Brustan

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Brustan

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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.

Overview of Brustan

Quick Facts

Property Description
Active Ingredients Ibuprofen, Paracetamol (Acetaminophen)
Form Oral Tablet, Oral Suspension
Pharmacological Class Combination Analgesic, Combination Antipyretic, NSAID member
General Purpose Symptomatic relief of pain, fever, and inflammation
Origin Synthetic

What is the Composition and Class of Brustan?

Brustan is defined as a synthetic, fixed-dose combination medicine containing two distinct active pharmaceutical ingredients: Ibuprofen and Paracetamol (Acetaminophen). This product is categorized primarily as a Combination Analgesic and Antipyretic, with its Ibuprofen component belonging to the Non-Steroidal Anti-Inflammatory Drug (NSAID) pharmacological class. The inclusion of both components in a single preparation is the defining characteristic of this drug entity. The combination of these two agents is designed to provide analgesia through the interaction of its components. This formulation is intended for achieving general pain relief.


Brustan’s Forms and General Therapeutic Purpose

Brustan is an oral medication available primarily in the dosage forms of a film-coated tablet and an oral suspension (such as Brustan NF Suspension). These preparations are formulated for systemic delivery via the oral route of administration. The availability of the oral suspension form is a differentiating factor, as it specifically targets pediatric patients or adults who may have difficulty swallowing tablets. The general therapeutic purpose of this fixed combination is to provide multimodal analgesia, a strategy that utilizes multiple non-overlapping mechanisms to manage symptoms. Fixed-dose combination products of this nature are generally utilized for the short-term treatment of mild to moderate pain. This reflects the drug's general use in reducing common discomforts.


Understanding the Multimodal Action

The design of Brustan leverages the complementary actions of Ibuprofen and Paracetamol to target symptoms simultaneously. This combination is utilized for its role in addressing general pain and elevated temperatures. The synergy between the components is intended to enhance the compound's overall effectiveness against discomfort and fever. The general benefits derived from this combined action are comprehensive: pain relief, the reduction of an elevated body temperature (antipyretic effect), and the alleviation of physical swelling and tissue inflammation due to the properties of the NSAID component.

Regulatory References

  1. About the MHRA
  2. MHRA Combined Pain Relief Approval

What side effects are possible with Brustan?

Brustan, a combination of Ibuprofen (a non-steroidal anti-inflammatory drug or NSAID) and Paracetamol (Acetaminophen), is generally well-tolerated when used at recommended doses for short periods. However, like all medications, it can cause side effects and requires specific precautions.


Common Side Effects

The most frequent adverse effects are typically gastrointestinal. These may include:

  • Gastrointestinal: Nausea, vomiting, heartburn, indigestion (dyspepsia), diarrhea, constipation, and stomach pain.
  • Nervous System: Headache, dizziness, and drowsiness.

If any of these side effects persist or worsen, consult a healthcare provider.


Serious and Long-Term Risks

Gastrointestinal Complications: Long-term use or high doses increase the risk of serious events such as gastrointestinal bleeding, ulceration, and perforation, which can be fatal. This risk is higher in the elderly and those with a prior history of ulcers.

Cardiovascular Risk: NSAIDs may increase the risk of serious cardiovascular thrombotic events, including heart attack and stroke, especially with long-term, high-dose use. Brustan is contraindicated for pain treatment before or after coronary artery bypass graft (CABG) surgery.

Liver and Kidney Damage: Both components carry a risk. Excessive paracetamol intake or long-term use can lead to serious liver damage (hepatotoxicity). Long-term use of Ibuprofen can lead to kidney damage (renal papillary necrosis and other renal conditions).

Allergic Reactions: Seek immediate medical attention if you develop signs of a severe allergic reaction (anaphylaxis), such as hives, difficulty breathing, or swelling of the face, throat, or tongue. Severe skin reactions, including Stevens-Johnson Syndrome (SJS), have also been reported.


Contraindications and Warnings

Brustan should be avoided by individuals with a known allergy to ibuprofen, paracetamol, aspirin, or other NSAIDs, as well as those with:

  • Active or recurrent peptic ulcer or gastrointestinal bleeding.
  • Severe heart, liver, or kidney impairment.
  • Late-stage pregnancy (third trimester).

Alcohol Consumption: Concurrent use of Brustan and alcohol is strongly discouraged, as it significantly increases the risk of stomach bleeding and severe liver damage.

Overdose and Emergency Response

Overdose Manifestations and Severe Outcomes

A Brustan overdose, due to the combination of Ibuprofen and Paracetamol, is strictly defined by regulatory bodies as a medical emergency. The documented profile is marked by the potential for severe, dual organ system damage. Initial manifestations may include nausea, vomiting, abdominal pain, severe headache, confusion, drowsiness, and Tinnitus.

The primary life-threatening outcomes documented in regulatory labeling are Acute Liver Failure (Hepatotoxicity) from the Paracetamol component and Acute Renal Failure from the Ibuprofen component. Overdose can also lead to profound metabolic changes, including Metabolic Acidosis, and severe neurological events such as seizures or coma.

Immediate Actions and Monitoring

Regulatory documents strictly mandate that individuals seek immediate medical attention by contacting emergency services or a Poison Control Center immediately upon known or suspected overdose. This action is critical because liver damage can be delayed, meaning symptoms may not appear immediately. Hospital monitoring is required and involves assessing vital signs and tracking laboratory parameters, including Serum Acetaminophen Concentration.

Management of the Paracetamol component is supported by a specific antidote, N-Acetyl Cysteine (NAC), though no specific antidote is known for Ibuprofen. Population-specific warnings note increased severity in the elderly and in patients with chronic alcoholism or malnutrition.

Therapeutic Uses of Brustan

What Brustan Treats: Main Uses and Benefits

Managing Acute Pain, Inflammation, and Discomfort

This fixed-combination medication is commonly used to help manage the combined symptomatic burden of mild to moderate pain and localized inflammation, and is considered relevant for conditions such as headaches, dental pain, musculoskeletal sprains, and dysmenorrhea (menstrual cramps). This combination is applied in contexts where supportive symptom management is needed for symptoms related to inflammatory or irritative states.

It is often used when symptoms intensify and supportive relief is needed for pain that interferes with daily functioning. The core therapeutic benefit contributes to symptomatic relief due to its combined analgesic benefit, which helps ease the overall burden of symptoms, contributing to improved comfort during periods of heightened symptoms. The rationale for this combination is its multimodal symptomatic support.

Relief for Systemic Fever, Aches, and Contextual Use

This medication is relevant in clinical settings marked by the heightened patient distress of elevated body temperature (fever) and generalized aches typical of seasonal or viral illnesses, such as colds or flu. Brustan helps address these symptom clusters that may appear suddenly, and is applied in addressing both elevated body temperature and symptoms related to systemic imbalance.

Common indications for which this medication is applicable include managing discomfort following minor surgical or dental procedures, addressing acute injuries, and supporting pediatric patients and adolescents with fever and pain. It offers symptomatic relief that helps patients cope more steadily with these difficult episodes, providing short-term symptomatic assistance and helping ease distress.

Quick Fact: Relief for Co-existing Symptoms
Primary Symptoms Pain, fever, and localized inflammation
Typical Severity Mild to moderate discomfort
Patient Benefit Supports general well-being during symptomatic phases

Regulatory References

  1. UK Government MHRA Regulatory Decision

Eligibility and Restrictions for Use

The eligibility profile for Brustan is determined by official government documentation, primarily based on the rules governing its Ibuprofen (NSAID) and Paracetamol components.

Contraindicated Populations

The medicine is absolutely contraindicated in patients with severe hepatic failure, severe renal failure, severe heart failure (NYHA Class IV), or active/recurrent peptic ulceration or GI bleeding. Use is also prohibited in patients with a known hypersensitivity to any of the active ingredients or other NSAIDs, or in those undergoing pain management for Coronary Artery Bypass Graft (CABG) surgery.

Age and Physiological Restrictions

Population Group Regulatory Status
Pediatric Use Adult formulations are not recommended for children under 12 years of age; use in infants under 3 months is generally contraindicated.
Older Adults Treatment must commence at the lowest effective dose due to the increased frequency of adverse reactions.
Pregnancy Contraindicated during the third trimester (30 weeks onward). Not recommended in the first and second trimesters unless clearly necessary.

Condition-Specific Limitations

Patients with mild-to-moderate renal or hepatic impairment, uncontrolled hypertension, or a history of inflammatory bowel disease require cautious, restricted use. Concomitant use with any other product containing Paracetamol or Ibuprofen is strictly prohibited.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Brustan, which contains Ibuprofen and Paracetamol, is governed by classifications defined in official regulatory documents regarding drug-drug and drug-substance interactions.

Category Official Regulatory Classification
Contraindicated Combinations Other NSAIDs (including COX-2 inhibitors) and any product containing Paracetamol (Acetaminophen) are formally prohibited. High-dose Acetylsalicylic Acid (Aspirin >75 mg/day) is also restricted.
Exposure Alteration Co-administration with potent CYP2C9 inhibitors (e.g., Fluconazole) may lead to increased plasma concentrations of the Ibuprofen component.

Official Interaction Statements

Co-administration with Anticoagulants like Warfarin increases the documented risk of bleeding due to the Ibuprofen component inhibiting platelet function. The NSAID component also causes a reduction in the renal clearance of substances such as Lithium and Methotrexate, resulting in an officially documented increase in their serum levels and potential toxicity. When taken alongside Diuretics or Antihypertensives (ACE inhibitors, Angiotensin II Antagonists), the product may cause a documented reduction of the blood pressure-lowering effect and increase the risk of renal impairment, which is particularly relevant in elderly patients. Official warnings also note that concurrent use with alcohol increases the risk of both gastrointestinal bleeding and hepatic toxicity.

Mechanism of Action

Peripheral Enzyme Inhibition and Anti-Inflammatory Modulation

Ibuprofen acts as a non-selective inhibitor of Cyclooxygenase (COX) enzymes (COX-1 and COX-2) in peripheral tissues. By blocking the conversion of arachidonic acid into prostaglandins, this mechanism restricts the biochemical processes that drive prostaglandin-mediated nociception and vascular changes at the site of tissue stress. This action results in the physiological consequence of reduced local nociceptor sensitization and diminished prostaglandin-mediated vascular permeability.


Central Nervous System Pathway Modulation

Paracetamol primarily targets the Central Nervous System (CNS), interfering with COX activity in the hypothalamus to reduce the core temperature set-point, which initiates thermoregulatory dissipation processes. Furthermore, its action, potentially via an active metabolite, modulates pain signaling by engaging with TRPV1 and the endocannabinoid system within the spinal cord. This dual central action influences the hypothalamic set-point and enhances descending inhibitory nociceptive pathway activity.


Non-Overlapping Multimodal Pharmacodynamic Coordination

The drug employs multimodal pharmacodynamic coordination, where the two agents address different biological sites in the fever and pain pathways. Ibuprofen provides peripheral anti-inflammatory and analgesic action, while Paracetamol provides central analgesic and antipyretic modulation. This combined strategy targets both the generation of peripheral pain signals and the central perception/control of those signals, leading to a coordinated physiological modulation of the pain pathways.

Dosage and Administration Information

Instruction Map: How to Use Brustan — Administration Guidelines

This section describes the administration protocol for the Ibuprofen/Paracetamol fixed-dose combination.


Administration Scope

Instruction Detail
Route of administration Oral administration (tablet, caplet, or suspension form). An intravenous (IV) infusion is also utilized in hospital settings for similar fixed combinations.
Dosing schedule Standard Adult Dosing: One tablet (e.g., 400 mg Ibuprofen / 325 mg Paracetamol or 500 mg Paracetamol / 150 mg Ibuprofen) to be taken up to three times per day. Maximum Daily Dose: Must not exceed six tablets/caplets in a 24-hour period.
Timing in relation to meals The tablet or capsule should be taken with or after food or milk, and swallowed with water, to mitigate potential gastrointestinal irritation.
Age-group administration rules The combination tablet is typically not recommended for children under 12 years of age; however, age-appropriate liquid forms exist. For older adults, no specific dosage adjustment is required, but the lowest effective dose should be used for the shortest duration.
Missed-dose rules A minimum of six hours must elapse between doses. If a dose is missed, it should only be taken when the required interval has passed, ensuring the daily maximum is not exceeded.
Special procedural conditions The total daily dose must not be exceeded, and users are instructed not to concurrently take any other products containing Ibuprofen or Paracetamol. The treatment is for short-term use only, and should not generally exceed three days without professional review.

Connection to the Overall Use Protocol

Standard usage frameworks define a constrained protocol for the oral use of Brustan that prioritizes dose discipline and short duration. This structure is built around maintaining a minimum six-hour interval between administrations and adhering to a set daily maximum dose. These requirements standardize the administration of the medicine as a time-limited intervention.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Brustan

The evidence base for the Ibuprofen/Paracetamol combination relies primarily on short-term, randomized controlled trials (RCTs). The combination was studied for research exploring symptom changes related to physical discomfort in conditions characterized by acute or disruptive episodes of mild-to-moderate pain. This research often focused on specific research models for pain, such as pain following minor surgical procedures like dental extractions, where symptom axes related to physical discomfort could be readily measured.

Studies monitored specific measurements, such as scores reflecting patient-reported experience over the first six to eight hours. Findings indicate that the studies contribute to the broader evidence landscape examining physical discomfort. Follow-up durations were limited, meaning the evidence base provides limited insight into long-term symptom patterns or repeated use.

Studies Evaluating Relief from Fever (Elevated Body Temperature)

Research exploring the combination's use for elevated body temperature was evaluated in studies involving pediatric populations. These trials were often comparative, examining the fixed-dose combination against treatment using just Ibuprofen or just Paracetamol. The primary symptom axes studied were physiological measures, specifically patterns in body temperature measurement and the time interval monitored to assess temperature normalization.

In some trials, findings were mixed regarding differences in the reported outcomes when comparing the fixed-dose combination against monotherapies. Certainty remains low when comparing the fixed combination directly against the single-ingredient components in every study.

What is Still Uncertain in the Brustan Research Landscape

A primary limitation is the lack of long-term evidence for repeated use, as the majority of studies assessed only single-dose or very brief treatment periods. This means the research provides context but not individual predictions for long-term usage. Comparative evidence designed to definitively show advantage over the sequential or alternating use of the individual components is uncertain across all indications, and subgroup findings are uncertain due to modest sample sizes in some studies.

Key Studies & References Combined paracetamol and ibuprofen medicine approved for general sale (UK MHRA Regulatory Decision)

Frequently Asked Questions (FAQ)

Common questions about Brustan (FAQ)


Q: Does taking Brustan make you sleepy or drowsy?

A: Yes, regulatory product information states that drowsiness and fatigue are common side effects associated with the use of this medicine. If these effects occur, activities requiring mental alertness, such as driving or operating machinery, should be avoided.


Q: Is Brustan safe to take every day for chronic pain?

A: Official information emphasizes that this medicine is strictly for short-term use only, typically not exceeding a few days. Long-term daily use of the active ingredients carries a risk of serious adverse effects, such as gastrointestinal bleeding and kidney damage. Use for chronic conditions requires ongoing medical supervision.


Q: Can Brustan affect blood pressure readings?

A: Yes, official warnings indicate that the NSAID component (Ibuprofen) may lead to the development of new hypertension (high blood pressure) or worsen existing high blood pressure. For patients with existing hypertension, close monitoring of blood pressure may be necessary during treatment.


Q: Is it normal to feel a slight headache after taking Brustan for the first time?

A: According to the official product label, headache is listed as one of the common side effects that can occur when taking this medicine. If a headache persists, it is advisable to seek professional medical guidance.


Q: Will Brustan help with toothache pain?

A: Official product information confirms that this combination medicine is indicated for the relief of minor aches and pains, which generally includes the management of dental pain and toothache.


Q: Is Brustan suitable for treating tension headaches?

A: Yes, the product is indicated for the symptomatic relief of mild to moderate pain, which includes general types of pain such as headaches.


Q: Can people with asthma safely use Brustan?

A: Regulatory agencies advise caution for patients with asthma. Specifically, the NSAID component requires caution or restriction in use, particularly in individuals with aspirin-sensitive asthma, due to the potential risk of causing bronchospasm (sudden airway narrowing).


Q: Does Brustan help with nerve pain or only inflammatory pain?

A: As a combination of an NSAID and paracetamol, this medicine is typically used for general, inflammatory, and fever-related pain. Its components are not generally classified or used as first-line treatments for documented neuropathic (nerve) pain.


Q: Can Brustan make existing heartburn or acid reflux worse?

A: Yes, gastrointestinal disturbances, including heartburn and indigestion, are common side effects of the medication. Official warnings state that the drug should be used with caution in patients who have a pre-existing history of gastrointestinal diseases. Consultation with a healthcare provider is generally recommended for those with pre-existing conditions.


Q: Has Brustan been studied in clinical trials for effectiveness and safety?

A: Yes. The combination has been the subject of short-term randomized controlled trials (RCTs) to assess its effectiveness and safety profile for the relief of mild-to-moderate pain and fever. This research supports the claims made in the official product labeling.


Q: Do I need to space out my doses of Brustan by a specific number of hours?

A: Yes, official dosing instructions require a minimum interval of six hours to elapse between doses. This protocol is in place to prevent accidental overdose and ensure the maximum daily dose is not exceeded.


Q: Is Brustan used for conditions other than pain and fever?

A: The medicine is primarily indicated for the symptomatic relief of pain, fever, and inflammation. The Ibuprofen component also gives the product anti-inflammatory properties, which can help manage symptoms associated with various inflammatory conditions.


Q: Can Brustan cause dizziness or lightheadedness?

A: Yes, official drug information lists dizziness as a common side effect of the medicine. Due to the potential for these effects, caution is advised regarding activities that require full mental alertness.


Q: Is it important to check the expiration date on Brustan?

A: Yes, all medicines, including this combination, must be stored, used, and disposed of according to the label instructions. This implicitly means the product should not be consumed past the expiration date printed on the packaging.


Q: What happens if I miss a scheduled dose of Brustan?

A: Official guidance indicates that if a dose is missed, it should only be taken once the required six-hour minimum interval has passed since your last dose. It is crucial to ensure that the total daily maximum dose is not exceeded.


Q: Are there any specific warnings about driving or operating machinery while taking Brustan?

A: Yes, official safety information advises caution regarding certain activities. Patients are specifically told not to drive or operate heavy machinery if they experience side effects such as dizziness, drowsiness, or visual disturbances.


Q: Can Brustan interact with medications for diabetes?

A: Yes, there is a known interaction risk. The Ibuprofen component may interact with certain oral antidiabetic agents (e.g., sulfonylureas). This can potentially increase the risk of low blood sugar, and closer monitoring by a healthcare provider may be necessary.


Q: Is there any evidence that Brustan can cause ringing in the ears (tinnitus)?

A: Yes, tinnitus (ringing or buzzing in the ears) is listed in the official safety information as a possible undesirable effect of the medicine.


Q: Does Brustan cause fluid retention or swelling in the ankles?

A: Yes, regulatory warnings note that the NSAID component (Ibuprofen) can cause fluid retention, known as edema. For this reason, caution is advised for patients with existing heart problems or high blood pressure.


Q: What are the most common things people take Brustan for?

A: The general therapeutic purpose of Brustan is to provide multimodal symptomatic relief. It is most commonly used for relief from mild-to-moderate pain, the reduction of fever, and the alleviation of inflammation.


Q: How long does the pain relief from one dose of Brustan typically last?

A: The precise duration of pain relief varies by individual. However, official dosing instructions require that a minimum of six hours must pass between administrations, suggesting that relief is intended to last for a substantial period of time.


Q: Is Brustan safe for older adults, say over 65?

A: Regulatory documents recommend that older adults begin treatment at the lowest effective dose for the shortest duration necessary. This caution is due to the increased frequency of documented adverse reactions in this age group, particularly risks related to the kidneys and gastrointestinal system.


Q: What are some less common but serious side effects of Brustan to watch for?

A: While rare, serious effects documented in official warnings include severe allergic reactions, cardiovascular thrombotic events (like heart attack or stroke), and life-threatening gastrointestinal issues, such as bleeding or ulceration. If any signs of these serious events occur, immediate medical attention should be sought.


Q: Can I take other cold and flu medications while on Brustan?

A: Official regulatory warnings strictly prohibit taking any other product that contains either Paracetamol (Acetaminophen) or Ibuprofen, which are common ingredients in many cold and flu preparations. It is essential to verify the active ingredients of all other medications to avoid prohibited combinations.


Q: Why is it recommended to take Brustan with food or milk?

A: The recommendation to take the medicine with or immediately after food or milk is given to mitigate or reduce the potential for gastrointestinal irritation, such as stomach upset or heartburn, caused by the medicine.

How should Brustan be stored and disposed of?

How to Store and Dispose of Brustan?

Brustan (Ibuprofen and Paracetamol) should be stored securely in its original container at room temperature, ensuring it remains in a cool, dry area away from excessive heat and moisture. To protect from accidental harm, the medication must be kept strictly out of the reach of children and pets and stored with the safety lock or closure tightened.

Disposal of unused or expired medicine should be handled responsibly. The preferred method is utilizing a drug take-back program, such as an authorized drop-off location or a mail-back envelope. If a take-back option is unavailable, the drug may be mixed with an unpalatable substance (like dirt or coffee grounds), sealed in a plastic bag, and placed in the household trash. It is crucial not to flush this medication down the sink or toilet.

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

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