Imodium capsules 2 mg blister 20 pcs.

• active ingredient: loperamide;
• 1 capsule contains 2 mg of loperamide hydrochloride;
• excipients: lactose monohydrate, corn starch, talc, magnesium stearate; capsule shell: yellow iron oxide (E 172), black iron oxide (E 172), titanium dioxide (E 171), indigo carmine (E 132), erythrosine (E 127), gelatin.

Imodium is contraindicated:

• patients with known hypersensitivity to loperamide hydrochloride or to any of the components of the drug;
• 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 should not be used at all if it is necessary to avoid inhibition of peristalsis due to the 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 common adverse reactions occurring at a frequency of 1% or more and reported in these clinical studies were constipation (2.7%), flatulence (1.7%), headache (1.2%), and nausea (1.1%).

From the nervous system: often – headache; infrequently – dizziness, drowsiness; rarely – loss of consciousness, stupor, depression of consciousness, hypertension, impaired coordination.

From the digestive tract: often – constipation, bloating, nausea; infrequently – abdominal pain and discomfort, dry mouth, upper abdominal pain, vomiting, dyspepsia; rarely – intestinal obstructiona (including paralytic ileus), megacolon (including toxic megacolonb), feeling of abdominal distension; frequency unknown – acute pancreatitis.

Symptomatic treatment of acute diarrhea in adults and children aged 12 years and over

The initial dose is 2 capsules (4 mg), then 1 capsule (2 mg) after each subsequent loose stool. The usual dose is 3–4 capsules (6–8 mg) per day. The total daily dose should not exceed 6 capsules (12 mg).

Symptomatic treatment of acute episodes of diarrhea due to irritable bowel syndrome in adults (aged 18 years and over) after initial diagnosis by a physician

The initial dose is 2 capsules (4 mg); then take 1 capsule (2 mg) after each subsequent loose stool or as previously recommended by your doctor. The maximum daily dose should not exceed 6 capsules (12 mg).

For oral use. Capsules should be taken with liquid.

Use during pregnancy or breastfeeding

As with all medicines, it is not recommended to use Imodium® during pregnancy, especially during the first trimester.

Since small amounts of loperamide may appear in breast milk, loperamide hydrochloride is not recommended for use during breastfeeding.

In this regard, pregnant and breastfeeding women should be advised to consult their doctor for appropriate treatment.

Children

The drug should be used in children aged 12 years and older for the symptomatic treatment of acute diarrhea.

Ability to influence reaction speed when driving vehicles or other mechanisms

Loss of consciousness, depressed level of consciousness, increased fatigue, dizziness or drowsiness in diarrhea syndrome are possible when using loperamide hydrochloride. Therefore, it is recommended to take this drug with caution when driving a car or operating machinery.

In case of overdose (including relative overdose due to impaired liver function), CNS depression (stupor, incoordination, drowsiness, miosis, muscle hypertonia and respiratory depression), constipation, urinary retention and intestinal obstruction are possible. Children and patients with impaired liver function may be more sensitive to CNS effects.

In individuals who exceeded the doses of loperamide, cardiac complications were observed: prolongation of the QT interval and QRS complex, torsades de pointes (pirouette type) and other serious ventricular arrhythmias, cardiac arrest and syncope.

Fatal cases have also been reported. Overdose may reveal existing Brugada syndrome.

Treatment

In case of overdose, ECG monitoring should be initiated to detect QT prolongation. If CNS symptoms of overdose occur, naloxone can be used as an antidote. Since the duration of action of loperamide hydrochloride is longer than that of naloxone (1–3 hours), repeated administration of naloxone may be necessary. The patient should be closely monitored for possible central nervous system depression for at least 48 hours.

Drugs that have a depressing effect on the central nervous system should not be used simultaneously with Imodium for children.

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 loperamide plasma concentrations. In the same study, the CYP2C8 inhibitor gemfibrozil increased loperamide exposure by approximately 2-fold. Combined administration of itraconazole and gemfibrozil resulted in a 4-fold increase in maximum plasma loperamide concentrations and a 13-fold increase in total plasma exposure. This increase was not associated with central nervous system (CNS) effects as measured by psychomotor tests (i.e. subjective drowsiness and digit 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 desmopressin concentrations, likely due to slower gastrointestinal motility.

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

Store at a temperature not exceeding 25C in a place inaccessible to children.