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BUDELIN NOVOLIZER is a brand name for Budesonide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Regular treatment of persistent asthma. Note: budesonide is not intended to be used as a reliever of acute asthma.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology If a patient is switched to Budelin Novolizer 200 micrograms from an alternative inhalation device the dose should be reviewed and adjusted, as necessary, on an individual basis. The active substance, dose regimen and method of delivery should be considered.
Steroid naive patients and patients previously controlled on inhaled steroids:
Adults (including older people) and children/adolescents over 12 years of age: Initial recommended dose: 200 - 400 micrograms once or twice daily Maximum recommended dose: 800 micrograms twice daily Children 6 - 12 years: Initial recommended dose: 200 micrograms twice or 200 - 400 micrograms once daily Maximum recommended dose: 400 micrograms twice daily Children below 6 years of age: Budelin Novolizer 200 micrograms is not recommended for use in children below age 6 due to insufficient data on safety and efficacy.
Note:
For the 400 micrograms doses a 400 micrograms strength is available. The dose should be adapted to the requirements of each individual, the severity of the disease and the clinical response of the patient. The dose should be adjusted until control is achieved and then should be titrated to the lowest dose at which effective control of asthma is maintained.
Posology limits:
Adults (including older people) and children/adolescents over 12 years of age: 200 - 1600 micrograms daily Children 6 - 12 years: 200 - 800 micrograms daily Twice daily dosing in children and adults, including older people should be used when starting treatment, during periods of severe asthma and while reducing or discontinuing oral glucocorticosteroids.
Once daily dosing up to 800 micrograms may be used in adults, including older people and children/adolescents over 12 years of age with mild to moderate asthma already controlled on inhaled glucocorticosteroids (either budesonide or beclometasone dipropionate) administered twice daily.
Once daily dosing up to 400 micrograms may be used in children 6-12 years of age with mild to moderate asthma already controlled on inhaled glucocorticosteroids (either budesonide or beclometasone dipropionate) administered twice daily.
If a patient is transferred from twice daily dosing to once daily dosing this should be at the same equivalent total daily dose (with consideration of the active substance and the method of delivery) and this dose should then be reduced to the minimum dose needed to maintain effective control of asthma.
Adverse events are listed below by system organ class and frequency. 4) Glaucoma Common Hoarseness Cough Throat irritation RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Rare Bronchospasm Dysphonia Hoarseness** GASTROINTESTINAL DISORDERS Common Oral mucosal irritation SKIN AND SUBCUTANEOUS TISSUE DISORDERS Rare Urticaria Rash Dermatitis Pruritus Erythema Bruising MUSCULOSKELETAL, CONNECTIVE TISSUE AND BONE DISORDERS Uncommon Very rare Muscle spasm Bone density decreased * refer to Paediatric population, below ** rare in children Occasionally, signs or symptoms of systemic glucocorticosteroid-side effects may occur with inhaled glucocorticosteroids, probably depending on dose, exposure time, concomitant and previous corticosteroid exposure, and individual sensitivity.
Description of selected adverse reactions Clinical trials with 13119 patients on inhaled budesonide and 7278 patients on placebo have been pooled. 15% on placebo. In placebo-controlled studies cataract was also uncommonly reported in the placebo group.
Mild mucosal irritations accompanied by throat irritation, hoarseness and cough may commonly occur. The susceptibility to infection can be increased. The ability to adapt to stress can be impaired. There is an increased risk of pneumonia in patients with newly diagnosed COPD starting treatment with inhaled corticosteroids.
However a weighted assessment of 8 pooled clinical trials involving 4643 COPD patients treated with budesonide and 3643 patients randomized to non-ICS treatments did not demonstrate an increased risk for pneumonia. The results from the first 7 of these 8 trials have been published as a metaanalysis.
Lactose-monohydrate contains small amounts of milk proteins and can therefore cause allergic reactions. 4. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
4.
Mode and duration of treatment:
Budelin Novolizer 200 micrograms is intended for long-term therapy. It should be administered regularly according to the recommended schedule even when the patient is asymptomatic. The improvement in the control of asthma can appear in 24 hours, although 1 - 2 weeks additional treatment period may be necessary to reach a maximum benefit.
Method of Administration Inhalation use In order to ensure that the active substance optimally reaches the intended site of action it is necessary to inhale steadily, deeply and as rapidly as possible (to the maximum inhalation). A clearly audible click and a colour change in the control window from green to red indicates that inhalation has been performed correctly.
If an audible click is not heard and there is no colour change in the control window, inhalation should be repeated. The inhaler remains locked until inhalation is performed correctly. To reduce the risk of oral candidiasis and hoarseness it is recommended that inhalation be performed before meals and that the mouth is rinsed with water or the teeth brushed after each inhalation.
Usage and handling of the powder inhaler (=Novolizer) Refilling 1. Lightly press together the ribbed surfaces on both sides of the lid, move the lid forwards and lift off. 2. Remove the protective aluminium foil from the cartridge container and take out the new cartridge.
3. Insert the cartridge into the powder inhaler (=Novolizer) with the dosage counter facing the mouthpiece. 4. Replace the lid into the side guides from above and push down flat towards the button until it snaps into place. The cartridge can be left in the powder inhaler (=Novolizer) until it has been used up, or for up to 6 months after insertion.
Note:
Hypersensitivity to the active substance budesonide or to the excipient lactose monohydrate (which contains small amounts of milk proteins).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Budesonide in United Kingdom.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
The once daily regimen can be considered only when asthma symptoms are controlled. In case of once daily dosing this dose should be taken in the evening. g. persistent respiratory symptoms, increased use of an inhaled bronchodilator) the dose of inhaled steroids should be increased.
Those patients receiving the once daily dose regimen, should be advised to double their dose of inhaled corticosteroid, such that a once daily dose would be administered twice daily. In any case of deterioration of asthma control the patient should seek advice from a medical doctor as soon as possible.
A short acting inhaled beta-2-agonist should be available for the relief of acute symptoms of asthma at all times. Asthma Budelin Novolizer 200 micrograms may permit replacement or significant reduction in dosage of oral glucocorticosteroids while maintaining asthma control.
When transferral from oral steroids to Budelin Novolizer 200 micrograms is started, the patient should be in a relatively stable phase. A high dose of Budelin Novolizer 200 micrograms is then given in combination with the previously used oral steroid dose for about 10 days.
5 milligrams prednisolone or the equivalent each month) to the lowest possible level. In many cases, it is possible to completely substitute the oral steroid with Budelin Novolizer 200 micrograms. For further information on the withdrawal of corticosteroids, see section
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.
Budelin Novolizer 200 micrograms cartridges may only be used in the Novolizer powder inhaler Usage 1. When using the powder inhaler (=Novolizer) always keep it horizontal. First remove the protective cap. 2. Completely depress the coloured button.
A loud double click will be heard and the colour of the control window (lower) will change from red to green. Then release the coloured button. The colour green in the window indicates that the powder inhaler (=Novolizer) is ready for use.
3. Exhale as far as possible (but not into the powder inhaler). 4. Put the lips around the mouthpiece. Inhale the powder steadily, deeply and as rapidly as possible (to the maximum inhalation). During this breath a loud click should be heard, indicating correct inhalation.
Hold the breath for a few seconds and then continue with normal breathing.
Note:
If the patient needs to take more than 1 actuation at a time, steps 2 - 4 should be repeated. 5. Replace the protective cap on the mouth piece - the dosing procedure is now complete. 6. The number in the top window indicates the number of inhalations left.
Note:
The coloured button should only be pressed immediately before inhalation. A double inhalation in error is not possible with the powder inhaler (=Novolizer). The click sound and the change of colour in the control window indicate that inhalation has been performed correctly.
If the colour of the control window does not change then inhalation should be repeated. If inhalation is not completed correctly after several attempts, then the patient should consult the doctor/physician. Cleaning The powder inhaler (=Novolizer) should be cleaned at regular intervals, but at least every time the cartridge is changed.
Instructions on how to clean the powder inhaler (=Novolizer) can be found in the operating instructions attached.
Note:
In order to ensure correct use of the inhaler, patients should receive thorough instructions on how to use the powder inhaler (=Novolizer). Children should only use this product under the supervision of an adult. 3 Contraindications Hypersensitivity to the active substance budesonide or to the excipient lactose monohydrate (which contains small amounts of milk proteins).
4 Special warnings and precautions for use Budesonide is not indicated for treatment of acute dyspnoea or status asthmaticus. These conditions should be treated in the normal way. Treatment of acute exacerbations of asthma and asthma symptoms may need an increase in the dose of budesonide.
The patient should be advised to use a short- acting inhaled bronchodilator as rescue medication to relieve acute asthma symptoms. Close observation and special care is needed in patients with both active and quiescent pulmonary tuberculosis.
Patients with active pulmonary tuberculosis may use budesonide only if they are treated simultaneously with effective tuberculostatics. Similarly patients with fungal, viral or other infections of the airways require close observation and special care and should use budesonide only if they are also receiving adequate treatment for such infections.
Patients who repeatedly fail to perform the inhalation correctly should consult their doctor. In patients with severe hepatic dysfunction treatment with budesonide - similar to treatment with other glucocorticosteroids - may lead to a reduced elimination rate and an increase in systemic availability.
Attention is to be paid to possible systemic effects. Therefore the hypothalamic pituitary adrenocortical (HPA) axis function of these patients should be checked at regular intervals. Prolonged treatment with high doses of inhaled corticosteroids, particularly higher than the recommended doses, may result in clinically significant adrenal suppression.
These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to severe stress. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. Systemic effects may occur with any inhaled corticosteroids, particularly at high doses prescribed for prolonged periods.
These effects are much less likely to occur with inhalation treatment than with oral corticosteroids. Possible systemic effects include Cushing's […]