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Flameril Retard

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Flameril Retard

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Medically reviewed

Marina Burgos

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.

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Overview of Flameril Retard

Property Description
Active Ingredient Diclofenac Sodium
Form Modified-release tablet (Sustained-release)
Pharmacological Class Nonsteroidal Anti-Inflammatory Drug (NSAID)
General Purpose Symptomatic relief of pain, inflammation, and fever
Origin Synthetic compound (Phenylacetic acid derivative)

Flameril Retard is a single-ingredient, synthetic prescription medicine intended for oral administration. Its active component, Diclofenac Sodium, is an active agent within the Nonsteroidal Anti-Inflammatory Drug (NSAID) class. This compound is fundamentally designed to provide symptomatic relief from pain and inflammation. Diclofenac's action is characterized by its established role in addressing discomfort where both pain and inflammation are present.

What Type of Medicine is Flameril Retard?

Flameril Retard is a synthetic NSAID, belonging to the class of medicines that counter the body's inflammatory response. The active ingredient, Diclofenac, is a derivative of Phenylacetic acid. As an NSAID, the substance acts as an inhibitor of cyclooxygenase enzymes, thereby reducing the synthesis of prostaglandins, which are key mediators in the pathways of pain, swelling, and fever. Diclofenac serves as an anti-inflammatory and analgesic agent, supporting its general application in situations requiring relief from acute musculoskeletal pain.

What Does the "Retard" Formulation Signify?

The "Retard" designation confirms that this is an oral dosage form presented as a modified-release tablet. This formulation represents a sustained-release dosage form specifically engineered to control the rate at which Diclofenac Sodium is released into the system. The key purpose of the sustained-release design is to achieve a prolonged therapeutic effect, which is intended to facilitate the maintenance of consistent drug levels in the body over an extended period compared to immediate-release preparations.

What is its General Therapeutic Purpose?

The general therapeutic purpose of Flameril Retard is to provide comprehensive symptomatic relief by utilizing its multi-faceted properties. The drug possesses combined analgesic (pain-relieving), anti-inflammatory (swelling-reducing), and antipyretic (fever-reducing) effects. These integrated actions establish the drug's primary role in addressing the discomfort and functional limitations associated with various inflammatory processes, such as those impacting the musculoskeletal system.

Regulatory References

  1. Diclofenac - LiverTox - NIH
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What side effects are possible with Flameril Retard?

Possible Side Effects and Safety Information

The official safety information for Diclofenac Sodium, the active ingredient in Flameril Retard, formally classifies potential adverse reactions by both frequency and the physiological system affected.

Adverse Reaction Scope

Classification System-Organ Classes Involved
Common (frequently documented effects) Gastrointestinal (e.g., dyspepsia, abdominal pain, nausea), Nervous System (headache, dizziness), and Hepatobiliary (elevated liver enzymes).
Rare or Very Rare (serious events) Cardiovascular, Hepatobiliary, Renal, Immune System, and Skin/Subcutaneous Tissue.

Serious Adverse Reactions and Safety Constraints

The regulatory label documents the potential for serious adverse reactions that are primarily associated with the Nonsteroidal Anti-Inflammatory Drug (NSAID) class:

  • Serious Cardiovascular Thrombotic Events: The risk of myocardial infarction (heart attack) and stroke is noted, which may increase with duration of use and is a primary safety constraint.
  • Serious Gastrointestinal Events: Bleeding, ulceration, and perforation of the stomach or intestine are documented events that can occur at any time during treatment, often without warning symptoms. Older adults are at greater risk for these complications.
  • Hepatotoxicity and Skin Reactions: Severe hepatic reactions, including liver failure, and rare, severe cutaneous adverse reactions like Stevens-Johnson Syndrome (SJS) are also explicitly listed.

Population-Specific Safety Considerations

The medicine is contraindicated in specific circumstances, including patients with established congestive heart failure (NYHA II–IV), ischemic heart disease, peripheral arterial disease, or cerebrovascular disease. It is also contraindicated in the setting of coronary artery bypass graft (CABG) surgery and during the last trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus. Use is also constrained in patients with severe hepatic or renal failure, or a history of allergic-type reactions to aspirin or other NSAIDs.


Connection to the Overall Safety Profile

The official safety documentation structures the understanding of risk by clearly defining potential effects across body systems and classifying their expected frequency. This framework emphasizes the critical risks associated with the NSAID class, ensuring that the limits of the safety profile, particularly concerning cardiovascular and gastrointestinal events, are clearly communicated based on regulatory requirements.

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Overdose and Emergency Response

Overdose of Flameril Retard (Diclofenac Sodium) is officially documented to present with a range of acute clinical manifestations. Gastrointestinal effects are common, including nausea, vomiting, diarrhea, and pain in the stomach area (epigastric pain). Central Nervous System (CNS) disturbances may involve lethargy, dizziness, headache, confusion, and tinnitus (ringing in the ears). Cardiovascular signs, such as changes in heart rate (tachycardia) or blood pressure, may also occur.

The regulatory guidance strictly requires individuals to seek immediate medical help or contact a Poison Control Center right away if an overdose is suspected. This is critical because severe overdose can result in life-threatening outcomes, including major gastrointestinal bleeding, ulceration, or perforation, as well as neurological complications such as seizures and coma. Elderly patients are officially noted to be at an increased risk for these serious gastrointestinal events.

Management following an overdose is strictly limited to symptomatic and supportive care, as official prescribing information states that no specific antidote is known. Procedures such as administering activated charcoal may be considered to reduce absorption. Hospital monitoring, including the assessment of vital signs and specific lab tests, is often required.

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Therapeutic Uses of Flameril Retard

What Flameril Retard Treats: Main Uses and Benefits

Flameril Retard is a nonsteroidal anti-inflammatory drug (NSAID) primarily used to manage symptoms related to inflammatory conditions. The medication is generally applied across conditions characterized by periods of heightened symptoms, and may assist in the management of pain and inflammation.

It is commonly used to help with symptomatic discomfort in conditions like Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis, and Acute Gout. It is also relevant for managing symptoms associated with acute episodes, such as pain and swelling following soft tissue sports injuries (sprains/strains) and post-operative discomfort.

Regulatory References

  1. NIH MedlinePlus overview of Diclofenac (oral route)
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Eligibility and Restrictions for Use

Flameril Retard, which contains diclofenac sodium (a non-steroidal anti-inflammatory drug or NSAID), is typically prescribed for adults. As with all prescription medicines, a healthcare provider determines its appropriateness based on a patient's full medical history.

Who Can Use Flameril Retard?

This medication is generally for adult patients experiencing pain and inflammation associated with conditions like rheumatoid arthritis, osteoarthritis, or ankylosing spondylitis. It is also used for acute conditions such as gout, backache, or pain following minor surgery.


Who Should NOT Use Flameril Retard (Contraindications)?

Flameril Retard is not suitable for individuals with certain pre-existing conditions. Do not take this medicine if you have:

  • A known allergy or hypersensitivity to diclofenac, aspirin, ibuprofen, or any other NSAID.
  • Active gastrointestinal bleeding, ulcers, or a history of recurrent peptic ulcers or perforation.
  • Severe heart failure or established heart disease (e.g., prior heart attack, stroke, or mini-stroke/TIA).
  • Severe kidney or liver failure.
  • The third trimester of pregnancy.
  • Just undergone coronary artery bypass graft (CABG) surgery.

Special caution is required for the elderly, individuals with uncontrolled high blood pressure, asthma, a bleeding disorder, or those taking other medications that increase the risk of bleeding or kidney problems.

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What should I know about interactions with other medicines?

Flameril Retard Interactions with other medicines and products

This section details officially documented interaction information for Flameril Retard (Diclofenac Sodium), strictly based on governmental regulatory sources.

Formal Contraindicated Combinations

Regulatory documents advise that Flameril Retard should not be co-administered with certain substances due to serious risks:

  • Other Systemic NSAIDs: Co-administration with other nonsteroidal anti-inflammatory drugs, including COX-2 selective inhibitors, must be avoided as it offers no benefit and significantly increases the risk of serious gastrointestinal adverse events, such as bleeding or ulceration.
  • Perioperative Pain: Use is explicitly contraindicated for the treatment of perioperative pain related to Coronary Artery Bypass Graft (CABG) surgery.

Documented Interaction Patterns

The active ingredient, Diclofenac, has documented interactions that require caution or monitoring:

  • Anticoagulants and Antiplatelet Agents: Concomitant use with agents like Warfarin or Aspirin (analgesic doses) increases the risk of bleeding due to additive effects on hemostasis.
  • Antihypertensives and Diuretics: Diclofenac may reduce the therapeutic effect of medicines for high blood pressure, such as ACE Inhibitors and ARBs, and the natriuretic effect of Diuretics.
  • CYP2C9 Inhibitors: Strong inhibitors like Voriconazole significantly increase the systemic exposure (AUC and Cmax) of Diclofenac, a pharmacokinetic interaction noted in regulatory labeling.
  • Alcohol: Intake of alcohol is explicitly linked in regulatory documentation to an increased risk of serious gastrointestinal adverse events.

Population-Specific Interaction Notes

Regulatory labels caution that co-administration with ACE Inhibitors or ARBs may lead to deterioration of renal function in high-risk groups, including the elderly and patients with pre-existing renal impairment.

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Mechanism of Action

How Flameril Retard Works: The Mechanism of Action

Targeting the Cyclooxygenase Enzyme System

Flameril Retard operates as an inhibitor of the Cyclooxygenase (COX) enzyme system, affecting both the COX-1 and COX-2 isoforms. By interacting with these enzymes, the drug prevents the conversion of arachidonic acid into various eicosanoids. This direct enzymatic block defines its primary action within the eicosanoid synthesis pathway.


Dampening Prostaglandin Signaling

The inhibition of COX enzymes directly modulates the body's ability to produce prostaglandins, which function as key local mediators in various physiological processes. This interference limits the generation of chemical signals, such as PGE2, that influence localized physiological events.


Adjusting Localized Physiological Responses

The consequence of blocking this signaling cascade is a lowered output of localized physiological signals. This mechanism results in decreased local afferent nerve signaling and reduced fluid extravasation, thereby producing an adjustment in the tissue's signaling profile.

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Dosage and Administration Information

How Flameril Retard is Used: Administration Guidelines

Flameril Retard is a modified-release (sustained-release) oral tablet, and its use follows specific guidelines to ensure proper release and absorption of the active ingredient, Diclofenac Sodium.

Administration and Dosage Protocol

Dosage is established according to standard clinical regimens. The regimen emphasizes the principle of using the lowest effective dose for the shortest duration possible.

Instruction Category Guidelines (Adults)
Route of Administration Oral (swallowed whole with liquid).
Standard Daily Dosing Typically 100 mg once daily for extended-release forms. Total doses between 100 mg and 150 mg per day are common in international labeling.
Maximum Dose Generally restricted to 150 mg per day in divided doses, with 100 mg being the typical maximum for once-daily extended-release use.
Administration Time May be taken with or without food. Some international labels advise taking the tablet before meals

Procedural Instructions and Special Populations

To preserve the modified-release formulation, the tablet must be swallowed whole. It is explicitly forbidden to crush, split, or chew the tablet, as this would compromise the slow-release properties.

For older adults, the guideline is to initiate treatment using the lowest effective dose due to increased susceptibility to adverse reactions. The modified-release form is not generally recommended or is considered not suitable for pediatric patients.

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Recent Clinical Evidence

Research evidence / Overview of studies for Flameril Retard

This overview describes the types of official research that have been conducted for the medicine's active component, Diclofenac Sodium, particularly in its oral, sustained-release form. It focuses on the structure of the evidence and what studies have explored, without providing any medical advice or treatment recommendations.


Evidence for Use in Rheumatoid Arthritis (RA)

Research for the active ingredient was evaluated in settings involving conditions characterized by fluctuating or episodic manifestations such as Rheumatoid Arthritis. This research primarily relies on short-term Randomized Controlled Trials (RCTs) and systematic reviews. Studies explored metrics related to outcomes related to physical discomfort such as joint pain and swelling, as well as the patient-reported experience of their condition. However, follow-up durations were limited in most trials, and research does not determine whether the medicine influences the underlying progression of joint damage.


Evidence for Use in Osteoarthritis (OA)

The active ingredient in Flameril Retard was studied for conditions involving conditions marked by functional limitations such as Osteoarthritis and was evaluated in randomized, double-blind trials and large-scale evidence syntheses. Researchers monitored outcomes reflecting daily functioning or activity level and outcomes related to physical discomfort over defined time intervals, typically up to three months. A key limitation is that evidence syntheses often include data where findings across different oral forms and doses of Diclofenac were sometimes pooled together, meaning evidence quality varies across studies when interpreting overall findings.


Evidence for Use in Ankylosing Spondylitis (AS) and Related Chronic Inflammatory Conditions

Flameril Retard was studied for its use in chronic inflammatory conditions like Ankylosing Spondylitis (AS) through both short-term randomized trials and long-term observational studies. Research explored outcomes related to physical discomfort and clinical measures, such as radiographic structural progression of the spine. For structural outcomes, research comparing different treatment strategies has shown that findings were mixed across various investigations, and certainty remains low in the interpretation of these patterns over time.


Research Gaps and Uncertainties

The evidence base contains several areas where certainty remains low. Follow-up durations were limited in many core trials for chronic conditions, meaning long-term effects are not fully established beyond the intermediate term. Furthermore, data for certain groups remain insufficient, particularly concerning pediatric patients, pregnant populations, and adults with specific limiting comorbidities.

Key Studies & References

  1. Valdecoxib is as effective as diclofenac in the management of rheumatoid arthritis with a lower incidence of gastroduodenal ulcers: results of a 26-week trial
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Frequently Asked Questions (FAQ)

Common questions about Flameril Retard (FAQ)

Q: What kind of pain is Flameril Retard typically used for?

A: Flameril Retard is generally used for the symptomatic relief of mild-to-moderate pain and inflammation. This usually involves discomfort linked to inflammatory chronic conditions, such as arthritis, and certain acute musculoskeletal issues. Its action is described as targeting pain signals related to inflammatory processes.

Q: Does Flameril Retard treat joint stiffness or just the pain?

A: The active ingredient in Flameril Retard is documented for use in conditions where symptoms include joint pain, swelling, and stiffness. Its purpose is to provide symptomatic relief across these various manifestations of inflammatory conditions.

Q: Can Flameril Retard cause stomach upset or acid reflux?

A: According to official documents, common gastrointestinal effects are documented, which may include abdominal pain, nausea, and indigestion. Indigestion, also known as dyspepsia, often involves symptoms like stomach upset and acid reflux.

Q: Is Flameril Retard safe for people who have a history of ulcers?

A: Regulatory documents state that the medicine is contraindicated (should not be used) in individuals who have a history of recurrent peptic ulcers or perforation, or gastrointestinal bleeding. This constraint is due to the potential for the active ingredient to cause serious gastrointestinal adverse events.

Q: Is it safe to breastfeed while taking Flameril Retard?

A: Regulatory reviews indicate that only tiny amounts of the active ingredient may pass into breast milk. Official instruction advises that the potential benefits must be weighed against the potential risks before using this medicine while breastfeeding.

Q: What should I do if I think I'm having an allergic reaction to Flameril Retard?

A: Signs of a serious reaction can include swelling of the face or mouth, breathing problems, or a widespread skin rash. Official regulatory information advises that if signs of hypersensitivity occur, the medicine should be stopped and prompt medical attention should be sought.

Q: Is it possible for Flameril Retard to interact with alcohol?

A: The use of alcohol while taking this medicine is explicitly linked in regulatory documentation to an increased risk of serious gastrointestinal adverse events. These serious events include the possibility of bleeding or ulceration in the stomach or intestine.

Q: Is Flameril Retard known to cause weight gain or loss?

A: While weight gain itself is not a commonly reported direct side effect, regulatory labels note the potential for fluid retention (edema). In some cases, this fluid buildup may lead to weight gain.

Q: Can Flameril Retard affect sleep, like causing insomnia or drowsiness?

A: The product information notes that some individuals have occasionally reported feeling tired or sleepy (drowsiness). This is a documented side effect.

Q: Are there any long-term side effects associated with Flameril Retard use?

A: Official safety constraints state that the risk of serious cardiovascular thrombotic events, such as heart attack or stroke, may increase with the duration of use. The risk of serious gastrointestinal events, like bleeding, is also noted to increase with prolonged use.

Q: Can Flameril Retard be taken with paracetamol (acetaminophen)?

A: No specific contraindications or drug interactions have been documented for co-administering this medicine with paracetamol (acetaminophen). However, individuals are generally advised to inform their healthcare provider of all medicines they are currently taking.

Q: What is the maximum duration someone can generally take Flameril Retard for?

A: Official regulatory guidance emphasizes using the lowest effective dose for the shortest duration possible to reduce the potential for serious side effects. No fixed maximum duration is set, as appropriateness depends on the specific condition and individual risk factors.

Q: Is there a known risk of kidney problems with Flameril Retard?

A: Regulatory labels note that long-term use of NSAIDs, including this medicine, has been associated with the potential for kidney injury. This risk is particularly relevant for patients who already have pre-existing kidney issues.

Q: Can individuals with asthma or allergies use Flameril Retard?

A: Regulatory documents state it is contraindicated (should not be used) in patients with a history of asthma, hives (urticaria), or allergic-type reactions after taking aspirin or other NSAIDs.

Q: Is there research evidence suggesting Flameril Retard is effective for treating chronic back pain?

A: Research has examined the use of the active ingredient for low back pain. However, evidence reviews often note methodological limitations or that findings were mixed regarding the long-term effectiveness for chronic conditions over extended periods.

Q: Is there a risk of dependency or addiction with Flameril Retard?

A: Flameril Retard belongs to the NSAID class of medicines. Regulatory documents do not list dependency or addiction as a known risk or adverse reaction associated with its use.

Q: Can Flameril Retard affect liver enzyme levels?

A: Yes, elevated liver enzymes is explicitly listed in official product information as a common documented effect. This is usually monitored during treatment.

Q: Are there any reported cases of hair loss linked to Flameril Retard?

A: Regulatory safety information lists hair loss and thinning of the hair among the less common side effects documented for the active ingredient, diclofenac.

Q: Can Flameril Retard be used for managing pain from gout?

A: Yes, the medicine's active ingredient is approved for the treatment of pain and inflammation associated with acute conditions. This documented use includes managing symptoms associated with gout.

Q: Why is Flameril Retard sometimes prescribed for menstrual cramps?

A: The active ingredient is documented for use in the treatment of primary dysmenorrhoea (menstrual cramps). This use is based on the drug's established anti-inflammatory and pain-relieving effects.

Q: Is Flameril Retard safe to use if I have diabetes?

A: Official warnings note that diabetes mellitus is considered a risk factor for cardiovascular events. Official documents note that individuals with diabetes and other cardiovascular risk factors are groups for whom careful consideration is advised before initiating treatment.

Q: Can Flameril Retard cause changes in mood or anxiety?

A: Changes in mood, such as anxiety or depression, have been reported as potential side effects of the active ingredient. These effects are potential side effects that have been reported.

Q: Are there certain foods that interact with Flameril Retard?

A: Official product information indicates that there are no known significant interactions between the extended-release tablet and specific foods or drinks.

Q: Is it described in official sources that Flameril Retard can cause fluid retention?

A: Yes, fluid retention (edema) has been observed in some patients taking the active ingredient. This is noted in regulatory safety warnings, and caution is required for patients with pre-existing fluid issues.

Q: Do studies suggest Flameril Retard affects fertility?

A: Official warnings indicate that the medicine may affect ovulation (the release of an egg) and potentially make it more difficult to get pregnant for some women. This documented effect is relevant for women who are planning pregnancy.

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How should Flameril Retard be stored and disposed of?

Flameril Retard (diclofenac sodium extended-release) must be stored and disposed of according to strict requirements documented in regulatory labeling to maintain its stability and ensure public safety.

Storage & Disposal Scope Official Regulatory Requirements
Labeled Storage Temperature Store at Controlled Room Temperature (20 C to 25 C / 68 F to 77 F).
Light/Moisture Protection Must be protected from light and stored in a well-closed container.
Handling Constraints The medicine must be kept from freezing.
Child-Protection Storage Must be kept out of the sight and reach of children.

Official disposal and waste management statements:

  • The product should not be stored past its labeled expiration date.
  • Disposal of unused or expired tablets must be conducted according to local regulations.
  • The medication should not be thrown into general household waste or flushed down the toilet unless specific guidance permits it.

These instructions define the mandatory environmental and handling controls for the product, requiring continuous compliance to ensure its quality and safe management.

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

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