The instruction for medical use
of ESPERAL medicine
the Trade name
the International non-proprietary name Disulfiramum Dosage Form
of the Tablet, 500 mg
One tablet contains
active agent – Disulfiramum of 500 mg,
excipients: magnesium stearate, K 30 povidone, sodium-carboxymethyl cellulose, cellulose microcrystalline.
of the Tablet of cream-white color, round, with a crosswise notch on one party and an engraving of Esperal on other party.
of Means for treatment of additive disorders. Means for treatment of alcohol addiction. Disulfiramum
the ATX NO7BB01 Code
Pharmacokinetics Later properties of intake Disulfiramum quickly and almost is completely soaked up (70%-90%). It is quickly metabolized to diethyldithiocarbamide which is removed in the form of a glucuronide or is transformed to diethyl amine and carbon sulfur. A part of carbon sulfur is removed by lungs. Other metabolites are removed with urine.
of Esperal® inhibits numerous enzymes. Suppression of atsetaldegid-dehydrogenase leads to increase in concentration of an atsetaldegid – a metabolite of the alcohol responsible for development of unpleasant symptoms: intensive inflows suit, nausea, vomitings, feeling sick, tachycardia and hypotension.
– prevention of a recurrence of alcohol addiction (as an additional tool).
To Accept a route of administration and doses on 1 tablet a day orally. The pill should be taken, washing down with a half of a glass of water, in the morning, during a breakfast, after 24-hour abstention from intake of alcoholic drinks.
Duration of a course of treatment is defined by the doctor.
the Undesirable phenomena are given below with use of the following classification: Very often (≥ 1/10), it is frequent (≥ 1/100 to & lt, 1/10), infrequently (≥ 1/1000 to ≤ 1/100), is rare (≥ 1/10,000 to ≤ 1/1000), is very rare (≤ 1/10,000), it is not known (assessment on the basis of the available data is impossible).
From digestive tract
– nausea, vomiting, stomach aches, diarrhea
– metal smack in a mouth, an unpleasant smell from a mouth
– an unpleasant smell from patients with kolostomy
from a liver
– increase in level of transaminases
– hepatitis (generally cytolytic)
– hepatitis with a liver failure or lightning hepatitis which can form the basis for transplantation of a liver or lead to death
from nervous system
– a polyneuritis of the lower extremities, neuritis of an optical nerve
– neurologic and psychiatric disturbances: memory loss, confusion of consciousness
– the increased drowsiness and feeling of fatigue in an initiation of treatment
– spasms, perhaps, connected with encephalopathy, as a rule, are reversible after completion of treatment
– the skin allergy which is, mainly, connected with cross sensitivity to rubber
Connected with Esperal’s reception in a combination with alcohol
– intensive inflows to the person, an erythema, nausea, vomiting, feeling sick, tachycardia and hypotension
– Isolated cases of heavier reactions: disturbances of a warm rhythm, stenocardia attacks, cardiovascular collapse, myocardial infarction, unexpected death, respiratory depression, neurologic symptoms: confusion of consciousness, encephalopathy and attacks.
The reporting under the suspected side reactions
the Reporting under the suspected side reactions is important after entry of a medicinal product into the market. It allows to continue monitoring of medicine on a ratio advantage/risk. Health workers ask to report about any suspected side reactions by means of regional network of the centers of pharmacovigilance.
– hypersensitivity to Disulfiramum or any of drug components
– a heavy liver failure
– a renal failure
– heavy respiratory insufficiency
– neurologic and psychiatric disorders
– cardiovascular disorders
– intake of the alcoholic drinks or medicines containing alcohol within the previous 24 hours
not recommended combinations
– alcohol (in the form of drink or in the form of a medicine component): disulfiramny reactions in the form of inflows, erubescence, vomitings, tachycardias. It is necessary to avoid intake of the alcoholic drinks and medicines containing alcohol until medicine completely is not removed from the patient’s organism. It is necessary to be guided by drug half-life period time.
– isoniazid: behavior disorders and coordinations of movement.
– 5-nitromidazola (metronidazole, ornidazol, seknidazol, Tinidazolum): risk of development of sharp psychotic episodes of an attack of nonsense, the confused consciousness reversible at the end of treatment
– Phenytoinum (and at extrapolation of a fosfenitoin): substantial and fast increase of plasma concentration of Phenytoinum with symptoms of intoxication (decrease in hepatic metabolism). If this combination cannot be prevented, it is necessary to carry out clinical monitoring and monitoring of concentration of Phenytoinum in plasma to time and after the treatment termination by Disulfiramum.
The combinations demanding precaution
– antagonists of vitamin K: strengthening of anticoagulating effect of vitamin K and risk of developing bleeding
It is necessary to control MNO indicators more often. The dose of the antagonist of vitamin K has to be corrected in the course of treatment by Disulfiramum and is sustained within 8 days after the treatment termination.
The special indications
of the Precautionary measure connected directly with Esperal
Pri the message about cases of the heavy toxic hepatitis leading to transplantation of a liver or by death: if there is a suspicion of hepatitis (asthenia, anorexia, nausea, vomiting, an abdominal pain or jaundice) it is necessary to carry out immediately clinical inspection and to carry out the laboratory analyses of function of a liver
of the Precautionary measure connected with Esperal’s combination and alcohol
It is necessary to warn patients about danger of development of disulfiramny reaction
of Disulfiramopodobnaya reaction: this reaction developing at the patients receiving treatment by Esperal during intake of alcoholic drinks including in small quantities, it is necessary to warn patients about presence of alcohol in some medicines (in particular, in solutions for oral administration), in food and also in some toilet accessories, such as aftershave lotions and perfumery products.
Unpleasant symptoms (intensive rush of blood to the person, an erythema, nausea and vomiting, feeling of an indisposition, tachycardia and hypotension) develop in 10 minutes after intake of alcoholic drink and last of 30 minutes till several o’clock. Reactions to alcohol can arise within 2 weeks after the treatment termination by Disulfiramum.
There are messages about several heavy reactions: disturbances of a warm rhythm, stenocardia attacks, cardiovascular collapse, myocardial infarction, sudden death, respiratory depression and neurologic reactions (confusion of consciousness, encephalopathy and spasms).
Use of Disulfiramum is not recommended along with the following substances:
– the alcohol and medicines containing alcohol
– an isoniazid
– 5 nitroimidazoles (metronidazole, ornidazol, seknidazol, Tinidazolum)
– Phenytoinum, fosfenitoin.
This medicine it is possible to appoint special cautions only after careful medical examination (physical and laboratory inspections).
Functional hepatic tests, including determination of levels of transaminases of blood, should be carried out prior to treatment by Esperal, and then to repeat regularly at least monthly, especially in the first 3 months of treatment. Triple exceeding the upper bound of norm of level of transaminases demands the immediate termination of treatment for long term. Patients are subjected to careful observation before full normalization of indicators of function of a liver.
In the presence of nickel eczema of Esperal® it is necessary to apply with care in view of the increased risk of developing hepatitis.
It is never not necessary to apply Esperal®, without having informed the patient of it.
Use of Disulfiramum is not recommended during pregnancy irrespective of term and also drug use is not recommended to women of childbearing age, not using various methods of contraception
Pregnancy and the period of a lactation
Esperal’s Use it is not recommended during pregnancy, irrespective of term and also at the women of childbearing age who are not applying contraceptives. Reaction to Disulfiramum at consumption of alcohol can lead to serious impact on a fruit.
Breastfeeding is not recommended during treatment by Esperal.
Possible drowsiness does to feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms driving and working mechanisms dangerous.
Symptoms: the overdose by only one Disulfiramum can provoke development of neurologic symptoms: extrapyramidal symptoms, consciousness disturbance, including to whom and consciousness turbidity, encephalopathy.
The overdose of Disulfiramum in combination with alcohol can provoke a coma, nonsense, cardiovascular collapse, sometimes with neurologic complications.
The form of release and packing
On 20 tablets place in a polypropylene container the containing dehumidifier, with the polyethylene stopper supplied with a spring.
On 1 container together with the instruction for medical use in the state and Russian languages place in a cardboard box.
To Store storage conditions at a temperature not above 25 °C.
To store out of children’s reach!
A period of storage
not to apply after an expiration date
According to the prescription
the Producer/packer Sofarimex Industriya Kimika and Ld’s Pharmaceutics, Portugal
the location Address: Av. Das Industrias, Alto de Colaride, Agualva, 2735 – 213 CACEM, Portugal
the Owner of the registration certificate
Sanofi-Aventis France, France
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of Sanofi-aventis Kazakhstan LLP Republic of Kazakhstan, 050013, Almaty, Furmanov St. 187b phone: 8-727-244-50-96факс: 8-727-258-25-96e-mail:
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