Normolact

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT NORMOLACT (NORMOLACT)

Composition:

Active substance: lactulose;

1 ml of syrup contains 670 mg of lactulose.

Pharmaceutical form. Syrup.

Main physicochemical properties: clear, viscous liquid, colorless or slightly brownish-yellow.

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 corresponding enzymes and is practically not absorbed. In the large intestine, lactulose is split by the action of 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 (particularly 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 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 action, 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, postoperative period following surgery on the colon and anorectal region);
• 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 tract 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, you must inform your doctor.

When Normolact is taken with enteric-coated, pH-dependent release formulations, it should be remembered that lactulose reduces the 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 the effects of glycosides due to potassium deficiency.

A possible synergistic effect with neomycin may occur.

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

Special precautions for use.

Before starting treatment with Normolact, it is advisable to consult a physician, as the physician must determine the dosage and duration of treatment.

Medical consultation is recommended if:

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

Considering the amount of sugar contained in the medication, the dose usually 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 medication should be taken into account when treating patients with diabetes mellitus.

100 ml of syrup contain ~1.4 bread units.

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

Prolonged use of the medication (more than 6 months) without proper 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 if concomitant treatment with cardiac glycosides, diuretics, or corticosteroids is administered. Plasma electrolyte levels should be monitored regularly, especially in elderly and debilitated patients.

Lactulose should be used in patients with gastroesophageal syndrome (Röhmheld syndrome) 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.

The medication contains lactose, galactose, and a small amount of fructose; therefore, this medication should not be administered to patients with rare hereditary conditions such as galactose or fructose intolerance, lactase deficiency, or glucose-galactose malabsorption.

If symptoms of the disease do not begin to subside, or if the patient's condition worsens, or if adverse reactions occur, the medication 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 may be used during pregnancy if necessary.

Breastfeeding period.

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

Fertility.

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

Ability to influence reaction speed when driving or operating machinery.

The use of Normolact 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 clinical response.

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

It is not advisable to exceed the recommended doses.

Dosage for constipation or conditions requiring facilitation of defecation

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

The single dose should preferably be taken once daily (without holding it in the mouth for a prolonged period) at the same time each day, for example in the morning with breakfast. The medication 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 treatment 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 drug 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 for 2–3 soft bowel movements per day).

Safety and efficacy of the drug 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 drug in children for hepatic encephalopathy.

It should be borne in mind 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 concomitant therapy with cardiac glycosides, diuretics, or corticosteroids is administered.

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

Adverse Reactions

During the first days of treatment, flatulence may occur, which usually resolves within a few days. When the drug is used at doses exceeding the recommended ones, abdominal pain and diarrhea may occur. 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 adverse reactions listed below occurred with the following frequencies 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 tract: 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 drug after the expiry date stated on the packaging.

After opening the bottle, the shelf life of the drug 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;

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

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

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

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

Prescription status. Over-the-counter.

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

Manufacturer's address and location of business activity.

17 Myru Street, Kyiv, 03134, Ukraine.