Romfalak (Syrup) Instructions for Use

Marketing Authorization Holder

S.C. Rompharm Company S.R.L. (Romania)

ATC Code

A06AD11 (Lactulose)

Active Substance

Lactulose (Rec.INN registered by WHO)

Dosage Form

Romfalak

Syrup 66.7 g/100 ml: 270 g bottle 1 pc. with a measuring spoon

Dosage Form, Packaging, and Composition

Syrup transparent, slightly viscous, without visible particles, with a sweet taste.

Excipients: water – up to 100 ml.

270 g (200 ml) – polyethylene bottles (1) in a set with a double-sided measuring spoon (capacity 2 ml and 5 ml) – cardboard packs.

Clinical-Pharmacological Group

Laxative drug with osmotic properties. Hypoammonemic agent

Pharmacotherapeutic Group

Laxative

Pharmacological Action

Laxative. Lactulose is a disaccharide consisting of galactose and fructose; it is not hydrolyzed by disaccharidases of the small intestinal mucosa.

It has a hyperosmotic laxative effect, stimulates intestinal peristalsis, improves the absorption of phosphates and calcium salts, and promotes the excretion of ammonium ions.

Lactulose is broken down by the colonic flora into low molecular weight organic acids, which leads to a decrease in pH and an increase in osmotic pressure and, as a result, an increase in the volume of intestinal contents.

These effects stimulate intestinal peristalsis and affect stool consistency. The physiological rhythm of colon emptying is restored.

In hepatic encephalopathy, the effect is attributed to the suppression of proteolytic bacteria by increasing the number of acidophilic bacteria (e.g., lactobacilli), the conversion of ammonia to the ionic form due to acidification of the colonic contents; bowel emptying due to decreased pH in the colon and osmotic effect; and a reduction in 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 suppress the growth of potentially pathogenic bacteria, such as Clostridium spp. and Escherichia coli, which provides a more favorable balance of intestinal flora.

Pharmacokinetics

Absorption is low. Lactulose is absorbed from the small intestine only by 0.4-2%, then reaches the large intestine, where it is broken down by the intestinal microflora. It is metabolized to form simple organic acids – mainly lactic acid and, to a lesser extent, acetic and formic acid.

Indications

Chronic constipation, as well as conditions requiring facilitation of defecation. Prevention and treatment of hepatic encephalopathy in adults.

ICD codes

Dosage Regimen

Administer orally. Use the provided double-sided measuring spoon for accurate dosing.

For chronic constipation in adults and adolescents: initiate with 15-30 ml (approximately 10-20 g of lactulose) per day. Adjust the daily dose based on individual response.

For hepatic encephalopathy in adults: initiate with a higher dose of 30-50 ml, three to four times daily. Adjust to produce 2-3 soft stools per day. The maintenance dose is individualized.

For children aged 7-14 years with constipation: administer 15 ml daily. For children 1-6 years: administer 5-10 ml daily. For infants under 1 year: initiate with up to 5 ml daily.

Divide the total daily dose into 1-2 intakes. Take single doses at regular intervals, preferably with meals.

Adjust the dosage until 2-3 soft bowel movements are achieved daily. A therapeutic effect may be delayed for 24-48 hours.

For long-term therapy exceeding 6 months, monitor plasma levels of potassium, chloride, and carbon dioxide.

Ensure adequate fluid intake of 1.5-2 liters per day during treatment.

Adverse Reactions

Metabolism disorders very rarely – hypernatremia; frequency unknown – water-electrolyte balance disorders that occur as a result of diarrhea.

Digestive system nausea, vomiting, abdominal pain, flatulence, diarrhea.

Contraindications

Hypersensitivity to lactulose; intestinal obstruction; fructose intolerance, galactose intolerance; lactase deficiency; glucose-galactose malabsorption; galactosemia; rectal bleeding (not caused by hemorrhoids); suspected appendicitis, acute inflammatory diseases of the abdominal organs.

With caution diabetes mellitus, colostomy or ileostomy.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, it should be used only after consultation with a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Pediatric Use

It can be used in children according to indications in age-appropriate recommended doses and dosage forms.

Special Precautions

Should not be used for abdominal pain, nausea, vomiting without diagnosis verification.

Should not be used for inflammatory gastrointestinal diseases in the acute stage, as well as for water-electrolyte balance disorders.

Use with caution in patients with gastrocardiac syndrome. In such cases, treatment should be started with low doses and increased gradually to avoid the development of flatulence.

Use with caution in patients with diabetes mellitus, especially with inflammatory lesions of the colon.

During long-term treatment (more than 6 months), the levels of potassium, chloride, and carbon dioxide in the blood plasma should be regularly monitored.

During therapy with laxatives, it is recommended to take a sufficient amount of fluid (1.5-2 l/day, which corresponds to 6-8 glasses of 250 ml volume).

Drug Interactions

With simultaneous use with diuretics, corticosteroids, amphotericin, an increase in potassium loss is possible.

Antacids and antibiotics active against lactobacilli and bifidobacteria (including neomycin, clindamycin, rifaximin) reduce the effects of lactulose.

With simultaneous use, Lactulose may disrupt the release of active substances from enteric-coated drugs with pH-dependent release due to the fact that it lowers the pH of the intestinal contents.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.