Colotal

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Colotal

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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 Colotal

What is Colotal?

Colotal is a medication primarily used for the symptomatic treatment of abdominal pain, cramps, and intestinal discomfort associated with functional bowel disorders. It belongs to a class of drugs known as antispasmodics, specifically acting as a musculotropic agent.

Mechanism of Action

The active ingredient in Colotal acts directly on the smooth muscles of the gastrointestinal tract. Unlike some other medications used for digestive issues, it works by relaxing the intestinal muscles without interfering with the normal motility of the gut. This targeted action helps to relieve spasms and the resulting pain or bloating without affecting the regular movement required for digestion.

Therapeutic Use

Colotal is commonly utilized to manage symptoms related to Irritable Bowel Syndrome (IBS) and other similar gastrointestinal conditions. By reducing the overactivity of the muscles in the colon, it helps stabilize bowel function and reduce the frequency of painful episodes. It is intended to address the physical symptoms of digestive distress rather than treating an underlying infection or inflammation.

What side effects are possible with Colotal?

Possible Side Effects and Safety Information

The official safety profile of Mebeverine Hydrochloride (Colotal) is documented by regulatory agencies based on data from clinical use and spontaneous reports. The medicine is classified as a musculotropic antispasmodic, and its safety profile is primarily characterized by the potential for hypersensitivity reactions.


Adverse Reactions and Classification

The most commonly reported adverse events are classified under Immune system disorders and Skin and subcutaneous tissue disorders.

Adverse Reaction Category Examples of Listed Effects
Skin Manifestations Urticaria (hives), Exanthema (skin rash), Face oedema
Serious Reactions Anaphylactic reactions, Angioedema (swelling that can affect the face, lips, tongue, or throat)

Because most safety data is derived from post-marketing surveillance rather than controlled studies, the formal incidence of the listed adverse reactions is classified as Not Known by regulatory authorities; a precise frequency cannot be estimated from the available data.


Population-Specific Safety Statements

Official labeling includes specific restrictions based on available data for certain groups:

  • Paediatric Population: Colotal is generally not recommended for use in children and adolescents below 18 years of age due to a lack of established safety and efficacy data in this population.
  • Pregnancy and Breastfeeding: Use is not recommended during pregnancy or breastfeeding, citing limited information regarding fetal safety and unknown excretion into human milk.
  • General Use: The medicine is contraindicated in individuals with a known hypersensitivity to Mebeverine Hydrochloride or any of its excipients. Post-marketing experience has not indicated any harmful effect on the ability to drive or operate machinery. Overdose observations have primarily involved symptoms of a neurological and cardiovascular nature.

Overdose and Emergency Response

Overdose and when to seek help

The following information is derived directly from government regulatory sources (e.g., Summary of Product Characteristics, Prescribing Information) concerning Mebeverine Hydrochloride overdose.

Documented Overdose Profile

Feature Official Regulatory Statement
Documented Clinical Presentation Overdose symptoms are commonly absent or mild and observed to be rapidly reversible.
Physiological Systems Affected Observed manifestations have been reported as being of a neurological nature and a cardiovascular nature.
Antidote Information No specific antidote is known for Mebeverine Hydrochloride overdose.

Required Emergency Action

If an overdose is suspected, individuals are required to talk to a doctor or go to a hospital straight away for immediate medical attention. The official regulatory instruction is to seek urgent medical help for any suspected over-ingestion.

Management and Considerations

Management is defined as symptomatic and supportive treatment. Procedural interventions such as gastric lavage should only be considered in specific circumstances, such as in cases of multiple intoxication or if the ingestion is identified within approximately one hour.

No specific risk for elderly or patients with renal or hepatic impairment has been identified from available post-marketing data regarding overdose severity.

Therapeutic Uses of Colotal

What Colotal treats: main uses and benefits

The active ingredient in Colotal, mebeverine hydrochloride, is applied across domains where additional symptomatic support is needed for functional gastrointestinal disorders. It is relevant for easing symptoms that interfere with daily functioning; it is relevant when supportive symptom management is appropriate.

The product is commonly used across conditions presenting with acute episodes and is considered relevant in conditions characterized by periods of heightened symptoms, such as irritable bowel syndrome (IBS). It is also applied in addressing related conditions presenting with systemic or localized discomfort, including chronic irritable colon and spastic colitis. Colotal assists with maintaining functional stability and contributes to improved comfort during periods of active symptoms.

The product generally may assist with managing symptom clusters that create noticeable functional strain. It supports the patient during difficult episodes by easing distress during symptomatic phases. It assists with maintaining functional stability.

Quick Fact: The product may be part of symptomatic management for symptoms related to physical discomfort.

Eligibility and Restrictions for Use

Who Can and Cannot Use Colotal?

The official eligibility criteria for Colotal (Mebeverine Hydrochloride) are defined by government regulatory agencies and delineate specific population groups for whom the medicine is approved, restricted, or prohibited.

Contraindications and Prohibited Use

Colotal is contraindicated and must not be used in patients with known hypersensitivity to mebeverine hydrochloride or any excipients. Use is also prohibited for individuals with paralytic ileus or rare hereditary metabolic disorders, such as total lactase deficiency, galactose intolerance, or glucose-galactose malabsorption.

Age and Reproductive Status

  • Adults (18 years and older): The medicine is primarily intended for use in the adult population. Use in older adults is permitted, as no specific dosage adjustment is deemed necessary.
  • Pediatric Patients: Use is not recommended in children and adolescents below 18 years due to insufficient data on both safety and efficacy.
  • Pregnancy and Lactation: Use is not recommended during pregnancy and should not be used while breastfeeding, due to a lack of sufficient safety data in these physiological states.

Cautionary Use

Caution is advised when the medicine is used in patients with pre-existing organ dysfunction, specifically advanced hepatic dysfunction (liver disease) or advanced renal disease (kidney disease).

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official prescribing information for Colotal (mebeverine hydrochloride) documents the product's interaction profile based on regulatory submissions and available clinical data. The overall structure of the official interaction map is characterized by a general absence of formal studies involving co-administration with other medicinal products.

Documented Interaction Status

Interaction Type Official Regulatory Statement
Interactions with Medicinal Products None documented. Regulatory documents state that specific interaction studies with other medicines have generally not been performed.
Contraindicated Combinations None listed. No specific medicinal products are formally designated as contraindicated for co-administration due to interaction risk.
Metabolic or Transporter Interactions None documented. Official labels do not contain information on specific mechanistic interactions, such as those involving CYP enzymes or drug transporters.

Interaction with Non-Medicinal Substances

Official regulatory texts specifically address the interaction with ethanol (alcohol). Studies have demonstrated the absence of any interaction between mebeverine hydrochloride and alcohol. This finding confirms that the official regulatory profile does not list alcohol as a restriction for individuals taking Colotal.

No other non-medicinal substances, such as specific foods, supplements, or herbal products, are explicitly listed in official prescribing information as having documented interactions with Colotal. Consequently, no specific timing-based rules or separation requirements for co-administration are mandated in the regulatory label.

Mechanism of Action

How Colotal Works: Mechanism of Action

Direct Modulation of Gastrointestinal Smooth Muscle Contraction

The primary mechanism of Mebeverine involves direct action on the smooth muscle cells in the gut wall. The compound functions by blocking Voltage-Dependent Calcium Channels to inhibit the critical influx of calcium ions ( Ca^2+). This molecular interference prevents the sustained activation of contractile proteins; the physiological consequence is smooth muscle relaxation.

Selective Reduction of Intestinal Motility

This musculotropic action is localized to the bowel. By stabilizing the muscle cell membrane and reducing cell excitability, Mebeverine reduces intestinal smooth muscle contractility at the tissue level. This focused mechanism reduces contractility in overly responsive muscle segments.

Multi-Target Cellular Stabilization

Mebeverine's action profile is based on multiple cellular targets, contributing to overall stability and reduced excitability of the muscle. This includes the primary Ca^2+ channel blockade alongside supplementary effects, such as potential modulation of Sodium Channels and weak inhibition of Noradrenaline Reuptake. These combined, local actions define the drug's focused physiological profile.

Dosage and Administration Information

Colotal, which contains the active ingredient mebeverine hydrochloride, is an antispasmodic medication intended for the symptomatic relief of pain, cramps, and abdominal discomfort associated with Irritable Bowel Syndrome (IBS) and similar gastrointestinal functional disorders.

Administration and Dosage

The standard adult oral dosage for mebeverine tablets is typically 135 mg taken three times a day. However, the dose may be reduced once symptoms have improved. Modified-release capsules, generally containing 200 mg, are usually taken twice a day.

Dosage Form Adult and Elderly Initial Dose Maximum Daily Tablets/Capsules
Tablets (e.g., 135 mg) One tablet three times a day 3 tablets
Modified-Release Capsules (e.g., 200 mg) One capsule twice a day 2 capsules

Instructions for Use

  • Timing: It is generally recommended to take Colotal approximately 20 minutes before a meal as some individuals experience stronger symptoms after eating.
  • Method: Swallow the tablet or capsule whole with water. They should not be chewed.
  • Missed Dose: If a dose is missed, take it as soon as you remember. If it is almost time for the next scheduled dose, skip the missed one and continue with the regular dosing schedule. Do not take a double dose to compensate for a forgotten one.
  • Duration: Consult a healthcare provider if symptoms do not improve after a period of time, or if new or worsening symptoms develop. Do not stop taking the medication without speaking to a doctor, even if feeling better. Colotal is not recommended for children and adolescents under 18 years of age.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Colotal (Mebeverine)


Evidence for Use in Irritable Bowel Syndrome (IBS)

Mebeverine (Colotal) was studied for the symptomatic management of Irritable Bowel Syndrome (IBS) in adults. These studies explored how symptoms change over time. The research base includes Randomized Controlled Trials (RCTs) and comprehensive systematic reviews that combine and analyze results from multiple individual trials. Research has monitored patient-reported outcomes describing perceived discomfort, specifically focusing on the intensity of abdominal pain and the overall sense of global symptom improvement.

Studies monitored these symptoms over defined time intervals, typically focusing on short-term symptom changes of between four and twelve weeks. Research highlights patterns measured during the study period, with some trials reporting changes in the recorded abdominal pain scores compared to baseline. However, when multiple studies are combined in a meta-analysis, findings were mixed regarding overall global symptom improvement compared to placebo. This variability across studies is often related to the differing ways that researchers defined and measured "improvement" in the observed populations.


Evidence for Functional Bowel Spasms and Discomfort

Colotal was studied for broader conditions characterized by fluctuating or episodic manifestations, such as general functional bowel disorders presenting with pain and spasm. The research exploring these conditions includes comparative Phase III studies and observational settings evaluating daily-life functioning. Studies explored outcomes related to physical discomfort, including the severity of pain and episodes of bloating or flatulence. The evidence for this general application contributes to the broader evidence landscape, primarily showing patterns observed when the medication is used in conditions where symptoms may vary in intensity. However, compared to the IBS research, there is limited information from placebo-controlled trials specifically for this generalized population.


Long-Term Research and Durability of Response

Clinical trials have focused mainly on research exploring short-term symptom changes, usually over periods up to three months. The follow-up durations for many of the key trials were limited. For patients using Colotal for a longer time, the long-term effects are not fully established in terms of sustained symptom support. There is limited information for long-term outcomes from formal, controlled trials designed to assess the durability of the response after six months or more.


Research in Specific Patient Groups

Most of the foundational research for Colotal was evaluated in adult patients. Data for certain groups, such as older adults, often remain inferred or insufficient compared to the core adult IBS population. Studies monitored a small number of adolescents with functional abdominal pain, but the sample sizes were modest, meaning findings describe group patterns but do not provide substantial evidence for this younger population. Information related to the use of Colotal in pregnant or breastfeeding populations is primarily observational and data are still emerging from these settings.

Key Studies & References

  1. Public Assessment Report Scientific discussion Mebeverine Aristo 200 mg modified release capsules, hard (mebeverine hydrochloride) NL
  2. Management of irritable bowel syndrome (IBS) - South & West Devon Formulary (References common IBS management and drug class)
  3. A03AA04 Mebeverine - WHO Anatomical Therapeutic Chemical (ATC) Classification

Frequently Asked Questions (FAQ)

Common questions about Colotal (FAQ)


Q: Is Colotal the same as similar-sounding medications?

Colotal is a brand name for the active ingredient mebeverine hydrochloride. Regulatory and official sources classify this substance as a musculotropic antispasmodic agent, which means it acts directly to relax the muscles in the gut. It is also chemically defined as a synthetic papaverine analog.


Q: How quickly do people generally notice the effects of Colotal?

According to one official source, mebeverine hydrochloride generally starts to work after approximately one hour following administration. The medication is often taken before a meal to best address symptoms that may be stronger after eating.


Q: What happens if I stop taking Colotal suddenly?

Official patient information advises that individuals should not stop taking the medicine without first discussing it with a healthcare professional, even if their symptoms appear to have improved. This requirement reflects a standard medical precaution for changes to medication treatment.


Q: Is Colotal meant to be taken long-term or short-term?

Official regulatory documentation for the tablet form indicates that the duration of use is not limited in the prescribing information. However, some sources suggest that it is often taken only for flare-ups, and the dose may be gradually reduced when symptoms improve.


Q: Are there any common lifestyle changes that should be considered while using Colotal?

Patient information leaflets often note that complementary changes in diet and lifestyle may also be part of a broader strategy for managing the condition. For example, some sources mention that a high-fibre diet and learning to relax may help lessen symptoms.


Q: Can Colotal cause changes in mood or sleep?

The official safety profile mainly lists skin and immune reactions. However, some adverse event reports have included neurological effects such as insomnia (trouble sleeping) and headache. Despite this, regulatory documents state that the available data do not indicate a harmful effect on the ability to drive or operate machinery.


Q: Is it true that Colotal can affect blood tests?

Yes. Official safety data indicates that Colotal has the potential to cause false-positive results for amphetamines in certain urine drug screening tests. This occurs due to a cross-reactivity with the components that the body breaks the medicine down into.


Q: Are there food types that are noted to interact with Colotal?

Official prescribing information and patient leaflets do not list specific food types or herbal products as having documented interactions with mebeverine. The medication is generally recommended to be taken 20 minutes before a meal.


Q: What is the difference between Colotal tablets and capsules, if both exist?

Colotal is available in different forms, typically immediate-release tablets and modified-release capsules (often called slow-release). The main difference is the design: modified-release capsules are engineered for the extended delivery of the medication, aiming to provide a sustained effect.


Q: What happens to Colotal in the body, generally speaking?

According to official pharmacokinetics data, mebeverine is rapidly and completely absorbed after swallowing. It is then metabolised (broken down) in the body by enzymes, and the resulting components are excreted mainly through the urine.


Q: Why is it important to tell the doctor about all other medicines before starting Colotal?

Although specific official studies have generally not documented interactions with other medicinal products, regulatory documents advise patients to inform their healthcare provider about all medicines they are taking. This is a standard medical precaution when starting any new medicine.


Q: Can Colotal be split or crushed?

No. Official patient documents advise that the tablets and capsules should be swallowed whole with water and should not be chewed. Official documentation advises against this to maintain the intended release profile and integrity of the medication.


Q: How is Colotal typically stored at home?

Official storage instructions require that the medicine be stored out of the sight and reach of children, typically in its original package. It must be kept protected from light and moisture and at a temperature not exceeding 30°C.


Q: Does Colotal affect alertness or driving ability?

Available information and post-marketing experience suggest the medicine does not commonly impair an individual’s ability to drive or operate machines. However, no specific studies have been performed to assess this.


Q: What are the most critical safety warnings associated with Colotal?

Official safety warnings describe serious reactions that have been documented, primarily related to hypersensitivity reactions (severe allergic responses). These reactions include anaphylaxis and angioedema (swelling of the face, lips, tongue, or throat) which can be serious.


Q: Are there any specific dietary restrictions mentioned in the Colotal patient leaflet?

Official patient leaflets and prescribing information do not list specific dietary restrictions or mandates to restrict any foods while taking Colotal. It is advised to take the medication about 20 minutes before a meal.


Q: Is Colotal considered a standard or alternative treatment for its main use?

Official regulatory summaries, such as systematic reviews, often describe antispasmodic agents like mebeverine as effective for the general symptomatic relief of Irritable Bowel Syndrome. The medicine is a recognized pharmacological approach for managing pain and cramping.


Q: Are there different brand names for the same drug as Colotal?

Yes. Colotal is just one brand name for the active substance mebeverine hydrochloride. The medication is available internationally under many different brand names, such as Colofac and Duspatalin.


Q: Is Colotal available in liquid form?

Yes. Official product listings confirm that mebeverine hydrochloride is available in a variety of presentations, including oral suspensions (a liquid form), in addition to the standard tablets and modified-release capsules.

How should Colotal be stored and disposed of?

Official Storage and Disposal Requirements

The storage and disposal of Colotal (mebeverine hydrochloride) must strictly adhere to the conditions documented in official regulatory labeling.

Storage Conditions

Requirement Details
Temperature Limit Store the product at a temperature not greater than 30°C.
Environmental Protection Must be stored in its original package to protect from light and to protect from moisture (for capsules).
Shelf-Life The stability period is typically 3 to 5 years, provided mandatory storage conditions are maintained.

Disposal Instructions

Colotal must be kept out of the sight and reach of children.

Expired or unused medicine must not be thrown away with household waste or disposed of via wastewater, as this is necessary to protect the environment. Disposal of the product should be carried out in accordance with local regulations or by consulting a pharmacist about proper collection points.

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

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