DIARSTOP 20CPS 1.5MG

DIARSTOP 1.5 MG CAPSUDE

active ingredients

Each capsule contains: Loperamide Hydrochloride 1.5 mg Eccipients with known effects: Lactose monohydrate: 85.2 mg For the full list of excipients, see paragraph 6.1

Excellent

Lactose monohydrate, Corn starch, Talco, Magnesium stearate, Gelatin, Glycerine, Eritrosina (E 127), Indigotin (E 132), Yellow iron oxide (E 172), Black iron oxide (E 172), Titanium dioxide.

Therapeutic indications

DIARSTOP is indicated for the symptomatic treatment of acute diarrhee.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Pregnancy and nursing (see paragraph 4.6). It is contraindicated in children under 12 years. It should not be used in cases where normal intestinal motility should be maintained.

Population

Population Adults: the recommended initial dose is 2 capsules to be taken at the same time, one after the other. After the initial dose take 1 capsule after each evacuation of soft feces (not formed). Maximum daily dose is 8 capsules. The capsules should not be chewed, but swallowed with little water or other drink. Do not exceed the recommended doses. Attention: do not use for more than two days. After this period without appreciable results, stop treatment and consult your doctor. Decrease the dose as the feces normalize and stop the treatment in case of stips. Pediatric population The use of DIARSTOP is contraindicated in children under 12 years old (See paragraph 4.3)

Conservation

No special education.

Warnings

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. In association with overdose, heart events were reported including the extension of the QT range and the QRS complex, point torsion. Some cases were fatal (see paragraph 4.9). Overdose can make the presence of Brugada syndrome manifest. Patients should not exceed the recommended dose and/or do not protract the duration of therapy. Pediatric population Keeping the medicine out of the reach of children, since an accidental ingestion in childhood age, especially under 4 years, can cause constipation and depression of the central nervous system with drowsiness and slowing breathing. In this case, the patient must be kept under observation for 48 hours by the doctor, to highlight a possible aggravation of the depression of the central nervous system.Important information about some excipients Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose mal absorption, should not take this medicine.

Interactions

Possible interactions can occur with drugs that slow intestinal peristalsis (e.g. anti-linergics), as the effects of loperamide could be enhanced. We do not recommend the concomitant use of cytochrome inhibitors CYP450 and glycoprotein inhibitors P.

Effects

No secondary effects were observed except for some rare case of modest abdominal dolorability and dry mouth. Gastrointestinal pathologies: acute pancreatis (frequency not known) Reporting of suspicious adverse reactions The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

In case of overdose, including that caused by hepatic dysfunction, depression of the SNC can occur (stupor, uncoordinated movements, drowsiness, myosis, muscle hypertonia, respiratory depression) and constipation. In subjects who have ingested excessive doses of loperamide, cardiac events were observed such as extension of the QT range and the QRS complex, point torsion, other severe ventricular arrhythmias, cardiac arrest and syncope (see paragraph 4.4). Fatal cases have also been reported. Overdose can make the presence of Brugada syndrome manifest. Measures in case of overdose: gastric lavender, vomiting, clisma or laxative administration. Urgent measures: inject naloxone; if necessary, repeat the injection of naloxone after 1-3 hours and monitor the patient for at least 48 hours to highlight a possible aggravation of the depression of the central nervous system. Pediatric population Children are more sensitive to the effects of overdose of loperamide than adults. Therefore it is recommended to keep the medicine outside of their reach because an accidental ingestion, especially in children under 4 years, can cause stipsis and depression of the central nervous system with drowsiness and slowing breathing. In this case the patient must be kept under careful observation for 48 hours.

The product is contraindicated in pregnant women and during nursing.

Source: Farmadati