Loading…
FOBUMIX EASYHALER is a brand name for Budesonide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Fobumix Easyhaler 80 micrograms/ 4.5 micrograms is indicated in adults, adolescents and children aged 6 years and older Fobumix Easyhaler 80 micrograms/ 4.5 micrograms is indicated for the regular treatment of asthma where use of a combination (inhaled corticosteroid and long- acting β2 adrenoceptor agonist) is…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Fobumix Easyhaler is not intended for the initial management of asthma. The dosage of the components of Fobumix Easyhaler is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated but also when the maintenance dose is adjusted.
If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of β2 adrenoceptor agonists and/or corticosteroids by individual inhalers should be prescribed.
The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. Patients should be regularly reassessed by their prescriber/health care provider so that the dosage of Fobumix Easyhaler remains optimal.
When long-term control of symptoms is maintained with the lowest recommended dosage, then the next step could include a test of inhaled corticosteroid alone.
For Fobumix Easyhaler there are two treatment approaches:
A. maintenance therapy: Fobumix Easyhaler is taken as regular maintenance treatment with a separate rapid-acting bronchodilator as rescue. B. maintenance and reliever therapy: Fobumix Easyhaler is taken as regular maintenance treatment and as needed in response to symptoms.
A. maintenance therapy Patients should be advised to have their separate rapid-acting bronchodilator available for rescue use at all times.
Recommended doses:
Adults (18 years and older): 1-2 inhalations twice daily. Some patients may require up to a maximum of 4 inhalations twice daily. Adolescents (12-17 years): 1-2 inhalations twice daily. Children (6 years and older): 2 inhalations twice daily.
In usual practice when control of symptoms is achieved with the twice daily regimen, titration to the lowest effective dose could include Fobumix Easyhaler given once daily, when in the opinion of the prescriber, a long-acting bronchodilator in combination with an inhaled corticosteroid would be required to maintain control.
Increasing use of a separate rapid-acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy. 5 micrograms is not recommended for children younger than 6 years. B. maintenance and reliever therapy Patients take a daily maintenance dose of Fobumix Easyhaler and in addition take Fobumix Easyhaler as needed in response to symptoms.
Since Fobumix Easyhaler contains both budesonide and formoterol, the same pattern of undesirable effects as reported for these substances may occur. No increased incidence of adverse reactions has been seen following concurrent administration of the two compounds.
The most common drug related adverse reactions are pharmacologically predictable side-effects of β2 agonist therapy, such as tremor and palpitations. These tend to be mild and usually disappear within a few days of treatment. Adverse reactions, which have been associated with budesonide or formoterol, are given below, listed by system organ class and frequency.
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000) and very rare (< 1/10 000). g. g. atrial fibrillation, supraventricular tachycardia, extrasystoles Cardiac disorders Very rare Angina pectoris.
Prolongation of QTc- interval Vascular disorders Very rare Variations in blood pressure Common Mild irritation in the throat, coughing, dysphonia including hoarseness Respiratory, thoracic and mediastinal disorders Rare Bronchospasm Gastrointestinal disorders Uncommon Nausea Skin and subcutaneous tissue disorders Uncommon Bruises Musculoskeletal and connective tissue disorders Uncommon Muscle cramps Candida infection in the oropharynx is due to drug deposition.
Advising the patient to rinse the mouth out with water after each maintenance dose will minimise the risk. Oropharyngeal Candida infection usually responds to topical anti-fungal treatment without the need to discontinue the inhaled corticosteroid.
If oropharyngeal thrush occurs, patients should also rinse their mouth with water after the as-needed inhalations. As with other inhalation therapy, paradoxical bronchospasm may occur very rarely, affecting less than 1 in 10,000 people, with an immediate increase in wheezing and shortness of breath after dosing.
It is recommended that the dose is tapered when the treatment is discontinued and should not be stopped abruptly. 2). Sudden and progressive deterioration in control of asthma is potentially life threatening and the patient should undergo urgent medical assessment.
g. a course of oral corticosteroids, or antibiotic treatment if an infection is present. Patients should be advised to have their rescue inhaler available at all times, either Fobumix Easyhaler (for asthma patients using Fobumix Easyhaler as maintenance and reliever therapy) or a separate rapid-acting bronchodilator (for all patients using Fobumix Easyhaler as maintenance therapy only).
Patients should be reminded to take their Fobumix Easyhaler maintenance dose as prescribed, even when asymptomatic. g. before exercise, has not been studied. g. before exercise. For such use, a separate rapid-acting bronchodilator should be considered.
Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Fobumix Easyhaler. Regular review of patients as treatment is stepped down is important. 2). Patients should not be initiated on Fobumix Easyhaler during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma.
Serious asthma-related adverse events and exacerbations may occur during treatment with Fobumix Easyhaler. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation of Fobumix Easyhaler.
As with other inhalation therapy, paradoxical bronchospasm may occur, with an immediate increase in wheezing and shortness of breath after dosing. If the patient experiences paradoxical bronchospasm Fobumix Easyhaler should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary.
8). Systemic effects may occur with any inhaled corticosteroid, particularly at high doses prescribed for long periods. These effects are much less likely to occur with inhalation treatment than with oral corticosteroids. 8). Visual disturbance may be reported with systemic and topical corticosteroid use.
1 (lactose, which contains small amounts of milk protein).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Budesonide in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
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.
Patients should be advised to always have Fobumix Easyhaler available for rescue use. Maintenance and reliever therapy should especially be considered for patients with: • inadequate asthma control and in frequent need of reliever medication • asthma exacerbations in the past requiring medical intervention Close monitoring for dose-related adverse effects is needed in patients who frequently take high numbers of Fobumix Easyhaler as-needed inhalations.
Recommended doses:
Adults and adolescents (12 years and older): The recommended maintenance dose is 2 inhalations per day, given either as one inhalation in the morning and evening or as 2 inhalations in either the morning or evening. Patients should take 1 additional inhalation as needed in response to symptoms.
If symptoms persist after a few minutes, an additional inhalation should be taken. Not more than 6 inhalations should be taken on any single occasion. A total daily dose of more than 8 inhalations is not normally needed; however, a total daily dose of up to 12 inhalations could be used for a limited period.
Patients using more than 8 inhalations daily should be strongly recommended to seek medical advice. They should be reassessed and their maintenance therapy should be reconsidered. Children under 12 years: maintenance and reliever therapy is not recommended for children.
General information Special patient groups:
There are no special dosing requirements for elderly patients. There are no data available for use of Fobumix Easyhaler in patients with hepatic or renal impairment. As budesonide and formoterol are primarily eliminated via hepatic metabolism, an increased exposure can be expected in patients with severe liver cirrhosis.
Method of administration For inhalation use The delivered dose corresponds to that received from other budesonide/formoterol combination products which have a metered dose of 100 micrograms of budesonide and 6 micrograms of formoterol fumarate dihydrate but similar delivered doses to Fobumix Easyhaler.
Instructions for correct use of Fobumix Easyhaler:
The inhaler is inspiratory flow-driven, which means that when the patient inhales through the mouthpiece, the substance will follow the inspired air into the airways.
Note:
It is important to instruct the patient • To carefully read the instructions for use in the patient information leaflet which is packed together with each Fobumix Easyhaler. • To hold the inhaler upright, gripping it between finger and thumb • To vigorously shake the inhaler up and down 3 to 5 times before actuation • To actuate (click) the inhaler before inhalation • To breathe in forcefully and deeply through the mouthpiece to ensure that an optimal dose is delivered to the lungs.
• Never to breathe out through the mouthpiece as this will result in a reduction in the delivered dose. Should this happen the patient is instructed to tap the mouthpiece onto a table top or the palm of a hand to empty the powder, and then to repeat the dosing procedure.
• Never to actuate the device more than once without inhalation of the powder. Should this happen the patient is instructed to tap the mouthpiece onto a table top or the palm of a hand to empty the powder, and then to repeat the dosing procedure.
• To always replace the dust cap (and, if in use, close the protective cover) after use to prevent accidental actuation of the device (which could result in either overdosing or under dosing the patient when subsequently used). • To rinse the mouth out with water […]
Paradoxical bronchospasm responds to a rapid-acting inhaled bronchodilator and should be treated straightaway. 4). Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids.
Possible systemic effects include Cushing’s Syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract and glaucoma. Increased susceptibility to infections and impairment of the ability to adapt to stress may also occur.
Effects are probably dependent on dose, exposure time, concomitant and previous steroid exposure and individual sensitivity. Treatment with β2 agonists may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies.
4). 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. uk/yellowcard.
If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Potential effects on bone density should be considered, particularly in patients on high doses for prolonged periods that have coexisting risk factors for osteoporosis. Long-term studies with inhaled budesonide in children at mean daily doses of 400 micrograms (metered dose) or in adults at daily doses of 800 micrograms (metered dose) have not shown any significant effects on bone mineral density.
No information regarding the effect at higher doses is available. If there is any reason to suppose that adrenal function is impaired from previous systemic steroid therapy, care should be taken when transferring patients to Fobumix Easyhaler therapy.
The benefits of inhaled budesonide therapy would normally minimise the need for oral steroids, but patients transferring from oral steroids may remain at risk of impaired adrenal reserve for a considerable time. Recovery may take a considerable amount of time after cessation of oral steroid therapy and hence oral steroid-dependent patients transferred to inhaled budesonide may remain at risk from impaired adrenal function for some considerable time.
In such circumstances HPA axis function should be monitored regularly. Prolonged treatment with high doses of inhaled corticosteroids, particularly higher than recommended doses, may also result in clinically significant adrenal suppression.
Therefore additional systemic corticosteroid cover should be considered during periods of stress such as severe infections or elective surgery. Rapid reduction in the dose of steroids can induce acute adrenal crisis. Symptoms and signs which might be seen in acute adrenal crisis may be somewhat vague but may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, decreased level of consciousness, seizures, hypotension and hypoglycaemia.
Treatment with supplementary systemic steroids or inhaled budesonide should not be stopped abruptly. During transfer from oral therapy to Fobumix Easyhaler a generally lower systemic steroid action will be experienced which may result in the appearance of allergic or arthritic symptoms such as rhinitis, eczema and muscle and joint pain.
Specific treatment should be initiated for these conditions. A general insufficient glucocorticosteroid effect should be suspected if, in rare cases, symptoms such as tiredness, headache, nausea and vomiting should occur. In these cases a temporary increase […]