Normase, 667mg/ml syrup 200ml vials

Composition

100 ml of the drug contains:

• Active ingredient:
• lactulose solution (in terms of lactulose) – 66.7 g
• excipients:
• citric acid -0.05 g,
• cream flavor (No. 7 bis) -0.06 g,
• purified water-up to 100 ml.

Composition of the flavoring agent:  propylene glycol, dihydrocoumarin, vanillin.

Pharmacological action

Pharmacodynamics shows hyperosmotic, hypoammonemic, laxative effects, stimulates intestinal motility, improves the absorption of phosphates and calcium salts. Under the influence of the drug, the flora of the large intestine changes (an increase in the number of lactobacilli), which leads to an increase in acidity in the lumen of the large intestine and stimulates its peristalsis. Along with this, the volume increases and the stool softens. As a result, the drug has a laxative effect, without directly affecting the mucous membrane and smooth muscles of the large intestine. In hepatic encephalopathy or hepatic (pre)coma, the effect is associated with the suppression of proteolytic bacteria by increasing the number of acidophilic bacteria (for example, lactobacilli), the transition of ammonia to the ionic form due to acidification of the contents of the colon, bowel emptying due to a decrease in the pH in the colon and osmotic effect, and the reduction of nitrogen-containing toxic substances by stimulating bacteria that utilize ammonia for bacterial protein synthesis. Lactulose, as a prebiotic substance, enhances the growth of beneficial bacteria such as bifidobacteria and lactobacilli, while it becomes possible to inhibit the growth of potentially pathogenic bacteria such as Clostridium and Escherichia coli, which provides a more favorable balance of the intestinal flora. Pharmacokineticabsorption is low. After ingestion, it reaches the large intestine in unchanged form, where it is broken down by the intestinal flora. It is completely metabolized at doses up to 40-75 ml; at a higher dosage, it is partially excreted unchanged.

Indications

Constipation: regulation of the physiological rhythm of colon emptying. Softening of the stool for medical purposes (hemorrhoids, conditions after surgery on the colon and in the anal area). Hepatic encephalopathy: treatment and prevention of hepatic coma or precoma.

Use during pregnancy and lactation

If necessary, Normase® can be used during pregnancy and lactation.

Contraindications

• Lactose intolerance;
• galactosemia;
• intestinal obstruction;
• hypersensitivity to any component of the drug.

Patients with rare congenital disorders, such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption, should not take this medicine. With caution:

• patients with hepatic (pre)coma, diabetes mellitus;
• undiagnosed rectal bleeding;
• colostomy, ileostomy.

Side effects

In the first days of taking lactulose, flatulence may occur. As a rule, it disappears after a few days. If elevated doses are used for a long time in the treatment of hepatic encephalopathy, the patient may develop electrolyte disturbances due to diarrhea. Disorders of the gastrointestinal tract: Flatulence, abdominal pain, nausea, vomiting. When using high doses, diarrhea may occur. Other violations: Disorders of water and electrolyte balance due to diarrhea.

Interaction

When used simultaneously, antibiotics and antacids reduce the effectiveness of lactulose. Lactulose alters the pH-dependent release of enteric drugs.

It is not recommended to take lactulose within 2 hours after taking other medications.

How to take, course of use and dosage

The drug is intended for oral use. Lactulose solution can be taken both in diluted and undiluted form. It is necessary to immediately swallow the taken single dose, without holding it in the mouth. All dosages should be selected individually. If a single daily dose is prescribed, it should be taken at the same time, for example, during breakfast. During laxative therapy, it is recommended to take a sufficient amount of liquid (1.5-2 liters, which is equal to 6-8 glasses) per day. Dosage for the treatment of constipation or for softening the stool for medical purposes: The daily dose of lactulose can be taken once, or divided into two, using a measuring cup. The initial dose can be adjusted to the maintenance dose depending on the response to the drug. The therapeutic effect may occur 2-3 days after the start of taking the drug. For constipation:  adults – in the first 3 days,15-40 ml per day, then-10 -25 ml. Children older than 6 years – in the first 3 days,15 ml per day, then 10 ml; 1-6 years-5-10 ml per day, up to 1 year-5 ml per day. The duration of treatment is from 4 weeks to 3-4 months. For hepatic coma, precoma, encephalopathy and hyperammonemia: the initial dose is 30-60 ml 3 times a day. Then the dose is selected so that the soft stool is 2-3 times a day. Treatment can last up to 3 months or more. For dysbiosis 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. The duration of treatment is 10-12 days, repeated courses 3 times with weekly breaks. In the postoperative period:  adults – 10-30 ml 3 times a day, children older than 1 year – 5-10 ml 2-3 times a day, up to 1 year-5 ml 2 times a day. The drug is prescribed 18-24 hours after surgery for 3-5 days.

Description

Transparent, colorless or light yellow with a brownish tinge of syrupy liquid.

Special instructions

If there is no therapeutic effect for several days, you should consult your doctor. Lactulose should be administered with caution in patients with lactose intolerance. Please note that Normase® may contain small amounts of bound sugars (for example, lactose, galactose, epilactose and fructose). The dosage commonly used in the treatment of constipation does not need to be adjusted for patients with diabetes mellitus. In the treatment of hepatic (pre)coma, higher doses of the drug are usually prescribed, which should be taken into account in patients with diabetes mellitus. Patients with rare congenital disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine. When treating children, laxatives should be used in exceptional cases and under the supervision of a doctor. It should be borne in mind that during treatment, disorders of the emptying reflex may occur. “The use of Normase® does not affect or has a slight effect on the ability to drive a car and mechanisms.

Form of production

Syrup

Storage conditions

Store at a temperature of 15 to 25 °C. Do not freeze it. Keep out of reach of children.

Shelf life

3 years

Active ingredient

Lactulose

Dosage form

solution for oral use

Description

For adults, Pregnant women as prescribed by a doctor, For children, Nursing mothers as prescribed by a doctor

Indications

Dysbiosis, Hemorrhoids, Constipation, Liver damage