Imodium 12 Capsules 2mg

Imodium 12 Capsules 2 mg is an antidiarrheal drug indicated for the treatment of acute and chronic diarrhea . Each capsule contains 2 mg of loperamide hydrochloride, the active ingredient that works by slowing intestinal movements, thus promoting greater absorption of liquids and reducing the frequency of bowel movements . Imodium is indicated for adults and children aged 12 years and over, and is effective in rapidly reducing the symptoms of diarrhea , improving stool consistency and reducing fluid loss.

Imodium is indicated for:

• Symptomatic treatment of acute diarrhoea in adults and children over 12 years.

• Treatment of chronic diarrhea associated with specific pathological conditions.

• Regulation of stool consistency in patients with ileostomy.

ACTIVE INGREDIENTS

Active ingredients contained in Imodium 8 Capsules 2 mg - What is the active ingredient in Imodium 8 Capsules 2 mg?

One hard capsule contains the active substance: loperamide hydrochloride 2 mg. One orodispersible tablet contains the active substance: loperamide hydrochloride 2 mg. One soft capsule contains the active substance: loperamide hydrochloride 2 mg. Excipients with known effect. Imodium 2 mg hard capsules: lactose 127 mg. Imodium 2 mg orodispersible tablets: each tablet contains 750 micrograms of aspartame; the mint flavour contains traces of sulphites. Imodium 2 mg soft capsules: each soft capsule contains 115.31 mg of propylene glycol. For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Imodium 8 Capsules 2 mg - What does Imodium 8 Capsules 2 mg contain?

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

DIRECTIONS

Therapeutic indications Imodium 8 Capsules 2 mg - Why is Imodium 8 Capsules 2 mg used? What is it used for?

Imodium is indicated for the symptomatic treatment of acute diarrhea.

CONTRAINDICATIONS SIDE EFFECTS

Contraindications Imodium 8 Capsules 2 mg - When should Imodium 8 Capsules 2 mg not be used?

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1; children under 6 years of age; Pregnancy and lactation (see section 4.6 ""Pregnancy and lactation""). Imodium should not be used as primary therapy: in acute dysentery characterized by 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 is to be initiated because of the possible risk of significant sequelae such as ileus, megacolon and toxic megacolon.

DOSAGE

Quantity and method of taking Imodium 8 Capsules 2 mg - How to take Imodium 8 Capsules 2 mg?

Dosage. Adults: the initial dose is 2 hard capsules or 2 soft capsules or 2 orodispersible tablets (4 mg). Continue treatment with 1 capsule or 1 tablet (2 mg), after each subsequent evacuation of loose (soft) stools. The maximum daily dose is 8 capsules or tablets per day (16 mg). Special populations. Children aged 6 to 17 years (see section 4.3): the initial dose is 1 hard capsule or 1 soft capsule or 1 orodispersible tablet (2 mg). Continue treatment with 1 capsule or 1 tablet (2 mg), after each subsequent evacuation of loose (soft) stools. The maximum daily dose in children must be established according to body weight (3 capsules or tablets/20 kg), but must not exceed the maximum of 8 capsules or tablets per day (16 mg). There are limited data available on the use of loperamide HCl in children under 12 years of age (see section 4.8 "Undesirable effects"). Elderly: No dose adjustment is necessary in the elderly. Renal impairment: No dose adjustment is necessary in patients with renal impairment. Hepatic impairment: Although no data are available in patients with hepatic impairment, loperamide HCl should be used with caution in these patients due to reduced 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 orodispersible tablets: leave the tablet to dissolve on the tongue for a few seconds; the tablet will dissolve rapidly in saliva. No water is required. Caution: do not use for more than 2 days. In any case, discontinue treatment when stools return to normal, or if you have not had bowel movements for 12 hours, or if constipation occurs. In episodes of acute diarrhea, loperamide HCl is generally able to stop the symptoms within 48 hours. If this period elapses without appreciable results, discontinue treatment and consult your doctor.

CONSERVATION

Storage Imodium 8 Capsules 2 mg - How is Imodium 8 Capsules 2 mg stored?

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

WARNINGS

Warnings Imodium 8 Capsules 2 mg - About Imodium 8 Capsules 2 mg it is important to know that:

Treatment of diarrhea with loperamide HCl is only symptomatic. Therefore, where possible, it is also advisable to address the causes of the disorder. In acute diarrhea, loperamide HCl is usually able to arrest the symptoms within 48 hours; if this period elapses without appreciable results, treatment should be stopped and the patient should be advised to consult a doctor. Patients with diarrhea, especially children, may experience significant fluid and electrolyte loss. In such cases, appropriate fluid and electrolyte replacement may be very important. Although no pharmacokinetic data are available in patients with hepatic dysfunction, loperamide HCl 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 insufficiency as it may lead to 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, isolated cases of intestinal obstruction with an increased risk of toxic megacolon have been observed. If constipation or abdominal or ileal distension occurs, treatment should be discontinued immediately. Cases of abuse and misuse of loperamide, used as an opioid substitute, in individuals with opioid dependence have been reported (see section 4.9). 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. Paediatric population: In children between 6 and 12 years of age, Imodium should be used only under medical supervision. There are limited data available on the use of loperamide HCl in children under 12 years of age (see section 4.8 "Undesirable effects"). Important information about some of the excipients: Imodium 2 mg hard capsules contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Imodium 2 mg orodispersible tablets contain: traces of sulphites. Sulphites may rarely cause severe hypersensitivity reactions and bronchospasm; 0.750 mg of aspartame per single dose which is equivalent to 0.011 mg/kg for a 70 kg adult and 0.038 mg/kg for a 20 kg child. Aspartame is hydrolysed in the gastrointestinal tract when taken orally. One of the major products of its hydrolysis is phenylalanine. There are no clinical or non-clinical data available to evaluate the use of aspartame in infants less than 12 weeks of age; less than 1 mmol (23 mg) sodium per single dose. It can therefore be considered essentially sodium-free; 0.00066 mg benzyl alcohol per single tablet. Benzyl alcohol may cause allergic reactions. It is possible that accumulation of large amounts of benzyl alcohol may cause metabolic acidosis; use with caution and only if necessary, especially in patients with hepatic or renal insufficiency; 0.00003 mg alcohol (ethanol) in each tablet. The amount of ethanol in this medicinal product is equivalent to less than 0.00000075 ml of beer or 0.0000003 of wine. This medicinal product contains enough ethanol to produce no relevant effects. Imodium 2 mg soft capsules contain: 115.31 mg propylene glycol. 115.31 mg propylene glycol per single dose, equivalent to 1.65 mg/kg for a 70 kg adult and 5.77 mg/kg for a 20 kg child; less than 1 mmol (23 mg) sodium per single dose. It can therefore be considered essentially sodium-free.

INTERACTIONS

Interactions Imodium 8 Capsules 2 mg - Which medicines or foods can modify the effect of Imodium 8 Capsules 2 mg?'

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 been shown to increase the plasma levels of loperamide by 2 to 3-fold. The clinical relevance of this pharmacokinetic interaction with P-glycoprotein inhibitors when loperamide is administered at the recommended doses (2 to a maximum of 16 mg daily) is unknown. Co-administration of loperamide (single dose of 4 mg) with itraconazole, an inhibitor of CYP3A4, and P-glycoprotein, has been shown to increase the plasma levels of loperamide by 34-fold. In the same study, gemfibrozil, an inhibitor of CYP2C8, has been shown to increase the plasma levels of loperamide by 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 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. Concomitant use of CYP450 inhibitors is not recommended. Substances that accelerate gastrointestinal transit may decrease Imodium. Drugs with pharmacological properties similar to those of loperamide or drugs that can slow intestinal peristalsis (e.g. anticholinergics) may increase Imodium.

SIDE EFFECTS

Like all medicines, Imodium 8 Capsules 2 mg can cause side effects - What are the side effects of Imodium 8 Capsules 2 mg?

Adults and children aged ≥12 years Adverse reactions reported in clinical trials with loperamide HCl The safety of Loperamide HCl has been evaluated in 3076 adult and child subjects aged ≥12 years who participated in 31 controlled and uncontrolled clinical trials with loperamide HCl used for the treatment of diarrhoea. Of these, 26 trials were for acute diarrhoea (N=2755) and 5 trials were for chronic diarrhoea (N=321). The most commonly reported adverse drug reactions (ADRs) (i.e. with an incidence of ≥1%) in clinical trials with Loperamide HCl for the treatment of acute diarrhoea were: constipation (2.7%), flatulence (1.7%), headache (1.2%) and nausea (1.1%). In clinical trials for the treatment of chronic diarrhoea, the most commonly reported ADRs (i.e. >=1% incidence) were: flatulence (2.8%), constipation (2.2%), nausea (1.2%) and dizziness (1.2%). The following list shows the ADRs that have been reported with the use of loperamide HCl in clinical trials (in acute or chronic diarrhoea) in adults and children aged ≥12 years. The frequency of adverse reactions presented below is defined 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). Adverse reactions reported with the use of loperamide HCl in clinical trials in adults and children aged ≥ 12 years. Nervous system disorders. Headache. Acute diarrhoea: common; chronic diarrhoea: uncommon. Dizziness. Acute diarrhoea: uncommon; chronic diarrhoea: common. Gastrointestinal disorders. Constipation, nausea, flatulence. Acute diarrhoea: common; chronic diarrhoea: common. Abdominal pain, abdominal discomfort, dry mouth. Acute diarrhoea: uncommon; chronic diarrhoea: uncommon. Upper abdominal pain, vomiting. Acute diarrhoea: uncommon. Dyspepsia. Chronic diarrhoea: uncommon. Abdominal distension. Acute diarrhoea: rare. Skin and subcutaneous tissue disorders. Rash. Acute diarrhoea: uncommon. Adverse reactions reported in post-marketing experience with loperamide HCl: The determination of adverse reactions via post-marketing experience for loperamide HCl does not distinguish between the indications acute and chronic diarrhoea or the populations adults and children; the data collected therefore represent the combination of the indications (acute and chronic diarrhoea) and the populations in question (adults and children). Adverse reactions observed during post-marketing experience for loperamide HCl are listed below by System Organ Class, using MedDRA terminology. Adverse reactions reported with the use of loperamide HCl in post-marketing experience in adults and children. Immune system disorders: hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock), anaphylactic reaction. Nervous system disorders: somnolence, loss of consciousness, drowsiness, depressed level of consciousness, hypertonia, coordination disorders. Eye disorders: miosis. Gastrointestinal disorders: ileus (including paralytic ileus), megacolon (including toxic megacolon), glossodynia, acute pancreatitis (frequency not known). Skin and subcutaneous tissue disorders: bullous eruption (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme), angioedema, urticaria, pruritus. Renal and urinary disorders: urinary retention. General disorders and administration site conditions: fatigue. Paediatric population: the safety of loperamide HCl has been 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 diarrhoea. In general, the ADR profile in this patient population was similar to that observed in clinical trials with loperamide HCl used in adults and children aged 12 years and above. 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 http://www.agenziafarmaco.gov.it/content/come-segnalare-unasospe tta-reazione-avversa.

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 8 Capsules 2 mg.

The administration of Imodium is contraindicated during pregnancy and breastfeeding. Pregnant or breastfeeding women should therefore be advised to consult their doctor for the most appropriate treatment.