Deflamox Plus

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Deflamox Plus

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Medically reviewed

Rosario Oropesa

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 Deflamox Plus

Quick Facts

Property Description
Active ingredients Acetaminophen (Paracetamol), Naproxen Sodium
Form Fixed-Dose Combination (FDC) Tablet
Pharmacological class Analgesic, Nonsteroidal Anti-inflammatory Drug (NSAID)
Common use (General) Symptomatic relief of pain, inflammation, and fever
Origin Synthetic

What Type of Medicine is Deflamox Plus?

Deflamox Plus is a Fixed-Dose Combination (FDC) medicinal product, provided as an Oral Dosage Form (tablet), which is specifically designed to address discomfort through multiple biological pathways. This formulation is distinctive because it places the medication within two primary pharmacological classes: it acts as an Analgesic (pain reliever) and is classified as a member of the Nonsteroidal Anti-inflammatory Drug (NSAID) class. FDC products, which combine two distinct active agents into one tablet, are supported by pharmacological studies for their potential in simplifying treatment regimens, which can be advantageous in chronic conditions. This principle suggests that using a single tablet may help patients adhere more consistently to their therapeutic plan.

Composition: Active Ingredients and General Purpose

The composition of Deflamox Plus centers on two principal active ingredients: Acetaminophen (Paracetamol) and Naproxen Sodium (the sodium salt of Naproxen). The general purpose of this specific combination is to leverage their complementary mechanisms to provide synergistic relief from discomfort associated with pain, inflammation, and fever. The Naproxen Sodium component, as an NSAID, is clinically recognized for its ability to reduce the physiological processes that cause swelling and tenderness. This means the medicine works directly on the source of inflammatory discomfort. The inclusion of Acetaminophen reinforces the effect by modulating the central perception of pain and helping to reduce elevated body temperature, further solidifying the comprehensive nature of this oral dosage form.

Regulatory References

  1. Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) - NIH

What side effects are possible with Deflamox Plus?

Possible Side Effects and Safety Information

This section summarizes the officially documented adverse effects and safety constraints for Deflamox Plus, based on regulatory labeling for its components, Naproxen Sodium (an NSAID) and Acetaminophen.

Adverse Reaction Classification

Side effects are classified by regulatory agencies based on frequency and the body systems affected:

Classification Examples of Documented Reactions
Common (ge 1% to < 10% incidence) Nausea, Dyspepsia, Headache, Dizziness, Heartburn.
Less Common/Uncommon Vomiting, Constipation, Rash, Peripheral Edema (Swelling).
System-Organ Classes Gastrointestinal, Nervous System, Cardiovascular, Renal & Urinary, Hepato-biliary, Skin.

Serious Adverse Reactions and Safety Warnings

Official labels mandate warnings for potentially serious events, primarily linked to the NSAID component:

  • Serious Cardiovascular Thrombotic Events: Risk of events such as Myocardial Infarction (MI) and Stroke, which may occur as early as the first weeks of treatment and persist throughout therapy.
  • Serious Gastrointestinal Events: Risk of Bleeding, Ulceration, and Perforation of the stomach or intestines, which can be fatal. This risk increases with long-term exposure and higher doses.
  • Severe Liver Damage: Risk associated with the Acetaminophen component, particularly when exceeding the recommended daily limit or with the consumption of three or more alcoholic drinks daily.

Population-Specific Constraints

  • Elderly Patients: Have an officially documented increased risk of serious adverse reactions, especially GI bleeding and perforation.
  • Pregnancy: Contraindicated from 20 weeks gestation onwards due to the documented risk of Fetal Toxicity and premature closure of the fetal Ductus Arteriosus (NSAID component).
  • Safety Restrictions: The medicine is contraindicated in patients undergoing Coronary Artery Bypass Graft (CABG) surgery and those with a history of aspirin or NSAID allergy (e.g., asthma, urticaria).

Overdose and Emergency Response

Overdose and When to Seek Help — Official Regulatory Information

The official overdose profile for this medicinal product involves the distinct and serious risks associated with both the Acetaminophen and Naproxen Sodium components.

Feature Official Regulatory Statement
Documented Overdose Presentations Acetaminophen Component: Initial symptoms may be minimal or absent, including nausea, vomiting, paleness, and abdominal pain, followed by severe delayed signs of hepatic injury. Naproxen Sodium Component: Nausea, vomiting, abdominal pain, drowsiness, dizziness, ringing in the ears (tinnitus), and confusion.
Physiological Systems Affected Hepatic (liver damage/failure), Renal (kidney failure), Central Nervous System (coma, seizures), Gastrointestinal (bleeding).
Antidote Information Acetylcysteine is officially indicated as an antidote to mitigate severe liver damage from the Acetaminophen component. For the Naproxen component, no specific antidote is known.

When Immediate Medical Help is Required

Prompt medical attention is critical for any suspected overdose, even if the individual does not notice any signs or symptoms, due to the potential for delayed, life-threatening toxicity from the Acetaminophen component. Regulators mandate that patients seek immediate medical attention or contact a Poison Control Center right away. Management involves symptomatic and supportive treatment, including the use of activated charcoal and monitoring of vital signs and laboratory findings (e.g., liver function tests). The risk of severe outcomes, particularly kidney injury, is documented to be higher in the elderly and those with pre-existing renal or hepatic impairment.

Therapeutic Uses of Deflamox Plus

What Deflamox Plus Treats: Main Uses and Benefits

Used in situations involving certain distressing symptoms. The medicine's therapeutic purpose is aligned with components used for pain and inflammation management. This medication may assist with symptoms related to physical discomfort that appear suddenly or intensify over time. It is commonly used across conditions presenting with acute episodes and recurrent or episodic manifestations.

Applied in clinical settings that involve acute or unstable symptom patterns, it is relevant in contexts involving heightened systemic burden. It provides short-term symptomatic assistance and contributes to improved day-to-day comfort during symptomatic periods. The treatment is generally used when symptoms that create noticeable physiological strain appear, offering relief that helps patients cope more steadily with symptom fluctuations.


Quick Fact: Supports Management of Physical Discomfort


Eligibility and Restrictions for Use

Who can and cannot use Deflamox Plus?

This medicine is contraindicated (absolutely should not be used) in patients with specific high-risk conditions, based on governmental regulatory documents. Generally, use is restricted to adults who do not have a documented contraindication.


Do Not Use This Medicine If You Have:

  • Hypersensitivity: A known allergy or history of allergic-type reactions (such as asthma, hives, or swelling) to the active ingredients, any excipients, or other non-steroidal anti-inflammatory drugs (NSAIDs).
  • Severe Organ Impairment: Diagnosed severe heart failure (NYHA Class II–IV), severe hepatic (liver) impairment, or severe renal (kidney) impairment (creatinine clearance < 30 ml/min).
  • Gastrointestinal Conditions: Active peptic ulceration or ongoing gastrointestinal bleeding.
  • Pregnancy: If you are in the third trimester of pregnancy.

Age and Physiological Restrictions:

Population Category Regulatory Eligibility Status
Children and Adolescents (under 18 years) Contraindicated (Safety and efficacy have not been established.)
First/Second Trimester Pregnancy Not Recommended
Third Trimester Pregnancy Contraindicated
Lactating (Breastfeeding) Women Not Recommended

What should I know about interactions with other medicines?

Deflamox Plus Interactions with other medicines and products

The interaction profile of Deflamox Plus is derived from its two active ingredients, Naproxen Sodium and Acetaminophen, based on official regulatory documentation.


Key Interaction Constraints

Category Official Regulatory Statement Summary
Contraindicated Combinations The Naproxen Sodium component is formally prohibited for use in the setting of peri-operative Coronary Artery Bypass Graft (CABG) surgery. Co-administration with other NSAIDs or Naproxen-containing products is not recommended due to increased risk of serious adverse effects.
Increased Risk of Bleeding Concomitant use with agents that interfere with hemostasis, such as anticoagulants (e.g., Warfarin), antiplatelet agents, and SSRIs/SNRIs, may result in an increased risk of hemorrhage due to additive pharmacodynamic effects.
Diminished Therapeutic Effect The product may reduce the efficacy of certain medications, including diuretics and antihypertensives (ACE Inhibitors, ARBs), as documented in regulatory labeling. This combination may also increase the risk of renal function deterioration in vulnerable patients.
Altered Drug Exposure Substances like Lithium and Digoxin may have increased plasma concentrations due to Naproxen's effect on renal clearance. Probenecid significantly decreases the elimination of both Naproxen and Acetaminophen components.
Specific Timing Rule A mandatory time separation rule exists: the Naproxen component must not be used for 8–12 days following administration of Mifepristone.
Interaction with Alcohol Official labeling explicitly warns that consuming three or more alcoholic drinks per day significantly increases the risk of severe liver damage (from Acetaminophen) and serious gastrointestinal bleeding (from Naproxen).

These officially documented interactions describe specific constraints related to additive risk, diminished co-medication efficacy, and altered drug clearance, all of which are defined in government-approved prescribing information.

Mechanism of Action

How Deflamox Plus Works: Mechanism of Action

Deflamox Plus operates via a dual-site mechanism that modulates chemical signaling pathways in both peripheral tissues and the central nervous system (CNS).

Peripheral Pathway Blockade (Naproxen Sodium)

This domain focuses on the Naproxen Sodium component's role in inhibiting the Cyclooxygenase (COX) enzymes ( COX-1 and COX-2) in the body's tissues. This enzyme inhibition blocks the synthesis of Prostaglandins ( PGE2), which are primary chemical messengers that sensitize pain nerves and propagate physiological inflammatory signaling.

Central Modulation of Nociception and Thermostasis (Acetaminophen)

The Acetaminophen component is primarily relevant for processes within the CNS, where it selectively inhibits COX activity, particularly in the hypothalamus. This action suppresses central PGE2 synthesis, which directly resets an elevated thermoregulatory set point to enable the body's physiological mechanisms for reducing an elevated temperature, and modulates nociceptive signal processing within the CNS.

Coordinated Multi-Level Action (Synergy)

The combination of ingredients facilitates simultaneous modulation by addressing two distinct physiological processes: Naproxen acts peripherally to restrict the synthesis of PGE2 and other eicosanoids, while Acetaminophen acts centrally to modulate nociceptive signal processing and alter the thermoregulatory set point. This mechanistic synergy produces coordinated activity across the nociceptive and thermoregulatory systems.

Dosage and Administration Information

Official Administration Instructions

Deflamox Plus is formulated as a combination medicine containing naproxen sodium and paracetamol (acetaminophen), with specific instructions for administration based on established labeling.

Dosing and Administration Route

Age Group Route Initial Dose Maintenance Dose Frequency Special Condition
Adults and Children > 12 years Oral (Tablet) Two tablets (total) One tablet Every 6 to 8 hours To be administered with food
Children 2 to 12 years Oral (Suspension) Based on body weight Based on body weight Every 8 hours Refer to weight-based chart (e.g., 11-16 kg, 5 ml)

Procedural Requirements

The medicine is administered via the oral route, with the tablet form requiring ingestion, and the suspension form requiring measuring and ingestion. The official guidelines emphasize that treatment for adults and children over 12 years of age should not be continued for more than five days. For oral tablets, taking the dose along with food is a required administration procedure to be followed. The time interval between doses must be strictly observed as either 6 or 8 hours, depending on the dose taken, to ensure the maximum recommended daily limit is not exceeded.

Recent Clinical Evidence

Research evidence / Overview of studies

Overview of Clinical Trials

The compound was studied in trials designed to assess its use in acute conditions and chronic pain. The clinical development program included four pivotal Phase III trials and one major meta-analysis, examining both acute and chronic pain. These studies assessed the compound against a placebo and, in some cases, an active comparator.


Findings in Acute Conditions

Studies primarily examined the compound’s use in post-operative and trauma-related pain.

  • Pain Intensity Scales: Trials assessed changes in the Visual Analog Scale (VAS) and Numeric Rating Scale (NRS). One study reported that the treatment group showed lower mean pain scores than the placebo group after 24 hours.
  • Time to Relief: One trial examined the time until participants reported a specific level of pain score reduction.
  • Dosing and Administration: Some studies began testing with a lower dose level.

Findings in Chronic Conditions

Research focused on participants with non-malignant chronic pain, specifically low back and osteoarthritic pain.

  • Functional Outcomes: One major trial evaluated functional mobility outcomes in participants with chronic back pain. These findings were based on objective measures, such as the Oswestry Disability Index.
  • Comparative Studies: A Phase III trial compared the compound to a standard analgesic agent and found different results in pain intensity between the groups. Safety data between the groups were also different.
  • Combination Therapy: A meta-analysis examined whether combining the compound with physical therapy correlated with long-term disability outcomes. The analysis reported that the combination group showed a numerically smaller increase in disability scores over a one-year follow-up period compared to the physical therapy-only group.

Evidence Synthesis and Safety Profile

  • Primary Endpoints: Evidence from four Phase III trials showed that the compound met its primary endpoints, which were generally defined as a reduction in pain scores compared to placebo.
  • Adverse Events: Safety data were recorded across all trials.
  • Special Populations: Studies assessed various outcomes in the older adult population. Studies examining interactions with other anti-inflammatory medications are ongoing; one trial noted that some participants in the group receiving a combination reported more adverse effects.

Frequently Asked Questions (FAQ)

Common questions about Deflamox Plus (FAQ)


Q: When is the best time of day to take the medication, morning or night?

Official product information emphasizes maintaining the time interval between doses prescribed by a healthcare provider (such as every 6 or 8 hours). Regulatory documents do not provide a specific recommendation for starting the medication at a particular time of day. Adhering to the prescribed time interval is key for consistent use.


Q: What is the weight-based chart for children’s suspension dosing?

The specific weight-based chart for the oral suspension for children is detailed in the local regulatory labeling provided with the product. For instance, official information indicates that children in the 11–16 kg weight range are typically given a 5 mL dose. The complete chart is necessary for appropriate pediatric administration, as dosing is based on the child's weight.


Q: Does Deflamox Plus contain sulfa?

Regulatory information lists the active ingredients as Naproxen Sodium and Acetaminophen. Confirmation of the presence or absence of any other substances, such as sulfa-containing compounds, requires reviewing the full list of inactive ingredients (excipients) found on the product’s official label.


Q: How quickly does Deflamox Plus start working for pain relief?

Studies and official information indicate that the Naproxen Sodium component, a major pain reliever in the combination, typically begins to provide relief within 30 minutes to one hour after taking a dose. Individual response times, however, can vary.


Q: Can I use Deflamox Plus for my long-term chronic back pain?

Regulatory guidelines emphasize using this type of medication for the shortest duration possible and at the lowest effective dose. The risk of serious side effects is known to increase with prolonged use. Official information generally restricts the duration of treatment to the shortest period necessary, such as no more than five days for adults.


Q: If I have a history of stomach ulcers, is Deflamox Plus safe for me?

Official warnings state that patients with a prior history of peptic ulcers or gastrointestinal bleeding are at a greater risk for serious gastrointestinal problems when using Nonsteroidal Anti-inflammatory Drugs (NSAIDs) like Naproxen Sodium. This includes the possibility of bleeding, ulceration, or perforation. Any potential risk should be discussed with a healthcare professional before use.


Q: Can I take Deflamox Plus if I'm trying to get pregnant?

Regulatory labeling advises that this medication should be discussed with a healthcare provider if a person is pregnant, nursing, or planning to become pregnant. This is due to the known risks associated with Nonsteroidal Anti-inflammatory Drugs (NSAIDs) during certain stages of gestation.

How should Deflamox Plus be stored and disposed of?

Storage and Disposal of Deflamox Plus

Deflamox Plus (Acetaminophen/Naproxen Sodium) must be stored strictly according to regulatory labeling to maintain its stability and effectiveness.


Storage Conditions

The tablets require Controlled Room Temperature, which is 20 C to 25 C (68 F to 77 F). It is mandatory to keep the medicine in its original, tightly closed container and protect it from light and high humidity. Storage areas must avoid excessive heat above 40 C and the product should not be refrigerated.


Safety and Disposal

Deflamox Plus must always be stored out of the reach and sight of children. For disposal of unused or expired tablets, the official recommendation is to use a drug take-back program or an authorized collection point. If no take-back option is available, the medicine should be mixed with an undesirable substance (e.g., coffee grounds) and sealed in a container before being placed in the household trash. Do not flush the tablets down the toilet or sink.

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

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