Normolact fruit

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NORMOLACT FRUIT (NORMOLACT FRUIT)

Composition:

Active substance: lactulose;

1 ml of syrup contains 667 mg of lactulose.

Excipients: orange flavor, purified water.

Pharmaceutical form. Syrup.

Main physicochemical properties: clear, viscous liquid, colorless or slightly brownish-yellow, with a characteristic orange odor.

Pharmacotherapeutic group. Osmotic laxatives. Lactulose.

ATC code A06AD11.

Pharmacological properties.

Pharmacodynamics.

Lactulose is a synthetic derivative of lactose. It is not broken down in the stomach and small intestine due to the absence of appropriate enzymes and is practically not absorbed. In the large intestine, lactulose is split by the intestinal microflora into low-molecular-weight organic acids, resulting in a decrease in pH and osmotic changes that stimulate intestinal peristalsis. The volume of fecal mass also increases, promoting normalization of the defecation process. As a prebiotic, lactulose enhances the growth of bifidobacteria and lactobacilli, thereby suppressing the growth of pathogenic intestinal microflora (including pathogens such as Clostridium and Escherichia coli).

In hepatic encephalopathy or hepatic (pre)coma, the therapeutic effect of lactulose is associated with inhibition of proteolytic bacterial growth due to an increase in the number of acidophilic bacteria (e.g., lactobacilli), transformation of ammonia into its ionized form due to acidification of intestinal contents, laxative effect caused by low pH and osmotic effect, and alteration of nitrogen metabolism in bacteria through stimulation of bacterial utilization of ammonia for protein synthesis.

Pharmacokinetics.

The drug is almost not absorbed in the intestine and, at a dose of 40–75 ml, is completely metabolized by bacterial flora. When higher doses are administered, part of the lactulose may be excreted unchanged.

Clinical characteristics.

Indications.

• Constipation: regulation of the physiological intestinal rhythm;
• conditions requiring facilitation of defecation (hemorrhoids, after surgery on the colon and anorectal area);
• portosystemic hepatic encephalopathy (PSE): treatment and prevention of hepatic precoma and coma.

Contraindications.

• Hypersensitivity to the active substance or to any of the excipients;
• galactosemia;
• acute abdominal pain of unknown origin;
• nausea, vomiting;
• gastrointestinal obstruction / intestinal stenosis;
• perforation of the gastrointestinal tract or risk of gastrointestinal perforation (e.g., acute inflammatory bowel diseases such as ulcerative colitis, Crohn’s disease);
• rectal bleeding;
• severe dehydration.

Interaction with other medicinal products and other forms of interaction.

If you are taking any other medicinal products, be sure to inform your physician.

When taking "Normolact fruit" with pH-dependent release enteric-coated drugs, it should be remembered that lactulose reduces intestinal pH.

Concomitant use with broad-spectrum antibiotics or antacids may reduce the therapeutic efficacy of lactulose.

Lactulose may increase potassium loss induced by other drugs (e.g., thiazides, corticosteroids, and amphotericin B).

Concomitant use with cardiac glycosides may enhance glycoside effects due to potassium deficiency.

A possible synergistic effect with neomycin may occur.

It is not recommended to take "Normolact fruit" within 2 hours after taking other medicinal products.

Special precautions for use

Before starting treatment with Normolact fruit, consult a physician, as the doctor must determine the dosage and duration of treatment.

Medical consultation is recommended if:

• there are painful abdominal symptoms of unknown origin before starting treatment;
• the therapeutic effect during several days of treatment is insufficient.

Considering the sugar content of the product, the usual dose used for the treatment of constipation does not cause problems in patients with diabetes mellitus. However, for the treatment of hepatic (pre)coma, significantly higher doses are usually prescribed; therefore, the sugar content of the preparation should be taken into account when treating diabetic patients.

100 ml of syrup contain ~1.4 bread units.

In patients with gastroesophageal reflux, the dose should be increased gradually to avoid meteorism.

Prolonged use of the drug (more than 6 months) without dose adjustment or incorrect use may lead to diarrhea and electrolyte imbalance. In severe cases, dehydration or hypokalemia may occur. Hypokalemia may cause cardiac or neuromuscular dysfunction, especially when concomitantly using cardiac glycosides, diuretics, or corticosteroids. Plasma electrolyte levels should be monitored regularly, especially in elderly and debilitated patients.

Patients with gastroesophageal syndrome (Röhmel's syndrome) should use lactulose only after consultation with a physician. If symptoms such as meteorism and bloating occur in these patients after taking lactulose, the dose should be reduced or treatment discontinued.

Normolact fruit contains lactose, galactose, and a small amount of fructose; therefore, patients with rare hereditary disorders of galactose intolerance, fructose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.

If symptoms of disease do not begin to subside, or if health condition worsens, or if adverse reactions occur, the use of the drug should be discontinued and medical advice should be sought regarding further treatment.

Use during pregnancy or breastfeeding.

Pregnancy.

During pregnancy, no adverse effects on the fetus are expected, as the systemic effect of lactulose on the pregnant woman is negligible. Normolact fruit may be used during pregnancy if necessary.

Period of breastfeeding.

During breastfeeding, no adverse effects on the newborn/infant are expected, as the systemic effect of lactulose on the mother is negligible. Normolact fruit may be used during breastfeeding.

Fertility.

No adverse effects are expected, as the systemic effect of lactulose is negligible.

Ability to affect reaction speed when driving or operating machinery.

The use of Normolact fruit does not affect or has a negligible effect on the ability to drive or operate machinery.

Method of administration and dosage.

Take orally, either diluted or undiluted.

Dosage should be adjusted according to the clinical response.

The dosing regimen should be individualized based on the patient's specific needs.

Exceeding the recommended doses is not advisable.

Dosage for constipation or conditions requiring relief of defecation

*For children under 1 year of age, the dose of the medicinal product should be measured according to the scale indicated on the dosing spoon provided.

The single dose should preferably be taken once daily (without holding in the oral cavity for prolonged periods) at the same time each day, for example in the morning during breakfast. It may be mixed with fruit or vegetable juices or food mixtures. The effect may be observed within 1–2 days, which is due to the action of lactulose.

During therapy with laxatives, it is recommended to consume an adequate amount of fluids (1.5–2 liters, corresponding to 6–8 glasses) per day.

In hepatic encephalopathy, hepatic coma, and precoma, the medicinal product should be administered at an initial adult dose of 30–45 ml 3–4 times daily.

The maintenance dose should be adjusted according to individual response (aiming to achieve 2–3 soft bowel movements per day).

The safety and efficacy of the medicinal product in children (0–18 years) with portosystemic encephalopathy have not been established. Data are lacking.

Elderly patients and patients with renal or hepatic impairment.

Since the systemic effects of lactulose are minimal, no special dosage recommendations are required for these patient groups.

Children.

Laxatives should be used in children only in exceptional cases and under medical supervision.

There are no data on the use of the medicinal product in children with hepatic encephalopathy.

It should be noted that the intestinal defecation reflex may be impaired during treatment.

Overdose.

Symptoms: abuse of laxatives (frequent or prolonged use in excessive doses) may lead to abdominal pain and persistent diarrhea, resulting in loss of water, mineral salts (especially potassium), and other essential nutrients. In severe cases, dehydration or hypokalemia may occur. Hypokalemia may cause cardiac or neuromuscular dysfunction, particularly if the patient is concurrently receiving cardiac glycosides, diuretics, or corticosteroids.

Treatment: there is no specific antidote; it is recommended to reduce the dose or discontinue the medicinal product. Excessive fluid loss due to vomiting and diarrhea may require correction of the electrolyte balance. After discontinuation of "Normolact Fruktu," these symptoms resolve.

Side effects

During the first days of treatment, flatulence may occur, which usually resolves after a few days. When the drug is used at doses exceeding the recommended ones, abdominal pain and diarrhea may develop. In such cases, the dose should be reduced. With prolonged use of high therapeutic doses (usually only in hepatic encephalopathy), electrolyte imbalance due to diarrhea may occur.

The following adverse reactions were observed with the specified frequency in patients receiving lactulose in placebo-controlled clinical trials: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000).

Gastrointestinal disorders: very common – diarrhea; common – flatulence, abdominal pain or colic, nausea and vomiting.

Skin and subcutaneous tissue disorders: not known – rash, pruritus, urticaria.

Immune system disorders: not known – hypersensitivity reactions.

Laboratory test abnormalities: uncommon – electrolyte imbalance due to diarrhea (usually only in patients with portosystemic encephalopathy).

Other: headache, dizziness, increased fatigue, weakness, myalgia, and arrhythmia.

Shelf life. 2 years.

Do not use the medicinal product after the expiry date stated on the packaging.

After opening the bottle, the shelf life of the preparation is 120 days when stored at a temperature not exceeding 25 °C.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

100 ml in a polymer bottle, 1 bottle with a dosing spoon in a carton box;

100 ml in a polymer flask, 1 flask with a dosing spoon in a carton box;

200 ml in a polymer flask, 1 flask with a dosing spoon in a carton box;

240 ml in a polymer flask, 1 flask with a dosing spoon in a carton box;

500 ml in a polymer flask, 1 flask with a dosing spoon in a carton box.

Supply category. Over-the-counter.

Manufacturer: Public Joint-Stock Company "Scientific and Production Center "Borshchagovskiy Chemical and Pharmaceutical Plant".

Manufacturer's address and location of business activity.

17 Miru Street, Kyiv, 03134, Ukraine.