0.125 mg / ml, 0.25 mg / ml and 0.5 mg / ml suspension for nebuliser
budesonide
What Pulmicort is and what it is used for
Pulmicort belongs to a group of medicines called corticosteroids. They are used to reduce inflammation.
Pulmicort is used to:
- treat, reduce and prevent inflammation of the airways in asthma,
- treat symptoms of chronic obstructive pulmonary disease (COPD) by reducing inflammation in the airways,
- treat very severe false croup (laryngitis that can cause difficulty breathing).
Pulmicort should not be used as a replacement for your bronchodilator.
What you need to know before using Pulmicort
Do not use Pulmicort
- if you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Tell your doctor if you:
- have or have had liver disease or problem with the liver,
- have pulmonary tuberculosis (active or inactive),
- have a fungal or viral infection of the respiratory tract.
If you switch from cortisone tablets to Pulmicort, your previous allergic symptoms, such as runny nose and eczema, may come back in some cases. You may also experience fatigue, headaches, muscle, and joint pain, as well as occasional nausea and vomiting. This is because the total amount of cortisone in the body is reduced by treating the disease locally in the lungs. These problems disappear after some time of treatment.
You should rinse your mouth with water after each dosing session, to minimize the risk of getting a fungal infection in the oral cavity and throat. Contact a doctor if you get symptoms of a fungal infection.
In rare cases, with long-term treatment with budesonide, growth in children and adolescents may decrease. If your child is using this medicine for a long time, your doctor will usually want to check your child’s height regularly.
If asthma worsens, consult a doctor. This may mean that one dose needs to be changed or that you need another treatment.
In the event of an acute asthma attack, you should use your fast-acting bronchodilator medication.
Contact a doctor if you experience blurred vision or other visual disturbances.
Children and young people
Your doctor will regularly check the height of children receiving long-term treatment with Pulmicort. If growth slows, treatment should be re-evaluated.
Other medicines and Pulmicort
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect or be affected by treatment with Pulmicort, such as those containing:
- ketoconazole or itraconazole (found in medicines used to treat fungal infections).
- saquinavir, indinavir, ritonavir, nelfinavir, amprenavir, lopinavir, fosamprenavir, atazanavir or tipranavir (so-called HIV protease inhibitors used against HIV ).
Pulmicort can affect a test that is done to check the function of the pituitary gland, the ACTH stimulation test, which can give incorrectly low values.
Pregnancy and breastfeeding
Experience with use during pregnancy does not indicate an increased risk of malformations. However, talk to your doctor before using Pulmicort during pregnancy, as your asthma severity may change and treatment may need to be adjusted.
Budesonide passes into breast milk. However, at therapeutic doses of Pulmicort, the risk of effects on breast-fed infants is considered unlikely. Pulmicort can be used during breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Pulmicort does not affect your ability to drive or use machines.
How to use Pulmicort
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Your doctor will decide on a dose to suit you.
The number of dosing sessions varies depending on how severe your illness is.
You should use Pulmicort regularly, or as directed by your doctor, even if you have no symptoms.
Pulmicort suspension for nebulizer is inhaled using a nebulizer (= inhaler). When inhaling through the mouthpiece or face mask, the medicine follows the inhaled air down to the airways. It is therefore important that you inhale with even and calm breaths when you take your dose, see the user manual.
User manual
Pulmicort suspension for nebulizers should only be used in a special inhaler called a nebulizer.
- Mix the solution before use by gently swirling the single-dose container.
- Hold the single-dose container with the tip facing up and open by turning the wing.
- Squeeze the liquid into the nebulization container.
The single-dose container is marked with a dash (only Pulmicort 0.25 mg/ml and 0.5 mg/ml). This line shows 1 ml when the single-dose container is held upside down.
If only 1 ml is to be used, empty the single-dose container until the liquid level reaches the line.
Keep the opened single-dose container protected from light.
The opened single-dose container should be used within 12 hours.
Gently swirl the single-dose container before using the remaining liquid.
As there should always be at least 2 ml in the nebulizer container from the beginning, dilute with saline solution (or mix with another nebulizer fluid, as prescribed by your doctor) if you are only inhaling 1 ml of Pulmicort nebulizer suspension.
When inhaling, it is important to inhale with even and calm breaths through the nebulizer nozzle. For children, a face mask can be used to make it easier for the child to cope with inhalation.
Rinse your mouth with water after each dosing session, so that you can remove any medicine that may remain in your mouth.
If a face mask is used: Make sure that the mask closes tightly when inhaling and that the face is washed afterward.
Cleaning
Clean the nebulization container and the mouthpiece or face mask in warm water with a mild detergent after each treatment session. Rinse well and dry.
For further information, see the nebulizer manufacturer’s recommendations.
If you take more Pulmicort than you should
If you have ever used a larger dose than your doctor prescribed, you are unlikely to experience any side effects. However, if you use a larger dose than your doctor prescribes for a longer period (months), there is a risk that you will experience side effects.
If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
You must take a dose as stated on the label on the package or as your doctor has informed you. Do not increase or decrease the dose without consulting a doctor.
If you forget to take Pulmicort
If you forget to take a dose, take the next dose as usual.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects are
Common (may affect up to 1 in 10 people): pneumonia (in COPD patients).
Tell your doctor if you have any of the following symptoms while taking Pulmicort as they may be symptoms of pneumonia:
- fever or chills
- increased mucus production changed the color of the mucus
- increased cough or increased difficulty breathing.
Rare (may affect up to 1 in 1,000 people ) : angioedema , anaphylactic reactions, bronchospasm (bronchospasm).
Stop taking Pulmicort and contact your doctor immediately if you get any of the following symptoms of angioedema:
- swelling of the face, tongue, or throat
- difficulty swallowing
- hives and difficulty breathing.
Other side effects ar
Common (may affect up to 1 in 10 people ): Throat irritation, cough, fungal infection of the oral cavity and throat.
Uncommon (may affect up to 1 in 100 people ): Cataracts (clouding of the lens of the eye), blurred vision, depression, anxiety, muscle cramps, tremors.
Rare (may affect up to 1 in 1,000 people ): Immediate and delayed hypersensitivity reactions such as hives and other skin rashes, contact dermatitis, and corticosteroid effects (see below). Bruising, dysphonia (speech difficulties), hoarseness, restlessness, anxiety, and behavioral disorders (occurs predominantly in children).
Has been reported (occurs in an unknown number of users): Cataracts (increased pressure in the eye), sleep problems, aggression, feeling very hurried, and/or irritability.
Skin irritations on the face have been reported in some cases when a face mask has been used. To avoid this, always wash your face after using a face mask, see the user manual.
Inhaled corticosteroids can affect the normal production of steroid hormones in the body, especially if you use high doses for a long time. The effects include:
- Changes in bone mineral density (thinning of the skeleton).
- Cataracts (cloudiness of the eye lens).
- Cataracts (increased pressure in the eye).
- A subdued growth rate in children and adolescents.
- An effect on the adrenal glands (a small gland that sits next to the kidney).
The likelihood of these effects occurring is much less for inhaled corticosteroids than for cortisone tablets.
How to store Pulmicort
- Store the single-dose containers in a sealed foil envelope. Sensitive to light.
- The single-dose containers should be stored upright and at a maximum of 30 ° C.
- Single-dose containers in an open foil envelope should be consumed within 3 months.
- Opened single-dose containers are stable for 12 hours. Note that if only 1 ml is used, the remaining volume is not sterile.
- 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 carton after EXP. The expiration date is the last day of the specified month.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
- The active substance is budesonide. A single-dose container (2 ml) contains 0.25 mg, 0.5 mg and 1 mg budesonide respectively.
- The other ingredients (excipients) are disodium edetate, sodium chloride, polysorbate 80, citric acid (anhydrous), sodium citrate, and water for injections. These ingredients are included as excipients so that the suspension can be manufactured.
What the medicine looks like and the contents of the pack
Each pack (20×2 ml) contains 4 foil envelopes with 5 single-dose containers of 2 ml each.
Marketing Authorization Holder and Manufacturer
AstraZeneca AB, 151 85 Södertälje.