Rostil

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Rostil

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 Rostil

Property Description
Active ingredient Mebeverine (Mebeverine hydrochloride)
Form Oral tablets, Sustained-release capsules
Pharmacological class Musculotropic Antispasmodic Agent
Common use Relief of painful gastrointestinal spasms
Origin Synthetic compound

Rostil: Identity and Pharmacological Class

Rostil is a brand-specific pharmaceutical preparation that functions as a synthetic musculotropic antispasmodic agent. The medicine's core component is the active ingredient, Mebeverine hydrochloride, a synthetic compound with a clinically recognized targeted effect on the gut muscle. It is classified within the antispasmodic pharmacological class.

Mebeverine's primary function is as a direct smooth muscle relaxant on the gastrointestinal tract, particularly the colon. This action is distinct because it is considered musculotropic and does not rely on the nerve-blocking properties characteristic of anticholinergic drugs, ensuring a more localized effect on the gut.


Composition and Brand Differentiation

Rostil is formulated for oral administration, typically as a single active substance product containing Mebeverine hydrochloride. A differentiating factor for Rostil is its availability in specialized sustained-release capsules.

This capsule format is designed to deliver the Mebeverine gradually over an extended period. This technological approach aims to maintain a consistent therapeutic concentration for prolonged relief. This structure helps simplify administration and ensures that the anti-spasmodic action is maintained in the lower gut to control chronic tension and spasms.


Primary Purpose: Relief of Gastrointestinal Spasms

The general purpose of Rostil is to alleviate the pain and discomfort caused by excessive, involuntary muscle contractions, or spasms, in the gut. The musculotropic action directly reduces the painful hyperactivity of the intestinal smooth muscle wall.

Its core benefit is calming these spasms, which provides essential symptomatic relief. Rostil is primarily intended to manage symptoms related to intestinal spastic conditions by addressing the muscular source of the pain and helping to restore a more comfortable, regular gut function.

What side effects are possible with Rostil?

Rostil: Possible Side Effects and Safety Information

This section details the adverse reactions and safety constraints officially documented in governmental regulatory labeling for Rostil (Mebeverine/Calcium Dobesilate).

Documented Adverse Reactions

Adverse reactions are classified by frequency and the body system affected, according to regulatory standards (e.g., EMA/ICH):

Classification System-Organ Class (SOC) Examples of Reactions
Frequency Not Known Immune System Disorders Hypersensitivity, Anaphylactic Reactions
Very Rare Skin and Subcutaneous Tissue Angioedema, Urticaria, Skin Rash
Rare Blood and Lymphatic System Agranulocytosis
Common/Expected Gastrointestinal Disorders Dyspepsia, Nausea, Vomiting

Serious Adverse Reactions

Regulatory sources explicitly document serious adverse reactions, which, while rare, are clinically significant. These include agranulocytosis (a severe decrease in white blood cells) and severe anaphylactic reactions or angioedema (severe swelling).

Population-Specific Safety Statements

Official labeling contains specific constraints regarding use in vulnerable populations:

  • Pregnancy/Breastfeeding: Rostil is not recommended or should not be used during pregnancy or breastfeeding, as sufficient safety data in these populations are lacking.
  • Paediatric Population: Safety and efficacy have only been evaluated in adults, and use in children is not supported by the product information.

Safety Restrictions and Limitations

The primary safety limitation is its use in individuals with a known hypersensitivity (severe allergic reaction) to the active substance or any of its excipients. The medicine is formally contraindicated in these instances.

Overdose and Emergency Response

Overdose and When to Seek Help

This section outlines the officially documented overdose manifestations for Mebeverine (the active ingredient in Rostil) and the emergency actions required, as stated in authoritative government regulatory documents.


Documented Overdose Presentations

Official regulatory sources indicate that symptoms in cases where Mebeverine was taken in overdose were typically absent or mild and usually rapidly reversible. The observed symptoms of overdose were of a neurological and cardiovascular nature.

  • Severity Classification: Symptoms are generally described as mild and rapidly reversible.
  • Observed System Effects: Neurological and cardiovascular symptoms have been observed in documented cases.
  • Theoretical Note: The possibility of Central Nervous System (CNS) excitability may theoretically occur in instances of overdosage.
  • Population Notes: No specific risk for elderly, renal, or hepatic impaired patients has been identified from available post-marketing data regarding overdose.

Required Emergency Actions

If an overdose is suspected, immediate medical attention is required.

Action Category Regulatory Statement
Urgent Medical Contact Seek immediate medical attention. Contact a doctor or hospital emergency department immediately.
Antidote Status No specific antidote is known for Mebeverine.
Supportive Treatment Treatment is symptomatic and supportive. Vital functions should be monitored closely.
Procedural Measures Gastric lavage should only be considered in cases of multiple intoxication or if discovered within about one hour of ingestion. Absorption reducing measures are generally not necessary.

The official profile mandates that the medicine packaging and any remaining tablets be taken to the hospital. This framework ensures proper management under close supervision, despite the typically mild clinical course observed in documented overdose events.

Therapeutic Uses of Rostil

Therapeutic Indications and Mechanism

Rostil is a medicinal product containing calcium dobesilate, a substance that acts on the walls of the capillaries—the smallest blood vessels in the circulatory system. Its primary function is to influence the resistance and permeability of these vessel walls, which plays a role in managing symptoms related to venous circulation disorders.

Main Uses

The medication is primarily indicated for the treatment of symptoms associated with chronic venous insufficiency. This condition occurs when the veins have difficulty sending blood from the limbs back to the heart, often due to weakened vessel walls or dysfunctional valves.

Common symptoms addressed by the treatment include:

  • Pain and heaviness in the legs
  • Nighttime muscle cramps in the calves
  • Sensation of tingling or numbness (paresthesia)
  • Swelling (edema) of the lower limbs

Benefits in Microcirculation

Calcium dobesilate works at the microcirculatory level by reducing the excessive permeability of capillaries. This helps to prevent the leakage of fluid from the blood vessels into the surrounding tissues, which is a primary cause of swelling. By improving the integrity of the vascular endothelium, the medication helps stabilize the blood-tissue barrier.

Adjunctive Treatment for Hemorrhoids

In addition to its use for lower limb circulation, Rostil is utilized as an adjunctive treatment for the symptomatic management of hemorrhoidal disease. It helps alleviate localized discomfort and swelling in the anal area by exerting similar stabilizing effects on the small blood vessels in that region.

Eligibility and Restrictions for Use

Who can and cannot use Rostil? - Official Regulatory Information

The eligibility profile for Rostil (calcium dobesilate) is defined by mandatory exclusions and conditional use rules established in official regulatory documents.

Category Regulatory Status
Populations for whom use is contraindicated: Individuals with known hypersensitivity or allergy to calcium dobesilate or any excipients in the product.
Populations for whom use is not recommended: Pediatric patients (generally under 18 years of age) are not recommended for routine use due to insufficient established data.
Comorbidity-dependent eligibility restrictions: Patients with severe renal insufficiency requiring dialysis must use the medicine under medical supervision and require a reduced dose.
Pregnancy and lactation eligibility status: Pregnancy: Use is generally not recommended unless a doctor determines that the potential benefit outweighs any potential risk to the fetus, as safety in human pregnancy is not fully established.
Lactation/Breastfeeding: The drug is excreted into breast milk in very low quantities; as a precautionary measure, either the treatment or breastfeeding should be discontinued.

These official regulatory statements classify known hypersensitivity as an absolute exclusion. For other populations, such as those with severe kidney impairment and pregnant or breastfeeding individuals, use is conditional and requires cautious assessment due to pharmacological data, risk-benefit evaluation, or insufficient data.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Rostil (Mebeverine hydrochloride) is characterized by the explicit statements found in regulatory documents regarding the absence of known clinically significant interactions.

Interaction Scope

Interaction Category Official Regulatory Statement
Documented Drug–Drug Interactions No interactions with other medicinal products are known or have been clinically studied, except with alcohol.
Contraindicated Combinations No medicinal products are formally listed as contraindicated for co-administration due to established interaction risk.
Metabolic/Transporter Interactions No specific pharmacokinetic mechanisms (e.g., CYP-mediated) or transporter-mediated interactions are documented in regulatory labels.
Timing-Based Rules No mandatory timing separation requirements (e.g., 'administer X hours apart') are specified for co-administered drugs.

Drug–Substance Interaction Profile

Regulatory documentation specifically addresses the co-administration of Mebeverine with ethanol (alcohol). Studies officially confirm that the use of Mebeverine hydrochloride does not result in a documented interaction with ethanol. This classification means no specific restrictions related to alcohol consumption are necessitated by the drug’s interaction profile.

The overall regulatory structure confirms that there are no known interactions that necessitate warnings, dosage adjustments for other medicines, or special administrative precautions based on currently available label information.

Mechanism of Action

Direct Smooth Muscle Modulation

Rostil exerts its pharmacological action as a musculotropic agent with a primary focus on the smooth muscle of the gastrointestinal (GI) tract. The molecule engages mechanisms that directly influence the contractile apparatus within the gut's smooth muscle cells, independent of neuronal signaling pathways. This action modifies early molecular steps that regulate the cell's baseline tone, thereby influencing the resultant Ca^2+-dependent contractile force.

Modulation of Smooth Muscle Ion Dynamics

The agent modulates key pathways associated with excitation-contraction coupling, specifically acting upon the voltage-gated Ca^2+ channels located in the intestinal smooth muscle cell membrane. By modulating the pattern of Ca^2+ flux across the membrane, Rostil influences the sustained contractile state of the muscle cell. This process leads to alterations in the spontaneous smooth muscle contraction frequency and amplitude, modifying the overall motility pattern of the GI smooth muscle tissue.

Dosage and Administration Information

How Rostil is Used: Administration Guidelines

Rostil (mebeverine hydrochloride) is administered for symptomatic management according to instructions which dictate the method, timing, and dosage schedule. The primary route of administration for both standard and modified-release forms is oral.


Standard Adult Dosing and Frequency

Dosage Form Strength Frequency Administration Detail
Tablet (Standard Release) 135 mg Three times daily (TID) One tablet per dose
Capsule (Modified-Release) 200 mg Twice daily (BID) One capsule per dose

Procedural Instructions and Constraints

The medicine is designed to be taken preferably 20 minutes before meals, and the full dose must be swallowed whole with a sufficient amount of water, such as at least 100 mL. It is a procedural instruction that the tablets and capsules should not be chewed or crushed. Doses should be spaced evenly throughout the day to support a consistent antispasmodic effect. If a dose is missed, the user is to skip the missed dose and continue with the next scheduled dose; no extra dose should be taken to compensate.

Course Duration and Population Rules

Administration of Rostil is considered to have an unlimited duration of use for symptomatic relief. The standard protocol allows for the dosage to be gradually reduced once the desired effect is achieved, typically after several weeks of use. The medication is not recommended for use in children and adolescents below 18 years due to a lack of safety and efficacy data. For older adults and patients with known hepatic or renal impairment, no routine dose adjustment is deemed necessary.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Rostil (Mebeverine)


Evidence for Symptomatic Relief in Irritable Bowled Syndrome (IBS) and Functional Bowel Disorders

The primary research for Rostil has explored its role in symptomatic management for conditions characterized by fluctuating or episodic manifestations of pain, particularly Irritable Bowel Syndrome (IBS) in adults. The evidence base includes many short-term Randomized Controlled Trials (RCTs) where the medicine was evaluated against an inactive placebo. Multiple Systematic Reviews and Meta-Analyses have explored the data from these studies. Research has explored whether symptoms change over time in the studied adult populations.

These studies focused on tracking how symptoms evolved in the observed populations, typically over periods of 3 to 16 weeks. Findings describe patterns observed in the studies. However, when results from different RCTs are pooled in high-level analyses, findings were mixed. Some pooled data described patterns related to measured changes in abdominal pain scores, while other high-quality reviews report that the pooled data on overall global symptom status were inconsistent or sometimes did not achieve statistical clarity.

How Trials Measured Symptom Change

The research primary outcomes focused on the Patient's Global Assessment of Symptom Status—the patient’s report of overall symptom evolution—which is relevant in evidence describing how symptoms are measured. Research monitored outcomes related to physical discomfort, including the severity and frequency of Abdominal Pain/Discomfort using numerical scales, and scores for Abdominal Distension/Bloating. Research provides insight into these short-term changes, but the reported patterns between groups varied across the different measures and research contexts.


Evidence for Use in Pediatric Populations

Research exploring Rostil's evaluation in children and adolescents, typically for Functional Abdominal Pain (FAP), is more limited. Studies conducted so far have included a small number of controlled trials, relevant in trials assessing short-term or episodic symptom patterns in patients aged 6 to 18 years.


Long-Term Studies and Follow-up Durations

The typical follow-up durations in the core studies for Rostil were short-term, with most treatment periods lasting only 3 to 16 weeks. This duration is relevant in trials assessing short-term or episodic symptom patterns, but it does not fully address chronic management. As a result, long-term effects are not fully established.


Evidence Quality and Research Gaps

Key limitations cited in the literature include that sample sizes were modest in some original trials and that findings were mixed regarding global symptom status across different meta-analyses. Data for certain groups, such as those with specific comorbidities or pregnant populations, remain insufficient. Research provides limited information for long-term outcomes, and research is ongoing to help contextualize how patients reported their experience.

Key Studies & References

  1. Mebeverine and the Influence of Labeling in Adolescents With Irritable Bowel Syndrome or Functional Abdominal Pain Not Otherwise Specified: A Randomized, Placebo-Controlled Trial
  2. Public Assessment Report Scientific discussion Mebeverine HCl Aurobindo Retard 200 mg modified release capsules, hard (regulatory document for indication/labeling)

Frequently Asked Questions (FAQ)

Common questions about Rostil (FAQ)

Q: What is Rostil used for besides its main purpose?

According to official documentation, the medicine is primarily used for the symptomatic relief of Irritable Bowel Syndrome (IBS). However, its use is also described for similar conditions characterized by painful spasms, such as chronic irritable colon, mucous colitis, and spastic colitis.


Q: Do the side effects of Rostil go away on their own?

Official information indicates that any adverse effects experienced are likely to be mild and will usually pass quickly as the body adjusts. If a side effect is persistent, severe, or causes concern, consulting a healthcare professional may be appropriate.


Q: Can Rostil affect my blood pressure?

Official adverse reaction lists are not commonly reported with changes in blood pressure, such as high or low blood pressure, as a side effect. Some documentation notes a decreased pulse rate in some cases.


Q: Is it normal to feel tired when first starting Rostil?

Yes, official product information notes that tiredness or fatigue is a potential adverse effect. If this effect is experienced, it is listed as one of the possible reactions associated with taking the medicine.


Q: How quickly does Rostil start working?

Evidence indicates that symptomatic relief may begin after approximately one hour. The medication works relatively quickly to target and relax the smooth muscle of the gut.


Q: How long does it take to see the full effects of Rostil?

While relief can begin quickly, the duration of use is often described as unlimited for symptomatic relief. Some reports suggest that symptoms can clear or stabilize after a short course of several weeks of use.


Q: Do I need a special diet while using Rostil?

Regulatory documents do not mandate a special diet that must be followed solely because of the medication. However, authoritative sources note that dietary adjustments, such as a high-fiber diet or avoiding triggers, can be a supportive measure for IBS symptom management.


Q: Why is Rostil sometimes prescribed alongside other medications?

The active ingredient in Rostil is sometimes found in combination products. These formulations may include a laxative, such as ispaghula husk, to help address specific constipation-related symptoms of IBS.


Q: Is Rostil known to cause weight gain or weight loss?

Official patient information and authoritative guides state that the medicine is not typically associated with causing changes in body weight, such as weight gain or weight loss.


Q: Does Rostil affect sleep?

Difficulty sleeping, also known as insomnia, is listed in regulatory safety documentation as a possible side effect. If sleep disturbances occur, they are considered a potential adverse reaction to the medicine.


Q: Do official documents mention any warnings about operating machinery while on Rostil?

Official regulatory documents indicate that the medicine is not likely to affect a person's ability to drive or operate any tools or machinery. No specific restrictions related to these activities are usually included in the patient instructions.


Q: Is Rostil a controlled substance?

In some regulatory systems, the medicine is classified as a 'Pharmacy medicine' (P). This classification means it is not designated as a strictly controlled substance requiring the highest level of regulatory control.


Q: What type of doctor usually prescribes Rostil?

Official documents refer to the medicine being prescribed by licensed healthcare providers, such as Medical Practitioners and Nurse Practitioners. This indicates it is generally prescribed by primary care providers or specialists managing the underlying condition.


Q: Where can I find the official patient information leaflet for Rostil?

The official Patient Information Leaflet (PIL) or Consumer Medicine Information (CMI) for your specific product is required to be included with the packaging. This document will be found inside the sealed box of the medicine you receive.


Q: Is Rostil considered a 'new' drug?

No. The active substance in Rostil, mebeverine hydrochloride, is an established compound. It has been registered and used in some regions for several decades, with its earliest registrations dating back to the 1960s.


Q: Is Rostil available over the counter in some countries?

In some countries, the medicine is classified as a Pharmacy medicine. This designation allows it to be purchased from a pharmacy without a doctor’s prescription for patients who have been previously diagnosed with IBS.


Q: Can Rostil make my existing condition worse?

Regulatory information notes that if symptoms worsen or do not improve after a certain period, it is important to consult a healthcare professional. This is a standard advisory to monitor the progression of the underlying condition while on treatment.


Q: How is the research on Rostil continuing?

As an established medicine, the active substance is subject to continued scientific review and systematic analysis by researchers and authorities. This process assesses its ongoing role in the symptomatic management of the condition it treats.


Q: Does my insurance typically cover Rostil?

Official documents from government-run schemes, such as the Australian Pharmaceutical Benefits Scheme (PBS), include specific details about coverage and maximum pricing for the medicine. Coverage details vary widely depending on the country and specific health plan.


Q: Do I need a prescription for Rostil?

The medicine is generally available on prescription from a doctor. However, its classification as a Pharmacy medicine in some regions allows specific forms of the product to be purchased directly from a pharmacist after a consultation.


Q: Is Rostil covered by regulatory agencies like the FDA or EMA?

Rostil has marketing authorization in certain global regions, such as Australia and Singapore. However, official databases indicate that it may not hold active approval or registration with the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA).


Q: What is the full list of ingredients in Rostil?

The full composition of the medicine, including the active ingredient and all inactive ingredients (excipients), is detailed in the official patient information leaflet. These inactive ingredients can include compounds like lactose monohydrate, povidone, talc, and magnesium stearate.


Q: Does Rostil interact with herbal supplements?

The official interaction profile states that no interactions with other medicinal products are known or have been clinically studied. This indicates that significant interactions with commonly used herbal supplements are not officially documented.


Q: Why does Rostil have a warning about [specific organ/system]?

Warnings are included for all reported serious adverse reactions, even if they are extremely rare. The exact mechanisms behind these rare effects are generally complex and relate to the medicine's required safety documentation, which must list all reported adverse reactions.


Q: Why do some people experience [mild common side effect] when taking Rostil?

Common side effects, such as nausea or vomiting, are considered expected outcomes because of the medicine's core function. Rostil works by acting directly on the smooth muscle of the gastrointestinal tract (gut) to modulate its function.

How should Rostil be stored and disposed of?

Official Storage and Disposal Instructions

This section outlines the mandatory storage and disposal requirements for Rostil (Mebeverine hydrochloride), as specified in official regulatory labeling.

Labeled Storage Requirements
Temperature: Store at a temperature not greater than 30 C; do not refrigerate or freeze.
Protection: Store in the original package to protect from light and moisture.
Child Safety: Must be kept out of the sight and reach of children.
Disposal: Dispose of unused or expired medicine according to local regulations and through a pharmacy program, not via household waste or wastewater.

Storage of Rostil must strictly comply with these environmental and packaging constraints to maintain the labeled quality and stability of the product until its expiry date. The specified disposal instructions are required to protect the environment.

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

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