ANTICHOLIUM

Indications: ANTICHOLIUM ® is indicated for: 1. the use as an antidote and/or antagonist in case of intoxication with and/or overdose of: alcohol tropane alkaloids (hyoscyamine, atropine, scopolamine, as e.g. in brugmansia, datura, atropa belladonna) amanita pantherina and amanita muscaria tricyclic antidepressants (amitriptyline, imipramine, trimipramine, clomipramine, doxepine) antiemetics/antihistamines (phenothiazine, thioridazine, chlorpromazine, promethazine, diphenhydramine, dimenhydrinate) neuroleptic drugs (especially butyrophenones) benzodiazepines tolterodine, oxybutynine amantadine, diphenhydramine baclofen 4-hydroxybutyric acid (GHB) inhalation anesthetics ketamine 3-quinuclidinyl benzilate 2. the treatment of postoperative disorders: Central anticholinergic syndrome (CAS) Delayed postoperative awakening Shivering

Dosage and Administration: Use in adults: For the treatment of postoperative awakening disorders: Slowly inject physostigmine intravenously at a dose of 0.04 mg/kg bodyweight (approx. 1 mg/min), the maximum individual dose is 2 mg. In case of insufficient effect, give subsequent injections after 5 to 20 minutes at the earliest, after a positive evaluation of the effect of the first injection. In cases of intoxication: Adults: Slowly inject 0.04 mg/kg bodyweight (2 mg) of physostigmine salicylate intravenously and subsequently inject 1-4 mg every 20 minutes. Repeat the effective dose if the intoxication symptoms recur, also in the form of a continuous infusion if deemed useful. Use in children and adolescents: In cases of intoxication: Infants: Start with a low dose of 0.5 mg of physostigmine salicylate administered intravenously, repeat this dose every 5 minutes up to the overall dose of 2 mg, as long as the toxic, anticholinergic symptoms continue to persist, and no cholinergic symptoms occur. Method of administration: Intravenously slowly or as brief infusion in 50 ml physiological saline solution over 10-15 minutes. A general criterion for adequate physostigmine dosing is the recognizable recovery of mental abilities and responsiveness (e.g. specifying name, address, date).

Contraindications: ANTICHOLIUM ® should not be used in the presence of hypersensitivity to physostigmine salicylate, bronchial asthma, ulcers associated with tissue destruction (gangrene), coronary heart disease, constipation (mechanical obstipation), mechanical ischuria (urinary retention), hereditary form of muscle atrophy (myotonic dystrophy), closed traumatic brain injuries, intestinal obstruction, spasms in the urinary tract collection system, inactivation of nerve and muscle cells after administration of drugs to relax the muscles (depolarization block after depolarizing muscle relaxants), in case of intoxication due to “irreversibly acting” cholinesterase inhibitors (drugs used to treat dementia), intoxication with phosphoric acid esters or barbiturates.

Precautions: Talk to your doctor before you are given ANTICHOLIUM ® if you suffer from diabetes mellitus, slowed heart rate (bradycardia), disturbances of the atrioventricular conduction system, Parkinson’s disease or ulcerative colitis. Hypersensitivity reactions may occur after administration of this medicine. These reactions may vary individually and may also cause life-threatening conditions. It is recommended to have emergency medication and medical aids ready. A risk/benefit analysis should be performed, and discontinuation of treatment should be considered. Acute cardiac arrest may be possible during treatment with tricyclic antidepressants; therefore, Anticholium should only be considered as an antidote for this indication while the patient has continuous ECG monitoring.

Interactions: Tell your doctor or pharmacist if you are taking/ using, have recently taken/used or intend to take/ use any other medicines. In case of simultaneous administration of other cholinesterase inhibitors (e.g. medicines for the treatment of dementia), caution should be exercised because of the potentiating effect. In intoxication with depolarizing muscle relaxants of the suxamethonium type, ANTICHOLIUM ® is contraindicated!

Adverse Reactions: Like all medicines, ANTICHOLIUM ® can cause side effects, although not everybody gets them. System organ class Frequency: Unknown Immune system disorders Hypersensitivity reactions Endocrine disorders Hypersalivation Heart diseases Changes of the heart rate (both bradycardia and tachycardia), sinoatrial block Vascular diseases Low blood pressure (hypotension) Respiratory, thoracic and mediastinal disorders Spasms of the respiratory tract (broncho spasms) Gastrointestinal disorders Nausea, vomiting Skin and subcutaneous tissue disorders Sweating

Pregnancy: There is no experience with the use of ANTICHOLIUM ® in pregnant women. Physostigmine, the active substance contained in ANTICHOLIUM ® , passes into 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. For this reason, ANTICHOLIUM ® may only be administered to pregnant women if deemed absolutely necessary by the attending doctor.