Dissenten 2 Mg 15 Tablets

Dissenten is indicated for the symptomatic treatment of acute diarrhea and exacerbations of chronic diarrhea.

Dosage and method of use
Dissenten should be taken in the following doses and methods: the tablets should be taken with a little liquid.

Adults and children aged 6-17 years: the starting dose is 2 tablets (4 mg) for adults and 1 tablet (2 mg) for children; thereafter 1 tablet (2 mg) after each subsequent evacuation of unformed (soft) faeces. The maximum daily dose for adults is 8 tablets (16 mg). For children, the dose should be related to body weight (3 tablets / 20 kg) but should not exceed a maximum of 8 tablets per day. Decrease the dose when the stool is normalized and stop treatment in case of constipation. Warning: do not use for more than two days.
Children under 6 years of age: Dissenten should not be used in children under 6 years of age.
Elderly: No dose adjustment is required in the elderly.
Renal impairment: No dose adjustment is required in patients with renal impairment.
Hepatic impairment: Although no pharmacokinetic data are available in patients with hepatic impairment, Dissenten should be used with caution in these patients due to impaired first pass metabolism.
Contraindications

Hypersensitivity to the active substance or to any of the excipients.
DISSENTEN is contraindicated in children under 6 years of age.
DISSENTEN should not be used as primary therapy: in patients with acute dysentery, characterized by blood in the stool and high fever, in patients with acute ulcerative colitis, in patients with pseudomembranous colitis associated with the use of broad-spectrum antibiotics, in patients with enterocolitis bacteria caused by invasive organisms including Salmonella, Shigella and Campilobacter.
In general, the use of DISSENTEN is contraindicated in all cases where inhibition of peristalsis must be avoided due to the possible risk of significant consequences such as ileus, megacolon and toxic megacolon. If constipation, abdominal distension or ileus occurs, stop treatment immediately.
Special warnings
Treatment of diarrhea with loperamide hydrochloride is symptomatic only. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate. Fluid and electrolyte depletion may occur in patients with diarrhea, especially children. In these cases, the most important countermeasure is the administration of adequate fluid and electrolyte replacement therapy.

Treatment with DISSENTEN should be discontinued if no improvement in clinical symptoms occurs within 48 hours after initiation of therapy and the patient should consult their physician. AIDS patients treated with DISSENTEN for diarrhea should discontinue therapy at the first signs of abdominal distension. In these patients with infectious colitis of bacterial or viral origin, treated with loperamide hydrochloride, there have been isolated cases of constipation with an increased risk of toxic megacolon.

Loperamide hydrochloride is subject to an intense first pass metabolism. Although no pharmacokinetic data are available in patients with
hepatic impairment, loperamide hydrochloride should be used with caution in these patients due to impaired first pass metabolism. Therefore, patients with hepatic impairment should be carefully monitored for signs of central nervous system (CNS) toxicity.

Pregnancy and breastfeeding
Although there are no indications that loperamide hydrochloride possesses teratogenic or embryotoxic properties, the anticipated therapeutic benefits must be weighed against the potential risks before administering loperamide hydrochloride during pregnancy, especially during the first trimester. Small amounts of loperamide can appear in human breast milk. Therefore loperamide hydrochloride is not recommended during breastfeeding.

Expiration and retention
Check the expiration date indicated on the package. The expiry date indicated on the package refers to the product in intact packaging, correctly stored. Store at a temperature not lower than + 4 ° C. Keep the bottle tightly closed.

Warning: do not use the medicine after the expiry date indicated on the package.

Composition
Dissenten contains:
Active ingredient: Loperamide hydrochloride 2 mg
Excipients: Magnesium stearate; microgranular cellulose.

Dissenten 2 Mg in packs of 15 Tablets