Neobrufen con Codeina

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Neobrufen con Codeina

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 Neobrufen con Codeina

Quick Facts

Property Description
Active ingredient Ibuprofen, Codeine
Form Oral tablet
Pharmacological class NSAID and Opioid Analgesic Combination
Common use Enhanced pain relief (moderate to severe pain)
Origin Synthetic

What Type of Medicine is Neobrufen con Codeina?

Neobrufen con Codeina is classified as a synthetic, fixed-dose combination analgesic. It is officially categorized as a product combining a Nonsteroidal Anti-inflammatory Drug (NSAID) with an Opioid Analgesic, a therapeutic approach recognized for enhanced pain management in discomfort that is resistant to non-opioid treatments. As a combination product, this dual identity ensures the medication is designed specifically for moderate to severe pain, providing a dual-action rationale for pain modulation.

Active Ingredients and Dosage Form

The preparation's composition consists of its two active ingredients: Ibuprofen and Codeine, which are exclusively formulated together as an oral tablet for oral administration. Ibuprofen is the non-opioid component, providing anti-inflammatory action, while Codeine, typically included as Codeine phosphate hemihydrate, acts as the central analgesic. This fixed-ratio formulation is often utilized when managing contexts such as acute musculoskeletal injury or post-operative recovery, ensuring that the benefits of both peripheral and central pain suppression are delivered simultaneously.

General Function of the Dual Composition

The two components are intentionally paired to provide complementary mechanisms of analgesia by targeting different sites in the body’s pain signalling pathway. Ibuprofen reduces the production of inflammatory mediators, offering a peripheral analgesic effect, while Codeine exerts a central analgesic action by altering how the brain processes pain signals. The core purpose of this synergistic design is to achieve a more potent and comprehensive modulation of pain than can be obtained from either the NSAID or the opioid component when utilized separately.

Regulatory References

  1. according to the National Institutes of Health

What side effects are possible with Neobrufen con Codeina?

Possible Side Effects and Safety Information

The safety profile of Neobrufen con Codeina is characterized by risks associated with both its active components: the NSAID (Ibuprofen) and the Opioid Analgesic (Codeine). Regulatory documents classify adverse reactions based on their frequency and the affected system-organ class.

Reactions categorized as Uncommon in official documents often include gastrointestinal effects such as abdominal pain, nausea, and dyspepsia, alongside central nervous system effects like headache and dizziness. Less frequent reactions (Very Rare) include serious events such as gastrointestinal perforation or hemorrhage and severe cutaneous adverse reactions (SCARs).

Serious adverse reactions are explicitly documented, highlighting the dual risk. NSAID-related risks include the potential for gastrointestinal bleeding, ulceration, or perforation, and an association with arterial thrombotic events (e.g., myocardial infarction or stroke). Opioid-related risks include the potential for life-threatening respiratory depression and the development of tolerance, physical dependence (addiction), and abuse upon repeated administration.

Population-Specific Safety Considerations

The label defines specific constraints for certain populations. Older adults are at a documented increased risk of serious adverse reactions, particularly fatal gastrointestinal events. The medicine is contraindicated in children under 12 years and in lactating women due to the risk of serious infant toxicity. Furthermore, the risk of dependence and metabolic issues (like renal tubular acidosis) is explicitly associated with prolonged use at higher than recommended levels.

Overdose and Emergency Response

Overdose and When to Seek Help

The officially documented overdose profile for the Ibuprofen and Codeine combination is defined by the acute risks associated with both active substances, strictly requiring immediate professional attention upon manifestation.

Documented Overdose Manifestations

Overdose presentations from the Codeine component primarily involve acute opioid toxicity, which may include excessive sleepiness, confusion, shallow breathing, and the characteristic sign of small pupils (miosis). The Ibuprofen component introduces the risk of severe gastrointestinal hemorrhage or perforation, and prolonged high-dose exposure is associated with outcomes such as acute renal failure and metabolic acidosis. Serious neurological effects, including progression to coma, are documented outcomes of severe opioid overdose.

Mandatory Emergency Action

Regulators explicitly mandate that individuals must stop giving the medicine and seek immediate medical attention if signs of CNS depression—such as slow or shallow breathing or excessive somnolence—are observed. Treatment is officially defined as symptomatic and supportive. While no specific antidote is available for Ibuprofen, the opioid effects of Codeine can be reversed by administering Naloxone. Continuous monitoring of vital signs is required in a clinical setting.

Overdose risk is heightened in specific groups, including children under 12 years due to the risk of fatal respiratory depression, and individuals identified as ultra-rapid metabolizers of Codeine.

Therapeutic Uses of Neobrufen con Codeina

What Neobrufen con Codeina Treats: Main Uses and Benefits

Neobrufen con Codeina is commonly used to help with symptomatic relief in situations where additional management of discomfort is required. Its application is generally focused on therapeutic domains characterized by heightened discomfort and conditions involving inflammatory or irritative processes.

This combination is typically used to treat a range of aches and pains, particularly when everyday painkillers such as ibuprofen or paracetamol have not worked on their own.

The combination is considered relevant for easing symptoms related to acute musculoskeletal pain, significant dental pain, severe migraine headaches, and intense dysmenorrhoea (period pain). It is applied in contexts that involve increased discomfort or tension, relevant when supportive symptom management is appropriate.

Enhanced Symptomatic Relief for Moderate to Severe Pain

This enhanced combination is applied in contexts where the intensity of pain—often categorized as moderate to severe—requires additional support for symptom management. The dual composition may assist with symptomatic relief for episodes of sudden escalation in discomfort, helping to ease the overall symptom burden and improving day-to-day comfort during symptomatic periods. It supports patients during difficult episodes by easing distress.


Quick Fact: Relief for Acute Discomfort
Relevant for Managing: Moderate to Severe Acute Pain
Type of Conditions: Musculoskeletal, Post-Traumatic, Episodic Pain
Benefit: Contributes to easing the overall symptom load

Eligibility and Restrictions for Use

This section details the officially documented eligibility rules and restrictions for Neobrufen con Codeina, established by regulatory authorities. Use of this product is strictly limited to adults aged 18 years and older for short-term pain management.

Eligibility Status Applicable Populations & Conditions
Contraindicated (Must Not Use) Patients with severe hepatic, renal, or heart failure; active or recurrent peptic ulcers or gastrointestinal bleeding. Individuals known to be CYP2D6 ultra-rapid metabolizers. Women in the last trimester of pregnancy and those breastfeeding. All pediatric patients (0–18 years) who have undergone tonsillectomy or adenoidectomy for Obstructive Sleep Apnoea Syndrome.
Not Recommended Children under 12 years of age. Adolescents (12–18 years) with compromised respiratory function. Women in the first and second trimesters of pregnancy.
Conditional Use (Caution) Elderly patients (due to increased risk); patients with a history of hypertension, ischaemic heart disease, or non-severe organ impairment.

These classifications define non-eligibility based on metabolic status, critical organ function, GI integrity, and specific life stages, ensuring the medicine is restricted to the adult population without these contraindicating risks.

What should I know about interactions with other medicines?

The interaction profile of Neobrufen con Codeina is officially defined by its dual analgesic components, Ibuprofen and Codeine, requiring consideration of both non-opioid and opioid interaction constraints documented in regulatory labeling.

Contraindicated and Avoided Combinations

Co-administration with Monoamine Oxidase Inhibitors (MAOIs) is formally contraindicated and restricted to a period of at least 14 days following MAOI cessation. Use with other Nonsteroidal Anti-inflammatory Drugs (NSAIDs) or COX-2 inhibitors should be avoided due to the additive risk of serious gastrointestinal adverse events.

Pharmacokinetic and Pharmacodynamic Effects

The codeine component may result in additive CNS depression when co-administered with other CNS depressants, including alcohol. Concomitant use with Serotonergic drugs may pose a risk of Serotonin Syndrome. Interactions with CYP2D6 inhibitors may reduce the formation of codeine's active metabolite, officially resulting in reduced analgesic efficacy. The ibuprofen component increases the plasma concentration of Lithium and Cardiac Glycosides by decreasing their renal clearance. Co-administration with Methotrexate is documented to result in reduced clearance of Methotrexate. Use with Anticoagulants (e.g., Warfarin) and Oral Corticosteroids carries an increased risk of bleeding. Additionally, use with certain Antihypertensive agents may reduce their efficacy and increase the risk of renal damage.

Population-Specific Constraints

Official warnings are documented for individuals with specific genetic profiles: CYP2D6 Ultra-rapid Metabolizers are constrained from using codeine-containing products due to the official risk of toxicity, and Poor Metabolizers may experience reduced efficacy. Similar constraints are advised for breastfeeding mothers with an Ultra-rapid Metabolizer phenotype.

Mechanism of Action

The mechanism of Neobrufen con Codeina involves a dual pharmacodynamic action via its two molecular components. Ibuprofen functions as a non-selective, reversible inhibitor of the cyclooxygenase (COX) enzymes, specifically COX-1 and COX-2. This inhibition prevents the conversion of arachidonic acid into prostanoids, including prostaglandins and thromboxanes, primarily at peripheral sites of accumulation. The reduced prostanoid biosynthesis modulates local cellular responses and vascular tone.

Codeine acts as a prodrug; a fraction is O-demethylated by the cytochrome P450 2D6 (CYP2D6) enzyme to its active metabolite, morphine. Morphine functions as an agonist, binding to mu-opioid receptors (MOR) within the central nervous system, predominantly in the brain and spinal cord. MOR activation is coupled to G-protein subunits (G i/ o), leading to the inhibition of adenylyl cyclase, a reduction in intracellular cyclic adenosine monophosphate (cAMP), and the hyperpolarization of neurons via enhanced potassium efflux. This intracellular cascade decreases neuronal excitability and inhibits the presynaptic release of nociceptive neurotransmitters, modulating signal transmission in ascending pathways.

Dosage and Administration Information

Official Administration Guidelines

The use of Neobrufen con Codeina, a fixed-dose combination of Ibuprofen (400 mg) and Codeine (30 mg), is defined by established protocols to ensure appropriate administration. The medicine is formulated as a film-coated tablet for oral administration and is intended for short-term use only, limited to a maximum of three consecutive days.


Dosage and Schedule Principles

The standard adult single dose is one tablet (400 mg Ibuprofen / 30 mg Codeine), taken when necessary according to the intensity of discomfort. Doses should be spaced to ensure a minimum interval of 4 hours between administrations. The maximum allowed intake is six tablets (2400 mg Ibuprofen / 180 mg Codeine) over a 24-hour period. A general principle of use is utilizing the lowest effective dose for the shortest necessary duration.


Administration Conditions

To manage potential gastrointestinal irritation, the tablets are generally advised to be taken with or immediately after food or a drink of milk. The tablets must be swallowed whole with water. It is a procedural requirement that the tablet must not be divided, even if a score line is present on the surface. If a patient does not experience adequate symptomatic relief within the maximum three-day course, re-evaluation by a healthcare professional is mandated.


Population-Specific Constraints

The medicine is not for use in patients under 18 years of age. For older adults and individuals with mild to moderate impairment of kidney or liver function, treatment must be initiated with a reduced dose and close patient monitoring is required. In older adults, the initial dosing interval may also need to be extended to at least eight hours.

Recent Clinical Evidence

Research evidence / Overview of studies

This section provides an overview of the designs and data collection of studies that have investigated the compound, which combines ibuprofen (a non-steroidal anti-inflammatory drug or NSAID) and codeine (an opioid analgesic).

Core Efficacy Studies

Research has explored trial metrics to see whether the compound was evaluated for potential changes in pain severity scores, particularly in adult patients experiencing moderate-to-severe pain, such as acute postoperative pain.

Fixed-dose combinations of ibuprofen and codeine have been investigated in randomized, double-blind, placebo-controlled trials. The primary endpoints usually involved composite measures of pain relief over time (e.g., total pain relief) over periods such as four or six hours.

Combination Efficacy and Comparators

Studies have assessed the combined formulation against its individual components (ibuprofen alone and codeine alone) as well as against placebo. Some high-quality evidence from systematic reviews on single-dose oral formulations, including codeine at high doses (e.g., 25.6 mg to 60 mg), suggests that the combination was superior to placebo for relieving acute postoperative pain.

Research focusing on the combination’s potential effect profile has been conducted, often alongside other conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) when studied in inflammatory conditions.

Pharmacokinetics and Trial Administration

Studies examined the absorption, distribution, metabolism, and excretion of both ibuprofen and codeine when administered together. Pharmacokinetic data have shown that the concentration of codeine in the blood plasma may be slightly greater with the combination formulation compared to codeine alone.

In clinical trials, the study design often included patients who had an inadequate response to other treatments. Exclusion criteria in trials often involved patients with severe kidney or liver issues, which relates to the body’s metabolic processing of the compound's ingredients.

Key Studies & References

  1. Pharmacokinetic Study of a New Ibuprofen 600mg plus Codeine 30mg Combination versus Ibuprofen or Codeine Alone in Single Oral Doses in Healthy Volunteers

Frequently Asked Questions (FAQ)

Common questions about Neobrufen con Codeina (FAQ)


Q: Can Neobrufen con Codeina be used for headaches?

A: Official product information indicates that medicines combining ibuprofen and codeine are generally used to treat a variety of aches and pains. This range of uses often includes common conditions such as headaches and migraines.


Q: Is Neobrufen con Codeina suitable for dental pain?

A: Regulatory-cited sources indicate that the combination of ibuprofen and codeine has been investigated for the management of acute pain. This includes common types of discomfort such as toothache and dental pain.


Q: What are the most common non-serious side effects reported with Neobrufen con Codeina?

A: According to official documentation, the most frequently reported non-serious side effects include digestive system issues such as indigestion, constipation, and abdominal pain. Central nervous system effects such as feeling sleepy have also been noted.


Q: Are there any specific foods or drinks to avoid while taking Neobrufen con Codeina?

A: Regulatory guidance strictly advises against consuming alcohol due to the increased risk of certain side effects. Some official sources also advise against consuming grapefruit or grapefruit juice while using codeine products. Otherwise, no other specific foods are generally prohibited.


Q: Is Neobrufen con Codeina a stronger painkiller than standard ibuprofen?

A: The combination is specifically designed to provide enhanced pain relief by utilizing the action of two different ingredients. Trial data indicates the combination was effective for more participants experiencing acute pain than ibuprofen alone.


Q: Does Neobrufen con Codeina contain aspirin?

A: The official descriptions of this drug list only Ibuprofen and Codeine as the active ingredients. Aspirin is not contained in this specific formulation.


Q: Can Neobrufen con Codeina affect my mood or emotional state?

A: Codeine acts in the central nervous system (CNS) and has been described in regulatory-cited information as helping to reduce the anxiety and stress often caused by pain. Changes in mood or emotional state are not listed as common side effects, but CNS effects like drowsiness are reported.


Q: Why do some people say they feel 'different' when taking codeine products?

A: Codeine is classified as an opioid, meaning it affects the central nervous system (CNS) and the brain. The effects of this action can result in feelings of sedation, calmness, or drowsiness, which some users may perceive as feeling 'different'.


Q: What happens if I miss a dose of Neobrufen con Codeina?

A: General regulatory guidance describes that a missed dose may be taken when remembered, provided the minimum required time interval between administrations is maintained.


Q: Is Neobrufen con Codeina considered a prescription-only medicine in most places?

A: Due to international regulatory changes aimed at mitigating the risks of misuse and dependence, products containing codeine, including this fixed combination with ibuprofen, are now considered prescription-only medicines in many countries.


Q: What is the risk of dependency associated with the codeine component?

A: The codeine component carries a known risk of tolerance, physical dependence, and addiction. Regulatory bodies consistently stress that this risk is primarily associated with using the medicine for prolonged periods or taking doses higher than recommended.


Q: Can I take Neobrufen con Codeina if I have kidney issues?

A: The medicine is strictly contraindicated (should not be used) in patients with severe renal (kidney) failure. For individuals with less severe kidney function impairment, official guidance requires starting with a reduced dose and receiving close monitoring from a healthcare professional.


Q: What should I do if I suspect an adverse reaction to Neobrufen con Codeina?

A: Official guidelines advise that a healthcare professional, such as a doctor or pharmacist, be contacted immediately for guidance if an adverse reaction is suspected. Severe reactions require contacting emergency services.


Q: Is it possible to become tolerant to the pain relief effects of Neobrufen con Codeina?

A: Yes, tolerance is a known risk associated with the codeine component. It means the body may require increased exposure over time to achieve a similar effect, which is why the medicine is limited to short-term use.


Q: What are the common misunderstandings about the codeine component in Neobrufen con Codeina?

A: Regulatory bodies have published information addressing common user misunderstandings, specifically highlighting the lack of public awareness regarding the potential for codeine-containing products to be habit-forming. They also clarify the potential for serious organ harm associated with long-term or high-dose misuse.


Q: Do studies suggest Neobrufen con Codeina is effective for musculoskeletal pain?

A: Official indications and associated regulatory guidance state the medicine is used for a range of aches and pains. This range commonly includes musculoskeletal discomforts such as back pain, sprains, and strains.


Q: Is Neobrufen con Codeina suitable for people with asthma?

A: The official product information indicates that codeine-containing products are typically contraindicated for patients who have acute or severe bronchial asthma. This warning is due to the potential risk of respiratory depression associated with the codeine component.


Q: What are the signs that Neobrufen con Codeina might not be working?

A: Official administration guidelines state that if a patient does not experience adequate symptomatic relief within the maximum duration of the course (three days), re-evaluation by a healthcare professional is generally mandated. This lack of relief indicates the medicine may not be effective for the condition.


Q: Does Neobrufen con Codeina interact with muscle relaxants?

A: Official warnings state that the codeine component may cause additive CNS depression (slowing the central nervous system) when used with other CNS depressants. Muscle relaxants are often classified as CNS depressants.


Q: What evidence exists regarding the use of Neobrufen con Codeina in post-operative pain?

A: Clinical trial evidence reviewed by regulatory bodies shows that the combination provided documented analgesic efficacy for a high percentage of participants experiencing acute moderate-to-severe post-operative pain when compared to an inactive substance (placebo).


Q: Is Neobrufen con Codeina used to treat inflammation as well as pain?

A: Yes. The medicine combines two active agents: Ibuprofen, which is classified as an NSAID and helps reduce hormones that cause both pain and swelling (inflammation), and Codeine, which acts specifically on pain signals.


Q: Are there non-pain-related uses for Neobrufen con Codeina described in official documents?

A: The official documents and regulatory labels for Neobrufen con Codeina list its sole purpose as the management of pain where treatment with an opioid is considered necessary. Non-pain-related uses, such as cough or fever suppression, are not listed.

How should Neobrufen con Codeina be stored and disposed of?

Storage and Disposal of Neobrufen con Codeina

Official regulatory labeling dictates strict requirements for storing and discarding Neobrufen con Codeina, primarily due to the security needs associated with the codeine component.

Requirement Regulatory Condition
Temperature Store at controlled room temperature, typically 20 C to 25 C.
Protection Keep in the original container, tightly closed, to protect from moisture and light.
Security Must be stored securely and out of the sight and reach of children to prevent accidental ingestion.
Disposal Preferred method is using a drug take-back program. If unavailable, mix the unused tablets with an unpalatable substance (e.g., coffee grounds), seal in a plastic bag, and place in household trash.
Wastewater The medicine must not be flushed down the toilet or poured into the sink.

These conditions ensure the chemical stability of the medication while adhering to mandatory security protocols for controlled substances.

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

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