Dissenten 2 mg 15 tablets

Dissenten 2 mg 15 tablets is an antidiarrheal medicine based on loperamide hydrochloride , specifically formulated for the symptomatic treatment of acute diarrhea and exacerbations of chronic diarrhea . Thanks to its targeted action, Dissenten works by slowing down intestinal movements and promoting the restoration of normal stool consistency, thus helping to stop diarrhea quickly and effectively. The 2 mg tablets are convenient to take and suitable for both adults and children aged 6 years and over, offering a reliable solution for those suffering from sudden or persistent intestinal disorders .

The active ingredient loperamide acts directly on the intestinal muscles, reducing the frequency and urgency of bowel movements, without interfering with the underlying cause of diarrhea. Dissenten is particularly indicated for those who need a diarrhea medication that is effective in both acute forms and exacerbations of chronic diarrhea , ensuring rapid relief from symptoms and improving the quality of daily life. The tablet formulation facilitates treatment management even when away from home, making Dissenten an ideal choice for those looking for antidiarrheal tablets of proven efficacy.

Thanks to its targeted action and the proven efficacy of the active ingredient loperamide , Dissenten 2 mg 15 tablets represents a reference solution for the treatment of diarrhea and intestinal disorders , offering rapid and safe support for the well-being of the digestive system.

ACTIVE INGREDIENTS

Active ingredients contained in Dissenten 2 mg 15 tablets - What is the active ingredient in Dissenten 2 mg 15 tablets?

Each tablet contains: Active substance: Loperamide hydrochloride 2 mg. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Dissenten 2 mg 15 tablets - What does Dissenten 2 mg 15 tablets contain?

Magnesium stearate; microgranular cellulose.

DIRECTIONS

Therapeutic indications Dissenten 2 mg 15 tablets - Why is Dissenten 2 mg 15 tablets used? What is it used for?

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

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Dissenten 2 mg 15 tablets - When should Dissenten 2 mg 15 tablets not be used?

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, characterised 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 occur, discontinue treatment immediately.

DOSAGE

Quantity and method of taking Dissenten 2 mg 15 tablets - How to take Dissenten 2 mg 15 tablets?

The tablets should be taken with some liquid. Adults and children aged 6 to 17 years The initial 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 loose (soft) stools. 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. Reduce the dose when stools normalize and stop treatment in case of constipation. Caution: 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 necessary in the elderly. Renal impairment No dose adjustment is necessary 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 reduced first-pass metabolism (see section 4.4 “Special warnings and precautions for use”).

CONSERVATION

Storage Dissenten 2 mg 15 tablets - How to store Dissenten 2 mg 15 tablets?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Dissenten 2 mg 15 tablets - About Dissenten 2 mg 15 tablets it is important to know that:

Treatment of diarrhoea 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 diarrhoea, especially in children. The most important countermeasure in these cases is the administration of adequate fluid and electrolyte replacement therapy. If there is no improvement in clinical symptoms within 48 hours of starting therapy, treatment with DISSENTEN should be discontinued and the patient should consult his or her physician. AIDS patients treated with DISSENTEN for diarrhoea should discontinue therapy at the first sign of abdominal distension. Isolated cases of constipation with an increased risk of toxic megacolon have been reported in these patients with infectious colitis of bacterial or viral origin treated with loperamide hydrochloride. 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 signs of central nervous system (CNS) toxicity. Cardiac events including QT prolongation, QRS prolongation, and torsade de pointes have been reported in association with overdose. Some cases have been fatal (see section 4.9). Overdose may unmask the presence of Brugada syndrome. Patients should not exceed the recommended dose and/or duration of therapy.

INTERACTIONS

Interactions Dissenten 2 mg 15 tablets - Which medicines or foods can modify the effect of Dissenten 2 mg 15 tablets?

Nonclinical data have shown that loperamide is a substrate of P-glycoprotein. Co-administration of loperamide (16 mg single dose) with quinidine or ritonavir, both inhibitors of P-glycoprotein, showed a 2- to 3-fold increase in loperamide plasma levels. The clinical relevance of this pharmacokinetic interaction with P-glycoprotein inhibitors, when loperamide is administered at the recommended doses, is unknown. Co-administration of loperamide (4 mg single dose) with itraconazole, an inhibitor of CYP3A4 and P-glycoprotein, showed a 3- to 4-fold increase in loperamide plasma concentrations. In the same study, gemfibrozil, an inhibitor of CYP2C8, increased loperamide plasma concentrations by approximately 2-fold. The combination of itraconazole and gemfibrozil resulted in 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 drowsiness 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 measured 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 may potentiate the effect of loperamide and drugs that accelerate intestinal transit may decrease its effect. Concomitant use of cytochrome CYP 450 inhibitors is not recommended.

SIDE EFFECTS

Like all medicines, Dissenten 2 mg 15 tablets can cause side effects - What are the side effects of Dissenten 2 mg 15 tablets?

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 diarrhoea. Of these, 26 studies were in acute diarrhoea (N=2755) and 5 in chronic diarrhoea (N=321). The most commonly reported adverse drug reactions (ADRs) (i.e. with an incidence ≥1%) during clinical trials with loperamide hydrochloride for the treatment of acute diarrhoea were: constipation (2.7%), flatulence (1.7%), headache (1.2%) and nausea (1.1%). In clinical trials for the treatment of chronic diarrhoea 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 subjects and children aged ≥12 years who participated in 31 controlled and uncontrolled clinical trials with loperamide hydrochloride used for the treatment of diarrhoea. Of these, 26 studies were for acute diarrhoea (N=2755) and 5 for chronic diarrhoea (N=321). The frequency categories presented in Table 1 use the following convention: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000) and very rare (<1/10,000). Table 1 Frequency of adverse reactions reported with the use of loperamide hydrochloride from clinical trials in adults and children aged ≥12 years

Classification by systems and organs	Indication
	Acute diarrhea	Chronic diarrhea
	(N=2755)	(N=321)
Nervous system disorders
Headache	Common	Uncommon
Dizziness	Uncommon	Common
Gastrointestinal disorders
Constipation, nausea, flatulence	Common	Common
Abdominal pain, abdominal discomfort, dry mouth	Uncommon	Uncommon
Upper abdominal pain, vomiting	Uncommon
Dyspepsia		Uncommon
Abdominal distension	Rare
Skin and subcutaneous tissue disorders
Rash	Uncommon

Loperamide hydrochloride, post-marketing adverse reaction data Since the post-marketing ADR determination process for loperamide hydrochloride 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 by System Organ Class and Medical Dictionary for Regulatory Activities (MeDRA) Preferred Terms (PT): Immune system disorders: hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock), anaphylactoid reaction. Nervous system disorders: somnolence, loss of consciousness, stupor, depressed level of consciousness, hypertonia, coordination abnormal. 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 eruption 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. Paediatric population The safety of loperamide hydrochloride has been 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 diarrhoea. In general, 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 authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse

OVERDOSE

Overdose Dissenten 2 mg 15 tablets - What are the risks of Dissenten 2 mg 15 tablets in case of overdose?

Symptoms In case of overdose, including that caused by liver dysfunction, CNS depression (stupor, coordination disorders, drowsiness, miosis, muscle hypertonia, respiratory depression), urinary retention and ileus may occur. Cardiac events such as QT interval prolongation and QRS complex prolongation, torsade de pointes, other serious ventricular arrhythmias, cardiac arrest and syncope have been observed in subjects who have ingested excessive doses of loperamide (see section 4.4). Fatal cases have also been reported. Overdose may reveal the presence of Brugada syndrome. 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 of age, may cause constipation and central nervous system depression with drowsiness and slow breathing. In such cases, the child should be kept under careful observation for 48 hours. Treatment Measures in case of overdose: gastric lavage, vomiting, enema or administration of laxatives. If symptoms of overdose occur, 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 should be carefully monitored for at least 48 hours for evidence of worsening of central nervous system depression.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Dissenten 2 mg 15 tablets.

Although there is no indication that loperamide hydrochloride has 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.

DRIVING AND USE OF MACHINERY

Take Dissenten 2 mg 15 tablets before driving or using machines - Does Dissenten 2 mg 15 tablets affect driving or using machines?

In 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.