Imodium diarrhea and meteorism 2 mg + 125 mg 12 tablets

In ottemperanza all'articolo 118 “autorizzazione della pubblicità presso il pubblico” del decreto legislativo 24 aprile 2006, numero 219

INDICATIONS

Imodium Diarrhea and Bloating is indicated for the symptomatic treatment of acute diarrhea in adults and adolescents over 12 years of age when acute diarrhea is associated with bloating-related abdominal discomfort, including bloating, cramps, or flatulence.

ACTIVE INGREDIENTS

Ogni compressa contiene loperamide cloridrato 2 mg e simeticone equivalente a 125 mg di dimeticone. Excipients with known effect Each tablet contains less than 0.026 mg of benzyl alcohol and less than 4.4 mg of maltodextrin (which contains glucose) For the full list of excipients, see section 6.1

EXCIPIENTS

Anhydrous calcium hydrogen phosphate Microcrystalline cellulose Acesulfame potassium Artificial vanilla flavor (includes propylene glycol, maltodextrin, and benzyl alcohol) Sodium starch glycolate (Type A) Stearic acid

CONTRAINDICATIONS AND SIDE EFFECTS

-Children under 12 years of age -Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1 -Patients with acute dysentery characterized by the presence of blood in the stool and high fever -Patients with acute ulcerative colitis -Patients with pseudomembranous colitis due to the use of broad-spectrum antibiotics -Patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella and Campylobacter. Imodium Diarrhea and Blote should not be used when it is necessary to avoid inhibition of peristalsis due to a possible risk of significant sequelae including ileus, megacolon, toxic megacolon. La terapia deve essere immediatamente interrotta quando sono presenti costipazione, ileo o quando si sviluppa distensione addominale.

DOSAGE

Dosage Adults over 18 years old Due compresse da prendere inizialmente, seguite da una compressa dopo ogni scarica diarroica. Non si devono prendere più di 4 compresse in un giorno, limitatamente a non più di 2 giorni. Adolescents between 12 and 18 years old Una compressa da prendere inizialmente, seguita da una compressa dopo ogni scarica diarroica. Non si devono prendere più di 4 compresse in un giorno, limitatamente a non più di 2 giorni. Pediatric population Imodium Diarrea e Meteorismo è controindicato nei bambini al di sotto dei 12 anni (vedere paragrafo 4.3). Use in the elderly No dose adjustment is necessary in the elderly. Uso nella compromissione della funzionalità renaleNo dose adjustment is necessary in patients with impaired renal function. Uso nella compromissione della funzionalità epatica Although no data are available in patients with impaired hepatic function, Imodium Diarrhea and Meteorism should be used with caution in these patients due to reduced first pass metabolism (see section 4.4).Method of administration Assumere per bocca il corretto numero di compresse intere con un po’ d’acqua.

CONSERVATION

This medicinal product does not require any special storage conditions.

WARNINGS

Treatment of diarrhea with the loperamide-simethicone association is only symptomatic. If appropriate, specific treatment should be administered whenever an underlying etiology can be determined. Fluid and electrolyte depletion may occur in patients with (severe) diarrhea. It is important to pay attention to adequate fluid and electrolyte replacement. If no clinical improvement is observed within 48 hours, the administration of Imodium Diarrhea and Meteorism should be discontinued. Patients should be advised to consult their doctor. AIDS patients treated with Imodium Diarrhea and Meteorismo for diarrhea should discontinue therapy at the first signs of abdominal distension. Isolated cases of constipation with an increased risk of toxic megacolon have been reported in AIDS patients with infectious colitis from both bacterial and viral pathogens treated with loperamide hydrochloride. Although no pharmacokinetic data are available in patients with hepatic dysfunction, Imodium Diarrhea and Meteorism should be used with caution in these patients due to the intense first pass metabolism. The drug should be used with caution in patients with hepatic impairment as it can lead to relative overdose with central nervous system (CNS) toxicity. In patients with severe liver dysfunction Imodium Diarrhea and Bloating tablets should be used under medical supervision. 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 manifest the presence of Brugada syndrome. Patients should not exceed the recommended dose and/or prolong the duration of therapy. Imodium Diarrhea and Bloating contains benzyl alcohol, which may cause allergic reactions. Imodium Diarrhea and Meteorism should be used with caution in patients with renal or hepatic impairment or in pregnant or breastfeeding patients, due to the risk of accumulation and toxicity (metabolic acidosis). This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially 'sodium-free'. This medicine contains less than 0.00044 mg of alcohol (ethanol) per tablet. The small amount of alcohol in this medicine will not produce any noticeable effects. This medicine contains maltodextrin which contains glucose. Patients with rare glucose-galactose malabsorption should not take this medicine.

INTERACTIONS

Non-clinical data have demonstrated that loperamide is a substrate of P-glycoprotein. Concomitant administration of loperamide (in a single dose of 16 mg) with quinidine or ritonavir (both inhibitors of P-glycoprotein) has shown increases in plasma levels of loperamide by 2 to 3 times. 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 3-4-fold increase in plasma levels of loperamide. 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 loperamide level 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, showed a 5-fold increase in plasma levels 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 desmopressin concentrations, presumably due to slowed gastrointestinal motility. It is expected that medicinal products with similar pharmacological properties may enhance the effect of loperamide and that medicinal products that accelerate gastrointestinal transit may reduce its effects. Since simethicone is not absorbed from the gastrointestinal tract, no relevant interactions are expected between simethicone and other medicinal products. Pediatric population Interaction studies have only been performed in adults.

SIDE EFFECTS

The safety of loperamide-simethicone was evaluated in 2040 patients who took part in 5 clinical studies. All clinical studies were conducted in patients with acute diarrhea and bloating-related disorder with loperamide-simethicone in chewable tablet formulation. Four studies compared loperamide-simethicone with loperamide, simethicone, and placebo, and one study compared two formulations of loperamide-simethicone with placebo. The most commonly reported adverse drug reactions (ADRs) (i.e. ≥1% incidence) in clinical trials were as follows (with % incidence): dysgeusia (2.6%) and nausea (1.6%). The safety of loperamide HCl was evaluated in 2755 patients aged ≥ 12 years who participated in 26 controlled and uncontrolled clinical trials of loperamide HCl used for the treatment of acute diarrhea. In clinical trials, the most common ADRs reported (>1%) were constipation (2.7%), flatulence (1.7%), headache (1.2%), and nausea (1.1%). The safety of loperamide HCl was also evaluated in 321 patients who participated in 5 controlled and uncontrolled clinical trials of loperamide HCl used for the treatment of chronic diarrhea. The most common ADRs (>1%) reported in these clinical trials were flatulence (2.8%), constipation (2.2%), dizziness (1.2%), and nausea (1.2%). Pediatric population The safety of loperamide HCl was evaluated in 607 patients aged 10 days to 13 years, who took part in 13 controlled and uncontrolled clinical trials with loperamide HCl used for the treatment of acute diarrhea. The only ADR reported for ≥1% of patients treated with loperamide HCl was vomiting. Table 1 shows ADRs that have been reported with the use of loperamide-simethicone in both clinical trials and post-marketing experience. Also shown are additional ADRs reported with the use of loperamide HCl (one of the components of Loperamide-Simethicone). Frequency categories are based on data from clinical trials with loperamide-simethicone and loperamide HCl using the following convention: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (frequency cannot be estimated from the available data). Table 1: Adverse reactions

System organ class - Adverse reactions: Frequency.

Municipalities. Adverse reactions: Uncommon. Rare. Not known.

Immune system disorders - hypersensitivity reactiona, anaphylactic reaction (including anaphylactic shock)a, anaphylactoid reaction.

Nervous system disorders - Headache, dysgeusia. Adverse reactions: Drowsinessa, dizzinessc. loss of consciousnessa, decreased level of consciousnessa, stupora, hypertoniaa, coordination disordera.

Eye pathologies - miosis a.

Gastrointestinal disorders - Nausea. Adverse reactions: Abdominal pain, abdominal discomfortb, upper abdominal painb, vomiting, constipation, abdominal distensionc, dyspepsic, flatulence, dry mouth. ileoa (including paralytic ileus), megacolon (including toxic megacolon). Acute pancreatitis.

Skin and subcutaneous tissue disorders - Adverse reactions: Skin rash. bullous rash (including Stevens-Johnson syndrome, toxic epidermal necrolysisa and erythema multiformea), angioedemaa, urticariaa, pruritusa.

Renal and urinary disorders - urinary retentiona.

Systemic disorders and conditions relating to the administration site - Adverse reactions: Asthenia. Tiredness.

^aThe inclusion of this term is based on post-marketing reports for loperamide HCl. Because the process to determine postmarketing ADRs did not differentiate between chronic and acute indications or between adults and children, the frequency is estimated across all clinical studies with combined loperamide HCl, including studies in children ≤ 12 years of age (N = 3683). ^b The inclusion of this term is based on ADRs reported in clinical trials with loperamide HCl. Frequency category assigned based on clinical trials with loperamide HCl in acute diarrhea (N = 2755). ^c The inclusion of this term is based on post-marketing experience with loperamide-simethicone. Frequency category assigned based on clinical trials with loperamide-simethicone in acute diarrhea (N = 618). Dizziness and abdominal distension have also been identified as ADRs of clinical trials with loperamide HCl. ^d See paragraph 4.4. 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 https://www.aifa.gov.it/content/segnalazioni-reazioniavverse.

OVERDOSE

Symptoms In case of overdose (including relative overdose due to hepatic dysfunction), central nervous system depression (stupor, impaired coordination, drowsiness, miosis, muscle hypertonia, respiratory depression), dry mouth, abdominal discomfort, nausea and vomiting, constipation, urinary retention and paralytic ileus may occur. In patients who have ingested excessive doses of loperamide, cardiac events such as prolongation of the QT interval and 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. After discontinuation, cases of drug withdrawal syndrome have been observed in individuals who abused, misused, or intentionally took excessively high doses of loperamide. Treatment In case of overdose, naloxone can be used as an antidote. Since loperamide has a longer duration of action than naloxone (1-3 hours), repeated treatment with naloxone may be indicated. The patient must be monitored for at least 48 hours to detect possible depression of the central nervous system. Pediatric population Children may be more sensitive to CNS effects than adults.

PREGNANCY AND BREASTFEEDING

Pregnancy Safety during pregnancy has not been established, however there is no indication from animal studies that loperamide or simethicone have teratogenic or embryotoxic properties. Imodium Diarrhea and Blote should not be administered during pregnancy, especially in the first trimester, unless clinically justified Breastfeeding Only small amounts of loperamide hydrochloride may appear in breast milk. Therefore, Imodium Diarrhea and Bloating is not recommended during breastfeeding. Fertility The effect on human fertility has not been evaluated.

EFFECTS ON DRIVING ABILITY

Imodium Diarrhea and Meteorism has no or negligible influence on the ability to drive and use machinery. However, tiredness, dizziness and drowsiness may occur in cases of diarrheal syndrome treated with loperamide HCl (see section 4.8). It is therefore preferable to use caution when driving motor vehicles or operating dangerous machinery.