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GORESP DIGIHALER is a brand name for Budesonide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: GoResp Digihaler is indicated in adults 18 years of age and older only. Asthma GoResp Digihaler is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: -in patients not adequately controlled with inhaled…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Asthma GoResp Digihaler is not intended for the initial management of asthma. GoResp Digihaler is not an appropriate treatment for the adult patient with only mild asthma. The dosage of GoResp Digihaler is individual and should be adjusted to the severity of the disease.
This should be considered not only when treatment with combination medicinal 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.
Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of GoResp Digihaler. Patients should be reassessed regularly by their prescriber/health care provider so that the dose of GoResp Digihaler remains optimal.
The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. When it is appropriate to titrate down to a lower strength than is available for GoResp Digihaler, a change to an alternative fixed-dose combination of budesonide and formoterol fumarate containing a lower dose of the inhaled corticosteroid is required.
When long-term control of symptoms is maintained with the lowest recommended dose, then the next step could include a test of inhaled corticosteroid alone. In usual practice when control of symptoms is achieved with the twice daily dose regimen with a lower strength product, titration to a lower effective dose could include once daily dosing when, in the opinion of the prescriber, a long-acting bronchodilator is required to maintain control rather than treatment with an inhaled corticosteroid alone.
For GoResp Digihaler there are two treatment approaches:
GoResp Digihaler maintenance therapy: GoResp Digihaler is taken as regular maintenance treatment with a separate rapid-acting bronchodilator reliever inhaler.
GoResp Digihaler maintenance and reliever therapy:
GoResp Digihaler is taken as regular maintenance treatment and as needed in response to symptoms. GoResp Digihaler maintenance therapy Patients should be advised to have their separate rapid-acting bronchodilator reliever inhaler available for rescue use at all times.
Summary of the safety profile Since GoResp Digihaler contains both budesonide and formoterol, the same pattern of adverse reactions 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 adverse reactions are pharmacologically predictable adverse reactions of β2 adrenoceptor agonist therapy, such as tremor and palpitations. These tend to be mild and usually disappear within a few days of treatment. 01, respectively).
Tabulated list of adverse reactions Adverse reactions, which have been associated with budesonide or formoterol, are given below and listed by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, < 1/100), rare (≥1/10,000, < 1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
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 Rare Bronchospasm Respiratory, thoracic and mediastinal disorders Very rare Paradoxical bronchospasm Gastrointestinal disorders Uncommon Nausea Skin and subcutaneous tissue disorders Uncommon Bruises Musculoskeletal and connective tissue disorders Uncommon Muscle cramps Description of selected adverse reactions Candida infection in the oropharynx is due to active substance deposition.
Advising the patient to rinse the mouth out with water after each dose will minimise the risk. Oropharyngeal Candida infection usually responds to topical anti-fungal treatment without the need to discontinue the inhaled corticosteroid.
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. Paradoxical bronchopasm responds to a rapid-acting inhaled bronchodilator and should be treated straightaway.
General It is recommended that the dose is tapered when the treatment is discontinued and should not be stopped abruptly. Complete withdrawal of inhaled corticosteroids should not be considered unless it is temporarily required to confirm diagnosis of asthma.
2). Sudden and progressive deterioration in control of asthma or COPD 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 GoResp Digihaler (for asthma patients using GoResp Digihaler as maintenance and reliever therapy) or a separate rapid-acting bronchodilator (for asthma patients using GoResp Digihaler as maintenance therapy only).
Patients should be reminded to take their GoResp Digihaler maintenance dose as prescribed, even when asymptomatic. g. before exercise, has not been studied. g. before exercise. For such, a separate rapid-acting bronchodilator should be considered.
Asthma symptoms Patients should be reassessed regularly by their prescriber/healthcare provider so that the dose of GoResp Digihaler remains optimal. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of GoResp Digihaler. When it is appropriate to titrate down to a lower strength than is available for GoResp Digihaler, a change to an alternative fixed-dose combination of budesonide and formoterol fumarate containing a lower dose of the inhaled corticosteroid is required.
Regular review of patients as treatment is stepped down is important. Patients should not be initiated on GoResp Digihaler during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma. Serious asthma-related adverse reactions and exacerbations may occur during treatment with GoResp Digihaler.
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. Increasing use of a separate rapid-acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of the asthma therapy.
GoResp Digihaler maintenance and reliever therapy Patients take a daily maintenance dose of GoResp Digihaler and in addition take GoResp Digihaler as needed in response to symptoms. Patients should be advised to always have GoResp Digihaler available for rescue use.
For patients taking GoResp Digihaler as reliever, preventative use of GoResp Digihaler for allergen- or exercise-induced bronchoconstriction should be discussed between physician and patient; the recommended use should take into consideration the frequency of need.
In case of frequent need of bronchodilation without corresponding need for an increased dose of inhaled corticosteroids, an alternative reliever should be used. GoResp Digihaler maintenance and reliever therapy should especially be considered for patients with: • inadequate asthma control and in frequent need of a reliever inhaler.
• asthma exacerbations in the past requiring medical intervention. Close monitoring for dose-related adverse reactions is needed in patients who frequently take high numbers of GoResp Digihaler as-needed inhalations.
Recommended doses:
Adults (18 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. For some patients a maintenance dose of 2 inhalations twice daily may be appropriate.
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.
COPD Recommended doses:
Adults (18 years and older): 2 inhalations twice daily Special populations: Elderly patients (≥65 years old) There are no special dosing requirements for elderly patients. Patients with renal or hepatic impairment There are no data available for use of a fixed-dose combination of budesonide and formoterol fumarate dihydrate 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. Paediatric population The safety and efficacy of GoResp Digihaler in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
2 but no recommendation on a posology can be made. This medicinal product is not recommended for use in children and adolescents under the age of 18 years. Method of administration Inhalation use. Digihaler is a breath actuated, inspiratory flow-driven inhaler, with an integrated eModule (a digital version of the commercially available multi-dose dry powder inhaler, Spiromax).
This means the active substances are delivered into the airways when the patient inhales through the mouthpiece. The integrated eModule does not impact the metering or dosing functionality of the inhaler, Moderate and severe asthmatic patients were shown to […]
4). Systemic effects of inhaled corticosteroids may occur, particularly at high doses prescribed for long 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 adrenoceptor agonists may result in an increase in blood levels of insulin, free fatty acids, glycerol and ketone bodies.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation with GoResp Digihaler. 1). Paradoxical bronchospasm may occur, with an immediate increase in wheezing and shortness of breath, after dosing.
If the patient experiences paradoxical bronchopasm GoResp Digihaler should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary. 8). Systemic effects 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 Visual disturbance may be reported with systemic and topical corticosteroid use. 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.
Effects on bone density Potential effects on bone density should be considered, particularly in patients on high doses for prolonged periods that have co-existing risk factors for osteoporosis. Long-term studies with inhaled budesonide 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 of a budesonide/formoterol fumarate dihydrate fixed-dose combination at higher doses is available. Adrenal function 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 a budesonide/formoterol fumarate fixed-dose combination 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 hypothalamic pituitary adrenocortical (HPA) axis function should be monitored regularly. High dose corticosteroids The 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. […]