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Brufen Retard

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Brufen 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 Brufen Retard

Quick Facts

Property Description
Active ingredient Ibuprofen
Form Prolonged-release tablet
Pharmacological class Nonsteroidal Anti-Inflammatory Drug (NSAID)
Common use Relief of pain, inflammation, and fever
Origin Synthetic compound

What Type of Medicine is Brufen Retard? (Classification and Identity)

Brufen Retard is a pharmaceutical preparation containing the active substance Ibuprofen, which belongs to the Nonsteroidal Anti-Inflammatory Drug (NSAID) pharmacological class. This synthetic compound is clinically recognized for its reliable action as an analgesic (pain-relieving), anti-inflammatory, and antipyretic (fever-reducing) agent. Ibuprofen is widely recognized for its clinical importance in managing core symptoms. As an NSAID, it differs from simple analgesics by possessing a significant anti-inflammatory component, which targets the underlying cause of pain linked to tissue swelling.

Understanding the Prolonged-Release Tablet and Composition

The defining feature of Brufen Retard is its dosage form: a prolonged-release tablet intended for oral administration. Unlike conventional Ibuprofen products designed for immediate absorption, this single-ingredient product utilizes a specialized sustained-release formulation. This structure is designed to release the contained Ibuprofen gradually over time. Such formulations are designed to reduce dosing frequency and improve adherence. This formulation design provides the benefit of consistent, long-lasting relief from a single dose, making it suitable for managing persistent symptoms.

What is the General Purpose of Brufen Retard? (High-Level Benefit)

The primary general purpose of Brufen Retard is to deliver a sustained analgesic, anti-inflammatory, and antipyretic effect. The action of Ibuprofen works by diminishing the production of specific chemical messengers that initiate discomfort and swelling. Due to its unique prolonged-release tablet design, the overall benefit centers on maintaining a persistent, long-term reduction in symptoms like generalized pain and inflammation, supporting general well-being without the requirement for frequent dosing.

Regulatory References

  1. WHO
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What side effects are possible with Brufen Retard?

Brufen Retard: Possible side effects and safety information

Brufen Retard (ibuprofen) is a non-steroidal anti-inflammatory drug (NSAID). Its safety profile is defined by officially documented adverse reactions classified by frequency and System-Organ Class (e.g., gastrointestinal, nervous system, and skin).

Common side effects include headache, dizziness, dyspepsia, nausea, vomiting, diarrhoea, abdominal pain, and rash. Uncommon reactions may involve hypersensitivity, visual impairment, gastritis, gastrointestinal ulceration, and various forms of nephrotoxicity.

Serious Adverse Reactions and Warnings

Serious risks associated with NSAIDs like Brufen Retard, especially when used long-term or at high doses, include an increased risk of cardiovascular thrombotic events (such as myocardial infarction and stroke). The drug also carries a significant risk of severe gastrointestinal complications, including bleeding, ulceration, and perforation, which can be fatal. Immediate medical attention is required for signs of severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome or DRESS syndrome, or signs of heart problems.

Contraindications and Restrictions

Brufen Retard is contraindicated in patients with active or recurrent peptic ulcers, severe heart, liver, or renal failure, or those who have had allergic reactions (asthma, urticaria) to ibuprofen or other NSAIDs. Use is strictly avoided during the third trimester of pregnancy due to risks to the fetus. Caution is advised for elderly patients and those with a history of heart failure or hypertension, as fluid retention and oedema have been reported. The lowest effective dose should be used for the shortest duration necessary.

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Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information describes the overdose profile for Ibuprofen (the active substance in Brufen Retard) as primarily involving the gastrointestinal and central nervous systems. Management is strictly symptomatic and supportive, as no specific antidote is known.

Documented Manifestations and Severe Outcomes

Classification Official Regulatory Finding
Common Manifestations Nausea, Vomiting, Abdominal pain, Headache, Dizziness, Drowsiness, Tinnitus, Nystagmus.
Severe Outcomes Convulsions, Coma, Acute Renal Failure, Metabolic Acidosis, Hypotension, Gastrointestinal bleeding.

Required Emergency Actions

Regulatory authorities mandate that immediate medical attention must be sought if an overdose is suspected or if more than the maximum recommended dose has been taken. This is due to the potential for life-threatening outcomes affecting the cardiac, renal, and central nervous systems, particularly following a large ingestion.

Hospital observation is required, and procedures may include the use of activated charcoal or gastric lavage, where appropriate, to limit absorption. Continuous monitoring of vital signs and assessment of acid-base status are necessary. Official labeling also notes that children may be more susceptible to Central Nervous System toxicity, including the risk of convulsions, compared to adults.

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Therapeutic Uses of Brufen Retard

Main Uses and Benefits of Brufen Retard

Brufen Retard is a sustained-release formulation of ibuprofen, a non-steroidal anti-inflammatory drug (NSAID). It is designed to provide a gradual release of the active ingredient into the bloodstream, allowing for prolonged management of symptoms associated with inflammation and pain.

Therapeutic Indications

Brufen Retard is primarily used for the symptomatic treatment of various inflammatory and painful conditions, including:

  • Rheumatoid Arthritis and Osteoarthritis: Management of joint pain, swelling, and stiffness associated with chronic degenerative and inflammatory joint diseases.
  • Ankylosing Spondylitis: Relief of pain and inflammation affecting the spine and large joints.
  • Soft Tissue Injuries: Treatment of symptoms resulting from sprains, strains, and other musculoskeletal injuries.
  • Other Musculoskeletal Conditions: Management of pain in conditions such as frozen shoulder (capsulitis), bursitis, tendonitis, and low back pain.

Mechanism of Action and Benefits

The active substance works by inhibiting the production of prostaglandins, which are chemicals in the body that signal pain and trigger inflammation. By reducing the concentration of these substances, the medication helps alleviate discomfort and reduce physical swelling in affected tissues.

The sustained-release nature of this specific formulation offers several clinical benefits:

  • Prolonged Symptom Control: The gradual release of the medication helps maintain consistent levels of the active ingredient in the blood, which is particularly useful for managing nocturnal pain and morning stiffness.
  • Reduced Frequency of Administration: Because the effect lasts longer than standard immediate-release formulations, fewer doses are required throughout a 24-hour period.
  • Management of Chronic Inflammation: It is specifically structured for long-term management of chronic conditions where continuous anti-inflammatory action is required.

Regulatory References

  1. NIH StatPearls overview of Ibuprofen uses
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Eligibility and Restrictions for Use

Who can and cannot use Brufen Retard?

This section outlines the official population eligibility rules for Brufen Retard (Ibuprofen prolonged-release tablets), as defined by governmental regulatory authorities.


Eligibility Scope

Category Official Regulatory Statement
Populations for whom use is allowed Adults and adolescents over 12 years of age (weighing 40 kg)
Populations for whom use is not recommended Children under 12 years; women attempting to conceive; breastfeeding women (use generally avoided)
Populations for whom use is contraindicated Patients with severe organ failure (heart, renal, or hepatic); active or history of recurrent gastrointestinal bleeding/ulcers; known hypersensitivity to NSAIDs; women in the last trimester of pregnancy; use for peri-operative pain in CABG surgery

Eligibility-Related Restrictions

Use requires special caution and careful consideration for several population groups. This includes the elderly and patients with pre-existing, non-severe conditions such as mild-to-moderate congestive heart failure or uncontrolled hypertension. Use is also restricted in those with non-severe renal or hepatic impairment, requiring monitoring of organ function. During the first and second trimesters of pregnancy, use is permitted only if clearly necessary, employing the lowest dose for the shortest duration.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Officially documented interaction patterns for Brufen Retard (Ibuprofen) detail specific restrictions and regulatory cautions concerning co-administration with other substances.

Documented Interaction Restrictions

The regulatory label for Ibuprofen indicates that co-administration with other NSAIDs, including COX-2 selective inhibitors, is generally restricted due to the additive risk of gastrointestinal ulceration and bleeding. Furthermore, the combination with high-dose aspirin is not recommended. Ibuprofen's pharmacodynamic profile requires that it be taken at least 8 hours before or 30 minutes after a dose of low-dose immediate-release aspirin to prevent interference with aspirin’s antiplatelet effects.

Exposure and Clearance Modification

Ibuprofen interacts with medicines that rely on metabolic processes or renal clearance. As a CYP2C9 substrate, co-administration with CYP2C9 inhibitors (e.g., Fluconazole) increases Ibuprofen plasma exposure. Ibuprofen also decreases the elimination and increases the plasma levels of drugs like Lithium and Methotrexate. These pharmacokinetic interactions necessitate regulatory caution for exposure management.

Pharmacodynamic Effects

Official documents note that Ibuprofen enhances the effects of anticoagulants (e.g., Warfarin), increasing the risk of hemorrhage. Conversely, it reduces the anti-hypertensive and diuretic effects of medications such as ACE inhibitors and ARBs. The risk of adverse events, particularly GI bleeding, is also increased when co-administered with Corticosteroids or SSRIs.

Non-Medicinal Substance Cautions

Regulatory cautions specify that concomitant use of Alcohol or Ginkgo biloba herbal medicine may potentiate the risk of bleeding or gastrointestinal undesirable effects.

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Mechanism of Action

The mechanism of action for Brufen Retard is fundamentally driven by its active ingredient, Ibuprofen, which targets the Cyclooxygenase (COX) enzyme system. The drug functions as a non-selective, reversible competitive inhibitor of both the COX-1 and COX-2 isoenzymes. This molecular interaction prevents the conversion of Arachidonic Acid into Prostanoids, including Prostaglandins.

By suppressing Prostaglandin production, Ibuprofen directly modulates inflammatory and thermal regulatory signaling pathways. This interference reduces the chemical mediators responsible for sensitizing peripheral nerve endings (nociceptors) and promoting local vasodilation and capillary permeability. This results in a suppression of physiological processes driven by excessive mediator activity.

The suppression of Prostaglandin E2 ( PGE2) drives two separate physiological outcomes. Peripherally, it decreases nociceptor sensitization. Centrally, PGE2 suppression alters the central thermal regulatory process by modulating the elevated temperature set-point in the hypothalamic thermoregulatory center.

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Dosage and Administration Information

Administration Guidelines for Brufen Retard

Brufen Retard is an oral medication designed as a prolonged-release tablet, meaning its administration is governed by specific constraints to ensure the sustained effect is maintained. The tablet must be swallowed whole with sufficient fluid and must not be crushed, chewed, or broken before ingestion, as these actions would compromise the modified-release mechanism. For patients experiencing stomach sensitivity, the tablet should be taken with or immediately after food.


Dosing and Scheduling Patterns

The established principle for using Brufen Retard is to employ the lowest effective dose for the shortest duration necessary to control symptoms. The following high-level dosage patterns are utilized:

Feature Guideline
Standard Daily Dose 1,600 mg (two 800 mg tablets).
Maximum Daily Dose 2,400 mg.
Frequency Usually a single dose once daily.
Timing Standard single dose is often recommended for the early evening.

Population-Specific Use and Constraints

Administration rules vary slightly across patient groups. Adolescents aged 12 years and older (weighing 40 kg or more) follow the same standard adult dosing regimen. However, Brufen Retard is generally not recommended for children under 12 years. For the elderly and patients with established renal or hepatic impairment, an individualized dosage assessment is required, ensuring that the dose be kept as low as possible to align with the lowest-dose principle.

This protocol ensures the administration method is aligned with the specific formulation of the drug and provides a structured frequency pattern (typically once daily).

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Recent Clinical Evidence

Research evidence / Overview of studies for Brufen Retard


Evidence for use in Osteoarthritis and Musculoskeletal Pain

Research was studied for its relevance in Osteoarthritis (OA), a condition characterized by fluctuating or episodic manifestations. Studies exploring this area include Randomized Controlled Trials (RCTs) and comparative trials, as well as specialized pharmacokinetic research. The research examined outcomes related to physical discomfort, stiffness, and functional capacity, with a key focus on measuring patterns related to symptomatic control over defined time intervals. Findings describe patterns observed in the studies regarding the release profile of the formulation and how the measured outcomes evolved in the observed populations. This research contributes to the broader evidence landscape.

However, certain aspects remain uncertain. Follow-up durations were limited in some of the specific comparative efficacy trials. Furthermore, long-term outcomes are not well characterized beyond several months for the prolonged-release formulation specifically. Research so far provides limited insight into whether this treatment influences non-symptomatic or structural changes in the joints over many years.


Evidence for use in Rheumatoid Arthritis and Inflammatory States

The prolonged-release formulation was studied for research settings applied in studies examining patient-reported experiences related to conditions involving periods of heightened symptoms like Rheumatoid Arthritis (RA). Research examined outcomes linked to inflammatory or irritative states and persistent pain. These studies monitored outcomes capturing phases of heightened symptom activity, such as joint swelling and the duration of morning stiffness. Findings indicate patterns related to symptomatic control in this patient population. Early comparative studies reported how symptoms evolved, and findings indicate patterns related to dose-response or tolerance were observed in some RA patients compared to patients with OA.


What is Still Uncertain About Brufen Retard Research

The research landscape, while containing high-level evidence for symptomatic management, still contains gaps. One research limitation frames the issue: certain specific efficacy trials comparing the prolonged-release product to standard formulations or placebo had sample sizes were modest. Furthermore, research does not determine whether an individual will respond similarly, as findings describe group patterns, not personal outcomes. The evidence is limited in that there is a distinct lack of long-term data specifically tracking non-symptomatic or structural outcomes over several years for the prolonged-release formulation. Research so far provides insight into short-term changes, but ongoing investigation is still needed in several areas.

Key Studies & References

  1. Ibuprofen (NIH StatPearls)
  2. Modified-Release Ibuprofen Products: Formulation, Clinical Implication, and Pharmacoeconomics (Review)
  3. WHO Model List of Essential Medicines (Ibuprofen inclusion)
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Frequently Asked Questions (FAQ)

Common questions about Brufen Retard (FAQ)


Q: Why is this specific formulation called 'Brufen Retard'?

The term 'Retard' in pharmaceutical naming is used to describe the prolonged-release nature of the medication. This means the tablet is specially designed to release the active ingredient, ibuprofen, gradually over an extended period. This mechanism is intended to provide a sustained effect, contrasting with standard tablets which release the drug all at once.


Q: What type of pain is Brufen Retard typically approved to treat?

Official regulatory documents authorize the drug for the symptomatic relief of pain and inflammation. This often includes persistent conditions such as rheumatoid arthritis and osteoarthritis. The medication works by targeting the underlying inflammatory processes that contribute to discomfort.


Q: How does the prolonged-release mechanism of Brufen Retard work in the body?

Brufen Retard is manufactured as a modified-release formulation, which is structurally designed to control the rate at which the active substance is released. Instead of being absorbed immediately, the ibuprofen is released slowly over time. This sustained process is designed to provide a longer-lasting effect from a single tablet.


Q: Is it necessary to take Brufen Retard with food, according to official guidance?

Official guidance indicates that taking the tablet with or immediately after food is a conditional recommendation. This practice is advised specifically for patients who may experience stomach sensitivity when taking the medication. This recommendation is provided based on the goal of minimizing potential gastrointestinal discomfort.


Q: What are the signs of a severe allergic reaction to Brufen Retard?

Severe allergic reactions require immediate medical attention, and the official product information lists several signs to watch for. These can include noticeable swelling of the face, lips, tongue, or throat, or the sudden onset of severe skin reactions. Difficulty breathing is also listed as a serious sign that requires urgent care.


Q: Does using Brufen Retard affect fertility in men or women?

According to official regulatory documents, the use of ibuprofen may temporarily impair female fertility. The official documentation describes that, due to this temporary effect, use is generally avoided in women who are actively attempting to conceive. The effect is described as being reversible upon discontinuation of the medication.


Q: Can Brufen Retard cause light sensitivity or skin reactions?

Official documents list various skin-related reactions, including rash as a common side effect and the potential for rare, severe cutaneous reactions. Photosensitivity, meaning an exaggerated reaction to sunlight, is sometimes noted as an uncommon or rare effect.


Q: What is the typical time frame for the initial onset of action after taking the tablet?

Pharmacokinetic studies, which examine how the drug is handled by the body, provide data on the concentration profile. The initial onset of the medication's effect is often observed approximately 1–2 hours after taking the tablet.


Q: Does Brufen Retard commonly cause drowsiness or fatigue?

Official documentation categorizes adverse effects by frequency. Drowsiness or fatigue is described as an uncommon side effect. Conversely, effects such as headache and dizziness are listed among the common side effects of the medication.


Q: How does Brufen Retard compare to other extended-release NSAIDs in terms of half-life?

Official documents describe the elimination half-life of the active substance, Ibuprofen, in the plasma. The half-life is a measurable property that defines how long it takes for half of the drug to be eliminated from the body. This data is available in the pharmacokinetic section of the product information.


Q: What is the official recommended maximum duration for continuous use of Brufen Retard?

Official labeling consistently emphasizes that the drug should be used for the shortest duration necessary to control symptoms. Regulatory guidance may specify a maximum number of days for non-prescription use, before a healthcare provider re-evaluation is required.


Q: Can Brufen Retard be associated with issues of dependence or addiction?

As described in regulatory documentation, the active substance, ibuprofen, is classified as a non-opioid pain reliever. It is not associated with issues of physical dependence or addiction.


Q: Where can I find the official regulatory documents (SmPC or package leaflet) for Brufen Retard?

Official product information, such as the Summary of Product Characteristics (SmPC) or the patient information leaflet, is published by governmental health authorities. These documents are generally found on the websites of bodies like the European Medicines Agency (EMA) or the FDA (DailyMed).


Q: Is Brufen Retard available to purchase without a prescription in some regions?

The drug's legal classification, often referred to as its prescription status, is defined by the regulatory authority in each local jurisdiction. This means that whether Brufen Retard is available over-the-counter or requires a prescription can vary by country or even by the specific tablet strength.


Q: Are there any specific dietary restrictions to be aware of when taking Brufen Retard?

Official product documents caution users against the concomitant use of alcohol and the herbal medicine Ginkgo biloba due to potential increased risks. However, they do not generally specify major restrictions concerning common food types.


Q: What should I do if I miss a dose of Brufen Retard?

The standard instruction in the patient information leaflet is to take the next dose at the usual scheduled time. Furthermore, the label states that a double dose should not be taken to compensate for a missed one.


Q: Does Brufen Retard carry a known risk of aseptic meningitis, as with other NSAIDs?

Regulatory documentation lists aseptic meningitis as an undesirable effect associated with the use of ibuprofen. This condition is described as a rare effect and is a known, though infrequent, risk with the NSAID class of medicines.

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How should Brufen Retard be stored and disposed of?

How to Store and Dispose of Brufen Retard?

The official storage and disposal requirements for Brufen Retard tablets are defined by regulatory documentation to ensure product stability and effectiveness.

Storage Conditions

Requirement Specifics
Temperature Do not store above 25 C.
Protection Store in the original package.
Shelf-Life The official shelf-life is 36 months.

Storage in the original package is required to protect the tablets from light and moisture. The mandated temperature control is essential to maintain the product's stability throughout its shelf-life. While no specific, universal disposal instructions are detailed in the storage section, unused or expired medicine must be returned to a pharmacist or disposed of according to local environmental regulations, as is common practice for medicinal products.

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

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