Imodium diarrhea and meteorism 2 mg + 125 mg 12 tablets

Imodium diarrhea and meteorism 2 mg + 125 mg 12 tablets is an over-the-counter medicine specifically formulated to provide rapid relief from the symptoms of acute diarrhea associated with intestinal swelling, abdominal cramps and meteorism . Thanks to the combination of loperamide hydrochloride (2 mg) and simethicone (equivalent to 125 mg of dimethicone), this product acts in a targeted manner both on the frequency of bowel movements and on annoying abdominal problems, such as swelling and flatulence.

Indicated for adults and adolescents over 12 years of age , Imodium diarrhea and meteorism is ideal for those seeking effective symptomatic treatment in the case of sudden diarrhea accompanied by intestinal disorders. The presence of loperamide helps reduce intestinal motility, promoting the restoration of normal stool consistency, while simethicone acts on air bubbles in the intestine, alleviating the sensation of bloating and cramps.

The 12 tablets in a practical blister are easy to take and represent a safe and fast self-medication solution to manage the symptoms of diarrhea and meteorism, allowing you to quickly return to normal daily activities. Imodium diarrhea and meteorism is one of the most used remedies for intestinal disorders , thanks to its clinically tested efficacy and its combined action on multiple symptoms.

Choose Imodium diarrhea and meteorism 2 mg + 125 mg 12 tablets for a complete treatment of intestinal symptoms related to acute diarrhea, bloating and abdominal cramps. A reliable ally for the well-being of your intestine, always at hand.

ACTIVE INGREDIENTS

Active ingredients contained in Imodium diarrhea and flatulence 2 mg + 125 mg 12 tablets - What is the active ingredient of Imodium diarrhea and flatulence 2 mg + 125 mg 12 tablets?

Each tablet contains loperamide hydrochloride 2 mg and simethicone equivalent to 125 mg dimethicone. Excipients with known effect Each tablet contains less than 0.026 mg benzyl alcohol and less than 4.4 mg maltodextrin (which contains glucose) For the full list of excipients, see section 6.1

EXCIPIENTS

Composition of Imodium diarrhea and flatulence 2 mg + 125 mg 12 tablets - What does Imodium diarrhea and flatulence 2 mg + 125 mg 12 tablets contain?

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

DIRECTIONS

Therapeutic indications Imodium diarrhea and flatulence 2 mg + 125 mg 12 tablets - Why is Imodium diarrhea and flatulence 2 mg + 125 mg 12 tablets used? What is it used for?

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

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Imodium diarrhea and flatulence 2 mg + 125 mg 12 tablets - When should Imodium diarrhea and flatulence 2 mg + 125 mg 12 tablets not be used?

-Children under 12 years -Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 -Patients with acute dysentery characterised by 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 Diarrhoea and Meteorism should not be used when inhibition of peristalsis is necessary due to the possible risk of significant sequelae including ileus, megacolon, toxic megacolon. Therapy should be discontinued immediately when constipation, ileus or when abdominal distension develops.

DOSAGE

Quantity and method of taking Imodium diarrhea and flatulence 2 mg + 125 mg 12 tablets - How to take Imodium diarrhea and flatulence 2 mg + 125 mg 12 tablets?

Dosage Adults over 18 years Two tablets to be taken initially, followed by one tablet after each diarrhoea. Do not take more than 4 tablets in one day, limited to no more than 2 days. Adolescents between 12 and 18 years One tablet to be taken initially, followed by one tablet after each diarrhoea. Do not take more than 4 tablets in one day, limited to no more than 2 days. Paediatric population Imodium Diarrhoea and Meteorism is contraindicated in children under 12 years (see section 4.3). Use in the elderly No dose adjustment is necessary in the elderly. Use in renal impairment No dose adjustment is necessary in patients with renal impairment. Use in hepatic impairment Although no data are available in patients with hepatic impairment, Imodium Diarrhoea and Meteorism should be used with caution in these patients due to reduced first pass metabolism (see section 4.4). Method of administration Take the correct number of whole tablets by mouth with a little water.

CONSERVATION

Storage Imodium diarrhea and flatulence 2 mg + 125 mg 12 tablets - How is Imodium diarrhea and flatulence 2 mg + 125 mg 12 tablets stored?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Imodium diarrhea and flatulence 2 mg + 125 mg 12 tablets - About Imodium diarrhea and flatulence 2 mg + 125 mg 12 tablets it is important to know that:

Treatment of diarrhoea with the loperamide-simethicone combination is only symptomatic. Specific treatment should be given, if appropriate, whenever an underlying etiology can be determined. Fluid and electrolyte depletion may occur in patients with (severe) diarrhoea. Attention to adequate fluid and electrolyte replacement is important. If no clinical improvement is observed within 48 hours, administration of Imodium Diarrhoea and Meteorism should be discontinued. Patients should be advised to consult their physician. AIDS patients treated with Imodium Diarrhoea and Meteorism 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 AIDS patients with infectious colitis due to both bacterial and viral pathogens treated with loperamide hydrochloride. Although no pharmacokinetic data are available in patients with hepatic impairment, Imodium Diarrhea and Meteorism should be used with caution in these patients due to extensive first-pass metabolism. The drug should be used with caution in patients with hepatic impairment as it may lead to relative overdose with central nervous system (CNS) toxicity. In patients with severe hepatic impairment Imodium Diarrhea and Meteorism tablets should be used under medical supervision. Cardiac events including QT and QRS prolongation and torsade de pointes have been reported in association with overdose. Some cases have had a fatal outcome (see section 4.9). Overdose may unmask the presence of Brugada syndrome. Patients should not exceed the recommended dose and/or prolong the duration of therapy. Imodium Diarrhea and Meteorism contains benzyl alcohol, which may cause allergic reactions. Imodium Diarrhea and Flatulence should be used with caution in patients with renal or hepatic insufficiency or in pregnant or breast-feeding patients, due to the risk of accumulation and toxicity (metabolic acidosis). This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially "sodium-free". This medicinal product contains less than 0.00044 mg alcohol (ethanol) per tablet. The small amount of alcohol in this medicinal product will not produce any relevant effects. This medicinal product contains maltodextrin which contains glucose. Patients with rare glucose-galactose malabsorption should not take this medicinal product.

INTERACTIONS

Interactions Imodium diarrhea and meteorism 2 mg + 125 mg 12 tablets - Which medicines or foods can modify the effect of Imodium diarrhea and meteorism 2 mg + 125 mg 12 tablets?

Non-clinical data have shown that loperamide is a substrate of P-glycoprotein. Co-administration of loperamide (single dose of 16 mg) with quinidine or ritonavir (both inhibitors of P-glycoprotein) has shown increases in loperamide plasma levels of 2 to 3-fold. 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 (single dose of 4 mg) with itraconazole, an inhibitor of CYP3A4, and P-glycoprotein, has shown an increase in loperamide plasma levels of 3 to 4-fold. In the same study, gemfibrozil, an inhibitor of CYP2C8, has shown an increase in loperamide plasma levels of 2-fold. The combination of itraconazole and gemfibrozil showed 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 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 measured 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 medicinal products that accelerate gastrointestinal transit may reduce its effects. Since simethicone is not absorbed from the gastrointestinal tract, no relevant interactions between simethicone and other medicinal products are expected. Paediatric population Interaction studies have only been performed in adults.

SIDE EFFECTS

Like all medicines, Imodium diarrhea and meteorism 2 mg + 125 mg 12 tablets can cause side effects - What are the side effects of Imodium diarrhea and meteorism 2 mg + 125 mg 12 tablets?

The safety of loperamide-simethicone has been evaluated in 2040 patients participating in 5 clinical studies. All clinical studies were conducted in patients with acute diarrhoea and flatulence with loperamide-simethicone in a 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. with an incidence ≥1%) in clinical studies were as follows (with % incidence): dysgeusia (2.6%) and nausea (1.6%). The safety of loperamide HCl has been evaluated in 2755 patients aged ≥12 years participating in 26 controlled and uncontrolled clinical studies of loperamide HCl used for the treatment of acute diarrhoea. In clinical trials the most commonly reported ADRs (>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 diarrhoea. The most common ADRs (>1%) reported in these clinical trials were flatulence (2.8%), constipation (2.2%), dizziness (1.2%) and nausea (1.2%). Paediatric population 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 of loperamide HCl used for the treatment of acute diarrhoea. The only ADR reported in ≥1% of patients treated with loperamide HCl was vomiting. Table 1 shows the ADRs that have been reported with the use of loperamide-simethicone in both clinical trials and post-marketing experience. Additional ADRs reported with the use of loperamide HCl (one of the components of Loperamide-simethicone) are also shown. The frequency categories are based on clinical trial data 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 (cannot be estimated from the available data). Table 1: Adverse reactions border=1 cellspacing=0 cellpadding=3>

Classification by systems and organs		Adverse reactions
		Frequency
	Municipalities	Uncommon	Rare	Not known
Immune system disorders			hypersensitivity reaction to , anaphylactic reaction (including anaphylactic shock) to , anaphylactoid reaction to
Nervous system disorders	Headache, dysgeusia	Drowsiness a , dizziness c	loss of consciousness a , reduced level of consciousness a , stupor a , hypertonia a , coordination disorders a
Eye pathologies			miosis a
Gastrointestinal disorders	Nausea	Abdominal pain, abdominal discomfort b , abdominal pain upper b , vomiting, constipation, abdominal distension c , dyspepsia c , flatulence, dry mouth	ileus a (including paralytic ileus), megacolon a (including toxic megacolon d )	Acute pancreatitis
Skin and subcutaneous tissue disorders		Rash	bullous eruption (including Stevens-Johnson syndrome a , toxic epidermal necrolysis a and erythema multiforme a ), angioedema a , urticaria a , pruritus a
Kidney and urinary disorders			urinary retention a
Systemic disorders and conditions related to the administration site		Asthenia	Tiredness at

^a The inclusion of this term is based on post-marketing reports for loperamide HCl. Since the process to determine post-marketing ADRs did not differentiate between chronic and acute indications or between adults and children, the frequency is estimated from all clinical trials 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 diarrhoea (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 diarrhoea (N = 618). Dizziness and abdominal distension were also identified as ADRs from clinical trials with loperamide HCl. ^d See section 4.4. 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 https://www.aifa.gov.it/content/segnalazioni-reazioniavverse.

OVERDOSE

Overdose Imodium diarrhea and flatulence 2 mg + 125 mg 12 tablets - What are the risks of Imodium diarrhea and flatulence 2 mg + 125 mg 12 tablets in case of overdose?

Symptoms In case of overdose (including overdose related to hepatic dysfunction), central nervous system depression (stupor, impaired coordination, drowsiness, miosis, muscular hypertonia, respiratory depression), dry mouth, abdominal discomfort, nausea and vomiting, constipation, urinary retention and paralytic ileus may occur. 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 in patients who have ingested excessive doses of loperamide (see section 4.4). Fatal cases have also been reported. Overdose may unmask the presence of Brugada syndrome. Cases of drug withdrawal syndrome have been observed after discontinuation in subjects who have abused, misused or intentionally taken excessively high doses of loperamide. Treatment In case of overdose, naloxone may 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 should be monitored for at least 48 hours for evidence of central nervous system depression. Paediatric population Children may be more sensitive to CNS effects than adults.

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 Imodium diarrhoea and meteorism 2 mg + 125 mg 12 tablets

Pregnancy Safety during pregnancy has not been established, however from animal studies there is no indication that loperamide or simethicone have teratogenic or embryotoxic properties. Imodium Diarrhea and Meteorism 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 Meteorism is not recommended during breastfeeding. Fertility The effect on human fertility has not been evaluated.

DRIVING AND USE OF MACHINERY

Taking Imodium diarrhea and flatulence 2 mg + 125 mg 12 tablets before driving or using machines - Does Imodium diarrhea and flatulence 2 mg + 125 mg 12 tablets affect driving or using machines?

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