Dolflam-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 Dolflam-Retard

Quick Facts

Property Description
Active ingredient Diclofenac sodium
Form Oral prolonged-release tablet (Retard)
Pharmacological class Non-steroidal anti-inflammatory drug (NSAID)
Common use Systemic relief of pain, inflammation, and fever
Origin Synthetic (Phenylacetic acid derivative)

Dolflam-Retard is a prescription-only pharmaceutical whose identity is defined by its active component, its pharmacological category, and its unique drug delivery system. It is designed for systemic use to address pain, inflammation, and fever in adults.

Diclofenac: Composition and Pharmacological Classification of Dolflam-Retard

Dolflam-Retard is a synthetic single-ingredient pharmaceutical that contains Diclofenac sodium as its sole active ingredient. Diclofenac is structurally classified as a derivative of Phenylacetic acid and is globally recognized as belonging to the Non-steroidal anti-inflammatory drug (NSAID) class. This classification establishes the medicine as a potent systemic agent possessing three core properties: anti-inflammatory, analgesic (pain-relieving), and antipyretic (fever-reducing) actions.

Prolonged-Release Tablet: The Meaning of the 'Retard' Form

The medicine is supplied for oral administration as an oral film-coated tablet engineered with a modified-release, or prolonged-release ("Retard") formulation. This design strategy embeds the Diclofenac sodium within a solid matrix that regulates the dissolution rate of the drug. The core difference from standard immediate-release tablets is that the prolonged-release kinetics ensure a more consistent and sustained concentration of the active substance in the bloodstream over an extended duration, supporting persistent therapeutic action. This specific tablet form is clinically valued for therapeutic situations requiring relief over a full dosing interval.

General Purpose of this Systemic NSAID

The overall general purpose of Dolflam-Retard is to provide sustained systemic relief by mediating the body's inflammatory response. The underlying mechanism of action is the inhibition of the cyclooxygenase (COX) enzymes, which are responsible for the synthesis of prostaglandins. By suppressing the production of these key chemical mediators of inflammation and pain, this systemic NSAID effectively mitigates the symptomatic experience of pain, reduces associated inflammation, and helps control elevated fever. A typical use, broadly supported by pharmacological studies, involves the management of persistent musculoskeletal discomfort.

Regulatory References

  1. NIH StatPearls: NSAIDs

What side effects are possible with Dolflam-Retard?

Possible Side Effects and Safety Information

This section outlines the officially documented adverse reactions and safety restrictions for Dolflam-Retard, based strictly on authoritative government regulatory sources.

Critical Safety Warnings

Official regulatory documents include prominent warnings regarding two major, potentially fatal risks associated with this medicine:

  • Serious Gastrointestinal (GI) Events: The drug may cause serious GI inflammation, bleeding, ulceration, and perforation, which can occur without warning symptoms and may be fatal. This risk may increase with higher doses and longer use.
  • Serious Cardiovascular (CV) Thrombotic Events: The drug increases the risk of heart attack, stroke, and other serious CV events, which can be fatal. This risk may increase with duration of use and dose.

Adverse Reactions by Frequency and System

Adverse reactions are documented and classified by frequency and the body system affected (System-Organ Class or SOC):

Classification Examples of Affected Systems
Common Gastrointestinal (e.g., dyspepsia, abdominal pain), Nervous System (e.g., headache, dizziness)
Uncommon / Rare Liver (e.g., elevated liver enzymes), Skin (e.g., rash, pruritus), Renal (e.g., renal impairment)
Very Rare Serious skin reactions (e.g., Stevens-Johnson syndrome), severe allergic reactions (anaphylaxis), blood disorders

Safety Restrictions and Limitations

The medicine is subject to specific limitations and restrictions documented in official labeling:

  • Contraindications: The medicine must not be used by patients who have had allergic-type reactions (such as asthma, hives) to aspirin or other Non-Steroidal Anti-inflammatory Drugs (NSAIDs).
  • Surgical Restriction: It is restricted from use right before or after coronary artery bypass graft (CABG) surgery.
  • Dose Guidance: Regulatory documents emphasize using the lowest effective dose for the shortest duration necessary to minimize potential risks, particularly for cardiovascular events.

Overdose and Emergency Response

Overdose and When to Seek Help

Dolflam-Retard (diclofenac sodium, a non-steroidal anti-inflammatory drug or NSAID) overdose should be treated as a medical emergency. Immediately contact your local emergency services or a poison control center if you suspect an overdose, even if no symptoms are present. The extended-release nature of this medicine means symptoms may be delayed.

Potential Symptoms of Overdose

Symptoms of an acute diclofenac overdose are typically non-life-threatening but can progress to severe complications, including serious damage to the kidneys, liver, or central nervous system. Common initial symptoms include:

System Common Symptoms
Gastrointestinal Nausea, vomiting (sometimes with blood or coffee-ground material), stomach pain, diarrhea
Neurological Headache, drowsiness, ringing in the ears (tinnitus), dizziness

When to Seek Emergency Medical Attention

Seek immediate emergency care for any of the following severe signs, which indicate a serious or life-threatening reaction:

  • Breathing or Circulation Issues: Shortness of breath, chest pain, irregular or rapid heartbeat.
  • Severe Gastrointestinal Bleeding: Black, tarry stools or vomiting blood.
  • Severe Neurological Changes: Confusion, agitation, loss of consciousness, or seizures.
  • Kidney Damage Signs: Swelling of the face, hands, or feet, or little to no urine output.

Treatment is supportive and focuses on managing symptoms and stabilizing the patient. Providing information on the amount ingested and the time of ingestion is crucial for medical staff.

Therapeutic Uses of Dolflam-Retard

The therapeutic role of Dolflam-Retard is considered relevant for providing sustained systemic relief by addressing the core symptoms of pain, inflammation, and fever in adult patients. Its prolonged-release design may be part of symptomatic management in conditions where consistent symptom control over an extended duration is appropriate.


This medication is commonly applied in the context of conditions presenting with systemic or localized discomfort, including rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout flares, postoperative pain, and primary dysmenorrhea. It is applied in addressing symptoms related to inflammatory or irritative states in a wide range of musculoskeletal and joint disorders. It helps address symptom clusters that may become intense or disruptive, such as joint pain, swelling, and stiffness.

The use of the medication may assist with easing the overall symptom burden, supporting improved day-to-day comfort and mobility during symptomatic periods. It is relevant in clinical settings that involve acute or unstable symptom patterns, providing supportive relief when symptoms interfere with routine activities.

Quick Fact: Relief for Persistent Discomfort
Primary Target Sustained relief from inflammatory pain and stiffness.
Typical Use Context Chronic maintenance therapy (e.g., arthritis) and management of acute episodes (e.g., gout, sprains).
Patient Benefit Contributes to easing the overall symptom load and supports general well-being during symptomatic phases where sustained action is important.

Eligibility and Restrictions for Use

Dolflam-Retard, a sustained-release formulation of diclofenac (an NSAID), is generally indicated for adults requiring management of pain and inflammation, such as in conditions like osteoarthritis and rheumatoid arthritis. It is typically not recommended for individuals under the age of 18.


Contraindications (Who Should NOT Use Dolflam-Retard)

This medication is not suitable for individuals with certain medical histories or conditions, as the risks may outweigh the benefits. These include:

Condition Category Specific Examples
Allergy Known hypersensitivity to diclofenac, aspirin, or other NSAIDs (which may manifest as asthma, hives, or acute rhinitis).
Cardiovascular Risk Established ischemic heart disease, peripheral arterial disease, cerebrovascular disease, or moderate-to-severe congestive heart failure. It is also contraindicated immediately before or after coronary artery bypass graft (CABG) surgery.
Gastrointestinal Issues Active gastrointestinal bleeding, perforation, or history of recurrent peptic ulcers.
Other Conditions Severe kidney or liver impairment, and the last trimester of pregnancy.

Caution is required for patients with a history of hypertension, existing cardiovascular risk factors (e.g., smoking, high blood pressure, diabetes), or certain blood clotting disorders, who should only use the drug under strict medical supervision.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Dolflam-Retard, containing diclofenac sodium, is involved in documented interaction patterns based on official regulatory labeling. These interactions are classified by their pharmacokinetic and pharmacodynamic outcomes.

Contraindications and Restrictions

Use of this medicine is contraindicated for treating perioperative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery. The co-administration of Dolflam-Retard with other systemic NSAIDs or analgesic doses of Aspirin (Acetylsalicylic Acid) is not generally recommended or should be avoided due to the increased potential for adverse effects.

Pharmacodynamic and Adverse Risk

Co-administration with Anticoagulants, Anti-platelet agents, SSRIs, and Systemic Corticosteroids results in an additive pharmacodynamic increase in the risk of serious gastrointestinal bleeding or ulceration. Furthermore, diclofenac may diminish the antihypertensive effect of ACE Inhibitors, ARBs, or Diuretics.

Exposure Modification and Other Substances

Diclofenac can increase the plasma concentrations of certain drugs, including Digoxin, Methotrexate, and Lithium. Conversely, strong enzyme inhibitors like Voriconazole significantly increase the systemic exposure of diclofenac itself. Regarding non-medicinal substances, alcohol consumption increases the risk of gastrointestinal bleeding, and food reduces the peak plasma level (Cmax) by approximately 30%.

Mechanism of Action

The mechanism of action for Dolflam-Retard is defined by its ability to modulate the production of specific chemical signals involved in the body's physiological response pathways.

Key Mechanism: Inhibition of Prostaglandin Synthesis

The drug's primary action is the competitive inhibition of Cyclooxygenase (COX) enzymes, particularly the inducible form, COX-2. By blocking these key targets, the active ingredient halts the conversion of Arachidonic acid into prostaglandins, which are lipid mediators that drive pain sensitization and local vascular changes. This mechanism is central to the inhibition of signaling within the prostaglandin synthesis pathway.

Central Action and Thermal Regulation

Diclofenac's mechanism extends to the brain, specifically the hypothalamus, where inhibition of COX enzymes limits the synthesis of Prostaglandin E2 ( PGE2). The suppression of PGE2 results in the lowering of the central temperature set point, which constitutes the drug's effect on thermoregulation.

Mechanistic Constraints and Specificity

The drug exhibits a non-selective interaction, meaning it also inhibits the constitutive COX-1 enzyme. While primarily targeting COX-2 for its main effects, the unavoidable inhibition of COX-1 interferes with the homeostatic prostaglandins required for processes such as maintaining gastric mucosal integrity. This functional overlap dictates that modulating the COX-2 pathway necessitates the simultaneous modulation of the COX-1-dependent regulatory system.

Dosage and Administration Information

How to Use Dolflam-Retard

This section outlines the administration principles for Dolflam-Retard (diclofenac sodium prolonged-release tablet).


Administration Scope

Feature Instruction
Route of administration Oral administration only.
Dosing schedule The standard adult dose is 100 mg once daily. The maximum recommended dose for the extended-release formulation is 100 mg per day.
Timing in relation to meals The tablet may be taken with or after food or milk.
Age-group administration rules Older adults or frail patients are instructed to use the lowest effective dose.
Missed-dose rules If a dose is missed, individuals should take the next dose at the regular time; a double dose must not be taken to compensate.

Official Procedural Structure

Feature Classification/Constraint
Frequency pattern Once Daily (OD)
Use-context constraints The prolonged-release tablet must be swallowed whole with liquid and must not be crushed, cut, or chewed.
Course duration Treatment should be limited to the lowest effective dose for the shortest duration necessary.

Connection to the Overall Use Protocol

These instructions define the required procedural structure for administering the prolonged-release formulation, specifically mandating once-daily use at a strict dosage limit. The constraint against physical alteration (crushing or cutting) is critical as it preserves the integrity of the extended-release system, which is fundamental to the defined once-daily dosing schedule. The protocol prioritizes maintaining the lowest required daily exposure for the minimum duration necessary.

Recent Clinical Evidence

Dolflam-Retard is a prolonged-release formulation of diclofenac sodium, a nonsteroidal anti-inflammatory drug (NSAID). Research on diclofenac focuses primarily on its established role in addressing inflammation and pain across various conditions. Its mechanism of action involves the reversible inhibition of cyclooxygenase (COX) enzymes, which are necessary for the formation of prostaglandin precursors that contribute to pain and inflammation.

Evidence in Pain and Inflammation

Clinical trials support the use of diclofenac for managing mild to moderate pain, as well as symptoms associated with inflammatory conditions. The prolonged-release nature of the Dolflam-Retard formulation is designed to maintain consistent drug levels in the bloodstream over an extended period. This pharmaceutical characteristic aims to allow for less frequent dosing compared to immediate-release formulations, which can be relevant in the context of chronic conditions.

Studies in specific contexts, such as post-operative inflammation, have compared diclofenac to other anti-inflammatory agents like corticosteroids. In one review, low-certainty evidence was found suggesting a potentially lower risk of cystoid macular edema (CME) in participants receiving NSAIDs, either alone or in combination with corticosteroids, following uncomplicated cataract surgery, when compared to corticosteroids alone.

Rheumatic Conditions and Chronic Pain

The most extensive evidence base for diclofenac relates to its use in rheumatic conditions, including forms of arthritis. Clinical guidelines for conditions such as axial spondyloarthritis and psoriatic arthritis often include NSAIDs like diclofenac as a component of treatment protocols for their anti-inflammatory and analgesic effects. These applications are supported by multiple clinical studies that examine its effect on joint pain and stiffness.

It is important to note that the efficacy and safety profile of diclofenac, including the prolonged-release version, must be weighed against established risks, particularly concerning cardiovascular and gastrointestinal events, which are common to the NSAID class. Research continually seeks to understand and mitigate these associated risks.

Frequently Asked Questions (FAQ)

Common questions about Dolflam-Retard (FAQ)

Q: Is Dolflam-Retard used for both acute pain and chronic inflammation?

Official indications state that the medication is used for the relief of pain and inflammation across a wide range of conditions. This includes both acute issues, such as musculo-skeletal disorders, and chronic conditions like rheumatoid arthritis.

Q: Can this medication be used for pain from muscle strains or sprains?

Official product information describes the medicine as indicated for painful conditions that result from trauma. This includes common injuries such as sprains and strains, as well as other acute musculo-skeletal disorders.

Q: What types of pain are most commonly treated by this class of medication?

The medicine is indicated for a number of inflammatory and painful conditions, including rheumatoid arthritis, osteoarthritis, acute musculo-skeletal disorders, and trauma-related pain. Official documentation also lists its use for low back pain.

Q: Are there any specific lifestyle habits that can affect how the drug works?

Regulatory information indicates that consuming the tablets with food can affect the drug's absorption timing. Taking the medication with food may delay the onset of absorption by one to four and a half hours, although the total amount of drug absorbed is generally unaffected.

Q: Are there specific warnings about long-term use of this medicine?

Official warnings emphasize that the risk of serious cardiovascular and gastrointestinal events may increase with the duration of use. Regulatory documents recommend limiting use to the lowest effective dose for the shortest duration possible to mitigate this risk.

Q: Does Dolflam-Retard interact with common over-the-counter pain relievers?

Regulatory warnings advise against taking this medication with analgesic doses of aspirin or other Non-Steroidal Anti-inflammatory Drugs (NSAIDs). Co-administration is generally not recommended as it can increase the risk of serious gastrointestinal adverse events.

Q: What is the information available regarding the drug's use during pregnancy or breastfeeding?

Use of NSAIDs is limited or avoided in the second half of pregnancy due to potential risks to the fetus. Only tiny amounts of the active ingredient pass into breast milk. Some expert opinion indicates that the use may be considered acceptable, though alternatives may be described as preferred for newborns.

Q: Has research examined the effectiveness of Dolflam-Retard for managing back pain?

The medicine is specifically indicated in official documentation for the relief of pain and inflammation in a wide range of conditions, including low back pain.

Q: What is the overall safety profile of this drug compared to other NSAIDs, as noted in official summaries?

Regulatory warnings state that the risks of serious adverse events, specifically gastrointestinal bleeding and cardiovascular thrombotic events, are considered common to the entire NSAID class of drugs.

Q: How long does it typically take for a user to feel the initial effect after taking a tablet?

The onset of absorption, which is when the drug begins to enter the bloodstream, may be delayed by 1 to 4.5 hours, especially if the tablet is taken with food. The prolonged-release formulation is designed to provide a sustained effect over time.

Q: What is the maximum duration of time the effects are expected to last?

While the active ingredient has a short elimination half-life (about two hours), the prolonged-release design is intended to provide sustained therapeutic action across the full once-daily dosing interval.

Q: How do patients typically distinguish between a common side effect and a serious reaction?

Regulatory guidance notes that individuals should be alert for the signs and symptoms of serious events, such as gastrointestinal bleeding or cardiovascular issues. It is recommended that individuals promptly seek medical evaluation and discontinue the medicine if a serious adverse event is suspected.

Q: Are there large-scale clinical trials that have studied the use of Dolflam-Retard over many years?

Official information indicates that clinical trials for NSAIDs, including this drug, have been reported with durations of up to three years.

Q: Can Dolflam-Retard cause drowsiness or affect a person's ability to concentrate?

Adverse reaction reports include effects on the nervous system. Official product information notes effects like drowsiness, headache, and confusion as reported adverse reactions.

Q: Does regulatory information mention any potential impact on fertility?

Regulatory documents note that NSAID use may delay or prevent the rupture of ovarian follicles, which has been associated with reversible infertility in some women. Official information suggests that discontinuation of the medicine may be considered if a patient is having difficulty conceiving.

Q: Are there reports that suggest this drug might make a patient sensitive to sunlight?

Official adverse reaction lists indicate that a photosensitivity reaction is a possible, though typically rare, side effect.

Q: Is Dolflam-Retard available in other strengths or only the sustained-release version?

The prolonged-release (Retard) formulation of this medication is available in more than one strength. Regulatory documents mention both 75 mg and 100 mg prolonged-release tablets.

Q: What should a patient do if they believe they have taken too much of the medication?

In case of a suspected overdose, regulatory guidance advises seeking emergency medical help immediately and contacting a local poison control center. The treatment provided by professionals is generally supportive.

How should Dolflam-Retard be stored and disposed of?

Storage and Disposal Conditions for Dolflam-Retard

Official regulatory information dictates specific conditions for storing and discarding Dolflam-Retard (diclofenac sodium prolonged-release tablets) to maintain product stability and protect public safety.


Storage Requirements

This medicine must be stored at controlled room temperature, typically between 20 C and 25 C, and not above 30 C. The tablets must be kept in their original, well-closed packaging to protect them from light and moisture. It is required that the product not be frozen and must be kept out of the sight and reach of children.


Disposal Instructions

Unused or expired Dolflam-Retard must not be thrown away via wastewater or household waste to prevent environmental contamination. Regulatory guidelines advise discarding the medicine through a formal drug take-back program or by following specific instructions from a pharmacist for mixing the product with an undesirable substance and sealing it before placing it in the trash.

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

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