NORMASE ® Lactulose

NORMASE ® is a Lactulose-based drug

THERAPEUTIC GROUP: Laxatives - Osmotic laxative

Indications NORMASE ® Lactulose

NORMASE ® is indicated in the treatment of chronic constipation, dyspepsia due to eating disorders, putrefactive syndromes in infants, during weaning and as an adjuvant in intestinal bacterial diseases.

Mechanism of action NORMASE ® Lactulose

NORMASE ® is a drug based on lactulose, a synthetic disaccharide originated by the association of a molecule of sucrose and one of galactose.Taken orally, it overcomes both the gastric and duodenal environments unaltered (given the absence of specific saccharases), and thanks to its osmotic activity it retains important quantities of liquids and minerals, accelerating intestinal transit.
The massive volume of liquids quickly reaches the colon, stretching its walls, increasing its peristalsis, and facilitating evacuation, sometimes characterized by abdominal pain. At the same time, lactulose is fermented by the intestinal flora in the large intestine, with the production of organic acids such as acetic acid and lactic acid, with a prebiotic effect useful for stimulating the growth of the resident flora to the detriment of the pathogenic one (important action in counteracting some consequences, clinically relevant, liver diseases such as cirrhosis) and osmotic effect.

Studies carried out and clinical efficacy


Med Hypotheses. 2010 Oct 29.

Lactulose: An indirect antioxidant ameliorating inflammatory bowel disease by increasing hydrogen production.

Chen X, Zuo Q, Hai Y, Sun XJ.

Although lactulose is known above all for its important laxative action, the latest studies are focusing on the other functional characteristics of this disaccharide. Recent evidence, in fact, hypothesizes an important antioxidant role of lactulose at the enteric level, which could prove to be important in the prevention of intestinal inflammatory diseases.


Int J Food Microbiol. 2010 Nov 13.

Use of lactulose as prebiotic and its influence on the growth, acidification profile and viable counts of different probiotics in fermented skim milk.

Oliveira RP, Florence AC, Perego P, De Oliveira MN, Convert A.

In addition to being an excellent osmotic laxative, lactulose has also proved useful for its prebiotic actions. In fact, being effectively hydrolyzed by the intestinal microflora into acetic acid and lactic acid, it can guarantee an important growth of the resident flora. This important ability has allowed lactulose to re-enter as a fortifying element in various foods, in particular in milk.


Cochrane Database Syst Rev. 2010 Jul 7;: CD007570.

Lactulose versus Polyethylene Glycol for Chronic Constipation.

Lee-Robichaud H, Thomas K, Morgan J, Nelson RL.

Chronic constipation is one of the most common problems in the Western population, and is often associated with poor nutrition. Among the most used treatments for this pathology it is possible to include osmotic laxatives, in particular lactulose and polyethylene glycol.
Despite the excellent efficacy of lactulose, polyethylene glycol has proved particularly useful in reducing abdominal pain and in increasing the weekly frequency of bowel movements.

Method of use and dosage

NORMASE ® 200ml syrup with 66.7g of lactulose per 100ml: The therapeutic process for the treatment of chronic constipation should include the intake of 20 ml on the first day, followed by daily administration of 10ml.
Any dosage adjustments should be decided by the physician, following the evaluation of the patient's health condition.
The therapeutic protocol used as an adjuvant for intestinal bacterial infections, on the other hand, provides for the assumption of 10-20ml of NORMASE ® ciroppo per day, for a maximum of 7 days.
In all the aforementioned cases, and especially in the case of patients under the age of 10, medical advice and control is required.

Warnings NORMASE ® Lactulose

NORMASE ® should be taken under strict medical advice, especially for patients with diabetes, cardiovascular diseases, acute diseases of the gastro-intestinal tract, nausea, vomiting and intestinal obstructions.
Excessive dosages of this drug could be associated with electrolyte imbalances and gastrointestinal diseases.


The various clinical trials and post-marketing monitoring have not shown any toxic effects on the health of the fetus or newborn, following the intake of NORMASE ® during pregnancy and lactation.


The efficacy of NORMASE ® can be reduced by the concomitant administration of broad spectrum antibiotics and antacids.
Possible interactions, not fully characterized and clinically insignificant, have been observed following the concomitant administration of lactulose and digitalis.

Contraindications NORMASE ® Lactulose

NORMASE ® is contraindicated in case of galactosemia and hypersensitivity to one of its components.

Undesirable Effects - Side Effects

The administration of NORMASE ® was found, both from clinical trials and from post-marketing experience, well tolerated, with occasional episodes of bloating and abdominal cramps.
The eventual presence of intense diarrheal discharges should be accompanied by a reduction in dosage or discontinuation of therapy.


NORMASE ® is a drug that can only be sold under medical prescription.

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