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OTC - Lactosorbit – Constipation - Lactosorbit

COMPOSITION: Each sachet contains:

Sorbitol……………………………………………….5g.


DESCRIPTION OF PRODUCT

Homogeneous, dried, separated, white, odorless powder, sweet taste.


PHARMACODYNAMICS:

Sorbitol (D – glucitol) is an alcohol with hydroxyl groups, with half the sweetness of sucrose. It promotes the hydration of the substances in the intestine. Sorbitol stimulates secretion of cholecystokinin – pancreazymin and increases intestinal motility by osmotic laxative effect.

Sorbitol is metabolized primarily in the liver into fructose, the catalyst is sorbitol dehydrogenase. Some sorbitols can be directly converted into glucose by aldose reductase.


PHARMACOKINETICS

Sorbitol is poorly absorbed from the gastrointestinal tract following oral or rectal administration.

A very small part of sorbitol is not metabolized, and excreted through the kidneys. The remainder is excreted as exhaled CO2 during respiration.


INDICATIONS:

Symptomatic treatment of constipation.


ADMINISTRATION AND DOSAGE:

Dissolve the powders of 1 sachet in ½ glass of water, and drink.

  • Adult: Take 1 sachet at fasting in the morning.
  • Children: ½ adult dose.

CONTRAINDICATIONS:

  • Colitis entity (Ulcerative rectocolitis, Crohn’s disease), occlusive or subocclusive syndrome, undiagnosed abdominal painful syndrome.
  • Anuria.
  • Biliary tract obstruction.
  • Patients with genetic fructose intolerance (rare metabolic diseases).

WARNINGS AND PRECAUTIONS:

  • Prolonged use of laxatives is not recommended.
  • Treatment of constipation with sorbitol is only an adjunctive to dietetic treatment.
  • In patients with “irritable colon”, avoid the administration of sorbitol while fasting and reduce the dosage.
  • Caution should be exercised in patients with colonic motility may be altered by colonic bulge, cause coproma.

Pregnancy and lactation: None reported.

Effects on ability to drive and use machines: None reported.


SIDE EFFECTS:

  • Diarrhea, abdominal pain, especially in patients with irritable bowel syndrome.
  • In case of an unexpected reaction, consult your physician.

INTERACTIONS:

Due to increasing intestinal motility, every laxative may shorten time of moving of drugs which are concomitantly taken with it. So it reduces absorption of the drugs.


OVERDOSAGE:

Water and electrolyte disturbances due to multiple repeated doses. Water and electrolytes must be compensated if necessary.


PRESENTATION:

Box of 20 sachets x 5 g.

STORAGE: Store at temperature below 30oC, in a dry place, protect from light.

SHELF-LIFE: 36 months from manufacturing date. Do not use after expiry date.

DATE OF REVISION OF PACKAGE INSERT:…