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Dissenten 15 Tablets 2 mg

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023694058
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WARNINGS
Treatment of diarrhea with loperamide hydrochloride is symptomatic only. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate. Fluid and electrolyte depletion may occur in patients with diarrhea, especially children. In these cases the most important countermeasure is the administration of adequate replacement therapy based on fluids and electrolytes. It is advisable to discontinue treatment with the drug if there is no improvement in clinical symptoms within 48 hours after the start of therapy and the patient should consult their doctor. AIDS patients treated with the drug 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 hydrochloride, there have been isolated cases of constipation with an increased risk of toxic megacolon. Loperamide hydrochloride is subject to an intense first pass metabolism. Although no pharmacokinetic data are available in patients with hepatic impairment, loperamide hydrochloride should be used with caution in these patients due to impaired first pass metabolism. Therefore patients with hepatic impairment should be carefully monitored for signs of toxicity to the central nervous system (CNS).
PHARMACOTHERAPEUTIC CATEGORY
Anti-propulsants.
STORAGE
This medicinal product does not require any special storage conditions.
CONTRAINDICATIONS / SECONDARY EFFECT
Hypersensitivity 'to the active substance or to any of the excipients. Contraindicated in children under 6 years. It should not be used as primary therapy: in patients with acute dysentery, characterized by blood in the stool and high fever; in patients with acute ulcerative colitis; in patients with pseudomembranous colitis associated with the use of broad-spectrum antibiotics; in patients with bacterial enterocolitis caused by invasive organisms including Salmonella, Shigella and Campilobacter. In general, its use is contraindicated in all cases where inhibition of peristalsis must be avoided due to the possible risk of significant consequences such as ileus, toxic megacolone megacolon. If constipation, abdominal distension or ileus occurs, stop treatment immediately.
NAME
DISSENTEN 2 MG TABLETS
EXCIPIENTS
Magnesium stearate; microgranular cellulose.
SIDE EFFECTS
The most commonly reported adverse drug reactions in clinical trials with loperamide hydrochloride for the treatment of acute diarrhea were: constipation, flatulence, headache and nausea. In clinical trials for the treatment of chronic diarrhea the most commonly reported adverse reactions were: flatulence, constipation, nausea and dizziness. Frequencies of adverse reactions: very common (> = 1/10), common (> = 1/100, <1/10), uncommon (> = 1/1000, <1/100), rare (> = 1 / 10,000 , <1/1000) and very rare (<1 / 10,000). >> Acute diarrhea. Nervous system disorders. Common: headache; uncommon: dizziness. Gastrointestinal disorders. Common: constipation, nausea, flatulence; uncommon: abdominal pain, abdominal discomfort, dry mouth, upper abdominal pain, vomiting; rare: abdominal distension. Skin and subcutaneous tissue disorders. Uncommon: rash. >> Chronic diarrhea. Nervous system disorders. Common: dizziness; uncommon: headache. Gastrointestinal disorders. Common: constipation, nausea, flatulence; uncommon: abdominal pain, abdominal discomfort, dry mouth, dyspepsia. Loperamide hydrochloride, data of post-marketing adverse reactions: Since the process of determining the post-marketing adverse reactions of loperamide hydrochloride did not differentiate between indications of chronic and acute diarrhea or between adults and children, the adverse reactions listed below represent the combined indications and the subject populations. Adverse reactions identified in the post-marketing period for loperamide hydrochloride. Immune system disorders: hypersensitivity reaction, anaphylactic reaction (including anaphylactic shock), anaphylactoid reaction. Nervous system disorders: drowsiness, loss of consciousness, stupor, depression of the levels of consciousness, hypertonia, abnormal coordination. Eye disorders: miosis. Gastrointestinal disorders: ileus (including paralytic ileus), megacolon (including toxic megacolon), glossodynia. Skin and subcutaneous tissue disorders: Bullous rash syndrome (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 hydrochloride was evaluated in 607 patients aged 10 days to 13 years who participated in 13 controlled and uncontrolled clinical trials with loperamide hydrochloride used for the treatment of acute diarrhea. In general, the adverse reaction profile in this patient population was similar to that observed in clinical trials with loperamide hydrochloride in adults and children aged 12 years and older. Report any suspected adverse reactions via the national reporting system.
PREGNANCY AND BREASTFEEDING
Although there are no indications that loperamide hydrochloride has teratogenic or embryotoxic properties, the anticipated therapeutic benefits should be weighed against the potential risks before administering loperamide hydrochloride during pregnancy, especially during the first trimester. Small amounts of loperamide can appear in human breast milk. Therefore loperamide hydrochloride is not recommended during breastfeeding.
INDICATIONS
Symptomatic treatment of acute diarrhea and flare-ups of chronic diarrhea.
INTERACTIONS
Non-clinical data demonstrated that loperamide is a substrate of P-glycoprotein. Concomitant administration of loperamide (16 mg indose single) with quinidine or ritonavir, both inhibitors of P-glycoprotein, resulted in a 2 to 3-fold increase in plasma levels of loperamide. The clinical relevance of this pharmacokinetic interaction with P-glycoprotein inhibitors when loperamide is administered at recommended doses is unknown. Concomitant administration of loperamide (4 mg single dose) and itraconazole, an inhibitor of CYP3A4 and P-glycoprotein, resulted in a 3 to 4-fold increase in plasma concentrations of operamide. In the same study, gemfibrozil, a CYP2C8 inhibitor, increased plasma concentrations of loperamide approximately 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 detected by psychomotor tests (e.g. subjective sleepiness and the Digit Symbol Substitution Test). Concomitant administration of loperamide (16 mg single dose) and ketoconazole, an inhibitor of CYP3A4 and P-glycoprotein, resulted in a 5-fold increase in plasma concentrations of loperamide. 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 plasma concentrations of desmopressin, presumably due to a slowing of gastrointestinal motility. Treatment with substances with similar pharmacological properties can enhance the effect of loperamide and drugs that accelerate intestinal transit can decrease its effect. Concomitant use of CYP 450 inhibitors is not recommended.
DOSAGE
The tablets should be taken with a little liquid. Adults and children diet between 6 and 17 years: the initial dose is 2 tablets (4 mg) for adults and 1 tablet (2 mg) for children; thereafter 1 tablet (2 mg) after each subsequent evacuation of loose stools. The maximum daily dose for adults is 8 tablets (16 mg). For children, the dose should be related to body weight (3 tablets / 20 kg) but should not exceed a maximum of 8 tablets per day. Decrease the dose when the stool is normalized and stop treatment in case of constipation. Warning: do not use for more than two days. Children under 6 years of age: the medicine should not be used in children under 6 years of age. Elderly: No dose adjustment is required in the elderly. Renal impairment: No dose adjustment is required in patients with renal impairment. Hepatic impairment: Although no pharmacokinetic data are available in patients with hepatic impairment, the medicinal product should be used with caution in these patients due to impaired first pass metabolism.
ACTIVE PRINCIPLES
Each tablet contains: 2 mg loperamide hydrochloride.
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Dissenten 15 Tablets 2 mg

€9.60 €8.90