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EAN code
Italian Ministry of Health Code:
Medical device class: II a
Italian National Classification of Medical Devices (CND): G99 &#; medical devices for the gastrointestinal system &#; others
GMDN:
COMPOSITION
3.0 g per dose of highly palatable, preservative-free Diosmectite.
PACKAGING
box containing 20 doses (bags). Excellent palatability.
FLAVOUR
citrus.
ACTION
Diosmectite is a special type of clay characterised by its structure made up of fine overlapping lamallae, which gives it a highly thickening and absorbing power, making it capable of incorporating the liquids present in the intestinal lumen, increasing stool consistency and slowing faecal transit and expulsion. Stopper may adsorb and neutralise microorganisms, endotoxins, food, drugs, bile salts, contaminating catabolites and waste material involved in the aetiology of diarrhoea symptoms. Stopper produces a coating film, which protect the intestinal mucosa.
INDICATIONS
Acute diarrhoea caused by toxin-mediated infection (viral, bacterial); traveller&#;s diarrhoea. Chronic diarrhoea related to irritable bowel syndrome or chronic inflammatory bowel disease. Diarrhoea related to chemotherapy or radiotherapy. Diarrhoea related to short bowel syndrome caused by colorectal surgery (intestinal anastomosis, ileo-anal anastomosis, colo-anal anastomosis with impaired continence, etc.). Diarrhoea following bariatric surgery (malabsorptive surgical procedures). Mild-to moderate faecal incontinence related to pelvic floor syndrome. Diarrhoea related to autonomic neuropathy.
In cases where diarrhoea leads to dehydration, Stopper can be advantageously used in combination with Idraton 245 (see data sheet that follows).
DOSAGE, TIMING AND MODE OF ADMINISTRATION FOR ADULTS
The amount of Stopper to be taken daily is highly variable and dependent upon individual patient conditions and/or Physician's opinion. As a general guide:
&#; For acute diarrhoea: 1-2 doses after each discharge.
&#; For bowel incontinence and chronic diarrhoea: 1-3 doses per day, starting with 1 bag and
increasing the dose gradually, to avoid an unbalanced increase in stool consistency.
DOSAGE, TIMING AND MODE OF ADMINISTRATION FOR PAEDIATRIC USE
Children older than 6 years: 2-3 doses per day. Children aged 1 to 6 years: 1-2 doses per day.
INTERACTIONS
Cardiac glycosides, alkaloids, oestrogens, chloroquine, clindamycin, digoxin, lincomycin.
WARNING
Assume Stopper at least 2 hours before or after consumption of other medicines, especially when the consumer is under treatment with any of the drugs listed above. If symptoms do not regress, consult a Physician.
SIDE EFFECTS
Constipation.
PREGNANCY AND BREASTFEEDING
Only if necessary and according to Physician&#;s advice.
DIABETIC SUBJECTS
Permitted.
CELIAC SUBJECTS
Up to date, all the product batches analysed at laboratories accredited by the Italian National Accreditation Institute (ACCREDIA) and the Italian Celiac Association (AIC) have given negative results for gluten (<10 ppm).
CONTRAINDICATIONS
Hypersensitivity to Diosmectite. Diarrhoea caused by pseudomembranous enterocolitis and, in general, by serious organic disorders of the gastroenterological tract.
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