Active substanceLactuloseLactulose
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  • Dosage form: & nbspsyrup
    Composition:

    The composition per 1 bottle of the drug contains:

    Active substance: liquid lactulose 66% (consisting of lactulose 66 g, water to 100 ml) - 270 g
    Description:Transparent, slightly viscous solution, with no visible particles with a sweet taste.
    Pharmacotherapeutic group:laxative
    ATX: & nbsp

    A.06.A.D   Laxative preparations with osmotic properties

    A.06.A.D.11   Lactulose

    Pharmacodynamics:

    Has a hyperosmotic, hypoammonemic, laxative effect, stimulates intestinal peristalsis, improves the absorption of phosphates and calcium salts. Under the influence of the drug there is a change in the flora of the large intestine (an increase in the number of lactobacilli), which leads to an increase in acidity in the lumen of the large intestine and stimulates peristalsis.Along with this, the volume increases and the feces softens. As a result, the drug has a laxative effect, without directly affecting the mucosa and smooth muscle of the large intestine. Under the action of the drug there is a migration of ammonia from the blood into the intestine, a decrease in the formation of nitrogen-containing toxic substances in its proximal part and, accordingly, their absorption into the vena cava system. The action occurs 24-48 hours after administration (delay is due to passagei of the drug through the gastrointestinal tract).

    Has the ability to inhibit the growth of salmonella in the large intestine. Does not reduce the absorption of vitamins and is not addictive.

    Pharmacokinetics:

    Absorption is low, is excreted through the intestine in an unchanged form (excretion by the kidneys - 3 %).

    Indications:Chronic constipation; regulation of stool with hemorrhoids, the need for surgery on the colon and in the anal opening, in the postoperative period; hepatic precoma and coma, hepatic encephalopathy, hyperammonemia; dysbacteriosis, salmonellosis (with the exception of generalized forms); syndrome of putrefactive dyspepsia children of early age as a result of food poisoning.
    Contraindications:

    Hypersensitivity, intolerance to galactose or fructose, galactosemia, intestinal obstruction, suspicion of appendicitis, rectal bleeding, colo-, ileostoma.

    Carefully:Diabetes.
    Pregnancy and lactation:

    Romfalak can be used during pregnancy and lactation (breastfeeding) according to the indications.

    Dosing and Administration:

    Inside, after eating.

    The dose of the drug is selected individually.

    For most of the indications of the dose of Romfalak are presented in the table:

    Patients

    Initial dose (3 days)

    Continuation of treatment

    Adults

    15-45 ml of syrup (1-3 tablespoons)

    15-30 ml of syrup (1-2 tablespoons)

    Children from 7 to 14 years old

    15 ml of syrup (1 tablespoon)

    10 ml of syrup (2 tsp)

    Children from 1 to 6 years

    5-10 ml of syrup (1-2 tsp)

    5-10 ml of syrup (1-2 tsp)

    Breast Children

    5 ml of syrup (1 teaspoon)

    5 ml of syrup (1 teaspoon)

    As a rule, the dose can be reduced after two days of admission, depending on the need of the patient. The drug should be taken once a day in the morning with meals. The dose is increased if, within two days of taking the drug there is no improvement in the patient's condition.
    With constipation: adults - in the first 3 days for 15-40 ml a day, then - for 10-25 ml.Children older than 6 years - in the first 3 days of 15 ml per day, then - 10 ml; 1-6 years - 5-10 ml per day, up to 1 year - 5 ml per day. Duration of treatment from 4 weeks to 3-4 months.
    In the treatment of hepatic coma, precoma and encephalopathy: the initial dose 3 times a day for 30-60 ml. Then they switch to an individually selected maintenance dose, so that the soft stool is maximum 2-3 times a day. Treatment can last up to 3 months or more.
    With dysbacteriosis and salmonellosis: adults - 15-30 ml 3-5 times a day, children older than 8 years - 45 ml per day, from 5 to 8 years - 25 ml per day, from 1 to 5 years - 15 ml per day, up to 1 year - 5-15 ml per day. Duration of treatment 10-12 days, repeated courses 3 times with weekly breaks.
    In the postoperative period: adults - 10-30 ml 3 times a day, children older. 1 year - 5-10 ml 2-3 times a day, up to 1 year - 5 ml 2-3 times a day. The drug is prescribed 18-24 hours after the operation within 3-5 days.
    Side effects:

    Convulsions, flatulence, nausea, diarrhea, headache, dizziness, arrhythmias, myalgia, fatigue, weakness. With long-term treatment - violation of water-electrolyte metabolism.

    Overdose:

    Symptoms: abdominal pain, nausea, diarrhea, loss of electrolytes.

    Treatment: discontinuation of the drug.

    Interaction:

    Antibiotics and antacids reduce the effect of Romfalak. Changes the pH-dependent release of enteric-soluble drugs. It is not recommended to take Romfalak within 2 hours after taking other medications.

    Special instructions:

    With prolonged use of the drug (more than 6 months), you should regularly monitor the level of potassium, chlorine and carbon dioxide in the blood plasma.

    In gastrocardial syndrome, you should gradually increase the dose to avoid flatulence (which disappears on its own on the 2-3 day of treatment).

    In elderly and weakened patients taking Rompalac for more than 6 months, it is recommended to periodically measure the level of electrolytes in the blood serum.

    When diarrhea occurs, treatment is canceled.

    If the constipation persists for several days of taking the drug or if the constipation resumes after stopping the medication, you should see a doctor.

    Form release / dosage:

    Syrup 667 mg / ml.

    Packaging:According to 270.0 g (200 ml) of the preparation in a white polyethylene bottle with a capacity of 200 ml, closed with a polyethylene lid with a locking ring, which ensures tightness. One bottle together with the instructions for use and with one measuring white spoon from PSE - 0600 with two ends (1 - with a capacity of 2.5 ml, 2 - with a capacity of 5 ml) is placed in a cardboard box.
    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 25 ° C.

    In a place inaccessible to children.

    Shelf life:3 years. Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-000882/09
    Date of registration:09.02.2009
    The owner of the registration certificate:K.O. Ромфарм Компани С.Р.Л.K.O. Ромфарм Компани С.Р.Л. Romania
    Manufacturer: & nbsp
    Representation: & nbspРомфарма ОООРомфарма ООО
    Information update date: & nbsp09.02.2009
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