IMODIUM * 8CPS 2MG

IMODIUM * 8CPS 2MG

Therapeutic indications

IMODIUM is indicated for the symptomatic treatment of acute diarrhea.

Dosage and method of use

Dosage.Adults:The starting dose is 2 hard capsules or 2 soft capsules or 2 buccal tablets (4 mg). Continue treatment with 1 capsule or 1 tablet (2 mg), after each subsequent evacuation of unformed (soft) faeces. The maximum daily dose is 8 capsules or tablets per day (16 mg). Special populations. Children aged 6-17 years (see section 4.3):The starting dose is 1 hard capsule or 1 soft capsule or 1 buccal tablet (2 mg). Continue treatment with 1 capsule or 1 tablet (2 mg), after each subsequent evacuation of unformed (soft) faeces. The maximum daily dose in children should be based on body weight (3 capsules or tablets / 20 kg), but should not exceed the maximum of 8 capsules or tablets per day (16 mg). There are limited data available regarding the use of loperamide HCl in children below 12 years of age (see section 4.8 “Undesirable effects”).Elderly people:No dose adjustment is necessary in the elderly.Impaired renal function:No dose adjustment is required in patients with impaired renal function.Impaired liver function:Although no data are available in patients with hepatic impairment, loperamide HCl should be used with caution in these patients due to impaired first pass metabolism (see section 4.4 “Special warnings and precautions for use”).Method of administration: IMODIUM 2 mg hard capsules / 2 mg soft capsules: take by mouth with a little water. IMODIUM 2 mg buccal tablets: let the tablet dissolve on the tongue for a few seconds; the tablet will dissolve quickly from the saliva. It does not require the use of water. Caution : Do not use for more than 2 days. In any case, discontinue treatment when stool is normalized, or if you have not had bowel movements for 12 hours, or if constipation appears. In episodes of acute diarrhea, loperamide HCl is generally able to stop symptoms within 48 hours. After this period without appreciable results, stop the treatment and consult your doctor.

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Children under the age of 6. Pregnancy and lactation (see section 4.6 “Pregnancy and lactation”) IMODIUM should not be used as primary therapy: • in acute dysentery characterized by the presence of blood in the stool and high fever; • in patients with acute ulcerative colitis or pseudomembranous colitis due to 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 loperamide HCl is contraindicated in all cases where inhibition of peristalsis has to be initiated due to the possible risk of significant consequences such as ileus, megacolon and toxic megacolon.

Side effects

Adverse reactions reported in clinical studies with loperamide HCl:The safety of Loperamide HCl was evaluated in 3076 adult and child subjects ≥12 years of age who participated in 31 controlled and uncontrolled clinical trials with loperamide HCl used for the treatment of diarrhea. Of these, 26 studies involved acute diarrhea (N = 2755) and 5 chronic diarrhea (N = 321). The most commonly reported adverse drug reactions (ADRs) (i.e. with an incidence ≥1%) in clinical trials with Loperamide HCl for the treatment of acute diarrhea were as follows: 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 as follows: flatulence (2.8%), constipation (2.2%), nausea (1, 2%) and dizziness (1.2%). Table 1 shows the ADRs that have been reported with the use of loperamide HCl in clinical studies (in case of acute or chronic diarrhea) in adults and children aged ≥ 12 years. The frequency of adverse reactions presented in Table 1 is defined using the following convention: Very common (≥1 / 10); Common (≥1 / 100 to Table 1: Adverse reactions reported with the use of loperamide HCl in clinical studies in adults and children aged ≥12 years.

Determination of adverse reactions from post-marketing experience for loperamide HCl does not distinguish between acute and chronic diarrhea indications or adult and child populations; the data collected therefore represent the combination of the indications (acute and chronic diarrhea) and the populations in question (adults and children). Adverse reactions observed during post-marketing experience for loperamide HCl are listed below in Table 2 by System Organ Class, using MedDRA terminology.Table 2: Adverse reactions reported with the use of loperamide HCl in post-marketing experience in adults and children.

The safety of loperamide HCl was evaluated in 607 patients aged 10 days to 13 years, who participated in 13 controlled and uncontrolled clinical trials with loperamide HCl 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 HCl used in adults and children aged 12 years and over.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 http://www.agenziafarmaco.gov.it/content/come-segnalare-unasospetta-reazione-avversa.

Special warnings

Treatment of diarrhea with loperamide HCl is symptomatic only. Therefore, where possible, it is also advisable to intervene on the causes of the disorder. In episodes of acute diarrhea, loperamide HCl is generally able to stop symptoms within 48 hours; after this period without appreciable results, the treatment should be stopped and the patient should be advised of the need to go to the doctor for a consultation. In patients with diarrhea, especially in children, significant loss of fluids and electrolytes may occur. In such cases it can be very important to properly replenish the fluids and electrolytes themselves. Although no pharmacokinetic data are available in patients with hepatic dysfunction, loperamide HCl should be used with caution in these patients due to intense first pass metabolism. The drug should be used with caution in patients with hepatic insufficiency as it can lead to a relative overdose with CNS toxicity. AIDS patients treated with loperamide HCl 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 HCl, there have been isolated cases of intestinal obstruction with an increased risk of toxic megacolon. If constipation or abdominal distension or ileus occurs, stop treatment immediately. There have been reports of abuse and misuse of loperamide, used as a substitute for opioids, in individuals with addiction to these substances (see section 4.9 “Overdose”). Cardiac events including QT and QRS complex prolongation and torsades de pointes have been reported in association with overdose. Some cases have been fatal (see section 4.9). Overdose can make the presence of Brugada syndrome manifest. Patients should not exceed the recommended dose and / or extend the duration of therapy.Pediatric population: In children between 6 and 12 years of age, IMODIUM should only be used under medical supervision. There are limited data available regarding the use of loperamide HCl in children below 12 years of age (see section 4.8 “Undesirable effects”).Important information about some of the ingredients:IMODIUM 2 mg hard capsules containslactose. Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.IMODIUM 2 mg buccal tablets contain traces ofsulphites : Sulphites can rarely cause severe hypersensitivity reactions and bronchospasm.

Pregnancy and breastfeeding

The administration of IMODIUM is contraindicated during pregnancy and lactation. Women who are pregnant or breastfeeding should therefore be advised of the need to consult their doctor for the most appropriate treatment.

Expiry and retention

Store the medicine at a temperature not exceeding 25 ° C.

Interactions with other drugs

Non-clinical data have shown that loperamide is a substrate of P-glycoprotein. Concomitant administration of loperamide (single dose of 16 mg) with quinidine or ritonavir (both P-glycoprotein inhibitors) showed increases in plasma levels of loperamide. 2 to 3 times. The clinical relevance of this pharmacokinetic interaction with P-glycoprotein inhibitors when loperamide is administered at recommended doses (2 to a maximum of 16 mg per day) is unknown. Concomitant administration of loperamide (single 4 mg dose) and itraconazole, an inhibitor of CYP3A4, and P-glycoprotein, resulted in a 3-4-fold increase in plasma loperamide levels. In the same study, gemfibrozil, a CYP2C8 inhibitor, showed a 2-fold increase in plasma levels of loperamide. The combination of itraconazole and gemfibrozil showed a 4-fold increase in peak plasma level 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 dizziness 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 loperamide levels. 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 desmopressin concentrations presumably due to slowed gastrointestinal motility. The concomitant use of CYP450 inhibitors is not recommended. Substances which accelerate gastrointestinal transit can decrease the effect of IMODIUM. Drugs with pharmacological properties similar to those of loperamide or drugs which can slow intestinal peristalsis (e.g. anticholinergics), may increase the effect of IMODIUM.

Overdose

SymptomsIn the event of overdose (absolute, by accidental overdose or relative, by accumulation in the blood of non-metabolised drug, even when administered at the correct doses), including relative overdose due to hepatic dysfunction, CNS depression (drowsiness, uncoordinated movements , somnolence, miosis, muscle hypertonia, respiratory depression), intestinal obstruction and urinary retention. Cardiac events such as prolongation of the QT interval and QRS complex, torsade de pointes, other severe ventricular arrhythmias, cardiac arrest and syncope have been observed in patients 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 are more sensitive than adults to the effects of an IMODIUM overdose. Therefore it is recommended to keep the product out of their reach because accidental ingestion, especially in children under the age of 4, can cause constipation and central nervous system depression with drowsiness and slowed breathing.TreatmentIn the event of an overdose, ECG monitoring for QT interval prolongation should be initiated.Urgent measures: if symptoms of overdose appear, naloxone can be used as an antidote; administer naloxone and possibly repeat the treatment after 1-3 hours as loperamide has a longer duration of action than that of the antidote. The patient should be monitored for at least 48 hours for any aggravation of central nervous system depression.

Active principles

One hard capsule contains: Active ingredient: Loperamide hydrochloride 2 mg. One buccal tablet contains: Active ingredient: Loperamide hydrochloride 2 mg. One soft capsule contains: Active ingredient: Loperamide hydrochloride 2 mg.Excipients with known effectsIMODIUM 2 mg hard capsules: lactose 127 mg. IMODIUM 2 mg buccal tablets: each tablet contains 750 micrograms of aspartame; the mint aroma contains traces of sulphites. For the full list of excipients, see section 6.1

Excipients

IMODIUM 2 mg hard capsules: lactose, corn starch, talc, magnesium stearate. A gray-green hard capsule consists of: erythrosine (E 127); indigo carmine (E 132); yellow iron oxide (E 172); black iron oxide (E 172); titanium dioxide and gelatinIMODIUM 2 mg buccal tablets: gelatin, mannitol, aspartame, mint flavor, sodium bicarbonate.IMODIUM 2 mg soft capsules: propylene glycol monocaprilat, propylene glycol, distilled water. One capsule consists of: gelatin, glycerol 99%, propylene glycol, FD&C blue n. 1.