Revision Year: 2011 Publisher: DR. FRANZ KÖHLER CHEMIE GMBH, Werner-von-Siemens-Str. 22-28, D-64625 Bensheim, Telephone 0 62 51/1083-0, Telefax 0 62 51 / 1083-146, E-Mail: info@koehler-chemie.de
Anticholium must not be used in case of hypersensitivity to physostigmine salicylate (Ph. Eur.), sodium metabisulfite (Ph. Eur.) or to any of the excipients. Bronchial asthma, gangrene, coronary heart disease, mechanical constipation and mechanical ischuria (urinary retention).
Myotonic dystrophy, depolarization block after depolarizing muscle relaxants, intoxications due to “irreversibly acting” cholinesterase inhibitors, closed traumatic brain injuries, obstruction of the gastrointestinal tract and of the lower urinary system.
Bronchial asthma, diabetes mellitus, bradycardia, disturbances of the atrioventricular conduction system, pregnancy, Parkinson’s disease, ulcerative colitis.
Due to the content of sodium metabisulfite, hypersensitivity reactions may occur in individual cases, particularly in asthmatics, which are manifested in nausea, diarrhoea, wheezing, acute asthma attack, disturbed consciousness or shock. These reactions may vary individually and may also cause lifethreatening conditions. Under these circumstances, a risk/benefit analysis should be performed for Anticholium as an intoxication antidote, and a cortisone product should be made available. Acute cardiac arrest may be possible during tricyclic antidepressant treatment, therefore Anticholium should only be considered as an antidote for this indication if the patient has continuous ECG monitoring.
Caution should be exercised in case of simultaneous administration of other cholinesterase inhibitors because of the potentiating effect.
Anticholium is contraindicated in intoxication with depolarizing muscle relaxants of the suxamethonium-type.
There is no experience of the use of Anticholium in pregnant women. Physostigmine, the active substance contained in Anticholium, passes to the placenta. Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal development, birth and postnatal development. The potential risk for humans is unknown. Anticholium should only be used during pregnancy if considered to be strictly necessary by the treating doctor.
There is no experience of the use of Anticholium during breastfeeding. It is unknown whether physostigmine, the active substance contained in Anticholium, is excreted in human breast milk. Anticholium should only be used during breastfeeding if considered to be strictly necessary by the treating doctor.
None known.
Nausea, vomiting, change of heart rate (both bradycardia and tachycardia), sinoatrial block, hypotension, hypersalivation, sweating. In rare cases, sodium metabisulfite (Ph. Eur.) may cause hypersensitivity reactions and bronchospasm.
None known.
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