Seretide Adverse Reactions

Accuhaler: As SERETIDE 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 are listed as follows by system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥1/100 and <1/10), uncommon (≥1/1000 and <1/100), rare (≥1/10,000 and <1/1000) and very rare (<1/10,000).
Clinical Trial Data: Infections and infestations: Common: Candidiasis of mouth and throat, pneumonia (in COPD patients).
Such patients may find it helpful to rinse out their mouth with water after inhalation. Symptomatic candidiasis can be treated with topical anti-fungal therapy whilst still continuing with the fluticasone propionate.
Rare: Oesophageal candidiasis.
Immune system disorders: Hypersensitivity Reactions: Uncommon: Cutaneous hypersensitivity reactions, dyspnoea.
Rare: Anaphylactic reactions.
Endocrine disorders: Possible systemic effects include (see Precautions): Uncommon: Cataract.
Rare: Glaucoma.
Metabolism and nutrition disorders: Uncommon: Hyperglycaemia.
Psychiatric disorders: Uncommon: Anxiety, sleep disorders.
Rare: Behavioural changes, including hyperactivity and irritability (predominantly in children).
Nervous system disorders: Very common: Headache (see Precautions).
Uncommon: Tremor (see Precautions).
Cardiac disorders: Common: Palpitations (see Precautions).
Uncommon: Tachycardia, atrial fibrillation.
Rare: Cardiac arrhythmias including supraventricular tachycardia and extrasystoles.
Peripheral vasodilation and a compensatory small increase in heart rate may occur in some patients.
Respiratory, thoracic and mediastinal disorders: Common: Hoarseness/dysphonia, throat irritation.
Skin and subcutaneous tissue disorders: Uncommon: Contusions.
Musculoskeletal and connective tissue disorders: Common: Muscle cramps, arthralgia.
Postmarketing Data: Immune system disorders: Hypersensitivity reactions manifesting as: Uncommon: Cutaneous hypersensitivity reactions.
Rare: Angioedema (mainly facial and oropharyngeal oedema) and respiratory symptoms (dyspnoea and/or bronchospasm), anaphylactic reactions.
Endocrine disorders: Possible systemic effects include (see Precautions): Rare: Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density.
Metabolism and nutrition disorders: Uncommon: Hyperglycaemia.
Psychiatric disorders: Uncommon: Anxiety, sleep disorders.
Rare: Behavioural changes, including hyperactivity and irritability (predominantly in children).
Respiratory, thoracic and mediastinal disorders: Rare: Paradoxical bronchospasm (see Precautions).
Inhaler: All of the adverse reactions associated with the individual components, salmeterol xinafoate and fluticasone propionate, are listed as follows. There are no additional adverse reactions attributed to the combination product when compared to the adverse event profiles of the individual components.
Adverse events are listed as follows 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 very rare (<1/10,000). The majority of frequencies were determined from pooled clinical trial data from 23 asthma and 7 COPD studies. Not all events were reported in clinical trials. For these events, the frequency was calculated based on spontaneous data.
Clinical Trial Data: Infections and infestations: Common: Candidiasis of mouth and throat, pneumonia (in COPD patients).
Such patients may find it helpful to rinse out their mouth with water after inhalation. Symptomatic candidiasis can be treated with topical anti-fungal therapy whilst still continuing with the fluticasone propionate.
Rare: Oesophageal candidiasis.
Immune system disorders: Hypersensitivity Reactions: Uncommon: Cutaneous hypersensitivity reactions, dyspnoea.
Rare: Anaphylactic reactions.
Endocrine disorders: Possible systemic effects include (see Precautions): Uncommon: Cataract.
Rare: Glaucoma.
Metabolism and nutrition disorders: Uncommon: Hyperglycaemia.
Psychiatric disorders: Uncommon: Anxiety, sleep disorders.
Rare: Behavioural changes, including hyperactivity and irritability (predominantly in children).
Nervous system disorders: Very common: Headache (see Precautions).
Uncommon: Tremor (see Precautions).
Cardiac disorders: Common: Palpitations (see Precautions).
Uncommon: Tachycardia, atrial fibrillation.
Rare: Cardiac arrhythmias including supraventricular tachycardia and extrasystoles.
Peripheral vasodilation and a compensatory small increase in heart rate may occur in some patients.
Respiratory, thoracic and mediastinal disorders: Common: Hoarseness/dysphonia, throat irritation.
Skin and subcutaneous tissue disorders: Uncommon: Contusions.
Musculoskeletal and connective tissue disorders: Common: Muscle cramps, arthralgia.
Postmarketing Data: Immune system disorders: Hypersensitivity reactions manifesting as: Uncommon: Cutaneous hypersensitivity reactions.
Rare: Angioedema (mainly facial and oropharyngeal oedema) and bronchospasm.
Endocrine disorders: Possible systemic effects include (see Precautions): Rare: Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decreased bone mineral density.
Metabolism and nutrition disorders: Uncommon: Hyperglycaemia.
Psychiatric disorders: Uncommon: Anxiety, sleep disorders.
Rare: Behavioural changes, including hyperactivity and irritability (predominantly in children).
Respiratory, thoracic and mediastinal disorders: Rare: Paradoxical bronchospasm (see Precautions).