NORMACOL ® Rubber sterculia

NORMACOL ® is a drug based on Rubber sterculia.

THERAPEUTIC GROUP: Laxatives - Mass-forming laxatives.

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications NORMACOL ® Rubber sterculia

NORMACOL ® is indicated for the symptomatic treatment of constipation.

Mechanism of action NORMACOL ® Rubber sterculia

NORMACOL ® is a drug based on gum sterculia, obtained by collecting the dried exudate from the stem and branches of Sterculia, a plant native to India.

As a mass-forming laxative, once introduced through the alimentary pathway, gum sterculia reaches intestinal level unaltered, being neither digested nor absorbed. Here it is able to retain water in the intestinal lumen, allowing an important increase in fecal mass, with volumes that can even reach 100 times those of departure. This property is not only used for laxative purposes (although it remains the only accepted therapeutic indication to date), but also for dietary purposes, given the possibility of interfering with the absorption of different nutrients and reducing the sensation of appetite.

Studies carried out and clinical efficacy

1. STERCULIA AND CHOLESTEROL

Recent studies are trying to characterize the effects of some natural substances, such as the saponins contained in sterculia. Experimental evidence has shown that this plant, both due to the presence of fibers and saponins, can exert a lipid-lowering action, reducing the dietary absorption of cholesterol.

2. STERCULIA RUBBER And diarrhea

The ability of the rubber sterculia to retain water in the intestinal lumen, and absorb it in the presence of watery stools, makes this particular fiber also useful in the treatment of non-specific diarrhea. This is why various groups are looking for a formulation that can significantly enhance this effect.

3. GUM STERCULIA AND PHARMACOCINETICS

Sterculia gum is a fiber widely used in the treatment of diverticulitis. In addition to its pharmacodynamic characteristics, this compound also owes much of its success to its pharmacokinetic characteristics, which make it today one of the most used excipients in the formulation of prolonged-release gastro-resistant tablets.

Method of use and dosage

NORMACOL ® 10 g sachets containing 6.1 g of Rubber sterculia: the recommended dosage in the symptomatic treatment of constipation involves taking 2-4 sachets a day, to be taken after meals with plenty of water. The laxative effects are enhanced by a diet rich in liquids, able to contribute to the formation of the fecal mass.

It is advisable to start the therapy with the lowest possible dosage, to eventually foresee an increase in case of reduced therapeutic efficacy.

The use of this medicine should not be prolonged for several days without the advice of your doctor; therefore, the intake of NORMACOL ® is found exclusively in the treatment of occasional constipation episodes.

Warnings NORMACOL ® Rubber sterculia

The intake of NORMACOL ® should be preceded and accompanied by compliance with food standards useful for improving the patient's intestinal health, so as to be able to resort to the use of laxatives only in the case of acute episodes of constipation (see diet for constipation) .

Prolonged administration of these medicines could be associated with the onset of profuse diarrhea, dehydration, hypokalaemia, reduction of intestinal motility, up to total atony and relative chronic constipation.

Although NORMACOL ® can be sold without a prescription, it would still be necessary to consult your doctor before use, especially for patients suffering from endocrine-metabolic and cardiovascular diseases.

NORMACOL ® does not interfere with the normal ability to drive vehicles and use machinery.

PREGNANCY AND BREASTFEEDING

To date, the international scientific literature does not allow to evaluate the safety profile of gum sterculia on the health of the unborn child and of the newborn, when taken during pregnancy or during the lactation period. However, the absence of intestinal absorption should prevent this compound from interfering with fetal physiological characteristics. Therefore, the advice remains to use laxatives during pregnancy only when really necessary and under strict medical supervision.

Interactions

The assumption of laxatives, in particular those forming mass, able not only to increase the speed of intestinal transit, but also to directly interfere with the absorption of nutrients and active ingredients, should take place at least two hours after the intake of other drugs, to avoid absorption interference.

Contraindications NORMACOL ® Rubber sterculia

NORMACOL ® is contraindicated in case of hypersensitivity to the active ingredient or to one of the excipients.

The use of laxatives is also contraindicated in case of intense abdominal pains, nausea, vomiting, diarrhea, gastro-intestinal affections, even with acute course, bedridden patients, dehydration and in case of intestinal obstruction.

Undesirable effects - Side effects

NORMACOL ® is a well tolerated drug with no particular side effects.

Generally speaking, the presence of side effects seems to be associated with the distension effect of the abdominal wall, which can be accompanied by abdominal pain, cramps and colic, which tend to regress promptly following the suspension of therapy.

Relevant undesirable effects have been observed following prolonged laxative use, with diarrhea, dehydration, hypokalemia and subsequent intestinal atony and loss of laxative efficacy of the drug.