Seretide Evohaler DC

Seretide Evohaler DC Tác dụng không mong muốn

salmeterol + fluticasone

Nhà sản xuất:

GlaxoSmithKline
Thông tin kê toa chi tiết tiếng Anh
Adverse Reactions
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), bronchitis.
Rare: Oesophageal candidiasis.
Immune system disorders: Hypersensitivity Reactions: Uncommon: Cutaneous hypersensitivity reactions, dyspnoea.
Rare: Anaphylactic reactions, bronchospasm, angioedema (mainly facial and oropharyngeal oedema).
Endocrine disorders: Cushing's syndrome, Cushingoid features, Adrenal suppression, Growth retardation in children and adolescents, Decreased bone mineral density.
Metabolism and nutrition disorders: Common: Hypokalaemia.
Uncommon: Hyperglycaemia.
Psychiatric disorders: Uncommon: Anxiety, sleep disorders.
Rare: Behavioural changes, including hyperactivity and irritability (predominantly in children).
Not known: Depression, aggression (predominantly in children).
Nervous system disorders: Very common: Headache (see Precautions).
Uncommon: Tremor (see Precautions).
Eye disorders: Uncommon: Cataract.
Rare: Glaucoma.
Cardiac disorders: Uncommon: Palpitations (see Precautions), tachycardia, atrial fibrillation, angina pectoris.
Rare: Cardiac arrhythmias including supraventricular tachycardia and extrasystoles.
Respiratory, thoracic and mediastinal disorders: Very common: Nasopharyngitis.
Common: Hoarseness/dysphonia, throat irritation, sinusitis.
Rare: Paradoxical bronchospasm.
Skin and subcutaneous tissue disorders: Uncommon: Contusions.
Musculoskeletal and connective tissue disorders: Common: Muscle cramps, arthralgia, traumatic fractures, myalgia.
Postmarketing Data: Cardiovascular: Arrhythmias (including atrial fibrillation, extrasystoles, supraventricular tachycardia), hypertension, ventricular tachycardia.
Ear, Nose, and Throat: Aphonia, earache, facial and oropharyngeal edema, paranasal sinus pain, rhinitis, throat soreness, tonsillitis.
Endocrine and Metabolic: Cushing's syndrome, Cushingoid features, growth velocity reduction in children/adolescents, hypercorticism, osteoporosis.
Eye: Cataracts, glaucoma.
Gastrointestinal: Dyspepsia, xerostomia.
Hepatobiliary Tract and Pancreas: Abnormal liver function tests.
Immune System: Immediate and delayed hypersensitivity reactions, including rash and rare events of angioedema, bronchospasm.
Infections and Infestations: Esophageal candidiasis.
Musculoskeletal: Back pain, myositis.
Neurology: Paresthesia, restlessness.
Non-Site Specific: Fever, pallor.
Psychiatry: Agitation, aggression, depression. Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children.
Respiratory: Asthma; asthma exacerbation; chest congestion; cough; dyspnea; immediate bronchospasm; influenza; paradoxical bronchospasm; tracheitis; wheezing; pneumonia; reports of upper respiratory symptoms of laryngeal spasm, irritation, or stridor or choking.
Skin: Contact dermatitis, contusions, ecchymoses, photodermatitis, pruritus.
Urogenital: Dysmenorrhea, irregular menstrual cycle, pelvic inflammatory disease, vaginal candidiasis, vaginitis, vulvovaginitis.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Đăng nhập
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Already a member? Đăng nhập