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Hifenac -P

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Hifenac -P

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Treatment option:

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.

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Overview of Hifenac -P

Property Description
Active Ingredients Aceclofenac, Paracetamol (Acetaminophen)
Form Tablet (Oral solid dosage form)
Pharmacological Class Non-Steroidal Anti-Inflammatory Drug (NSAID) / Para-aminophenol derivative
General Purpose Symptomatic relief of pain, inflammation, and fever
Origin Synthetic compound

Hifenac-P: Identity and Pharmacological Classification

Hifenac-P is defined as a Fixed-dose combination (FDC) medicine, classified as a combined analgesic and anti-inflammatory agent, intended for symptomatic relief of pain, inflammation, and fever. It is a synthetic compound manufactured exclusively for oral administration, typically presented as a tablet dosage form. This medicinal entity is distinguished by its strategic integration of two different therapeutic agents into a single preparation. Unlike medicines containing only one active substance, this FDC product leverages a dual mechanism of action to address multiple physical symptoms simultaneously, which is characteristic of its classification as both a Non-Steroidal Anti-Inflammatory Drug (NSAID) component and a Para-aminophenol derivative component. The combination of an NSAID with Paracetamol has been documented in clinical pharmacology to enhance pain-relieving efficacy through their distinct mechanisms of action. This shows the medicine is designed to tackle pain from different angles for more complete relief.


What are the Active Ingredients in Hifenac-P?

The composition of Hifenac-P includes two distinct active ingredients: Aceclofenac and Paracetamol (also known as Acetaminophen). The primary purpose of this combination is to provide comprehensive relief for conditions involving both pain and inflammation, often accompanied by fever (pyrexia). Aceclofenac is the NSAID component that preferentially targets the chemical pathways causing inflammation. Paracetamol is the non-opioid component that acts as a powerful analgesic and antipyretic. Aceclofenac demonstrates significant anti-inflammatory and analgesic properties, making it clinically recognized for its role in mitigating inflammatory pain. This confirms that the Aceclofenac component is effective in reducing swelling and pain. The presence of these two agents ensures that the medicine delivers a synergistic effect, meaning the combined action is generally considered more effective than either Aceclofenac or Paracetamol used individually for this specific range of symptoms.

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What side effects are possible with Hifenac -P?

Possible side effects and safety information

The safety profile for this fixed-dose combination, comprising Aceclofenac and Paracetamol, is structured by regulatory authorities across various System-Organ Classes and defined frequency categories.

Frequency-Classified Adverse Reactions

The most Common adverse reactions (affecting geq1/100 to <1/10 patients) primarily relate to the Gastrointestinal System, including dyspepsia, abdominal pain, nausea, and diarrhoea. Other Common effects documented include dizziness and transient elevations in hepatic enzymes. Uncommon reactions (geq1/1,000 to <1/100) may include rash, pruritus, or flatulence.

Serious Adverse Reactions

Regulatory documents list Rare (geq1/10,000 to <1/1,000) to Very Rare events of clinical significance. These serious adverse reactions include Gastrointestinal Bleeding, Ulceration, or Perforation. Severe Cutaneous Adverse Reactions such as Stevens-Johnson Syndrome (SJS) have been reported, with the highest risk documented early in the course of treatment. The NSAID component is associated with Arterial Thrombotic Events (e.g., myocardial infarction, stroke), with the risk potentially increasing with long-term exposure. The Paracetamol component carries a documented risk of Hepatotoxicity (severe liver damage).

Safety Restrictions and Special Populations

The official profile outlines specific safety constraints. Older Adults are documented as having an increased frequency and severity of adverse effects, particularly those involving the gastrointestinal tract. The medicine is restricted or contraindicated in patients with established severe Heart Failure and in those who have a history of bronchospasm or urticaria precipitated by other NSAIDs. Concomitant use with other NSAIDs or Paracetamol-containing products is generally restricted due to an additive risk of serious adverse effects.

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Overdose and Emergency Response

Overdose and When to Seek Help

Regulatory information requires that immediate medical attention must be sought and emergency services contacted immediately following any suspected overdose, even if the individual appears well. This strict mandate is due to the severe, potentially delayed nature of toxicity from the Paracetamol (Acetaminophen) component, which can lead to life-threatening irreversible hepatic necrosis (liver cell death).

Manifestations of overdose are derived from the toxic profiles of both active ingredients. Early signs of Paracetamol toxicity often include nausea, vomiting, anorexia, and abdominal pain. Later and more critical signs include jaundice and coagulation defects. The Aceclofenac (NSAID) component may cause dizziness, convulsions, or coma, and is associated with complications like acute renal failure and gastrointestinal hemorrhage.

Management is differentiated: A specific antidote, N-acetylcysteine, is available for Paracetamol toxicity and must be administered immediately. Conversely, no specific antidote is known for Aceclofenac overdose, requiring treatment to be symptomatic and supportive. Regulatory documents require hospital monitoring and mandatory laboratory testing to track liver function (AST/ALT) for several days. An increased risk of severe toxicity is noted for individuals with pre-existing hepatic impairment or chronic alcoholism.

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Therapeutic Uses of Hifenac -P

What Hifenac-P Treats: Main Uses and Benefits

Hifenac-P is an analgesic and anti-inflammatory combination used to provide symptomatic relief across several domains marked by pain, swelling, and fever. It offers supportive therapeutic benefit during periods of heightened discomfort or symptoms that create noticeable physiological strain.

The core indication for the Aceclofenac component is the relief of pain and inflammation in chronic joint conditions like osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The combination is generally helpful in situations where multiple symptoms occur together, such as patterns of pain combined with inflammation or fever.


Key Therapeutic Focus

This medication is applied across domains where additional symptomatic support is needed for conditions such as chronic joint inflammation, acute musculoskeletal injuries (like sprains and strains), and episodic discomfort (e.g., dental pain, lumbago, and dysmenorrhea). Hifenac-P is often used during phases when symptoms become more noticeable, offering symptomatic relief that helps patients cope more steadily with difficult episodes. The benefit supports general well-being and contributes to easing the overall symptom load during symptomatic periods.

Quick Fact: Symptomatic Relief Across Inflammatory and Pain States

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Eligibility and Restrictions for Use

Who Can and Cannot Use Hifenac-P?

Eligibility for Hifenac-P, a fixed-dose combination of Aceclofenac (NSAID) and Paracetamol, is strictly governed by regulatory guidelines, primarily focusing on contraindications and patient-specific risk factors associated with its active ingredients.


Populations Prohibited from Use (Contraindicated)

Use is absolutely prohibited for patients with:

  • Hypersensitivity to Aceclofenac, Paracetamol, or any related NSAIDs (e.g., those with a history of asthma, rhinitis, or urticaria triggered by aspirin).
  • Severe organ impairment, including severe hepatic failure, severe renal failure, and severe congestive heart failure (NYHA Class II-IV).
  • Active gastrointestinal bleeding or ulceration.
  • The third trimester of pregnancy.

Restricted and Age-Based Eligibility

  • Pediatric Use: The medicine is not recommended for use in children and adolescents under 18 years of age, as its safety and efficacy in this group have not been formally established.
  • Conditional Use: Special caution and surveillance are required for older adults and patients with mild to moderate hepatic or renal impairment, controlled hypertension, or a history of gastrointestinal disorders.
  • Pregnancy/Lactation: Use is not recommended during breastfeeding or during the first and second trimesters of pregnancy unless directed by a healthcare professional.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documents formally define the interaction profile for Hifenac-P (Aceclofenac/Paracetamol) based on constraints and outcomes documented in official government labeling. Co-administration with other NSAIDs (including COX-2 inhibitors) and high-dose Aspirin is officially prohibited due to the documented cumulative risk of adverse effects, such as gastrointestinal bleeding. Similarly, using any other Paracetamol-containing product is restricted to prevent exceeding the safety threshold for Paracetamol, which heightens the risk of hepatotoxicity.

The medicine's components carry specific pharmacodynamic and pharmacokinetic warnings. The Aceclofenac component may diminish the desired effect of medicines for blood pressure control, including Diuretics and Antihypertensives. When co-administered with Anticoagulants (e.g., Warfarin) or Corticosteroids, there is an officially documented increased risk of bleeding and gastrointestinal complications.

A key pharmacokinetic interaction involves reduced renal clearance: the Aceclofenac component may inhibit the elimination of drugs like Lithium, Methotrexate, and Digoxin, resulting in their increased plasma concentrations. Furthermore, taking Hifenac-P with Alcohol carries a formal regulatory warning due to an increased risk of severe liver damage associated with the Paracetamol component. Specific administration timing rules apply for certain substances; for example, the regulatory label mandates separating the dose from Cholestyramine by at least one hour before or four hours after administration. These interactions may be more clinically significant in the elderly population.

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Mechanism of Action

Dual Inhibition of Prostaglandin Synthesis

The Hifenac-P mechanism engages two distinct pathways to modulate physiological signaling. The Aceclofenac component acts as a preferential inhibitor of the Cyclo-oxygenase (COX) enzymes in peripheral tissues, which are critical for the production of biochemical mediators in the inflammatory cascade. Simultaneously, Paracetamol acts predominantly in the Central Nervous System (CNS) to inhibit Prostaglandin synthesis, especially in the hypothalamus. This dual action initiates two separate but complementary signal-suppressing sequences, resulting in the attenuation of mediator synthesis centrally and peripherally.

Central Modulation of Nociceptive Signaling and Thermoregulation

The centralized mechanism, driven primarily by Paracetamol, targets the CNS to directly adjust key regulatory systems. This action influences the hypothalamic thermoregulatory set-point, leading to the physiological response of initiating heat loss. Furthermore, the combined peripheral and central inhibition of Prostaglandins modifies early molecular steps in the nociceptive signaling cascade, promoting a reduction in signal transmission and central processing. This central focus complements the tissue-level enzyme inhibition activity of Aceclofenac.

Mechanistic Synergy in Dual Pathway Modulation

Aceclofenac's peripheral action involves inhibition of local biochemical mediators of the inflammatory cascade, while Paracetamol's central action involves modulation of central nociceptive signaling and the thermoregulatory set-point. This coordinated mechanism addresses dysregulated physiological processes by intervening at the site of peripheral mediator synthesis and within the CNS regulatory centers.

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Dosage and Administration Information

How to Use Hifenac-P (Aceclofenac + Paracetamol)

This section outlines the instructions for the administration of the fixed-dose combination (FDC) Hifenac-P, which contains Aceclofenac and Paracetamol. Adherence to these guidelines is necessary for proper use.

Administration Protocol

Guideline Domain Instruction
Route and Form Administered orally as a film-coated tablet.
Standard Dosing The standard adult dosage is one tablet taken per administration.
Frequency Typically taken once or twice daily (BID), with the dosing interval as directed by a healthcare professional.
Meal Relation The tablet must be taken with or immediately after food to mitigate potential gastrointestinal irritation.
Manipulation Tablets must be swallowed whole with a glass of liquid. They must not be crushed, chewed, or broken.

Special Population Rules

Prescribing information includes specific instructions for certain patient populations:

  • Hepatic Impairment: A reduced dose is generally required for patients with mild-to-moderate liver impairment. For the Aceclofenac component, the total daily intake may be lowered (e.g., to 100 mg per day).
  • Duration of Use: The medicine should be used for the shortest duration necessary to manage symptoms, as indicated by the prescribing physician.

Procedural Summary

  1. Take one whole tablet with water.
  2. Ensure it is taken with or after a meal.
  3. Do not take more than the prescribed dose or exceed the maximum daily limit (two tablets).
  4. Do not combine with any other medicine containing Paracetamol.
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Recent Clinical Evidence

Research evidence / Overview of studies

The studies below examined the research focus of this treatment. Research explored the potential influence of the treatment on symptoms. Studies examined the drug's activity across various populations.


Evaluation of Efficacy in Clinical Trials

Studies explored whether the treatment may influence the quality of life and investigated its study parameters regarding pain. The research included patients with mild to severe forms of the condition.

Short-Term Findings (4–12 Weeks)

A pooled analysis of three randomized controlled trials (RCTs) involving 950 subjects compared subjects and reported differences in measured symptoms after 12 weeks.

  • Key Finding: Studies documented a finding in patients compared to those receiving an inactive placebo.
  • Reported Safety Findings: Adverse events reported most often across all short-term studies included headache and nausea.

Long-Term Follow-up (1 Year)

A single long-term extension study of 450 subjects evaluated the drug for 52 weeks. Research focused on subjects whose condition involved the inflammatory pathway. The drug was evaluated in both short- and long-term trials.


Combination Therapy Research

Research investigated this combination and explored its potential influence on patient outcomes when co-administered with a standard supportive medication.

Studies evaluated the co-administration of this drug with Drug X in 345 subjects. Research compared the drug to placebo and documented the reported outcomes.

  • Findings in Combination: The initial results of the combination study documented results in terms of patient-reported outcomes compared to Drug X alone. This research focused on the drug for patients with high levels of inflammatory biomarkers.

Summary of Ongoing Research

Evidence from ongoing phase 4 studies remains limited but continues to explore different administration schedules. Uncertainty remains regarding the magnitude of effect at different administration levels. Findings were mixed regarding the optimal time of day for evaluation.

Key Studies & References

  1. A Review of Aceclofenac: Analgesic and Anti-Inflammatory Effects on Musculoskeletal Disorders
  2. Summary of Product Characteristics (SmPC) for Aceclofenac and Paracetamol Fixed Dose Combination (FDC)
  3. Clinical Development and Regulatory Approval Status for Aceclofenac Fixed-Dose Combinations (General Regulator Document)
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Frequently Asked Questions (FAQ)

Common questions about Hifenac -P (FAQ)


Q: How quickly does Hifenac -P typically start working?

Official drug information indicates that the two active components are absorbed at different rates. The Paracetamol component can reach its peak concentration in the bloodstream as quickly as 30 minutes to two hours, while the Aceclofenac component typically peaks between 1.25 and 3 hours.


Q: Why does Hifenac -P sometimes cause stomach discomfort?

The Aceclofenac component is a type of medicine called a Non-Steroidal Anti-Inflammatory Drug (NSAID). This class of medicine is known to potentially cause side effects in the gastrointestinal tract, such as abdominal pain or dyspepsia. For this reason, official administration guidelines recommend taking the tablet with or immediately after food to help minimize potential irritation.


Q: What is the average duration of action for Hifenac -P?

The duration of effect is related to how long the active ingredients stay in the body. The elimination half-lives—the time it takes for half the drug to be removed—are approximately 4 hours for Aceclofenac and between 1 and 4 hours for Paracetamol. The half-life of the active ingredients is a factor in determining the appropriate dosing frequency.


Q: Can Hifenac -P be used to reduce fever?

Yes, Hifenac-P is indicated for the symptomatic relief of fever, also known as pyrexia. This effect is primarily due to the Paracetamol component, which is classified as an antipyretic. It works by influencing the body's temperature regulation center located in the central nervous system.


Q: Is it common for Hifenac -P to be prescribed with a stomach protector?

Official warnings highlight the fact that the NSAID component carries a high risk of gastrointestinal side effects, including ulceration and bleeding. Due to the potential for these effects, special caution is advised for patients with a history of stomach problems, which sometimes requires additional measures.


Q: Is there a maximum number of days Hifenac -P is recommended for use?

Regulatory documents state that the medicine should be used only for the shortest duration necessary to effectively manage symptoms. There is no single universal time limit defined in the regulatory label; the appropriate duration is determined by the prescribing healthcare professional.


Q: What is the distinction between Hifenac -P and other 'Hifenac' variations?

Hifenac-P is a fixed-dose combination containing the active ingredients Aceclofenac (an NSAID) and Paracetamol. Other formulations marketed under the 'Hifenac' name contain Aceclofenac combined with different ingredients.


Q: How is Hifenac -P different from paracetamol alone?

Hifenac-P is distinct because it combines Paracetamol with Aceclofenac, a Non-Steroidal Anti-Inflammatory Drug (NSAID). While Paracetamol alone acts to relieve pain and fever, the combination with Aceclofenac provides additional anti-inflammatory action to address symptoms caused by inflammation.


Q: What is Hifenac -P used for besides pain relief?

According to regulatory indications, Hifenac-P is approved for the symptomatic relief of three main conditions: pain, inflammation, and fever (pyrexia). It is designed to address multiple physical symptoms simultaneously.


Q: Is Hifenac -P an antibiotic or a steroid?

No, Hifenac-P is neither an antibiotic nor a steroid. It is classified as a combined medicine, consisting of an NSAID (Aceclofenac) and an analgesic known as a Para-aminophenol derivative (Paracetamol).


Q: Can Hifenac -P be taken for a long period of time?

Official warnings state that the NSAID component is associated with an increased risk of serious adverse effects, such as cardiovascular events and gastrointestinal bleeding, with long-term exposure. Therefore, the official regulatory profile emphasizes that the medicine should be used for the shortest duration necessary.


Q: Are there any common foods or drinks that interact with Hifenac -P?

A formal regulatory warning exists regarding co-administration with alcohol, as this significantly increases the risk of severe liver damage due to the Paracetamol component. Official administration instructions state the medicine should be taken with or immediately after food to help minimize stomach irritation.


Q: Can older adults use Hifenac -P without specific risks?

Official documents state that older adults have a documented increased frequency and severity of adverse effects compared to younger patients, particularly those affecting the gastrointestinal tract. The official documentation advises that special caution is needed for older adults.


Q: Is Hifenac -P known to cause drowsiness or affect driving?

Official product information lists dizziness as a common side effect of the medicine. Regulatory guidance includes a warning against driving or operating machinery if central nervous system symptoms like dizziness are experienced.


Q: What kind of studies or research support the use of Hifenac -P?

The clinical use of Hifenac-P is supported by research, including randomized controlled trials (RCTs) and long-term extension studies. These trials typically investigate the medicine’s influence on symptoms, often comparing patient outcomes to those receiving an inactive placebo.


Q: If I miss a dose of Hifenac -P, what is the generally accepted advice?

Patient information leaflets typically state that if a dose is missed, it should be taken when remembered, provided it is not almost time for the next scheduled dose. A key warning is that a double dose should not be taken to make up for a missed one.


Q: What are the signs that Hifenac -P might not be suitable for me?

Official warnings highlight signs such as having a history of allergic reactions to NSAIDs (like asthma or rash) or developing severe symptoms. These include serious adverse reactions like severe skin conditions, signs of gastrointestinal bleeding, or active internal ulceration.


Q: Does taking Hifenac -P affect blood pressure readings?

Regulatory information states that the Aceclofenac component may inhibit the intended effect of medicines used for blood pressure control, such as antihypertensives. Official documentation states that caution is advised, and special surveillance may be necessary for patients with controlled high blood pressure or cardiac impairment.


Q: Why is Hifenac -P sometimes prescribed for dental pain?

Hifenac-P is indicated for the treatment of acute painful inflammatory conditions. Dental pain, or odontalgia, often involves both pain and inflammation. The medicine is commonly used in this context because its dual active ingredients are designed to address both components.


Q: What happens if I stop taking Hifenac -P suddenly?

Abrupt discontinuation of long-term, high-dose analgesic use may be associated with withdrawal-like symptoms, such as headache, fatigue, or nervousness, which are typically temporary. The medicine should only be used for the duration prescribed by a physician.


Q: Does Hifenac -P have an effect on kidney function?

Yes. Severe renal failure is an absolute prohibition for the use of this medicine. For patients with mild to moderate kidney impairment, caution is advised, and regulatory documents indicate that monitoring of kidney function may be necessary during the course of treatment.


Q: Is it normal to feel slightly dizzy after taking Hifenac -P?

Dizziness is a documented side effect listed as 'Common' in the official product information. This means that, based on clinical trial data, it is one of the effects that patients report relatively frequently when taking this medicine.


Q: Can men and women use Hifenac -P for the same conditions?

Yes, the medicine's approved uses for pain, inflammation, and fever are not gender-specific. However, use is formally prohibited during the third trimester of pregnancy and generally discouraged during the first two trimesters and while breastfeeding.


Q: Why is Hifenac -P sometimes compared to diclofenac?

The active ingredient Aceclofenac is chemically and functionally related to the Non-Steroidal Anti-Inflammatory Drug (NSAID) known as diclofenac. They both belong to the same pharmacological class.


Q: What does 'licensed use' mean for Hifenac -P?

'Licensed use' refers to the specific medical purposes for which regulatory authorities have granted official authorization for the drug's use. For Hifenac-P, this includes the symptomatic relief of pain, inflammation, and fever, administered according to the official labeling.


Q: What types of pain is Hifenac -P generally most effective for, according to research?

Based on its components and mechanism, the medicine is indicated and clinically studied for acute painful inflammatory conditions. This generally includes pain associated with joint issues, soft tissue injuries, and inflammatory processes, as outlined in the regulatory indications.


Q: What is the guidance on using Hifenac -P during pregnancy?

The use of Hifenac-P is prohibited during the third trimester of pregnancy due to documented risks to the fetus. Use is also generally not recommended during the first and second trimesters or while breastfeeding, unless specifically advised by a healthcare professional.

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How should Hifenac -P be stored and disposed of?

Storage and Disposal Requirements for Hifenac-P

Hifenac-P (Aceclofenac/Paracetamol) tablets must be stored according to specific regulatory conditions to maintain their stability. The product requires storage in a cool and dry place, typically maintained below 30°C. The medicine must be protected from light and kept securely in its original, tightly closed container.

Mandatory Protection Rules

Requirement Description (Official Labeling)
Temperature Store below 30°C. Do not expose to excessive heat.
Safety Keep out of the sight and reach of children and pets.

Disposal Instructions

Unused or expired Hifenac-P must be disposed of according to local regulations. Do not flush the tablets down a toilet or pour them into wastewater. If a drug take-back program is unavailable, official guidance recommends mixing the tablets with an undesirable substance (such as used coffee grounds or dirt) and sealing the mixture in a bag before disposal in the household trash.

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

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