IMODIUM DIARRECT AND METEOR 12CPR

IMODIUM DIARRHOEA AND WEATHER 2 MG/125 MG

active ingredients

Each tablet contains loperamide hydrochloride 2 mg and simeticone equivalent to 125 mg dimeticone. Excipients with known effect Each tablet contains less than 0.026 mg of benzilic alcohol and less than 4.4 mg of maltodextrin (which contains gluscose) For the full list of excipients, see paragraph 6.1

Excellent

Calcium hydrogen phosphate anidro Cellulosa microcrystalline Potassium acesulphame Aroma of artificial vanilla (includes propylene glycol, maltodextrin and benzilic alcohol) Sodium glyculate starch (Tipo A) Stearic acid

Therapeutic indications

Imodium Diarrea and Meteorism is indicated for the symptomatic treatment of acute diarrhea in adults and adolescents over the age of 12 when acute diarrhea is associated with abdominal disorder related to meteorism, including swelling, cramps or flatulence.

Contraindications

-Children under 12 years - Hypersensitivity to the active ingredient or any of the excipients listed in paragraph 6.1 - Patients with acute dysentery characterized by presence of blood in the feces and by high fever - Patients with ulcerative acute colitis - Patients with pseudomembranous colitis due to the use of antibiotics with broad spectrum -Pazienti with bacteria enterocoliti. Imodium Diarrea and Meteorism should not be used when it is necessary to avoid inhibition of peristalsis due to a possible risk of significant sequels including ileo, megacolon, toxic megacolon. The therapy must be immediately interrupted when constipation, ileum or when abdominal distension develops.

Population

Population Adults over 18 years Two tablets to be taken initially, followed by a tablet after each diarroic discharge. You should not take more than 4 tablets in one day, limited to no more than 2 days. Teenagers between 12 and 18 years A tablet to be taken initially, followed by a tablet after each diarroic discharge. You should not take more than 4 tablets in one day, limited to no more than 2 days. Paediatric population Imodium Diarrea and Meteorism is contraindicated in children under 12 years (see paragraph 4.3). Use in the elderly In the elderly, dose adjustment is not necessary. Use in compromising renal functionalityIn patients with impairment of kidney function, dose adjustment is not required. Use in compromising liver function Although data is not available in patients with impairment of liver function, Imodium Diarrea and Meteorism must be used with caution in these patients due to reduced first-pass metabolism (see paragraph 4.4).Method of administration Take by mouth the correct number of whole tablets with a little water.

Conservation

This medicine does not require any special condition of conservation.

Warnings

The treatment of diarrhea with loperamide-simeticone is only symptomatic. If appropriate, a specific treatment should be given whenever a basic etiology can be determined. In patients with diarrhea (grave) hydroelectrolytic depletion may occur. It is important to pay attention to an adequate recovery of liquids and electrolytes. If no clinical improvement is observed within 48 hours, the administration of Imodium Diarrea and Meteorism must be interrupted. Patients should be advised to consult the doctor. Patients with AIDS treated with Imodium Diarrea and Meteorism for diarrhea must stop therapy at the first signs of abdominal distension. Insulated cases of constipation were reported with increased risk of toxic megacolons in patients with AIDS with infectious colitis from both bacterial and viral pathogens treated with loperamide hydrochloride. Although there is no pharmacokinetic data available in patients with liver dysfunction, Imodium Diarrea and Meteorism must be used with caution in these patients due to the intense first-pass metabolism. The drug must be used with caution in patients with liver failure as it can lead to a relative overdose with toxicity to the central nervous system (SNC). In patients with severe liver dysfunction Imodium Diarrea and Meteorism tablets should be used under medical supervision. Heart events have been reported including the extension of the QT and the QRS complex and point twists in association with overdose. Some cases were fatal (see paragraph 4.9). Overdose can make the presence of Brugada syndrome manifest. Patients should not exceed the recommended dose and/or do not protract the duration of therapy. Imodium Diarrea and Meteorism contains benzyl alcohol, which can cause allergic reactions. Imodium Diarrea and Meteorism should be used with caution in patients with kidney or liver failure or pregnant or breastfeeding patients, due to the risk of accumulation and toxicity ( metabolic acidosis). This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially "without sodium". This medicine contains less than 0.00044 mg of alcohol (ethanol) per tablet. The small amount of alcohol in this medicine will not produce significant effects. This medicine contains maltodextrin containing glucose. Patients with rare glucose-galactose mal absorption should not take this medicine.

Interactions

Non-clinical data have shown that loperamide is a substrate of glycoprotein P. Concurrent administration of loperamide (in a single dose of 16 mg) with chinidine or ritonavir (both glycoprotein inhibitors P) showed increases in plasma levels of loperamide 2 to 3 times. The clinical relevance of this drug interaction with glycoprotein inhibitors P, when loperamide is administered at recommended doses is unknown. Concurrent administration of loperamide (in a single dose of 4 mg) and itraconazole, an inhibitor of CYP3A4, and glycoprotein P, showed an increase in plasma levels of loperamide 3-4 times. In the same study the gemfibrozil, a CYP2C8 inhibitor showed an increase in plasma levels of loperamide 2 times. The combination of itraconazole and gemfibrozil showed an increase in the plasma level peak of loperamide 4 times and an increase in total plasma exposure of 13 times. These increments were not associated with the effects on the central nervous system (SNC) as detected by psychomotor tests (e.g. subjective dizziness and the Digit Symbol Substitution Test). Concurrent administration of loperamide (in a single dose of 16 mg) and ketoconazole, a CYP3A4 inhibitor, and glycoprotein P, showed an increase in plasma levels of loperamide 5 times. This increase was not associated with an increase in pharmacodynamic effects as detected by the pupillometry. Concurrent treatment with oral desmopressin was an increase in plasma desmopressin concentrations of 3 times, presumably due to a slow gastrointestinal motility. It is expected that medicines with similar pharmacological properties can enhance the effect of loperamide and that medicines that accelerate gastrointestinal transit can reduce its effects. Since symeticons are not absorbed by the gastrointestinal tract, there are no significant interactions between symeticons and other medicines. Paediatric population Interaction studies were carried out only in adults.

Effects

The safety of loperamide-simeticone was assessed in 2040 patients who took part in 5 clinical studies. All clinical studies were conducted on patients with acute diarrhea and meteorism related disorder with loperamide-simeticone in formulation of chewable tablet. Four studies compared loperamide-simeticone with loperamide, simeticone and placebo and a study compared two formulations of loperamide-simeticone with placebo. The most commonly reported adverse reactions to the drug (ADR) (i.e. with an incidence of ≥1%) in clinical studies were the following (with % of incidence): disgeusia (2.6%) and nausea (1.6%). The safety of HCl loperamide has been assessed in 2755 patients aged ≥ 12 years who participated in 26 controlled and uncontrolled clinical trials of HCl loperamide used for treating acute diarrhea. In clinical studies the most common ADRs reported (>1%) were constipation (2.7%), flatulence (1.7%), headache (1.2%) and nausea (1.1%). The safety of HCl loperamide was also assessed in 321 patients who participated in 5 controlled and uncontrolled clinical trials of HCl loperamide used for the treatment of chronic diarrhea. The most common ADRs (>1%) reported in these clinical studies were flatulence (2.8%), constipation (2.2%), dizziness (1.2%) and nausea (1.2%). Paediatric population The safety of loperamide HCl has been evaluated in 607 patients aged 10 days and 13 years, who took part in 13 controlled and uncontrolled clinical trials with loperamide HCl used for treating acute diarrhea. The only ADR reported for ≥1% of patients treated with loperamide HCl was vomiting. Table 1 shows the ADRs that have been reported with the use of loperamide-simeticone both in clinical studies and post-marketing epierience. Additional ADRs are also shown with the use of HCl loperamide (one of the components of Loperamide-simeticone). Frequency categories are based on the data of clinical studies with loperamide-simeticone and loperamide HCl through the following convention: Very common (≥1/10); Common (≥1/100 up to Table 1: Adverse reactions border=1 cellspacing=0 cellpadding=3>

Classification for systems and organs		Adverse reactions
		Frequency
	Municipalities	Not common	Rare	Notable
Immune system disorders			reaction of hypersensitivitya, anaphylactic reaction (including anaphylactic shock)a, anaphylactic reactiona
Nervous system disorders	Headache, disgeusia	Sleepa, chiefc	loss of consciousnessa, reduction of consciousness levela, stupora, hypertoniaa, coordination disordersa
Pathologies of the eye			mysteries a
Gastrointestinal diseases	Nausea	Abdominal pain, abdominal disorderb, upper abdominal painb, vomiting, constipation, abdominal distensionc, despairc, flatulence, dry mouth	othera (including paralytical ileum), megacolona (including toxic megacolond)	Acute pancreatis
Pathologies of skin and subcutaneous tissue		Skin rash	bollous eruption (including Stevens-Johnson syndromea, toxic epidermal necrolysisa and multiform erythemaa), angioedema a, hivesa, itchinga
Kidney and urinary pathologies			urinary retentiona
Systemic pathologies and conditions for administration		Austria	Tireda

^aThe inclusion of this term is based on post-marketing reports for loperamide HCl. Since the process to determine postmarketing ADRs has not differentiated between chronic and acute indications or between adults and children, the frequency is estimated in all clinical studies with combined HCl loperamide, including studies in children aged ≤ 12 years (N = 3683). ^b The inclusion of this term is based on ADR reported in clinical studies with HCl loperamide. Frequency category assigned according to clinical studies with HCl loperamide in case of acute diarrhea (N = 2755). ^c The inclusion of this term is based on post-marketing experience with loperamide-simeticone. Frequency category assigned on the basis of clinical studies with loperamide-simeticone in case of acute diarrhea (N = 618). Capogyro and abdominal distension have also been identified as clinical trial ADR with HCl loperamide. ^d See paragraph 4.4. Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioniavverse.

Overdosing

Synonyms In case of overdose (including an overdose related to hepatic dysfunction), depression of the central nervous system may occur (stupor, alteration of coordination, drowsiness, myosis, muscle hypertonia, respiratory depression), dry mouth, abdominal disorders, nausea and vomiting, constipation, urinary retention and paralytic ileum. In patients who ingested excessive doses of loperamide, cardiac events such as extension of the QT range and QRS complex, point torsion, other severe ventricular arrhythmias, cardiac arrest and syncope (see paragraph 4.4) were observed. Fatal cases have also been reported. Overdose can make the presence of Brugada syndrome manifest. After the interruption, cases of withdrawal syndrome were observed from drugs in subjects who abused, improperly used or intentionally assumed 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 could be indicated. The patient must be monitored for at least 48 hours to highlight a possible depression of the central nervous system. Paediatric population Children may be more sensitive to the effects on the SNC of adults.

Pregnancy

Safety was not established during pregnancy, however from studies carried out on animals there are no indications that loperamide or symeticons have teratogenic or embryotoxic properties. Imodium Diarrea and Meteorism should not be administered during pregnancy, especially in the first quarter, if not clinically justified

Breastfeeding

Only small amounts of loperamide hydrochloride can appear in breast milk. Therefore, Imodium Diarrea and Meteorism is not recommended during lactation.

Fertility

The effect on human fertility has not been evaluated.

Source: Farmadati