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JOHNSON & JOHNSON SpA

IMODIUM*8CPS 2MG

IMODIUM*8CPS 2MG

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023673066

MINSAN

023673066

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IMODIUM is indicated for the symptomatic treatment of acute diarrhoea.


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Therapeutic indications

IMODIUM is indicated for the symptomatic treatment of acute diarrhoea.

Dosage and method of use

Posology Adults The initial 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 successive evacuation of unformed (soft) stools. The maximum daily dose is 8 capsules or tablets per day (16 mg). Special populations Children aged between 6 and 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 successive evacuation of unformed (soft) stools. 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 lopeamide HCl in children under 12 years of age (see section 4.8 "Undesirable effects"). Elderly No dose adjustment is necessary in the elderly. Impaired renal function No dose adjustment is necessary in patients with impaired renal function. 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 buccal tablets: let the tablet dissolve on the tongue for a few seconds; the tablet will be dissolved quickly by saliva. Does not require the use of water. Warning : Do not use for more than 2 days. In any case, interrupt the treatment when the stools normalize, or if there are no more bowel movements for 12 hours, or if constipation appears. In episodes of acute diarrhea loperamide HCl is usually able to arrest the 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 6 years old. Pregnancy and lactation (see section 4.6 "Pregnancy and lactation") IMODIUM must not be used as primary therapy: - in acute dysentery characterized by the presence of blood in the 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 an inhibition of peristalsis has to be initiated due to the possible risk of significant consequences such as ileus, megacolon and toxic megacolon.

Side effects

Adults and children ≥12 years of age Adverse reactions reported in clinical studies with loperamide HCl The safety of Loperamide HCl was evaluated in 3076 adults and children ≥12 years of age who participated in 31 controlled and uncontrolled clinical studies with loperamide HCl used to treat diarrhea. Of these, 26 studies were acute diarrhea (N=2755) and 5 were chronic diarrhea (N=321). The most commonly reported (i.e., ≥1% incidence) adverse drug reactions (ADRs) 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 diarrhoea, 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 trials (in cases of acute or chronic diarrhea), in adults and in children ≥ 12 years of age. The frequency of adverse reactions presented in Table 1 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). Table 1: Adverse reactions reported with the use of loperamide HCl in clinical trials in adults and children 12 years of age

System Organ Classification Indication
Acute diarrhea (N=2755) Chronic diarrhea ( N=321)
Pathologies of the nervous system
Headache Common Uncommon
Dizziness Uncommon Common
Gastrointestinal pathologies
Constipation, Nausea, Flatulence Common Common
Abdominal pain, Abdominal discomfort, Dry mouth Uncommon Uncommon
Abdominal pain upper, Vomiting Uncommon
Dyspepsia Uncommon
Abdominal distention Rare
Pathology of the skin and subcutaneous tissue
Rash Uncommon

Adverse Reactions Reported from Loperamide HCl Post-Marketing Experience The determination of adverse reactions via post-marketing experience for loperamide HCl does not distinguish acute and chronic diarrhea indications or adult and pediatric populations; the data collected therefore represents the combination of indications (acute and chronic diarrhea) and populations in question (adults and children). Adverse reactions observed during post-marketing experience for loperamide HCl are listed below in Table 2 according to 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

System Organ Classification Indication Acute diarrhea + Chronic diarrhea
Immune system disorders hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock), anaphylactoid reaction
Nervous system disorders drowsiness, loss of consciousness, stupor, depressed level of consciousness, hypertonia, impaired coordination
Pathologies of the eye miosis
Gastrointestinal pathologies ileus (including paralytic ileus), megacolon (including toxic megacolon), glossodynia
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

Pediatric 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 12 years of age and older. Reporting of suspected adverse reactions. Reporting suspected adverse reactions after authorization of the medicinal product is important, as it allows continuous 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 www.agenziafarmaco.gov.it/it/responsabili.

Special warnings

Treatment of diarrhea with loperamide HCl is only symptomatic. Therefore, where possible, it is also advisable to intervene on the causes of the disorder. In episodes of acute diarrhea loperamide HCl is usually able to arrest the symptoms within 48 hours; after this period without appreciable results, the treatment must be stopped and the patient must be advised of the need to go to the doctor for a consultation. In patients with diarrhoea, especially in children, significant fluid and electrolyte losses may occur. In such cases it can be very important to replace fluids and electrolytes appropriately. 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, there have been isolated cases of intestinal obstruction with an increased risk of toxic megacolon. If constipation or abdominal or ileal distension occurs, stop treatment immediately. Pediatric population In children between 6 and 12 years, IMODIUM should only be used under medical supervision. There are limited data available regarding the use of lopeamide HCl in children under 12 years of age (see section 4.8 "Undesirable effects"). Important information about some of the ingredients IMODIUM 2 mg hard capsules contains lactose . Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Pregnancy and breastfeeding

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

Expiration and conservation

Store in the original package in order to protect from moisture. Store the medicine at a temperature not exceeding 25°C.

Interactions with other drugs

Non-clinical data have demonstrated that loperamide is a substrate of P-glycoprotein. Concomitant administration of loperamide (16 mg single dose) with quinidine or ritonavir (both P-glycoprotein inhibitors) has shown 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 the recommended doses (2 to a maximum of 16 mg per day) 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 loperamide plasma levels. In the same study, gemfibrozil, an inhibitor of CYP2C8, showed a 2-fold increase in loperamide plasma levels. The combination of itraconazole and gemfibrozil showed a 4-fold increase in the 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 measured by psychomotor testing (eg, subjective dizziness and the Digit Symbol Substitution Test). Concomitant administration of loperamide (16 mg single dose) and ketoconazole, an inhibitor of CYP3A4, and P-glycoprotein, showed a 5-fold increase in loperamide plasma levels. 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 plasma concentrations, presumably due to slowed gastrointestinal motility. Concomitant use of inhibitors of cytochrome CYP450 is not recommended. Substances which accelerate gastrointestinal transit may decrease the effect of IMODIUM. Drugs with pharmacological properties similar to those of loperamide or drugs which can slow down intestinal peristalsis (e.g. anticholinergics), may increase the effect of IMODIUM.

Overdose

Symptoms In case of overdose (absolute, by accidental overdose, or relative by accumulation in the blood of unmetabolised drug, given at the correct doses), including a relative overdose by hepatic dysfunction, CNS depression (numbness, uncoordinated movements, drowsiness, miosis, muscular hypertonia, respiratory depression), intestinal obstruction and urinary retention. 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 4 years of age, can cause constipation and depression of the central nervous system with drowsiness and slow breathing. Treatment Measures in case of overdose : gastric lavage, inducement of vomiting, enema or administration of laxatives. 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 the antidote. The patient should be monitored for at least 48 hours in order to detect 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 2mg. One soft capsule contains: Active ingredient: Loperamide hydrochloride 2mg. Excipients with known effects IMODIUM 2 mg hard capsules: lactose 127 mg. For the full list of excipients, see section 6.1

Excipients

IMODIUM 2 mg hard capsules : lactose, maize starch, talc, magnesium stearate. A green-gray 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 buccal tablets : gelatin, mannitol, aspartame, mint flavour, sodium bicarbonate. IMODIUM 2 mg soft capsule: propylene glycol monocaprylate, propylene glycol, distilled water. One capsule consists of: gelatin, glycerol 99%, propylene glycol, FD&C blue n. 1.

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