Physostigmine Salicylate

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

Composition: Anticholium is available in 5 mL ampules, each mL containing 0.4 mg physostigmine salicylate in a vehicle composed of sodium edetate (Ph. Eur.) and water for injection.

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.

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

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!

Usage in pregnancy: Pregnancy and breast-feeding 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. Breast-feeding: There is no experience with the use of ANTICHOLIUM ® during breastfeeding. It is not known whether physostigmine, the active substance contained in ANTICHOLIUM ® , is excreted in human breast milk. For this reason, ANTICHOLIUM ® may only be used during breastfeeding if deemed absolutely necessary by the attending doctor.