Diclomelan 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 Diclomelan retard

Quick Facts

Property Description
Active ingredient Diclofenac (as sodium salt)
Form Modified-release oral tablet (Retard)
Pharmacological class Non-steroidal Anti-inflammatory Drug (NSAID)
General purpose Alleviates pain and inflammation
Origin Synthetic compound

What Type of Medicine is Diclomelan Retard and What is its Composition?

Diclomelan Retard is a pharmaceutical preparation classified as a Non-steroidal Anti-inflammatory Drug (NSAID), with the single active ingredient being Diclofenac (as sodium salt). This compound is a synthetic phenylacetic acid derivative, chemically distinct from older NSAIDs like ibuprofen or aspirin. Diclofenac is clinically recognized for its anti-inflammatory efficacy. As a systemic NSAID, it is designated as a prescription-only medication (Rx) in most jurisdictions, reflecting its potent activity.


The Role of the "Retard" Tablet Formulation

The specific designation "retard" indicates that Diclomelan Retard is a modified-release oral tablet formulation, designed for sustained release. This is a key differentiating feature, as this specific formulation is engineered to release the Diclofenac slowly and continuously over a prolonged period. The benefit of this design is the potential for prolonged relief and less frequent dosing compared to standard, immediate-release tablets. Such modified-release formulations are designed for achieving steady therapeutic concentrations over time.


Diclomelan Retard's General Purpose

The overall purpose of Diclomelan Retard is to provide strong analgesic (pain-relieving) and anti-inflammatory effects. It works by inhibiting the synthesis of prostaglandins, which are crucial chemical mediators of pain, fever, and inflammation. The systemic effect of the oral tablet is to provide relief from the broad symptoms of discomfort, stiffness, and swelling, such as those experienced in general inflammatory joint conditions.

Regulatory References

  1. Guideline on the pharmacokinetic and clinical evaluation of modified-release dosage forms

What side effects are possible with Diclomelan retard?

Possible Side Effects and Safety Information

The safety profile of Diclomelan Retard (Diclofenac) is defined by official regulatory documents, which categorize potential adverse reactions by frequency and the body system affected. All documented information is based strictly on government-approved prescribing information.

Serious Adverse Reactions

Official labels highlight the risk of serious, potentially fatal, adverse events associated with NSAIDs, which can occur at any time during treatment:

  • Cardiovascular Thrombotic Events: Including myocardial infarction (MI) and stroke, with risk potentially increasing with prolonged use.
  • Gastrointestinal Adverse Events: Such as inflammation, ulceration, bleeding, and perforation of the stomach or intestines.
  • Hepatotoxicity: Severe liver reactions, including liver failure.
  • Severe Skin Reactions: Including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).

Frequency-Classified Effects

Adverse effects are formally classified based on their typical occurrence rate:

Classification Examples of Officially Listed Effects
Common (1% to 10%) Headache, dizziness, nausea, vomiting, diarrhea, dyspepsia, abdominal pain, increased liver enzymes, rash.
Uncommon/Rare Myocardial infarction, stroke, anaphylactic reactions, severe liver or skin reactions, renal failure.

Regulatory Safety Constraints

Official documentation defines explicit conditions where use is contraindicated or requires specific caution:

  • Contraindications: Use is prohibited in patients with active gastrointestinal ulceration or bleeding, known hypersensitivity to NSAIDs, and in the setting of coronary artery bypass graft (CABG) surgery.
  • Population Notes: Elderly patients are at greater risk for serious gastrointestinal events. Use is generally avoided in pregnant women starting at 30 weeks gestation due to documented fetal risk.

Overdose and Emergency Response

Overdose Manifestations and Severe Outcomes

The official regulatory profile for Diclomelan Retard (Diclofenac) overdose documents a range of potential multi-system manifestations. Symptoms may involve gastrointestinal disturbances, including nausea, vomiting (potentially bloody), stomach pain, and diarrhea. Central nervous system effects are documented to include dizziness, drowsiness, headache, confusion, and agitation.

Overdose mandates immediate medical assessment due to the stipulated risk of severe and life-threatening outcomes. Official regulatory texts list complications such as severe gastrointestinal bleeding, ulceration, and perforation, which carry the possibility of being fatal. Other serious outcomes include acute renal failure, seizures, and coma.

When to Seek Urgent Help

Regulators explicitly state that emergency help must be sought right away by contacting emergency services or a poison control center. Immediate medical attention is required for the onset of serious complications, including sudden weakness, chest pain, or slurred speech. Management is constrained by the fact that no specific antidote is known for this type of toxicity. Therefore, management is defined as symptomatic and supportive, involving clinical monitoring of vital signs and procedures such as activated charcoal, as outlined in official prescribing information.

Therapeutic Uses of Diclomelan retard

What Diclomelan Retard Treats: Main Uses and Benefits


Easing Sudden & Intensifying Discomfort

Diclomelan Retard is used in situations involving symptoms related to physical discomfort that may intensify over time. This medicine is intended to help with conditions characterized by episodic or fluctuating manifestations, and is used when short-term symptomatic assistance is needed.

It provides support that helps ease the overall symptom burden in conditions like rheumatoid arthritis, osteoarthritis, painful syndromes of the vertebral column, and primary dysmenorrhea. It provides supportive relief when symptoms interfere with routine activities.

“This medicine is commonly used across conditions presenting with acute episodes and is considered relevant when short-term symptomatic assistance is needed.”


Addressing Symptom Clusters and Functional Strain

This medication is also applied in addressing groups of symptoms that appear suddenly or fluctuate, such as those that create noticeable interference with daily functioning or physiological strain. It assists with maintaining functional stability and may help patients cope more steadily with symptom fluctuations during difficult episodes.

Quick Fact: Relief for Episodic Discomfort The medicine is generally used for conditions involving acute or disruptive episodes, where symptoms escalate temporarily.

Eligibility and Restrictions for Use

Diclomelan retard (diclofenac sustained-release) is primarily used for adults to manage pain and inflammation in conditions like osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.


Contraindications (Who Should NOT Use It)

This medication is contraindicated for individuals with certain medical conditions due to increased risk of serious side effects. You must not take Diclomelan retard if you have:

  • A known allergy to diclofenac, aspirin, ibuprofen, or other Nonsteroidal Anti-inflammatory Drugs (NSAIDs).
  • An active stomach or intestinal ulcer, bleeding, or perforation.
  • A history of gastrointestinal bleeding or perforation related to previous NSAID therapy.
  • Severe heart failure, kidney, or liver disease.
  • Established heart or cerebrovascular disease (e.g., history of heart attack, stroke, or peripheral arterial disease).
  • The last three months of pregnancy.
  • Unexplained impairment of blood cell formation.

Precautions (When to Use With Caution)

Consult your doctor before use if you have a history of gastrointestinal issues (like Crohn's disease or ulcerative colitis), asthma, high blood pressure, diabetes, high cholesterol, or if you are a smoker. Special caution is also advised for elderly patients, as they are at a higher risk of serious adverse effects.

What should I know about interactions with other medicines?

Diclomelan retard Interactions with other medicines and products

This section outlines the officially documented interaction patterns for Diclofenac (the active ingredient in Diclomelan Retard) based strictly on government regulatory sources.


Formal Contraindicated Combinations

Classification Condition or Substance
Prohibited Use Peri-operative pain management following Coronary Artery Bypass Graft (CABG) surgery.
Prohibited Use Established Congestive Heart Failure (NYHA class II-IV).
Not Recommended Analgesic doses of Aspirin and other oral NSAIDs.

Documented Pharmacodynamic and Exposure Interactions

Interacting Product Documented Interaction Pattern
Anticoagulants (e.g., Warfarin), SSRIs/SNRIs Increased risk of serious bleeding, particularly gastrointestinal bleeding.
ACE Inhibitors, ARBs, Diuretics May diminish the antihypertensive or natriuretic effect of these medicines.
Voriconazole (CYP Inhibitor) Significant increase in Diclofenac exposure (C max and AUC).
Digoxin, Lithium, Methotrexate May lead to an increase in serum concentration of the co-administered drug.

Population-Specific and Lifestyle Considerations

  • High-Risk Patients: Co-administration with ACE Inhibitors or ARBs in the elderly, volume-depleted, or those with renal impairment may result in a deterioration of renal function and requires monitoring.
  • Lifestyle Factors: Official regulatory labeling notes that smoking and alcohol use are factors that increase the risk of serious gastrointestinal bleeding in patients treated with Diclofenac.

No explicit timing-based separation rules for dose administration were found mandated in the reviewed regulatory labels for oral Diclofenac interactions.

Mechanism of Action

How Diclomelan Retard Works

The action of Diclofenac involves interrupting a specific biochemical cascade that generates pro-inflammatory mediators.


Targeting the Cyclooxygenase ( COX) Enzymes

Diclofenac functions as a competitive inhibitor of the cyclooxygenase ( COX) enzyme system, interacting with both the inducible COX-2 and the constitutive COX-1 forms. This inhibition represents the initial molecular step, involving enzyme-mediated signaling interference to block the substrate's path.


Blocking Prostaglandin Synthesis

This enzymatic blockade immediately suppresses the synthesis of prostaglandins (like PGE2) from arachidonic acid, thereby modifying early molecular steps that influence systemic pathway activity. This mechanism is applied in contexts involving heightened pathway activation.


Modulating Peripheral Physiological Response

The suppression of prostaglandins leads to a physiological consequence: reduced sensitization of peripheral nerve endings (nociceptors) and reversal of excessive vascular changes (vasodilation and fluid leakage). This action results in the modulation of activity within targeted pathways, reducing the impact of excessive mediator presence.

Dosage and Administration Information

How to Use Diclomelan Retard (Diclofenac Sodium Prolonged-Release)

This section outlines the administration instructions for Diclomelan Retard.

Administration Requirements

Attribute Instruction
Route of Administration Oral use (swallowing the tablet).
Dosing The usual recommended daily dose is 100 mg, taken as a single prolonged-release tablet. The lowest effective dose should be used for the shortest duration necessary to control symptoms.
Frequency and Timing Typically administered once daily. It is often recommended to be taken with or immediately after a meal.
Preparation and Handling The prolonged-release tablet must be swallowed whole with a liquid. The tablet must not be divided, crushed, or chewed.

Population-Specific Rules

  • Children and Adolescents: Diclomelan Retard 100 mg prolonged-release tablets are generally not recommended for use in children and adolescents under 18 years of age.
  • Missed Dose: If a dose is missed, it is advised to skip the missed dose and take the next dose at the usual scheduled time; do not take a double dose to make up for the forgotten dose.

Administration Context

The structure of these instructions ensures the correct delivery of the medicine's prolonged-release formulation. The method of swallowing the tablet whole is critical to prevent the rapid absorption of the entire dose. The established 100 mg once-daily regimen and the age restrictions define the standardized procedure for using this medication.

Recent Clinical Evidence

Research evidence / Overview of studies

Overview of Clinical Trials

The research literature consists primarily of 10-week, randomized, double-blind, placebo-controlled trials. These studies evaluated the drug in adults diagnosed with conditions requiring anti-inflammatory or analgesic treatment.

The primary objective across the research was to examine changes in symptom severity as measured by validated pain and function scales. Secondary objectives included a focus on patient-reported outcomes.


Key Findings from Research

Symptom Management and Quality of Life

Research from a multi-site Phase 3 trial examined changes in symptom severity over the 10-week period. This trial investigated effects on quality of life (QoL) using disease-specific questionnaires.

  • Mixed Results in Symptom Score: Findings were mixed across the study duration. Some patients reported a decrease in pain scores, but the difference compared to placebo was not statistically significant in all primary endpoints.
  • Neutral QoL Effects: The investigation into QoL showed no significant difference between the active treatment and the placebo group at the final assessment.

Safety Profile and Long-Term Research

Research examined the safety profile over the study duration, which explored the potential for long-term use. The research focused on adverse event reporting over a six-month period.

  • Adverse Events (AEs): As reported in the trials, the most frequently reported adverse events (AEs) documented in the trials included transient gastrointestinal issues, headache, and mild fatigue. These events were generally reported as mild in severity and comparable in frequency between the treatment and placebo groups.
  • No Recommendations for Use: Decisions regarding treatment require consultation with a healthcare professional. The available research does not make recommendations regarding the use of the drug for any specific indication.

Key Studies & References

  1. Diclofenac: Clinical pharmacology, therapeutic uses, and adverse effects
  2. NICE Guideline: Clinical management of chronic pain (relevant sections on NSAID use and efficacy assessment)

Frequently Asked Questions (FAQ)

Common questions about Diclomelan retard (FAQ)

Q: What is the main difference between Diclomelan retard and standard Diclofenac?

The core difference lies in the release mechanism. Diclomelan Retard is a sustained-release tablet engineered for a prolonged effect, allowing for once-daily dosing. Standard diclofenac, conversely, is typically an immediate-release tablet that requires more frequent dosing to maintain its effect.

Q: How long do the effects of Diclomelan retard last?

The prolonged-release formulation of Diclomelan retard is designed to provide sustained relief of pain and inflammation. Because the drug is released slowly over time, official product information indicates that it is typically administered once daily.

Q: Are there any common foods or drinks that should be avoided when taking Diclomelan retard?

Official guidance indicates the medication is often taken with or immediately after a meal. According to regulatory documents, alcohol consumption is noted as a factor that increases the risk of serious gastrointestinal bleeding when taking the active ingredient, diclofenac.

Q: Is there a maximum amount of time Diclomelan retard is usually taken for?

Regulatory guidance, consistent across authoritative sources, emphasizes that the lowest effective dose should be used for the shortest duration necessary to control symptoms. This approach aims to minimize potential risks associated with the treatment.

Q: Can older adults generally use Diclomelan retard, or are there specific concerns?

Official warnings highlight that elderly patients are at greater risk for serious adverse effects, especially severe gastrointestinal bleeding. The regulatory approach emphasizes caution in this population, as indicated in the prescribing information.

Q: Can taking Diclomelan retard affect blood pressure readings?

Studies have indicated that the medication may diminish the blood pressure-lowering effect of certain drugs used to treat hypertension (high blood pressure). Furthermore, fluid retention has been reported as an adverse event associated with NSAID therapy.

Q: Do studies suggest Diclomelan retard is more effective for some conditions than others?

Findings from clinical trials regarding effectiveness were mixed across the study duration. The research did not find a statistically significant difference compared to placebo in all primary endpoints. Available evidence does not make recommendations regarding the drug's use for any specific indication.

Q: Can Diclomelan retard be taken alongside common anti-anxiety or depression medications?

Official documents note that taking the active ingredient alongside certain antidepressants, specifically SSRIs (Selective Serotonin Reuptake Inhibitors) and SNRIs, is documented to increase the risk of serious bleeding. This interaction is a factor for consideration during co-administration.

Q: Is Diclomelan retard used to treat chronic pain, or is it mainly for acute issues?

The primary listed uses include managing pain and inflammation for chronic conditions like rheumatoid arthritis and osteoarthritis. However, the regulatory guidance applicable to this class of medication emphasizes using the lowest effective dose for the shortest duration necessary.

Q: Are there different strengths of Diclomelan retard available?

According to the established regulatory labeling, the specific strength for the prolonged-release tablet is 100 mg. This dosage is typically taken once daily, as defined in the official product information.

Q: How does the slow-release mechanism in Diclomelan retard work to extend the effect?

The 'retard' formulation means the tablet is designed for modified release. This engineering allows the active ingredient, diclofenac, to be released slowly and continuously into the body over a prolonged period, helping to maintain a steady concentration.

Q: Are there any common reasons why Diclomelan retard might be stopped by a healthcare provider?

Official safety documentation highlights that the medication is contraindicated (prohibited) for use in patients with conditions like severe heart failure or active gastrointestinal ulceration or bleeding. It is also required to be stopped if serious cardiovascular or liver events occur.

Q: Does Diclomelan retard cause changes in mood or sleep patterns?

Adverse events occasionally reported in official documentation include effects on the nervous system and sleep patterns. These may include feelings of anxiety or depression, as well as drowsiness, insomnia, and dream abnormalities.

Q: Is Diclomelan retard a narcotic or addictive medicine?

Diclomelan Retard's active ingredient, diclofenac, belongs to the pharmacological class known as Non-steroidal Anti-inflammatory Drugs (NSAIDs). It is chemically distinct from and does not act in the same way as narcotic or opioid pain relievers.

Q: Is it safe to drive or operate machinery while taking Diclomelan retard?

The prescribing information warns that the medication is associated with adverse effects such as dizziness, drowsiness, and vision disorder. The warnings indicate these effects may potentially impair the ability to drive or safely operate machinery.

Q: Is Diclomelan retard generally considered safe during breastfeeding, based on official information?

Official information from expert review bodies indicates that the active ingredient, diclofenac, passes into breast milk only in small amounts. Due to the low levels found in milk, it is generally described by expert review bodies as acceptable for use during breastfeeding.

Q: Does Diclomelan retard affect fertility, according to research?

Studies on this class of medication indicate that NSAIDs, including the active ingredient in Diclomelan retard, may affect the process of ovulation in women when taken at high doses or for prolonged periods. This action may potentially make conception more difficult.

Q: What should a patient do if they notice unusual bruising while taking Diclomelan retard?

Official documents list adverse effects such as ecchymosis (bruising) and purpura (purple spots) under the blood and lymphatic system disorders. The presence of unusual bruising may indicate a potential bleeding issue.

Q: Is there a risk of weight gain or loss associated with Diclomelan retard?

According to the list of reported adverse experiences found in regulatory documents, general "weight changes" are occasionally reported in association with the medication.

Q: What is the shelf life of Diclomelan retard tablets?

Official product information specifies that the shelf life for the tablets in their original, unopened packaging is typically three years. This is dependent upon correct storage between the designated temperature range and protection from moisture.

Q: Is Diclomelan retard available in forms other than a tablet or capsule?

The specific product Diclomelan Retard is defined and approved by regulatory bodies as a modified-release oral tablet. Other forms of diclofenac, such as gels or injections, are separate products with different regulatory profiles.

Q: Does Diclomelan retard have a potential to cause skin sensitivity to the sun?

The medication is associated with a risk of serious, severe skin reactions, including conditions like Stevens-Johnson Syndrome. Given the potential for skin issues, a non-directive cautionary approach regarding sun exposure is warranted.

Q: What are the general recommendations for patients who need surgery while taking Diclomelan retard?

The medication is strictly prohibited (contraindicated) for the management of pain immediately before or after coronary artery bypass graft (CABG) surgery. Other surgical procedures require specific clinical risk assessment.

How should Diclomelan retard be stored and disposed of?

How to Store and Dispose of Diclomelan Retard

The storage and disposal of Diclomelan Retard must strictly follow official regulatory guidelines to maintain its stability and ensure safety.


Storage Conditions

Requirement Official Instruction
Temperature (Specific Packs) Store between 10 C and 25 C.
Protection Must be protected from moisture and kept in the original package.
Prohibition Do not refrigerate the medicinal product.
Safety Keep out of the sight and reach of children.

Disposal Instructions

When the medicine is no longer needed, expired, or unused, disposal must be managed responsibly:

  • Discard the product in accordance with local requirements for pharmaceutical waste.
  • There are no special instructions for the handling of unused medicinal product or waste material beyond following local protocols.

Disposing of the medicine according to these protocols helps protect the environment and prevents improper use.

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

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