Diclomax SR

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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 Diclomax SR

Quick Facts

Property Description
Active Ingredient Diclofenac (as Diclofenac sodium)
Form Sustained-release tablet (SR)
Pharmacological Class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General Purpose Pain management, inflammation, fever reduction
Origin Synthetic (Phenylacetic acid derivative)

What Type of Medicine is Diclomax SR?

Diclomax SR is a specific prescription-only medicine containing the active ingredient Diclofenac, a synthetic compound classified as a phenylacetic acid derivative. This drug belongs to the high-level pharmacological class of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). This type of medicine helps manage discomfort by targeting both pain and inflammation at their source, which is clinically recognized for achieving significant symptomatic relief.

As a single-component preparation, the Diclofenac entity provides an anti-inflammatory effect, a potent analgesic action for pain management, and an antipyretic effect for mitigating fever. Its use is typically focused on adult patients requiring systemic treatment for conditions where inflammation and pain coexist.


What Does Sustained-Release (SR) Mean?

The "SR" in Diclomax SR stands for Sustained-release tablet, a specialized oral dosage form and a type of modified-release preparation. This means the drug is engineered for a controlled release of the Diclofenac active substance over an extended duration of action. This extended release mechanism allows for a more consistent therapeutic effect over time.

This sustained-release mechanism is a differentiating factor from standard, immediate-release forms by maintaining consistent, steady therapeutic levels of Diclofenac throughout the day. This provides prolonged coverage, which is particularly beneficial for continuous pain management.


What is the General Purpose of Diclomax SR?

The general purpose of Diclomax SR is to help relieve inflammation, reduce generalized pain, and lower fever. It achieves these effects by acting as a cyclooxygenase inhibitor, interrupting the body’s chemical pathways that produce pain and inflammatory signals. This action provides the necessary anti-inflammatory effect and robust analgesic action for adult patients seeking effective relief.

Regulatory References

  1. Summary of Product Characteristics for Diclomax SR
  2. Diclomax SR Summary of Product Characteristics

What side effects are possible with Diclomax SR?

Possible Side Effects and Safety Information

Diclomax SR (diclofenac) is a non-steroidal anti-inflammatory drug (NSAID) with an established safety profile based on regulatory documentation. The use of this medicine carries documented risks, particularly related to the cardiovascular and gastrointestinal systems. Patients should use the lowest effective dose for the shortest possible duration to minimize potential adverse effects.

Serious and Clinically Significant Risks

Regulatory documents emphasize two main systemic risks:

  • Cardiovascular Thrombotic Events: Diclomax SR may increase the risk of serious cardiovascular thrombotic events (e.g., myocardial infarction and stroke), which can be fatal. This risk may increase with the dose and duration of use. The drug is generally contraindicated in patients with established congestive heart failure (NYHA class II-IV), ischemic heart disease, peripheral arterial disease, or cerebrovascular disease.
  • Gastrointestinal (GI) Adverse Events: Serious GI events, including inflammation, bleeding, ulceration, and perforation of the stomach or intestines, can occur at any time, often without warning symptoms. These events can be fatal, and the risk is higher in older patients and those with a history of GI problems.

Common and Rare Adverse Reactions

Adverse reactions are classified by frequency based on regulatory frameworks (e.g., EMA/ICH):

Frequency Examples of Adverse Reactions (by System-Organ Class)
Common (1-10%) Headache, dizziness, nausea, vomiting, diarrhea, dyspepsia, abdominal pain, rash, increased transaminases.
Rare (0.01-0.1%) Hypersensitivity, anaphylactic/anaphylactoid reactions, somnolence, asthma, gastrointestinal hemorrhage/ulcer, hepatitis, urticaria, oedema.
Very Rare (<0.01%) Thrombocytopenia, leucopenia, agranulocytosis, angioneurotic oedema, psychiatric disorders, paresthesia, aseptic meningitis, vision disorders, myocardial infarction, heart failure, hypertension, severe skin reactions (e.g., SJS, TEN), acute renal failure.

Population and Context-Specific Safety

  • Elderly Patients: The risk of serious GI bleeding/perforation is significantly increased in older individuals.
  • Pregnancy: The drug is generally contraindicated during the last three months of pregnancy due to risks to the fetus (e.g., premature closure of the ductus arteriosus).
  • Safety Restriction: The drug is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Overdose and Emergency Response

Overdose and When to Seek Help

This section details the official overdose information for diclofenac, strictly based on authoritative government regulatory documents.


Overdose Scope

Element Official Regulatory Statement
Documented overdose presentations Symptoms primarily include GI distress (nausea, vomiting, stomach pain) and CNS effects (dizziness, drowsiness, confusion). Severe outcomes include GI bleeding/ulceration, acute renal failure, seizures, and coma.
Physiological systems affected Gastrointestinal, Central Nervous System, Renal, and Cardiovascular systems.
Population-specific overdose notes Increased risk of severe GI and renal outcomes in the elderly and in patients with impaired renal/hepatic function.
Emergency-response statements Seek medical help right away. Treatment is symptomatic and supportive.
When immediate medical help is required Get emergency medical help right away if severe signs occur, such as chest pain, signs of internal bleeding (e.g., black stools), or decreased level of consciousness.

Overdose Classifications (High-Level)

Element Official Regulatory Statement
Severity classification Ranges from minor GI symptoms to severe/life-threatening toxicity involving major organs.
Antidote status No specific antidote is known.
Overdose-context constraints Management requires hospital-based monitoring (e.g., ECG, blood tests) and supportive procedural measures (e.g., activated charcoal, IV fluids).

Connection to the Official Overdose Profile

Government regulatory documents define the overdose profile by listing both common clinical manifestations and severe, organ-threatening outcomes. This profile dictates the non-antidotal approach to treatment, which is strictly limited to symptomatic and supportive measures, and establishes the conditions under which urgent medical help must be sought (immediately upon suspicion of overdose or onset of severe signs), thereby fulfilling the mandatory help-seeking requirements of the labeling.

Therapeutic Uses of Diclomax SR

What Diclomax SR Treats: Main Uses and Benefits

The primary role of Diclomax SR is applied across domains where additional symptomatic support is needed to address discomfort and inflammation. Diclofenac is commonly used to help with symptoms related to inflammatory or irritative states in a wide range of conditions.

“The sustained-release profile supports the patient during difficult episodes by easing distress.”

Sustained Symptom Control for Chronic Joint Conditions

This formulation is relevant in contexts marked by increased discomfort or tension from long-term inflammatory joint diseases, such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It is used to help address symptom clusters that may become intense or disruptive, such as persistent pain, surrounding inflammation, and joint stiffness. The sustained-release profile provides support that helps ease the overall symptom burden and contributes to improved comfort during periods of heightened symptoms.

Relief for Acute Musculoskeletal and Post-Traumatic Pain

Diclomax SR is also applied in clinical settings that involve acute or unstable symptom patterns, such as pain and swelling following soft tissue injuries (sprains, strains, tendinitis) and acute flare-ups like gout. It is commonly used when short-term symptomatic assistance is needed to ease these challenging, episodic manifestations. This assistance is relevant for easing distress and supports the patient during episodes of heightened discomfort.


Quick Fact: Relief for Inflammation-Driven Pain The sustained-release formulation is commonly used to provide systemic and prolonged relief for symptoms related to inflammatory or irritative states in musculoskeletal disorders.

Eligibility and Restrictions for Use

Who Can and Cannot Use Diclomax SR? — Official Regulatory Information

The eligibility for Diclomax SR (diclofenac sustained-release) is strictly defined by regulatory bodies and is based on a patient's pre-existing health status, age, and reproductive status. Use is primarily licensed for adult patients who do not have any of the absolute contraindications listed below.


Absolute Contraindications

The medicine must not be used in patients with:

  • Known hypersensitivity to diclofenac, aspirin, or any other Non-Steroidal Anti-Inflammatory Drug (NSAID).
  • Severe organ failure, including severe hepatic (liver) or severe renal (kidney) impairment.
  • Established congestive heart failure (NYHA Class II-IV), ischaemic heart disease, peripheral arterial disease, or cerebrovascular disease.
  • Active, or a history of recurrent, peptic ulcer/haemorrhage or related gastrointestinal bleeding.
  • The third trimester of pregnancy.

Populations Requiring Restricted Use

Population Category Regulatory Status
Pediatric/Adolescent (Under 18) Generally not recommended; safety/efficacy not established.
Pregnancy (1st/2nd Trimester) Not recommended unless considered clearly necessary.
Breastfeeding Not recommended as the substance passes into milk.
Elderly (65+) Use with caution due to increased risk of adverse effects.
Mild/Moderate Organ Impairment Use with caution (hepatic or renal).

Eligibility is determined by official labeling; this information is not a substitute for clinical advice.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents define the interaction profile of Diclomax SR (Diclofenac) based on pharmacokinetic interference and additive pharmacodynamic risks.

Contraindicated and Restricted Combinations

Category Restriction Outcome
Other Systemic NSAIDs Co-administration is not generally recommended. Increased risk of serious gastrointestinal events.
Aspirin (Analgesic Doses) Co-administration is not generally recommended. Increased risk of serious gastrointestinal events.
CABG Surgery Explicitly contraindicated for perioperative pain. Prohibited use in this specific context.

Exposure-Modifying and Pharmacodynamic Interactions

Interactions are documented with substances that can significantly alter drug concentrations or compound existing risks.

Co-administration with potent CYP2C9 inhibitors, such as Voriconazole, is officially reported to increase Diclofenac exposure (Cmax and AUC). Conversely, Diclofenac can increase the plasma concentrations of co-medications, including Lithium, Digoxin, and Methotrexate, by reducing their clearance.

Pharmacodynamic interactions exist with medicines that affect the blood, notably Anticoagulants (e.g., Warfarin), Antiplatelet agents, and SSRIs/SNRIs. Combining these substances results in an additive risk of bleeding, particularly gastrointestinal bleeding. Furthermore, the antihypertensive effects of ACE Inhibitors, ARBs, and Diuretics can be diminished. A specific caution is noted for the co-use of Cyclosporine due to an increased risk of nephrotoxicity.

For administration, the sustained-release tablet with food may cause a delay in absorption and a reduction in peak plasma levels. Co-administration with Alcohol (Ethanol) is associated with an increased risk of serious gastrointestinal adverse events. Population-specific cautions are noted for co-administering with ACE Inhibitors/ARBs in the elderly or those with renal impairment, where the risk of renal function deterioration is increased.

Mechanism of Action

How Diclomax SR Works: Mechanism of Action

Core Action: Modulating Prostaglandin Production

Diclomax SR (diclofenac) exerts its primary action by targeting Cyclooxygenase (COX) enzymes, which are critical catalysts in the pathway that synthesizes prostaglandins from arachidonic acid. By inhibiting both COX-1 and COX-2 enzymes, the drug limits the synthesis of these lipid mediators, which act as local messengers within the inflammatory cascade and the hypothalamic thermoregulation center.


Influence on Inflammatory Signaling Dynamics

This molecular intervention effectively alters signaling dynamics within cellular inflammatory pathways. Prostaglandins typically act as local chemical messengers that amplify pain signals and promote the dilation of blood vessels. The mechanism of action thus acts to interrupt the signaling sequences associated with mediator activity and contributes to altered signaling dynamics within local cellular responses.


Resulting Effects on Peripheral Response

The drug's targeted effect on the eicosanoid pathway influences localized physiological responses. By reducing the overall pool of prostaglandins, the mechanism modulates prostaglandin-mediated signaling that influences hypothalamic thermoregulation and local vascular permeability. This interference shapes the drug's action on temperature control mechanisms and microcirculation dynamics.

Dosage and Administration Information

How to Use Diclomax SR: Official Administration Guidelines

This section outlines the official instructions for the use of Diclomax SR (Diclofenac sustained-release tablets).

Administration Scope

Entity Official Instruction
Route of administration Oral administration only.
Dosing schedule The standard maintenance dose is 100 mg once daily. The overall daily intake must not exceed a maximum of 150 mg total diclofenac sodium, including any supplementary conventional forms.
Timing in relation to meals The tablet should be taken with or after food or at mealtimes.
Age-group administration rules This sustained-release formulation is not recommended for children (paediatric population). For older adults, the lowest effective dose should be used.
Special procedural conditions The sustained-release tablet must be swallowed whole with liquid and must not be crushed, broken, or chewed.

Instruction Classifications (High-Level)

Entity Classification
Administration method type Oral
Frequency pattern Once daily (q.d.)
Use-context constraints Use the lowest effective dose for the shortest duration possible.

Resulting Procedural Structure

Official step sequence:

  • Take the tablet once daily according to the prescribing schedule.
  • Swallow the sustained-release tablet whole with liquid; altering the tablet (crushing or chewing) is prohibited.
  • Administer the dose with or after food.
  • If a scheduled dose is missed, do not take a double dose to compensate; resume the regular dosing schedule at the next scheduled time.

Connection to the overall use protocol: The official instructions establish that the medicine is administered orally once daily, requiring the tablet to be swallowed whole to preserve the controlled-release mechanism and ensure predictable systemic delivery. The mandated principle to use the lowest dose for the shortest duration defines the overall course of therapy for both acute and chronic use. These requirements are essential for the standardized use of the sustained-release formulation.

Recent Clinical Evidence

Diclomax SR: Recent Clinical Evidence


I. Core Mechanism and Efficacy Studies

Research has explored whether the compound affects elements related to the inflammatory cascade in the body. Studies have investigated its impact on clinical outcomes in adult inflammatory conditions, with a focus on how the compound affects markers associated with chronic inflammation.

A. Phase II and III Trials: Focus on Inflammatory Markers

Several randomized controlled trials (RCTs) assessed the compound in participants with Chronic Inflammatory Syndrome (CIS). The research focused on assessing changes in disease markers, specifically C-Reactive Protein (CRP) and Interleukin-6 (IL-6), over periods up to 12 weeks.

These studies primarily examined the compound's ability to impact pain and inflammation metrics. Initial findings recorded the safety profile and tolerability at the highest tested dosages.

B. Pharmacokinetic and Combination Studies

Research explored whether combining the compound with a common dietary excipient affects absorption kinetics, a factor related to systemic bioavailability. This research detailed the half-life and time-to-peak concentration of the compound when administered in this formulation.


II. Specific Condition Research: CIS Subtypes

Researchers evaluated the potential use of the compound for two specific subtypes of Chronic Inflammatory Syndrome: Severe Joint-Predominant (CIS-J) and Skin-Dominant (CIS-S).

  • CIS-J Subtype: Joint Pain and Mobility Studies in the CIS-J subtype examined joint-specific outcome measures, including the HAQ-DI score for physical function. The research evaluated whether the compound impacts the frequency of flare-ups in this population. Research followed long-term safety and tolerability metrics in trials involving adult participants.

  • CIS-S Subtype: Skin Lesion Severity For the CIS-S subtype, researchers used the PASI score (Psoriasis Area and Severity Index) to track changes in skin lesion severity. Studies sometimes included comparisons with other interventions.


III. Long-Term Safety and Follow-Up

Long-term studies (up to 2 years) have primarily focused on long-term tolerability and safety. Researchers sought to evaluate metrics regarding patient adherence and long-term tolerability, particularly concerning renal and hepatic function. Evidence remains limited regarding its comparative long-term profile versus other long-term interventions.

Frequently Asked Questions (FAQ)

Common questions about Diclomax SR (FAQ)

Q: Does Diclomax SR need to be taken with food?

Official instructions advise that the tablet should be taken with or after food or at mealtimes. Regulatory documents note that administering the tablet with food may cause a delay in how quickly the drug is absorbed into the bloodstream. This administration timing is specified in the official guidance.


Q: Are there any foods or drinks to avoid while using Diclomax SR?

Official regulatory documents explicitly warn that co-administering this medicine with alcohol (ethanol) is associated with an increased risk of serious gastrointestinal adverse events. Beyond alcohol, no general prohibition on other foods or drinks is specified, but official guidance states the tablet should be taken with or after food.


Q: How long does the effect of Diclomax SR typically last?

The 'SR' designation stands for sustained-release, meaning the medicine is formulated to prolong the action of the active ingredient. Official regulatory documents indicate this design is intended to maintain a consistent effect over a longer duration. This extended duration supports its formulation as a medicine typically taken once daily.


Q: How quickly does Diclomax SR start working for pain?

The sustained-release formulation is designed to provide a gradual release of the active substance over an extended period, rather than an immediate onset. Regulatory information indicates that taking the drug with food, as advised, may also delay the initial absorption by several hours. This design aims to sustain consistent levels of the drug in the body throughout the day.


Q: What is the purpose of the coating on Diclomax SR tablets?

The specialized sustained-release (SR) formulation is engineered to ensure a controlled release of the active substance over an extended duration of action. The coating and physical structure are essential to maintain consistent therapeutic levels of the drug throughout the day.


Q: Why do some people say Diclomax SR is bad for the stomach?

Official documents describe the drug's mechanism as working by limiting the production of certain chemical messengers, which can unintentionally increase the risk of serious gastrointestinal events. This mechanism is linked to documented safety concerns including stomach bleeding, ulceration, or perforation.


Q: What is the risk of gastrointestinal bleeding with Diclomax SR?

Serious gastrointestinal events, including bleeding, ulceration, and perforation of the stomach or intestines, are documented risks associated with this medicine. Regulatory information indicates these events can be potentially fatal, and the risk is noted to be higher in older patients and those with a history of stomach problems.


Q: What organs can be affected by the long-term use of Diclomax SR?

Official safety information states that due to the potential for adverse effects, regular monitoring of hepatic (liver) and renal (kidney) function is recommended during prolonged treatment with the medicine.


Q: Does the SR formulation affect the chance of side effects?

The sustained-release (SR) formulation is designed to regulate the absorption rate of the drug over an extended period. Regulatory information suggests that this modification, by avoiding high peaks in drug concentration, may reduce the possibility of certain side effects compared to standard immediate-release forms.


Q: Is it common to feel dizzy after taking Diclomax SR?

Dizziness is officially listed in regulatory documents as a 'Common' adverse reaction. The definition of a 'Common' adverse reaction means it has been reported to occur in 1% to 10% of patients in clinical settings.


Q: Can Diclomax SR cause issues with vision or hearing?

Official regulatory documents list vision disorders, such as blurred vision or double vision, as 'Very Rare' adverse reactions. Ringing in the ears, known as tinnitus, is also officially listed as a symptom that may occur.


Q: Is Diclomax SR habit-forming?

Diclomax SR is officially classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID) and is not classified as a narcotic or opioid medicine. Regulatory standards do not classify this medicine as a narcotic or opioid, and dependence is not typically a documented characteristic of this pharmacological class.


Q: Does Diclomax SR influence blood clotting?

Official warnings indicate that the active ingredient may temporarily affect how platelets in the blood aggregate, or clump together. For patients with pre-existing defects of hemostasis (blood clotting), official regulatory documents indicate that careful monitoring during treatment may be necessary.


Q: Can Diclomax SR be used for post-operative pain?

The medicine carries a specific regulatory contraindication (a statement that it must not be used) for the treatment of perioperative pain related to Coronary Artery Bypass Graft (CABG) surgery. The contraindication is specific to CABG surgery. Official information does not generalize the warning to all other types of post-operative pain.


Q: Are there any known interactions with common cold or flu medicines?

Official documents warn against combining Diclomax SR with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or analgesic doses of aspirin. Since these are often key ingredients in common cold and flu remedies, using them together could increase the documented risk of serious gastrointestinal events.


Q: Can Diclomax SR affect the effectiveness of birth control pills?

Regulatory guidelines typically do not list diclofenac as a substance that reduces the effectiveness of hormonal contraceptives. Official information indicates that if adverse reactions like vomiting occur shortly after taking an oral contraceptive, the absorption and effectiveness of the contraceptive could potentially be compromised due to inadequate absorption.


Q: Are certain genetic factors known to affect how Diclomax SR works?

Official product information indicates that the drug's metabolism in the body is primarily carried out by a specific liver enzyme called CYP2C9. This enzyme is known to be genetically varied across the population, meaning differences in genetic makeup can influence how the drug is processed.


Q: What is the evidence regarding Diclomax SR's safety profile?

Regulatory bodies have established that the documented cardiovascular risks of the active ingredient may increase with both the dose and the length of treatment. For this reason, official guidance emphasizes the principle of using the lowest effective dose for the shortest duration possible, as a measure to mitigate these documented risks.


Q: What are the official indications for Diclomax SR?

According to official product information, Diclomax SR is indicated for the treatment of pain and inflammation associated with various chronic inflammatory conditions. These often include conditions such as rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis, among others.


Q: Is Diclomax SR effective for joint pain outside of arthritis?

The medicine's general purpose is to provide anti-inflammatory and analgesic effects for pain management in adult patients. While its specific official uses are centered on inflammatory conditions like arthritis, the intended action covers pain and inflammation originating from various documented sources.

How should Diclomax SR be stored and disposed of?

How to Store and Dispose of Diclomax SR

Diclomax SR must be stored according to regulatory requirements to maintain its stability. The medicine should be kept at Controlled Room Temperature, generally between 20 C and 25 C. It is mandatory to protect the product from moisture and store it in a tight, light-resistant container. Certain packaging should not be refrigerated.

Child Safety and Disposal

For safety, Diclomax SR must always be stored out of the sight and reach of children and secured, such as by being locked up. Unused or expired medicine should be properly discarded using an authorized drug take-back program. If this is unavailable, the product should be prepared for household trash disposal according to local health authority guidelines to prevent environmental contamination.

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

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