{"product_id":"dissenten-2-mg-15-compresse","title":"Dissenten 2 mg 15 tablets","description":"\u003cp\u003e\u003cstrong\u003eINDICATIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eDissenten is indicated for the symptomatic treatment of acute diarrhea and exacerbations of chronic diarrhea.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eACTIVE INGREDIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eEach tablet contains: Active ingredient: Loperamide hydrochloride 2 mg. \u003ci\u003e For the full list of excipients, see section 6.1.\u003c\/i\u003e\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEXCIPIENTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eMagnesium stearate; microgranular cellulose.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONTRAINDICATIONS AND SIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eHypersensitivity to the active substance or to any of the excipients. DISSENTEN is contraindicated in children under 6 years of age. DISSENTEN must 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 Campylobacter. 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, discontinue treatment immediately.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOSAGE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThe tablets should be taken with a little liquid. \u003cu\u003eAdults and children aged between 6 and 17\u003c\/u\u003e The starting dose is 2 tablets (4 mg) for adults and 1 tablet (2 mg) for children; then 1 tablet (2 mg) after each subsequent evacuation of unformed (soft) stools. The maximum daily dose for adults is 8 tablets (16 mg). For children the dose must be related to body weight (3 tablets\/20 kg) but must not exceed a maximum of 8 tablets per day. Decrease the dose when stool returns to normal and interrupt treatment in case of constipation. Warning: do not use for more than two days. \u003ci\u003e Children under 6 years of age\u003c\/i\u003e Dissenten should not be used in children under 6 years of age. \u003ci\u003eElderly\u003c\/i\u003e No dose adjustment is necessary in the elderly. \u003ci\u003eKidney damage\u003c\/i\u003e No dose adjustment is necessary in patients with renal impairment. \u003ci\u003eHepatic impairment\u003c\/i\u003e Although no pharmacokinetic data are available in patients with hepatic impairment, DISSENTEN should be used with caution in these patients due to reduced first pass metabolism (see section 4.4 “Special warnings and precautions for use”).\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eCONSERVATION\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eThis medicinal product does not require any special precautions for storage.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eWARNINGS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eTreatment of diarrhea with loperamide hydrochloride is symptomatic only. Whenever an underlying etiology can be determined, specific treatment should be administered when appropriate. Fluid and electrolyte depletion may occur in patients with diarrhea, especially in children. In these cases the most important countermeasure is the administration of adequate replacement therapy based on fluids and electrolytes. It is advisable to suspend treatment with DISSENTEN if there is no improvement in clinical symptoms within 48 hours following the start of therapy and the patient should consult his doctor. 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, isolated cases of constipation with an increased risk of toxic megacolon have been found. Loperamide hydrochloride is subject to extensive 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 reduced first pass metabolism. Therefore, patients with hepatic impairment should be carefully monitored for any signs of central nervous system (CNS) toxicity. In association with overdose, cardiac events including QT interval prolongation, QRS complex prolongation and torsade de pointes have been reported. Some cases have been fatal (see section 4.9). Overdose can manifest the presence of Brugada syndrome. Patients should not exceed the recommended dose and\/or prolong the recommended duration of therapy.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eINTERACTIONS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eNon-clinical data have demonstrated that loperamide is a substrate of P-glycoprotein. Concomitant administration of loperamide (16 mg single dose) with quinidine or ritonavir, both inhibitors of P-glycoprotein, showed 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, showed 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 measured by psychomotor tests (e.g. subjective sleepiness and the Digit Symbol Substitution Test). Concomitant administration of loperamide (16 mg single dose) 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 cytochrome CYP 450 inhibitors is not recommended.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eSIDE EFFECTS\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003ci\u003e \u003cu\u003eAdults and children aged ≥12 years\u003c\/u\u003e \u003c\/i\u003e 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., ≥1% incidence) during 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., ≥1% incidence) were: flatulence (2.8%), constipation (2.2%), nausea (1.2%), and dizziness (1.2%). Table 1 presents the results of 3076 adult subjects 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 dealt with acute diarrhea (N=2755) and 5 with chronic diarrhea (N=321). The frequency categories presented in Table 1 use the following convention: very common (≥1\/10), common (≥1\/100, \u003c1\/10), uncommon (≥1\/1000, \u003c1\/100), rare (≥1\/10,000, \u003c1\/1000) and very rare (\u003c1\/10,000). \u003cb\u003eTable 1\u003c\/b\u003e Frequency of adverse reactions reported with the use of loperamide hydrochloride from clinical trials in adults and children aged ≥12 years\u003c\/p\u003e\n\u003cp\u003eSystem organ class: Indication.\u003c\/p\u003e\n\u003cp\u003eSystem organ class: Acute diarrhea Chronic diarrhea.\u003c\/p\u003e\n\u003cp\u003eSystem organ class: (N=2755) (N=321).\u003c\/p\u003e\n\u003cp\u003eNervous system disorders.\u003c\/p\u003e\n\u003cp\u003eHeadache: Common Uncommon.\u003c\/p\u003e\n\u003cp\u003eDizziness: Uncommon Common.\u003c\/p\u003e\n\u003cp\u003eGastrointestinal disorders.\u003c\/p\u003e\n\u003cp\u003eConstipation, nausea, flatulence: Common Common.\u003c\/p\u003e\n\u003cp\u003eAbdominal pain, abdominal discomfort, dry mouth: Uncommon Uncommon.\u003c\/p\u003e\n\u003cp\u003eUpper abdominal pain, vomiting: Uncommon.\u003c\/p\u003e\n\u003cp\u003eDyspepsia: Uncommon.\u003c\/p\u003e\n\u003cp\u003eAbdominal distension: Rare.\u003c\/p\u003e\n\u003cp\u003ePathologies of the skin and subcutaneous tissue.\u003c\/p\u003e\n\u003cp\u003eRash: Uncommon.\u003c\/p\u003e\n\u003cp\u003e\u003cb\u003eLoperamide hydrochloride, post-marketing adverse reaction data\u003c\/b\u003e Since the loperamide hydrochloride post-marketing ADR determination process did not differentiate between chronic and acute diarrhea indications 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): \u003cb\u003e \u003ci\u003eImmune system disorders:\u003c\/i\u003e \u003c\/b\u003e hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock), anaphylactoid reaction. \u003cb\u003e \u003ci\u003eNervous system disorders:\u003c\/i\u003e \u003c\/b\u003e drowsiness, loss of consciousness, stupor, depressed levels of consciousness, hypertonia, abnormal coordination. \u003cb\u003e \u003ci\u003eEye disorders:\u003c\/i\u003e \u003c\/b\u003e miosis. \u003cb\u003e \u003ci\u003eGastrointestinal disorders:\u003c\/i\u003e \u003c\/b\u003e ileus (including paralytic ileus), megacolon (including toxic megacolon), glossodynia, acute pancreatitis (frequency not known). \u003cb\u003e \u003ci\u003eSkin and subcutaneous tissue disorders:\u003c\/i\u003e \u003c\/b\u003e bullous rash syndrome (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme), angioedema, urticaria, pruritus. \u003cb\u003e \u003ci\u003eRenal and urinary disorders:\u003c\/i\u003e \u003c\/b\u003e urinary retention. \u003cb\u003e \u003ci\u003eSystemic disorders and conditions relating to the administration site:\u003c\/i\u003e \u003c\/b\u003e fatigue. \u003ci\u003e \u003cu\u003ePediatric population\u003c\/u\u003e \u003c\/i\u003e 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. Overall, the ADR profile 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 suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit\/risk balance 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\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eOVERDOSE\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003e\u003ci\u003e \u003cu\u003eSymptoms\u003c\/u\u003e \u003c\/i\u003e In case of overdose, including that caused by hepatic dysfunction, CNS depression (stupor, coordination abnormalities, drowsiness, miosis, muscle hypertonia, respiratory depression), urinary retention and ileus may occur. In subjects who have ingested excessive doses of loperamide, cardiac events such as prolongation of the QT interval and that of the QRS complex, torsade de pointes, other serious ventricular arrhythmias, cardiac arrest and syncope have been observed (see section 4.4). Fatal cases have also been reported. Overdose can manifest the presence of Brugada syndrome. Children may be more sensitive than adults to the effects of a loperamide overdose. It is therefore recommended to keep the product out of their reach because accidental ingestion, especially in children under 4 years of age, can cause constipation and depression of the central nervous system with drowsiness and slowing of breathing. In this case the child must be kept under careful observation for 48 hours. \u003ci\u003e \u003cu\u003eTreatment\u003c\/u\u003e \u003c\/i\u003e Measures in case of overdose: gastric lavage, provocation of vomiting, enema or administration of laxatives. If symptoms of overdose arise, naloxone may be administered 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 must be carefully monitored for at least 48 hours to detect any worsening of central nervous system depression.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003ePREGNANCY AND BREASTFEEDING\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eAlthough there is no indication that loperamide hydrochloride possesses teratogenic or embryotoxic properties, the anticipated therapeutic benefits should be weighed against the potential risks before administering loperamide hydrochloride during pregnancy, especially during the first trimester. Small amounts of loperamide may appear in human breast milk. Therefore loperamide hydrochloride is not recommended during breastfeeding.\u003c\/p\u003e\n\u003cp\u003e \u003c\/p\u003e\n\u003cp\u003e\u003cstrong\u003eEFFECTS ON DRIVING ABILITY\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp\u003eIn the context of diarrheal syndromes treated with loperamide hydrochloride, tiredness, dizziness or drowsiness may occur. Therefore, caution is advised when driving a vehicle or operating machinery.\u003c\/p\u003e","brand":"Spa Prodotti Antibiotici","offers":[{"title":"Default Title","offer_id":51730208325959,"sku":"023694058","price":9.58,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0564\/4989\/2467\/files\/spa-soc-pro-antibiotici-spa-dissenten-2-mg-15-compresse-farmacia-dottor-tili-1213791077.jpg?v=1767154271","url":"https:\/\/www.dottortili.com\/en-eu\/products\/disentenden-2-mg-15-tablets","provider":"Farmacia Dottor Tili","version":"1.0","type":"link"}