Instructions for Strezam capsules 50 mg No. 60
Composition
active ingredient: etifoxine hydrochloride;
1 capsule contains etifoxine hydrochloride 50 mg;
excipients: lactose monohydrate; talc; microcrystalline cellulose; colloidal anhydrous silica; magnesium stearate;
capsule shell: titanium dioxide (E 171); indigotine (E 132); gelatin.
Dosage form
Capsules.
Main physicochemical properties: size No. 2 capsules with a blue cap and an opaque white body, containing white powder.
Pharmacotherapeutic group
Agents acting on the nervous system. Psycholeptics. Anxiolytics. Other anxiolytics. Etifoxine. ATX code N05B X03.
Pharmacological properties
Pharmacodynamics.
In therapeutic doses, etifoxine hydrochloride exhibits anxiolytic properties and has a neurovegetative regulatory effect.
In vitro and in vivo animal studies have shown that the anxiolytic effect of etifoxine is due to a dual mechanism of action (direct and indirect) on the GABAA receptor to enhance GABAergic transmission:
- direct effect on the GABA receptor through positive allosteric modulation by binding predominantly to β2 or β3 subunits; studies indicate that the binding site of etifoxine on the GABA receptor is different from the binding site of benzodiazepines;
- indirect effect by increasing the production of neurosteroids in the brain (by activating mitochondrial protein translocation), including allopregnanolone, which are positive allosteric modulators of the GABA receptor.
Clinical studies have not established any withdrawal effects and dependence potential (physical or psychological).
Animal studies have not shown the possibility of developing pharmacological dependence on etifoxine.
Pharmacokinetics.
Etifoxine hydrochloride is well absorbed from the gastrointestinal tract. It is rapidly metabolized, does not bind to blood cells, and its plasma levels decline slowly in three phases. The drug and its main metabolite are excreted mainly in the urine. Etifoxine hydrochloride crosses the placental barrier.
Indication
Psychosomatic manifestations of anxiety.
Contraindication
Hypersensitivity to the components of the drug, shock, myasthenia gravis, severe liver and/or kidney dysfunction.
The drug is contraindicated in patients who have had severe hepatitis or cytolytic syndrome during previous treatment with etifoxine; in patients who have had severe skin reactions, including DRESS syndrome, Stevens-Johnson syndrome (SJS), and generalized exfoliative dermatitis, during previous treatment with etifoxine.
Pregnancy or breastfeeding.
Interaction with other medicinal products and other types of interactions
When Strezam® is used simultaneously with drugs that depress the central nervous system (morphine derivatives (analgesics, cough suppressants and opioid substitution therapy for drug addiction), benzodiazepines, hypnotics, neuroleptics, histamine H1 receptor blockers, antidepressants, antihypertensive drugs of the central mechanism of action, baclofen, thalidomide), mutual potentiation of effects is possible.
Alcohol enhances the sedative effect of Strezam®.
The simultaneous use of Strezam® with alcohol or with drugs that depress the central nervous system (morphine derivatives (analgesics, cough suppressants and opioid substitution therapy for drug addiction), benzodiazepines, hypnotics, neuroleptics, histamine H1 receptor blockers, antidepressants, centrally acting antihypertensive drugs, baclofen, thalidomide) may cause impaired reaction speed, which in turn may pose a danger when driving or operating other mechanisms. It is not recommended to consume alcohol, drugs containing alcohol, and drugs that depress the central nervous system during treatment with the drug.
Application features
It is not recommended to drink alcohol and use other centrally acting drugs (haloperidol, diazepam, imipramine, etc.) during treatment with Strezam®.
In case of skin or allergic reactions or severe liver disorders, treatment with etifoxine should be discontinued immediately.
The drug contains lactose, therefore it is not recommended to prescribe the drug to patients with congenital galactosemia, glucose/galactose malabsorption syndrome, or lactase deficiency.
Very rare cases of severe skin reactions, including drug-induced eosinophilia with systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and generalised exfoliative dermatitis, have been reported in association with etifoxine. The onset of a toxic skin reaction with Strezam® usually ranged from a few days to 1 month depending on the type of reaction. According to post-marketing surveillance after discontinuation of etifoxine, the outcome of skin reactions was mostly favourable. There have been no reports of fatal outcomes of severe adverse skin reactions with etifoxine. The patient should be informed of the risk of skin toxicity and closely monitored for skin signs and symptoms. If a skin toxicity occurs with etifoxine, the medicinal product should be discontinued immediately and should not be re-administered under any circumstances.
Severe hepatic reactions
Very rare severe cases of cytolytic syndrome associated with etifoxine have been reported in post-marketing experience. In post-marketing experience, hepatic reactions following etifoxine administration have mostly occurred between 2 weeks and 1 month of treatment. The drug should be used with caution in patients with risk factors for hepatic dysfunction, including the elderly, patients with a history of viral hepatitis, or any other conditions identified by the physician on an individual basis. Liver dysfunction may be asymptomatic and may only be detected by specific laboratory tests. In patients with risk factors for hepatic dysfunction, liver function tests should be performed before starting etifoxine and approximately one month after starting treatment. If a hepatic toxicity reaction occurs while taking etifoxine, the drug should be discontinued immediately and should not be re-administered under any circumstances.
Lymphocytic colitis
Several cases of lymphocytic colitis associated with etifoxine have been reported during post-marketing surveillance. If watery diarrhea occurs in patients receiving etifoxine, appropriate investigation and immediate discontinuation of the drug should be considered.
Metrorrhagia
During post-marketing surveillance, cases of metrorrhagia have been reported in women taking oral contraceptives during treatment with etifoxine.
Use during pregnancy or breastfeeding
The drug is contraindicated for women during pregnancy.
If necessary, breastfeeding should be discontinued.
The ability to influence the reaction speed when driving or working with other mechanisms
Given the significant individual adverse reactions (dizziness, drowsiness), the possibility of a temporary deterioration in the ability to drive vehicles and operate potentially dangerous mechanisms during treatment with the drug cannot be ruled out.
Method of administration and doses
The dose and duration of treatment are determined by the doctor individually, depending on the severity of the disease.
Adults are prescribed 3-4 capsules in 2-3 doses. Capsules are taken before meals, washed down with a small amount of water.
The course of treatment lasts from several days to several weeks.
Children
The drug is not prescribed to children due to the lack of sufficient clinical studies.
Overdose
Manifested by arterial hypotension. There is a risk of drowsiness. Gastric lavage is recommended. If necessary, symptomatic treatment. There is no specific antidote.
Side effects
Dizziness is sometimes observed, which may occur at the beginning of treatment and disappear on its own during long-term treatment.
Classification of adverse reactions by organ system and frequency: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), frequency unknown (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
From the nervous system: rarely - mild drowsiness at the beginning of treatment, which disappears spontaneously as treatment continues.
Skin and subcutaneous tissue disorders: rarely – skin rashes: maculopapular rash, polymorphic erythema, pruritus, facial edema; very rarely – allergic reactions: urticaria, angioedema; severe skin reactions: DRESS syndrome, Stevens-Johnson syndrome, generalized exfoliative dermatitis; frequency unknown – anaphylactic shock, leukocytoclastic vasculitis.
On the part of the immune system: very rarely - urticaria, angioedema, angioedema; unknown frequency - anaphylactic shock, drug reaction with eosinophilia and symptoms of damage to various organ systems (MRESSO syndrome), Stevens-Johnson syndrome, leukocytoclastic vasculitis.
Hepatobiliary system: very rarely - liver damage: hepatitis, cytolytic hepatitis.
Gastrointestinal: very rarely - lymphocytic colitis.
Reporting possible adverse reactions
Reporting of suspected adverse reactions identified after the marketing authorisation of a medicinal product is important. This allows for continuous monitoring of the risk/benefit ratio of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ºС, out of the reach of children.
Packaging
12 capsules in a blister, 5 blisters in a pack.
20 capsules in a blister, 3 blisters in a pack.
Vacation category
According to the recipe.
Producer
BIOCODEX.
Location of the manufacturer and its business address.
1 Avenue Blaise Pascal, 60000 Beauvais, France.
