Acf-PLUS

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Acf-PLUS

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Acf-PLUS

Property Description
Active Ingredients Aceclofenac and Paracetamol (Acetaminophen)
Form Oral tablet (Fixed-Dose Combination)
Pharmacological Class NSAID and Non-Opioid Analgesic/Antipyretic
General Purpose Relief of pain, inflammation, and fever
Origin Synthetic

What Type of Medicine is Acf-PLUS?

Acf-PLUS is a fixed-dose combination (FDC) medicinal product, typically formulated for oral administration as a tablet. This medicine is a synthetic preparation that combines two distinct therapeutic agents: a Non-Steroidal Anti-Inflammatory Drug (NSAID) and a Non-Opioid Analgesic with antipyretic capabilities. Its classification as a dual-action agent is clinically recognized for its efficacy in managing acute painful and inflammatory states. Aceclofenac, a key component, is well-regarded for its established anti-inflammatory and analgesic efficacy in treating painful conditions.


What is the Composition of Acf-PLUS?

The composition of Acf-PLUS is defined by its two core active ingredients: Aceclofenac and Paracetamol (Acetaminophen). Aceclofenac contributes the primary anti-inflammatory properties, while Paracetamol is included for its reliable pain-relieving (analgesic) and fever-reducing (antipyretic) effects. This formulation is designed to offer improved outcomes compared to using either agent alone for symptomatic relief. Other common trade names containing this exact formulation include Aceclo Plus and Hifenac P, demonstrating the widespread acceptance of this particular fixed-dose composition.


What is the General Purpose of This Combination?

The general purpose of the Acf-PLUS combination is to achieve integrated symptomatic relief by efficiently targeting pain and inflammation. The medicine is broadly utilized to alleviate discomfort linked to painful and inflammatory states, such as those associated with acute musculoskeletal discomfort. By working through two different pathways, the product aims to effectively reduce the overall sensation of pain, decrease localized swelling caused by inflammation, and assist in lowering an elevated body temperature.

What side effects are possible with Acf-PLUS?

Possible Side Effects and Safety Information

Common Adverse Reactions

The most frequently reported side effects involve the Gastrointestinal System (e.g., nausea, vomiting, stomach pain, indigestion, diarrhea, constipation, and heartburn) and the Central Nervous System (e.g., dizziness, headache, and sleepiness). These common reactions often resolve with continued use or by taking the medication with food.

Serious and Clinically Significant Risks

Acf-PLUS, containing a Non-Steroidal Anti-Inflammatory Drug (NSAID) and paracetamol, carries risks of serious adverse reactions impacting vital organs. These include: Gastrointestinal Toxicity (ulceration, bleeding, or perforation of the stomach/intestine, which can be fatal), Hepatic Damage (severe liver injury or failure, particularly with high doses or chronic use), and Renal Impairment (kidney damage or failure, especially with long-term use). Serious allergic reactions (hypersensitivity, including swelling of the face, throat, or tongue) have also been reported and require immediate medical attention.

Safety Restrictions and Precautions

  • Contraindications: This medicine is contraindicated in the third trimester of pregnancy, in patients with severe heart failure, active or recurrent stomach ulcers/bleeding, and severe liver or kidney disease. It should also be avoided by individuals with a known allergy to any component or to other NSAIDs.
  • Dosing/Exposure: Taking more than the recommended daily dose significantly increases the risk of side effects, including liver damage. Prolonged use is not recommended and increases the risk of kidney damage.
  • Concomitant Use: Alcohol consumption is unsafe and must be avoided, as it significantly increases the risk of gastrointestinal bleeding and severe liver toxicity. Use with other medicines containing paracetamol or other NSAIDs is prohibited due to the heightened risk of serious adverse effects.
  • Vulnerable Populations: Caution and medical supervision are required for the elderly and for patients with pre-existing heart conditions (e.g., high blood pressure, heart disease), asthma, or mild-to-moderate liver or kidney dysfunction. Due to the potential for dizziness or drowsiness, activities requiring mental alertness, such as driving or operating heavy machinery, should be avoided until the individual's response to the drug is known. (275 words)

Overdose and Emergency Response

Overdose and when to seek help for Acf-PLUS

The information in this section summarizes official regulatory statements regarding Acf-PLUS overdose and necessary emergency actions. This information should not be used as a substitute for professional medical advice.


Overdose Scope

Official regulatory documents indicate that an overdose is associated with ingesting more than the prescribed dosage. Patients are explicitly warned to never exceed this dosage without medical guidance.

Common symptoms of overdose may include nausea, vomiting, and sleepiness. These manifestations primarily affect the gastrointestinal and central nervous systems. Official texts note that these symptoms might worsen over time.

Required Action

If an overdose is suspected, it is crucial to immediately inform your doctor or seek urgent medical attention. Do not ignore symptoms, as prompt consultation is required. The risk profile suggests that older patients may be more susceptible to adverse effects, which is a factor to consider in overdose situations.


Summary of Regulatory Profile

The regulatory profile emphasizes prevention, stressing strict adherence to the prescribed dosage to mitigate overdose risk. The listed symptoms—nausea, vomiting, and sleepiness—form the defined clinical presentation. Seeking help is mandatory upon suspicion of overdose, driven by the potential for symptoms to deteriorate.

Therapeutic Uses of Acf-PLUS

The primary therapeutic benefit of this combination may be part of symptomatic management for symptom clusters related to physical discomfort and systemic imbalance associated with inflammatory or irritative states. Acf-PLUS is applied in addressing symptom clusters that may become intense or disruptive. The combination is commonly used to help with discomfort in conditions such as Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, and pain following minor surgical procedures or soft-tissue injuries.

It is applied in clinical settings that involve acute or unstable symptom patterns, such as during flare-ups of chronic conditions or in managing post-procedural pain. By addressing a combination of symptoms, the medication may assist with managing pronounced acute discomfort and contributes to easing the overall symptom load, and may assist with maintaining functional stability during episodes of heightened discomfort.

It is considered relevant to assist patients in coping more steadily with difficult episodes characterized by concurrent pain and inflammation.”


Quick Fact: Symptomatic Relief for Acute Musculoskeletal and Inflammatory Pain

Eligibility and Restrictions for Use

Population Eligibility for Acf-PLUS

The medicine Acf-PLUS (Aceclofenac/Paracetamol FDC) is only permitted for use in adults who do not meet any specific exclusion criteria documented by regulatory authorities. Eligibility is strictly governed by age, specific diseases, and physiological states.

Absolute Contraindications

Use is prohibited in patients with the following severe conditions, as explicitly stated in the official labeling:

  • Severe organ insufficiency: Severe heart failure (NYHA Class II–IV), severe hepatic (liver) failure, or severe renal (kidney) failure.
  • Gastrointestinal status: Active or suspected peptic ulcers, gastrointestinal bleeding, or active bleeding disorders.
  • Hypersensitivity: Known reactions (e.g., bronchospasm, acute rhinitis, urticaria) to aspirin, other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), or any components of Acf-PLUS.
  • Pregnancy: During the third trimester of pregnancy.

Restricted and Conditional Use

Eligibility Status Population/Condition Regulatory Classification
Not Recommended Children and Adolescents Safety and efficacy has not been established.
Not Recommended Pregnant women (1st and 2nd trimester) Should be avoided unless compelling reasons exist.
Not Recommended Breastfeeding women Use should be avoided.
Caution Required Elderly patients Due to increased risk of impaired renal/hepatic/cardiac function.
Caution Required Mild to moderate organ impairment Requires close medical surveillance.
Caution Required Patients with history of certain conditions Includes peptic ulcers, ulcerative colitis, Crohn's disease, or hypertension.

Connection to the overall eligibility profile: The regulatory documents strictly define who can and cannot use Acf-PLUS primarily through a list of absolute contraindications that prohibits use for patients with severe organ function impairment, active gastrointestinal bleeding, or late-stage pregnancy. For populations with milder organ dysfunction, specific pre-existing conditions, or those in the early stages of pregnancy, the regulatory profile mandates caution or states that use is not recommended, establishing clear, documented limitations on eligibility.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Acf-PLUS, a fixed-dose combination of Aceclofenac and Paracetamol, establishes specific interaction patterns based on governmental prescribing documents.

Official Interaction Statements

Interaction Type Interacting Substances Official Outcome/Restriction
Contraindicated/Avoided Other NSAIDs (including aspirin) & Corticosteroids Documented increased risk of serious gastrointestinal events (bleeding/ulceration).
Drug Exposure Increase Lithium, Digoxin, Methotrexate Aceclofenac component may increase plasma concentrations, potentially requiring caution or monitoring.
Pharmacodynamic Effect Anticoagulants (e.g., Warfarin) Aceclofenac component may enhance anticoagulant activity, increasing the documented risk of bleeding.
Toxicity Risk Hepatic Enzyme Inducers (e.g., Carbamazepine, Rifampicin) Officially increases the risk of Paracetamol-linked liver toxicity.
Reduced Effectiveness Antihypertensives (Diuretics, ACE-inhibitors) Aceclofenac component may reduce the effectiveness of these agents and increase renal risk.

Additional Constraints

Co-administration with Mifepristone requires a separation period; the drug should not be used within 8 to 12 days following its administration. The use of Alcohol is noted in regulatory sources as officially increasing the risk of liver damage due to the Paracetamol component. Specific caution is required for Elderly Patients and those with Hepatic Impairment, as they may experience an increased susceptibility to interaction-related toxicity, as explicitly stated in product labeling. These statements strictly reflect the documented interaction requirements and official risk profiles.

Mechanism of Action

How Acf-PLUS Works

The action of Acf-PLUS is defined by a multimodal mechanism that targets two distinct physiological systems—peripheral inflammation and central pain/temperature control—through the complementary action of its two active components.

Modulation of Peripheral Inflammatory Mediators

This domain focuses on Aceclofenac, which acts as an inhibitor of the Cyclooxygenase (COX) enzyme system (preferentially COX-2) in peripheral tissues. By suppressing the enzyme, the molecule limits the synthesis of pro-inflammatory chemicals, such as prostaglandin E2 (PGE2). This mechanistic action leads to the physiological outcome of suppressing the propagation of the inflammatory cascade and reducing the excitability of peripheral nociceptors.

Central Modulation of Nociception and Thermoregulation

This domain highlights the role of Paracetamol, which primarily acts within the Central Nervous System (CNS). Its mechanism involves modulating central pain pathways via TRPV1 and CB1 receptors and inhibiting prostaglandin synthesis in the hypothalamus. This dual central action promotes the modulation of nociceptive signaling and resets the elevated body temperature set-point, initiating thermoregulatory adjustments.

Mechanistic Complementarity

The combination leverages the strengths of both agents: the peripheral control of inflammatory mediator synthesis by Aceclofenac and the central control of nociception and temperature regulation by Paracetamol. This complementary action addresses both peripheral and central components of the nociceptive pathway, combining distinct mechanistic actions.

Dosage and Administration Information

Official Administration Guidelines

Acf-PLUS is a fixed-dose combination product intended solely for oral administration as a film-coated tablet. This medicine must be swallowed whole with an adequate amount of liquid and should not be crushed or chewed. Typically, the tablet is taken preferably with or after food to help minimize potential gastrointestinal discomfort.


Standard Dosing and Frequency

The standard adult regimen involves taking one tablet twice daily, which establishes a twice-daily frequency and limits the maximum intake to two tablets daily. This dosage principle adheres to the general guidance of utilizing the lowest effective dose for the shortest duration necessary to control symptoms. If a dose is missed, it is advised to skip that dose and continue with the next scheduled dose, strictly prohibiting the taking of a double dose to compensate.


Population-Specific Use Constraints

There are specific procedural constraints for certain patient groups:

Population Group Administration Rule
Pediatric Patients Not recommended due to insufficient clinical data
Hepatic Impairment Dose reduction is suggested, typically to one tablet once daily
Older Adults No general dose modification is required

These guidelines define the structured, high-level protocol for the proper administration of Acf-PLUS.

Recent Clinical Evidence

Research Evidence / Overview of Studies


Efficacy Data: Pain and Mobility

Research explored the association between Acf-PLUS and patient outcomes in two key areas: pain and mobility.

  • Pain Score Research: Studies evaluated whether the drug was associated with changes in pain scores. One study reported an average reduction of 40% when assessing pain change using a validated 10-point scale.
  • Speed of Impact: One study examined the treatment's impact on joint discomfort and reported an assessment of the speed of relief.
  • Swelling and Inflammation: A study reported on changes in swelling over a 6-month period. Research also evaluated standard inflammation markers in blood tests.

Long-Term Outcomes and Combination Use

Research has examined long-term outcomes and the use of the drug in combination with other treatments.

  • Flexibility and Function: One study evaluated whether the combination of Acf-PLUS with physical therapy was associated with changes in long-term flexibility.
  • Duration of Treatment: Research has examined the outcomes associated with a treatment duration of 12 weeks.
  • Comparative Research: Some studies compared outcomes of the drug to standard over-the-counter medication.

Safety and Tolerability Profile

Safety studies were conducted on adults. Safety studies identified temporary digestive discomfort and headache among the reported findings.

  • Specific Populations: Research examined use in individuals with severe liver impairment. Studies have also looked at the drug's interaction profile with common blood thinners.

The information presented here is strictly descriptive of the research that has been conducted and does not constitute medical advice or a recommendation for treatment.

Key Studies & References Clinical Guidance on the Management of Painful Musculoskeletal Conditions (Relevant National Guideline)

Frequently Asked Questions (FAQ)

Common questions about Acf-PLUS (FAQ)


Q: How long do common side effects from Acf-PLUS usually last?

A: Common, transient side effects are often known to occur but may resolve with continued use of the medication. Temporary symptoms such as headache or fatigue, which may occur after discontinuing long-term use of the analgesic component, may typically resolve within a few days.

Q: Are there any major food groups or drinks to avoid while using Acf-PLUS?

A: Official administration guidelines suggest taking this medication with or after food to help minimize potential stomach discomfort. Regulatory documents explicitly caution against or prohibit the consumption of mathbfalcohol, as it significantly increases the risk of liver toxicity and gastrointestinal bleeding. There are no specific food groups officially listed for avoidance.

Q: I take a medication for [other condition]; does Acf-PLUS interact with it?

A: Regulatory information lists several drug classes that are known to interact with Acf-PLUS. This includes other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), anticoagulants, lithium, digoxin, and certain antihypertensives. This list is available in the regulatory documents, and comprehensive risk review is done by a healthcare professional.

Q: How long does it typically take for Acf-PLUS to start working?

A: According to regulatory information, the combination product’s therapeutic action is measured by its onset. The onset of therapeutic action is typically observed mathbfwithin mathbf30 mathbfminutes of administration.

Q: What is the difference between a common side effect and an allergic reaction to Acf-PLUS?

A: Common side effects, such as stomach pain or a mild headache, are generally temporary adverse reactions. Serious allergic reactions (hypersensitivity) involve symptoms like swelling of the face or throat, rash, or difficulty breathing. Regulatory documents detail that these reactions are serious events necessitating immediate medical evaluation.

Q: Is there a generic version of Acf-PLUS available?

A: Acf-PLUS is a mathbffixed -mathbfdosemathbfcombination of the two active ingredients, Aceclofenac and Paracetamol. Regulatory information confirms that this specific formulation is widely available and marketed under mathbfmultiple mathbftrade mathbfnames (for example, Aceclo Plus or Hifenac P).

Q: Does Acf-PLUS have a maximum recommended period of use?

A: The regulatory guidance is based on the principle of utilizing the mathbflowest mathbfeffective mathbfdose for the mathbfshortest mathbfduration mathbfnecessary to control symptoms. For the Paracetamol component, use without medical consultation is often limited to mathbf3 mathbfdays.

Q: What is the regulatory status of Acf-PLUS in other countries?

A: The product is officially regulated by national agencies such as the Rwanda FDA and NAFDAC, establishing its status in those regions. To determine its regulatory status in mathbfother mathbfcountries (such as those under the EMA, FDA, or TGA), information is generally sourced from the respective national health authority.

Q: What is the expected duration of the effects of Acf-PLUS?

A: The therapeutic effect is generally measured to last up to mathbf4 mathbfto mathbf6 mathbfhours after taking a dose. This aligns with the half-life figures for the components, which are approximately mathbf4 mathbfhours for Aceclofenac and mathbf1 mathbfto mathbf4 mathbfhours for Paracetamol.

Q: Are there different strengths or formulations of Acf-PLUS available?

A: Regulatory information confirms that this fixed-dose combination is available in mathbfdifferent mathbfstrengths, such as mathbf100mathbfmg/mathbf500mathbfmg and mathbf100mathbfmg/mathbf325mathbfmg tablets. It mathbfmay mathbfalso mathbfbe mathbfavailable mathbfin mathbfa mathbfsuspension mathbfform.

Q: Is Acf-PLUS classified as a controlled substance?

A: Official regulatory documents classify this medicine as a mathbfPrescription mathbfOnly mathbfMedicine (POM) in many regions. However, it is important to note that it is mathbfnot mathbfclassified as a federally mathbfcontrolled mathbfsubstance (scheduled drug) by US or EU authorities.

Q: Does Acf-PLUS contain common allergens like gluten or lactose?

A: According to the official composition documents, some specific formulations of Aceclofenac/Paracetamol tablets mathbfcontain mathbflactose as a non-active ingredient (excipient). A full list of excipients, which includes any potential allergens, is provided in the official Summary of Product Characteristics (SmPC) for the product.

Q: What is the meaning of a 'long half-life' for a drug like Acf-PLUS?

A: The term mathbfhalf -mathbflife is a pharmaceutical measurement that refers to the time it takes for the concentration of the medicine in the body to reduce by half. The half-life for Aceclofenac is approximately mathbf4 mathbfhours, and for Paracetamol is mathbf1 mathbfto mathbf4 mathbfhours.

Q: Does Acf-PLUS need to be taken at the exact same time every day?

A: The regulatory recommended regimen is mathbftwice mathbfdaily (BID). The consistent dosing interval is intended to maintain steady medication levels, typically requiring a mathbf12mathbfhour mathbfinterval between the morning and evening doses.

Q: How long after stopping the medication does Acf-PLUS stay in the body?

A: The time a medicine stays in the body is directly related to its mathbfhalf -mathbflife of elimination. Given the longest half-life of the components is approximately mathbf4 mathbfhours, it generally takes about mathbf20 mathbfhours (five half-lives) for the medicine to be almost fully eliminated from the body.

Q: Will Acf-PLUS interfere with routine blood test results?

A: Regulatory documents indicate that the drug can affect mathbfliver mathbfenzymes, mathbfkidney mathbffunction, and mathbfblood mathbfcounts. The product label states that patients receiving long-term treatment are monitored regularly for these specific laboratory parameters.

Q: Is Acf-PLUS known to cause sun sensitivity (photosensitivity)?

A: Official regulatory-linked reports indicate the Aceclofenac component is a photoallergic agent, and cases of mathbfphotodermatitis (sun-related skin reactions) have been reported. Precautions regarding sun exposure are generally advised for phototoxic agents.

Q: Are there special monitoring requirements (like blood tests) for people taking Acf-PLUS?

A: The product label mandates specific mathbfmonitoring mathbfrequirements for individuals receiving long-term treatment with this medicine. These tests include mathbfrenal mathbffunction mathbftests, mathbfliver mathbffunction mathbftests, and mathbfblood mathbfcounts, which are monitored by a physician.

Q: Why is Acf-PLUS sometimes referred to as a 'prodrug'?

A: The term 'prodrug' is used because the Aceclofenac component is mathbfmetabolized mathbfin mathbfthe mathbfbody after consumption. Regulatory documents describe that it is converted into mathbf4' -mathbfhydroxyaceclofenac, which is its primary active metabolite.

Q: What should I generally expect when stopping Acf-PLUS?

A: Abrupt discontinuation after mathbflong -mathbftermmathbfhighmathbfdose use of the analgesic component mathbfmay mathbflead mathbfto mathbftemporary mathbfwithdrawal mathbfsymptoms. These symptoms, which can include headache or fatigue, typically mathbfresolve mathbfwithin mathbfamathbffewmathbfdays according to regulatory information.

Q: Why are the tablets sometimes different colors?

A: The specific color of the tablet is determined by the mathbfcoloring mathbfagents mathbfand mathbfexcipients used by the manufacturer in that formulation. Because different manufacturers and strengths may use mathbfdifferent mathbfcolors (such as Ferric Oxide Yellow), the appearance can vary. The coloring agents are listed in the official composition document.

How should Acf-PLUS be stored and disposed of?

Official Storage and Disposal Instructions

Acf-PLUS tablets must be stored according to official regulatory specifications to maintain the product's quality and ensure safety.

Storage Requirement Official Rule
Temperature Store below 30 C in a cool, dry place.
Environmental Protection The tablets must be protected from light and moisture.
Child Safety Keep out of the sight and reach of children.

This medicine has a labeled shelf-life of 36 months, which is contingent upon adherence to these temperature and environmental constraints.

For disposal, unused or expired Acf-PLUS must be managed in accordance with local requirements for pharmaceutical waste. Do not dispose of the tablets via household wastewater. The best disposal option is typically a formal drug take-back program or authorized collection site. If no program is available, follow federal guidelines for mixing the medicine with an undesirable substance before discarding it in the household trash.

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

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