Salmeterol is an active pharmaceutical ingredient in the Selective Beta-2-Adrenoreceptor Agonists group (R03AC). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised May 22, 2026[1]
Campona Airmaster is indicated in adults and adolescents 12 years of age and older. Asthma Campona Airmaster is indicated in the regular treatment of asthma where use of a combination product (long- acting β2 agonist and inhaled corticosteroid) is appropriate: - patients not adequately controlled with inhaled corticosteroids and 'as needed' inhaled short-acting β2 agonist or - patients already adequately controlled on both inhaled corticosteroid and long-acting β2 agonist Note: Campona Airmaster 50 microgram /100 microgram strength is not appropriate in adults and children with severe asthma.
How to take
CACanada· Health Canada
15 products
Uses
CAOfficial regulatory label· revised March 22, 2025[2]
Asthma SEREVENT DISKUS (salmeterol xinafoate) is indicated for the treatment of asthma only as add-on therapy to an inhaled corticosteroid; a long-term asthma control medication; in patients 4 years of age and older with reversible obstructive airway disease, including patients with nocturnal asthma.
Corticosteroids should not be stopped because salmeterol is prescribed. Long-acting beta2-adrenergic agonists (LABA), such as salmeterol, the active ingredient in SEREVENT DISKUS, increase the risk of asthma-related death (see WARNINGS AND PRECAUTIONS).
Use of SEREVENT DISKUS for the treatment of asthma without concomitant use of an inhaled corticosteroid; a long-term asthma control medication; is contraindicated (see CONTRAINDICATIONS). Use SEREVENT DISKUS only as add-on therapy for patients with asthma who are currently taking but are inadequately controlled on an inhaled corticosteroid.
Once asthma control is achieved and maintained, assess the patient at regular intervals. If possible without loss of asthma control, discontinue SEREVENT DISKUS and maintain the patient on an inhaled corticosteroid; a long-term asthma control medication.
EUEuropean Union· EMA
1 product
Uses
EUOfficial regulatory label· revised December 16, 2025[3]
Seffalair Spiromax is indicated in the regular treatment of asthma in adults and adolescents aged 12 years and older not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting β2 agonists.
How to take
EU
Drug interactions
Known interactions involving Salmeterol. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 557. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[2]Health Canada (DPD) · 02231129 · revised March 22, 2025
[3]European Medicines Agency · EMEA/H/C/004881 · revised December 16, 2025
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
GBOfficial regulatory label· revised May 22, 2026[1]
Posology Patients are to be made aware that Campona Airmaster must be used daily for optimal benefit, even when asymptomatic. Patients should be regularly reassessed by a doctor, so that the strength of Campona Airmaster 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. Where the control of symptoms is maintained with the lowest strength of the 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 Campona Airmaster 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.
Patients should be given the strength of Campona Airmaster 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:
Asthma Adults and adolescents 12 years and older: - One inhalation of 50 micrograms salmeterol and 100 micrograms fluticasone propionate twice daily. or - One inhalation of 50 micrograms salmeterol and 250 micrograms fluticasone propionate twice daily.
A short-term trial of Campona Airmaster may be considered as initial maintenance therapy in adults or adolescents 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 one inhalation of 50 micrograms salmeterol and 100 micrograms fluticasone propionate twice daily. Once control of asthma is attained treatment should be reviewed and consideration given as to whether patients should be stepped down to an inhaled corticosteroid alone.
Regular review of patients as treatment is stepped down is important. A clear benefit has not been shown as compared to 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. Campona Airmaster is not intended for the initial management of mild asthma. Campona Airmaster 50 microgram/100 micrograms strength is not appropriate in adults and children with severe 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 Campona Airmaster is not recommended for use in children aged under 12 years of age. The safety and efficacy of Campona Airmaster in children aged less than 12 years of age has not been established. Special patient groups There is no need to adjust the dose in elderly patients or in those with renal impairment.
There are no data available for use of Campona Airmaster in patients with hepatic impairment. Method of administration Inhalation use. Required training Campona Airmaster must be used correctly in order to achieve effective treatment.
All patients must be advised to read the patient information leaflet carefully and follow the instructions for use as detailed in the leaflet. All patients must be trained by the prescribing health care professional on how to use Campona Airmaster, especially if this is their first time in using this inhaler.
This is to ensure that they understand how to use the inhaler correctly. The use of Campona Airmaster follows three simple steps, which are outlined below: 1. The device is opened by depressing the red safety lock and primed by sliding the light pink (for 50/100 microgram strength) mouthpiece cover until a “click” is heard.
2. The patient must first exhale. The mouthpiece is then placed in the mouth and the lips closed round it. The dose can then be inhaled through the inhaler by breathing in steadily and deeply. The inhaler is then removed from the mouth and the patient must hold their breath for about 10 seconds or as long as is comfortable.
3. The patient must then be instructed to breathe out gently and close the inhaler cover until a “click” is heard. Patients must also be advised to rinse their mouth afterwards with water and spit it out and/or brush their teeth after inhaling.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised May 22, 2026[1]
Summary of safety profile As Campona Airmaster 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 (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) 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. 4) Not Known2 Palpitations Uncommon Tachycardia Uncommon Cardiac disorders Cardiac arrhythmias (including Rare supraventricular tachycardia and extrasystoles).
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. Campona Airmaster 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 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 Campona Airmaster.
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/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised May 22, 2026[1]
Deterioration of disease Campona Airmaster 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 Campona Airmaster 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 Campona Airmaster.
Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on Campona Airmaster. Increased requirements for use of reliever medication (short-acting bronchodilators), or decreased response to reliever medication indicate deterioration of 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 Campona Airmaster.
Regular review of patients as treatment is stepped down is important. 2). Cessation of therapy Treatment with Campona Airmaster should not be stopped abruptly in patients with asthma due to risk of exacerbation. Therapy should be down-titrated under physician supervision.
Caution with special diseases As with all inhaled medication containing corticosteroids, Campona Airmaster 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 Campona Airmaster 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.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised May 22, 2026[1]
1.
This is not medical advice. Consult a qualified healthcare professional.
Do not use SEREVENT DISKUS for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids. SEREVENT DISKUS is a slow onset, long-acting, beta2-agonist and should not be used as a rescue medication. g.
salbutamol) should be used.
Pediatrics and Adolescent Patients:
Available data from controlled clinical trials suggest that LABA increase the risk of asthma- related hospitalization in pediatric and adolescent patients (see WARNINGS AND PRECAUTIONS). For pediatric and adolescent patients with asthma who require addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and LABA should ordinarily be used to ensure adherence with both drugs.
In cases where use of a separate inhaled corticosteroid and LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components. If adherence cannot be assured, a fixed-dose combination product containing both an inhaled corticosteroid and LABA is recommended.
Chronic Obstructive Pulmonary Disease (COPD) SEREVENT DISKUS is indicated for: long term, twice daily (morning and evening) administration in the maintenance treatment of bronchospasm and relief of dyspnea associated with COPD, including chronic bronchitis and emphysema.
SEREVENT DISKUS should not be used as a rescue medication. 1 Pediatrics Pediatrics (< 4 years of age): At present, there is insufficient clinical data to recommend the use of salmeterol xinafoate in children younger than 4 years of age.
2 Geriatrics There is no need to adjust the dose in otherwise healthy elderly patients.
How to take
CAOfficial regulatory label· revised March 22, 2025[2]
1 Dosing Considerations Asthma Long-acting beta2-adrenergic agonists (LABA), such as salmeterol, the active ingredient in SEREVENT DISKUS, increase the risk of asthma-related death (see WARNINGS AND PRECAUTIONS). Because of this risk, use of SEREVENT DISKUS for the treatment of asthma without concomitant use of an inhaled corticosteroid, a long-term asthma control medication, is contraindicated (see CONTRAINDICATIONS).
Use SEREVENT DISKUS only as add-on therapy for patients with asthma who are currently taking but are inadequately controlled on an inhaled corticosteroid. Once asthma control is achieved and maintained, assess the patient at regular intervals.
If possible without loss of asthma control, discontinue SEREVENT DISKUS and maintain the patient on an inhaled corticosteroid, a long-term asthma control medication. Do not use SEREVENT DISKUS for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids (see WARNINGS AND PRECAUTIONS).
Pediatric and Adolescent Patients (4 to 17 years of age):
Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. For patients with asthma less than 18 years of age who require addition of a LABA to an inhaled corticosteroid, a fixed-dose combination product containing both an inhaled corticosteroid and LABA should ordinarily be used to ensure adherence with both drugs.
In cases where use of a separate inhaled corticosteroid and LABA is clinically indicated, appropriate steps must be taken to ensure adherence with both treatment components. If adherence cannot be assured, a fixed-dose combination product containing both an inhaled corticosteroid and LABA is recommended (see WARNINGS AND PRECAUTIONS).
At present, there are insufficient clinical data to recommend the use of salmeterol xinafoate in children younger than 4 years of age. Based on available data, no adjustment of salmeterol dosage in pediatric patients is warranted. In adolescents/children the severity of asthma may be variable with age and periodic reassessment should be considered to determine if continued maintenance therapy with SEREVENT DISKUS is still indicated.
SEREVENT DISKUS (salmeterol xinafoate) should not be initiated in patients with significantly worsening or acutely deteriorating asthma, which may be a life-threatening condition (see WARNINGS AND PRECAUTIONS). SEREVENT DISKUS is not a replacement for inhaled or oral corticosteroid therapy; its use is complementary to it.
Patients must be warned not to stop or reduce anti- inflammatory therapy (see CONTRAINDICATIONS). SEREVENT DISKUS should not be used to treat acute symptoms. It is crucial to inform patients of this and prescribe a rapid onset, short duration beta2-agonist for this purpose.
The need for additional symptomatic bronchodilator therapy is usually reduced with SEREVENT DISKUS (see WARNINGS AND PRECAUTIONS section). Medical attention should be sought if patients find that rapid onset, short duration relief bronchodilator treatment becomes less effective or if they need more inhalations than usual.
Page 8 of 49 Bronchodilators should not be the only or the main treatment in patients with moderate to severe or unstable asthma. Patients with severe asthma require regular medical assessment since death may occur. These patients will require high dose inhaled or oral corticosteroid therapy.
Sudden worsening of symptoms may require increased corticosteroid dosage which should be administered under medical supervision. g. salbutamol) when optimum corticosteroid therapy is being used. For full therapeutic benefit, regular usage of SEREVENT DISKUS is recommended in the treatment of reversible airways obstruction.
Chronic Obstructive Pulmonary Disease (COPD) Counselling on smoking cessation should be the first step in treating patients with COPD. Smoking cessation produces symptomatic benefits and has been shown to confer a survival advantage by slowing or stopping the progression of chronic bronchitis and emphysema.
Use with Rapid Onset, Short Duration Bronchodilators:
When beginning treatment with SEREVENT DISKUS, COPD patients should be instructed to use their rapid onset, short duration bronchodilators as determined by their treating physician, at the lowest dose to relieve their symptoms. The regular twice-daily administration of SEREVENT DISKUS should reduce the excessive use of rapid onset, short duration, inhaled bronchodilators.
General Considerations for Asthma and COPD The dosage or frequency of SEREVENT DISKUS administration should not be increased since there may be serious adverse effects associated with excessive dosing. SEREVENT DISKUS should not be used more than twice daily.
Elderly and patients with impaired renal or hepatic function:
There is no need to adjust the dose in the otherwise healthy elderly or in patients with impaired renal function. Because salmeterol is predominantly cleared by hepatic metabolism, patients with hepatic disease should be closely monitored.
2 Recommended Dose and Dosage Adjustment Asthma Maintenance Therapy Patients 4 years of age and older: One blister [50 micrograms of salmeterol (as the xinafoate)] twice daily. COPD One blister [50 micrograms of salmeterol (as the xinafoate)] twice daily.
4 Administration SEREVENT DISKUS is administered by the inhaled route only. 5 Missed Dose If a patient forgets to inhale a dose, instruct the patient to inhale another as soon as they remember unless it is near the time for their next dose.
If so the patient should wait until the next dose and resume the regular dosing schedule. Do not double dose.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[2]
1 Adverse Reaction Overview As with other inhalation therapy, the potential for paradoxical bronchospasm should be kept in mind. If it occurs, the preparation should be discontinued immediately and alternative therapy instituted. e. palpitation; immediate hypersensitivity reactions, including urticaria, rash, bronchospasm, edema, angioedema, and anaphylactic shock or anaphylactic reaction; headache; tremor; nervousness; oropharyngeal irritation, and paradoxical bronchospasm.
There have also been reports of arthralgia and muscle cramps. Page 15 of 49 Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) have been reported, usually in susceptible patients. Clinically significant changes in blood glucose and/or serum potassium were seen rarely during clinical studies with long-term administration of SEREVENT at recommended doses.
Asthma Long-acting beta2-adrenergic agonists (LABA), including salmeterol, the active ingredient in SEREVENT DISKUS, increase the risk of asthma-related death. Data from a large, 28-week, placebo-controlled US study that compared the safety of salmeterol (SEREVENT Inhalation Aerosol) or placebo added to usual asthma therapy showed an increase in asthma-related death in patients receiving salmeterol.
Post-hoc analysis of the SMART trial data suggests that the risks may be lower in patients who were using inhaled corticosteroids (ICS) at study entry. However, these post-hoc analysis results are not conclusive (see 14 CLINICAL TRIALS: Salmeterol Multi-center Asthma Research Trial (SMART)).
Available data from controlled clinical trials suggest that LABA increase the risk of asthma- related hospitalization in pediatric and adolescent patients (see WARNINGS AND PRECAUTIONS, and 14 CLINICAL TRIALS: Salmeterol Multi-center Asthma Research Trial (SMART)).
2 Clinical Trial Adverse Reactions Because clinical trials are conducted under very specific conditions, the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Asthma Use in Adolescents and Adults (18 years of age and above) In controlled, multidose clinical trials (treatment period of up to 1 year) involving almost 2000 patients (≥18 years old), the most frequently occurring adverse events were headache, tremor and palpitations (see Table 2 below), which are pharmacologically predictable effects of beta2- adrenoceptor agonists.
Tremor tended to be transient, dose-related and reduced with regular therapy. Headache and palpitations were reported but the incidence was not significantly different from placebo. 1) In a subsequent 24 week controlled clinical trial, 738 patients (≥18 years old) received either salmeterol in combination with beclomethasone dipropionate (BDP) or BDP alone.
A rapid onset, short duration inhaled beta2-adrenergic drug was also provided to all patients for use on Page 16 of 49 an as-needed basis. The incidence of pharmacologically predictable adverse events was similar in all groups except for tremor which was significantly higher in the salmeterol 100 mcg group compared with the other two groups (see Table 3 below).
Table 3 Number (and percentage) of patients with drug-related adverse events Adverse Event Salmeterol 50 mcg bid + BDP* 500 mcg bid n= 243 (%) Salmeterol 100 mcg bid1 + BDP* 500 mcg bid n= 244 (%) BDP* 1000 mcg n= 251 (%) Headache 26 (11) 38 (16) 42 (17) Tremors 6 (2) 19 (8) 2 (<1) Palpitations 4 (2) 6 (2) 4 (2) Tachycardia 4 (2) 5 (2) 2 (<1) BDP* = beclomethasone dipropionate 1 = 100 mcg bid is not a recommended dose Chronic Obstructive Pulmonary Disease (COPD) Two multicenter, 12-week, controlled studies have evaluated twice-daily doses of SEREVENT inhalation aerosol in patients (≥35 years old) with COPD.
In clinical trials, SEREVENT was generally well tolerated over chronic dosing periods. The most frequently reported adverse events with SEREVENT 50 mcg twice daily were headache, upper respiratory tract infection and sore throat. Table 4 below includes all events (whether considered drug-related or non-drug-related by the investigator) that occurred at a rate of over 3% in the SEREVENT inhalation aerosol treatment group and were more common in the SEREVENT inhalation aerosol group than in the placebo group.
Table 4 Adverse experience incidence (>3%) in two large 12-week COPD clinical trials Adverse Event SEREVENT 50 mcg bid n= 267 (%) Placebo n= 278 (%) Ipratropium 40 mcg qid n= 271 (%) Ear/Nose/Throat Upper Resp. Tract Infection (URTI) 9 7 9 Sore Throat 8 3 6 Nasal Sinus Infection 4 1 2 Gastrointestinal Diarrhea 5 3 4 Musculoskeletal Back Pain 4 3 3 Neurological Headache 12 10 8 Respiratory Chest Congestion 4 3 3 Page 17 of 49 Common cold, rhinorrhea, bronchitis, cough, exacerbation of chest congestion, chest pain, and dizziness occurred at 3% or more but were equally common on placebo.
Electrocardiographic Monitoring in Patients with COPD Continuous electrocardiographic (Holter) monitoring was performed on 284 patients in two large COPD clinical trials during five 24-hour periods. No significant increase in the incidence of ventricular and supraventricular ectopic events was observed between SEREVENT and placebo.
No cases of sustained ventricular tachycardia were observed. 0%) patients in the placebo, SEREVENT, and […]
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]
Please see the Serious Warnings and Precautions Box at the beginning of Part I:
Health Professional Information. Page 10 of 49 Use in Asthma Important Information SEREVENT DISKUS (salmeterol xinafoate) should not be initiated in patients with significantly worsening or acutely deteriorating asthma, which may be a life-threatening condition.
Serious acute respiratory events, including fatalities, have been reported worldwide, when SEREVENT has been initiated in this situation. Although it is not possible from these reports to determine whether SEREVENT contributed to these events or simply failed to relieve the deteriorating asthma, the use of SEREVENT DISKUS in this setting is inappropriate.
, unresponsive to usual medications, increasing need for inhaled rapid onset, short duration beta2-agonists, increasing need for systemic corticosteroids, significant increase in symptoms, recent emergency room visits, sudden or progressive deterioration in pulmonary function).
However, they have occurred in a few patients with less severe asthma as well. There are no data demonstrating that SEREVENT DISKUS provides greater efficacy than or additional efficacy to rapid onset, short duration, inhaled beta2-agonists in patients with worsening asthma.
General SEREVENT DISKUS is not a substitute for inhaled or oral corticosteroids All asthma patients should be advised that they must also use corticosteroids if they are taking SEREVENT DISKUS. Corticosteroid therapy should not be stopped or reduced when SEREVENT DISKUS is initiated.
There are no data demonstrating that SEREVENT has a clinical anti-inflammatory effect and could be expected to take the place of, or reduce the dose of, corticosteroids. Asthmatic patients must be warned not to stop or reduce corticosteroid therapy even if they feel better as a result of initiating SEREVENT DISKUS.
Any change in corticosteroid dosage should be made ONLY after clinical evaluation. In the treatment of COPD, the role of inhaled corticosteroid therapy is less well established and SEREVENT DISKUS could be used with or without concomitant corticosteroids.
The use of oral or inhaled corticosteroids should be determined by the treating physician. SEREVENT DISKUS should not be used to treat acute asthma or COPD symptoms It is crucial to inform patients of this and prescribe a rapid onset, short duration, inhaled bronchodilator to relieve acute symptoms.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[2]
SEREVENT DISKUS is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient or component of the container and to adrenergic compounds. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Patients with cardiac tachyarrhythmias. SEREVENT DISKUS (salmeterol xinafoate) dry powder for inhalation formulation contains lactose (which contains milk protein) and is therefore contraindicated in patients with an allergy to lactose or milk.
Patients with a history of anaphylactic shock, anaphylactic reaction or angioedema associated with salmeterol xinafoate or any component of this drug. Because of the risk of asthma-related death and hospitalization, use of SEREVENT DISKUS for the treatment of asthma without concomitant use of an inhaled corticosteroid; a long-term asthma control medication; is contraindicated (see WARNINGS AND PRECAUTIONS).
Page 6 of 49
This is not medical advice. Consult a qualified healthcare professional.
Posology Patients should be advised to take Seffalair Spiromax every day, even when asymptomatic. If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be used for immediate relief. 75/202 micrograms high ICS dose), the patients’ disease severity, their previous asthma therapy including ICS dose as well as the patients’ current control of asthma symptoms should be considered.
Patients should be regularly reassessed by a doctor, so that the strength of the salmeterol/fluticasone propionate 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 that the delivered doses for Seffalair Spiromax are different from other salmeterol/fluticasone containing products on the market. The different dose strengths (medium/high doses of fluticasone) for 3 different products do not necessarily correspond to each other, thus the products are not interchangeable based on the corresponding dose strengths.
75 micrograms salmeterol and 100 micrograms fluticasone propionate twice daily. 75 micrograms salmeterol and 202 micrograms fluticasone propionate twice daily. Once control of asthma is attained, treatment should be reviewed and consideration given as to whether patients should be stepped down to salmeterol/fluticasone propionate containing a lower dose of the inhaled corticosteroid, and then, ultimately, to an inhaled corticosteroid alone.
Regular review of patients as treatment is stepped down is important. If an individual patient should require dosages outside the recommended regimen, appropriate doses of β2 agonist and/or inhaled corticosteroid should be prescribed.
Special populations Elderly There is no need to adjust the dose in elderly patients Renal impairment There is no need to adjust the dose in patients with renal impairment. Hepatic impairment There are no data available on the use of Seffalair Spiromax in patients with hepatic impairment.
Paediatric population The posology in patients 12 years of age and older is the same posology as in adults. The safety and efficacy in paediatric patients below 12 years of age have not been established. No data are available. Method of administration For inhalation use.
The device is a breath actuated, inspiratory flow-driven inhaler, which means that the active substances are delivered into the airways when the patient inhales through the mouthpiece. Required training This medicinal product should be used correctly in order to achieve effective treatment.
As such, the patients should be advised to read the patient information leaflet carefully and follow the instructions for use as detailed in the leaflet. All patients should be provided with training by the prescribing Health Care Professional on how to use this medicinal product.
This is to ensure that they understand how to use the inhaler correctly, and so that they understand the need to breathe in forcefully when inhaling to obtain the required dose. It is important to inhale forcefully to ensure optimal dosing.
The use of this medicinal product follows 3 simple steps: open, breathe, and close, which are outlined below.
Open:
Hold the device with the mouthpiece cover at the bottom and open the mouthpiece cover by folding it down until it is fully opened when 1 click is heard. 4 Breathe: Breathe out fully. Do not breathe out through your inhaler. Put the mouthpiece in your mouth and close your lips tightly around it.
Breathe in forcefully and deeply through the mouthpiece. Remove the device from the mouth and hold the breath for 10 seconds or as long as comfortable for you.
Close:
Breathe out gently and close the mouthpiece cover. Patients should not block the air vents at any time, or breathe out through the device when they are preparing the “Breathe” step. Patients are not required to shake the inhaler prior to use.
4). Patients may notice a taste when using this medicinal product due to the lactose excipient. Patients should be advised to keep their inhaler dry and clean at all times by gently wiping the mouthpiece with a dry cloth or tissue as needed.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised December 16, 2025[3]
Summary of the safety profile As this medicinal product contains salmeterol and fluticasone propionate, the type and severity of adverse reactions associated with each of the active substance may be expected. No increased incidence of adverse reactions has been seen following concurrent administration of the two compounds.
4%). 9 Tabulated list of adverse reactions Adverse reactions which have been associated with fluticasone propionate and salmeterol are presented 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), very rare (<1/10,000) and not known (cannot be estimated from the available data).
Frequencies were derived from clinical trial data.
Table 1:
Tabulated list of adverse reactions System Organ Class Adverse reaction Frequency Infections and infestations Oral candidiasisa Common1 Influenza Common Nasopharyngitis Common Rhinitis Common Sinusitis Common Pharyngitis Uncommon Respiratory tract infection Uncommon Oesophageal candidiasis Rare Endocrine disorders Cushing's syndrome, Cushingoid features, adrenal suppression and growth retardation in children and adolescents Rare1 Metabolism and nutrition disorders Hypokalaemia Common2 Hyperglycaemia Uncommon Psychiatric disorders Anxiety Uncommon Insomnia Uncommon Behavioural changes, including hyperactivity and irritability, especially in children Uncommon Nervous system disorders Headache Common Dizziness Common Tremor Uncommon Eye disorders Cataract Uncommon Glaucoma Rare1 Vision blurred Not known1 Cardiac disorders Palpitations Uncommon1 Tachycardia Uncommon Atrial fibrillation Uncommon Cardiac arrhythmias (including supraventricular tachycardia and extrasystoles) Rare Respiratory, thoracic and mediastinal disorders Cough Common Throat irritation Common Hoarseness/dysphonia Common Oropharyngeal pain Common Rhinitis allergic Uncommon Nasal congestion Uncommon Paradoxical bronchospasm Rare1 Gastrointestinal disorders Abdominal pain upper Uncommon Dyspepsia Uncommon Skin and subcutaneous tissue disorders Dermatitis contact Uncommon Musculoskeletal and connective tissue disorders Back pain Common Myalgia Common 10 System Organ Class Adverse reaction Frequency Pain in extremity Uncommon Injury, poisoning and procedural complications Laceration Uncommon a.
Includes oral candidiasis, oral fungal infection, oropharyngeal candidiasis, and oropharyngitis fungal 1. 4 2. 5 Description of selected adverse reactions Specific β2 agonist treatment effects The pharmacological effects of β2 agonist treatment, such as tremor, palpitations and headache, have been reported, but tend to be transient and reduce with regular therapy.
4). 4). Paediatric population Frequency, type and severity of adverse reactions in adolescents aged 12 years and older are expected to be the same as in adults. 4). The growth of paediatric patients receiving orally inhaled corticosteroids, including salmeterol/fluticasone propionate, should be monitored routinely.
To minimize the systemic effects of orally inhaled corticosteroids, including salmeterol/fluticasone propionate titrate each patient’s dosage to the lowest dosage that effectively controls his/her symptoms. 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
EUOfficial regulatory label· Warnings and precautions· revised December 16, 2025[3]
Deterioration of disease Salmeterol/fluticasone propionate 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 rescue inhaler available to be used for relief in an acute asthma attack at all times.
Patients should not be initiated on salmeterol/fluticasone propionate 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 salmeterol/fluticasone propionate.
Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation on salmeterol/fluticasone propionate. 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 inhaled corticosteroid therapy. Cessation of therapy Treatment with salmeterol/fluticasone propionate should not be stopped abruptly in patients with asthma due to risk of exacerbation.
Therapy should be down-titrated under physician supervision. Coexisting conditions Salmeterol/fluticasone propionate 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. , supraventricular tachycardia, extrasystoles and atrial fibrillation, and a mild transient reduction in serum potassium at high therapeutic doses. Salmeterol/fluticasone propionate should be used with caution in patients with severe cardiovascular disorders or heart rhythm abnormalities and in patients with thyrotoxicosis,.
Hypokalaemia and hyperglycaemia Beta-adrenergic agonist medicines may produce significant hypokalaemia in some patients, possibly through intracellular shunting, which has the potential to product adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised December 16, 2025[3]
1.
This is not medical advice. Consult a qualified healthcare professional.
8) and this should be considered when prescribing to patients with a history of diabetes mellitus. Paradoxical bronchospasm 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. Campona Airmaster should be discontinued immediately, the patient assessed and alternative therapy instituted if necessary. Beta 2 adrenoreceptor agonists 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.
Excipients Campona Airmaster contains approximately 13 milligram/dose of lactose monohydrate. This amount does not normally cause problems in lactose intolerant people. The excipient lactose contains small amounts of milk proteins, which may cause allergic reactions.
Systemic corticosteroid 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 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. Adrenal function 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 1,000 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.
The benefits of inhaled fluticasone propionate therapy should minimise the need for oral steroids, but patients transferring from oral steroids may remain at risk of impaired adrenal reserve for a considerable time. Therefore these patients should be treated with special care and adrenocortical function regularly monitored.
Patients who have required high dose emergency corticosteroid therapy in the past may also be at risk. This possibility of residual impairment should always be borne in mind in emergency and elective situations likely to produce stress, and appropriate corticosteroid treatment must be considered.
The extent of the adrenal impairment may require specialist advice before elective procedures. Interactions with other medicinal products Ritonavir can greatly increase the concentration of fluticasone propionate in plasma. […]
The use of bronchodilator should be determined by the treating physician. The role of long-acting beta2-agonists in the Management of Asthma and COPD The management of asthma should normally follow a stepwise programme, and patient response should be monitored clinically and by lung function tests.
Sudden or progressive deterioration in asthma control is potentially life-threatening; treatment plan must be re- evaluated, and consideration be given to increasing corticosteroid therapy. In patients at risk, daily peak flow monitoring with precise instructions for acceptable variation limits should be Page 11 of 49 considered.
Increased use of inhaled, rapid onset, short duration beta2-agonists is a marker of destabilization of asthma and requires re-evaluation of the patient and consideration of alternative treatment regimens, especially inhaled or systemic corticosteroids.
Long-acting beta2-agonists are an alternative additional therapy for patients with moderate asthma with unsatisfactory symptom control despite an optimal dose of inhaled steroids particularly when there are nocturnal symptoms. Before introducing long-acting beta2-agonists, adequate education should be provided to the patient on how to use the drug and what to do if asthma flares up.
Long-acting beta2-agonists are an additional therapy for COPD patients requiring long-acting control of symptoms. Use with rapid onset, short duration bronchodilators When asthmatic patients begin treatment with SEREVENT DISKUS, those who have been taking rapid onset, short duration, inhaled beta2-agonists on a regular daily basis should be advised to discontinue their regular daily-dosing regimen and should be clearly instructed to use rapid onset, short duration, inhaled beta2-agonists only for symptomatic relief if they develop asthma symptoms while taking SEREVENT DISKUS.
When beginning treatment with SEREVENT DISKUS, COPD patients should be instructed to use their rapid onset, short duration bronchodilators as determined by their treating physician, at the lowest dose to relieve their symptoms. The regular twice daily administration of SEREVENT DISKUS should reduce the excessive use of rapid onset, short duration inhaled bronchodilators.
Cardiovascular The pharmacological side-effects of beta2-agonist treatment, such as palpitations have been reported, but tend to be transient and to reduce with regular therapy (see ADVERSE REACTIONS). A small increase in QTc interval has been reported at therapeutic doses.
Large doses of inhaled or oral salmeterol (12 to 20 times the recommended dose) have been associated with clinically significant prolongation of the QTc interval, which has the potential for producing ventricular arrhythmias. Fatalities have been reported following excessive use of aerosol preparations containing sympathomimetic amines, the exact cause of which is unknown.
Cardiac arrest was reported in several instances. 17% vs. 308). The […]
8). 8) and this should be considered when prescribing to patients with a history of diabetes mellitus. Salmeterol/fluticasone propionate should be used with caution in patients with diabetes mellitus, uncorrected hypokalaemia, or patients predisposed to low levels of serum potassium.
8). This should be treated immediately with a short-acting inhaled bronchodilator. Salmeterol/fluticasone propionate should be discontinued immediately, the patient assessed, and alternative therapy instituted if necessary. Βeta 2 adrenoreceptor agonists The pharmacological 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 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. 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.
Adrenal function 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 micrograms and less than 1000 micrograms.
Situations, which could potentially trigger acute adrenal crisis include trauma, surgery, infection, or any 6 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 treatment should be considered during periods of stress or elective surgery. The benefits of inhaled fluticasone propionate therapy should minimise the need for oral steroids, but patients transferring from oral steroids may remain at risk of impaired adrenal reserve for a considerable time.
Therefore, these patients should be treated with special […]