System Organ Class
Immune system disorders
Allergic reactions
Anaphylaxis
Nervous system disorders
Excitement, incoordination, mental confusion, and/or hallucinations (especially with higher dosages), hyperthermia
Psychotic reactions
Seizure, drowsiness
Headache, restlessness, ataxia, insomnia
Eye disorders
Visual disturbances (mydriasis, inhibition of accommodation, blurred vision, photophobia)
Cardiac disorders
Tachycardia (arrhythmias, transient exacerbation of bradycardia)
Atrial arrhythmias, ventricular fibrillation, angina, hypertensive crisis
Vascular disorders
Flushing
Respiratory, thoracic and mediastinal disorders
Reduced bronchial secretion
Gastrointestinal disorders
Dryness of the mouth (difficulty in swallowing and talking, thirst), parasympathetic inhibition of gastrointestinal tract (constipation and reflux), inhibition of gastric secretion, loss of taste, nausea, vomiting, bloated feeling
Skin and subcutaneous tissue disorders
Anhidrosis, urticaria, rash
Renal and urinary disorders
Inhibition of the parasympathetic control of the urinary bladder, urinary retention
Paediatric population
Infants, children and children with spastic paralysis or brain damage may be more susceptible to antimuscarinic effects.
Special populations
Atropine may cause excitement, incoordination, confusion and/or hallucinations especially in the elderly. An epidemiological study similarly reported lower cognitive performance in elderly patients receiving antimuscarinics.
Patients with Down syndrome may be more susceptible to antimuscarinic effects.
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:
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.
4.9 Overdose
Symptoms:
Flushing and dryness of the skin, dilated pupils with photophobia, dry mouth and tongue accompanied by a burning sensation, difficulty in swallowing, tachycardia, rapid respiration, hyperpyrexia, nausea, vomiting, hypertension, rash and excitement. Symptoms of CNS stimulation include restlessness, confusion, hallucinations, paranoid and psychotic reactions, incoordination, delirium and occasionally convulsions. In severe overdose, drowsiness, stupor and CNS depression may occur with coma, circulatory and respiratory failure and death.
Treatment:
Treatment should be supportive. An adequate airway should be maintained. Diazepam may be administered to control excitement and convulsions but the risk of CNS depression should be considered.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Belladonna alkaloids, tertiary amines.
ATC code: A
