Asthalin Adverse Reactions

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), very rare (<1/10,000) including isolated reports and not known (cannot be estimated from the available data). Very common and common events were generally determined from clinical trial data. Rare, very rare and unknown events were generally determined from spontaneous data.
Immune system disorders: Very rare: Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse.
Metabolism and nutrition disorders: Rare: Hypokalaemia (especially in combination with xanthine derivatives, corticosteroids and diuretics) increased serum lactate levels and acidosis lactic.
Psychiatric disorders: Common: Tenseness.
Rare: Sleep disturbances and hallucinations (especially in children).
Very rare: Insomnia, Hyperactivity.
Nervous system disorders: Common: Headache, Dizziness, Fine tremor (particularly in hands).
Cardiac disorders: Common: Tachycardia.
Uncommon: Palpitations.
Very rare: Cardiac arrhythmias (including atrial fibrillation, supraventricular tachycardia and extrasystoles) - especially if used concomitantly with other β₂-agonists.
Not known: Myocardial ischaemia, chest pain (see Precautions).
Vascular disorders: Rare: Peripheral vasodilatation.
Respiratory, thoracic and mediastinal disorders: Uncommon: Throat irritation.
Very rare: Paradoxical bronchospasm (with an immediate increase in wheezing after dosing). (As with other inhalation therapy, paradoxical bronchospasm may occur immediately after dosing. If this occurs, salbutamol should be discontinued immediately and, if needed, an alternative therapy instituted).
Gastrointestinal disorders: Uncommon: Mouth irritation.
Rare: nausea, vomiting, dry mouth, sore mouth.
Skin and subcutaneous tissue disorders: Very rare: Pruritus.
Musculoskeletal and connective tissue disorders: Uncommon: Myalgia, muscle cramps.
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 Yellow Card Scheme at: https://yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store.