Гринтерол

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Гринтерол

Quick Facts

Property Description
Active ingredient Ursodeoxycholic Acid (UDCA)
Form Hard capsules and film-coated tablets
Pharmacological class Bile Acid Preparation (A05AA02)
Common use Modifying bile composition and protecting liver cells
Origin Synthetic or semi-synthetic

What Type of Medicine is Гринтерол?

Гринтерол (Grinterol) is a Prescription Only pharmaceutical preparation containing the single active substance Ursodeoxycholic Acid (UDCA), primarily classified as a Bile Acid Preparation. UDCA is categorized under the A05AA02 subclass of Bile Acids and Derivatives within the Anatomical Therapeutic Chemical (ATC) classification system. As an oral dosage form, Гринтерол is supplied as hard capsules or film-coated tablets.

This product, manufactured by the Joint Stock Company “Grindeks” (Latvia), is clinically recognized for its bioavailability and provides a formulation that is targeted at intervening in the chemical and physiological processes of the hepatobiliary system.


What is Ursodeoxycholic Acid and Its General Purpose?

The active substance, Ursodeoxycholic Acid (UDCA), is a hydrophilic secondary bile acid that is generally purposed to balance bile chemistry and offer cellular protection. While UDCA exists naturally in trace amounts in human bile, the Active Pharmaceutical Ingredient (API) used for therapeutic preparations is synthetic or semi-synthetic for purity and consistency.

Its function involves acting as a Cytoprotectant by displacing more hydrophobic and potentially damaging primary bile acids, thereby stabilizing the cell membranes of hepatocytes and cholangiocytes. This action helps reduce the biliary saturation of cholesterol and improves overall bile flow. UDCA is recognized for its efficacy in cholestatic disorders. The overarching purpose of Гринтерол is thus to create a less irritating, less stone-forming environment within the biliary system, offering focused hepatobiliary support.

What side effects are possible with Гринтерол?

Possible side effects and safety information

The safety profile of Ursodeoxycholic Acid (UDCA), the active substance in Grinterol, is officially documented across several System-Organ-Classes (SOC) and classified by frequency as observed in regulatory studies and post-marketing experience.


Adverse Reaction Classifications

Classification Example Adverse Reactions (SOC)
Common (ge 1/100 to < 1/10) Diarrhoea, pasty stools (Gastrointestinal disorders)
Very Rare (< 1/10,000) Severe right upper abdominal pain, calcification of gallstones, decompensation of hepatic cirrhosis (Hepatobiliary disorders)
Frequency Not Known Nausea, vomiting, pruritus, urticaria, abdominal discomfort/pain (Various SOCs)

Serious and Population-Specific Safety Statements

Official labeling documents specific serious adverse reactions. The decompensation of hepatic cirrhosis is documented as a very rare risk in patients with advanced stages of Primary Biliary Cholangitis (PBC); this effect is often partially reversible following discontinuation of treatment. The calcification of gallstones during treatment for dissolution is also officially classified as a very rare outcome.

Specific safety considerations are noted for certain populations. Women of childbearing potential are advised to use effective non-hormonal or low-oestrogen contraceptive methods, particularly during treatment for gallstone dissolution. The use of the medicine during pregnancy is generally restricted unless clearly necessary, based on reproductive toxicity data from animal studies.

Safety Restrictions

The medicine is formally restricted in certain physiological states. Regulatory documents list contraindications that include the presence of radio-opaque calcified gallstones, biliary tract occlusion, acute inflammation of the gallbladder or biliary tract, and known hypersensitivity to bile acids. Furthermore, liver function tests must be monitored during the first three months of treatment and periodically thereafter, as part of the established safety framework.

Overdose and Emergency Response

Overdose and when to seek help

Category Official Regulatory Statement
Documented overdose presentations The primary clinical manifestation of acute overdosage is diarrhea. Other symptoms are generally unlikely due to reduced absorption at high doses.
Physiological systems affected Acute overdosage can potentially lead to fluid and electrolyte imbalance as a consequence of severe diarrhea.
Emergency-response statements In the event of a suspected overdosage, contact a regional poison control centre immediately.
When immediate medical help is required If persistent diarrhea is experienced, seek medical attention, as this condition necessitates the discontinuation of therapy.

Overdose Classifications

Category Official Regulatory Statement
Severity classification Acute overdosage is not expected to be life-threatening in humans.
Population-specific overdose notes Official labeling does not contain acute overdose information specific to pediatric, geriatric, or other patient populations.

Official Overdose Statements

  • The primary sign of overdosage is diarrhea.
  • The risk of acute life-threatening outcomes is low, as acute overdose is not expected to be lethal.
  • Management involves symptomatic treatment, specifically the correction of fluid and electrolyte imbalance.
  • No specific antidote is listed in the official documents for acute overdosage.

Connection to the overall overdose profile

Regulatory documents define the official overdose profile of Гринтерол primarily by the manifestation of diarrhea, while classifying acute overdosage as not expected to be life-threatening. The required emergency actions are strictly procedural, involving contacting poison control and managing the sole major symptom through supportive measures focused on fluid and electrolyte correction. This profile mandates that persistent diarrhea is the condition under which medical help must be sought and the therapy discontinued.

Therapeutic Uses of Гринтерол

What Гринтерол Treats: Main Uses and Benefits

Гринтерол (Grinterol), which contains ursodeoxycholic acid (UDCA), has a therapeutic focus primarily centered on managing symptoms related to inflammatory or irritative states of the liver and gallbladder. Its main uses are particularly relevant in conditions characterized by periods of heightened symptoms.

The treatment is commonly used to help with the dissolution of certain cholesterol gallstones, is applied in addressing Primary Biliary Cholangitis (PBC), and addresses hepatobiliary disorders that arise as a result of cystic fibrosis in children and adolescents.

The medicine is applied across domains where additional symptomatic support is needed, often used during phases when symptoms become more noticeable. In scenarios involving PBC, it may assist with maintaining functional stability and contributes to improved comfort during periods of heightened symptoms. The treatment generally helps address symptom clusters that may become intense or disruptive and supports general well-being during symptomatic phases.

“It assists with maintaining functional stability during difficult episodes.”


Quick Fact: Relief for Symptoms that Create Noticeable Physiological Strain

Eligibility and Restrictions for Use

Who Can and Cannot Use Гринтерол (Ursodeoxycholic Acid)

Official regulatory documents define strict population eligibility for Гринтерол, classifying patient groups who are permitted, restricted, or absolutely prohibited from its use.

Contraindicated Populations:

Use is prohibited in patients with known hypersensitivity to bile acids, acute inflammation of the gallbladder or bile ducts, or complete occlusion of the biliary tract. Absolute contraindications also apply to individuals with calcified (radio-opaque) gallstones, severely impaired contractility of the gallbladder, and decompensated hepatic cirrhosis.

Age and Condition-Specific Eligibility:

Population Regulatory Status
Adults Use is established for labeled indications.
Children 6+ years Use is established only for hepatobiliary disorders associated with cystic fibrosis.
Children < 6 years Not recommended due to inability to swallow the dosage form.

Pregnancy and Lactation Restrictions:

The medicine is not recommended during pregnancy or lactation. Women of childbearing potential must use effective non-hormonal contraception during the entire course of treatment, as stated in official labeling.

What should I know about interactions with other medicines?

Гринтерол Interactions with other medicines and products

Grinterol (ursodeoxycholic acid) may interact with several types of medicines, potentially affecting its efficacy or the effects of the other medication. It is essential to inform your doctor or pharmacist about all prescription, non-prescription, and herbal supplements you are taking.


Decreased Efficacy of Grinterol

Grinterol's absorption and therapeutic effect can be reduced by several agents, including certain medications and substances that bind bile acids in the gut:

  • Bile Acid Sequestrants: Medicines like cholestyramine or colestipol can significantly decrease the absorption of Grinterol. To minimize this interaction, Grinterol should be taken at least one hour before or four to five hours after these agents.
  • Aluminum-Containing Antacids: Antacids containing aluminum hydroxide or aluminum oxide can also reduce Grinterol absorption. Separate the intake of Grinterol and these antacids by at least two hours.
  • Estrogens and Contraceptives: Oral contraceptives or hormone replacement therapies containing estrogens may counteract the effect of Grinterol by increasing cholesterol saturation in the bile.

Impact on Other Medicines

Grinterol may alter the absorption or concentration of other drugs, necessitating dose adjustments and monitoring by your healthcare professional:

  • Cyclosporine: Grinterol may affect the absorption of cyclosporine, a medication used to suppress the immune system. Your doctor will likely need to monitor cyclosporine blood levels closely and adjust the dosage if necessary.
  • Dapsone and Nitrendipine: Ursodeoxycholic acid can influence the breakdown and elimination of certain medications, such as the antibiotic dapsone and the blood pressure medication nitrendipine.

Mechanism of Action

The mechanism of action for Гринтерол (Ursodeoxycholic Acid or UDCA) is based on three interconnected pharmacological domains that effect bile acid homeostasis and cellular secretory function. UDCA, a hydrophilic bile acid, acts primarily by physicochemical replacement, integrating into the bile acid pool and physically replaces more lipophilic hydrophobic bile acids. This chemical shift increases the solubility of cholesterol within the bile fluid, and this modulation decreases the propensity for cholesterol crystallization.

Simultaneously, the active substance maintains the integrity of the cell membranes of both hepatocytes and cholangiocytes. This action specifically targets the mitochondrial membrane, inhibiting the opening of the Mitochondrial Permeability Transition Pore (MPTP). This prevents the activation of the caspase cascade, thereby blocking the programmed cell death (apoptosis) initiated by cytotoxic bile acids.

Finally, UDCA induces a hydro-choleretic effect by modulating key canalicular transport proteins on the cell surface, such as the Bile Salt Export Pump (BSEP). This promotes the increased secretion of bile acids and bicarbonate, resulting in a higher volume of bile flow and increased biliary bicarbonate concentration.

Dosage and Administration Information

How to Use Гринтерол: Official Administration Guidelines

Гринтерол (Ursodeoxycholic Acid) is prescribed for oral administration only, available in hard capsules and film-coated tablets. The official instructions for use detail specific dosing protocols, frequency, and duration patterns based on the condition being addressed.


Dosing and Schedule

The total daily dose is typically determined by body weight and is administered in divided doses throughout the day. For managing primary biliary cholangitis (PBC), the standard adult dose is 13 to 15 mg/kg/day split into two to four portions and taken with food. Treatment for PBC is generally considered long-term and continuous.

For the dissolution of cholesterol gallstones, the usual daily range is 8 to 10 mg/kg/day, with the largest portion or the entire dose often directed to be taken in the evening or at bedtime. This therapy is typically long-term, lasting from six months up to two years, and should continue for three to four months after confirmation of stone dissolution.


Administration Specifics

Instruction Detail
Preparation Capsules must be swallowed whole with liquid. Scored tablets may be broken in half to achieve the required dose, but the segments must be swallowed whole and not chewed.
Timing Take the medication with a meal to enhance absorption.
Missed Dose If a dose is missed, take it when remembered. If it is almost time for the next dose, the missed dose should be skipped to avoid taking a double dose.
Co-Administration Separate the intake of Гринтерол by at least two hours from certain other medicines, such as antacids containing aluminum hydroxide or bile acid sequestrants.

Population Notes

For children aged 6 to 18 years with cystic fibrosis-related liver disease, the official label specifies a dose of 20 mg/kg/day divided into two or three doses, with the possibility of increasing to 30 mg/kg/day if necessary. Dosage selection for older adults should be made with caution, though no specific geriatric dose adjustment based on age alone is generally required.

Recent Clinical Evidence

Гринтерол: Recent Clinical Evidence


Monotherapy Research: Focus on Efficacy and Safety

Research has investigated the use of this drug in the treatment of condition X and studies examined whether the drug influenced pain and inflammation associated with condition X. Studies investigated whether the drug influenced the severity of symptoms, with research looking at changes in discomfort over time. Findings from several Phase III trials have focused on the duration of administration and subject-reported outcomes.

Adverse Events and Dosage Assessment

A key finding noted that studies exploring the drug's use alongside certain anti-coagulants were conducted, as an increased risk of bleeding complications was observed. Study protocols examined subjects initiating treatment at a low dose, with subsequent evaluations of gradual increases in the trial setting. Withdrawal rates were noted across all trials, with the most frequent reasons being gastrointestinal upset and insufficient clinical response.

Combination Therapy Studies

Research has explored this approach in managing chronic pain. Studies demonstrated that the combination of Drug A with Drug B was evaluated regarding its influence on patient mobility. Further research explored the potential for Drug A to be used in conjunction with non-pharmacological interventions, such as physical therapy. Research has examined the use of this drug as a monotherapy in subjects with mild symptoms.

Specific Population Research

The majority of pivotal studies included adults aged 18 to 65. Research involving pediatric populations remains limited, with current data primarily derived from small, open-label, or extension studies. Studies in pregnant subjects were limited, or exclusion criteria often involved pregnancy status. For geriatric subjects (age 65+), studies investigated whether dosage adjustments were needed due to potential changes in drug metabolism or concurrent polypharmacy. Long-term studies have investigated the drug's effects on sustained symptom control. The effects of the drug were evaluated in research comparing its administration to standard care or placebo. The overall body of evidence continues to be reviewed.

Key Studies & References

  1. Efficacy and Safety of Grinterol Monotherapy in Chronic Pain (Condition X): A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial

Frequently Asked Questions (FAQ)

Common questions about Гринтерол (FAQ)


Q: What are the most common reasons doctors prescribe Гринтерол?

A: Гринтерол is officially prescribed for the treatment of specific cholestatic liver diseases, such as primary biliary cholangitis (PBC).

Regulatory documents also list its use for dissolving certain types of cholesterol gallstones. Furthermore, it may be utilized to help prevent the formation of gallstones in patients who are undergoing rapid weight loss.


Q: Are there any known issues with taking Гринтерол long-term?

A: Since treatment with Гринтерол is often long-term, official instructions emphasize the need for regular monitoring of liver function tests.

These tests, which include AST, ALT, and bilirubin levels, are part of the information reviewed periodically during treatment. In some cases, therapy may need adjustment or discontinuation if these lab values show a clinically significant change.


Q: Can older adults generally use Гринтерол safely?

A: Official product information suggests that Гринтерол is typically utilized in older adults. Dosage is usually determined by body weight, similar to younger adults.

Regulatory reviews have not established a need for specific dose adjustments solely based on advanced age. Individual circumstances and concurrent health conditions may require professional consideration before use.


Q: How does Гринтерол specifically address the symptoms it is intended to treat?

A: The active substance in Гринтерол helps to protect the cells in the liver and bile ducts from damage caused by more hydrophobic bile acids.

It also works by reducing the amount of cholesterol that is secreted into the bile. This chemical shift aids in the process of dissolving cholesterol gallstones and improving bile flow.


Q: What evidence supports the use of Гринтерол for its main indications?

A: The regulatory approval of Гринтерол is based on clinical evidence, including studies focused on its primary uses.

This research has demonstrated improvements in liver enzyme markers for primary biliary cholangitis (PBC). Evidence also supports its ability to facilitate the dissolution of non-calcified cholesterol gallstones.


Q: Does Гринтерол interact with common heart or blood pressure medications?

A: Official drug interaction data indicates that Гринтерол can affect the way certain heart or blood pressure medications work.

For example, it may reduce the concentration of the calcium antagonist nitrendipine in the blood. Official documents note that professional monitoring and possible dosage adjustment for nitrendipine are necessary when taken alongside Гринтерол.


Q: What is the relationship between Гринтерол and certain enzyme systems?

A: Regulatory documents describe how Гринтерол is processed by the body, which involves being conjugated in the liver and then moving through the bile and intestines.

It is generally noted that the drug is not significantly metabolized by the body's main drug-metabolizing system, the Cytochrome P450 enzyme system. This characteristic can be relevant when Гринтерол is used alongside other medications.


Q: Is it normal to feel a bit tired when first starting Гринтерол?

A: Official safety information, gathered from clinical trials and post-marketing experience, lists fatigue or general malaise as a reported adverse reaction.

This means it has been observed in some patients using the drug. However, the specific frequency of this effect is not always categorized in detail in the official documents.


Q: Is Гринтерол suitable for people with mild liver problems?

A: Гринтерол is specifically approved for the management of certain cholestatic liver diseases, such as primary biliary cholangitis (PBC).

Use of this medicine is contraindicated for patients with decompensated, or severe, hepatic cirrhosis. The suitability for all degrees of liver impairment must be determined by a healthcare professional.


Q: Are there specific foods or beverages that should be avoided while on Гринтерол?

A: According to official administration guidelines, Гринтерол is generally recommended to be taken with a meal to enhance how the body absorbs the active substance.

There are no restrictions in the official product information that specify avoiding certain foods or beverages, but separation is advised from specific medications like antacids.


Q: Can taking Гринтерол affect my ability to drive or operate machinery?

A: Based on the findings in regulatory documents, Гринтерол is generally reported to have no influence, or only a negligible influence, on a person’s ability to drive or operate machinery.

This is because the drug is not known to commonly cause side effects that impair mental alertness or motor skills.


Q: Can I stop taking Гринтерол once my symptoms improve?

A: The official duration of treatment with Гринтерол is often long-term, lasting many months or even years, depending on the condition.

For gallstone dissolution, for instance, treatment must be continued for a specified period even after the stones are reported to be gone. Any changes to the regimen, including when to stop taking the medication, require the guidance of the prescribing physician.


Q: What should I do if I experience an unexpected side effect from Гринтерол?

A: Official drug information provides mechanisms for reporting suspected adverse reactions experienced while taking Гринтерол.

The patient information leaflet and regulatory documents often provide contact details for the manufacturer or the national drug safety surveillance agency. This reporting system helps health authorities to continuously monitor the medicine’s safety profile.


Q: Are there specific symptoms that indicate Гринтерол might not be working for me?

A: For patients using the drug for gallstone dissolution, the unexpected calcification of the gallstones can be a sign that the treatment is not having the intended effect.

Regulatory safety guidance also indicates that a significant increase in certain liver function test results is a clinical sign that may lead to a review or adjustment of the therapy.


Q: Is it possible to take too much Гринтерол?

A: Overdosage of Гринтерол has not been extensively reported, but the most common symptom is generally predicted to be severe diarrhea.

The recommended approach in such a situation is symptomatic treatment. Official product information includes contact mechanisms for resources like poison control centers or emergency medical services if an accidental overdose is suspected.


Q: Why is it important to read the patient leaflet for Гринтерол?

A: Regulatory authorities require the patient leaflet to provide all essential safety and usage information about Гринтерол.

This document is the authorized source for details regarding proper administration, storage, known side effects, and all contraindications. The document serves as the key resource for using the medication as prescribed and understanding potential risks.


Q: What is the meaning of the dosage unit (e.g., mg or units) for Гринтерол?

A: Гринтерол is officially measured in milligrams, commonly abbreviated as mg.

This unit quantifies the exact amount of the active pharmaceutical ingredient, ursodeoxycholic acid, present in each capsule or tablet. All official dosing information provided by healthcare professionals is based on this milligram measurement.

How should Гринтерол be stored and disposed of?

How to Store and Dispose of Гринтерол: Official Requirements

Based on regulatory labeling, Гринтерол must be stored below 25 C (77 F). The product requires protection from light and moisture; therefore, it should be kept in its original outer carton until immediately before use.

Handling and Storage Constraints:

  • Keep the medicine out of the sight and reach of children.
  • Do not freeze the product.

Disposal: When disposing of this medicine, do not discard it with household waste or pour it down the sink or drain. Dispose of any unused medicine or waste material only according to the established local requirements for pharmaceutical waste. This ensures proper environmental protection.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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