Eflagen

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Medically reviewed

Rosario Oropesa

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 Eflagen

Quick Facts

Property Description
Active ingredient Diclofenac (Diclofenac Sodium)
Form Tablets, Capsules, Suppositories, Gel, Injectable solution
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
Origin Synthetic, Phenylacetic acid derivative

What Type of Medicine is Eflagen?

Eflagen is a medication whose primary active ingredient is Diclofenac, classifying it as a Nonsteroidal Anti-inflammatory Drug (NSAID). This drug belongs to the Phenylacetic acid derivative family, making it a synthetic compound within the broader group of antirheumatic agents. Unlike simple analgesics, the NSAID class is clinically recognized for providing a dual action: it addresses both the sensation of pain and the underlying biological process of inflammation.


Composition and Available Forms of Diclofenac

The core component of Eflagen is typically Diclofenac Sodium, which is consistently formulated as a single-ingredient product. The drug is designed for both systemic administration and localized relief, which accounts for its availability in multiple dosage forms. These include tablets (often enteric-coated to reduce stomach irritation), capsules for oral administration, and gel for topical use. Other available forms, such as suppositories and injectable solution, offer alternative routes of administration for diverse patient needs.


Eflagen's General Purpose and Core Benefits

The general purpose of Eflagen is to provide therapeutic relief by simultaneously executing three core benefits: an analgesic effect (pain-relieving), an anti-inflammatory effect (swelling reduction), and an antipyretic effect (fever reduction). These actions are achieved by targeting the body's production of key inflammatory mediators. This triple action is why the medicine is used to diminish discomfort associated with painful, irritated, and febrile conditions, such as managing the localized discomfort of a sprain.

Regulatory References

  1. Diclofenac: MedlinePlus Drug Information
  2. Diclofenac - StatPearls - NCBI Bookshelf - NIH

What side effects are possible with Eflagen?

Possible Side Effects and Safety Information for Eflagen

This section outlines the officially documented safety information for Eflagen, based on data compiled by government regulatory authorities.


Adverse Reactions Classification

Adverse reactions associated with Eflagen are classified by frequency and grouped by the System-Organ Class (SOC) affected. Frequency categories follow international standards (e.g., Very Common, Common, Uncommon, Rare, Very Rare, and Not Known):

Frequency Category Example SOCs Affected
Very Common (ge 1/10) Gastrointestinal disorders (e.g., nausea), Nervous system disorders (e.g., headache)
Common (ge 1/100 to < 1/10) Skin and subcutaneous tissue disorders (e.g., rash), General disorders (e.g., fatigue)
Rare (< 1/1,000) Hepatobiliary disorders (e.g., elevated liver enzymes)

Serious Adverse Reactions (SARs)

Clinically significant, severe reactions are documented separately. These include rare but critical events such as Angioedema, Severe Cutaneous Adverse Reactions (SCARs), and specific presentations of Drug-Induced Liver Injury (DILI), which may require immediate medical attention.

Safety Constraints and Monitoring

Official labeling defines specific restrictions on the use of Eflagen:

  • Contraindications: Use is prohibited in patients with known hypersensitivity to Eflagen or its components, and in specific medical states, such as concomitant use with certain other drugs.
  • Population-Specific Warnings: Caution and/or dose adjustment are mandated for patients with severe hepatic impairment and renal impairment. Specific safety data is provided for use during pregnancy and lactation.
  • Monitoring Requirements: Periodic laboratory monitoring, such as Liver Function Tests (LFTs) and electrolyte monitoring, is often required as a condition of use to manage potential adverse effects.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documents define the overdose profile for Eflagen (Diclofenac) based on documented systemic manifestations and the required immediate emergency response. A suspected overdose may initially present with gastrointestinal distress, including nausea, vomiting, stomach pain, and diarrhea. Central nervous system effects are also documented, which may include headache, drowsiness, dizziness, confusion, or ringing in the ears (tinnitus).

In severe cases, the official labeling warns of potential life-threatening outcomes. These documented severe manifestations include seizures, coma, acute renal failure (severe kidney damage), and large-scale internal gastrointestinal bleeding.

When Immediate Medical Help is Required

Regulatory guidance mandates that any suspected Eflagen overdose requires seeking medical attention immediately. Contacting local emergency services or a poison control center is the required first step. Urgent medical help must be sought if any severe symptoms develop, such as chest pain, shortness of breath, sudden weakness, or slurred speech.

Management for overdose is strictly symptomatic and supportive, as official sources state that no specific antidote is known. Procedures within a clinical setting may include administering activated charcoal, performing gastric lavage, and continuous monitoring of vital signs to manage the documented manifestations and prevent severe complications.

Therapeutic Uses of Eflagen

Eflagen is commonly used to help with symptomatic support across multiple therapeutic domains, primarily for conditions involving inflammatory or irritative processes. The medication may assist with managing symptoms that create noticeable physiological strain in conditions like chronic Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis, as well as during acute episodes of migraine attacks, gouty arthritis flares, and primary dysmenorrhea.

The medication is applicable within clinical settings that involve acute or disruptive symptom patterns, such as following minor strains, sprains, or contusions. It helps address symptom clusters that may become intense or disruptive. The core utility is related to symptomatic management, which provides support that helps ease the overall symptom burden. By providing supportive relief, Eflagen contributes to easing discomfort during symptomatic periods and may assist with managing symptoms that interfere with routine activities.

Quick Fact: Relief for Pain and Inflammation
Relevant Conditions Inflammatory joint disorders, acute soft tissue injuries, episodic pain syndromes (migraine, dysmenorrhea).
Core Symptom Relief Supportive relief for pain, stiffness, and swelling.
Clinical Context Used when short-term symptomatic assistance or chronic symptom management is needed.

Eligibility and Restrictions for Use

Who Can and Cannot Use Eflagen?

Eflagen (Diclofenac) is strictly contraindicated for specific patient populations as defined by regulatory authorities (e.g., FDA, EMA). The medicine must not be used by individuals with a known hypersensitivity to diclofenac, aspirin, or other NSAIDs, including those with a history of Aspirin-Sensitive Asthma.


Absolute Contraindications and Prohibited Use

Absolute non-eligibility applies to:

  • Patients with active gastric or intestinal ulceration, bleeding, or perforation.
  • Patients with severe renal failure or severe hepatic failure.
  • Use in the setting of Coronary Artery Bypass Graft (CABG) surgery.
  • Use in the third trimester of pregnancy (starting at 30 weeks gestation).

Restricted and Age-Specific Eligibility

Regulatory documents generally classify patients with established congestive heart failure (NYHA Class II–IV), ischemic heart disease, or cerebrovascular disease as ineligible for use. For those with cardiovascular risk factors or mild-to-moderate organ impairment, use is restricted and requires careful consideration. Most systemic formulations are generally not suitable for children under 14 years of age, although specific uses for children 12 and older exist. Use is advised with caution in the elderly and during lactation.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Eflagen (Diclofenac) has documented interaction patterns with various drug classes that affect systemic exposure, efficacy, or risk of adverse events, as stated in official government regulatory documents.

Exposure and Pharmacodynamic Interactions

Interacting Agents Official Regulatory Statement
Anticoagulants / Antiplatelets / SSRIs Concomitant use increases the labeled risk of bleeding.
Other NSAIDs / Aspirin Concurrent use is generally not recommended due to increased risk of serious gastrointestinal events.
ACE Inhibitors / ARBs / Diuretics Diclofenac may reduce the blood pressure-lowering and natriuretic (salt-excreting) effect of these medicines.
Voriconazole Co-administration is documented to increase the plasma concentration (Cmax and AUC) of Diclofenac due to inhibition of CYP enzymes.
Digoxin / Lithium Concomitant use may increase the serum concentration and prolong the half-life of these substances.
Methotrexate Diclofenac may increase the plasma concentration of Methotrexate.

Interaction-Related Constraints

Official labeling contraindicates the use of Eflagen for perioperative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery. A formulation-specific note exists for the powder for oral solution, which may have reduced effectiveness when administered with food compared to an empty stomach. Furthermore, co-administration with ACE Inhibitors or ARBs carries a specific caution regarding a heightened risk of deterioration of renal function in the elderly, volume-depleted, or those with renal impairment, as detailed in official prescribing information.

Mechanism of Action

Inhibiting the Synthesis of Prostaglandins

Eflagen acts through inhibition of the Cyclooxygenase (COX) enzymes (specifically COX-1 and COX-2). This molecular action directly blocks the enzymes from converting arachidonic acid into prostaglandins, which are key eicosanoid mediators in the body’s signaling cascades for tissue exudation and nociceptor sensitization.


Modulating Systemic Physiological Responses

By reducing the intracellular concentration of these signaling mediators, Eflagen influences both local and central physiological systems. This mechanistic domain affects peripheral nerve endings to decrease nociceptor sensitization and adjusts the brain’s thermoregulatory set-point within the hypothalamus. This modulation alters signaling dynamics within the targeted pathways, resulting in subsequent physiological adjustments that reduce tissue exudation and decrease the body's thermoregulatory set-point toward normal.

Dosage and Administration Information

Eflagen, containing Diclofenac, is administered across multiple official routes, including oral (tablets, capsules), rectal (suppositories), intramuscular, intravenous, and topical applications, depending on the required use context. The overarching principle governing its use is the administration of the lowest effective dosage for the shortest necessary duration, with the total systemic daily dose generally not exceeding 150 mg.


Systemic Administration Patterns

For long-term conditions like certain forms of arthritis, oral systemic dosing typically falls in the range of 75 mg to 150 mg per day, commonly taken in divided doses. The manner of intake is specific to the formulation: delayed-release tablets must be swallowed whole and cannot be crushed or chewed, while the timing relative to meals may vary by formulation.

Parenteral administration, such as an intramuscular injection of 75 mg, is generally reserved for acute situations. This use is time-constrained and often limited to one or two days before the patient transitions to an oral or rectal form of the medicine. Intravenous use requires dilution and buffering and must be given as a slow infusion over a minimum of 30 minutes, not as a bolus injection.


Use in Specific Populations

Specific instructions for older adults and pediatric patients are documented. Older adults should begin treatment at the lowest effective dosage. Pediatric systemic use is determined using a weight-based regimen, typically administered in two to three divided doses daily.

Recent Clinical Evidence

Evidence for Use in Chronic Inflammatory Joint Disorders

Research has focused on the active ingredient in Eflagen in studies for long-term conditions characterized by functional limitations and inflammation, such as Osteoarthritis (OA), Rheumatoid Arthritis (RA), and Ankylosing Spondylitis (AS). Studies have been conducted during periods of increased symptom activity in adults and older adults to examine patient-reported outcomes. These studies primarily use Randomized Controlled Trials (RCTs) and observational settings known as Real-World Evidence (RWE), which monitor patient experiences over defined time intervals.

In these research scenarios, Diclofenac was studied for its association with outcomes related to physical discomfort. Studies monitored outcomes related to physical discomfort, including pain intensity, joint stiffness, and measures reflecting daily functioning or activity level, such as reported ability to move joints. Findings describe patterns observed in the short-term studies, where research recorded measurements of symptoms during the study period. Studies also explored outcomes in comparison to an inactive substance (placebo) or other treatments used for these conditions. For chronic conditions, long-term observational studies were also used to collect data on patterns of use over many months, which provides insight into patient-reported experiences when managing long-lasting symptoms.


⏳ Evidence for Use in Acute and Episodic Pain Syndromes

Eflagen was evaluated in studies relevant in trials assessing short-term or episodic symptom patterns, such as primary dysmenorrhea (menstrual pain), acute soft tissue injuries like strains and sprains, and migraine attacks. These trials are typically very short-term, focusing on a single episode or event where symptoms become more noticeable. This research explores short-term symptom changes, focusing on outcomes describing episodic or acute changes in pain and discomfort.

In these acute pain research scenarios, studies monitored the speed at which symptom change was observed and how long the measured outcomes lasted within the immediate hours following administration. Studies monitored the frequency of rescue medication use following the study drug administration across the single, treated episode. Findings describe patterns observed in the studies regarding the time over which symptom changes were measured. Research contributes to the broader evidence landscape by providing insight into short-term changes during phases of heightened symptom activity.


️ Long-Term Studies and Follow-Up Data

Long-term outcomes are not fully established through initial RCTs, so research also explores observational data. These studies monitor responses over defined time intervals, sometimes for a year or more. The data show patterns related to how frequently patients continue to use the medication and the associated event rates tracked over the extended observation periods.

However, follow-up durations were limited in many initial trials. Data for certain groups remain insufficient, meaning there is limited information for long-term outcomes, especially regarding the consistency of measured symptom changes over multiple years of use. This area of research indicates that data are still emerging, and more research is ongoing to help characterize the outcomes over an extended time.

Frequently Asked Questions (FAQ)

Common questions about Eflagen (FAQ)

Q: Is it safe to drink alcohol while taking Eflagen?

A: Official product information states that the use of alcohol is not recommended while taking Eflagen. Alcohol consumption can increase the risk of serious gastrointestinal events associated with this medicine, such as stomach bleeding or ulceration.

Q: Can Eflagen affect fertility?

A: Studies and official information indicate that Eflagen's active ingredient is associated with reversible infertility in women. In women who are experiencing difficulty conceiving, official labeling suggests that withdrawal of the drug should be considered.

Q: What are the signs of fluid retention or swelling caused by Eflagen?

A: Eflagen can cause the body to retain fluid, resulting in edema. Signs of this include swelling, often noticed in the feet or ankles, and potential unexplained weight gain. Regulatory information indicates this is a factor that may require monitoring, particularly in patients with existing heart conditions.

Q: What are the signs of an overdose on Eflagen?

A: Taking more Eflagen than prescribed can lead to symptoms such as stomach ache, nausea, vomiting, or diarrhea. Serious consequences can occur, and emergency medical help should be sought if an overdose is suspected.

Q: Is there a generic version of Eflagen available?

A: Yes, the active ingredient in Eflagen, diclofenac sodium, is widely available in generic formulations. These generics, including tablets, gels, and patches, are generally considered therapeutically equivalent to the brand-name product.

Q: Will Eflagen interact with an aspirin regimen for heart health?

A: Official information advises against the concurrent use of Eflagen with an aspirin regimen. Taking both medicines together increases the labeled risk of serious gastrointestinal events, particularly bleeding. Eflagen has not been shown to mitigate cardiovascular risks associated with NSAIDs.

Q: Can Eflagen be used to treat actinic keratosis?

A: Specific topical formulations of Eflagen's active ingredient are officially indicated for the treatment of actinic keratosis, which is a type of sun-damaged skin lesion, according to regulatory documents.

Q: Are there different types of Eflagen based on the salt form (e.g., sodium vs. potassium)?

A: The active ingredient is manufactured and available as both the diclofenac sodium and diclofenac potassium salt forms. These different salt forms are associated with variations in formulation and may be used for different indications.

Q: Can Eflagen cause an increased sensitivity to sunlight?

A: When using the specific topical formulation of Eflagen's active ingredient that is indicated for actinic keratosis, sun avoidance and protective clothing are officially recommended during the course of therapy.

Q: What happens if I forget to take a dose of Eflagen?

A: If a dose is missed, regulatory guidance suggests taking it only if there is sufficient time before the next scheduled dose. If it is close to the next dose, the missed dose is typically skipped to avoid taking two doses too closely together.

Q: Does Eflagen come in different forms, such as topical gel or patch?

A: Yes, the active ingredient in Eflagen is available in many different forms. These include forms for systemic use like tablets and capsules, as well as topical applications like a gel or a topical patch/system.

Q: Is it normal to feel dizzy or lightheaded after taking Eflagen?

A: Official product information notes that the active ingredient can be associated with nervous system effects. Dizziness and drowsiness are among the potential side effects that have been reported.

Q: Can Eflagen cause ringing in the ears (tinnitus)?

A: Official product information for the active ingredient lists tinnitus (ringing or buzzing in the ears) as a potential adverse reaction. This is noted under the category of ear and labyrinth disorders.

Q: Can people with a history of asthma or allergies use Eflagen?

A: Eflagen is strictly contraindicated for individuals who have a history of Aspirin-Sensitive Asthma or allergic reactions to aspirin or other NSAIDs. For individuals with general asthma not sensitive to aspirin, caution is still advised.

Q: Will Eflagen affect my ability to drive or operate machinery?

A: Because Eflagen has the potential to cause side effects such as dizziness or visual changes, the regulatory label indicates that patients who experience these effects may need to avoid driving or operating machinery.

Q: Can Eflagen cause changes in appetite or unusual weight gain?

A: Regulatory documents list unexplained weight gain and edema (swelling due to fluid retention) in the warnings section. Sudden or significant changes, such as unexplained weight gain, are listed in warnings and are effects that may need attention.

Q: Is Eflagen considered an over-the-counter (OTC) drug or is it prescription-only?

A: Eflagen is available in both prescription-strength formulations and, in some locations, certain lower-dose concentrations may be available without a prescription. The exact status depends on the specific concentration and country of sale.

Q: What is the difference between Eflagen's immediate-release and extended-release forms?

A: Official information states that delayed-release tablets are designed to bypass the stomach and dissolve in the intestine, which helps reduce irritation. Immediate-release forms dissolve more quickly, which generally leads to faster peak levels of the medicine in the blood.

How should Eflagen be stored and disposed of?

How to Store and Dispose of Eflagen?

Eflagen (Diclofenac tablets) must be stored at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F). The medication is required to be kept in its original, closed container and must be protected from both moisture and direct light. It is mandatory to keep Eflagen out of the reach and sight of children, and the drug must not be subjected to freezing or excessive heat.

For disposal, unused or expired Eflagen should be discarded according to local regulations. The official method is often a drug take-back program. If take-back is unavailable, the product may be mixed with an unappealing substance, sealed in a container, and placed in household trash; it must not be flushed down a toilet.

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

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