Active ingredient: Etifoxine hydrochloride 50 mg
Excipients/Inactive Ingredients: Lactose, talc, microcrystalline cellulose, colloidal silica, magnesium stearate.
Antiaxiety agent (N: Central nervous system).
Pharmacology: Pharmacodynamics: Etifoxine hydrochloride belongs to the benzoxazines chemical group. As antianxiety agent, it has an autonomic regulatory action. Animal and human studies have failed to establish any rebound effect, nor dependency potential (physical or psychological).
Pharmacokinetics: Etifoxine hydrochloride is well absorbed by oral route, it does not bind to blood cells. After etifoxine administration, the plasma concentration of the compound increases up to a maximal value, and then decreases in three phases, with elimination constants qualified of short (# 1min), intermediate (4-5 hours) and long (40-60 hours) and it is mainly eliminated in urine. Etifoxine hydrochloride crosses the placenta barrier.
Toxicology: Preclinical safety data: Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, toxicity to reproduction.
Psychosomatic manifestations of anxiety such as autonomic nervous system imbalance, notably of a cardiovascular nature.
Posology: Usually 3 to 4 capsules a day, taken as 2 or 3 divided doses.
Treatment duration: A few days to a few weeks.
In order that the treatment is well adapted to the anxietic state of the patient, the treatment must be prescribed for a maximum duration of 12 weeks. At the end of this period the patient must consult his/her doctor in order to check if the treatment has to be reconducted or can be stopped or if the dosage must be modified according to the patient's response.
Method of administration: Swallow the capsules with a little amount of water.
If a massive amount is taken, gastric washout should be the first step, followed by symptomatic treatment if necessary. There is no specific antidote.
States of shock, severely impaired liver and/or renal function, myasthenia.
Because of the presence of lactose, this medicine is contraindicated in patients with congenital galactosemia, glucose and galactose malabsorption syndrome or lactase deficit.
Because of risks of reciprocal potentialisation: combination with central depressants must be prescribed cautiously, simultaneous intake of alcoholic drinks is inadvisable.
Effects on ability to drive and use machines: Attention is drawn, of vehicle drivers and machinery operators in particular, to the risks of drowsiness associated with this medicine.
In the absence of sufficient clinical data, this medicine is inadvisable during pregnancy and while breast feeding.
Slight drowsiness, occurring within the first days of treatment and disappearing spontaneously with its continuation.
Rare skin rashes, very rare allergic reactions in the form of urticaria and angioedema.
Inadvisable Combinations: Alcohol: Alcohol increases the sedative effect of these substances. Impaired alertness may make vehicle driving and machinery operation dangerous. Avoid alcoholic drinks and medicines containing alcohol.
Combinations Needing To Be Taken Into Account: Other central nervous system (CNS) depressants: Morphine derivatives (analgesics, antitussives and narcotic substitutes); benzodiazepines; hypnotics; neuroleptics; sedative H1 antihistamines; sedative antidepressants; central antihypertensives; baclofene, thalidomide. Increased central depression. Impaired alertness may make vehicle driving or machinery operation dangerous.
Instructions for use and handling (and disposal): See Dosage & Administration.
Incompatibilities: Not applicable.
Special precautions for storage: STRESAM should be stored under normal conditions of temperature and humidity.
Shelf-Life: 3 years.
N05BX03 - etifoxine ; Belongs to the class of other anxiolytics. Used in the management of anxiety, agitation or tension.
Cap 50 mg (blue and white) x 60's.