Racecadotril Rivopharm: Uses, Dosage & Side Effects

What Is Racecadotril Rivopharm and What Is It Used For?

Racecadotril Rivopharm is a generic version of racecadotril marketed by the Swiss pharmaceutical company Rivopharm SA. The medicinal product belongs to a small but pharmacologically distinct group of antidiarrhoeal drugs known as peripherally-acting enkephalinase inhibitors. Unlike most other antidiarrhoeal medicines, racecadotril does not affect intestinal motility or activate central opioid receptors. Instead, it targets one of the underlying biochemical mechanisms by which acute diarrhoea actually develops: the abnormal secretion of water and electrolytes from the intestinal mucosa into the gut lumen, driven by the breakdown of endogenous opioid peptides called enkephalins.

To understand why racecadotril is useful, it helps to understand what acute diarrhoea actually is. Acute infectious diarrhoea — whether viral (most commonly norovirus, rotavirus or astrovirus), bacterial (such as enterotoxigenic Escherichia coli, Vibrio cholerae, non-typhoidal Salmonella or Campylobacter) or parasitic — primarily produces its symptoms not by speeding up intestinal transit, but by triggering the active secretion of fluid into the small bowel. Bacterial enterotoxins and inflammatory mediators activate intracellular signalling pathways (most importantly cyclic AMP and cyclic GMP) that open chloride channels in the apical membrane of enterocytes, drawing water osmotically into the lumen. Within hours, this can overwhelm the absorptive capacity of the colon and produce the high-volume, watery stools characteristic of acute infectious diarrhoea.

Racecadotril addresses this secretory mechanism directly. After oral administration, racecadotril is rapidly hydrolysed in the bloodstream to its active metabolite, thiorphan. Thiorphan is a selective, reversible inhibitor of enkephalinase, also known as neutral endopeptidase (NEP) or membrane metalloendopeptidase. Enkephalinase normally breaks down endogenous opioid peptides — the enkephalins — which act on delta-opioid receptors in the gut wall to reduce intestinal fluid secretion. By blocking this enzyme, racecadotril prolongs the action of the body’s own enkephalins, restoring a normal balance between absorption and secretion in the small intestine. The result is a measurable reduction in stool volume and stool frequency, and a shorter duration of diarrhoea.

An important pharmacological feature of racecadotril is its peripheral selectivity. Although it acts indirectly through opioid signalling, its active metabolite thiorphan does not cross the blood-brain barrier in clinically meaningful amounts, and the drug does not produce central opioid effects such as sedation, analgesia, respiratory depression or euphoria. There is no recognised potential for dependence or abuse. Equally important, racecadotril does not slow intestinal motility — gut transit time, as measured by radio-opaque markers in clinical pharmacology studies, is unchanged. This means that the drug does not produce the bloating, flatulence and rebound constipation that are common with motility-slowing antidiarrhoeals, and it does not run the theoretical risk of retaining bacterial pathogens or toxins in the bowel for an extended period.

Racecadotril Rivopharm 100 mg hard capsules are licensed for the symptomatic treatment of acute diarrhoea in adults aged 18 years and over when causal treatment is not possible. The medicine is intended to be used complementary to oral rehydration and the usual hygiene and dietary measures, and it is not a substitute for them. In other words, racecadotril does not treat the underlying infection or condition causing the diarrhoea; it relieves the symptom. Restoration of fluid and electrolyte balance with an appropriate oral rehydration solution remains the single most important intervention in any episode of acute diarrhoea, and is the only intervention proven to reduce mortality from infectious gastroenteritis worldwide.

Racecadotril was first developed in France in the 1980s and is now marketed in many European countries (including France, Italy, Spain, Sweden, Germany, the United Kingdom, the Netherlands and Greece), in parts of Asia and in Latin America under various brand names including Hidrasec, Tiorfan, Tiorfix and now generic versions such as Racecadotril Rivopharm. It is not currently approved by the U.S. Food and Drug Administration (FDA) for use in the United States. The 100 mg adult capsule is the standard adult formulation; paediatric racecadotril is supplied as 10 mg and 30 mg granules for oral suspension under separate marketing authorisations and is dosed on a per-kilogram basis — the 100 mg adult capsule should not be used in children under 18 years of age.

What Should You Know Before Taking Racecadotril Rivopharm?

Racecadotril Rivopharm is generally well tolerated in healthy adults with acute, uncomplicated diarrhoea, but several clinical situations make it unsuitable or require special caution. The most important consideration is to recognise the relatively narrow indication of the medicine: it is intended for short-term use in acute diarrhoea in adults whose stools are watery and who do not have features of invasive infection. Diarrhoea with blood, pus, high fever or severe systemic symptoms requires medical assessment because it may signal invasive bacterial enteritis, inflammatory bowel disease, or another condition where antisecretory treatment alone would be inappropriate or unsafe.

Contraindications

Racecadotril Rivopharm must not be taken if any of the following apply to you. These are absolute contraindications based on the European Summary of Product Characteristics:

• Known hypersensitivity: Allergy to racecadotril or to any of the inactive ingredients listed in section 7. Reactions have included rash, hives, severe pruritus, angioedema and, very rarely, anaphylactic reactions.
• Hereditary problems of galactose intolerance: Including total lactase deficiency or glucose-galactose malabsorption. The capsule contains lactose monohydrate as an excipient.
• Hereditary fructose intolerance, sucrase-isomaltase deficiency or glucose-galactose malabsorption: The capsule may contain sucrose-derived excipients in some formulations; check the packaging insert.
• Pregnancy: There are insufficient clinical data on the use of racecadotril during pregnancy. Animal studies do not show direct or indirect harmful effects, but as a precaution it is preferable not to use racecadotril during pregnancy — see dedicated section below.
• Breastfeeding: It is not known whether racecadotril or its metabolites are excreted in human milk. The medicine is not recommended during breastfeeding.
• Children and adolescents under 18 years: The 100 mg adult capsule has not been studied in this age group. Paediatric formulations of racecadotril (10 mg and 30 mg granules for oral suspension) are dosed by body weight and should be used instead under medical supervision.

Warnings and Precautions

Talk to your doctor, pharmacist or nurse before starting Racecadotril Rivopharm if any of the following apply to you. These are not absolute contraindications, but they may modify the risk profile or change how the medicine should be used:

• Bloody or purulent stools, high fever (>38.5 °C): These may indicate invasive bacterial infection (such as Shigella, invasive Salmonella, Campylobacter or E. coli O157), inflammatory bowel disease or another condition that requires specific assessment. Use of antidiarrhoeal medicines in this setting can mask important diagnostic features.
• Severe or worsening dehydration: Especially in elderly patients or those with reduced food and fluid intake. Oral rehydration with an oral rehydration solution (ORS) is the cornerstone of treatment; antidiarrhoeal medicines do not replace it. Severe dehydration with inability to keep fluids down may require intravenous rehydration in hospital.
• Chronic diarrhoea: Racecadotril Rivopharm is licensed for acute diarrhoea only. Diarrhoea lasting more than 14 days, or recurrent diarrhoea, requires medical evaluation to identify an underlying cause such as inflammatory bowel disease, microscopic colitis, coeliac disease, malabsorption, irritable bowel syndrome or chronic infection.
• Antibiotic-associated diarrhoea: Use the medicine with caution in patients who have received antibiotics, particularly broad-spectrum antibiotics, in the previous weeks. Persistent or bloody diarrhoea after antibiotic therapy may suggest Clostridioides difficile infection, which requires specific diagnosis and targeted antimicrobial treatment, not symptomatic antidiarrhoeal therapy alone.
• Severe hepatic or renal impairment: Limited data are available on the pharmacokinetics of racecadotril in patients with significant hepatic or renal disease. Plasma concentrations of the active metabolite may be increased and the duration of action prolonged. Caution is advised; specialist input may be needed.
• Diabetes mellitus: The capsule contains small amounts of carbohydrate excipients but is unlikely to affect blood glucose meaningfully. Continue your usual diabetic medication, and remember that diarrhoea can itself disrupt the absorption of oral hypoglycaemic drugs.
• Concomitant ACE inhibitor therapy (e.g., enalapril, ramipril, lisinopril, perindopril): The combined use of racecadotril and an ACE inhibitor has been associated with isolated cases of angioedema, possibly because both drug classes can interfere with the metabolism of bradykinin. Patients on ACE inhibitors should be aware of this risk; if angioedema occurs, racecadotril should be stopped immediately and the situation discussed with the prescriber.
• Older patients: No specific dose adjustment is required for age alone, but elderly patients are more susceptible to dehydration, electrolyte disturbance and the consequences of polypharmacy. Particular attention to fluid status and to interacting medicines is warranted.
• Recurrent vomiting: If vomiting prevents the capsule from being absorbed, antiemetic therapy or rehydration may be needed before symptomatic antidiarrhoeal treatment can be effective.

Pregnancy and Breastfeeding

The available human safety data on racecadotril during pregnancy are limited and come mainly from spontaneous post-marketing reports rather than controlled studies. There is no clear signal of teratogenicity or adverse pregnancy outcome attributable to the medicine, but the absence of evidence of harm is not the same as evidence of safety. The European product information consequently advises that racecadotril should be avoided in pregnancy unless clearly necessary, and that the decision to treat should be made by a doctor who can balance the severity of the diarrhoea, the woman’s hydration status and the alternative treatment options (principally oral rehydration).

For breastfeeding, it is not definitively known whether racecadotril or its active metabolite thiorphan are excreted in human milk. Because of this uncertainty, racecadotril is not recommended for use in nursing mothers. If a breastfeeding mother develops acute diarrhoea, oral rehydration and dietary measures should be the first-line approach; if symptomatic drug therapy is judged necessary, the prescriber should consider the risks and benefits and may prefer alternative treatments with better established safety in lactation.

Animal fertility studies with racecadotril at doses substantially above the human therapeutic range have not shown effects on fertility or reproductive performance. Human data are limited.

Driving and Operating Machinery

Racecadotril Rivopharm has no or negligible influence on the ability to drive and use machines. Because the active metabolite does not cross the blood-brain barrier in clinically meaningful amounts, the drug does not produce sedation, dizziness or other central nervous system effects that would be expected to impair driving performance. However, the underlying illness causing the diarrhoea — with dehydration, fatigue and electrolyte disturbance — may itself reduce alertness and reaction time, and you should not drive if you feel unwell.

Important Information About Some Ingredients

Racecadotril Rivopharm 100 mg hard capsules contain lactose monohydrate. If your doctor has told you that you have an intolerance to certain sugars (such as galactose intolerance, total lactase deficiency or glucose-galactose malabsorption), you should not take this medicine; contact your doctor for an alternative.

The capsule shell contains gelatin, titanium dioxide (E171) and may contain other colourants such as iron oxides; patients with rare hypersensitivity to these excipients should review the full ingredient list in the patient leaflet supplied with the pack. Each capsule also contains very small amounts of sodium (less than 1 mmol or 23 mg per dose, essentially “sodium-free”) and is therefore suitable for patients on a low-sodium diet.

How Does Racecadotril Rivopharm Interact with Other Drugs?

Racecadotril and its active metabolite thiorphan are extensively bound to plasma albumin only at high concentrations and have a short plasma half-life of about 3 hours, with elimination predominantly via the kidneys. The drug is not a clinically significant inhibitor or inducer of the cytochrome P450 system at therapeutic doses, which limits its potential for the pharmacokinetic interactions that complicate prescribing of many other medicines. Most of the interactions of practical importance with racecadotril are pharmacodynamic in nature — they relate to the way racecadotril and the other drug both act on common physiological systems — or are caused by the underlying diarrhoea itself altering the absorption of other oral medications.

Major Interactions

Moderate Interactions

Food, Drink and Lifestyle Interactions

Food: The first capsule of racecadotril can be taken regardless of meal time; subsequent capsules should be taken before main meals (breakfast, lunch and dinner). Food does not significantly alter the antidiarrhoeal efficacy of the drug, although it may slightly delay the time to peak plasma concentration of the active metabolite. Continue eating small, frequent, easily digestible meals (such as the “BRAT” diet of bananas, rice, apple sauce and toast) as tolerated; prolonged fasting is not recommended in acute diarrhoea.

Alcohol: There is no specific pharmacological interaction between racecadotril and alcohol, but alcohol worsens dehydration, irritates the gastrointestinal tract and can interact with many other medicines. Avoid alcohol while you have active diarrhoea and during recovery.

Grapefruit juice: Racecadotril is not significantly metabolised by CYP3A4, and grapefruit juice does not have a clinically meaningful interaction with this medicine.

Oral rehydration solution (ORS): ORS is not an interaction but the foundation of treatment. Adults with acute diarrhoea should aim to replace lost fluid and electrolytes by drinking small, frequent sips of ORS or other clear fluids; in severe cases or if oral intake is not possible, intravenous rehydration in hospital is required.

What Is the Correct Dosage of Racecadotril Rivopharm?

Before starting Racecadotril Rivopharm, your doctor or pharmacist will assess whether the diarrhoea is acute, uncomplicated and not associated with features that would require alternative management (such as bloody stools, high fever, severe dehydration or recent antibiotic therapy). Oral rehydration with an oral rehydration solution (ORS) and the usual hygiene and dietary measures must always accompany the medicine; symptomatic antisecretory therapy is not a substitute for fluid replacement.

Adults (18 Years and Over)

Children and Adolescents Under 18 Years

Elderly Patients (65 Years and Older)

No specific dose adjustment is required on the basis of age alone. However, elderly patients are particularly vulnerable to the consequences of acute diarrhoea, including dehydration, electrolyte disturbance (notably hyponatraemia and hypokalaemia), acute kidney injury and falls. Special attention should be paid to maintaining adequate fluid intake with an oral rehydration solution. If oral intake is not possible because of vomiting, weakness or confusion, hospital assessment for intravenous rehydration may be required. Racecadotril does not affect cognition or balance and is therefore generally well tolerated in older patients with normal renal and hepatic function.

Patients with Kidney Problems

Pharmacokinetic data on racecadotril in patients with significant renal impairment are limited. The active metabolite thiorphan is eliminated mainly by the kidneys, and reduced renal clearance may increase plasma exposure and prolong the duration of action. The European product information advises that racecadotril should be used with caution in patients with renal impairment and avoided in those with severe renal failure. Where treatment is considered necessary, close clinical monitoring is recommended, and the prescriber may prefer to limit the duration of therapy.

Patients with Liver Problems

Pharmacokinetic data in patients with hepatic impairment are also limited. Plasma exposure to racecadotril and thiorphan may be increased in patients with significant liver disease. Caution is advised, and the medicine should be avoided in those with severe hepatic insufficiency. In mild to moderate hepatic impairment, no specific dose adjustment is recommended, but treatment should be reassessed if there is no clinical improvement after 48 hours.

Missed Dose

If you forget to take a dose of Racecadotril Rivopharm, take the next dose at the usual time. Do not take a double dose to make up for a forgotten one. Because the medicine acts on enkephalinase only for a few hours after each capsule is absorbed, missing a single dose will simply mean that the antisecretory effect briefly wears off; symptoms may transiently return until the next dose takes effect. Resume the regular three-times-daily schedule and continue oral rehydration in the meantime.

Overdose

Single doses of racecadotril of up to 2 grams (the equivalent of 20 capsules) have been administered to healthy adults in clinical pharmacology studies without producing serious adverse effects. There is therefore a wide safety margin between the recommended therapeutic dose and the dose at which clinically significant toxicity might be expected. Nevertheless, if a person has taken more capsules than prescribed, or if a child has accidentally swallowed an adult capsule, contact a doctor, hospital emergency department or poison control centre for advice. Treatment is supportive and symptomatic; there is no specific antidote, and gastric decontamination is not generally indicated. The drug is not removed by haemodialysis to any clinically meaningful extent because of its high protein binding.

If You Stop Taking Racecadotril Rivopharm

There is no medical danger in stopping racecadotril at any time. The drug has no withdrawal effect and no rebound diarrhoea has been reported on discontinuation. In practice, treatment should be stopped as soon as two normal stools have been passed. If you wish to stop earlier, consult your doctor or pharmacist if you are concerned that the diarrhoea may not be fully resolved.

What Are the Side Effects of Racecadotril Rivopharm?

Like all medicines, Racecadotril Rivopharm can cause side effects, although not everyone gets them. The frequency categories used below are the standard CIOMS frequency intervals applied throughout European product information. The vast majority of patients tolerate racecadotril well; the most common adverse effect — headache — is mild and self-limiting. Serious adverse reactions are rare but, when they occur, they typically involve hypersensitivity (allergic) phenomena and require prompt recognition.

What These Side Effects Mean in Practice

For the average healthy adult taking racecadotril for an episode of acute viral gastroenteritis, the realistic risk of any clinically meaningful adverse effect is low. Headache is the only side effect reported in clinical trials at a frequency above 1 in 100, and it is usually mild and short-lived. Skin reactions occur in fewer than 1 patient in 100; most are limited rashes that resolve when the medicine is stopped. The most clinically important adverse reaction — angioedema — is rare (fewer than 1 in 1,000 patients), but it can be life-threatening because it may obstruct the airway. Patients who are also taking ACE inhibitors appear to be at greater risk and should be especially vigilant.

It is important to distinguish between side effects of the medicine and symptoms of the underlying diarrhoeal illness. Persistent abdominal pain, fever, vomiting, weakness, dizziness on standing, dark urine and reduced urine output are typically features of the diarrhoeal illness itself rather than of racecadotril, and they generally indicate inadequate fluid replacement, complications of the infection or, occasionally, an alternative diagnosis. They are not reasons to stop racecadotril per se, but they are reasons to seek medical assessment.

How Should You Store Racecadotril Rivopharm?

Keep Racecadotril Rivopharm capsules out of the sight and reach of children at all times. Although the medicine is supplied in child-resistant blister packaging, accidental ingestion by a young child requires medical evaluation, particularly to assess hydration and to consider whether emergency review is needed.

This medicinal product does not require any special storage temperature in most climates. Capsules should be stored below 30 °C and protected from excessive moisture by keeping them in their original blister pack until immediately before use. Do not transfer the capsules to a different container, such as a pill organiser, as this may compromise the protective packaging and shorten shelf life. Avoid storing the capsules in places that experience humidity or temperature fluctuations, such as bathroom cabinets or near radiators.

Do not use Racecadotril Rivopharm after the expiry date stated on the blister pack and outer carton after “EXP.” The expiry date refers to the last day of that month. If you find expired or unused capsules, do not throw them in the rubbish or flush them down the toilet. Take them to a community pharmacy, which can dispose of them safely through pharmaceutical waste channels. These measures help to protect the environment and prevent accidental ingestion by others.

If a capsule is visibly damaged, discoloured or shows signs of moisture damage, do not take it. Contact your pharmacist for advice and to obtain a replacement supply if necessary.

What Does Racecadotril Rivopharm Contain?

Active Ingredient

The single active substance in Racecadotril Rivopharm is:

• Racecadotril 100 mg — a peripherally-acting enkephalinase (neutral endopeptidase) inhibitor and prodrug of thiorphan. Racecadotril is rapidly converted in plasma to its active form, which preserves endogenous enkephalins acting on intestinal delta-opioid receptors. The result is reduced abnormal hypersecretion of water and electrolytes in the small intestine, without any effect on intestinal motility, central opioid receptors or other major physiological systems. Racecadotril is also known by the chemical name acetorphan and was originally developed under the research code BP 88.

Inactive Ingredients (Excipients)

The capsule fill of Racecadotril Rivopharm typically contains the following inactive ingredients:

• Lactose monohydrate — a sugar used as a filler. Patients with intolerance to lactose, hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
• Pregelatinised starch — a starch that has been chemically modified to improve flow and compressibility.
• Magnesium stearate (E572) — a lubricant that prevents the capsule contents from sticking to manufacturing equipment.
• Colloidal anhydrous silica (E551) — an anti-caking agent and glidant.

The hard gelatin capsule shell typically contains:

• Gelatin — the structural component of the capsule. Note: gelatin is derived from animal sources and may not be acceptable to patients following strict vegetarian or vegan diets.
• Titanium dioxide (E171) — an opacifying agent.
• Iron oxides and other permitted colourants may be used to provide identification colour to the capsule body and cap.

The capsules are usually presented in blister packs (PVC/aluminium or PVDC/aluminium). Pack sizes commonly available include 10, 20, 30 and 100 capsules, although not all pack sizes may be marketed in every country. The marketing authorisation holder is Rivopharm SA, a Swiss pharmaceutical company that markets racecadotril and other generics across Europe and selected international markets. Always consult the patient information leaflet supplied with your specific pack to confirm the exact composition, since formulations may vary slightly between markets and over time.

For a complete and current list of all excipients, refer to the patient information leaflet provided with the medicine, or to the published Summary of Product Characteristics (SmPC) for Racecadotril Rivopharm in your country.