Imodium Duo tablets 6 pcs

Symptomatic treatment of acute diarrhoea in adults and adolescents aged 12 years and over, when acute diarrhoea is accompanied by gas-related abdominal discomfort, including bloating, cramps and flatulence.

• active ingredients: loperamide hydrochloride, simeticone;
• 1 tablet contains loperamide hydrochloride 2 mg and simethicone equivalent to polydimethylsiloxane 125 mg;
• excipients: calcium hydrogen phosphate, microcrystalline cellulose, acesulfame potassium, artificial vanilla flavor (includes propylene glycol, maltodextrin and benzyl alcohol), sodium starch glycolate (type A), stearic acid.

Imodium Duo is contraindicated:

• patients with known hypersensitivity to loperamide hydrochloride, simethicone or any of the components of the drug, to prevent severe skin manifestations, including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme;
• children under 12 years of age;
• patients with acute dysentery, characterized by the presence of blood in the stool and elevated body temperature;
• patients with acute ulcerative colitis or pseudomembranous colitis associated with the use of broad-spectrum antibiotics;
• patients with bacterial enterocolitis caused by microorganisms of the Salmonella, Shigella and Campylobacter families.

IMODIUM DUO should not be used at all if it is necessary to avoid inhibition of peristalsis due to the possible risk of significant complications, including intestinal obstruction, megacolon and toxic megacolon.

The drug should be discontinued immediately if constipation, bloating, or intestinal obstruction develops.

The most frequently reported adverse reactions (ARs) (i.e., with a frequency ≥ 1%) in clinical trials were (percentage frequency): dysgeusia (2.6%) and nausea (1.6%).

The most commonly (> 1%) reported adverse reactions in these clinical trials were constipation (2.7%), flatulence (1.7%), headache (1.2%), and nausea (1.1%).

The most commonly (> 1%) reported adverse reactions in these clinical trials were flatulence (2.8%), constipation (2.2%), dizziness (1.2%), and nausea (1.2%).

Nervous system disorders: common: headache, dysgeusia; uncommon: drowsiness, dizziness; rare: loss of consciousness, depression of consciousness, stupor, hypertonia, impaired coordination.

Adults aged 18 and over

Initially take 2 tablets, then 1 tablet after each loose bowel movement. Do not take more than 4 tablets per day for longer than 2 days.

Adolescents aged 12 to 18 years

Initially, take 1 tablet, then 1 tablet after each loose bowel movement. Do not take more than 4 tablets per day for longer than 2 days.

Swallow the tablets whole with water.

Use during pregnancy or breastfeeding

The safety of use in women during pregnancy has not been established, although animal studies have not shown teratogenic or embryotoxic properties of loperamide or simethicone. IMODIUM DUO should not be used during pregnancy, especially during the first trimester, unless clinically justified.

Small amounts of loperamide may pass into human breast milk. Therefore, the use of IMODIUM DUO is not recommended during breastfeeding.

Children

The drug is used in children over 12 years of age.

IMODIUM DUO has no or negligible influence on the ability to drive and use machines. However, fatigue, dizziness and drowsiness may occur during treatment with loperamide hydrochloride for diarrheal syndromes. Therefore, caution is recommended when driving or operating machinery.

In case of overdose (including relative overdose due to impaired liver function), central nervous system depression (stupor, incoordination, drowsiness, miosis, muscle hypertonia, respiratory depression), dry mouth, abdominal discomfort, nausea and vomiting, constipation, urinary retention and paralytic ileus may occur. Children and patients with impaired liver function may be more sensitive to CNS effects.

Cardiac adverse reactions such as QT and QRS prolongation, torsades de pointes, other serious ventricular arrhythmias, cardiac arrest and syncope have been reported in patients who have taken excessive doses of loperamide. Fatalities have also been reported. Overdose may precipitate pre-existing Brugada syndrome.

In case of overdose, ECG monitoring should be initiated. If symptoms of overdose occur, naloxone can be administered as an antidote. Since the duration of action of loperamide is longer than that of naloxone (1 to 3 hours), retreatment with naloxone may be indicated. The patient should be closely monitored for at least 48 hours for possible CNS depression. Children may be more sensitive to CNS effects than adults.

Interactions have been reported with drugs with similar pharmacological properties. Drugs that depress the central nervous system should not be used in children simultaneously with IMODIUM DUO.

Preclinical studies have shown that loperamide is a substrate for P-glycoprotein. Concomitant administration of loperamide (16 mg single dose) and quinidine or ritonavir, which are P-glycoprotein inhibitors, resulted in a 2- to 3-fold increase in loperamide plasma concentrations. The clinical significance of this pharmacokinetic interaction with P-glycoprotein inhibitors at recommended doses of loperamide is unknown.

Concomitant administration of loperamide (4 mg once daily) and itraconazole, a CYP3A4 and P-glycoprotein inhibitor, resulted in a 3- to 4-fold increase in loperamide plasma concentrations. In the same study, gemfibrozil, a CYP2C8 inhibitor, increased loperamide concentrations by approximately 2-fold. The combination of itraconazole and gemfibrozil resulted in a 4-fold increase in maximum plasma loperamide concentrations and a 13-fold increase in total plasma exposure. These increases were not accompanied by central nervous system (CNS) effects as measured by psychomotor tests (i.e. 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 loperamide plasma concentrations. This increase was not accompanied by an increase in pharmacodynamic effects as determined by pupillometry.

Concomitant treatment with oral desmopressin resulted in a 3-fold increase in plasma desmopressin concentrations, probably due to decreased gastrointestinal motility.

It is expected that drugs with similar pharmacological properties may enhance the effect of loperamide, and drugs that accelerate gastrointestinal transit may reduce its effect.

Since simethicone is not absorbed from the gastrointestinal tract, no significant interactions between simethicone and other drugs are expected.

This medicinal product does not require any special storage conditions. Keep out of the reach of children.