Active substanceSmectite is dioctahedralSmectite is dioctahedral
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  • Dosage form: & nbsppowder for the preparation of a suspension for oral administration [orange, vanilla]
    Composition:

    For one sachet:

    Active substance: smectite dioctahedral 3 g.

    Excipients:

    powder for suspension for oral administration [orange]: dextrose monohydrate 0,679 g, sodium saccharinate dihydrate 0.021 g, orange flavoring 0.01 g, vanilla flavor 0.05 g;

    powder for suspension for oral administration [vanilla]: dextrose monohydrate 0.749 g, sodium saccharinate dihydrate 0.007 g, vanillin 0.004 g.

    Description:Powder from almost white or white-gray or white-yellow color to yellow-gray or yellow-brown color, with a smell from weak nonspecific to weak vanilla.
    Pharmacotherapeutic group:Antidiarrhoeic remedy
    ATX: & nbsp

    A.07.B.C   Other intestinal adsorbents

    A.07.B.C.05   Diosmectite

    Pharmacodynamics:

    The drug is of natural origin, has an adsorbing effect. Stabilizes the mucous barrier of the gastrointestinal tract,It forms polyvalent bonds with mucosal glycoproteins, increases its amount, improves gastroprotective properties (against the negative effects of hydrochloric acid, bile salts, microorganisms and their toxins). It has selective sorption properties, which are explained by its discoid-crystal structure. Adsorbs bacteria in the lumen of the gastrointestinal tract, viruses and toxins. In therapeutic doses does not affect intestinal motility. Smectite is dioctahedral is radiopaque and does not stain the stool.

    Pharmacokinetics:

    It is not absorbed in the gastrointestinal tract, incl. with diseases of the gastrointestinal tract, accompanied by symptoms of colitis and colonopathy. Not absorbed, displayed unchanged.

    Indications:

    Acute and chronic diarrhea (allergic, medicinal origin, with a violation of diet and quality of food), diarrhea of ​​infectious genesis - as part of complex therapy.

    Treatment of symptoms associated with diseases of the stomach and intestines: heartburn, a feeling of heaviness, bloating, abdominal discomfort and other symptoms of dyspepsia.
    Contraindications:

    Hypersensitivity, intestinal obstruction.

    Carefully:Use with caution in patients with severe chronic constipation.
    Pregnancy and lactation:

    The drug is approved for use during pregnancy and during breastfeeding. Correction of dosage and mode of reception is not required.

    Dosing and Administration:

    Inside.

    Application in acute diarrhea

    Adults and children over 12 years of age: 1 packet 3 times a day. The daily dose can be doubled at the beginning of the treatment.

    Children under 12 years: for 1 sachet 4 times a day for 3 days, then 1 sachet 2 times a day.

    Children under 1 year: 1 packet 2 times a day for 3 days, then 1 packet per day.

    Use with other indications

    Adults and children over 12 years of age: 1 packet 3 times a day.

    Children over 2 years: 1 packet 2-3 times a day.

    Children from 1 to 2 years old: 1 packet 1-2 times a day.

    Children under 1 year: 1 sachet per day.

    The recommended course of treatment is 3-7 days.

    When esophagitis the drug should be taken orally after a meal, with other indications - between meals.

    For adults, the contents of the sachet are dissolved in 100 ml of water, gradually adding powder and stirring it evenly.

    For children under 12 years old, the contents of the sachet are dissolved in 50 ml of liquid or mixed with a semi-liquid product (porridge, mashed potatoes, baby food).

    If necessary, it is possible to distribute the daily dose to several doses during the day. The prepared unused suspension should be stored in a closed container in a refrigerator at a temperature of 2-8 ° C for not more than 16 hours. Before each intake, the suspension should be shaken thoroughly.

    Side effects:In clinical studies, reported rare cases of constipation. In all cases, this phenomenon was poorly expressed and passed after an individual dosing regimen.
    In routine practice, in very rare cases, hypersensitivity reactions have been reported, including urticaria, rash, itching, or Quincke's edema.
    Overdose:

    Overdose can cause severe constipation or bezoar.

    Interaction:

    The drug can reduce the rate and extent of absorption of concomitant medications.

    It is recommended to observe the interval of 1-2 hours between taking the drug and other medications.

    Special instructions:

    In children with acute diarrhea, the drug should be used in combination with rehydration measures.

    If necessary, adults can also be prescribed therapy with the drug in combination with measures for rehydration.

    A set of rehydration measures is assigned depending on the course of the disease, age and patient characteristics.

    Effect on the ability to drive transp. cf. and fur:

    No information.

    Form release / dosage:

    Powder for the preparation of a suspension for oral administration [orange, vanilla], 3 g.

    Packaging:

    3.76 g of powder are placed in a bag of packaging multilayer packaging material "laminated foil (buffered)".

    For 10 or 30 bags with instructions for medical use put in a pack of cardboard.

    Storage conditions:

    Store in a place inaccessible to children, at a temperature not exceeding 25 ° C.

    Shelf life:

    3 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-004074
    Date of registration:16.01.2017
    Expiration Date:16.01.2022
    The owner of the registration certificate:OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC OBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSC Russia
    Manufacturer: & nbsp
    Representation: & nbspOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCOBOLENSKOE PHARMACEUTICAL ENTERPRISE, CJSCRussia
    Information update date: & nbsp29.01.2017
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