Flectadol

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Flectadol

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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 Flectadol

Property Description
Active ingredient Ibuprofen, Tizanidine
Form Tablet or Capsule (Oral dosage forms)
Pharmacological class Nonsteroidal Anti-Inflammatory Drug (NSAID) and Centrally Acting Skeletal Muscle Relaxant
Common use (General) Management of pain and spasms in acute musculoskeletal conditions
Origin Synthetic, Fixed-Dose Combination Product

Identity, Composition, and Pharmacological Class

The medicine referenced as Flectadol, in the context of this specific formulation, is a synthetic fixed-dose combination product designed for oral dosage forms, such as tablets or capsules. Its core consists of two distinct active ingredients: Ibuprofen, an NSAID, and Tizanidine, a muscle relaxant. This composition provides a targeted approach intended to address complex pain states more comprehensively than single agents.

This dual classification means the product functions simultaneously as a Nonsteroidal Anti-Inflammatory Drug (NSAID) and a Centrally Acting Skeletal Muscle Relaxant. The muscle relaxant component, Tizanidine, is specifically identified as an Alpha-2 Adrenergic Agonist.


General Purpose and Dual Action Differentiation

The general purpose of this combination is to provide symptomatic relief in acute musculoskeletal conditions where both pain and involuntary muscle tightening are prevalent. The product’s design is differentiated by its two therapeutic agents working synergistically: Ibuprofen targets the peripheral inflammatory cause of discomfort, while Tizanidine acts centrally in the nervous system to ease muscle stiffness. This specific dual-action strategy is utilized when patients require concurrent management of both significant pain and acute muscle spasms, such as those experienced following a strain or injury. By tackling both the pain component and the restrictive muscle tension, the combination promotes improved patient comfort and function.

Regulatory References

  1. Tizanidine - StatPearls (NCBI Bookshelf)

What side effects are possible with Flectadol?

Possible side effects and safety information

The official safety documentation for this fixed-dose combination (Ibuprofen/Tizanidine) classifies potential adverse effects based on frequency and the body systems involved, as established in government regulatory profiles.

Adverse Reaction Classifications

Category Regulatory Finding
Common Effects Nervous System (dizziness, somnolence/drowsiness, headache, fatigue) and Gastrointestinal (dry mouth, nausea, dyspepsia, abdominal pain).
System-Organ Classes Effects are formally documented in the Gastrointestinal Disorders, Nervous System Disorders, Hepatobiliary Disorders, and Renal and Urinary Disorders classes.
Time-Related Patterns Effects such as somnolence and low blood pressure are typically more noticeable during treatment initiation and dose escalation. The risk of serious GI injury is associated with long-term use of the NSAID component.

Serious Adverse Reactions and Restrictions

Regulatory sources define several serious adverse reactions. The NSAID component is associated with risks of gastrointestinal bleeding, ulceration, or perforation, and serious cardiovascular thrombotic events (e.g., heart attack, stroke). The muscle relaxant component is associated with the risk of severe hypotension (profound low blood pressure) and hepatotoxicity (liver injury).

Safety Restrictions: The medicine is officially contraindicated in the presence of severe renal failure, severe hepatic failure, active peptic ulcer/hemorrhage, and severe heart failure. Furthermore, it is restricted for use with strong CYP1A2 inhibitors due to the risk of severe Tizanidine exposure.

Overdose and Emergency Response

Flectadol Overdose and when to seek help

Flectadol is an acetaminophen (paracetamol) based product. The most critical risk of overdose is severe, potentially fatal liver injury (hepatotoxicity). This risk is dose-dependent, arising from a single acute ingestion of a toxic quantity or from repeated use exceeding the maximum recommended daily dose (supratherapeutic ingestion).

Overdose Manifestations and Risks

Initial symptoms within the first 24 hours are often nonspecific or absent, but may include nausea, vomiting, abdominal pain, and diaphoresis (sweating). These early signs can progress, often with a delay of one to four days, to evidence of liver damage, potentially including jaundice (yellowing of the skin and eyes), loss of appetite, and significant changes in blood clotting factors and liver enzyme levels.

Required Emergency Actions

Immediate medical attention must be sought if an overdose is suspected or confirmed, even if the patient appears well. Due to the potential for delayed, serious toxicity, treatment must not be postponed while awaiting symptoms. Emergency management involves administering N-acetylcysteine (NAC), the specific antidote, which is most effective when given within the first eight hours after an acute ingestion. Medical personnel will also perform laboratory tests to monitor serum acetaminophen concentration and hepatic function to guide the required duration of treatment.

Therapeutic Uses of Flectadol

What Flectadol treats: main uses and benefits

This combination product is generally used to provide symptomatic relief for conditions presenting with acute episodes. The combination is used across domains where additional symptomatic support is needed for both symptoms related to physical discomfort and symptoms related to inflammatory or irritative states.

The medication is commonly used across conditions presenting with acute episodes and relevant in situations involving symptoms associated with acute or episodic changes. It is relevant for easing symptom clusters that may become intense or disruptive, specifically focusing on pain, inflammation, and associated involuntary muscle tightening.

“The medication is commonly used to help with easing distress and assists with maintaining functional stability during difficult episodes.”

Management of Restrictive Symptom Patterns

The medication helps address symptom clusters that may become intense or disruptive, relevant for managing symptoms like muscle stiffness that interfere with daily functioning. Applied in scenarios where short-term symptomatic assistance is needed, this supportive therapeutic benefit assists with maintaining functional stability and helps patients cope more steadily with difficult episodes. It contributes to easing the overall symptom load during symptomatic periods, supports patients during episodes of heightened discomfort.


Quick Fact: Relief for Pain and Muscle Spasms

Regulatory References

  1. NIH StatPearls overview on Ibuprofen

Eligibility and Restrictions for Use

Flectadol, a combination of Ibuprofen and Tizanidine, is officially designated for use primarily in the adult population (18 years and older). Regulatory documentation establishes clear rules for who is strictly prohibited from using the medicine (contraindications) and who requires limited or conditional use (restrictions).

The medicine must not be used by individuals with a known hypersensitivity to either active ingredient, those with active gastric bleeding or ulcers, or patients with severe hepatic (liver) or renal (kidney) impairment. Use is also strictly contraindicated in the third trimester of pregnancy (at or after 30 weeks gestation) and for patients concurrently taking strong CYP1A2 inhibitors like Fluvoxamine or Ciprofloxacin.

The safety and efficacy of the combination have not been established in the pediatric population (under 18 years). Use is restricted and requires caution for elderly patients due to reduced Tizanidine clearance, those with a history of cardiovascular disease or hypertension, and patients with non-severe chronic kidney or liver conditions. These constraints ensure alignment with official label guidelines.

What should I know about interactions with other medicines?

The active ingredient in Flectadol is a non-steroidal anti-inflammatory drug (NSAID), and its interactions are primarily rooted in its inhibition of prostaglandin synthesis. Do not combine this medicine with other products containing the same active substance, other NSAIDs (such as naproxen or aspirin), or other anti-inflammatory agents, as this significantly raises the risk of serious side effects, including gastrointestinal bleeding.

Interactions that Increase Bleeding or Toxicity Risk

Concomitant use with anticoagulants (e.g., warfarin-type) and certain antiplatelet agents (e.g., low-dose aspirin) is generally discouraged due to an increased risk of severe and sometimes fatal bleeding, particularly from the digestive tract. Corticosteroids also amplify the risk of gastrointestinal ulceration and bleeding. The combination with methotrexate may increase its plasma levels and toxicity, as ibuprofen reduces its clearance. Plasma levels of lithium and cardiac glycosides may also be elevated, requiring careful monitoring.

Interactions Affecting Blood Pressure

Ibuprofen may diminish the therapeutic effectiveness of certain antihypertensive medicines, including ACE inhibitors, beta-blockers, and diuretics, which can lead to reduced blood pressure control and may, in some cases, increase the risk of renal impairment.

Mechanism of Action

Flectadol engages a dual-action mechanism that addresses two distinct physiological phenomena: peripheral inflammatory signaling and central muscle facilitation.

Peripheral Enzyme Inhibition and Prostanoid Signaling

This domain describes the action of Ibuprofen, which functions as a non-selective, reversible inhibitor of the Cyclooxygenase ( COX-1 and COX-2) enzymes . This inhibition interferes with the early molecular step in the Arachidonic Acid Cascade, decreasing the synthesis of mediators such as Prostaglandin E2 ( PGE2). The resulting physiological change is a reduced concentration of local inflammatory mediators and a modification of peripheral nociceptor signaling thresholds.

Central Alpha-2 Adrenergic Modulation of Motor Facilitation

This domain involves the action of Tizanidine, which functions as an agonist of Alpha-2 Adrenergic Receptors (alpha2) located primarily in the spinal cord. This mechanism suppresses the release of excitatory amino acid neurotransmitters (e.g., Glutamate) from spinal interneurons, particularly within the polysynaptic reflex pathways. The physiological consequence is a reduction in the excessive nerve signaling that drives involuntary muscle motor unit firing.

Mechanistic Integration

The two mechanisms modulate separate biological environments—local prostanoid generation and spinal excitatory drive—that contribute to sustained nociceptive signaling. This combined action efficiently modulates two interconnected but separate physiological systems, allowing for a broader influence on local tissue responses and central motor reflex activity.

Dosage and Administration Information

The medicine Flectadol, an oral fixed-dose combination, is administered exclusively by mouth for short-term symptomatic use. The standard regimen is defined by the Tizanidine component, starting at 2 mg per dose, taken every 6 to 8 hours as needed. The total daily dosage must not exceed 36 mg of the Tizanidine component.

Usage requires a specific titration schedule to establish the appropriate individual dose. Increases in the dosage are made gradually, in increments of 2 mg to 4 mg, with a required interval of one to four days between adjustments. Dosing recommendations may vary by region.


Procedural and Contextual Usage

Condition Official Use Protocol
Administration with Food May be taken with or without food, but consistent administration (always with food or always without) is recommended to manage variability in drug exposure.
Discontinuation The dosage must be slowly decreased (tapered) when stopping the medicine, typically by 2 mg to 4 mg per day, to minimize procedural risks.
Renal/Hepatic Adjustment For patients with severe renal or hepatic impairment, the initial dose and subsequent dose increases should utilize lower individual doses. The frequency of administration should not be increased.

These guidelines establish a comprehensive procedural protocol for both initiating and concluding the short-term course of treatment, defining the gradual dose adjustment and consistent intake required.

Recent Clinical Evidence

Research evidence / Overview of studies


Evidence for use in Chronic Pain

Research has evaluated its use in studies exploring chronic non-cancer pain, with results from these studies being evaluated. Studies have evaluated whether the drug influences patient-reported pain scores and explored whether there was a change in the use of other analgesic medications.

  • RCT Findings on Efficacy

    • In a large-scale randomized controlled trial (RCT), participants receiving the drug reported changes in pain sensation and reported changes in pain severity over six months. Information includes awareness that the study design examined various dosages and titration schedules.
  • Combination Therapy Research

    • Research has explored whether the combination with physical therapy is associated with different outcomes. The evidence reported for non-pharmacological co-interventions was limited in the included studies.

Comparative Studies

Findings were reported in comparative studies examining the drug and placebo in achieving a 50% reduction in pain. Head-to-head trials comparing the drug to an established analgesic explored equivalence in efficacy over three months. Findings were mixed regarding time-to-onset of reported change.


Use in Neuropathic Conditions

For neuropathic pain, studies have examined the drug as an option in research which included individuals who had failed first-line treatments. A pooled analysis examined outcomes across different types of neuropathic pain; the results reported consistency across central and peripheral etiologies.


Safety and Tolerability Profile

Research reported on the drug’s side-effect profile, including investigations into long-term use in adults. The most frequently reported adverse events in studies were dry mouth and dizziness. The study documentation noted that no adverse events outside of the expected events were reported during the studied period.

Frequently Asked Questions (FAQ)

Common questions about Flectadol (FAQ)

Q: Is Flectadol considered a simple over-the-counter pain reliever or a prescription-only drug?

Official product information confirms that Flectadol is available by prescription only. This is because it is a fixed-dose combination product that includes the centrally acting muscle relaxant component, Tizanidine.

Q: Is Flectadol the same class of medication as ibuprofen or naproxen?

Flectadol is classified as a combination medicine because it contains two distinct active ingredients. It is both a Nonsteroidal Anti-Inflammatory Drug (NSAID), like ibuprofen, and a Centrally Acting Skeletal Muscle Relaxant.

Q: Is Flectadol classified as a narcotic or opioid-based pain medicine?

Regulatory documents classify Flectadol as an NSAID and a skeletal muscle relaxant. It is officially not categorized as a narcotic or opioid-based pain medication.

Q: Does Flectadol treat the root cause of the discomfort or only relieve the symptoms?

The medicine works by a dual mechanism of action, which involves modulating peripheral inflammation and reducing excessive nerve signaling in the spinal cord. This specific action is designed to contribute to the symptomatic relief of pain and spasms associated with acute musculoskeletal conditions.

Q: Can Flectadol cause drowsiness or affect my concentration or ability to drive?

Due to potential risks, official documentation includes warnings regarding the performance of tasks requiring mental alertness, such as driving or operating machinery. This is because the medicine is associated with risks of somnolence (drowsiness), dizziness, and low blood pressure.

Q: Do the common side effects of Flectadol typically subside after the first few days of use?

Regulatory documents indicate that certain side effects, such as somnolence and low blood pressure, are often more noticeable when treatment is initiated and during dose escalation. This time-related documentation suggests that these specific effects are often less pronounced after the initial phase of treatment.

Q: Can Flectadol cause lightheadedness or dizziness, and what is the reason for this?

Dizziness is a commonly reported effect in official safety documentation. This effect is primarily related to the Tizanidine component, which is associated with a risk of severe hypotension, or profound low blood pressure.

Q: Are there any documented withdrawal effects if Flectadol treatment is stopped suddenly?

Regulatory documents indicate that discontinuation requires a dosage reduction procedure, often referred to as tapering. This gradual process is recommended to minimize procedural risks, such as sudden increases in blood pressure (rebound hypertension) and elevated heart rate (tachycardia).

Q: How quickly does Flectadol typically begin to work after an oral dose?

Official pharmacokinetic documentation reports the time it takes for the active components to reach their maximum concentration (Tmax) in the body. This measure provides a pharmacokinetic indication of the time profile of drug absorption.

Q: What is the expected duration of the pain-relieving effect from a single dose of Flectadol?

The standard regimen for the Tizanidine component, as defined in regulatory documents, involves administering doses every 6 to 8 hours as needed. The schedule reflects the period of time between administrations.

Q: Does consuming food affect how quickly the pain relief from Flectadol begins?

Official recommendations state that taking the medicine with food may affect the rate and extent of drug exposure in the body. Regulatory information recommends consistent administration—always taking it either with food or always without—to manage variability in drug exposure.

Q: Does Flectadol interact with common over-the-counter medications like cold remedies or acid reducers?

Regulatory warnings strictly restrict combining Flectadol with other NSAIDs, which are commonly found in many over-the-counter cold and pain relief products. Additionally, official documentation notes interactions with certain medications that may affect the clearance of the drug by the kidneys.

Q: Can people who have a history of stomach ulcers or gastrointestinal bleeding use Flectadol?

The regulatory label indicates that the presence of active gastrointestinal bleeding or ulcers is a strict contraindication. Official documentation notes that patients with a prior history of GI disease are among those who require special consideration due to the increased risk of serious GI injury.

Q: What is the official regulatory advice concerning Flectadol use during pregnancy or while breastfeeding?

The medicine is strictly contraindicated for use in the third trimester of pregnancy. Official information is available on risks during the first and second trimesters, and regulatory documents include limited data regarding its excretion into human milk during breastfeeding.

Q: Is there information available on how Flectadol is used in pain management outside of the United States?

While dosing recommendations may vary by region, the official documentation notes that the regimen described is based on U.S. regulatory guidelines. This indicates that protocols and use may differ in other countries.

Q: Does Flectadol have any potential for physical dependence or addiction?

The Tizanidine component of the medicine is not listed as a controlled substance by the DEA in the United States. The official regulatory label does not document a potential for physical dependence or addiction.

Q: What are the typical signs or symptoms of a mild allergic reaction to Flectadol?

The regulatory label lists hypersensitivity (allergic reaction) as a contraindication. The full adverse reaction profile may contain reports of milder hypersensitivity signs, such as rash or pruritus (itching).

Q: Is an increase in heart rate or palpitations a possible known side effect of Flectadol?

While the label specifically highlights the risk of severe low blood pressure, the full regulatory documentation may include reports of cardiovascular events such as palpitations or an increased heart rate (tachycardia).

Q: What should be done if I miss or forget to take a dose of Flectadol?

Official procedural instructions outline that a missed dose is generally taken as soon as it is remembered. However, if that time is close to the time for the next scheduled dose, the regulatory guidance is to skip the missed dose.

Q: Is it normal to experience a mild burning sensation in the throat or stomach after taking Flectadol?

The regulatory label lists gastrointestinal effects under the adverse reaction class, including nausea, dyspepsia (indigestion), and abdominal pain. The documented gastrointestinal effects are consistent with symptoms that may include a burning sensation.

Q: Can taking Flectadol lead to feelings of anxiety or restlessness in some people?

Common adverse reactions listed include nervous system effects such as dizziness and somnolence. The full regulatory documentation may contain reports of mood changes, such as anxiety or restlessness, as less common nervous system effects.

Q: Is there a concern about the active ingredient in Flectadol building up in the body over time?

Regulatory documentation defines the time required for the active components to reach a steady state, which is the point where the amount of drug entering the body equals the amount being cleared. This information helps to describe the pharmacokinetic profile related to drug concentration over time.

Q: Is there a period after stopping Flectadol during which it remains active in the body?

The official half-life of both active ingredients is defined in regulatory sources. This pharmacokinetic data provides the biological half-life, which is used to estimate the period over which the medicine is cleared from the body.

Q: What is the official guidance regarding the consumption of alcohol while taking Flectadol?

Official regulatory warnings indicate that alcohol may increase the risk of central nervous system (CNS) effects, such as dizziness and drowsiness. Co-administration may also increase the risk of gastrointestinal side effects, including bleeding.

Q: Is Flectadol specifically restricted for use in patients who also have asthma or other respiratory conditions?

Yes, the NSAID component of the medicine carries a formal regulatory warning regarding its potential for causing bronchospasm (tightening of the airways). This is a specific regulatory consideration for patients with conditions such as aspirin-sensitive asthma.

Q: Does Flectadol contain caffeine or other stimulating agents?

The active ingredients are Ibuprofen and Tizanidine. Official regulatory documentation for the formulation does not list caffeine or other stimulating agents as either an active or an inactive ingredient.

How should Flectadol be stored and disposed of?

How to Store and Dispose of Flectadol: Official Regulatory Requirements

Official regulatory documents define specific requirements for storing and disposing of Flectadol (ketoprofen lysine salt) to maintain its quality and ensure safety.

Storage Conditions

Requirement Specifics
Temperature Store at room temperature, typically below 25 C or 30 C.
Protection Must be protected from light and moisture; keep in the original packaging.
Handling Keep the container tightly closed and store out of the sight and reach of children.

Disposal

Unused or expired Flectadol must not be disposed of via household trash or wastewater. Regulatory guidelines instruct returning the medicine to a community pharmacy or authorized take-back program to ensure safe and environmentally responsible disposal.

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

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