Dissenten antidiarrhea 10 tablets 2mg 043905013

DISSENTEN ANTIDIARREA * 10CPR2MG

Therapeutic indications

Dissenten ANTIDIARREA is indicated for the symptomatic treatment of acute diarrhea.

Dosage and method of use

Adults and children between the ages of 6 and 17The 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.The tablets should be taken with a little liquid.Children under 6 years of ageDISSENTEN ANTIDIARREA should not be used in children under 6 years of age.Elderly peopleNo dose adjustment is necessary in the elderly.Kidney damageNo dose adjustment is necessary in patients with renal impairment.Hepatic impairmentAlthough no pharmacokinetic data are available in patients with hepatic impairment, DISSENTEN ANTIDIARREA should be used with caution in these patients due to impaired first pass metabolism (see section 4.4).

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. DISSENTEN ANTIDIARREA is contraindicated in children under 6 years of age. DISSENTEN ANTIDIARREA 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 bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella and Campilobacter. In general, the use of DISSENTEN ANTIDIARREA 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.

Side effects

Adults and children aged ≥12 years The safety of loperamide hydrochloride was evaluated in 3076 adults and children aged ≥12 years who participated in 31 controlled and uncontrolled clinical trials with loperamide hydrochloride used for the treatment of diarrhea. Of these, 26 studies were on acute diarrhea (N = 2755) and 5 on chronic diarrhea (N = 321). The most commonly reported adverse drug reactions (ADRs) (i.e. with an incidence ≥1%) in clinical trials with loperamide hydrochloride for the treatment of acute diarrhea were: constipation (2.7%), flatulence ( 1.7%), headache (1.2%) and nausea (1.1%). In clinical trials for the treatment of chronic diarrhea the most commonly reported ADRs (i.e. with an incidence ≥1%) were: flatulence (2.8%), constipation (2.2%), nausea (1.2 %) and dizziness (1.2%). Table 1 presents the results of 3076 adult and child subjects ≥12 years of age who participated in 31 controlled and uncontrolled clinical trials with loperamide hydrochloride used for the treatment of diarrhea. Of these, 26 studies involved acute diarrhea (N = 2755) and 5 chronic diarrhea (N = 321). The frequency categories presented in Table 1 use the following convention: very common (≥1 / 10), common (≥1 / 100, Table 1 Frequency of adverse reactions reported with the use of loperamide hydrochloride from clinical studies in adults and children aged ≥12 years

Loperamide hydrochloride, post-marketing adverse reaction data

Since the post-marketing ADR determination process of loperamide hydrochloride did not differentiate between indications of chronic and acute diarrhea or between adults and children, the adverse reactions listed below represent the combined indications and subject populations. Adverse reactions identified in the post-marketing period for loperamide hydrochloride are listed through the System Organ Class and the Medical Dictionary for Regulatory Activities (MeDRA) under Preferred Terms (PT): Immune system disorders: hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock), anaphylactoid reaction. Nervous system disorders: drowsiness, loss of consciousness, stupor, depression of consciousness levels, hypertonia, abnormal coordination. Eye disorders: miosis. Gastrointestinal disorders:ileus (including paralytic ileus), megacolon (including toxic megacolon), glossodynia, acute pancreatitis (frequency not known). Skin and subcutaneous tissue disorders:bullous rash syndrome (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme), angioedema, urticaria, pruritus. Renal and urinary disorders:urinary retention. General disorders and administration site conditions: fatigue. Pediatric population The safety of loperamide hydrochloride was evaluated in 607 patients aged 10 days to 13 years who participated in 13 controlled and uncontrolled clinical trials with loperamide hydrochloride used for the treatment of acute diarrhea. In general, the profile of ADRs in this patient population was similar to that observed in clinical trials with loperamide hydrochloride in adults and children aged 12 years and older. Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse

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 ANTIDIARREA should be discontinued if there is no improvement in clinical symptoms within 48 hours after starting therapy and the patient should consult their doctor. AIDS patients treated with DISSENTEN ANTIDIARREA 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 intense first pass metabolism. The drug should be used with caution in patients with hepatic insufficiency as it may lead to relative overdose with CNS toxicity. In children between 6 and 12 years DISSENTEN ANTIDIARREA should only be used under medical supervision. Cardiac events including QT interval prolongation and QRS complex prolongation, torsades de pointes have been reported in association with overdose. Some cases had a fatal outcome (see section 4.9). Overdose can make the presence of Brugada syndrome manifest. Patients should not exceed the recommended dose and / or extend the recommended duration of therapy.

Pregnancy and breastfeeding

The administration of DISSENTEN ANTIDIARREA during pregnancy and lactation is not recommended. Pregnant or lactating women should therefore consult their doctor for appropriate treatment.

Expiration and retention

No special storage precautions.

Interactions with other drugs

Non-clinical data demonstrated that loperamide is a substrate of P-glycoprotein. Concomitant administration of loperamide (single 16 mg dose) with quinidine or ritonavir, both of which are inhibitors of P-glycoprotein, resulted in a 2 to 3-fold increase in plasma levels of loperamide. The clinical relevance of this pharmacokinetic interaction with P-glycoprotein inhibitors when loperamide is administered at recommended doses is unknown. Concomitant administration of loperamide (4 mg single dose) and itraconazole, an inhibitor of CYP3A4 and P-glycoprotein, resulted in a 3 to 4-fold increase in plasma concentrations of loperamide. In the same study, gemfibrozil, a CYP2C8 inhibitor, increased plasma concentrations of loperamide approximately 2-fold. The combination of itraconazole and gemfibrozil showed a 4-fold increase in peak plasma levels of loperamide and a 13-fold increase in total plasma exposure. These increases were not associated with central nervous system (CNS) effects, as detected by psychomotor tests (e.g. subjective sleepiness and the Digit Symbol Substitution Test). Concomitant administration of loperamide (single dose of 16 mg) and ketoconazole, an inhibitor of CYP3A4 and P-glycoprotein, resulted in a 5-fold increase in plasma concentrations of loperamide. This increase was not associated with an increase in pharmacodynamic effects, as detected by pupillometry. Concomitant treatment with oral desmopressin resulted in a 3-fold increase in plasma concentrations of desmopressin, presumably due to a slowing of gastrointestinal motility. Treatment with substances with similar pharmacological properties can enhance the effect of loperamide and drugs that accelerate intestinal transit can decrease its effect. Concomitant use of CYP 450 inhibitors is not recommended.

Overdose

Symptoms In the event of overdose, including that caused by hepatic dysfunction, CNS depression (stupor, coordination abnormalities, somnolence, miosis, muscle hypertonia, respiratory depression), urinary retention and ileus may occur. Cardiac events such as prolongation of the QT interval and prolongation of the QRS complex, torsade de pointes, other severe ventricular arrhythmias, cardiac arrest and syncope have been observed in subjects who ingested excessive doses of loperamide (see section 4.4). Fatal cases have also been reported. Overdose can make the presence of Brugada syndrome manifest. Children may be more sensitive than adults to the effects of a loperamide overdose. Therefore it is recommended to keep the product out of their reach because accidental ingestion, especially in children under 4 years old, can cause constipation and central nervous system depression with drowsiness and slowed breathing. In this case, the child must be kept under careful observation for 48 hours. Treatment Measures in case of overdose: gastric lavage, induction of vomiting, enema or administration of laxatives. If symptoms of overdose develop, naloxone can be given as an antidote. Since the duration of action of loperamide is longer than that of naloxone (1 to 3 hours), repeated treatment with naloxone may be indicated. Therefore the patient should be monitored closely for at least 48 hours for any aggravation of central nervous system depression.

Active principles

Each tablet contains: Active ingredient: Loperamide hydrochloride 2 mgFor the full list of excipients, see section 6.1.

Excipients

Magnesium stearate; microgranular cellulose.