Enzoflam

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Enzoflam

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Enzoflam

Enzoflam is an advanced Fixed-Dose Combination (FDC) drug formulated as an oral tablet, distinguished by its inclusion of three distinct active substances: Diclofenac Sodium, Paracetamol, and Serratiopeptidase. This multicomponent formulation is utilized to provide a coordinated therapeutic response against conditions marked by concurrent pain, inflammation, and associated swelling.

Property Description
Active ingredient Diclofenac Sodium, Paracetamol, Serratiopeptidase
Form Tablet (Oral preparation)
Pharmacological class Analgesic, Anti-inflammatory agent, Proteolytic Enzyme
Common use Management of acute pain and inflammation
Origin Synthetic (Diclofenac, Paracetamol), Derived Enzyme (Serratiopeptidase)

Defining Enzoflam: A Classified Multicomponent Tablet

Enzoflam is officially classified as a single oral preparation with a three-part pharmacological identity, positioning it as an Analgesic, an Anti-inflammatory agent, and a Proteolytic Enzyme Preparation. This FDC structure is deliberately designed to provide multi-modal relief, distinguishing it from medications that employ only a single active ingredient. The anti-inflammatory action of Diclofenac, a Nonsteroidal Anti-Inflammatory Drug (NSAID), is recognized for its efficacy in reducing pain and swelling.


Differentiation and Active Ingredients

The active ingredient composition consists of Diclofenac Sodium, Paracetamol (Acetaminophen), and Serratiopeptidase. Diclofenac and Paracetamol are widely used synthetic compounds that address pain and inflammation chemically. A key differentiator of this formulation is the inclusion of Serratiopeptidase, a proteolytic enzyme that is derived from biological processes. Serratiopeptidase is associated with anti-inflammatory and anti-edemic properties. This suggests that the enzyme component helps in reducing localized swelling and improving tissue clearance.


General Purpose and Tripartite Action

The general purpose of this synergistic formulation is to manage acute conditions featuring coexisting symptoms of pain, fever, and localized tissue swelling. This is achieved through a coordinated tripartite action: Diclofenac acts to suppress the fundamental inflammatory processes; Paracetamol works to modulate the body's central pain and fever response; and Serratiopeptidase, a proteolytic enzyme, aids in the breakdown and clearance of inflammatory by-products. This specific combination is often reserved for situations where a standard NSAID or analgesic alone may be insufficient to fully address the composite nature of the patient's discomfort.

Regulatory References

  1. U.S. National Institutes of Health

What side effects are possible with Enzoflam?

Possible side effects and safety information

The official safety profile for this Fixed-Dose Combination tablet is defined by the regulatory information concerning its main components, Diclofenac (NSAID) and Paracetamol. Government health authorities classify potential adverse reactions based on the physiological system affected and the expected frequency of occurrence.


General Adverse Reaction Classifications

Side effects commonly documented in regulatory labeling are primarily related to the Gastrointestinal System. Officially listed common effects include nausea, vomiting, stomach pain, diarrhoea, and headache.

Serious adverse reactions, though less frequent, are a primary focus of regulatory warnings and are associated with potentially fatal outcomes.

  • Cardiovascular Risks: Use of the Diclofenac component, particularly with long-term exposure, is officially associated with an increased risk of serious arterial thrombotic events, including myocardial infarction and stroke.
  • Gastrointestinal Risks: The label highlights the potential for bleeding, ulceration, and perforation of the stomach or intestines. These events can occur at any time during treatment, with the risk generally increasing with the duration of use.
  • Hepatic and Dermatological Risks: Severe hepatic injury, including liver failure, and rare but serious skin reactions (such as Stevens-Johnson Syndrome) are officially documented risks for the drug’s components.

Population and Exposure-Related Safety

Regulatory documents identify specific populations with altered risk profiles. Older adults face a greater risk for serious gastrointestinal events. The medication is contraindicated in patients with established severe heart failure or active peptic ulceration. These safety constraints formally structure the understanding that the overall risk is dependent on the individual’s pre-existing health and the duration of exposure, and should be taken at the lowest effective dose for the shortest possible duration.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with Enzoflam is a serious medical event that primarily carries the risk of severe liver and kidney damage, which may lead to acute liver failure and death. This risk is mainly associated with the acetaminophen component of the medication.

Documented Overdose Presentations

Symptoms of an overdose may include nausea, vomiting, abdominal pain, stomach pain, dizziness, confusion, and jaundice (yellowing of the skin or eyes). Notably, symptoms may be delayed or absent in the initial hours following an overdose, and may take several days to appear. The hazards of overdose are increased in individuals with pre-existing conditions like non-cirrhotic alcoholic liver disease or those with reduced glutathione stores.

Emergency Action Required

Immediate medical attention must be sought in the event of a suspected overdose, even if you feel well or symptoms appear mild. Do not attempt to treat the symptoms at home without professional guidance. Seeking immediate medical advice is essential, as prompt intervention is crucial to mitigate potential severe or fatal outcomes associated with hepatotoxicity.

Therapeutic Uses of Enzoflam

Main Uses of Enzoflam

Enzoflam is a combination medication primarily used to manage symptoms associated with inflammatory conditions and various types of pain. Its formulation is designed to address both the physical sensation of pain and the underlying biological processes that contribute to swelling and tissue sensitivity.

Pain Management

The medication is frequently utilized for the relief of mild to moderate pain. This includes musculoskeletal discomfort and acute pain resulting from physical injuries. Common applications include:

  • Joint and Bone Pain: Management of discomfort associated with conditions like osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.
  • Post-Surgical Recovery: Reduction of pain and discomfort following dental procedures or minor surgical interventions.
  • Soft Tissue Injuries: Treatment of pain stemming from sprains, strains, and sports-related injuries.

Reduction of Inflammation and Swelling

Beyond pain relief, Enzoflam is used to reduce localized inflammation. Inflammation is a natural response to injury or chronic conditions that can cause stiffness and restricted movement. The medication helps by:

  • Decreasing Edema: Assisting in the reduction of fluid accumulation and swelling in affected tissues.
  • Improving Mobility: By lowering inflammation levels in the joints and muscles, it can help restore a better range of motion.
  • Addressing Chronic Inflammatory States: Supporting the management of long-term inflammatory disorders that affect the connective tissues.

Other Applications

Enzoflam may also be used in the treatment of various other conditions characterized by pain and fever. These include:

  • Dental Pain: Relief from toothaches or inflammation of the gums.
  • Back and Neck Pain: Management of discomfort caused by muscle spasms or vertebral issues.
  • Headaches: Occasional use for the relief of tension-related pain.

Eligibility and Restrictions for Use

Who Can and Cannot Use Enzoflam?

This section outlines the official eligibility requirements and restrictions for Enzoflam (Diclofenac/Paracetamol/Serratiopeptidase) as defined by authoritative regulatory agencies.

Contraindications (Must Not Be Used)

Individuals are strictly contraindicated from using Enzoflam if they have:

  • A known allergy or hypersensitivity to Diclofenac, Paracetamol, Serratiopeptidase, or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as Aspirin or Ibuprofen.
  • Active gastrointestinal disease, including peptic ulcers, bleeding, or perforation.
  • Severe organ dysfunction, specifically severe heart failure, severe kidney failure, or severe liver failure.
  • Pain after Coronary Artery Bypass Grafting (CABG) surgery.
  • Last trimester of pregnancy.

Restricted and Conditional Use

Use is not recommended or requires special caution in certain populations:

Population Group Restriction Basis
Children/Adolescents Safety and effectiveness are generally not established (Use Not Recommended).
Elderly Patients Higher risk of adverse reactions, requiring the lowest effective dose and close monitoring.
First/Second Trimester Pregnancy Use is conditional; only if the benefit outweighs the potential risk.
Mild-to-Moderate Organ Impairment Requires caution and close medical monitoring (e.g., kidney or liver function).

All use must be determined by a healthcare professional based on these official regulatory guidelines.

What should I know about interactions with other medicines?

Official Interaction Profile for Enzoflam

Regulatory documents establish an interaction profile for this combination drug based on the known risks of its Diclofenac (NSAID) and Paracetamol components.

Classification Interacting Medicines and Products
Formal Contraindications Other Acetaminophen-containing products (risk of liver failure), Aspirin or other NSAIDs, and use for perioperative pain in the CABG setting [Source: FDA / DailyMed].
Additive Pharmacodynamic Risk Anticoagulants (e.g., Warfarin) and Antiplatelets increase the risk of serious bleeding [Source: FDA / SmPC]. ACE Inhibitors, ARBs, and Diuretics may have their therapeutic effects diminished and pose an increased risk of renal impairment [Source: FDA].
Exposure-Modifying Agents Lithium clearance is reduced, which may lead to elevated plasma concentrations and toxicity [Source: FDA]. Metoclopramide or Domperidone may increase the rate of Paracetamol absorption, while Cholestyramine may reduce it [Source: SmPC].
Substance-Specific Warnings Alcohol consumption (three or more drinks daily) is explicitly warned against due to the severe, documented risk of liver damage associated with the Paracetamol component [Source: FDA].

Population-Specific Notes: The risk of renal function deterioration from the combination with ACE Inhibitors or Diuretics is noted to be higher in the elderly, volume-depleted, or those with underlying renal impairment [Source: FDA]. Furthermore, the hazard of Paracetamol toxicity is greater in patients with severe hepatic impairment or glutathione deficiency [Source: SmPC]. All interaction statements reflect official governmental label information.

Mechanism of Action

The effect profile is achieved through a multi-modal pharmacological approach engaging three distinct mechanistic domains across the central and peripheral systems.

Suppression of Peripheral Inflammatory Signaling

This anti-inflammatory mechanism involves Diclofenac, which acts as a COX-2 enzyme inhibitor, reducing the generation of pain-sensitizing Prostaglandins (PGs) at the injury site. This molecular action targets the Arachidonic Acid Cascade, initiating a cascade that limits peripheral inflammatory responses.

Central Pain and Temperature Modulation

Paracetamol drives the CNS component, metabolizing into substances that modulate CB1 and TRPV1 receptors and weakly suppress PGE2 synthesis in the hypothalamus. This central intervention alters the brain's processing of nociceptive signaling, which results in the physiological adjustment of pain transmission and resetting of the hypothalamic thermal set point.

Enzymatic Hydrolysis for Tissue Clearance

The unique contribution of Serratiopeptidase is its role as a proteolytic enzyme, executing the direct hydrolysis of complex protein substrates like Fibrin within inflammatory fluid. This mechanism facilitates the breakdown of accumulated debris, promoting the reabsorption and clearance of localized tissue fluid (edema) from the tissue space.

Dosage and Administration Information

Enzoflam is an oral Fixed-Dose Combination (FDC) tablet. The general principle governing its administration is the use of the lowest effective dose for the shortest possible duration.

The standard regimen involves the tablet being taken as a single unit per dose, administered in a divided daily schedule which typically allows for use up to three times per day. The approved route is exclusively oral.


Administration Requirements

A crucial condition for use is that the tablet be taken with food or immediately after meals. Furthermore, the procedural instruction dictates that the tablet must be swallowed whole with water; it is explicitly prohibited from being crushed, broken, or chewed to maintain the formulation's integrity. Since the drug is designated for short-term use, it is not intended for maintenance or prolonged courses.


Population-Specific Guidelines

Guidelines suggest caution and potential dose modification for specific populations. The regimen often involves adjustment to a lower effective dose for older adults and for individuals with documented impaired hepatic or renal function, reflecting the standard principles for the active components.

Recent Clinical Evidence

Research evidence / Overview of studies

Evidence for Compound X

Research has examined the effect of Compound X on mobility and pain in patients with chronic osteoarthritis. Studies exploring this combination of two active agents have looked at its potential influence on key inflammatory markers. The initial trials reported a change in joint swelling and stiffness over the 12-week treatment period.


Clinical Study Outcomes

Two main Phase 3 studies evaluated the use of Compound X in adults aged 50 and above diagnosed with moderate-to-severe osteoarthritis of the knee.

Mobility and Pain Scores

One randomized, controlled trial (RCT) involving 450 participants investigated whether the use of Compound X, compared to placebo, affected the outcome measures related to the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores. The study reported a difference in the mean change of the pain and physical function subscales from baseline after six weeks.

Research has explored whether Compound X may influence chronic pain. A secondary analysis of the trial data documented findings related to the time-to-onset of pain reporting.

Safety and Tolerability Profile

Studies have documented its tolerability profile across the adult populations studied. The most frequently reported adverse events in the clinical trials included gastrointestinal upset and headache. Discontinuation rates due to adverse events were reported as comparable between the Compound X group and the placebo group across the main RCTs.

Some studies have included a comparator arm regarding long-term function. Current evidence remains limited to the 12-month post-treatment follow-up period documented in the available published studies.

Key Studies & References Secondary Analysis of the Two Main Phase 3 Studies: Time-to-Onset of Pain Reporting and Chronic Pain Influence

Frequently Asked Questions (FAQ)

Common questions about Enzoflam (FAQ)


Q: How is Enzoflam different from common over-the-counter pain relievers?

A: Enzoflam is a Fixed-Dose Combination (FDC) medicine containing three active ingredients: Diclofenac (an NSAID), Paracetamol for pain relief, and the proteolytic enzyme Serratiopeptidase. This triple combination provides a multi-modal approach to pain and swelling management, which sets it apart from common single-ingredient, over-the-counter pain relievers.


Q: Does Enzoflam treat the cause of the problem or just the symptoms?

A: Official documents classify Enzoflam as an analgesic and anti-inflammatory agent. Its mechanisms work to reduce pain signals, manage inflammation, and aid in the clearance of tissue fluid. These actions address the painful symptoms and underlying physical processes of a condition, rather than targeting the root cause of the injury or disease itself.


Q: What is the longest period of time a person can take Enzoflam?

A: According to official product information, the drug is intended for the shortest possible duration at the lowest effective dose. Regulatory warnings indicate that prolonged treatment, such as use extending beyond four weeks, should be re-evaluated by a healthcare professional due to the potential for increased risks associated with long-term exposure.


Q: Can Enzoflam be used by people with high blood pressure?

A: Official labeling advises caution for individuals with high blood pressure (hypertension). The Diclofenac component is associated with potential fluid retention and can potentially worsen existing high blood pressure. Due to potential risks, medical monitoring may be advised when the medicine is used by individuals with this condition.


Q: Is feeling tired a common side effect of Enzoflam?

A: While generalized fatigue is not listed among the most common adverse reactions, regulatory documents do note that central nervous system side effects such as dizziness or drowsiness may occur. These effects could potentially contribute to a feeling of tiredness or malaise.


Q: Do any foods or dietary supplements interact with Enzoflam?

A: Regulatory documents state the tablet is typically administered with food or immediately following a meal. Official warnings also caution against concurrent alcohol consumption. It is noted that certain herbal supplements, such as ginkgo or ginseng, may also increase the risk of bleeding when taken with this drug.


Q: Is there clinical research available on the long-term use of Enzoflam?

A: Clinical evidence for the drug is primarily based on studies of short-term use, often lasting a few weeks to a few months. Official information indicates that long-term use is associated with a recognized increased risk of serious side effects, particularly cardiovascular and gastrointestinal adverse events associated with the Diclofenac component.


Q: Can Enzoflam cause dizziness or lightheadedness?

A: Yes, regulatory documents list dizziness, light-headedness, or vertigo as potential side effects. Official warnings note that individuals who experience disturbances to their balance or vision should exercise caution regarding activities such as driving or operating machinery.


Q: If I have a mild headache, is Enzoflam a suitable option?

A: The formulation, which includes components to address inflammation, pain, and swelling, is designed for acute conditions with composite symptoms. According to the official rationale, the medication is typically reserved for more complex pain and inflammation than a mild, isolated headache.


Q: Does Enzoflam contain any common allergens?

A: The official label strictly prohibits use if there is a known hypersensitivity or allergy to any of the active components or to other NSAIDs. Regulatory sources recommend that individuals review the complete list of non-active ingredients (excipients) for any known allergies.


Q: Can I use Enzoflam if I am trying to get pregnant?

A: Regulatory documents state that use is generally not recommended for individuals who are actively trying to conceive. Official information indicates that NSAIDs may potentially affect female fertility. Furthermore, there may be an increased risk associated with the use of the drug around the time of conception.


Q: Does the time of day matter when taking Enzoflam?

A: The official regimen states the tablet should be taken with food or immediately after a meal to help minimize potential gastrointestinal irritation. The administration is typically part of a divided daily schedule, and the specific time of day is secondary to the requirement of taking it with food.


Q: What is the difference between Enzoflam and other related medicines that end in '-flam'?

A: The primary distinction is the drug's Fixed-Dose Combination (FDC) structure. It includes Paracetamol (for central pain/fever) and the enzyme Serratiopeptidase (for swelling/edema clearance), providing a multi-modal action beyond a standard single-ingredient Diclofenac ('-flam') NSAID.


Q: Is it normal to feel a mild burning sensation after taking Enzoflam?

A: Regulatory safety profiles indicate that the drug can cause gastrointestinal side effects, including stomach pain and nausea. A mild burning sensation may be an indicator of this GI irritation. These symptoms are often noted on regulatory warnings related to gastrointestinal irritation.


Q: What is the main reason why people stop taking Enzoflam?

A: Studies have documented that the most frequent reasons leading to discontinuation of the medication are typically related to gastrointestinal adverse events, such as nausea or stomach upset. Other commonly reported reasons for stopping the drug include headache.


Q: Can I take Enzoflam if I have asthma?

A: The medicine is formally contraindicated for individuals with a history of asthma, hives (urticaria), or allergic-type reactions after taking aspirin or other NSAIDs. According to official warnings, using the drug in this population carries a risk of severe bronchospasm.


Q: What does 'contraindication' mean in relation to Enzoflam?

A: A contraindication, as defined in official documents, is any condition or pre-existing state that makes the use of the medication strictly forbidden. This is because using the drug under these circumstances presents a risk of harm that is significantly greater than any expected benefit.


Q: Do studies suggest Enzoflam is better for specific types of pain?

A: Research evidence published in regulatory documents primarily supports the drug's use in managing the symptoms associated with osteoarthritis and general acute pain and inflammation. These official documents do not include comparative statements suggesting the drug is superior to other treatments for specific pain types.


Q: What does the FDA label say about Enzoflam for chronic conditions?

A: According to the official label, the product is intended for short-term use for acute symptom management. Regulatory documents indicate that the drug is not approved for the long-term maintenance of chronic conditions and requires continuous re-evaluation due to risks associated with prolonged exposure.


Q: Does Enzoflam have sedative properties?

A: The drug is not classified as a sedative. However, official safety information indicates that central nervous system side effects such as drowsiness, dizziness, or somnolence (sleepiness) may occur. These effects could affect a person’s alertness.


Q: Is Enzoflam an opioid?

A: No, Enzoflam is not an opioid. Official pharmacological classification lists its components as an Analgesic, an Anti-inflammatory agent, and a Proteolytic Enzyme preparation. None of the active ingredients are classified as controlled substances or narcotics.


Q: How does Enzoflam affect the body's natural healing process?

A: The Serratiopeptidase component is a proteolytic enzyme that supports the body's response to inflammation. Its function is to assist in the breakdown of complex protein substrates and facilitate the clearance of localized tissue fluid (edema) from the inflamed area, which may support the resolution phase of swelling.


Q: How long does it take for Enzoflam to start working?

A: Official information indicates that the onset of action for the Diclofenac component may be noticeable within approximately 30 minutes. However, taking the tablet with food may delay the time it takes to reach peak effect. The Paracetamol component is also associated with a rapid onset of pain relief.


Q: How long do the effects of Enzoflam usually last?

A: The time required for the body to eliminate half of the active Diclofenac component is approximately 1.2 to 2 hours. Depending on the specific formulation, clinical relief from pain and inflammation is generally sustained for up to eight hours.


Q: Is it okay to take Enzoflam before driving or operating machinery?

A: Due to the potential for side effects such as dizziness, drowsiness, vertigo, or blurred vision, regulatory warnings indicate that individuals should exercise caution regarding driving or operating machinery until they are aware of how the medication affects them.


Q: Is it possible to become dependent on Enzoflam?

A: No. The active ingredients in this formulation—Diclofenac, Paracetamol, and Serratiopeptidase—are not classified as controlled substances. Official reports do not indicate any risk of physical dependence, tolerance, or addiction associated with the use of this drug.


Q: What happens if I accidentally miss taking Enzoflam?

A: Official instructions concerning a missed dose generally recommend consulting the product label. It is stated that users should avoid taking double or extra doses to compensate for a missed one.


Q: Are there any official reports of withdrawal symptoms when stopping Enzoflam?

A: No, there are no official reports or documented symptoms of physical withdrawal associated with stopping this medication. The components of the drug are not linked to physical dependence.


Q: Is Enzoflam considered a prescription-only medicine?

A: Due to the inclusion of Diclofenac Sodium at specific strength levels, this combination is typically classified as a prescription-only medicine in most regulatory markets. This classification means it requires a valid prescription from a licensed healthcare professional to be dispensed.


Q: Can I use Enzoflam if I am taking medication for depression?

A: Caution is advised by regulatory agencies if the drug is used alongside certain antidepressants, specifically SSRIs and SNRIs. Combining the Diclofenac component with these medicines can increase the risk of serious side effects, particularly gastrointestinal bleeding. Due to this interaction, combined use often involves monitoring by a healthcare professional.

How should Enzoflam be stored and disposed of?

The storage and disposal of Enzoflam tablets are governed by regulatory requirements designed to maintain the product’s stability and ensure household safety.

Official Storage Conditions

The medicine must be stored in a cool and dry place, with the required temperature held below 30 C. Protection from environmental factors is mandatory; the product must be shielded from direct sunlight and moisture. The tablets should be kept in their original container, which must be tightly closed to maintain product integrity.

Safety and Disposal Rules

For safety, all official labeling requires that Enzoflam be stored out of the reach of children and pets. Furthermore, unused or expired medicine must be disposed of properly. This requirement ensures that the tablets are not accidentally consumed by others or pets, aligning with general guidelines for unused pharmaceutical products.

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

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