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SEREFLO is a brand name for Fluticasone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Sereflo is indicated for use in adults with asthma 18 years of age and older only. Sereflo is indicated in the regular treatment of patients with moderate to severe asthma where use of a combination product (long-acting β2 agonist and inhaled corticosteroid) is appropriate: - patients not adequately controlled on a…
Verbatim from this product's MHRA label. Tap a section to expand.
Sereflo is indicated in adults 18 years of age and older only. Sereflo is not indicated for use in children, 12 years of age or younger, or adolescents, 13 to 17 years of age.
Posology Route of administration:
Inhalation use. Patients should be made aware that Sereflo must be used daily for optimum benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the strength of Sereflo they are receiving remains optimal and is only changed on medical advice.
The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
Note:
Sereflo is only available in two strengths, it is not available in a lower strength product containing salmeterol 25 microgram and fluticasone propionate 50 microgram, a strength which is available for other similar fixed-dose combination products containing these two actives and currently available on the market.
Therefore, when it is appropriate to titrate down to a dose of inhaled corticosteroid below 125 micrograms, a change to an alternative fixed-dose combination of salmeterol and fluticasone propionate containing a lower dose of the inhaled corticosteroid is required.
Sereflo should not be used for patients with mild asthma and may not be appropriate for patients with mild to moderate asthma, in whom a low dose of the inhaled corticosteroid, either alone or with a long-acting β2 agonist, may be required .
Sereflo could be considered for use in patients with moderate persistent asthma but only where control of symptoms cannot be maintained with a lower strength product containing a lower dose of the corticosteroid. Where the control of symptoms is maintained with the lowest strength of such an alternative fixed-dose combination given twice daily then the next step could include a test of inhaled corticosteroid alone.
As an alternative, patients requiring a long- acting β2 agonist could be titrated to salmeterol and fluticasone propionate given once daily if, in the opinion of the prescriber, it would be adequate to maintain disease control. In the event of once daily dosing when the patient has a history of nocturnal symptoms the dose should be given at night and when the patient has a history of mainly daytime symptoms the dose should be given in the morning.
As Sereflo contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the compounds may be expected. There is no incidence of additional adverse events following concurrent administration of the two compounds.
Adverse events which have been associated with salmeterol/fluticasone propionate 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 (≥1/1000 to <1/100), rare (≥ 1/10,000 to <1/1000) and not known (cannot be estimated from the available data).
Frequencies were derived from clinical trial data. The incidence in placebo was not taken into account. System Organ Class Adverse Event Frequency Infections & Infestations Candidiasis of the mouth and throat Pneumonia Bronchitis Oesophageal candidiasis Common Common1,3 Common1,3 Rare Immune System Disorders Hypersensitivity reactions with the following manifestations: Cutaneous hypersensitivity reactions Angioedema (mainly facial and oropharyngeal oedema) Respiratory symptoms (dyspnoea) Respiratory symptoms (bronchospasm) Anaphylactic reactions including anaphylactic shock Uncommon Rare Uncommon Rare Rare Endocrine Disorders Cushing's syndrome, Cushingoid features, Adrenal suppression, Growth retardation in children and adolescents, Decreased bone mineral density Rare4 Metabolism & Nutrition Disorders Hypokalaemia Hyperglycaemia Common3 Uncommon4 Psychiatric Disorders Anxiety Sleep disorders Behavioural changes, including psychomotor hyperactivity and irritability (predominantly in children) Depression, aggression (predominantly in children) Uncommon Uncommon Rare Not known Nervous System Disorders Headache Tremor Very Common1 Uncommon Eye Disorders Cataract Glaucoma Vision blurred Uncommon Rare4 Not known4 Cardiac Disorders Palpitations Tachycardia Cardiac arrhythmias (including supraventricular tachycardia and extrasystoles).
Sereflo should not be used to treat acute asthma symptoms for which a fast- and short- acting bronchodilator is required. Patients should be advised to have their inhaler to be used for relief in an acute asthma attack available at all times.
Patients should not be initiated on Sereflo 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 Sereflo.
Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on Sereflo. Increased requirements for use of reliever medication (short-acting bronchodilators), or decreased response to reliever medication indicate deterioration of asthma control and patients should be reviewed by a physician.
Sudden and progressive deterioration in control of asthma is potentially life- threatening and the patient should undergo urgent medical assessment. Consideration should be given to increasing corticosteroid therapy. Once asthma symptoms are controlled, consideration may be given to gradually reducing the dose of Sereflo.
Regular review of patients as treatment is stepped down is important. 2). Treatment with Sereflo should not be stopped abruptly due to risk of exacerbation. Therapy should be down-titrated under physician supervision. As with all inhaled medication containing corticosteroids, Sereflo should be administered with caution in patients with active or quiescent pulmonary tuberculosis and fungal, viral or other infections of the airway.
Appropriate treatment should be promptly instituted, if indicated. g. supraventricular tachycardia, extrasystoles and atrial fibrillation, and a mild transient reduction in serum potassium at high therapeutic doses. Salmeterol and fluticasone propionate should be used with caution in patients with severe cardiovascular disorders or heart rhythm abnormalities and in patients with diabetes mellitus, thyrotoxicosis, uncorrected hypokalaemia or patients predisposed to low levels of serum potassium.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Patients should be given the strength of Sereflo containing the appropriate fluticasone propionate dosage for the severity of their disease. If an individual patient should require dosages outside the recommended regimen, appropriate doses of β2 agonist and/or corticosteroid should be prescribed.
Recommended Doses:
Adults 18 years and older: - Two inhalations of 25 micrograms salmeterol and 125 micrograms fluticasone propionate twice daily. or - Two inhalations of 25 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily. A short-term trial of salmeterol and fluticasone propionate may be considered as initial maintenance therapy in adults with moderate persistent asthma (defined as patients with daily symptoms, daily rescue use and moderate to severe airflow limitation) for whom rapid control of asthma is essential.
In these cases, the recommended initial dose is two inhalations of 25 micrograms salmeterol and 50 micrograms fluticasone propionate twice daily. However Sereflo is not available in the lowest strength of this combination as currently available on the market and therefore an alternative fixed-dose combination of salmeterol and fluticasone propionate containing a lower dose of the inhaled corticosteroid would need to be prescribed for the initial maintenance therapy in adults with moderate persistent asthma.
Without the lowest strength (25/50 microgram) of this fixed-dose combination, initiation of therapy in the majority of patients with asthma may be difficult and the lowest strength of the innovator product may be required. The dose of the inhaled corticosteroid may need to be increased to achieve control of asthma symptoms but once control is attained treatment should be reviewed and the dose of the inhaled corticosteroid titrated downwards to the lowest dose at which effective control of symptoms is maintained.
Consideration may be given as to whether patients should be stepped down to an inhaled corticosteroid alone from the lowest strength combination product. Regular review of patients as treatment is stepped down is important. A clear benefit has not been shown as compared with inhaled fluticasone propionate alone used as initial maintenance therapy when one or two of the criteria of severity are missing.
In general inhaled corticosteroids remain the first line treatment for most patients. Sereflo is not intended for the initial management of mild asthma or mild to moderate asthma. It is recommended to establish the appropriate dosage of inhaled corticosteroid before any fixed-combination can be used in patients with severe asthma.
Paediatric population The safety and efficacy of Sereflo in children, 12 years and younger and adolescents, 13-17 years of age have not been established. No data are available. Sereflo is not recommended for use in children and adolescents under 18 years of age.
Note:
Neither of the two available strengths of this fixed-dose combination of salmeterol xinafoate and fluticasone propionate can be used in the management of asthma in children as the maximum authorised dose of fluticasone propionate for use in children is 100 microgram twice daily.
This dose of fluticasone propionate can only be attained by use of a lower strength of this fixed-dose combination than is currently available for Sereflo. Use of a lower strength of this fixed-dose combination can only be obtained by downward dose titration to the lowest strength of this fixed dose combination (containing 50 micrograms of fluticasone propionate).
This is not available as Sereflo. Therefore the healthcare provider should down-titrate patients to the lowest strength (25/50 microgram) by using the innovator product. […]
Atrial fibrillation Angina pectoris Uncommon Uncommon Rare Uncommon Uncommon Respiratory, Thoracic & Mediastinal Disorders Nasopharyngitis Throat irritation Hoarseness/dysphonia Sinusitis Paradoxical bronchospasm Very Common2,3 Common Common Common1,3 Rare4 Skin and subcutaneous tissue disorders Contusions Common1,3 Musculoskeletal & Connective Tissue Disorders Muscle cramps Traumatic fractures Arthralgia Myalgia Common Common1,3 Common Common 1.
Reported commonly in placebo 2. Reported very commonly in placebo 3. Reported over 3 years in a COPD study 4. 4 Description of selected adverse reactions The pharmacological side effects of β2 agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy.
As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing. Paradoxical bronchospasm responds to a rapid acting bronchodilator and should be treated straightaway.
Sereflo should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary. Due to the fluticasone propionate component, hoarseness and candidiasis (thrush) of the mouth and throat and, rarely, of the oesophagus can occur in some patients.
Both hoarseness and incidence of mouth and throat candidiasis may be relieved by rinsing the mouth with water and/or brushing the teeth after using the product. Symptomatic mouth and throat candidiasis can be treated with topical anti-fungal therapy whilst still continuing with the Sereflo.
4). Children may also experience anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability. 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/ or search for MHRA Yellow Card in the Google Play or Apple App Store.
8) and this should be considered when prescribing to patients with a history of diabetes mellitus. As with other inhalation therapy paradoxical bronchospasm may occur with an immediate increase in wheezing and shortness of breath after dosing.
Paradoxical bronchospasm responds to a rapid-acting bronchodilator and should be treated straightaway. Sereflo should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary. The pharmacological side effects of β2 agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy.
Systemic effects may occur with any inhaled corticosteroid, 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, decrease in bone mineral density, cataract and glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children) (see Paediatric population sub-heading below for information on the systemic effects of inhaled corticosteroids in children and adolescents).
It is important, therefore, that the patient is reviewed regularly and the dose of inhaled corticosteroid is reduced to the lowest dose at which effective control of asthma is maintained. Prolonged treatment of patients with high doses of inhaled corticosteroids may result in adrenal suppression and acute adrenal crisis.
Very rare cases of adrenal suppression and acute adrenal crisis have also been described with doses of fluticasone propionate between 500 and less than 1000 micrograms. Situations, which could potentially trigger acute adrenal crisis, include trauma, surgery, infection or any rapid reduction in dosage.
Presenting symptoms are typically vague and may include anorexia, abdominal pain, weight loss, tiredness, headache, nausea, vomiting, hypotension, decreased level of consciousness, hypoglycaemia, and seizures. Additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
Spacer devices Systemic absorption of salmeterol and fluticasone propionate is largely through the lungs. As the use of a spacer device with a metered dose inhaler may increase drug delivery to the lungs it should be noted that this could potentially lead to an increase in the risk of systemic adverse effects.
Only limited data are available investigating the increase seen in drug delivery to the lungs with Sereflo when used with either the Volumatic spacer device or the AeroChamber Plus spacer device. However, a single dose pharmacokinetic study, Study PRC/CRD/13/11 (with spacers washed in detergent solution and drip dried prior to use) has demonstrated that the systemic exposure to salmeterol and fluticasone propionate may be increased almost two-fold when the Volumatic spacer device is used with Sereflo as compared with the AeroChamber Plus spacer device.
Use of a spacer device is recommended only for Sereflo containing salmeterol 25 microgram and fluticasone propionate 250 microgram (the high strength inhaler). A spacer device is not recommended for use with Sereflo containing salmeterol 25 microgram and fluticasone propionate 125 microgram (the mid/lower strength inhaler).
If a spacing device is required for this mid/lower strength, the patient will have to change to an alternative fixed-dose combination of salmeterol and fluticasone propionate […]