Portalac
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PORTALAC
Composition:
Active substance: lactulose;
100 ml of syrup contains: lactulose (in the form of liquid lactulose) 66.7 g.
Pharmaceutical form. Syrup.
Main physico-chemical properties: clear, viscous liquid, colorless to yellowish-brown.
Pharmacotherapeutic group.
Osmotic laxatives. ATC code A06AD11.
Pharmacological properties.
Pharmacodynamics.
Lactulose is a synthetic disaccharide that is broken down into low-molecular-weight organic acids by intestinal bacteria in the colon. The formation of acids leads to a decrease in pH within the lumen of the colon. The acids promote local hyperosmotic action, increasing the volume of fecal content and normalizing its consistency, thereby stimulating intestinal peristalsis and bowel evacuation. Physiological digestive rhythm is restored.
In portosystemic encephalopathy or hepatic (pre)coma, the drug's effect is due to suppression of proteolytic bacterial growth as a result of increased numbers of acidophilic bacteria (e.g., lactobacilli), transformation of ammonia into its ionized form due to acidification of intestinal contents, intestinal cleansing due to low pH, as well as osmotic effects and alteration of bacterial nitrogen metabolism through stimulation of ammonia utilization by bacteria for bacterial protein synthesis.
As a prebiotic, lactulose enhances the growth of beneficial bacteria such as bifidobacteria and lactobacilli, while suppressing the growth of potentially pathogenic bacteria such as clostridia and Escherichia coli. This creates a favorable balance of intestinal flora.
Pharmacokinetics.
Lactulose is virtually not absorbed after oral administration and reaches the intestine unchanged. When Portalac is administered at a dose of 25–50 g or 40–75 mL, lactulose is completely metabolized by the bacterial flora. When higher doses are used, part of the lactulose may be excreted unchanged.
Clinical characteristics.
Indications.
Constipation: regulation of the physiological rhythm of intestinal defecation, conditions requiring facilitation of defecation and softening of stools for medical reasons (hemorrhoids, postoperative states following surgery on the large intestine and anorectal area).
Hepatic encephalopathy: treatment and prevention of hepatic precoma and coma.
Contraindications.
Hypersensitivity to lactulose or to any of the excipients, acute abdominal pain of unknown origin, nausea, vomiting, gastrointestinal obstruction/intestinal stenosis, gastrointestinal perforation or risk of gastrointestinal perforation (e.g., acute inflammatory bowel diseases such as ulcerative colitis, Crohn's disease), rectal bleeding, severe dehydration, galactosemia.
Interaction with other medicinal products and other forms of interaction.
Interaction studies have not been conducted.
If the patient is taking any other medicinal products, this should be reported to the physician.
When administering lactulose with enteric-coated pH-dependent release formulations, it should be remembered that lactulose reduces intestinal pH.
Concomitant use with broad-spectrum antibiotics or antacids may reduce the therapeutic efficacy of lactulose.
It is not recommended to take lactulose within 2 hours after taking other medications.
Lactulose may increase potassium loss induced by other drugs (e.g., thiazides, corticosteroids, and amphotericin B). Concomitant use with cardiac glycosides may enhance the effect of glycosides due to potassium deficiency.
Special precautions for use.
This medicinal product contains lactose, galactose, and a small amount of fructose. Therefore, patients with rare hereditary galactose or fructose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Portalac should be used with caution in patients with lactose intolerance.
Prolonged use of the medicinal product (more than 6 months) without dose adjustment or inappropriate 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 concomitant therapy includes cardiac glycosides, diuretics, or corticosteroids. Plasma electrolyte levels should be monitored regularly, particularly in elderly and debilitated patients.
Portalac should be used in patients with gastroesophageal syndrome (Römer's syndrome) only after consultation with a physician. To prevent the occurrence of flatulence, it is recommended to gradually increase the dose. If flatulence occurs, the dose should be reduced or treatment discontinued.
The dose of lactulose used in the treatment of constipation is safe for patients with diabetes mellitus. However, in the treatment of hepatic precoma and coma, when the dose of lactulose is much higher, the sugar content of the medicinal product should be considered when treating patients with diabetes mellitus.
If abdominal pain of unknown origin is present before the start of treatment or the therapeutic effect is insufficient within a few days of treatment, medical consultation is recommended.
Use during pregnancy or breastfeeding.
During pregnancy, no adverse effects on the fetus are expected, as the systemic effect of lactulose on the pregnant woman is negligible.
Portalac syrup can be used during pregnancy.
Breastfeeding period
During breastfeeding, no effects on the newborn/infant are expected, as the systemic effect of lactulose on the nursing mother is negligible.
Portalac syrup can be used during breastfeeding.
Fertility
No effects on fertility are expected, as the systemic effect of lactulose is negligible.
Ability to affect reaction speed when driving or operating machinery.
Portalac has no effect or has a negligible effect on the ability to drive a vehicle or operate complex machinery.
Dosage and Administration.
Portalac can be taken either undiluted or diluted. The dose should be adjusted according to the clinical response.
The single dose of lactulose should be swallowed immediately.
The dosing regimen should be tailored according to the individual needs of the patient.
If the medication is prescribed once daily, the dose should always be taken at the same time of day, for example during breakfast. During therapy with laxatives, it is recommended to consume an adequate amount of fluid (1.5–2 liters per day, equivalent to 6–8 glasses).
Dosing for constipation or conditions requiring easier defecation
The daily dose of lactulose may be taken in one or two divided doses.
After a few days, the initial dose may be adjusted to a maintenance dose, depending on the response to treatment. It may take several days of therapy (2–3 days) before the therapeutic effect becomes apparent. If there is no effect within two days after starting treatment, the dose may be increased.
| Age |
Initial dose, per day |
Maintenance dose, per day |
| Adults and children aged 14 years and older |
15–45 ml (1–3 tablespoons) |
15–30 ml (1–2 tablespoons) |
| Children 7–14 years |
15 ml (1 tablespoon) |
10–15 ml (1 tablespoon) |
| Children 1–6 years |
5–10 ml (1–2 teaspoons) |
5–10 ml (1–2 teaspoons) |
| Children under 1 year |
up to 5 ml (1 teaspoon) |
up to 5 ml (1 teaspoon) |
Dosage in hepatic coma and precoma (for adults only)
Initial dose: 30–45 mL 3–4 times daily.
This dose may be adjusted until a maintenance dose is achieved that produces soft bowel movements 2 to 3 times 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 effect of lactulose is negligible, no specific dosage recommendations are required for these patient groups.
Children.
The use of laxatives in children should occur only in exceptional cases and requires medical supervision.
It should be taken into account that the defecation reflex may be impaired during treatment.
Overdose.
If doses are too high, abdominal pain and diarrhea may occur, accompanied by loss of water and electrolytes, and in severe cases may lead to hypernatremia and hyperkalemia.
Recommended treatment includes discontinuation of the drug or dose reduction, and correction of electrolyte imbalance caused by excessive fluid loss due to diarrhea or vomiting.
Adverse reactions.
During the first days of treatment, flatulence may occur, which usually resolves after a few days. When the drug is used in 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 patients with portosystemic encephalopathy), electrolyte imbalance due to diarrhea may be observed. The adverse reactions listed below were reported in patients receiving lactulose therapy in placebo-controlled clinical trials. The frequency is defined as follows: 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, nausea and vomiting.
Immune system disorders: frequency not known – hypersensitivity reactions.
Skin and subcutaneous tissue disorders: frequency not known – rash, pruritus, urticaria.
Laboratory test abnormalities: uncommon – electrolyte imbalance due to diarrhea.
Children
The safety profile in children is expected to be the same as in adults.
Shelf life. 3 years.
Storage conditions.
Store at a temperature not exceeding 25 °C. Keep out of reach of children. Do not freeze due to the tendency of lactulose to crystallize.
Packaging.
250 ml or 500 ml in a bottle with a cap and a measuring cup. 1 bottle in a cardboard box.
Prescription status.
Over-the-counter.
Manufacturer.
Belupo, lijekovi i kozmetika, d.d.
Manufacturer's address and site of operation.
Danica 5 Street, 48000 Koprivnica, Croatia.