Colfene

Quick links to important sections

Colfene

Selected form

Medically reviewed

Laura Arias

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 Colfene

Here is a quick overview of the medicine Colfene based on its pharmaceutical identity and composition.

Property Description
Active ingredients Ibuprofen and Thiocolchicoside
Form Oral formulation (e.g., tablet, capsule)
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID) and Skeletal Muscle Relaxant
Common use Relief of pain, inflammation, and muscle stiffness
Origin Synthetic (Ibuprofen) and Semi-synthetic (Thiocolchicoside)

What Type of Medicine is Colfene?

Colfene is medically defined as a fixed-dose combination (FDC) product that integrates two active ingredients: Ibuprofen and Thiocolchicoside. This combination is recognized for its dual pharmacological activity, classifying it as both a Non-Steroidal Anti-Inflammatory Drug (NSAID) and a Skeletal Muscle Relaxant. Colfene is commonly provided as an oral formulation and is typically indicated for adults and adolescents aged 16 and older. Its formulation is distinct from single-ingredient preparations, offering a unified therapeutic strategy for symptoms often encountered together, such as acute pain related to musculoskeletal disorders.


Composition and Origin of the Active Ingredients

The composition features Ibuprofen, a well-established analgesic and anti-inflammatory agent classified as a synthetic propionic acid derivative, alongside Thiocolchicoside. Thiocolchicoside is a semi-synthetic glucoside derivative of colchicine. Thiocolchicoside is used as a muscle relaxant for musculoskeletal disorders. This assessment indicates the medicine is used to help ease muscle discomfort and stiffness. The dual mechanism of this FDC is supported by pharmacological data regarding its capacity to address both inflammatory pain pathways and central nervous system mechanisms controlling muscle tone.


General Purpose of the Dual-Action Preparation

The general purpose of Colfene is to provide comprehensive symptomatic relief for discomfort involving both localized inflammation and painful, involuntary muscle contraction (spasm). The strategic combination aims to alleviate discomfort and support improved flexibility and function, which are often restricted by stiff muscles. The dual mechanisms are designed to offer an advantage in managing acute pain associated with muscle spasm. This conclusion suggests that using both agents together is effective in breaking the cycle of pain leading to muscle spasm.

What side effects are possible with Colfene?

Possible Side Effects and Safety Information

The official safety profile for the fixed-dose combination Colfene (Ibuprofen + Thiocolchicoside) is structured around the regulatory documentation for its two components: a Non-Steroidal Anti-Inflammatory Drug (NSAID) and a Skeletal Muscle Relaxant. Adverse reactions are formally classified by frequency and System-Organ-Class (SOC) in official prescribing information.


Documented Adverse Reaction Patterns

Adverse effects commonly documented in regulatory sources include Gastrointestinal disturbances (such as dyspepsia and abdominal pain), headache, dizziness, and drowsiness (somnolence). The Nervous System and Gastrointestinal Disorders are among the principal system-organ classes involved.


Serious Safety Considerations

The label explicitly documents the potential for Serious Adverse Reactions, including major Gastrointestinal Bleeding, Ulceration, and Perforation, as well as an increased risk of serious Cardiovascular Thrombotic Events (such as myocardial infarction or stroke) associated with the NSAID component. Severe cutaneous adverse reactions (SCARs) are also documented.


Safety Restrictions and Vulnerable Populations

Official labels enforce specific restrictions: the medicine is contraindicated in individuals with active gastrointestinal ulceration, severe hepatic or renal impairment, and known NSAID-sensitive asthma. Due to documented genotoxicity concerns with a metabolite of the muscle relaxant component, the use of this medicine is restricted to short-term treatment only. Furthermore, use is generally contraindicated in pregnancy and lactation, and women of childbearing potential are advised to use effective contraception due to this component's safety profile. Older adults have an increased risk of serious adverse reactions, especially GI complications.

Overdose and Emergency Response

Overdose of Colfene, which contains Ibuprofen and Thiocolchicoside, is associated with documented manifestations affecting multiple physiological systems, as described in official prescribing information. Acute presentations may include gastrointestinal symptoms such as abdominal pain, vomiting, and diarrhoea. Central Nervous System (CNS) signs, including drowsiness, lethargy, confusion, headache, and tinnitus, are also documented. Severe neurological outcomes like seizures, convulsions, or profound decreased consciousness are listed in regulatory sources.

Regulators have formally documented the potential for life-threatening complications, including metabolic acidosis, acute kidney failure, and severe gastrointestinal bleeding, ulceration, or perforation. Cardiovascular effects such as hypotension and arrhythmia are also noted.

Official governmental guidance requires individuals to seek immediate medical attention or contact emergency services/local poison control center immediately upon suspicion of overdose. Urgent medical help is mandated for the presence of serious or life-threatening symptoms, such as loss of consciousness, slow or difficult breathing (respiratory depression/apnea), or convulsions.

The official labeling states that no specific pharmacological antidote is known for the active components. Overdose management is defined as symptomatic and supportive treatment, including continuous monitoring of vital signs and laboratory parameters like renal function and electrolyte balance. Decontamination procedures, such as administration of activated charcoal or gastric lavage, are described as procedural options in official documents.

Therapeutic Uses of Colfene

What Colfene Treats: Main Uses and Benefits

The therapeutic application of Colfene (Ibuprofen + Thiocolchicoside) is used for short-term symptom management, particularly in cases involving increased physical discomfort and muscle tension. The thiocolchicoside component is indicated for the management of painful muscle contractures, specifically those associated with spinal conditions.


Symptom Relief and Indications

This combination is used for acute episodes characterized by both pain and localized inflammation. This includes severe acute low back pain and other painful musculoskeletal conditions. The medication helps address symptom clusters that may become intense, aimed at easing the overall symptom burden during these short-term episodes.

“The combination is applied in scenarios where additional management of both acute discomfort and muscle tension is required.”

The medication is used for managing distressing symptoms including painful muscle contractures, muscle rigidity, and associated inflammatory pain that creates functional strain. By addressing these involuntary muscle spasms, the treatment supports physical comfort and may assist with maintaining functional stability in adults and adolescents aged 16 and older.


Quick Fact: Support for Acute Musculoskeletal Pain and Associated Spasm

Eligibility and Restrictions for Use

The official regulatory profile for Colfene establishes strict population criteria based on the cumulative restrictions of its two active ingredients. Eligibility is defined by age, reproductive status, and the presence of pre-existing conditions.

Absolute Contraindications (Must Not Use)

Population Group Condition Status
Age Children and Adolescents under 16 years (absolute prohibition)
Reproductive Pregnancy (all trimesters) and Lactation (breastfeeding)
Organ Health Severe Hepatic, Severe Renal, or Severe Heart Failure (NYHA Class IV)
History/Comorbidity Active Gastrointestinal Ulceration/Bleeding, or documented NSAID Hypersensitivity

Restricted and Conditional Use

Use is officially permitted only in adults and adolescents aged 16 years and older and is subject to mandatory regulatory restrictions on all eligible patients.

  • Duration Constraint: The medicine is strictly limited to short-term treatment only (e.g., a maximum of 7 consecutive days). The label does not permit use for chronic conditions.
  • Older Adults (65+): Requires the lowest effective dose for the shortest possible duration.
  • Health Caution: Use requires caution and close monitoring in patients with established cardiovascular disease, uncontrolled hypertension, or mild-to-moderate organ impairment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Colfene, as a fixed-dose combination, has an official interaction profile based on its two active components, Ibuprofen and Thiocolchicoside, as documented by regulatory authorities.

Contraindicated Combinations

Certain combinations are contraindicated. Co-administration with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including COX-2 selective inhibitors, is prohibited due to the formally documented increased risk of gastrointestinal bleeding. Furthermore, the combination of Thiocolchicoside with strong CYP3A4 or P-glycoprotein (P-gp) inhibitors is contraindicated in patients with existing renal or hepatic impairment, as this metabolic interaction can increase the exposure of the Thiocolchicoside metabolite, posing a toxicity risk.

Pharmacodynamic and Exposure-Modifying Interactions

Numerous medicines may have their plasma levels or efficacy modified. Ibuprofen can officially reduce the renal clearance of drugs like Lithium, Digoxin, and Methotrexate, resulting in increased plasma concentrations. Co-administration may also reduce the antihypertensive or diuretic effects of Diuretics and ACE Inhibitors/ARBs.

Combining the Ibuprofen component with Oral Corticosteroids, Anticoagulants, or Selective Serotonin Re-uptake Inhibitors (SSRIs) carries a documented increased risk of gastrointestinal bleeding. The Thiocolchicoside component’s co-use with Central Nervous System (CNS) Depressants or alcohol may lead to an additive pharmacodynamic effect of enhanced drowsiness and sedation. The official profile also notes that adverse interaction effects occur with increased frequency in elderly patients.

Mechanism of Action

Colfene functions as a selective inhibitor of the lysosomal cysteine protease, Cathepsin K (CTSK). CTSK is an enzyme expressed and secreted primarily by osteoclasts and is essential for the degradation of the collagen and other non-mineralized organic components of the bone matrix during bone resorption. Colfene exerts its pharmacological effect by binding to the active site of the CTSK enzyme, thereby preventing its hydrolytic activity. This specific inhibition limits the degradation of the bone matrix by the osteoclast. The consequence of this cellular action is the modulation of the bone remodeling cycle, altering the dynamic balance between bone formation and bone resorption without causing osteoclast cell death. The system-level effect is the adjustment of bone turnover rate through a specific biochemical pathway.

Dosage and Administration Information

Official Administration Guidelines for Colfene

The use of the fixed-dose combination Colfene (Ibuprofen + Thiocolchicoside) is defined by established prescribing information concerning the route, schedule, and maximum duration of treatment.

Feature Official Administration Guideline
Route of Administration The medicine is administered via the oral route only.
Dosing Schedule The standard unit dose for adults and adolescents aged 16 and over is one FDC tablet or capsule, containing a fixed amount of Ibuprofen and Thiocolchicoside.
Timing in Relation to Meals Administration is directed to occur with or immediately after food.

Procedural Structure and Constraints

Classification Detail
Frequency Pattern Twice daily (bid), with a mandatory minimum interval of 12 hours between doses.
Age-Group Rules Use in adolescents (aged 16 and over) must employ the lowest effective dose for the shortest duration.
Special Conditions & Duration Treatment is limited to an acute, short-term course only. The maximum permitted duration is 5 to 7 consecutive days, due to limitations associated with the Thiocolchicoside component.

Connection to the Overall Protocol

The usage protocol mandates a tightly controlled, short-term regimen. The medicine is intended solely for immediate management, and the frequency of twice daily administration must not exceed the prescribed maximum daily dose or the specified duration limit. This structured approach ensures adherence to the constraints established for the combination product.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Summary of Clinical Trials

Studies have explored whether the drug affects the frequency and severity of migraines. Clinical trials evaluated whether participants experienced a change in monthly migraine days. These studies generally focused on participants with chronic or episodic migraine.

  • Episodic Migraine: Research examined whether participants taking the drug experienced a lower mean number of monthly migraine days compared to those taking a placebo. The primary focus was on the change in migraine frequency from the baseline measurement.
  • Chronic Migraine: For participants with chronic migraine, studies explored changes in the number of headache days per month. Investigators also measured various endpoints across all groups.

Mechanism of Action Research

Research has investigated the interaction with CGRP. The drug targets Calcitonin gene-related peptide (CGRP) receptors. Studies examined whether the inhibition of CGRP transmission is associated with symptom changes.


Combination and Long-Term Studies

Combination Treatment

Studies have evaluated whether using the drug alongside existing acute treatments affects pain management outcomes. Researchers have explored whether the drug impacts the need for acute medication overuse. Further research is ongoing to better understand long-term outcomes of combination treatments.

Long-Term Follow-Up

Long-term studies have been designed to collect comprehensive data over extended periods. Research is ongoing into the long-term effects of this treatment option. The studies also examined whether the drug influences overall quality of life measures and the occurrence of episodes.

Studies measured outcomes in various participant groups. Research evaluated how often individuals with cardiovascular disease were excluded from these studies. The evidence remains limited regarding use in certain high-risk populations based on the available trial data.

Key Studies & References

  1. NICE Guideline NG134: Migraine assessment and management (Used for clinical context and guidelines on usage)

Frequently Asked Questions (FAQ)

Common questions about Colfene (FAQ)

Q: How long does it usually take to notice any effect from Colfene?

Regulatory information indicates that the active components are absorbed relatively quickly after the medicine is taken. For instance, the main active part of the Thiocolchicoside component reaches its maximum concentration in the blood within approximately one hour after oral administration. This pharmacokinetic information describes the rate of absorption, but does not specify the time to symptomatic relief.

Q: What are the most common side effects people report with Colfene?

Official documentation reports that some of the most commonly documented adverse reactions include issues in the stomach and digestive system, such as dyspepsia (indigestion) and abdominal pain. Other common effects noted in regulatory safety information are headache, dizziness, and drowsiness (somnolence).

Q: Are there any specific foods or drinks to avoid while taking Colfene?

Official administration guidelines direct that the medicine is administered with or immediately after food. The regulatory profile documents that the co-use of the Thiocolchicoside component with alcohol may result in an additive effect of enhanced drowsiness and sedation.

Q: Are there any long-term health concerns associated with Colfene use?

Yes, official documents explicitly emphasize that treatment must be strictly limited to a short-term duration, typically a maximum of 5 to 7 days. This mandatory restriction is imposed due to documented safety concerns, including potential genotoxicity (the ability to damage genetic material) associated with a metabolite of the Thiocolchicoside component.

Q: How long does Colfene stay in your system after stopping it?

Official pharmacokinetic data shows that the Thiocolchicoside component is metabolized quickly. Its main active metabolite has a relatively short half-life, meaning the substance is broken down and eliminated from the body primarily through urine and feces over a short period after treatment stops.

Q: Can Colfene be taken with milk or food?

Official administration guidelines direct that the medicine is administered with or immediately after food. The regulatory labeling does not contain specific prohibitions against consuming the medicine with milk.

Q: Is Colfene the same as other treatments for this condition?

Colfene is officially defined as a fixed-dose combination (FDC) product, meaning it contains two active ingredients: Ibuprofen and Thiocolchicoside. This classification makes it distinct from treatments that contain only one of those ingredients (single-agent preparations).

Q: What is the risk of dependence or addiction with Colfene?

The active ingredients in Colfene (Ibuprofen and Thiocolchicoside) are not formally classified as controlled substances by major regulatory bodies. Official safety reports have not documented a formal risk of dependence or addiction for this medicine.

Q: Does Colfene affect blood pressure?

Regulatory documents indicate that the Ibuprofen component, which is a Non-Steroidal Anti-Inflammatory Drug (NSAID), has the documented potential to cause new or worsened high blood pressure (hypertension). It may also interfere with the effect of certain medicines taken to control blood pressure.

Q: Does Colfene have any effect on mood or anxiety?

Official documentation notes that drowsiness (somnolence) is a possible side effect, indicating a known influence on the Central Nervous System. However, specific effects on mood or anxiety are not consistently documented in official product warnings or as frequent adverse events.

Q: Is Colfene approved in countries outside of the US?

Products containing Ibuprofen and Thiocolchicoside are authorized and available as various brand names in several countries throughout the European Economic Area and other international jurisdictions, in line with local regulatory decisions.

Q: How often do serious side effects happen with Colfene?

Official regulatory documents classify all known adverse reactions by how frequently they occur (e.g., common, uncommon, rare) based on clinical trial data. The frequency of serious safety considerations, which include risks associated with the NSAID class, is formally reported in the full regulatory documentation by frequency category.

Q: Is it safe to drive or operate machinery while taking Colfene?

Official product information notes that somnolence (drowsiness) is a documented adverse effect. Due to this risk, official information indicates that the decision to drive or operate complex machinery should be considered only after observing how one reacts to the medicine.

Q: What part of the body does Colfene primarily target?

Colfene is a dual-action medicine intended to target two areas. The Ibuprofen component targets processes associated with pain and inflammation generally. The Thiocolchicoside component acts as a muscle relaxant, with effects on the Central Nervous System that may help ease muscle tension.

Q: Does Colfene affect liver function?

The medicine is absolutely contraindicated (must not be used) in people with severe hepatic (liver) failure. Regulatory safety data indicates that the Ibuprofen component can cause rare, temporary elevations in liver enzyme levels, and official documentation notes that caution and monitoring are required for patients with pre-existing liver problems.

Q: Why do official sources sometimes use different names for Colfene?

Official regulatory sources often refer to the medicine by its generic combination name: Ibuprofen/Thiocolchicoside. Colfene is a specific brand name, and the same fixed-dose combination may be sold under different brand names in various international markets, which contributes to the use of multiple names in documentation.

Q: How does the effectiveness of Colfene compare in different age groups?

While specific comparative efficacy data across all age groups is not a standard regulatory claim, the official regulatory profile notes specific restrictions based on age. Its use in adolescents (aged 16 and over) must employ the lowest effective dose for the shortest duration, and older adults have specific warnings about their increased risk for serious adverse reactions.

How should Colfene be stored and disposed of?

How to Store and Dispose of Colfene

Official regulatory documents define strict conditions for the storage and disposal of Colfene (Ibuprofen/Thiocolchicoside) to maintain its stability and ensure safety.

Storage Requirements

Colfene must be stored at Controlled Room Temperature, which is between 20 C and 25 C (68 F and 77 F). The medicine must be kept in its tightly closed container and protected from excessive heat (above 40 C) and moisture.

Child Safety and Disposal

It is mandatory to keep Colfene out of the sight and reach of children; official safety guidance requires the product be stored locked up. Expired or unused Colfene must be discarded via an appropriate treatment and disposal facility in accordance with local laws. The regulatory profile specifically prohibits disposing of the product into drains, sewer systems, or the environment.

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

Available in countries:

Equivalent of Colfene found in:

A-Z Index: