0.25 mg / ml & 0.5 mg / ml suspension for nebuliser
budesonide
1. What Budesonide STADA is and what it is used for
What Budesonide Stada is
Budesonide Stada is a suspension for a nebuliser containing the active substance budesonide. This belongs to a group of medicines called “corticosteroids”.
What Budesonide Stada is used for
Budesonide Stada is used for treating lung diseases such as
- Asthma , when inhalation spray or inhalation powder can not be used.
- Exacerbated chronic obstructive pulmonary disease (COPD), as an alternative to oral corticosteroids .
- Very severe false croup (laryngitis), in hospital treatment.
Budesonide Stada should NOT be used for the relief of acute bronchospasm(contraction of the muscles of the airways that cause wheezing) and shortness of breath ( apnea ).
How Budesonide Stada works
When you inhale Budesonide Stada, it goes directly into your lungs, where it reduces and prevents swelling and inflammation .
Budesonide contained in Budesonide Stada may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist or other healthcare professional if you have any further questions and always follow their instructions.
2. What you need to know before using Budesonide STADA
Do not use Budesonide STADA
- if you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before using Budesonide Stada.
Contact your doctor immediately
- if your breathing deteriorates or if you often wake up at night with asthma
- you feel a pressure over your chest in the morning or if the pressure over your chest lasts longer than usual.
These signs may mean that your condition is not sufficiently under control, and you may need another or additional treatment immediately.
Contact a doctor if you experience blurred vision or other visual disturbances.
Continue to use Budesonide Stada, but contact your doctor as soon as possible
- if you become short of breath or have wheezing, as you may need further treatment.
Before using Budesonide Stada, talk to your doctor or pharmacist
- if you have pneumonia , a cold or any other respiratory infection
- if you have liver problems.
Children and young people
Regular growth monitoring in children receiving long-term treatment with high- doseinhaled corticosteroids is recommended. If growth slows, treatment should be re-evaluated to reduce the dose of one inhaled corticosteroid , if possible, to the lowest dose at which effective control of asthma is maintained. The benefits of corticosteroid therapy and the potential risks of growth retardation must be carefully considered. In addition, consider referring the patient to a pediatrician who specializes in respiratory diseases.
Other medicines and Budesonide STADA
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes over-the-counter and herbal medicines. This is because Budesonide Stada may affect the way some medicines work and some medicines may affect the way Budesonide Stada works and your doctor may want to monitor you closely.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
- steroid drugs
- medicines to treat fungal infections (such as itraconazole and ketoconazole )
- HIV medicines, such as ritonavir, nelfinavir or medicines containing cobicistat.
Pregnancy, breastfeeding 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 taking this medicine.
- If you become pregnant while using Budesonide Stada, continue to use Budesonide Stada, but contact your doctor immediately.
Driving and using machines
Budesonide Stada is unlikely to affect your ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects . Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Budesonide STADA
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Budesonide Stada should be inhaled.
Treatment of asthma
| Initialdos | Maintenance dose | Maximum doseper day | |
| Infants (6-23 months) and children (2-11 years) | 0.5 – 1 mg budesonide twice daily | 0.25 – 0.5 mg budesonide twice daily | 2 mg budesonide |
| Adolescents (12–17 years) and adults | 1-2 mg budesonide twice daily | 0.5 – 1 mg budesonide twice daily | 4 mg budesonide |
- Your doctor will tell you how much to take and how long your treatment with Budesonide Stada will last. It depends on how severe your asthma is. Your asthmacan be improved within 2 days. However, it may take up to 4 weeks for the drug to reach full effect. Your doctor may lower your dose when your asthma improves to the lowest dose needed to keep your asthma under control.
- Budesonide Stada is intended for the long-term treatment of asthma .
- It is important that you use Budesonide Stada every day, even if you have no symptoms.
- The maximum daily dose (2 mg budesonide) for infants and children under 12 years of age should only be given to children with severe asthma and for limited periods.
Treatment of false croup
The usual dose for infants and children is 2 mg per day. 2 mg can be given at the same time, or 1 mg can be given followed by another 1 mg 30 minutes later. This treatment can be repeated every 12 hours for a maximum of 36 hours or until the condition improves.
Treatment of COPD
Patients with COPD should be treated with a daily dose of 1-2 mg Budesonide Stada. The treatment should be divided into two dosing sessions at 12-hour intervals.
Recommended dosing schedule for Budesonide Stada
| Dosage in mg | Volume Budesonide STADA 0.25 mg / ml suspension of the nebuliser | Volume STADA Budesonide 0.5 mg / ml suspension of the nebuliser |
| 0.25 mg | – | – |
| 0.5 mg | 2 ml | – |
| 0.75 mg | – | – |
| 1.0 mg | 4 ml | 2 ml |
| 1.5 mg | 6 ml | – |
| 2.0 mg | – | 4 ml |
For doses that are not achievable / practical with these strengths, other drugs are available.
Preparations for inhalation treatment
To inhale Budesonide Stada, you need an inhalation system including a nebulizer (= inhaler) with compressors .
All nebuliser you and compressors are not suitable for inhalation of Budesonide STADA suspension for nebuliser .
Suitable inhalation device is the nebulizer PARI LC PLUS equipped with a mouthpiece or a suitable face mask (PARI Child mask with an angle that allows inhalation to be done both lying and sitting) with compresses (PARI Boy SX).
If you are being treated at home, your doctor or nurse will show you how to inhale Budesonide Stada with your nebuliser when you start using the medicine for the first time. Children should only inhale Budesonide Stada under adult supervision.
Carefully read the operating instructions for using the nebuliser .
Instructions for use of Budesonide Stada single-dose container
- Remove the desired number of single-dose containers from the strip. Leave the rest in the foil envelope.
- Gently shake the single-dose container for 30 seconds.
- Hold the single-dose container upright. Open the single-dose container by turning the top.
- Top up the amount of medicine your doctor has prescribed in the nebulizer
- The empty single-dose container is discarded and the lid of the nebulizer container is replaced.
- Connect the face mask or mouthpiece to the nebulizer according to the nebulizer’s instructions for use.
- Connect the air hose to the compressor.
- Start the compressor. Use the face mask or mouthpiece and inhale the steam with calm and deep breaths while sitting or standing upright. If you use a face mask: make sure that the mask closes tightly during inhalation .
- You know that you have inhaled all the medicine, when no more steam comes out of the mouthpiece or face mask.
- How long it takes to inhale all the medicine depends on the type of equipment you use and how much medicine you use.
- Several drops of the drug will remain in the nebulizer after inhalation.
- Rinse mouth with water. Spit out the water. Do not swallow. If you have used a face mask, you should also wash your face.
- Clean the nebulizer and the nozzle (or face mask) after each use.
Any remaining suspension should be discarded immediately.
See the manufacturer’s recommendations for cleaning and disinfecting the nebulizer.
Mixing Budesonide Stada with other nebulization solutions
Budesonide Stada can be mixed with sodium chloride 9 mg / ml (0.9%) solution for injection . Mixture one should be used within 30 minutes.
If you forget to use Budesonide STADA
If you forget to inhale one dose , skip the missed dose and use the next dose as usual. Do not use a double dose to make up for a forgotten dose .
If you have any further questions on the use of this product, ask your doctor or pharmacist .
4. Possible side effects
Like all medicines, this medicine can cause side effects , although not everybody gets them.
If any of the following occur, stop using Budesonide Stada and contact your doctor immediately:
Uncommon (may affect up to 1 in 100 people)
- blurred vision, cataracts (cloudiness of the eye lens, ie cataracts).
Rare (may affect up to 1 in 1,000 people)
- Allergic reactions, swelling of the face, especially around your mouth (with possible swelling of the lips, tongue, eyes, ears), itching , rash or irritation ( contact dermatitis ), hives and bronchospasm (contraction of muscles in the airways that cause wheezing). This may mean that you have had an allergic reaction .
- Sudden wheezing after inhalation of the drug. This happens very rarely (may affect up to 1 in 10,000 people) .
Other possible side effects:
Common (may affect up to 1 in 10 people)
- fungal infection in the mouth. This is less likely to happen if you rinse your mouth with water after using Budesonide Stada.
- a little sore throat, cough and a hoarse voice
- pneumonia (in patients with COPD).
Tell your doctor if you have any of the following symptoms while taking Budesonide Stada as they may be symptoms of pneumonia:
- fever or chills
- increased mucus production, changed color of the mucus
- increased cough or increased difficulty breathing.
Uncommon (may affect up to 1 in 100 people)
- anxiety, depression, tremors, muscle cramps, osteoporosis (with prolonged use).
Rare (may affect up to 1 in 1,000 people)
- rash on the face when a face mask is used. To avoid this, always wash your face after applying face mask.
- aggression, feeling of restlessness, nervousness, anxiety or irritation. These side effects are more likely to occur in children.
- bruises
- speech difficulties
- stunted growth in children and adolescents
- impact on the adrenal glands (small glands above the kidneys).
Has been reported (occurs in an unknown number of users)
- sleeping problems
- glaucoma (increased pressure in the eye).
Inhaled corticosteroids can affect the normal production of steroid hormones in the body, especially if you use high doses for a long time.
The likelihood of these effects occurring is much less for inhaled corticosteroids than for cortisone tablets.
Budesonide Stada should be used before a meal to reduce any side effects in the throat.
The mouth should be rinsed with water after inhalation.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Budesonide STADA
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 single-dose container, sachet and carton after EXP. The expiration date is the last day of the specified month.
Do not freeze.
Store in the outer carton. Sensitive to light.
Shelf life after first opening the aluminum foil envelope: 3 months.
After dilution of the drug, the mixture should be used within 30 minutes.
If only a portion of the suspension in a single-dose container is used, any remaining suspension should be discarded immediately.
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.
6. Contents of the packaging and other information
Content declaration
The active substance is budesonide.
1 single-dose container of 2 ml contains: 0.5 mg budesonide.
1 single-dose container of 2 ml contains: 1 mg budesonide.
The other ingredients are disodium edetate, sodium chloride, polysorbate 80, citric acid (anhydrous), sodium citrate and water for injections.
What the medicine looks like and contents of the pack
Each single-dose container contains 2 milliliters (ml) of a white to off-white sterilenebulizer suspension .
The single-dose containers are packed in strips of 5 in an envelope. 4, 8 or 12 sealed aluminum envelopes are packed in a carton.
• Pack sizes: each carton contains 20, 40 or 60 single-dose containers .
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2–18
61118 Bad Vilbel
Germany
Other manufacturers
GENETIC SPA
Contrada Canfora
84084 Fisciano (SA)
Italy
Genetic SpA
Via G. Della Monica, 26
I-84083 CASTEL SAN GIORGIO (SA)
Italy
Local representative
STADA Nordic ApS
Marielundvej 46A
2730 Herlev
Denmark