; 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data). Due to the clinical trial database size rare
and very rare categories are not represented.
Within each system organ class, adverse reactions are presented in order of decreasing seriousness.
Infections and infestations Metabolism and nutrition disorders
Very Common Common Uncommon Not known
Bronchitis Bronchiolitis
Decreased appetite
Very Common
Common
Uncommon
Not known
Psychiatric
Sleep disorder
Agitation
disorders
Nightmares
Irritability
Nervous system
Somnolence
Hypoglycemic
disorders
seizure
Cardiac
AV block
Bradycardia
disorders
Vascular
Peripheral
Hypotension
disorders
coldness
Vasoconstriction
Raynaud’s
phenomenon
Respiratory,
Bronchospasm
thoracic and
mediastinal
disorders
Gastrointestinal
Diarrhea
Constipation
disorders
Vomiting
Abdominal pain
Skin and
Erythema
Urticaria
subcutaneous
Alopecia
tissue disorders
Investigations
Decreased blood
Decreased blood
Agranulocytosis
pressure
glucose
Hyperkaliemia
Decreased heart
rate
Neutropenia
Description of selected adverse reactions
Concerning the lower respiratory tract infections like bronchitis or bronchiolitis, an aggravation of symptoms (including bronchospasm) has been observed in patients treated with HEMANGIOL due to the bronchoconstrictive effect of propranolol. These effects rarely led to definitive treatment discontinuation (see section 4.4).
Sleep disorders corresponded to insomnia, poor quality of sleep and hypersomnia. Other Central
Nervous System disorders were principally observed during the early periods of treatment.
Diarrhea was frequently reported and was not always associated with an infectious gastrointestinal disease. The occurrence of diarrhea seems to be dose-dependent between 1 and 3 mg/kg/day. None of cases was of severe intensity and led to treatment discontinuation.
Cardiovascular events reported during clinical studies were asymptomatic. In the context of the
4 hours cardiovascular monitoring during the titration days, it was observed a decrease of heart rate (about 7 bpm) and of systolic blood pressure (less than 3 mmHg) following drug administration. One case of second degree atrioventricular heart block in a patient with underlying conduction disorder led to definitive treatment discontinuation. Isolated cases of symptomatic bradycardia and hypotension have been reported in literature.
Blood sugar decreases observed during clinical studies were asymptomatic. However, several reports of hypoglycaemia with related hypoglycaemic seizure were reported during the compassionate use program and in literature, especially in case of fasting period during intercurrent illness (see section
4.4).
Concomitant treatment with systemic corticosteroids may increase the risk of hypoglycemia (see section 4.5).
Hyperkalaemia has been reported in the literature in few patients with large ulcerated haemangi |
