Essentsiale® H (30 capsules)s forte
- $18.10
Sku:
3fa8dd48c722
The instruction for medical use
of medicine
Essentiale forte of N
the Trade name
Essentiale forte of N
the International unlicensed name
Is not present
the Dosage form
of the Capsule of 300 mg
Structure
One capsule contains
active agent: the essential phospholipids from soybeans containing 76% (3-sn-fosfatidil) - sincaline, 300.0 mg,
excipients: solid fat, the oil soy purified all-rac - tocopherol, the castor oil hydrogenated, fat firm, alcohol of 96%, ethylvanillin, 4-metoksiatsetofenon,
structure of the capsule: gelatin, water purified the titan dioxide (E 171), gland (III) oxide yellow (E 172), gland (II, III) oxide black (E 172), gland (III) oxide red (E 172), sodium lauryl sulfate.
The description
the Opaque gelatin capsules of color of oblong shape khaki containing the pastelike weight, similar to honey.
Pharmacotherapeutic group
Drugs for treatment of diseases of a liver and biliary tract. Drugs for treatment of diseases of a liver.
The ATX A05BA code
the Pharmacological
Pharmacokinetics of 90% of Essential Phospholipids (EFL) properties at an oral way of receipt is soaked up in a small intestine. The most part of EFL is split by a phospholipase And to 1-acyl-lizofosfatidilkholina which 50% reatsilirutsya at once to polyunsaturated phosphatidylsincaline during process of absorption in mucous a small intestine. Polyunsaturated phosphatidylsincaline gets to blood through a lymph, from where, mainly, as a part of LPVP gets into a liver.
As a result of pharmacokinetic researches it is established that the maximum concentration 3H (a marked choline component) is reached in 6-24 hours and makes 19.9% of a dose. The half-life period of a choline component is 66 hours.
The maximum concentration 14C (marked linolic acid) is reached in 4-12 hours, and makes 27.9% of a dose. The half-life period of this component is 32 hours.
In excrements 2% of a component, marked 3H, and 4.5% of a component, marked 14C, in urine - 6% of a component, marked 3H, and insignificant quantity of a component, marked 14C are found.
Both isotopes were soaked up in intestines up to 90%.
The pharmacodynamics
Essentiale forte of N is drug of plant origin, the essential phospholipids which are its part have hepatoprotective properties and are basic elements of a cover and mitochondrions of hepatocytes. Essential phospholipids protect liver cells in acute hepatic diseases (for example, induced by ethanol, salicyl alcohol, tetrachloride carbon, paracetamol and galaktozaminy). Essentiale forte the N suppresses development of a steatosis and fibrosis at the chronic toxic damages of a liver connected with use of ethanol, acetothioamide, organic solvents. Moreover, essential phospholipids accelerate restoration and stabilization of cell membranes of a liver, suppress peroxide oxidation of lipids in the course of which liver cells, and collagen synthesis are damaged.
Indications
- a liver steatosis (fat dystrophy of a liver)
- toxic injuries of a liver
- acute hepatitises
- chronic hepatitis
- an alcoholic liver disease
- medicinal damages of a liver
- unbalanced food,
Routes of administration and doses which are followed by lack of appetite and heavy feeling in right hypochondrium
Essentiale forte the N is intended for use for adults and children 12 years are more senior (with body weight more than 43 kg).
The single dose makes 2 capsules (600 mg of essential phospholipids).
The daily dose makes on 2 capsules 3 times a day (1800 mg of essential phospholipids).
Forte the N needs to accept Essentiale, without chewing, together with food, washing down with enough water (for example, a glass of water).
Duration of administration of drug is not less than 3 months. If necessary the term of treatment lasts.
Side effects
Sometimes
- stomach aches, the easy ease of a chair
Is rare
- diarrhea
Very seldom
- allergic reactions in the form of rash and urticaria
the Frequency is unknown
-
naggers Priyem Essentiale forte the N has to be stopped in case of above-mentioned side effects, especially, in case of hypersensitivity. The patient has to see a doctor who will estimate gravity of a symptom and will take adequate measures for its elimination.
Contraindications
- patients with the known hypersensitivity to soy - to the containing drugs and/or other components of drug
Medicinal interactions
Are possible medicinal interactions of essential phospholipids with anticoagulants. For this reason, it is necessary to adjust an anticoagulant dose.
In case of a concomitant use, the patient has to consult with the doctor.
Special instructions
Because of the content of soy oil, medicine can cause allergic reaction, cm. Side effects.
Pry does not exempt medicine from need of the termination of the use of the substances doing harm to a liver (for example, alcohol).
In chronic hepatitis the intake of phospholipids from soybeans as a part of complex therapy is allowed if during treatment the health of the patient improves.
In case of disturbing symptoms or deterioration in health it is necessary to consult with the doctor.
Use in pediatrics
As the special researches Essentiale forte N were not conducted, this drug it is impossible to use at children 12 years are younger.
Pregnancy and the period of a lactation
Drugs from soybeans are widely used in food, and no risk from their inclusion in the pregnancy period was noted. Specific results of researches are absent. For this reason, Essentiale forte N is not recommended to be accepted during pregnancy and feeding by a breast.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Pry Essentsiale forte the N does not affect ability to drive and work with the equipment.
Overdose
of Cases of overdose Essentiale forte in N is not registered.
Symptoms: it is possible to assume strengthening of side effects
Treatment: drug withdrawal, consultation of the attending physician, symptomatic therapy.
A form of release and packing
On 10 capsules in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 3 or 10 blister strip packagings together with the instruction for medical use in the state and Russian languages put in a pack from cardboard.
To Store storage conditions in the dry place at a temperature not over 21C
to Store out of children's reach!
A period of storage
3 years
not to apply after an expiration date
Prescription status
Without prescription
the Producer A. Nattermann and Siye. GmbH, Germany
the location Address: Nattermannallee 1, D-50829, Kὅln, Germany
the Owner of the registration certificate
A. Nattermann and Siye. GmbH, Germany
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 Respublika Kazakhstan LLP, 050013, Almaty, Furmanov St. of 187 B
phone number: +7 (727) 244-50-96
fax: +7 (727) 258-25-96
e-mail: quality.info@sanofi.com
the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine
of Sanofi-aventis Kazakhstan Respublika Kazakhstan LLP, 050013, Almaty, Furmanov St. of 187 B
phone number: +7 (727) 244-50-96
fax: +7 (727) 258-25-96
e-mail: Kazakhstan.Pharmacovigilance@sanofi.com
of medicine
Essentiale forte of N
the Trade name
Essentiale forte of N
the International unlicensed name
Is not present
the Dosage form
of the Capsule of 300 mg
Structure
One capsule contains
active agent: the essential phospholipids from soybeans containing 76% (3-sn-fosfatidil) - sincaline, 300.0 mg,
excipients: solid fat, the oil soy purified all-rac - tocopherol, the castor oil hydrogenated, fat firm, alcohol of 96%, ethylvanillin, 4-metoksiatsetofenon,
structure of the capsule: gelatin, water purified the titan dioxide (E 171), gland (III) oxide yellow (E 172), gland (II, III) oxide black (E 172), gland (III) oxide red (E 172), sodium lauryl sulfate.
The description
the Opaque gelatin capsules of color of oblong shape khaki containing the pastelike weight, similar to honey.
Pharmacotherapeutic group
Drugs for treatment of diseases of a liver and biliary tract. Drugs for treatment of diseases of a liver.
The ATX A05BA code
the Pharmacological
Pharmacokinetics of 90% of Essential Phospholipids (EFL) properties at an oral way of receipt is soaked up in a small intestine. The most part of EFL is split by a phospholipase And to 1-acyl-lizofosfatidilkholina which 50% reatsilirutsya at once to polyunsaturated phosphatidylsincaline during process of absorption in mucous a small intestine. Polyunsaturated phosphatidylsincaline gets to blood through a lymph, from where, mainly, as a part of LPVP gets into a liver.
As a result of pharmacokinetic researches it is established that the maximum concentration 3H (a marked choline component) is reached in 6-24 hours and makes 19.9% of a dose. The half-life period of a choline component is 66 hours.
The maximum concentration 14C (marked linolic acid) is reached in 4-12 hours, and makes 27.9% of a dose. The half-life period of this component is 32 hours.
In excrements 2% of a component, marked 3H, and 4.5% of a component, marked 14C, in urine - 6% of a component, marked 3H, and insignificant quantity of a component, marked 14C are found.
Both isotopes were soaked up in intestines up to 90%.
The pharmacodynamics
Essentiale forte of N is drug of plant origin, the essential phospholipids which are its part have hepatoprotective properties and are basic elements of a cover and mitochondrions of hepatocytes. Essential phospholipids protect liver cells in acute hepatic diseases (for example, induced by ethanol, salicyl alcohol, tetrachloride carbon, paracetamol and galaktozaminy). Essentiale forte the N suppresses development of a steatosis and fibrosis at the chronic toxic damages of a liver connected with use of ethanol, acetothioamide, organic solvents. Moreover, essential phospholipids accelerate restoration and stabilization of cell membranes of a liver, suppress peroxide oxidation of lipids in the course of which liver cells, and collagen synthesis are damaged.
Indications
- a liver steatosis (fat dystrophy of a liver)
- toxic injuries of a liver
- acute hepatitises
- chronic hepatitis
- an alcoholic liver disease
- medicinal damages of a liver
- unbalanced food,
Routes of administration and doses which are followed by lack of appetite and heavy feeling in right hypochondrium
Essentiale forte the N is intended for use for adults and children 12 years are more senior (with body weight more than 43 kg).
The single dose makes 2 capsules (600 mg of essential phospholipids).
The daily dose makes on 2 capsules 3 times a day (1800 mg of essential phospholipids).
Forte the N needs to accept Essentiale, without chewing, together with food, washing down with enough water (for example, a glass of water).
Duration of administration of drug is not less than 3 months. If necessary the term of treatment lasts.
Side effects
Sometimes
- stomach aches, the easy ease of a chair
Is rare
- diarrhea
Very seldom
- allergic reactions in the form of rash and urticaria
the Frequency is unknown
-
naggers Priyem Essentiale forte the N has to be stopped in case of above-mentioned side effects, especially, in case of hypersensitivity. The patient has to see a doctor who will estimate gravity of a symptom and will take adequate measures for its elimination.
Contraindications
- patients with the known hypersensitivity to soy - to the containing drugs and/or other components of drug
Medicinal interactions
Are possible medicinal interactions of essential phospholipids with anticoagulants. For this reason, it is necessary to adjust an anticoagulant dose.
In case of a concomitant use, the patient has to consult with the doctor.
Special instructions
Because of the content of soy oil, medicine can cause allergic reaction, cm. Side effects.
Pry does not exempt medicine from need of the termination of the use of the substances doing harm to a liver (for example, alcohol).
In chronic hepatitis the intake of phospholipids from soybeans as a part of complex therapy is allowed if during treatment the health of the patient improves.
In case of disturbing symptoms or deterioration in health it is necessary to consult with the doctor.
Use in pediatrics
As the special researches Essentiale forte N were not conducted, this drug it is impossible to use at children 12 years are younger.
Pregnancy and the period of a lactation
Drugs from soybeans are widely used in food, and no risk from their inclusion in the pregnancy period was noted. Specific results of researches are absent. For this reason, Essentiale forte N is not recommended to be accepted during pregnancy and feeding by a breast.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Pry Essentsiale forte the N does not affect ability to drive and work with the equipment.
Overdose
of Cases of overdose Essentiale forte in N is not registered.
Symptoms: it is possible to assume strengthening of side effects
Treatment: drug withdrawal, consultation of the attending physician, symptomatic therapy.
A form of release and packing
On 10 capsules in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 3 or 10 blister strip packagings together with the instruction for medical use in the state and Russian languages put in a pack from cardboard.
To Store storage conditions in the dry place at a temperature not over 21C
to Store out of children's reach!
A period of storage
3 years
not to apply after an expiration date
Prescription status
Without prescription
the Producer A. Nattermann and Siye. GmbH, Germany
the location Address: Nattermannallee 1, D-50829, Kὅln, Germany
the Owner of the registration certificate
A. Nattermann and Siye. GmbH, Germany
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 Respublika Kazakhstan LLP, 050013, Almaty, Furmanov St. of 187 B
phone number: +7 (727) 244-50-96
fax: +7 (727) 258-25-96
e-mail: quality.info@sanofi.com
the Name, the address and a contact information (phone, the fax, e-mail) of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine
of Sanofi-aventis Kazakhstan Respublika Kazakhstan LLP, 050013, Almaty, Furmanov St. of 187 B
phone number: +7 (727) 244-50-96
fax: +7 (727) 258-25-96
e-mail: Kazakhstan.Pharmacovigilance@sanofi.com
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