Profenid 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 Profenid retard

Property Description
Active Ingredient Ketoprofen
Form Oral Prolonged-Release Tablet
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common Use Anti-inflammatory, Analgesic, and Antipyretic
Origin Synthetic (Propionic Acid Derivative)

What Type of Medicine is Profenid retard and What is its Composition?

Profenid retard is an oral medicinal product whose active substance is Ketoprofen. It is specifically classified as a Nonsteroidal Anti-inflammatory Drug (NSAID), a pharmacological class designed to manage pain, fever, and inflammation.

The active ingredient, Ketoprofen, is a synthetic compound that belongs to the propionic acid derivative chemical class. The medication is a monotherapy, utilizing Ketoprofen as the single active ingredient. This classification confirms the drug’s role in managing the symptoms of inflammatory conditions, which involves its potent combined inhibition of COX-1 and COX-2 enzymes.

What Does "Retard" Mean for the Tablet Form?

The designation "retard" in Profenid retard signifies the specific pharmaceutical preparation as a sustained-release formulation, making it distinct from immediate-release tablets. This prolonged-release tablet is engineered with a special solid matrix composition that controls the gradual liberation of Ketoprofen into the body.

This feature is a key differentiating factor, as the sustained-release design ensures that therapeutic concentrations of the drug are maintained consistently over an extended period. This mechanism is intended to improve patient convenience by utilizing an extended-release NSAID delivery system.

What is the General Purpose of Profenid retard?

The general therapeutic purpose of Profenid retard is to provide a comprehensive triple action effect, offering simultaneous anti-inflammatory, analgesic, and antipyretic relief. This effect is derived from Ketoprofen's function as a cyclooxygenase inhibitor, effectively limiting the production of prostaglandins, which are chemical messengers responsible for causing pain and inflammation.

This combined action means the drug's primary role is systemic symptomatic relief, such as easing the generalized joint pain and swelling characteristic of rheumatic conditions. The medication addresses the key symptomatic triad by simultaneously reducing inflammation, alleviating the associated pain, and helping to normalize an elevated body temperature.

Regulatory References

  1. MedlinePlus: Ketoprofen Drug Information
  2. NIH: Ketoprofen - LiverTox

What side effects are possible with Profenid retard?

Possible Side Effects and Safety Information

The safety profile of Profenid retard (Ketoprofen) is defined by classifications found in official regulatory documents, grouping potential adverse reactions by the body system affected and their reported frequency.


Adverse Reaction Categories

Adverse effects are documented across various System-Organ Classes (SOC), with effects on the Gastrointestinal (GI) Disorders and Nervous System Disorders being frequently listed. Common adverse reactions include dyspepsia, nausea, abdominal pain, headache, and dizziness.

Classification Examples of Reactions
Common Dyspepsia, nausea, abdominal pain, headache, somnolence.
Uncommon/Rare Hypertension, peripheral edema, severe GI complications.

Serious Adverse Reactions and Safety Constraints

Official labeling highlights the risk of Serious Adverse Reactions (SARs), which, while rare, are critical safety considerations for this class of medicine. These include the risk of serious cardiovascular thrombotic events (such as Myocardial Infarction or Stroke) and severe Gastrointestinal ulceration, bleeding, or perforation.

The risk of cardiovascular events may increase with the duration of use. Conversely, some GI effects may be more common at the start of treatment.

Safety constraints prohibit the use of the medicine in patients with active peptic ulcer/GI haemorrhage, severe heart failure, severe renal failure, or those with a history of anaphylactoid reactions to other NSAIDs or aspirin.


Population-Specific Safety Notes

Regulatory documents state that older adults are at a greater risk for serious gastrointestinal adverse events. Use is generally contraindicated around or after 20 weeks of pregnancy due to documented risks of fetal harm.

Overdose and Emergency Response

If you suspect an overdose of Profenid retard (ketoprofen sustained-release), you must seek immediate medical attention. The severity of symptoms can vary significantly based on the amount taken and individual factors. Given that Profenid retard is an extended-release formulation, the effects of an overdose may be delayed.

Potential Overdose Symptoms

Symptoms of a significant overdose involving the active ingredient ketoprofen, a non-steroidal anti-inflammatory drug (NSAID), primarily involve the digestive and central nervous systems. They can include:

System Common/Early Signs Severe/Late Signs
Gastrointestinal Nausea, vomiting (sometimes bloody), abdominal pain, diarrhea. Gastrointestinal bleeding, ulceration.
Neurological Headache, dizziness, drowsiness. Seizures, confusion, agitation, coma (in severe cases).
Other Ringing in the ears (tinnitus). Acute kidney failure, low blood pressure, difficulty breathing.

When to Seek Help

Contact your local emergency services immediately if you or someone else has taken more than the prescribed dose, even if no symptoms are present. Do not wait for severe symptoms to appear. The treatment for ketoprofen overdose is generally supportive, focusing on managing symptoms and stabilizing the patient. Medical professionals may use activated charcoal or employ other measures to limit drug absorption, depending on the elapsed time since ingestion.

Therapeutic Uses of Profenid retard

What Profenid retard Treats: Main Uses and Benefits

Profenid retard (Ketoprofen) is commonly used across conditions presenting with both acute and chronic symptoms related to inflammatory or irritative states.

Symptomatic Relief in Inflammatory and Painful Conditions

This medication is generally considered relevant for managing symptoms that interfere with daily functioning across conditions characterized by periods of heightened symptoms. It is applied across therapeutic domains where additional symptomatic support is needed, notably in chronic conditions like rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis, as well as in acute episodes such as gouty arthritis, sprains, and postoperative pain. Profenid retard is used to address the core symptom clusters of joint pain, swelling, and fever.

“It is often used during phases when symptoms become more noticeable and when short-term symptomatic assistance is needed.”

The prolonged-release feature is relevant for continuous symptomatic control. This unique delivery supports patients during difficult episodes, assisting with maintaining functional stability and contributing to easing the overall symptom load.


Quick Fact: Relief for Nocturnal Discomfort The sustained-release profile supports patients during episodes of heightened discomfort, such as when symptoms interfere with sleep, contributing to general well-being during symptomatic phases.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Official Population Eligibility Rules

Absolute Contraindications

Profenid retard is strictly contraindicated for patients with known hypersensitivity to Ketoprofen, aspirin, or other nonsteroidal anti-inflammatory drugs (NSAIDs), including those with aspirin-sensitive asthma. It must not be used to treat perioperative pain in the setting of Coronary Artery Bypass Graft (CABG) surgery. Use is also prohibited for individuals with active peptic ulcer or a history of serious Gastrointestinal (GI) bleeding, as well as for those with severe hepatic or severe renal insufficiency.

Age and Physiological Restrictions

The drug is contraindicated during the last trimester of pregnancy (from 30 weeks gestation onward). The safety and efficacy are NOT established in the pediatric population (under 18 years of age) according to official regulatory documents. Elderly patients are noted to be at greater risk for serious GI and renal adverse events and require special caution. Individuals with moderate organ impairment or conditions like uncontrolled hypertension are restricted to closely monitored, limited use, as classified in official labeling.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Profenid retard (Ketoprofen) focuses on pharmacological classes that may alter drug exposure or result in additive risks, as outlined by regulatory authorities.

Documented Interaction Patterns

Interaction Type Interacting Agent Category Official Outcome Description
Contraindicated Use Other NSAIDs / Aspirin Significantly increased risk of serious gastrointestinal adverse events, including bleeding and perforation.
CABG Surgery (Peri-operative) Formal prohibition due to increased risk of serious cardiovascular thrombotic events (myocardial infarction and stroke).
Increased Bleeding Risk Oral Anticoagulants (e.g., Warfarin), Corticosteroids, SSRIs Documented additive risk of hemorrhage and gastrointestinal adverse events.
Exposure Modification Lithium, Methotrexate Co-administration elevates plasma concentrations and reduces the renal clearance of these agents, increasing the risk of toxicity.
Pharmacodynamic Diuretics, ACE Inhibitors / ARBs May diminish the antihypertensive and natriuretic effects; increased risk of renal impairment, particularly in susceptible populations.

Restrictions and Considerations

The administration of Alcohol is cited as a risk factor that officially increases the potential for serious gastrointestinal bleeding. For patients with pre-existing renal or hepatic impairment, the risk for drug accumulation and interaction-related adverse events is heightened, requiring specific consideration based on official labeling. The interaction profile highlights that Ketoprofen is not documented to induce drug-metabolizing enzymes.

Mechanism of Action

Modulation of Eicosanoid Synthesis

The active ingredient, Ketoprofen, functions as a non-selective, reversible inhibitor of the Cyclooxygenase (COX-1 and COX-2) enzymes. This interaction suppresses the arachidonic acid cascade, which is the major pathway responsible for the production of pro-inflammatory prostaglandins ( PGE2). The resulting physiological effect is the dampening of mediators that drive vasodilation and increased vascular permeability.


Dual Action on Nociceptive Signal Modulation

The drug engages two mechanisms to alter nociceptive signal sensitization: it reduces prostaglandin-mediated hyper-responsiveness of peripheral nerve endings, and it exerts an additional antagonistic effect on bradykinin function. By influencing both these chemical mediators, the mechanism contributes to the modulation of peripheral nociceptive excitability.


Central Thermostatic Control

Ketoprofen's high lipid solubility enables it to cross the blood-brain barrier to access the hypothalamus in the central nervous system. Once there, it inhibits PGE2 synthesis. This action leads to the physiological adjustment of the thermoregulatory set-point, facilitating processes of heat dissipation.

Dosage and Administration Information

The prolonged-release form of ketoprofen, typically supplied as a 200 mg unit dose, is administered via the oral route. This medication is specifically designed for a once-daily schedule, with the 200 mg dose representing the maximum daily limit for this particular formulation.


Official Administration Procedures

To preserve the prolonged-release mechanism, the capsule or tablet must be swallowed whole and must not be cut, crushed, or chewed. Each dose should be taken with a full glass of water. The medication may be taken with food, milk, or an antacid. After ingestion, the user should not lie down for at least 10 minutes.

The treatment is generally intended for the shortest duration consistent with the clinical plan. For pediatric patients, the safety and effectiveness of this formulation have not been established.


Dose Adjustment and Missed Dose Rules

Specific dose ceilings apply for adult patients with organ impairment. For those with severe renal or hepatic impairment, the maximum recommended daily dose must be reduced to 100 mg/day. Patients with mild renal impairment have a maximum dose limit of 150 mg/day.

If an administration is forgotten, the missed dose is skipped and the regular once-daily schedule is resumed. A double dose should not be taken to compensate for the skipped dose.

Recent Clinical Evidence

Profenid retard: Recent Clinical Evidence

Profenid retard is an extended-release formulation of ketoprofen, a nonsteroidal anti-inflammatory drug (NSAID). Research on this formulation focuses on its unique pharmacokinetic profile and its role in managing long-term inflammatory conditions.


Extended-Release Pharmacokinetics

Studies have investigated how the extended-release formulation maintains therapeutic concentrations of ketoprofen over a longer period compared to immediate-release formulations. Pharmacokinetic studies have shown that Profenid retard exhibits a slower dissolution rate, resulting in a more sustained release of the active ingredient. This mechanism is designed to reduce the peaks and troughs in plasma concentration typically seen with standard ketoprofen, supporting once-daily dosing.


Clinical Efficacy and Patient Cohorts

Clinical trials have evaluated the use of extended-release ketoprofen for managing the signs and symptoms of chronic inflammatory conditions, primarily osteoarthritis and rheumatoid arthritis. Post-marketing surveys involving large patient cohorts with osteoarthritis have been conducted to assess pain control over time. One such survey noted that a substantial percentage of patients achieved satisfactory pain control with extended-release ketoprofen monotherapy. Clinical evaluations have also compared the extended-release formulation with older NSAIDs in terms of symptom control.


Safety Profile in Research

The safety profile observed in clinical trials for the extended-release formulation is generally consistent with the known class effects of NSAIDs. Common adverse events reported by participants include gastrointestinal disturbances, such as dyspepsia and abdominal pain, along with headache and dizziness. Trials monitor the rate of treatment discontinuation due to adverse events, and specific attention is given to the digestive system, as is standard for NSAID research.

Frequently Asked Questions (FAQ)

Common questions about Profenid retard (FAQ)

Q: Is Profenid retard used only for chronic conditions like arthritis?

The extended-release formulation is primarily indicated for the long-term management of signs and symptoms associated with chronic inflammatory conditions such as rheumatoid arthritis and osteoarthritis. While the active ingredient is a general pain reliever and anti-inflammatory, official product information notes that the extended-release capsule is not typically intended for treating immediate, acute pain.

Q: Can Profenid retard be used to relieve general muscle or soft tissue pain?

This medication contains Ketoprofen, a non-steroidal anti-inflammatory drug (NSAID) with general pain-relieving (analgesic) properties. According to official product information, it is indicated for managing pain and inflammation. However, the extended-release form is usually described in official documents in the context of chronic pain and inflammation, rather than isolated or short-term muscle or soft tissue pain.

Q: How long does it typically take to feel the first pain relief effect after taking the capsule?

As a controlled-release formulation, the drug is released gradually over time. Studies indicate that the concentration of the active ingredient in the bloodstream begins to increase around 2 to 3 hours after the capsule is taken. Peak plasma concentrations are generally reached 6 to 7 hours after dosing, which is the point where the highest amount of the active ingredient is measured in the blood.

Q: How long is Profenid retard active in the body?

The extended-release formulation is specifically designed to provide consistent concentrations of the active ingredient over an extended time to support a once-daily schedule. The mean elimination half-life, which is the time it takes for half the drug to be cleared from the body, has been reported to be approximately 5.4 hours.

Q: What are the signs of a serious allergic reaction to Profenid retard?

Official labeling advises patients to be aware of signs of an anaphylactoid reaction, including difficulty breathing, swelling of the face or throat, rash, itching, or hoarseness. Official labeling indicates that in the event these signs occur, prompt medical attention is necessary.

Q: What risk factors increase the chance of experiencing serious side effects?

Official documents describe that some individuals may have a greater risk of serious side effects. Risk factors noted in official labeling include advanced age, pre-existing cardiovascular disease, a history of stomach ulcers or gastrointestinal bleeding, smoking, alcohol use, and prolonged use of this class of medication.

Q: What warning signs should patients look for regarding potential kidney problems?

Official patient guides describe common warning signs that are important to be aware of, due to the potential for NSAIDs to affect kidney function. These signs may include a decrease in the amount of urine, blood in the urine, lower back or side pain, swelling of the face or lower legs, or unusual tiredness.

Q: Can Profenid retard be taken at the same time as paracetamol (acetaminophen)?

Formal regulatory interaction checks between the active ingredient and paracetamol generally do not show a contraindication or formal drug interaction. Combining paracetamol with NSAIDs is frequently cited in clinical guidance when discussing combined approaches for managing pain.

Q: What are the restrictions on driving or operating machinery while taking this medication?

Official product information notes that this medicine may cause side effects such as dizziness, drowsiness (somnolence), or blurred vision. Due to these potential effects, official information notes that driving, operating heavy machinery, or engaging in activities requiring alertness should be avoided until an individual knows how this medication affects them.

Q: Does Profenid retard make the skin more sensitive to the sun?

Photosensitivity (increased skin sensitivity to light or sunlamps) has been reported as a potential adverse reaction in official product labeling. Due to this potential adverse reaction, official safety information highlights the importance of limiting sun exposure and using protective clothing.

Q: What is the difference between Profenid retard and Ketoprofen immediate-release?

The core difference lies in their release mechanisms and effect profiles. The extended-release form uses a special design to release the drug at a controlled, slower rate, resulting in a significantly delayed time to peak concentration (6–7 hours) and a longer half-life (around 5.4 hours). In contrast, the immediate-release form releases the drug much faster, resulting in a quicker, shorter effect.

How should Profenid retard be stored and disposed of?

Storage and Disposal for Profenid Retard (Ketoprofen)

The storage and disposal of Profenid retard must strictly adhere to the requirements documented in regulatory labeling to maintain product stability and safety.

Storage Conditions

The medicine must be stored at Controlled Room Temperature (CRT), defined as 20^circ to 25 C (68^circ to 77 F). The product must be kept from freezing, excessive heat, and moisture. It is required to store the tablets in their original container and keep the container tightly closed and out of the reach of children.

Disposal Requirements

Unused or expired Profenid retard should not be discarded in household trash or flushed down the toilet. Patients must consult a healthcare professional or pharmacist for instructions on the proper disposal of the product according to local regulations.

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

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