Flenac

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Flenac

Quick Facts

Property Description
Active Ingredient Diclofenac (typically as sodium or potassium salt)
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common Use Symptomatic relief of pain and inflammatory conditions
Origin Synthetic chemical compound
Forms Tablet, capsule, topical gel, injection, suppository

Identity, Composition, and Classification

Flenac is a single-ingredient pharmaceutical preparation containing the Active Pharmaceutical Ingredient (API), Diclofenac. This substance, a synthetic chemical compound chemically categorized as a Phenylacetic acid derivative, belongs to the widely recognized pharmacological class of Nonsteroidal Anti-inflammatory Drugs (NSAIDs). The Diclofenac compound is often prepared as the sodium or potassium salt, a chemical distinction that influences its initial absorption profile. Diclofenac is categorized as an anti-inflammatory agent and analgesic** considered essential in foundational healthcare systems.

Forms and General Therapeutic Purpose

As an NSAID, the general therapeutic purpose of Flenac is to provide effective pain management and an anti-inflammatory effect for various acute and chronic conditions, particularly those involving the musculoskeletal system. The Diclofenac compound is formulated into diverse dosage forms for flexibility in the route of administration, including oral tablets (often specialized with enteric coatings), capsules, suppositories, and solutions for parenteral injection. Furthermore, it is available as topical gels for local delivery. This variety ensures flexibility in addressing symptoms associated with general musculoskeletal disorders and other inflammatory issues.

Regulatory References

  1. See WHO Essential Medicines List

What side effects are possible with Flenac?

Possible Side Effects and Safety Information: Flenac

Flenac (Diclofenac) is a nonsteroidal anti-inflammatory drug (NSAID) associated with serious warnings regarding cardiovascular and gastrointestinal risks, which are formally documented in regulatory labeling.

Serious and Clinically Significant Adverse Reactions

Flenac is associated with an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may increase with higher doses and longer duration of use. It is contraindicated for peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery, and in patients with established congestive heart failure (NYHA Class II–IV), ischemic heart disease, peripheral arterial disease, or cerebrovascular disease.

It also carries an increased risk of serious gastrointestinal adverse events, including inflammation, bleeding, ulceration, and perforation of the stomach or intestines, which can occur without warning symptoms and be fatal. Additional serious risks include Hepatotoxicity, Renal Toxicity (potentially leading to hyperkalemia), Anaphylactic Reactions, and severe Skin Reactions (e.g., Stevens-Johnson syndrome, Toxic Epidermal Necrolysis).

Common Adverse Reactions and Population-Specific Safety

Commonly reported side effects often involve the gastrointestinal system and include dyspepsia, nausea, abdominal pain, diarrhea, constipation, and flatulence, as well as headache and dizziness. Fluid retention and edema are also common.

Pregnancy: Use of Flenac should be avoided starting at 30 weeks gestation due to the risk of premature closure of the fetal ductus arteriosus. Use is generally limited between 20 to 30 weeks due to the risk of fetal renal dysfunction.

Safety Monitoring: To minimize the potential for adverse cardiovascular and gastrointestinal events, the lowest effective dose for the shortest duration necessary to control symptoms is required by regulatory guidance. Patients with pre-existing risk factors, such as hypertension or cardiovascular disease, require careful medical consideration and monitoring.

Overdose and Emergency Response

Overdose and when to seek help — Official Regulatory Information for Flenac (Diclofenac)

Overdose Scope

Documented overdose presentations: Gastrointestinal symptoms (nausea, vomiting, epigastric pain, potential bleeding); Central Nervous System symptoms (drowsiness, confusion, agitation, headache, tinnitus).
Physiological systems affected (as stated in label): Gastrointestinal system, CNS, Renal system (acute renal failure), Cardiovascular system, Respiratory system.
Dose-related or exposure-related factors (if applicable): Ingestion of a large overdose is associated with more severe outcomes, including seizures and coma.
Population-specific overdose notes (if applicable): Overdose has more serious consequences in the elderly (especially severe GI events) and can be very harmful to children; patients with pre-existing asthma may experience exacerbated respiratory symptoms.

Emergency-Response and Management

Emergency-response statements: Seek emergency medical attention right away. Contact a Poison Help line or local emergency services immediately.
When immediate medical help is required: Immediate medical help is required in all cases of suspected overdose.
Antidote information: No specific antidote is known for Diclofenac overdose.

Official Overdose Statements

  • Immediate medical attention is required for suspected Flenac overdose due to the potential for severe and life-threatening systemic outcomes.
  • Officially documented severe outcomes include acute renal failure, severe gastrointestinal bleeding, and the risk of seizures in large ingestions.
  • Management listed in official documents is symptomatic and supportive care, including administration of activated charcoal (within 4 hours of ingestion) and monitoring of vital signs and ECG.

Connection to the overall overdose profile

Regulatory documents define the overdose profile of Flenac by listing specific clinical manifestations that necessitate immediate intervention. The official regulatory stance mandates that individuals seek emergency medical help immediately upon suspicion of overdose due to the documented risk of severe complications. This urgency is reinforced by the explicit statement that no specific antidote is available and that management must be focused entirely on supportive care and rigorous monitoring.

Therapeutic Uses of Flenac

What Flenac Treats: Main Uses and Benefits

Flenac (diclofenac) is generally classified as a non-steroidal anti-inflammatory drug (NSAID) and is applied across domains where additional symptomatic support is needed. Its main therapeutic area is easing pain and reducing inflammation and swelling. It is commonly used to help with symptoms related to inflammatory or irritative states.

This medicine is relevant for easing symptoms related to physical discomfort associated with various musculoskeletal and joint issues. Conditions where symptoms may intensify temporarily, such as chronic conditions like osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, are common targets for Flenac use. It is also applied in addressing acute issues like sprains, strains, back pain, migraines, or discomfort following minor surgical procedures.

Using Flenac supports the patient during difficult episodes by easing distress and contributes to improved comfort during symptomatic periods. It is commonly used when short-term symptomatic assistance is appropriate. Flenac may assist with maintaining comfort and stability when symptoms interfere with routine activities.


Quick Fact: Helps manage Symptoms that interfere with daily functioning

Eligibility and Restrictions for Use

Flenac (Diclofenac) eligibility is strictly defined by regulatory documents, distinguishing between populations permitted to use the medicine and those who are formally contraindicated or restricted. Use is prohibited for individuals with known hypersensitivity to NSAIDs or aspirin, or for those with active gastrointestinal ulceration, bleeding, or perforation. Absolute contraindications also apply to patients with established congestive heart failure (NYHA Class II–IV), ischemic heart disease, and those recovering from Coronary Artery Bypass Graft (CABG) surgery. Severe hepatic or advanced renal disease also constitutes non-eligibility.

Restrictions apply to specific physiological states. Flenac is contraindicated during the third trimester of pregnancy (at 30 weeks gestation and later) and its use should be avoided after 20 weeks. Caution is formally advised for the elderly due to a higher risk of adverse effects. Safety and effectiveness have generally not been established for systemic use in the pediatric population younger than 12 years of age. For patients with cardiovascular risk factors or mild-to-moderate organ impairment, treatment requires careful consideration as defined by official labeling.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Flenac (Diclofenac) exhibits documented interactions categorized by their effects on drug exposure and pharmacodynamic risks, as stated in official regulatory documents. Certain combinations are strictly contraindicated.

Official Regulatory Classifications

Classification Documented Interaction Constraints
Contraindicated Combinations Co-administration with other systemic NSAIDs (including COX-2 inhibitors) should be avoided due to the increased risk of adverse effects. Flenac is also contraindicated for perioperative pain in CABG surgery and in patients with a history of allergic-type reactions to aspirin or other NSAIDs.
Pharmacokinetic Interactions Strong CYP2C9 inhibitors (e.g., Voriconazole) significantly increase Flenac plasma concentrations (AUC and Cmax). Flenac can increase the plasma levels of co-administered Lithium and Digoxin by reducing their renal clearance.
Pharmacodynamic Interactions Concomitant use with Anticoagulants, Antiplatelet Agents, SSRIs, and Systemic Corticosteroids increases the risk of serious GI bleeding and ulceration. Flenac may reduce the antihypertensive or diuretic effect of ACE Inhibitors, ARBs, and Diuretics.

Substance and Timing Restrictions

Administration with food may reduce the effectiveness of certain Flenac formulations. The use of alcohol is linked to an increased risk of serious GI bleeding. Specific cautions apply to elderly, volume depleted, or renal impaired patients taking Flenac alongside ACE inhibitors/ARBs, due to the potential for deterioration of renal function.

Mechanism of Action

Cyclooxygenase Enzyme Inhibition

Flenac exerts its primary mechanism of action as a non-selective inhibitor of Cyclooxygenase (COX) enzymes, targeting both the constitutive COX-1 and the inducible COX-2 isoforms. The drug binds to the active site of these enzymes, thereby preventing the conversion of arachidonic acid into prostanoids, which include various prostaglandins and thromboxanes. This molecular interaction initiates a biochemical cascade that results in a diminished synthesis and release of these potent lipid mediators.


Pathway and Systemic Modulation

The suppression of prostaglandin synthesis is the central pathway effect, occurring across relevant physiological systems. Because prostanoids are key modulators of signal transduction pathways associated with heightened physiological responses, their reduced availability contributes to modulating the activity of downstream signaling components. This modification of the prostaglandin regulatory loop affects the physiological mechanism of thermoregulation and influences activity in peripheral nociceptive (pain-sensing) signaling pathways.

Dosage and Administration Information

How Flenac is Used: Official Administration Guidelines

Flenac (Diclofenac) must be administered strictly according to the prescribing information. The guiding principle for all uses is to employ the lowest effective dosage for the shortest duration necessary for the condition.


Official Routes and Administration Forms

Flenac is approved for administration via multiple routes, ensuring flexibility for various clinical settings:

Route Applicable Dosage Forms
Oral Tablets (Delayed/Extended-Release), Capsules, Powder for Oral Solution
Parenteral Solution for Intramuscular (IM) and Intravenous (IV) Injection
Topical Gel and Solution for dermal application
Rectal Suppositories

Standard Dosing and Frequency

Condition (General) Typical Adult Dosing Range Frequency
Chronic Inflammatory States 100 mg to 200 mg total daily dose Divided doses (e.g., two to four times daily)
Acute Pain / Migraine Single dose of 50 mg to 75 mg As needed (PRN)

Note: Oral doses exceeding 150 mg to 200 mg total daily dose are generally outside standard labeled limits, depending on the specific formulation.


Key Administration Instructions

  • Tablet Handling: Delayed-release and extended-release forms must be swallowed whole; they should not be crushed, chewed, or divided. This ensures the intended release of the medicine is maintained.
  • Parenteral Duration: Administration by IM or IV injection is generally intended for acute, short-term treatment and should typically be restricted to no more than two days before transitioning to an oral or rectal formulation.
  • Intake Timing: While many oral forms may be taken with food, specific forms like the oral powder solution for acute use must often be taken on an empty stomach for optimal effect. The powder must be mixed with water only.
  • Population Use: The lowest effective dose must be used, with particular caution and vigilance recommended when administering to older adults.

Recent Clinical Evidence

Research evidence / Overview of studies for Flenac

For Managing Acute Physical Discomfort

Research examined conditions characterized by fluctuating or episodic manifestations for which Flenac was studied for research exploring short-term symptom changes involving outcomes related to physical discomfort. These investigations focused on episodes where symptoms become more noticeable. The studies monitored how individuals reported changes over defined time intervals using patient-reported outcomes describing perceived discomfort.

Findings describe patterns observed in the studies, which evaluated episodic or acute changes in symptoms over a defined time interval. Research highlights changes measured during the study period in terms of perceived discomfort. Findings help contextualize how patients reported their experience during these acute phases, which may involve measured changes.

It is important to understand that the follow-up durations were limited in many of these trials. Because these studies are often short-term, long-term effects are not fully established. Research provides context but not individual predictions about how Flenac can affect outcomes related to physical discomfort beyond the observed study period.


For Conditions Involving Long-Term Functional Limitations

Flenac was evaluated in observational settings evaluating daily-life functioning for conditions marked by functional limitations. These studies monitored outcomes reflecting daily functioning or activity level in people dealing with conditions presenting with cycles of stability and flare-ups. The research examined how individuals managed their typical activities over time, using outcomes related to systemic or functional imbalance as markers for assessment.


Special Populations: Research in the Elderly

Research is ongoing into the use of Flenac among elderly populations who have conditions where symptoms may vary in intensity. Research examined whether symptoms changed over time in a limited number of older participants. This research often uses outcomes monitoring physiological strain or stress and outcomes related to systemic or functional imbalance. Evidence is limited for older patients, and subgroup findings are uncertain.

Frequently Asked Questions (FAQ)

Common questions about Flenac (FAQ)

Q: I forgot to take my morning dose of Flenac. What should I do now?

Official patient information states that if a dose of Flenac is missed, patients are typically advised to take it as soon as they remember. However, if it is already close to the time for the next scheduled dose, the missed dose should be skipped, and the regular schedule resumed. Official guidance stresses that two doses should not be taken at the same time to compensate for a missed dose.


Q: Can Flenac be used for managing rheumatoid arthritis?

Yes, regulatory documents indicate that Diclofenac (Flenac) is approved for the relief of the signs and symptoms associated with certain chronic inflammatory conditions. Specifically, the official prescribing information includes its use for conditions like rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.


Q: Can children take Flenac? If so, what is the approved age?

Official product information suggests that for some oral forms of Flenac, the safety and effectiveness have been established for use in children who are 12 years of age and older. For children younger than 12 years, consultation with a healthcare provider is necessary to determine the appropriate dose and use in this age group.


Q: How soon can I expect Flenac to start working for acute pain?

Flenac is generally considered a rapidly absorbed medication after oral administration, according to official studies on its pharmacokinetics (how the body processes the drug). While the time it takes for the drug concentration to peak in the bloodstream varies by formulation, this measurement is related to, but distinct from, the actual onset of pain relief.


Q: What should I do if I accidentally take too much Flenac (overdose)?

Seeking emergency medical attention immediately is necessary in the event of an accidental overdose of Flenac. Official prescribing information states there is no specific antidote for Diclofenac overdose. Treatment provided by medical professionals is typically supportive and symptomatic, and clinical management may involve monitoring of the patient's vital functions.


Q: How long does Flenac stay in your system after stopping treatment?

Official pharmacokinetic data indicates that the unchanged drug typically has a terminal half-life of approximately two hours for many oral formulations. This half-life refers to the time it takes for the concentration of the drug in the body to decrease by half. Flenac is mainly eliminated from the body through its breakdown products via the urine and bile.


Q: Can Flenac be crushed or chewed to make it easier to swallow?

For specific forms of Flenac, such as delayed-release and extended-release tablets, the official instructions strictly advise against crushing, chewing, or dividing them. These forms must be swallowed whole to ensure the medicine is released into the body as intended. Instructions for other, non-modified release tablet forms may differ, so checking the specific product's label is advised.


Q: If I have mild kidney problems, can I still take Flenac?

Regulatory information advises that patients with pre-existing mild to moderate kidney function issues usually do not require a dosage adjustment for the core drug itself. However, because Flenac can affect the kidneys, official guidelines emphasize the need for careful medical monitoring in these patients. The use of Flenac is strongly advised against in cases of advanced renal disease.

How should Flenac be stored and disposed of?

How to Store and Dispose of Flenac (Diclofenac)

The storage and disposal of Flenac must strictly follow regulatory standards to ensure product stability and safety.


Storage Requirements

Flenac tablets must be stored at Controlled Room Temperature, specifically between 20 C and 25 C (68 F and 77 F). The product must be protected from moisture and kept in a tight, light-resistant container. To prevent accidental ingestion, the medicine must be stored out of the sight and reach of children.


Disposal Instructions

Unused or expired Flenac should be disposed of using official drug take-back programs or mail-back disposal options when available. If these are not accessible, the product should be mixed with an undesirable substance, such as dirt or cat litter, sealed in a container, and placed in the household trash. The medicine should not be disposed of by flushing down the toilet or pouring into a drain.

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

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