Imodium 2mg - acute diarrhea treatment 12 rigid capsules

Product Description

Drug based on loperamide hydrochloride, indicated for the symptomatic treatment of acute diarrhea.

Indications

Imodium is an effective symptomatic treatment for the management of acute diarrhea. Its hard capsules contain the active ingredient loperamide hydrochloride, which acts by slowing intestinal transit, thus reducing the frequency of bowel movements and improving stool consistency.

Composition

Active ingredients

One hard capsule contains the active ingredient: loperamide hydrochloride 2 mg.

Excipients

Imodium mg hard capsules: lactose, corn starch, talc, magnesium stearate. One green-grey hard capsule is composed of: erythrosine (E 127); indigo carmine (E 132); yellow iron oxide (E 172); black iron oxide (E 172); titanium dioxide and gelatin.

Directions for use and Dosage

Adults: The initial dose is 2 hard capsules (4 mg). Continue treatment with 1 capsule (2 mg) after each subsequent loose (soft) stool. The maximum daily dose is 8 capsules or tablets per day (16 mg).

Children aged 6 to 17 years: The initial dose is 1 hard capsule (2 mg). Continue treatment with 1 capsule (2 mg) after each subsequent loose (soft) stool. The maximum daily dose in children should 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). Available data regarding the use of loperamide HCl in children under 12 years of age are limited.

Elderly: No dose adjustment is necessary in the elderly.

Impaired renal function: No dose adjustment is necessary in patients with impaired renal function.

Impaired liver function: Although no data are available in patients with impaired liver function, loperamide HCl should be used with caution in these patients due to reduced first-pass metabolism.

Directions for use

Take by mouth with a little water. In any case, discontinue treatment when stools return to normal, or if bowel movements have not been had for 12 hours, or if constipation occurs. In acute diarrhea, loperamide HCl is generally able to stop symptoms within 48 hours. If this period elapses without noticeable results, discontinue treatment and consult your doctor.

Warnings

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 generally able to stop symptoms within 48 hours; if this period elapses without noticeable results, treatment should be discontinued 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 impairment as it may lead to relative overdose with CNS toxicity. AIDS patients treated with loperamide HCl for diarrhea should discontinue therapy at the first sign of abdominal distension. Isolated cases of intestinal obstruction with an increased risk of toxic megacolon have been observed in these patients with infectious colitis of bacterial or viral origin treated with loperamide HCl. If constipation or abdominal or ileal distension occurs, discontinue treatment immediately. Cases of abuse and misuse of loperamide, used as an opioid substitute, have been reported in individuals dependent on these substances. Cardiac events, including QT and QRS prolongation and torsades de pointes, have been reported in association with overdose. Some cases have been fatal. 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. Available data regarding the use of loperamide HCl in children under 12 years of age are limited. 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 can 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 hydrolyzed in the gastrointestinal tract when taken orally. One of the major hydrolysis products is phenylalanine. No clinical or non-clinical data are available to evaluate the use of aspartame in infants under 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 can cause allergic reactions. 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 impairment; 0.00003 mg of alcohol (ethanol) in each tablet. The ethanol content of this medicine is equivalent to less than 0.00000075 ml of beer or 0.0000003 ml of wine. This medicine contains enough ethanol to produce no significant 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

Non-clinical data have shown that loperamide is a substrate of P-glycoprotein. Concomitant administration of loperamide (a single 16 mg dose) with quinidine or ritonavir (both P-glycoprotein inhibitors) has shown a 2- to 3-fold increase in loperamide plasma levels. 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 daily) is unknown. Concomitant administration of loperamide (a single 4 mg dose) and itraconazole, a CYP3A4 and P-glycoprotein inhibitor, showed a 3- to 4-fold increase in loperamide plasma levels. In the same study, gemfibrozil, a CYP2C8 inhibitor, showed a 2-fold increase in loperamide plasma levels. The combination of itraconazole and gemfibrozil showed a 4-fold increase in peak loperamide plasma levels 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, a CYP3A4 and P-glycoprotein inhibitor, resulted in a 5-fold increase in loperamide plasma 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 desmopressin plasma concentrations, presumably due to slowed gastrointestinal motility. Concomitant use of CYP450 inhibitors is not recommended. Substances that accelerate gastrointestinal transit may decrease the effect of Imodium. Drugs with pharmacological properties similar to those of loperamide or drugs that can slow intestinal peristalsis (e.g., anticholinergics) may increase the effect of Imodium.

Contraindications

Hypersensitivity to the active substance or to any of the excipients; Children under 6 years of age; pregnancy and breastfeeding. Imodium should not be used as primary therapy for acute dysentery characterized by bloody stools 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 must be avoided due to the possible risk of significant consequences such as ileus, megacolon, and toxic megacolon.

Undesirable effects

Adults and children aged >= 12 years:

Adverse reactions reported in clinical studies with loperamide HCl

The safety of Loperamide HCl has been evaluated in 3076 adults and children aged >= 12 years who participated in 31 controlled and uncontrolled clinical studies with loperamide HCl used for the treatment of diarrhea. Of these, 26 studies were for acute diarrhea (N=2755) and 5 for chronic diarrhea (N=321).

The most common adverse drug reactions (ADRs) are: The most commonly reported ADRs (i.e. with an incidence >=1%) in clinical trials with Loperamide HCl for the treatment of acute diarrhoea were:

• Constipation (2.7%)
• Flatulence (1.7%)
• Headache (1.2%)
• Nausea (1.1%)

In clinical trials for the treatment of chronic diarrhoea, the most commonly reported ADRs were: The most commonly reported adverse reactions (i.e. >=1% incidence) were as follows:

• Flatulence (2.8%)
• Constipation (2.2%)
• Nausea (1.2%)
• 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)

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

Determination of adverse reactions from post-marketing experience for loperamide HCl does not differentiate between acute and chronic diarrhoea indications or between adult and paediatric populations; the data collected therefore represent the combination of the indications (acute and chronic diarrhoea) and the relevant populations (adults and paediatrics). 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)
• Anaphylactoid reaction

Nervous system disorders

• Drowsiness
• Loss of consciousness
• Drowsiness
• Decreased 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 studies 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 studies 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 authorization of the medicinal product is important, as it allows continued monitoring of the benefit/risk balance of the medicinal product.

Pregnancy and breastfeeding

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.

Storage

Store the medicinal product at a temperature not exceeding 25 degrees C.

Format

Pack of 12 hard capsules of 2 mg.