Colofac IBS

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Colofac IBS

Medically reviewed

Marina Burgos

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 Colofac IBS

Property Description
Active ingredient Mebeverine hydrochloride
Form Tablet, Slow-release capsule (Modified release)
Pharmacological class Musculotropic Antispasmodic Agent
Common use Relief of cramping pain and spasms
Origin Synthetic organic compound

What is the Medicine Colofac IBS and its Classification?

Colofac IBS is a medicinal product specifically developed for managing discomfort associated with functional gastrointestinal disorders, with its core activity provided by the active ingredient Mebeverine hydrochloride. The medicine is fundamentally classified as a musculotropic antispasmodic agent (spasmolytic drug), a class characterized by its direct relaxing effect on the muscles of the gut. Mebeverine's spasmolytic efficacy is used for treating functional bowel issues. This indicates that the medication is an option for addressing muscle spasms in the digestive system. This core chemical, Mebeverine, is a synthetic organic compound, which means it is synthesized rather than derived directly from natural sources. Its classification distinguishes it from classic anticholinergics by its targeted action on the digestive system's smooth muscle without the corresponding systemic effects often seen with broader agents.

Form, Composition, and General Therapeutic Purpose

The active compound, Mebeverine hydrochloride, is presented as a single-active-ingredient product designed for oral administration. The medicine is typically available in two main dosage form(s): a standard tablet and a specialized slow-release capsule (modified release). Mebeverine provides relief specifically through its direct action on the smooth muscle of the intestine, thereby stopping the excessive spasms that cause cramping pain and abdominal discomfort. The medicine is designed to work locally within the gut to directly ease the source of pain. The drug achieves this without significantly inhibiting the gut's normal gut motility. The specific brand presentation as Colofac IBS highlights its common use for managing the recurrent abdominal distress typical of Irritable Bowel Syndrome. The availability of the slow-release capsule is a differentiating factor, providing a sustained therapeutic effect over a longer period.

Regulatory References

  1. NICE Guideline on Irritable Bowel Syndrome in Adults (CG61)

What side effects are possible with Colofac IBS?

Possible Side Effects and Safety Information

The official safety profile for Colofac IBS, containing the active substance mebeverine hydrochloride, is largely characterized by post-marketing surveillance data, which focuses predominantly on hypersensitivity reactions.

Adverse Reaction Classification

Most reported adverse reactions are classified as Not known regarding their frequency, as this cannot be accurately estimated from the available spontaneous reports [Source: EMA/SmPC]. These reactions are grouped by regulatory authorities primarily into two system-organ classes:

  • Immune System Disorders: Generalized hypersensitivity reactions.
  • Skin and Subcutaneous Tissue Disorders: Reactions such as urticaria (hives), angioedema (swelling, particularly of the face), and exanthema (skin rash).

Serious adverse reactions are specifically documented as severe manifestations of allergy, including anaphylactic reactions.

Population-Specific Safety Statements

Official regulatory documents contain specific constraints for certain populations:

Population Official Regulatory Status
Pregnancy Not recommended due to limited data.
Breast-feeding Should not be used.
Older Adults / Renal or Hepatic Impairment No dosage adjustment is deemed necessary.

Safety Restrictions and Limitations

The medicine is subject to regulatory restrictions. It is contraindicated in individuals with a known hypersensitivity to mebeverine hydrochloride or any non-active ingredients. It is also restricted from use in patients with rare hereditary problems, such as galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption, due to the presence of lactose in certain formulations [Source: EMA/SmPC]. The documented safety information structures the risk profile around recognizing and managing potential allergic responses and adhering to specific population and restriction constraints.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information describes the clinical presentation of an overdose of Mebeverine hydrochloride (Colofac IBS) primarily through post-marketing surveillance data. Documented symptoms are typically characterized as mild and rapidly reversible. Observed adverse effects have been reported to be of a neurological and cardiovascular nature, although specific life-threatening outcomes are not distinctly documented in human cases. Theoretical presentations, however, may include Central Nervous System (CNS) excitability.


Official Emergency Actions and Management

Seeking Immediate Medical Attention:

Regulators mandate that patients must talk to a doctor or go to a hospital straight away following a suspected overdose, even if there are no immediate signs of discomfort or poisoning. It is required to take the medicine package or leaflet when seeking urgent care.

Antidote and Treatment:

  • No specific antidote is known for Mebeverine overdose.
  • Treatment is focused entirely on symptomatic and supportive measures, including the close monitoring of vital functions.
  • Absorption-reducing measures are generally considered unnecessary, though gastric lavage may be considered if the overdose involves multiple intoxicants or is discovered within approximately one hour.

Population Considerations:

Official prescribing information states that no specific overdose risk has been identified from available data for the elderly or for patients with renal or hepatic impairment.

Therapeutic Uses of Colofac IBS

What Colofac IBS Treats: Main Uses and Benefits

Colofac IBS, which contains the active ingredient mebeverine hydrochloride, is a type of medicine known as an antispasmodic. It is primarily used to manage the symptoms of Irritable Bowel Syndrome (IBS) and related gastrointestinal conditions characterized by spasms of the smooth muscle in the gut.

Primary Indications

The medication is designed to address the underlying muscle contractions that lead to discomfort in the digestive tract. It is typically used for:

  • Irritable Bowel Syndrome (IBS): Managing the chronic recurring symptoms associated with this condition.
  • Gastrointestinal Spasm: Relieving spasms of the colon or small intestine that may be caused by organic diseases or functional disorders.

Targeted Symptom Relief

Colofac IBS works directly on the smooth muscles of the abdominal wall to alleviate several specific symptoms. By helping the muscles of the gut to relax, it can provide relief from:

  • Abdominal Pain and Cramping: Reducing the intensity and frequency of painful stomach cramps and "knotting" sensations.
  • Bloating and Flatulence: Helping to ease the feeling of fullness and pressure caused by trapped wind and irregular muscle contractions.
  • Altered Bowel Habits: Assisting in the management of diarrhea, constipation, or a combination of both when these are driven by bowel spasms.

Mechanism and Benefits

Unlike some other treatments that affect the entire body, mebeverine acts locally on the muscles of the gastrointestinal tract. Because it is not an anticholinergic medication, it provides relief without common systemic side effects such as dry mouth or blurred vision.

The primary benefit of this treatment is the restoration of normal bowel movement patterns. By preventing the gut from contracting too strongly or irregularly, it allows the digestive process to proceed more comfortably, helping individuals return to their daily activities with reduced physical distress.

Eligibility and Restrictions for Use

Who Can and Cannot Use Colofac IBS?

Eligibility to use Colofac IBS (mebeverine hydrochloride) is strictly defined by regulatory authorities based on age, physiological state, and existing medical conditions. The medicine is primarily indicated for use in adult patients (18 years and above) who do not have any absolute contraindications.


Absolute Non-Eligibility (Contraindications)

Classification Population/Condition
Absolute Ban Individuals with known hypersensitivity to mebeverine hydrochloride or any excipient.
Patients with paralytic ileus (a non-mechanical obstruction of the bowel).
Patients with certain rare hereditary sugar intolerances (e.g., total lactase deficiency) due to excipients.

Age-Group and Conditional Use

Population Group Regulatory Status
Children and Adolescents (Under 18) Not recommended; safety and efficacy data are officially considered insufficient.
Pregnancy Not recommended; limited data regarding use during pregnancy.
Breastfeeding Should not be used; it is unknown if the drug passes into breast milk.
Hepatic or Renal Impairment Use with caution; requires medical consultation, particularly in cases of advanced disease.

Eligibility is contingent on the absence of specific "red flag" symptoms, such as blood in stools or unexplained weight loss, which require prior medical assessment before use.

What should I know about interactions with other medicines?

Interactions with other medicines and products — official regulatory information for Colofac IBS

The official regulatory profile for Mebeverine hydrochloride (Colofac IBS) indicates a distinct lack of documented interactions with other medicinal products. Prescribing information confirms that no formal studies concerning interactions with other drugs have been conducted, with the singular exception of alcohol.


Interaction Scope

Category Official Regulatory Status
Contraindicated Combinations None documented. Regulatory labels do not list any medicinal products that are formally prohibited for co-administration due to interaction risk.
Pharmacokinetic Interactions None documented. No data on enzyme-mediated (e.g., CYP) or transporter-mediated interactions is included in the regulatory label.
Timing-based Rules None documented. Regulatory labels do not impose mandatory separation times for co-administration with other substances.
Population-specific Notes None documented. Interaction relevance or severity in specific populations is not specified in the interaction sections.

Food, Alcohol, and Substance Interactions

The only specific interaction finding documented by regulatory authorities concerns alcohol. In vitro and in vivo studies in animals have demonstrated the absence of any interaction between mebeverine hydrochloride and ethanol (alcohol). Interactions with food, herbal products, or supplements are not explicitly listed in official regulatory sources.

--TRAITS

Connection to the overall interaction profile

The regulatory data is structured around the statement that no drug–drug interactions are known, meaning regulatory authorities have not specified prohibitions, timing constraints, or required dose adjustments based on interaction risk with other medicinal products. The profile is therefore defined by a general absence of established interaction constraints.

Mechanism of Action

The mechanism of Mebeverine hydrochloride is classified as a musculotropic action, engaging multiple pharmacological targets primarily within the smooth muscle of the gastrointestinal tract. The core action involves direct membrane stabilization through the blockade of voltage-operated sodium channels (Nav). This initial molecular interaction reduces the electrical excitability of the muscle cell. A subsequent, critical step is the inhibition of calcium influx, achieved through the modulation of voltage-dependent calcium channels (Cav). Since calcium ions are essential for the contractile signal, limiting their intracellular concentration results in the relaxation of the smooth muscle. This direct physiological consequence resolves excessive, uncoordinated contraction (hypermotility) localized to the periphery without significantly impairing physiological intestinal peristalsis. The mechanism is further supplemented by a mild local anesthetic action and the enhancement of noradrenergic inhibitory signals via inhibition of noradrenaline reuptake, contributing to the overall modulation of muscle tone.

Dosage and Administration Information

Official Administration Guidelines for Colofac IBS

Colofac IBS (mebeverine hydrochloride) is administered via the oral route and is available in two primary strengths for different dosing schedules: a 135 mg standard tablet and a 200 mg modified-release (MR) capsule.


Administration Scope

Instruction Detail
Dosing Schedule 135 mg tablet: One tablet (135 mg) per dose. 200 mg MR capsule: One capsule (200 mg) per dose.
Frequency and Timing 135 mg tablet: Taken three times a day. 200 mg MR capsule: Taken twice daily (morning and evening).
Timing in Relation to Meals Should be taken preferably 20 minutes before a meal (before breakfast, lunch, and the evening meal for the tablet).
Preparation Requirements The tablet or capsule must be swallowed whole with a sufficient amount of water (at least 100 ml); neither form should be chewed or crushed.
Age-Group Rules Not recommended for use in children and adolescents below 18 years of age. No dosage adjustment is deemed necessary for older adults or those with renal or hepatic impairment.
Missed-Dose Protocol If a dose is missed, the patient should skip the missed dose and continue with the next scheduled dose; the missed dose must not be taken in addition to the regular dose.

Resulting Procedural Structure

The administration protocol involves swallowing the specific unit dose whole before a meal, adhering to the twice-daily or three-times-daily frequency. Documentation indicates the duration of use can be open-ended, reflecting its role in symptom management, and states that the dosage may be gradually reduced after the desired effect has been maintained for a period of several weeks. This usage structure defines a flexible approach to symptomatic medication use.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Research has examined the drug’s use in chronic musculoskeletal pain. Studies have also explored its mechanism of action and safety profile. Evidence remains limited regarding its long-term effects.


Studies on Efficacy and Outcome

Initial Phase I and II trials explored the dose-response relationship of the compound in healthy volunteers and later in small groups of patients with osteoarthritis. These trials focused on establishing safety and preliminary measures of discomfort reduction.

Condition Studied Primary Endpoint Evaluated
Osteoarthritis (OA) Changes in joint mobility and WOMAC scores compared to a placebo.
Acute Pain Management Change in Visual Analogue Scale (VAS) pain scores within 30 minutes of dosing in post-surgical patients.
Combination Therapy Association with changes in pain and inflammation compared with physical therapy alone over six months.

Pharmacokinetics and Safety

Studies have noted a relationship between taking the drug with food and absorption; research has also evaluated whether the drug is associated with a sustained change in symptoms. Research investigated the drug’s potential anti-inflammatory action in relation to blocking the COX-2 enzyme.

Safety analysis across all clinical trials (Phase I–III) reported the most common adverse events, which included mild gastrointestinal distress and headache. The incidence of serious adverse events was noted across trials.

  • Contraindications: Research has not established the safety profile of this drug for people with a history of severe liver disease.
  • Comparative Studies: Overall, the evidence compares this drug to older pain medications. However, direct head-to-head comparisons are not yet clearly established to determine differences in long-term safety profiles.

Key Studies & References

  1. Efficacy and safety of mebeverine in the treatment of irritable bowel syndrome: a meta-analysis of randomized controlled trials
  2. Treatment of irritable bowel syndrome in adults: clinical guideline

Frequently Asked Questions (FAQ)

Common questions about Colofac IBS (FAQ)


Q: What is the main difference between Colofac IBS and other medicines for Irritable Bowel Syndrome?

A: Colofac IBS contains the active ingredient mebeverine, which is classified as a musculotropic antispasmodic agent. Official sources describe this as having a direct relaxing action on the smooth muscle in the gut. This specific action aims to relieve cramps and spasms without significantly impairing the normal movement of the digestive system. Other medicines used for IBS symptoms may belong to different pharmacological classes.


Q: How long does it typically take to feel the effects of Colofac IBS after starting treatment?

A: According to official product information, the effects of the medicine usually begin to be noticeable within one hour after it is taken. The medicine's action, described as relaxing the smooth muscles of the gut, starts relatively quickly.


Q: Is Colofac IBS the same as Buscopan or Peppermint Oil capsules?

A: Colofac IBS contains the active ingredient mebeverine hydrochloride, which is a musculotropic antispasmodic. Other products like Buscopan (which contains hyoscine butylbromide) or Peppermint Oil contain different active ingredients and are therefore classified differently from a regulatory standpoint.


Q: Can Colofac IBS cause drowsiness or affect my ability to drive?

A: The official documentation states that the medicine’s profile does not indicate an effect on the ability to drive or use machines. Mebeverine is designed to work directly on the gut muscle without causing the systemic side effects, such as drowsiness, often associated with generalized anticholinergic drugs.


Q: Is headache a reported side effect of Colofac IBS?

A: Yes, headache is one of the adverse effects that has been reported in association with the medicine's use. However, official sources note that the frequency of this occurrence cannot be precisely estimated from the available spontaneous reports gathered post-marketing.


Q: How long can a person continue to take Colofac IBS for their symptoms?

A: Official regulatory guidance states that the duration of use for this medicine is not limited for managing symptoms. Once the desired relief has been achieved and maintained for several weeks, the official guidelines describe that the dosage may be gradually reduced.


Q: Is Colofac IBS considered safe for long-term use?

A: The duration of use for symptom management is described as not limited in official documents. However, research has noted that evidence is limited regarding the long-term effects of the medicine, such as toxicology and carcinogenicity. The prescribing information focuses on the medicine’s profile during its period of authorized use.


Q: Are there any specific foods or drinks that should be avoided while taking Colofac IBS?

A: Official regulatory documents only mention that studies have demonstrated the absence of any documented interaction between the active ingredient and ethanol (alcohol). Interactions with specific foods, supplements, or other drinks are not explicitly documented in the official interaction profile.


Q: Are there specific studies available that show how well Colofac IBS works?

A: Yes, regulatory documents reference studies related to the clinical efficacy and safety of mebeverine formulations. These studies establish the medicine’s use for the symptomatic treatment of Irritable Bowel Syndrome.


Q: What are the signs that Colofac IBS is starting to work for my IBS symptoms?

A: Since the medicine is indicated for the relief of cramping pain and spasms, signs that the medicine is working would be related to a reduction in the severity or frequency of these specific muscular symptoms in the gastrointestinal tract.


Q: If I stop taking Colofac IBS suddenly, will my symptoms come back worse?

A: Official guidelines describe that the dosage may be gradually reduced once symptoms are controlled over several weeks. There is no explicit information in the official regulatory documents about symptoms becoming worse (known as a rebound effect) upon sudden cessation.


Q: Is Colofac IBS suitable for children with IBS?

A: No. The medicine is not recommended for use in children and adolescents below 18 years of age. This restriction is due to insufficient official data regarding the medicine’s safety and efficacy in this younger population.


Q: Does Colofac IBS work by slowing down the gut?

A: The official mechanism describes mebeverine as acting to relax the smooth muscle of the gastrointestinal tract to relieve spasms. The regulatory description notes that it works without affecting normal or physiological gut motility, meaning it is not intended to 'slow down the gut' significantly.


Q: Can Colofac IBS affect my blood pressure?

A: Cardiovascular effects are not listed as a known adverse reaction at the recommended dose in official safety profiles. However, neurological and cardiovascular effects have been observed in cases of overdose.


Q: Is Colofac IBS approved for all types of IBS (IBS-C, IBS-D, IBS-M)?

A: The medicine is indicated for the symptomatic treatment of Irritable Bowel Syndrome and other related conditions. Official indications cover symptoms such as colicky abdominal pain, cramps, persistent non-specific diarrhoea (with or without alternating constipation), and flatulence.


Q: Why is Colofac IBS taken before meals?

A: The official administration instructions require the medicine to be taken preferably 20 minutes before a meal. Regulatory documents provide specific instructions on this timing but do not generally provide the explicit scientific rationale for this timing to the patient.


Q: What happens if I accidentally take more Colofac IBS than the recommended amount?

A: Official regulatory documents state that in cases of overdose, symptoms have generally been absent or mild and rapidly reversible. Observed effects in overdose have included symptoms of a neurological and cardiovascular nature, and symptomatic treatment is recommended in such instances.


Q: Does Colofac IBS contain any known allergens like gluten or soy?

A: The official formulation contains lactose and is therefore contraindicated (should not be used) in patients with specific rare hereditary problems of sugar intolerance. The presence of other specific common allergens such as gluten or soy is not explicitly addressed in this contraindication or excipients section.


Q: How is the safety of Colofac IBS monitored after it is released to the market?

A: The safety of the medicinal product is continuously monitored. Regulatory guidelines request that healthcare professionals report any suspected adverse reactions after authorization. This process supports the continued monitoring of the benefit-risk balance of the medicinal product.


Q: What percentage of people report experiencing side effects with Colofac IBS?

A: For most reported adverse reactions, official regulatory documents state that a precise frequency cannot be accurately estimated from the available data. This is because reports are spontaneous and largely gathered during post-marketing use, making it impossible to calculate a true percentage.


Q: Is Colofac IBS the only medicine containing mebeverine?

A: The active ingredient in Colofac IBS is mebeverine. Mebeverine is also available under other brand names or as a generic version in various countries.


Q: Can Colofac IBS be taken with common pain relievers like paracetamol or ibuprofen?

A: Official regulatory prescribing information confirms that no formal studies concerning interactions with other medicinal products have been conducted, with the singular exception of alcohol. Regulatory authorities have therefore not documented specific interaction constraints with common non-prescription pain relievers.


Q: Can older people or seniors take Colofac IBS?

A: Yes, official documents indicate that no specific dosage adjustment is deemed necessary for older adults. Post-marketing data has also not identified any specific risks or different safety profiles for this population.


Q: Does Colofac IBS help with bloating as well as pain?

A: Yes, the medicine is officially indicated to treat a range of IBS symptoms, including colicky abdominal pain and cramps, as well as flatulence (gas/bloating), which is often associated with the condition.


Q: What is the difference between Colofac IBS and generic mebeverine?

A: Colofac IBS contains the active ingredient mebeverine hydrochloride, just like generic mebeverine. The brand-name product is specifically available in two forms: a standard tablet and a modified-release (slow-release) capsule. Generic versions contain the same active ingredient but may differ in non-active ingredients or the availability of the slow-release formulation.


Q: Can people with lactose intolerance use Colofac IBS?

A: Certain formulations of the medicine contain lactose. It is officially contraindicated (should not be used) in patients with specific rare hereditary problems of sugar intolerance, such as total lactase deficiency or galactose-related malabsorption.


Q: Can taking Colofac IBS make me constipated?

A: Constipation has been reported as an adverse effect in post-marketing experience. Although this is noted in official documentation, the precise frequency of this side effect is not known from the available data.


Q: What if I take another medication that also causes dry mouth—will Colofac IBS make it worse?

A: The medicine is classified as a musculotropic antispasmodic. Official documents state that systemic side effects often seen with typical anticholinergics, such as dry mouth, are absent. This lack of systemic effect suggests it would not contribute to the dry mouth caused by other medicines.

How should Colofac IBS be stored and disposed of?

Storage and Disposal Requirements for Colofac IBS

Colofac IBS (mebeverine hydrochloride) must be stored according to regulatory mandates to maintain its stability. The official labeling specifies strict environmental control, packaging rules, and disposal procedures.


Storage Conditions

The product must be stored at a temperature not greater than 30°C and should not be refrigerated or frozen. The medicine requires protection from light and moisture, necessitating storage in a dry place and keeping the product in its original container.

Condition Requirement
Temperature Not greater than 30°C; Do not freeze
Protection Protect from light and moisture
Container Keep in original package
Safety Keep out of the sight and reach of children

Disposal Instructions

To protect the environment, unused or expired Colofac IBS must not be thrown away via wastewater or household waste. Official guidance instructs the consumer to return the medicine to a pharmacist for proper disposal.

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

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