rarely, affecting less than 1 in 10,000 people.
Other possible side effects:
Common: may affect up to 1 in 10 people
- Thrush (a fungal infection) in the mouth. This is less likely if you rinse your mouth out with water after using Budesonide.
- Mild sore throat, coughing and a hoarse voice.
- Pneumonia (infection of the lung) in COPD patients.
Tell your doctor if you have any of the following while taking budesonide, they could be symptoms of a lung infection:
- fever or chills
- increased mucus production, change in mucus colour
- increased cough or increased breathing difficulties.
Uncommon: may affect up to 1 in 100 people
- Feeling worried, restless and nervous.
- Depression.
- Trembling and shaking.
- Cataract (clouding of the lens in the eye).
- Muscle cramps
- Blurred vision
Rare: may affect up to 1 in 1,000 people
- Rash on the face after using the face mask. You can stop this from happening by washing your face after using the face mask.
- Sleeping problems, feeling over-excited or irritable. These effects are more likely to occur in children.
- Bruising of the skin.
- Loss of voice.
- Hoarse voice (in children).
Inhaled corticosteroids can affect the normal production of steroid hormones in your body, particularly if you use high doses for a long time. The effects include:
- changes in bone mineral density (thinning of the bones)
- glaucoma (increased pressure in the eye)
- a slowing of the rate of growth of children and adolescents (rare). If high doses are given over several years, final height may be reduced by about 1 cm.
- an effect on the adrenal gland (a small gland next to the kidney) (rare).
These effects are much less likely to happen with inhaled corticosteroids than with corticosteroid tablets.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, at www.mhra.gov.uk/yellow card or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE BUDESONIDE 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 refers to the last day of that month.
Do not freeze. Store in the original package in order to protect from light.
After opening a pouch, the containers should be used within 3 months.
Use the product immediately after first opening of the single-dose container.
After use, the remaining suspension should be discarded immediately.
This medicinal product does not require any special temperature storage condition.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Budesonide contains
The active substance is budesonide.
Each ml of nebuliser suspension contains budesonide 0.25 mg or 0.5 mg.
- The other ingredients are sodium chloride, sodium citrate, disodium edetate, polysorbate 80, citric acid anhydrous, water for injections.
What Budesonide looks like and contents of the pack
Budesonide is easily resuspendable, white to off-white suspension filled into polyethylene single-dose units.
Budesonide is available in 2 mL single-dose containers made of low density polyethylene. Strips of five containers are packed in a laminated aluminium foil pouch. 4 pouches are packed into a carton.
Pack size: 20 single-dose containers.
Marketing Authorisation Holder and manufacturer
Farmak Pharmaceuticals UK Ltd,
First Floor, 47 Queen Street,
Hull,
HU1 1UU
United Kingdom
This leaflet was last revised in April 2026
WIP URN: 030425-XXXXX-PIL-01
Package leaflet: Information for the user Budesonide 0.5 mg nebuliser suspension Budesonide 1 mg nebuliser suspension
Budesonide
| WIP URN | ✓ | 030425-XXXXX-PIL-01 |
| APPROVED URN | ||
| JOB | Budesonide PIL | |
| 180 x 600mm | ||
| DATE | 3 April 2025 | |
| BOH APPROVAL DATE | ||
| SAVED AS | XXXXX-01 Budesonide PIL Farmak | |
| PRINTS | 1 colour - black |