Deflamat 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 Deflamat retard

Property Description
Active ingredient Diclofenac (as sodium or potassium salt)
Form Sustained-release tablet (Retard)
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common use Systemic relief of pain and inflammation
Origin Synthetic substance (Phenylacetic acid derivative)

The Identity of Deflamat retard: A Nonsteroidal Anti-inflammatory Drug (NSAID)

Deflamat retard is a prescription-only medicine whose active ingredient is Diclofenac, a synthetic substance chemically recognized as a phenylacetic acid derivative. It is classified in the pharmacological class of Nonsteroidal Anti-inflammatory Drugs (NSAIDs), meaning the medicine is designed to exert systemic effects primarily targeting processes that cause inflammation, fever, and pain. Within this class, Diclofenac is utilized for analgesia in cases of mild to moderate pain. Its identity as an NSAID determines its essential function as a substance offering combined anti-inflammatory and analgesic effect.


What Does "Sustained-Release Tablet" (Retard) Mean?

Deflamat retard is presented as an oral preparation in the form of a sustained-release tablet, a specialized modified-release dosage form. The term "retard" is a key differentiating feature, indicating this formulation is engineered with a unique solid base that deliberately controls and slows the rate at which the Diclofenac is released into the bloodstream following ingestion. The mechanism is designed to maintain a more stable and constant drug concentration over an extended duration. This design is intended to provide continuous, prolonged action, a typical use scenario being the stable management of chronic pain or persistent inflammation throughout a 24-hour period.


General Purpose: Relief from Inflammation and Pain

The general purpose of the Diclofenac in Deflamat retard is to provide symptomatic relief by reducing the biological process of inflammation and its associated pain signals. The medicine's action involves prostaglandin synthesis inhibition, effectively slowing the production of chemical messengers that are responsible for initiating swelling, stiffness, and fever. Diclofenac is characterized by its anti-inflammatory and pain-relieving effects. This means the medicine is used to provide stable relief that addresses both swelling and pain. This dual analgesic effect and anti-inflammatory effect make it suitable for addressing discomfort where inflammation is a primary component, providing systemic relief that targets the underlying physical response.

What side effects are possible with Deflamat retard?

Possible Side Effects and Safety Information

The safety profile of Deflamat retard (diclofenac sodium) is organized by regulatory authorities into frequency categories and organ system involvement. All reported adverse reactions are based on official government labeling and post-market surveillance data.

Adverse Reactions by Frequency

Frequency Examples of Officially Documented Side Effects
Common (ge 1/100 to < 1/10) Gastrointestinal issues (e.g., abdominal pain, nausea, dyspepsia), headache, dizziness, rash, elevated liver enzyme levels.
Uncommon (ge 1/1,000 to < 1/100) Cardiac events, such as chest pain and myocardial infarction (more associated with high dose/long-term use).
Rare (ge 1/10,000 to < 1/1,000) Hypersensitivity reactions (including anaphylactic shock), gastrointestinal bleeding or ulceration, hepatitis.
Very Rare (< 1/10,000) Severe skin reactions (e.g., Stevens-Johnson Syndrome), cerebrovascular accident, acute renal failure, blood disorders.

Serious Adverse Reactions

The official labeling highlights several serious risks, including gastrointestinal bleeding, ulceration, or perforation, which may be life-threatening. Other serious risks include arterial thrombotic events (heart attack or stroke) and severe, sometimes fatal, skin reactions.

Population-Specific Safety Statements

  • Elderly Patients: Have an increased risk of serious adverse reactions, particularly gastrointestinal complications.
  • Pregnancy (Third Trimester): The drug is contraindicated due to the risk of premature closure of the fetal ductus arteriosus.
  • Dose and Duration: The risk of serious cardiovascular events is associated with high doses and long-term treatment; the lowest effective dose for the shortest duration is specified in regulatory documents to minimize risk.

Official safety documents mandate caution in patients with pre-existing heart conditions, hepatic impairment, or renal impairment, and specify that regular monitoring of hepatic function is indicated during prolonged treatment.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation identifies specific clinical signs and manifestations associated with Diclofenac overdose. Documented presentations commonly involve the gastrointestinal system, including nausea, vomiting, and epigastric pain. Central nervous system effects such as lethargy, drowsiness, and dizziness are also listed in official labeling.

In situations of significant overdose, the risk of severe systemic outcomes is documented. Regulator-documented life-threatening events include Acute Renal Failure, severe Hepatic Reactions, and the potential for serious Gastrointestinal Bleeding or perforation. Rare but severe outcomes listed are convulsions, coma, and the risk of a systemic anaphylactoid reaction.

Immediate Emergency Actions

The explicit instruction from official sources is to seek immediate medical attention or contact emergency services upon suspicion of overdose. Given that regulatory information states that no specific antidote is known for Diclofenac overdose, the required management is strictly symptomatic and supportive care. Procedural guidance may involve the use of activated charcoal or an osmotic cathartic, along with required monitoring of vital signs and the use of an Electrocardiogram (ECG). Population-specific warnings note the increased fatality risk from GI events in elderly patients.

Therapeutic Uses of Deflamat retard

Deflamat retard is applied across therapeutic domains that involve heightened discomfort or systemic imbalance, particularly where inflammation is a key factor.

Deflamat retard is commonly used to help with conditions presenting with systemic or localized discomfort, such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and acute inflammatory episodes like gout. It is also used for symptom management for specific conditions including primary dysmenorrhea and migraine attacks. The sustained-release formulation is applied in clinical settings that involve acute or unstable symptom patterns, which helps address symptom clusters that may become intense or disruptive, including persistent joint stiffness and swelling.

“The treatment may provide supportive relief that helps ease the overall symptom burden during periods of increased discomfort.”

The medication is often used during phases when symptoms become more noticeable, such as discomfort following traumatic injuries or in the postoperative period. This supports the management of difficult episodes by easing distress and functional strain, assisting with maintaining functional stability for patients with chronic conditions.

Quick Fact: Relief for Persistent Swelling The sustained-release form is relevant for easing chronic symptoms, providing support over extended periods.

Eligibility and Restrictions for Use

Official Eligibility Profile: Who Can and Cannot Use Deflamat Retard?

The eligibility for Deflamat retard (Diclofenac sustained-release) is strictly defined by regulatory documents, focusing on pre-existing health conditions and life stage.

Classification Population/Condition
Absolutely Contraindicated History of allergy to Diclofenac or other NSAIDs (e.g., aspirin-sensitive asthma).
Active or recurrent GI ulceration, bleeding, or perforation.
Severe heart, liver, or kidney failure.
Patients undergoing perioperative pain treatment for CABG surgery.
Women in the third trimester of pregnancy (from 30 weeks gestation).
Restricted/Not Recommended Children and adolescents under 14 years of age.
Older adults (requires close medical supervision).
Breastfeeding women.
Patients with established cardiovascular disease or risk factors for thrombotic events.

The official label states that use is generally established for adults for the systemic management of pain and inflammation. Contraindications define non-negotiable exclusions, particularly concerning severe organ impairment and a history of hypersensitivity or serious gastrointestinal events. These official rules establish conditional use for those with non-severe organ impairment or specific cardiac risk factors, requiring caution and monitoring.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Deflamat retard (Diclofenac) is documented by regulatory authorities, outlining specific restrictions and risks when co-administered with other substances.

Formal Restrictions and Contraindications Co-administration with other systemic Nonsteroidal Anti-inflammatory Drugs (NSAIDs) and analgesic doses of aspirin is not recommended due to a significantly increased risk of serious gastrointestinal events. Furthermore, the use of Diclofenac is contraindicated for treating peri-operative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery.

Interactions Affecting Plasma Concentration The systemic exposure of Diclofenac is increased when co-administered with strong inhibitors of the CYP2C9 enzyme, such as Voriconazole. Conversely, Diclofenac can affect the plasma concentrations of certain co-administered medicines, including Lithium, Digoxin, and Methotrexate, which may result in elevated levels of these substances.

Pharmacodynamic Risk Combinations Diclofenac co-administration with drugs that interfere with hemostasis, such as anticoagulants, antiplatelet agents, and Selective Serotonin Reuptake Inhibitors (SSRIs), carries a documented risk of serious bleeding. Additionally, combining the medicine with ACE Inhibitors, ARBs, Beta-Blockers, or Diuretics may diminish the therapeutic efficacy of these blood pressure and fluid-management medications. For the elderly or those with renal impairment, the combination with ACE Inhibitors or ARBs heightens the risk of renal function deterioration.

Substance Interaction Regulatory guidance notes that the consumption of alcohol increases the risk of gastrointestinal bleeding associated with this medicine.

Mechanism of Action

The mechanism of action for Diclofenac focuses on interrupting a core biological cascade responsible for the generation of inflammation and the elevation of body temperature.

Interruption of Prostaglandin Production (Enzyme Inhibition) The fundamental molecular action involves the reversible inhibition of the Cyclooxygenase (COX) enzymes (COX-1 and COX-2), thereby blocking the conversion of arachidonic acid into chemical mediators. This early molecular suppression of the arachidonic acid cascade initiates the molecule’s overall physiological response by reducing the overall biosynthesis of these chemical mediators.

Modulation of Nociceptive Sensitization and Thermoregulation This mechanism addresses the downstream consequences of reduced chemical mediators within key physiological systems. By lowering the concentration of prostaglandins at peripheral nerve endings and in the brain's hypothalamus, the action decreases the chemical sensitization of nociceptive signaling and reverses the prostaglandin-induced elevation of the body's central temperature set-point when elevated.

Mechanistic Constraints of Non-Selectivity The drug’s non-selective inhibition of the two COX isoforms is the necessary action to engage the pathway, but it also influences physiological processes reliant on constitutive prostaglandins, defining the system's operational constraints.

Dosage and Administration Information

The usage of Deflamat retard, a prolonged-release tablet containing Diclofenac, involves specific administration pathways and dosing schedules.

Administration Route and Preparation

The medicine is designated for oral administration and is taken whole with liquid. It is necessary that the tablet must not be crushed, chewed, or broken to preserve the sustained-release mechanism designed to control the drug’s delivery over time. For reasons of tolerability, the tablet is often ingested with or immediately after a meal.


Labeled Dosing and Frequency

Deflamat retard is typically prescribed at an overall daily dose ranging from 100 mg to 150 mg. Due to its prolonged-release characteristic, the frequency is generally limited to once daily or, in some contexts, twice daily. For example, regimens include 100 mg once daily or 75 mg once or twice daily, with 150 mg representing the established maximum daily intake.


Use Principles for Duration and Populations

Standard application of the medication is at the lowest effective dose for the shortest possible duration consistent with the therapeutic objective. Dose selection is guided by specific population considerations: the lowest effective dosage is required for older adults. Furthermore, the prolonged-release 75 mg and 100 mg tablets are generally not considered suitable for pediatric patients.

Recent Clinical Evidence

Deflamat retard is a modified-release pharmaceutical formulation combining the nonsteroidal anti-inflammatory drug (NSAID) diclofenac and the gastroprotective agent misoprostol. This fixed-dose combination is primarily indicated for the treatment of signs and symptoms of osteoarthritis (OA) and rheumatoid arthritis (RA) in patients who are at high risk of developing NSAID-induced gastrointestinal (GI) ulcers, complications, or bleeding.

Recent clinical evidence and long-term observational data reinforce the foundational role of this combination product in managing chronic inflammatory joint conditions while mitigating GI risk.

Efficacy and GI Safety

Clinical trials have consistently demonstrated that the anti-inflammatory and analgesic efficacy of the diclofenac component in the fixed-dose combination is comparable to that of diclofenac administered alone for both RA and OA. The benefit of the combined formulation lies in the protective effect of misoprostol.

Studies comparing the fixed combination to diclofenac alone showed a significant reduction in the incidence of serious GI events, such as ulcers and their complications, in at-risk patients requiring long-term NSAID therapy. This mucosal protection is critical, as NSAID-related GI damage can occur without warning symptoms.


Tolerability Profile

While highly effective in reducing GI risk, the misoprostol component introduces its own set of common adverse effects, notably diarrhea and abdominal pain. These events are typically mild to moderate and are the most frequent reasons for discontinuation. However, the overall rate of patient withdrawal due to adverse events, including those related to the GI tract, is generally reported to be similar between the fixed-dose combination and diclofenac monotherapy in clinical settings, with a notable shift in the type of adverse event.


Risk Considerations

Like all systemic NSAIDs, diclofenac carries warnings regarding potential dose-dependent cardiovascular (CV) thrombotic events (e.g., heart attack and stroke) and renal adverse effects. This risk is particularly relevant with long-term use and higher doses. Furthermore, misoprostol is contraindicated in pregnancy due to its abortifacient properties, a critical safety consideration for women of childbearing potential, who must receive proper counseling regarding contraceptive use.

Frequently Asked Questions (FAQ)

Common questions about Deflamat retard (FAQ)


Q: What should I do if I miss a dose of the medication?

The official prescribing information details the general instructions on handling a missed dose. This guidance addresses criteria for when to take the missed dose or when to skip it entirely, to avoid accidental double dosing. Specific steps regarding a missed dose are provided in the regulatory text, typically in the Dosage and Administration section.

Q: Does this medicine contain an active ingredient that can cause an allergic reaction?

Regulatory documents list all active and inactive components (excipients) of the medicine. If hypersensitivity (a severe allergic reaction) to the active substance or any of the inactive ingredients is identified, it is typically listed as a contraindication, indicating a circumstance where the medicine is generally not recommended for use. This can be verified in the sections detailing the medicine's composition and contraindications.

Q: Can I take this medicine with food, or must I take it on an empty stomach?

Official product information specifies the required conditions for taking the medicine. Instructions regarding whether Deflamat retard should be taken with or without food are defined in the regulatory documentation. This guidance is usually found in the Posology and Method of Administration or Dosage and Administration sections.

Q: Can I take this medication if I am pregnant or planning to become pregnant?

The official product labeling contains a detailed Risk Summary and Clinical Considerations regarding use during pregnancy. This section states the known risks and provides clarity on whether the medicine is contraindicated or if it may only be used when the potential benefit is judged to outweigh the potential risk.

Q: Does this drug have any known interactions with commonly used over-the-counter medicines or supplements?

The regulatory text includes a dedicated section listing known drug-drug interactions. This information covers interactions with other prescribed medicines, as well as those identified with certain over-the-counter products and supplements. The official product labeling is the source for a comprehensive list of known potential interactions.

Q: What is the recommended storage temperature and light protection requirements for this drug?

Official documentation specifies the necessary storage conditions to help maintain the medicine’s quality and effectiveness. This includes the required temperature range and any precautions needed to protect the medicine from light or moisture. This information is typically found in the storage and handling section of the regulatory documents.

Q: How long will I have to take this medicine before I start to feel better?

The Clinical Studies section of the regulatory documents summarizes the time course of improvement observed across the population studied in trials. This clinical trial data reflects the average patient response, but the official data does not provide a guaranteed precise time frame for when an individual patient will begin to feel better.

Q: Is it safe to drink alcohol while taking this medicine?

The official drug information includes specific statements on whether there is a known interaction or increased risk when the medication is taken with alcohol. Information regarding this potential interaction is addressed within the section dedicated to drug and other interactions.

Q: Can children 2 years old use it?

The official prescribing information specifies the approved pediatric population for whom the drug's safety and effectiveness have been studied. The sections on Dosage and Administration or Pediatric Use contain the official information used to determine if the medicine is indicated and studied for children in a specific age range, such as 2 years old.

Q: What happens if I suddenly stop taking this medication?

The regulatory documents provide directions for the recommended process for discontinuation of the medicine. This may include information about potential withdrawal effects or the necessity of gradually reducing the dose instead of stopping suddenly, depending on the drug.

Q: Can I take this drug long-term?

The Clinical Studies section of the regulatory documents provides details about the duration of the clinical trials that established the medicine's efficacy and safety profile. This clinical trial data informs the maximum duration of treatment studied and approved by regulatory authorities.

How should Deflamat retard be stored and disposed of?

How to Store and Dispose of Deflamat Retard

Deflamat retard (diclofenac sustained-release tablets) must be stored according to regulatory specifications to ensure stability and effectiveness.


Storage Requirements

The medicine is required to be stored at controlled room temperature, typically between 20 C and 25 C. It must be protected from light and stored away from moisture and high humidity. Regulatory labeling requires the product to be kept in its original, well-closed packaging. For certain types, the product must not be refrigerated. All medicines must be stored out of the sight and reach of children.


Disposal Instructions

Unused or expired Deflamat retard must be properly managed. The medicine must not be thrown into household trash or disposed of via wastewater due to environmental concerns. Instead, disposal must follow local regulatory requirements, which typically involve returning the product to a pharmacy or designated collection program.

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

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