Dicloflex Retard

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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 Dicloflex Retard

Property Description
Active ingredient Diclofenac (Sodium/Potassium)
Form Prolonged-release tablet, Sustained-release capsule
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General purpose Symptomatic relief of pain, inflammation, and fever
Origin Synthetic, Phenylacetic acid derivative

Dicloflex Retard is a pharmaceutical preparation belonging to the Non-Steroidal Anti-Inflammatory Drug (NSAID) class. Its core identity is the single active ingredient, Diclofenac, which is a powerful synthetic compound derived from the phenylacetic acid family. This medicine is intended exclusively for oral use and functions by modulating the body’s systemic inflammatory responses.


What Type of Medicine is Dicloflex Retard?

Dicloflex Retard is an NSAID containing Diclofenac, an agent clinically recognized for its established anti-inflammatory, analgesic, and anti-pyretic properties. As a representative of the acetic acid derivatives, its mechanism involves the systemic inhibition of prostaglandin synthesis, the chemical mediators responsible for generating pain and inflammation. This classification distinguishes it from non-NSAID analgesics and supports its capability to address both the symptom of pain and the underlying inflammation.

The Prolonged-Release (Retard) Formulation Explained

The term “Retard” indicates that the medicine is a sustained-release preparation, typically provided as a prolonged-release tablet or modified-release capsule. This specialized oral use formulation is engineered with an internal solid matrix designed to release the contained Diclofenac slowly and consistently over an extended period following ingestion. Such sustained-release forms are specifically utilized to maintain effective plasma levels and reduce the frequency of dosing. This design provides the practical benefit of a relatively constant concentration of the active substance in the body, providing reliable, long-lasting relief from discomfort, such as during the nighttime hours.

General Purpose and Symptomatic Benefit

The general purpose of Dicloflex Retard is to provide comprehensive symptomatic treatment by reducing the key physical manifestations of inflammation. Its triple action—reducing pain, decreasing associated swelling, and lowering fever—allows it to address multiple types of physical discomfort simultaneously. The benefit lies in its ability to effectively alleviate the symptoms that arise from various inflammatory conditions, ensuring continuous relief due to its prolonged action design.

Regulatory References

  1. Diclofenac: MedlinePlus Drug Information

What side effects are possible with Dicloflex Retard?

Dicloflex Retard: Possible Side Effects and Safety Information

Dicloflex Retard (diclofenac) is a Non-Steroidal Anti-Inflammatory Drug (NSAID) used to relieve pain and inflammation. As with all medications, it can cause side effects, though not everyone experiences them. You should always use the lowest effective dose for the shortest possible duration.

Serious Warnings and Contraindications

Do not take Dicloflex Retard if you have or have had a stomach or intestinal ulcer, bleeding, or perforation. Diclofenac, like other NSAIDs, may increase the risk of serious, potentially fatal, cardiovascular thrombotic events (heart attack or stroke), especially with high doses or prolonged use. It should not be used immediately before or after coronary artery bypass graft (CABG) surgery.

Immediate medical attention is required if you experience:

  • Gastrointestinal Bleeding: Black, tarry stools, bloody vomit, or severe stomach pain.
  • Allergic Reactions: Swelling of the face, lips, throat (angioedema), difficulty breathing, severe blistering, or skin rash.
  • Cardiovascular Symptoms: Chest pain, sudden weakness, or shortness of breath.

Common Side Effects

The following are among the more frequently reported side effects:

System Common Side Effects (Affecting up to 1 in 10 people)
Gastrointestinal Nausea, vomiting, diarrhea, indigestion, abdominal pain, flatulence, loss of appetite.
Nervous System Headache, dizziness.
Other Rash, raised liver enzyme levels (seen in blood tests).

Other Safety Information

Diclofenac is generally not recommended during pregnancy, particularly after 20 weeks, as it may cause harm to the fetus (e.g., kidney or heart issues) or complications during delivery. It is advised to avoid use while breastfeeding. If you experience dizziness, drowsiness, or visual disturbances, you should not drive or operate machinery.

Talk to your doctor before taking this medicine if you have heart problems, high blood pressure, high cholesterol, diabetes, a history of asthma, kidney or liver problems, or if you smoke.

Overdose and Emergency Response

Overdose and when to seek help

The regulatory information for Dicloflex Retard overdose focuses strictly on documented manifestations and mandated emergency actions.

Immediate Emergency Actions Required

Immediate emergency assistance is required if an overdose is suspected or if specific life-threatening symptoms occur. These mandated triggers include chest pain, shortness of breath, slurred speech, weakness in one part or side of the body, or swelling of the face or throat. Immediate medical therapy must also be sought upon developing signs of severe hepatotoxicity (e.g., jaundice, right upper quadrant tenderness) or a serious skin reaction.

Documented Overdose Presentations

Overdosage may present with gastrointestinal symptoms such as nausea, vomiting, epigastric pain, and evidence of bleeding. Central Nervous System (CNS) effects are also documented, including drowsiness, lethargy, headache, tinnitus, confusion, and, in very severe cases, seizures and coma. The most serious outcomes listed are potentially fatal cardiovascular thrombotic events (MI, stroke), GI perforation, and acute organ failure.

Supportive Care and Risk Notes

Management is strictly symptomatic and supportive care, as regulatory documents state that no specific antidote is known for Diclofenac overdosage. Monitoring of renal function, blood pressure, and close observation for signs of bleeding are advised. Elderly patients and those with pre-existing impaired renal, hepatic, or cardiac function are noted as being at greater risk for developing serious adverse events during a period of overdosage.

Therapeutic Uses of Dicloflex Retard

What Dicloflex Retard treats: main uses and benefits

Dicloflex Retard is a prolonged-release formulation of diclofenac sodium, a non-steroidal anti-inflammatory drug (NSAID). It is primarily used to manage chronic pain and reduce inflammation in various musculoskeletal and joint conditions. Because it is a "retard" or prolonged-release tablet, the active ingredient is released slowly into the body over an extended period, making it suitable for long-term symptom management rather than immediate acute pain relief.

Main Uses

This medication is typically prescribed for the following conditions:

  • Rheumatoid Arthritis: An autoimmune condition where the immune system attacks the joints, causing pain, swelling, and stiffness.
  • Osteoarthritis: A degenerative joint disease involving the breakdown of cartilage, commonly affecting the knees, hips, and hands.
  • Ankylosing Spondylitis: A chronic type of arthritis that primarily affects the spine and the sacroiliac joints.
  • Chronic Back Pain: Long-term discomfort in the spinal region resulting from inflammatory or degenerative changes.
  • Soft Tissue Disorders: Management of inflammation in conditions such as frozen shoulder, tendonitis, and tenosynovitis.

Benefits

The primary benefit of Dicloflex Retard is its ability to provide sustained relief from symptoms associated with chronic inflammatory diseases.

  • Reduction of Inflammation: By inhibiting the production of prostaglandins—chemicals in the body that signal pain and inflammation—the medication helps reduce swelling and redness in affected tissues.
  • Pain Management: It effectively decreases the persistent pain associated with joint and bone disorders, helping to improve daily comfort.
  • Improved Mobility: By reducing joint stiffness and swelling, the medication can help individuals maintain a better range of motion and functional independence.
  • Sustained Release: The formulation allows for a more stable concentration of the medication in the bloodstream, which often reduces the frequency of doses required compared to immediate-release versions.

Regulatory References

  1. NIH MedlinePlus overview of Diclofenac

Eligibility and Restrictions for Use

Who Can and Cannot Use Dicloflex Retard?

This section summarizes the official population eligibility and non-eligibility for Dicloflex Retard, based on governmental regulatory documents.


Populations Who Must Not Use (Contraindicated)

Use of Dicloflex Retard is strictly prohibited for individuals with the following conditions:

  • Gastrointestinal Pathology: Active or recurrent gastric or intestinal ulceration, bleeding, or perforation, or a history of related bleeding/perforation due to prior NSAID use.
  • Cardiovascular Disease: Established ischemic heart disease, peripheral arterial disease, cerebrovascular disease, or severe/uncontrolled congestive heart failure (NYHA Class II–IV).
  • Severe Organ Impairment: Severe liver or kidney failure.
  • Allergy: Known hypersensitivity to diclofenac, aspirin, or any other Non-Steroidal Anti-Inflammatory Drug (NSAID) where this has previously caused asthma, urticaria, or acute rhinitis.
  • Pregnancy: Use is contraindicated during the last three months (third trimester) of pregnancy.

Restricted or Cautioned Use

Age: The prolonged-release formulation is not suitable for children and adolescents and is used with caution in the elderly, who require the lowest effective dose for the shortest duration.

Conditions: Patients with a history of heart problems, risk factors for cardiovascular events (e.g., hypertension), or existing mild to moderate liver or kidney impairment should only be treated after careful medical assessment and under close supervision.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Diclofenac outlines several required constraints and clinically significant interaction patterns. The medicine is contraindicated for the treatment of perioperative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery. Co-administration with other systemic NSAIDs or COX-2 inhibitors is prohibited due to the risk of additive adverse effects. Furthermore, the use of alcohol is documented to increase the risk of serious gastrointestinal (GI) problems, including bleeding and ulcers.

The interaction structure is defined by both pharmacodynamic and pharmacokinetic effects. A key pharmacodynamic risk is the reinforcement of bleeding, necessitating regulatory warnings for co-administration with Anticoagulants (e.g., Warfarin), Antiplatelet Agents, and SSRIs/SNRIs. Diclofenac may also reduce the antihypertensive efficacy of ACE-Inhibitors, ARBs, and Diuretics; this is linked to the inhibition of renal prostaglandin synthesis.

Pharmacokinetically, co-administration with CYP2C9 inhibitors (such as Voriconazole) is documented to increase the plasma exposure of Diclofenac. Diclofenac is also known to elevate plasma levels of Lithium and Methotrexate by reducing their renal clearance. A mandatory time separation of 8 to 12 days following administration of Mifepristone is required by the regulatory label. Interaction consequences, particularly GI events and the risk of renal deterioration, are noted to be generally more serious in elderly patients and those who are volume-depleted.

Mechanism of Action

How Dicloflex Retard Works: Mechanism of Action

The mechanism of Dicloflex Retard is defined by its action on molecular pathways that lead to prostaglandin synthesis. The core action involves the competitive inhibition of the Cyclooxygenase (COX) enzymes, specifically targeting both the COX-1 and COX-2 isoforms. This interaction blocks the enzyme's active site, suppressing its ability to convert arachidonic acid into prostaglandins and other prostanoids. This molecular interference modulates enzyme-mediated prostaglandin synthesis.

The resulting reduction in prostaglandin concentration leads to a modulation of specific physiological responses. In peripheral tissues, fewer prostaglandins are available to sensitize nociceptors, which modulates afferent nerve activity. Centrally, the reduced concentration of PGE2 in the hypothalamus supports the re-establishment of a thermal set point. The mechanism acts within systems characterized by heightened prostanoid activity.

The sustained-release (“Retard”) design influences the kinetic profile required for prolonged enzyme suppression. By releasing the active ingredient slowly and continuously, the formulation maintains a stable, continuous inhibitory concentration necessary for the extended suppression of prostaglandin synthesis, thereby sustaining the modulation of pathway activity over an extended duration.

Dosage and Administration Information

How to use Dicloflex Retard

The administration of Dicloflex Retard, a prolonged-release oral formulation of diclofenac, is governed by specific instructions. The medication is designated exclusively for oral use. Due to its extended-release design, the tablet must be swallowed whole with an adequate amount of liquid; it is a critical procedural requirement that the tablet not be crushed, cut, broken, or chewed. Altering the tablet structure compromises the controlled release of the active substance.


The standard labeled regimen for adults is 100 mg taken once daily. This once-daily frequency is supported by the prolonged-release characteristics, which aim to provide sustained systemic levels over 24 hours. The medication can be taken with or without food, and the schedule permits the dose to be taken in the evening if symptoms are more pronounced during the night or upon waking.


General guidance emphasizes that the medication must be used at the lowest effective dosage for the shortest duration necessary for symptomatic management. Specific instructions apply to certain populations: the 100 mg prolonged-release tablet is not suitable for children or adolescents, and the lowest effective dose should be used when administered to older adults. If a dose is missed, it should be skipped, and the next dose should be resumed at the regularly scheduled time; double dosing is not permitted.

Recent Clinical Evidence

Research evidence / Overview of Studies for Dicloflex Retard

This section provides an overview of the research and clinical studies that have been conducted for the prolonged-release formulation of diclofenac, focusing only on what was studied and what remains uncertain, based on authoritative scientific and regulatory sources.


Evidence for Use in Osteoarthritis (OA)

Research exploring how symptoms change over time in Osteoarthritis (OA) has primarily relied on short-term Randomized Controlled Trials (RCTs) and meta-analyses. These studies typically last between 2 and 12 weeks and were designed to explore patient-reported outcomes describing perceived discomfort and functional ability in adult and older adult populations. Findings describe patterns observed in the studies related to outcomes related to physical discomfort and functional measurements. Comparisons were sometimes made against an inactive substance or other established therapies. Studies explored the use of the prolonged-release formulation in trials assessing extended time intervals.

Evidence for Use in Rheumatoid Arthritis (RA)

Research explored the prolonged-release formulation in research scenarios related to Rheumatoid Arthritis (RA) through short-term RCTs, generally following patients for up to 12 weeks. These studies were applied in research contexts involving fluctuating or unstable symptoms, and research examined outcomes related to joint swelling, tenderness, and patient-reported measures of functional capacity in adult populations. Findings describe patterns observed in the studies regarding changes in joint counts and subjective assessments of pain.


What is Still Uncertain About the Research

This summary synthesizes the key areas where research is still developing or where certainty remains low. Follow-up durations were limited in many of the key trials relative to the chronic nature of the diseases the medicine is studied for. There is limited information for long-term outcomes, particularly regarding the maintenance of functional activity levels over many years. Furthermore, comparative evidence is lacking for certain subgroups, and specific findings were sometimes mixed across studies, indicating that evidence quality varies across the overall research landscape. Research provides context but not individual predictions, and findings describe group patterns, not personal outcomes.

Key Studies & References

  1. Safety review of diclofenac - Therapeutic Goods Administration (TGA)
  2. Bioequivalence Study of Diclofenac 150 mg XR: A Single-Dose, Randomized, Open Label, 2-Period Crossover Study in Healthy Adult Volunteers

Frequently Asked Questions (FAQ)

Common questions about Dicloflex Retard (FAQ)

Q: Does taking Dicloflex Retard require a prescription in most places?

A: In many major governmental jurisdictions, including the US and countries under the European Medicines Agency, oral diclofenac formulations are generally classified as Prescription Only Medicine (POM).

This classification is due to the potential risk of serious side effects, such as cardiovascular events, which often necessitates a medical assessment before the medicine can be dispensed.

Q: What are the regulatory approvals for Dicloflex Retard?

A: Diclofenac prolonged-release formulations undergo a rigorous regulatory process to ensure their safety and efficacy before market entry.

Official approval is granted by governmental bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), following a thorough review of the New Drug Application or Marketing Authorization Application.

Q: What should I do if I think I have accidentally taken too much Dicloflex Retard?

A: In the event of a suspected overdose, immediate emergency medical attention is required.

Official guidance for suspected overdose is to contact a national emergency number or a regional poison control center without delay, as symptoms can include severe stomach pain, vomiting, and possible cardiovascular effects.

Q: Do you need to stop taking Dicloflex Retard gradually?

A: According to regulatory documents, for oral diclofenac used for pain and inflammation, there is no official requirement mentioned for gradual discontinuation or tapering.

If discontinuing treatment, discussion with a healthcare professional regarding suitable alternative symptom relief is recommended.

Q: Is Dicloflex Retard known to interact with herbal remedies?

A: Official drug labels and guides contain limited specific information regarding the safety of combining diclofenac with many herbal remedies and supplements.

Because these substances are often not tested for specific drug-drug interactions, official sources note that discussion with a healthcare professional is important before simultaneous use.

Q: Does Dicloflex Retard affect the effectiveness of birth control pills?

A: According to official product information, diclofenac is not known to directly interfere with the mechanism or effectiveness of hormonal contraceptives, including birth control pills.

However, if the medication causes severe adverse effects like vomiting or diarrhea, this can potentially reduce the absorption of any oral contraceptive medicine.

Q: What are the official recommendations regarding sun exposure while taking this medicine?

A: Official warnings note that diclofenac can cause photosensitivity, which is an increased sensitivity to the sun's rays.

Official warnings state that avoiding excessive exposure and using protective measures are common considerations when using this medication due to the risk of severe rash or burn-like reaction upon sun exposure.

Q: Can Dicloflex Retard be used for common headaches or is it just for chronic pain?

A: While the primary indications for the prolonged-release formulation focus on chronic conditions like arthritis, Dicloflex Retard relieves general pain and inflammation.

Official guidance requires limiting its use to the lowest effective dose for the shortest duration necessary for symptom control.

Q: Is Dicloflex Retard only for people with long-term conditions?

A: Diclofenac is primarily indicated in official documents for the chronic treatment of long-term inflammatory conditions, such as certain forms of arthritis.

Regulatory guidance requires that the medication is used for the shortest duration necessary for managing symptoms, regardless of the condition it is addressing.

Q: What is the general maximum duration of time that people use Dicloflex Retard?

A: Official regulatory guidance consistently mandates using the lowest effective dose for the shortest duration possible, primarily due to the increased risks associated with prolonged use.

There is no single, fixed maximum duration of use stated in the regulatory documents; the length of treatment depends on the specific patient assessment.

Q: How quickly does Dicloflex Retard usually start to provide relief?

A: The sustained-release design of Dicloflex Retard means the active ingredient is released slowly and consistently over time, which affects the time it takes to reach peak concentration in the body.

While this formulation provides long-lasting effects, studies indicate that for chronic conditions, relief may typically begin within the first week of treatment.

Q: Is it possible to develop a dependency on Dicloflex Retard?

A: Dicloflex Retard belongs to the Non-Steroidal Anti-Inflammatory Drug (NSAID) class.

This type of medicine is generally not associated with the development of physical or psychological dependency, and it is not regulated as a controlled substance.

Q: Are there any documented effects of Dicloflex Retard on sleep?

A: Official adverse effects listed in regulatory documents include central nervous system effects such as dizziness and drowsiness (somnolence).

These effects may indirectly impact a patient's normal wake-sleep cycle or quality of rest.

Q: Can Dicloflex Retard cause fluid retention?

A: Official product information indicates that diclofenac has been associated with certain effects on the cardiovascular system.

These effects can include edema, which is the official term for swelling or fluid retention in the body or legs. Official information indicates that this is an adverse effect that may require medical monitoring.

Q: Can I use Dicloflex Retard alongside supplements like Glucosamine?

A: Official drug labels focus on interactions with prescription and non-prescription medicines but typically do not list specific dietary supplements.

Regulatory bodies caution that supplements are often not tested for their combined effects with medicines, and discussion with a healthcare professional is noted as an important step before co-administration.

How should Dicloflex Retard be stored and disposed of?

Official Storage and Disposal Requirements

Regulatory documentation specifies strict conditions for storing and disposing of Dicloflex Retard (Diclofenac Retard) to maintain its stability and ensure environmental safety.

Storage and Handling

The medicine must be stored below 25 C and kept in its original packaging to protect it from both moisture and direct light. It is explicitly stated that the product must not be refrigerated. Users must also ensure the medicine is stored out of the sight and reach of children.

Stability and Disposal

The medicine must not be used after the expiry date printed on the carton. For disposal, official guidance states that the medicine must not be thrown away via wastewater or household waste. Unused or expired medication should be returned to a pharmacist or a recognized collection point to follow local pharmaceutical waste protocols, thereby helping to protect the environment.

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

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