Expiration date: 04/2025

The composition and form of issue:

Syrup 66, 7% 100 ml contains:

lactulose concentrate 66, 7 g

excipients: purified water 

in bottles, PE, 250 or 500 ml cartons 1 a bottle.

Description pharmaceutical form:

Transparent viscous liquid from light-yellow to brownish-yellow.

Pharmacokinetics:

Lactulose is practically not absorbed from the gastrointestinal tract (absorbed less than 3% of the dose), reduce the absorption of vitamins, is not addictive.

Description pharmacological action:

Having Hyper-osmotic, laxative effect, stimulates peristalsis, improves the absorption of phosphates and salts of Ca2+, promotes the excretion of ammonium ions. Under the influence of lactulose the reproduction of Lactobacillus acidophilus, Lactobacillus bifidus in the intestine that in turn leads to a decrease in pH in the lumen of the large intestine and increase its motility. Along with this increased volume and softening the stool. The drug has a laxative effect without having any impact directly to the mucous membrane and the smooth muscles of the colon.

Under the influence of lactulose decreases the formation of nitrogen-containing toxic substances in the proximal colon and their absorption into the systemic circulation.

The concentration of ammonium ions in the blood is reduced by 25-50% reduces the severity of hepatic encephalopathy, improves mental condition and normalizes the EEG.

The product has the ability to inhibit the growth of Salmonella in the large intestine.

The effect of the drug occurs 24-48 hours after ingestion, with the passage of the drug through the gastrointestinal tract.

Indications:

• constipation of various etiologies (including chronic)
  
• the need to soften the stool for medical purposes (hemorrhoids, need surgical operations on the colon and/or anus, pain syndrome after removal of hemorrhoids, postoperative period
  
• intestinal dysbiosis
  
• hepatic encephalopathy
  
• hepatic precoma and coma (treatment and prevention)
  
• the hyperammonemia
  
• enteritis caused by Salmonella, Shigella, salmonellonoyestvo
  
• syndrome of putrefactive dyspepsia (in children of early age as a result of acute food poisoning).
  

Contraindications:

• hypersensitivity to lactulose or other components of the drug
  
• bowel obstruction
  
• rectal bleeding (the cause of which is not hemorrhoids)
  
• Colo - or ileostomy
  
• a suspected appendicitis.
  

Application of pregnancy and breast-feeding:

Lactulose may be safely used in pregnant and nursing mothers.

Side effects:

Side effects are generally mild and reversible and are a consequence of exceeding the dose.

Cramps, discomfort or pain in the abdomen, and diarrhea can be eliminated with dose reduction. Flatulence, appearing at the beginning of treatment, usually goes away after 1-2 days.

There have been cases of skin reactions (rash).

With long-term therapy and high doses of lactulose in the treatment of hepatic encephalopathy may develop violation of water-electrolyte balance, and as a consequence, cramps, nausea, headache, dizziness, arrhythmia, myalgia, fatigue, weakness.

Drug interactions:

When using therapeutic doses of lactulose is clinically reliable interactions with other drugs was observed. However, it is not recommended to take Portalac within 2 hours after taking other drugs. While receiving lactulose may inhibit the action of drugs, for which release in the colon creates an unfavorable environment (e.g. preparations containing mesalazine).

Antibiotics (neomycin) and antacids reduce the effect.

Method of application and dose:

Inside, in the morning during or after a meal, once or divided into 2 doses, with water or other liquid.

Dose picked individually (table. 1).

Table 1

Dose of syrup Portalac in the treatment of constipation and for softening the stool

Age	Initial dose (3 days)	The continuation of treatment
Children up to 1 year	5 ml (1 teaspoon)	5 ml (1 teaspoon)
Children from 1 year to 7 years	5-10 ml (1-2 teaspoons)	5-10 ml (1-2 teaspoons)
Children from 7 to 14 years	15 ml (1 tablespoon)	10 ml (1 teaspoon)
Adults	15-45 ml (1-3 tablespoons)	15–30 ml (1–2 tablespoon)

The patient can select and change the dose and time of drug intake on demand. Laxative effect of the drug develops within the first 2 days of admission. The duration of treatment for constipation — from 4 weeks to 3-4 months.

In the treatment of hepatic (portal) encephalopathy, hepatic coma and precoma: 30-50 ml of syrup (2-3 tbsp) 3 times a day.

In the initial phase of treatment can be administered doses of 30-45 ml of syrup every 1-2 hours to achieve a rapid effect (first bowel movement). Then move on to supporting dose, selecting her individually to get the soft stool 2-3 times a day.

Table 2

Dose of syrup Portalac in the treatment of dysbacteriosis and normalization of the intestinal microflora

Age	Single dose
Children up to 1 year	1, 5–3 ml
Children from 1 year to 3 years	3 ml
Children from 3 year to 7 years	5 ml (1 teaspoon)
Adults and children over 7 years	5–10 ml (1–2 teaspoons)

The drug is administered during or after meals 2-4 times a day. The duration of treatment is 10-14 days, repeated courses are assigned weekly intervals.

Overdose:

Symptoms: receiving too high doses can cause diarrhea and the disruption of water and electrolyte balance.

Treatment: cancel the drug.

Special instructions:

If constipation is not resolved within a few days of taking the drug, as well as the resumption of constipation after discontinuation of the drug should consult a doctor.

In connection with the presence in the preparation of small amounts of sugars (15 ml of syrup contain up to 1, 7 g of galactose and 1 g of lactose) care must be taken when administering the drug to patients with diabetes and lactose intolerance.

With caution is prescribed to patients with gastrocardiac syndrome: treatment start with low doses and increase them gradually to avoid flatulence.

In the treatment of hepatic encephalopathy, especially in the initial phase of therapy, do not use other laxatives, because the increased bowel movements may lead to erroneous conclusion about the achievement of an adequate dose of therapy for encephalopathy.

Effects on ability to drive vehicles and mechanisms. In recommended doses, the drug has no effect on the ability to drive vehicles and mechanisms.

Storage conditions:

Do not freeze due to the possible crystallization of lactulose.