Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Aerius

Aerius 0.5 mg/ml oral solution · Abschnitt 4.8 · PDF-Seite 11–12

HOS-091341 · Präparat HOS-084275

Tabulated list of adverse reactions The frequency of the clinical trial adverse reactions reported in excess of placebo and other undesirable effects reported during the post-marketing period are listed in the following table. 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). 11  System Organ Class Frequency Adverse reactions seen with Aerius Metabolism and nutrition Not known Increased appetite disorders Psychiatric disorders Very rare Hallucinations Not known Abnormal behaviour*, aggression*, depressed mood Nervous system disorders Common Headache Common (children less Insomnia than 2 years) Very rare Dizziness, somnolence, insomnia, psychomotor hyperactivity, seizures Eye disorders Not known Eye dryness Cardiac disorders Very rare Tachycardia, palpitations Not known QT prolongation* Gastrointestinal disorders Common Dry mouth Common (children less Diarrhoea than 2 years) Very rare Abdominal pain, nausea, vomiting, dyspepsia, diarrhoea Hepatobiliary disorders Very rare Elevations of liver enzymes, increased bilirubin, hepatitis Not known Jaundice Skin and subcutaneous tissue Not known Photosensitivity disorders Musculoskeletal and Very rare Myalgia connective tissue disorders General disorders and Common Fatigue administration site conditions Common (children less Fever than 2 years) Very rare Hypersensitivity reactions (such as anaphylaxis, angioedema, dyspnoea, pruritus, rash, and urticaria) Not known Asthenia Investigations Not known Weight increased * Undesirable effects reported during the post-marketing period also in paediatric patients.

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