Instructions Portalac syrup 667 mg/ml bottle 250 ml
Composition
active ingredient: lactulose;
100 ml of syrup contain: lactulose (as liquid lactulose) 66.7 g.
Dosage form
Syrup.
Main physicochemical properties: transparent, thick liquid, from colorless to yellow-brown.
Pharmacotherapeutic group
Osmotic laxatives. ATX code A06A D11.
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 in the lumen of the colon. Acids contribute to a local hyperosmotic effect, which increases the volume of fecal contents and normalizes its consistency, stimulates peristalsis and bowel movements. Constipation is corrected, the physiological rhythm of digestion is restored.
In portosystemic encephalopathy or hepatic (pre)coma, the effect of the drug is due to the inhibition of the growth of proteolytic bacteria by increasing the number of acidophilic bacteria (e.g. lactobacilli), the transformation of ammonia into an ionized form due to acidification of the intestinal contents, intestinal cleansing due to low pH, as well as the osmotic effect, and the change in bacterial nitrogen metabolism by stimulating the utilization of ammonia by bacteria for the synthesis of bacterial proteins.
Lactulose, as a prebiotic, enhances the growth of beneficial bacteria such as bifidobacteria and lactobacteria, while inhibiting the growth of potentially pathogenic bacteria such as clostridia and E. coli. This creates a favorable balance of intestinal flora.
Pharmacokinetics
Lactulose is almost not absorbed after oral administration and reaches the intestine unchanged. When using Portalac in a dose of 25-50 g or 40-75 ml, lactulose is completely metabolized by bacterial flora. When using higher doses, part of lactulose may be excreted unchanged.
Indication
Constipation: regulation of the physiological rhythm of bowel movements, conditions requiring relief of defecation and softening of stools for medical reasons (hemorrhoids, after operations on the large intestine and anorectal area).
Portal hepatic encephalopathy: treatment and prevention of hepatic precoma and coma.
Contraindication
Hypersensitivity to lactulose or other components of the drug, gastrointestinal obstruction, perforation of the digestive tract or risk of perforation of the digestive tract, galactosemia.
Interaction with other medicinal products and other types of interactions
Interaction studies have not been conducted.
Application features
This medicinal product contains lactose, galactose and small amounts of fructose. Therefore, patients with rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Patients with lactose intolerance should use Portalac with caution.
The dose of lactulose used in the treatment of constipation is safe for patients with diabetes.
However, in the treatment of hepatic precoma and coma, where the dose of lactulose is much higher, the sugar content of the drug should be taken into account when treating patients with diabetes.
If, before starting treatment, there are painful symptoms in the abdominal area of unknown origin or the therapeutic effect is insufficient within several days of treatment, it is recommended to consult a doctor.
Use during pregnancy or breastfeeding
During pregnancy, no effects on the fetus are expected, as the systemic effects of lactulose on the pregnant woman are negligible.
Portalac syrup can be used during pregnancy.
Breastfeeding period
During breastfeeding, no effects on the newborn/infant are expected, as the systemic exposure of lactulose to the nursing woman is negligible.
Portalac syrup can be used during breastfeeding.
Fertility
No effects are expected, as the systemic exposure to lactulose is negligible.
Ability to influence reaction speed when driving vehicles or other mechanisms
Portalac has no or negligible influence on the ability to drive and use machines.
Method of administration and doses
Portalac can be taken either undiluted or diluted. The dose should be selected based on the clinical effect.
A single dose of lactulose should be swallowed immediately.
The drug regimen should be selected according to the patient's needs.
If the patient is prescribed the drug once a day, the dose should always be taken at the same time of day, for example during breakfast. During laxative therapy, it is recommended to drink sufficient amounts of fluid (1.5-2 liters per day, which corresponds to 6-8 glasses).
Dosage for constipation or conditions requiring easier bowel movements
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 is manifested, if within two days of starting the drug, the dose may be increased.
| Age | Initial dose, per day | Maintenance dose, per day |
| Adults and children aged 14 and over | 15-45 ml (1-3 tablespoons) | 15-30 ml (1-2 tablespoons) |
| Children 7-14 years old | 15 ml (1 tablespoon) | 10-15 ml (1 tablespoon) |
| Children 1-6 years old | 5-10 ml (1-2 teaspoons) | 5-10 ml (1-2 teaspoons) |
| Children under 1 year old | up to 5 ml (1 teaspoon) | up to 5 ml (1 teaspoon) |
Dosage for hepatic coma and precoma (adults only)
Initial dose: 30-45 ml 3-4 times a day.
This dose may be adjusted to a maintenance dose that allows for soft stools 2 to 3 times daily. The safety and efficacy of the drug in children (0-18 years) with portosystemic encephalopathy have not been established. Data are not available.
Elderly patients and patients with renal or hepatic insufficiency
Since the systemic exposure to lactulose is negligible, there are no specific dosage recommendations for these patient groups.
Children.
The use of laxatives in children should be in exceptional cases and requires medical supervision.
It should be noted 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 reduction of the dose, correction of electrolyte imbalance in case of excessive fluid loss due to diarrhea or vomiting.
Adverse reactions
Overall safety profile
During the first days of treatment, flatulence may occur, which usually disappears after a few days. When using the drug in doses exceeding the recommended ones, abdominal pain and diarrhea may occur. In this case, the dose should be reduced. When using high therapeutic doses for a long time (usually only in patients with portosystemic encephalopathy), electrolyte imbalance may occur due to diarrhea. The following adverse reactions occurred in patients treated with lactulose 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.
Laboratory abnormalities: uncommon – electrolyte imbalance due to diarrhea.
Children
The safety profile in children is expected to be the same as in adults.
Expiration date
3 years.
Storage conditions
Store at a temperature not exceeding 25 ºС. Keep out of the reach of children! Do not freeze due to the ability of lactulose to crystallize.
Packaging
250 ml or 500 ml in a bottle. 1 bottle in a cardboard pack.
Vacation category
Without a prescription.
Producer
Belupo, medicines and cosmetics, d.d., Croatia
Location of the manufacturer and its business address.
48000, Koprivnica, Danica Street, 5, Croatia.
