The instruction for medical use
of Lineks® medicine
the Trade name
of Lineks®
the International unlicensed name
Is not present
the Dosage form
of the Structure One Capsule Capsule contains
active agent – powder of lebenina1 280 mg,
excipients: magnesium stearate,
capsule: the titan dioxide (E 171), gelatin, water purified a gipromelloza,
powder lebenina1: the lactobacilli resistant to antibiotikam2 5.04 mg, lactose of 98.28 mg, a dextrin of 13.16 mg, potato starch up to 280 mg,
lactobacilli, steady to antibiotikam2 (1 g of powder of a lebenin contains): not less than 1.2 × 108, WHICH the lactobacilli resistant to antibiotics (not less than 4.5 × 107 WHICH Lactobacillus acidophilus (L. gasseri), not less than 3.0 × 107 WHICH Bifidobacterium infantis and not less than 4.5 × 107 WHICH (Enterococcus faecium)
Description
Gelatin capsules of white color, contents of capsules – powder of white color
Pharmacotherapeutic group
Antidiarrheal drugs. Anti-diarrheal microorganisms / the Combination of the microorganisms which are producing lactic acid with other
drugs ATX A07FA51 Code Pharmacological Pharmacokinetics Components Properties, being a part of drug do not come to a system blood stream, and have local effect in digestive tract therefore carrying out kinetic researches is not possible.
A pharmacodynamics
of the Lineks® Capsule contain three various species of the viable lyophilized lactobacilli which are a part of normal intestinal microflora and participate in creation and maintenance of balance and function of intestinal microflora.
Lineks® of a bifidobacterium, a lactobacillus which are a part and not toxicogenic lactic enterokokk are a usual part of intestinal microflora. These bacteria work in the preventive and therapeutic way by means of numerous mechanisms:
- fermentation of lactose displaces pH to the acid area. Acidic environment prevents growth of harmful and conditionally harmful bacteria, and does possible optimal effect of digestive enzymes
- participate in synthesis of B1, B2, B6, B12 vitamins and vitamin K
- participate in metabolism of bile acids and bilious pigments
- prevent attachment of harmful microorganisms to an intestines wall
- synthesize antibiotic substances (bacteriocines)
- stimulate the humoral and intestinal immune system.
Indications
- for prevention and as supportive application at a disbioz (dysbacteriosis), diarrhea, an abdominal distension and other gastrointestinal disturbances which are caused: viral and bacterial infections of digestive tract at newborns, children and adults (for example, a rotavirus infection, diarrhea of travellers), antibiotics of a broad spectrum of activity and chemotherapeutic drugs, radiation therapy of an abdominal cavity and pelvic bodies.
The route of administration and doses
to Babies and children up to 2 years
Is recommended to accept on 1 capsule 3 times a day, after meal. If the child cannot swallow the capsule, it is possible to open and mix it contents with a small amount of liquid - tea, juice, the sugared water. It does not affect viability of the bacteria which are a part of drug.
At children of early age the level of acidity of gastric juice is lower, than at adults therefore bacteria of Lineks® are resistant to effect of gastric juice at children and reach intestines in an invariable look.
To children from 2 to 6 years
about 1 - 2 capsules 3 times a day, after meal Are recommended to accept. The capsule it is necessary to open and mix contents with a small amount of liquid - tea, juice, the sugared water.
About 1 - 2 capsules 3 times a day after a meal Are recommended to children from 6 to 12 years, washing down with a small amount of liquid.
To adults and children 12 years are more senior
3 times a day, after a meal Are recommended on 2 capsules, washing down with a small amount of liquid.
The maximum single dose - 2 capsules.
The maximum daily dose - 6 capsules.
Duration of treatment depends on the reason of development of dysbacteriosis and specific features of an organism.
If the condition of the patient after two days of treatment of Lineks® does not improve, it is necessary to see a doctor.
Side effects
Very seldom:
- allergic reactions
of the Contraindication
- hypersensitivity (intolerance) to any of components of drug or dairy products
- hereditary intolerance of fructose, deficiency of Lapp-lactoses enzyme, glucose galactose malabsorption
Medicinal interactions
interaction of Lineks® with other drugs is noted.
The structure of Lineks® allows to accept it with antibiotics and chemotherapeutic means, but at different times. For increase in efficiency it is recommended to accept Lineks® not earlier than in three hours after use of antibiotics or chemotherapeutic drugs.
Special instructions
should not be washed down drug with hot drinks and to accept along with alcohol. One capsule contains 98.28 mg of lactose, in this regard the care when prescribing drug is required by sick diabetes.
Before reception of Lineks® it is necessary to consult with the attending physician in the following cases:
- fervescence is above 38 °C
- presence of blood or slime in a chair
- in the diarrhea proceeding more than 2 days
- in the acute diarrhea which is followed by dehydration and sharp loss of weight
- in the diarrhea which is followed by severe pains
- in the presence of other chronic diseases (diabetes), immunological insufficiency (AIDS, HIV)
- the children's age is younger than 6 years
At independent treatment of Lineks®, it is necessary to make up for loss of liquid and electrolytes, by reception of additional amount of liquid.
Pregnancy and a lactation
Treatment of diarrhea at pregnant women and the feeding women has to be carried out under control of the attending physician.
As there are no sufficient data on safety of use of Lineks® during pregnancy and feeding by a breast, use of drug is not recommended.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Drug does not affect ability to concentration of attention.
The overdose
is not revealed
the Form of release and packing
On 8 capsules in blister strip packagings from aluminum foil.
On 2 or 4 or 6 blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the dry place at a temperature not above 25 °C.
To store out of children's reach!
2 years
not to apply a period of storage after expiry date.
Prescription status
Without prescription
the Producer/packer
Lek of of, Kolodvorsk of tsest 27, Menges, Slovenia
the Owner of the registration certificate
Lek Pharmasyyutikals of of, Verovshkova 57, Ljubljana, Slovenia
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
Representative office of JSC Sandoz Pharmasyyutikals d. d. in Republic of Kazakhstan, Almaty, Luganskogo St. 96
ph. +7 (727) 2581048 Fax: +7 (727) 2581047
e-mail: kzsdz.drugsafety@sandoz.com
of Lineks® medicine
the Trade name
of Lineks®
the International unlicensed name
Is not present
the Dosage form
of the Structure One Capsule Capsule contains
active agent – powder of lebenina1 280 mg,
excipients: magnesium stearate,
capsule: the titan dioxide (E 171), gelatin, water purified a gipromelloza,
powder lebenina1: the lactobacilli resistant to antibiotikam2 5.04 mg, lactose of 98.28 mg, a dextrin of 13.16 mg, potato starch up to 280 mg,
lactobacilli, steady to antibiotikam2 (1 g of powder of a lebenin contains): not less than 1.2 × 108, WHICH the lactobacilli resistant to antibiotics (not less than 4.5 × 107 WHICH Lactobacillus acidophilus (L. gasseri), not less than 3.0 × 107 WHICH Bifidobacterium infantis and not less than 4.5 × 107 WHICH (Enterococcus faecium)
Description
Gelatin capsules of white color, contents of capsules – powder of white color
Pharmacotherapeutic group
Antidiarrheal drugs. Anti-diarrheal microorganisms / the Combination of the microorganisms which are producing lactic acid with other
drugs ATX A07FA51 Code Pharmacological Pharmacokinetics Components Properties, being a part of drug do not come to a system blood stream, and have local effect in digestive tract therefore carrying out kinetic researches is not possible.
A pharmacodynamics
of the Lineks® Capsule contain three various species of the viable lyophilized lactobacilli which are a part of normal intestinal microflora and participate in creation and maintenance of balance and function of intestinal microflora.
Lineks® of a bifidobacterium, a lactobacillus which are a part and not toxicogenic lactic enterokokk are a usual part of intestinal microflora. These bacteria work in the preventive and therapeutic way by means of numerous mechanisms:
- fermentation of lactose displaces pH to the acid area. Acidic environment prevents growth of harmful and conditionally harmful bacteria, and does possible optimal effect of digestive enzymes
- participate in synthesis of B1, B2, B6, B12 vitamins and vitamin K
- participate in metabolism of bile acids and bilious pigments
- prevent attachment of harmful microorganisms to an intestines wall
- synthesize antibiotic substances (bacteriocines)
- stimulate the humoral and intestinal immune system.
Indications
- for prevention and as supportive application at a disbioz (dysbacteriosis), diarrhea, an abdominal distension and other gastrointestinal disturbances which are caused: viral and bacterial infections of digestive tract at newborns, children and adults (for example, a rotavirus infection, diarrhea of travellers), antibiotics of a broad spectrum of activity and chemotherapeutic drugs, radiation therapy of an abdominal cavity and pelvic bodies.
The route of administration and doses
to Babies and children up to 2 years
Is recommended to accept on 1 capsule 3 times a day, after meal. If the child cannot swallow the capsule, it is possible to open and mix it contents with a small amount of liquid - tea, juice, the sugared water. It does not affect viability of the bacteria which are a part of drug.
At children of early age the level of acidity of gastric juice is lower, than at adults therefore bacteria of Lineks® are resistant to effect of gastric juice at children and reach intestines in an invariable look.
To children from 2 to 6 years
about 1 - 2 capsules 3 times a day, after meal Are recommended to accept. The capsule it is necessary to open and mix contents with a small amount of liquid - tea, juice, the sugared water.
About 1 - 2 capsules 3 times a day after a meal Are recommended to children from 6 to 12 years, washing down with a small amount of liquid.
To adults and children 12 years are more senior
3 times a day, after a meal Are recommended on 2 capsules, washing down with a small amount of liquid.
The maximum single dose - 2 capsules.
The maximum daily dose - 6 capsules.
Duration of treatment depends on the reason of development of dysbacteriosis and specific features of an organism.
If the condition of the patient after two days of treatment of Lineks® does not improve, it is necessary to see a doctor.
Side effects
Very seldom:
- allergic reactions
of the Contraindication
- hypersensitivity (intolerance) to any of components of drug or dairy products
- hereditary intolerance of fructose, deficiency of Lapp-lactoses enzyme, glucose galactose malabsorption
Medicinal interactions
interaction of Lineks® with other drugs is noted.
The structure of Lineks® allows to accept it with antibiotics and chemotherapeutic means, but at different times. For increase in efficiency it is recommended to accept Lineks® not earlier than in three hours after use of antibiotics or chemotherapeutic drugs.
Special instructions
should not be washed down drug with hot drinks and to accept along with alcohol. One capsule contains 98.28 mg of lactose, in this regard the care when prescribing drug is required by sick diabetes.
Before reception of Lineks® it is necessary to consult with the attending physician in the following cases:
- fervescence is above 38 °C
- presence of blood or slime in a chair
- in the diarrhea proceeding more than 2 days
- in the acute diarrhea which is followed by dehydration and sharp loss of weight
- in the diarrhea which is followed by severe pains
- in the presence of other chronic diseases (diabetes), immunological insufficiency (AIDS, HIV)
- the children's age is younger than 6 years
At independent treatment of Lineks®, it is necessary to make up for loss of liquid and electrolytes, by reception of additional amount of liquid.
Pregnancy and a lactation
Treatment of diarrhea at pregnant women and the feeding women has to be carried out under control of the attending physician.
As there are no sufficient data on safety of use of Lineks® during pregnancy and feeding by a breast, use of drug is not recommended.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Drug does not affect ability to concentration of attention.
The overdose
is not revealed
the Form of release and packing
On 8 capsules in blister strip packagings from aluminum foil.
On 2 or 4 or 6 blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the dry place at a temperature not above 25 °C.
To store out of children's reach!
2 years
not to apply a period of storage after expiry date.
Prescription status
Without prescription
the Producer/packer
Lek of of, Kolodvorsk of tsest 27, Menges, Slovenia
the Owner of the registration certificate
Lek Pharmasyyutikals of of, Verovshkova 57, Ljubljana, Slovenia
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
Representative office of JSC Sandoz Pharmasyyutikals d. d. in Republic of Kazakhstan, Almaty, Luganskogo St. 96
ph. +7 (727) 2581048 Fax: +7 (727) 2581047
e-mail: kzsdz.drugsafety@sandoz.com
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