12CPR2MG

ENTEROG ANTIDIARRO

active ingredients

Each tablet contains: Active ingredient: loperamide hydrochloride 2 mg. Excipient with known effect: lactose monohydrate. For the full list of excipients, see paragraph 6.1.

Excellent

Lactose monohydrate, calcium phosphate dibasic dihydrate, microcrystalline cellulose, talc, corn starch, magnesium stearate.

Therapeutic indications

Syntomatic treatment of acute diarrhea.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1. Pregnancy and lactation (See paragraph 4.6 “Gravidence and lactation”). Not to be used in children under 12 years of age. ENTEROG ANTIDIARROICO should not be used in the following cases: - presence of blood in the feces and high fever; - inflammation of the lower part of the intestine (e.g. ulcerative colitis or pseudomembranous colitis following antibiotic therapy); - constipation or meteorism (presence of air in the stomach); - in all cases where an inhibition of intestinal motility must be avoided.

Population

Posology 2 tablets as an attack dose followed by 1 tablet after each discharge up to a maximum of 8 tablets per day. Stop the treatment if you no longer have bowel movements for 24 hours. Caution: do not use for more than two days. In fact, in sudden episodes of acute diarrhea ANTIDIARROICO is generally able to stop symptoms in 48 hours. Pediatric population The product is contraindicated in children under 12 years of age. How to administer swallow the tablet with a little water. Don't chew. Use this medication only as recommended. Do not exceed the recommended doses or duration of treatment.

Conservation

This medicine does not require any special condition of conservation.

Warnings

During diarrhea a loss of liquids and electrolytes may occur which may require adequate rehydration. Patients with ulcerative colitis must use the drug with caution and stop treatment in case of appearance of abdominal distension. Consult a doctor if symptomatology is not resolved or improved after two days. Suspend the use of the drug in case of appearance of stips. 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 recommended duration of therapy. Hepatopathic patients should take the drug under medical control as the drug is inactive from the liver. Loperamide must be used with caution in young subjects due to the great variability of response. In particular, children can more easily manifest a dehydration that makes the response to the drug even more variable. Patients who have been treated with antibiotics in the previous weeks should contact their doctor before starting treatment with antidiarrhosis. Cases of abuse and misuse were reported with Enterog Antidiarroico, used as a substitute for opioids, in individuals with opioid dependence (see par.4.9). Therefore it is recommended caution in patients with anamnesi of drug abuse or if used in association with other drugs with potential abuse. Acute pancreatititis can be observed in patients taking loperamide. Patients should be informed about the characteristic symptoms of acute pancreatis. If a pancreatitis is suspected, the administration of the drug must be stopped; if confirmed, the drug should not be resumed. Caution is recommended in patients with cholecystectomy anamnesis or pancreatitis. Important information about some excipients ENTEROG ANTIDIARRO contains lactose: patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose mal absorption, should not take this medicine. ENTEROG ANTIDIARRO contains sodium: this medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially ‘without sodium’.

Interactions

Possible with drugs having pharmaceutical properties similar to those of loperamide or drugs that can slow down intestinal peristalsis (e.g. anti-linergic), as the effects of ANTIDIARROICO ENTEROG could be enhanced.

Effects

If ANTIDIARROIC ENTEROG is correctly assumed the unwanted effects are few and modest. The following effects may occur: - constipation and meteorism and/or abdominal distension. In very rare cases and in which the product has not been used correctly, these last effects may be associated with intestinal occlusion; - hypersensitivity reactions (e.g. skin rashes, itching, dispnea or facial edema); - other effects that are usually difficult to distinguish from those associated with diarrhoic syndrome such as: pain or feeling of abdominal discomfort, nausea and vomiting, fatigue, dizziness or stunness, dry mouth; - acute pancreatitis with unknown frequency (see paragraph 4.4). 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 “ https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse”.

Overdosing

Synonyms In case of overdose (absolute, for accidental intake of excessive or relative doses, for accumulation in the blood of the non-metabolized drug, while administered at the correct doses), including an overdose related to liver dysfunction, can manifest depression of the SNC (stupor, disorderly movements, drowsiness, muscle hypertonia, respiratory depression) and intestinal occlusion. In subjects with excessive doses of loperamide, cardiac events such as the extension of the QT range and that of the QRS complex, point torsion, other severe ventricular arrhythmias, cardiac arrest and syncope (see paragraph 4.4) were observed. Fatal cases have also been reported. Overdose can make the presence of Brugada syndrome manifest. Pediatric population Children are more sensitive than adults to the effects of ANTIDIARROIC ENTEROG overdose. Therefore it is recommended to keep the product out of their reach because an accidental ingestion, especially in children under 4 years can cause stips and depression of the central nervous system with drowsiness and slowing breathing. Treatment To administer nalossone and possibly repeat the treatment after 1-3 hours as ANTIDIARROICO ENTEROG has a longer duration of action than that of the antidote. It would be appropriate, then, to monitor the patient for at least 48 hours to highlight a possible aggravation of the depression of the central nervous system.

The use of ANTIDIARROIC ENTEROG is not recommended during the first trimester of pregnancy and during breastfeeding. In the second and third quarter the product must be used only in case of actual need and under the direct control of the doctor.

Source: Farmadati