A-Fenac Plus

Quick links to important sections

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of A-Fenac Plus

Quick Facts

Property Description
Active Ingredient Diclofenac
Form Oral Tablet
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common Action Anti-inflammatory, Analgesic, Antipyretic
Origin Synthetic Compound

What Type of Medicine is A-Fenac Plus?

A-Fenac Plus is classified as a pharmaceutical preparation that belongs to the Nonsteroidal Anti-inflammatory Drug (NSAID) pharmacological class. This essential classification defines its core function as modulating the body's inflammatory and pain responses. The active ingredient, Diclofenac, is a synthetic compound derived from Phenylacetic acid. Diclofenac is characterized by its systemic action throughout the body. This preparation is typically supplied as a prescription-only medicine, underscoring the need for professional oversight in its use.

Active Ingredient, Form, and Origin

The core therapeutic component of A-Fenac Plus is the active ingredient, Diclofenac, which provides the preparation with its fundamental analgesic and anti-inflammatory properties. The product is manufactured as an oral dosage form, specifically a tablet, designed to be swallowed for absorption and subsequent systemic action. The designation "Plus" implies that A-Fenac Plus is a combination preparation, containing Diclofenac along with an additional therapeutic or enhancing substance, a distinction based on product labeling.

General Purpose and Action Group

The general purpose of A-Fenac Plus is to provide relief by addressing symptoms related to inflammation, pain, and pyrexia. The preparation belongs to the action group responsible for achieving anti-inflammatory, analgesic (pain relief), and antipyretic (fever reduction) effects. Diclofenac's action involves inhibiting the biosynthesis of prostaglandins, the chemical messengers of inflammation. It serves as a tool for managing inflammation-related discomfort, with a typical use scenario involving the temporary relief of generalized body aches accompanied by mild fever.

Regulatory References

  1. Diclofenac - MedlinePlus Drug Information

What side effects are possible with A-Fenac Plus?

Possible Side Effects and Safety Information

This section outlines the officially documented adverse reactions and safety restrictions for A-Fenac Plus, as categorized by government regulatory bodies.

Serious Safety Concerns and Restrictions

The most serious safety concerns documented are related to specific organ systems and include major cardiovascular thrombotic events (such as myocardial infarction and stroke), severe gastrointestinal injury (bleeding, ulceration, or perforation), and severe hepatic (liver) failure. These risks often increase with higher doses and longer durations of use, necessitating the use of the lowest effective dose for the shortest period required.

The medicine is contraindicated (should not be used) in certain high-risk situations. This includes patients with established congestive heart failure, ischemic heart disease, active gastrointestinal bleeding or ulceration, severe hepatic or renal impairment, and during the third trimester of pregnancy.

Frequency-Classified Adverse Reactions

Side effects are categorized by the frequency of their occurrence in regulatory documents:

  • Common Reactions (occurring in 1 to 10 out of 100 people):

    • Gastrointestinal complaints (nausea, dyspepsia, abdominal pain)
    • Headache, dizziness, and vertigo
    • Elevated liver enzymes (transaminases)
  • Rare Reactions (occurring in 1 to 10 out of 10,000 people):

    • Hypersensitivity and anaphylactic reactions
    • Asthma (including dyspnoea)
    • Gastrointestinal bleeding or ulceration
    • Hepatitis (liver inflammation)
  • Very Rare Reactions (occurring in less than 1 out of 10,000 people):

    • Severe skin reactions (e.g., Stevens-Johnson syndrome)
    • Bone marrow depression or agranulocytosis
    • Severe hypertension or heart failure
    • Nephritis (kidney inflammation)

These classifications reflect the official summary of the medicine's risk profile based on clinical and post-marketing safety data.

Overdose and Emergency Response

A-Fenac Plus Overdose and when to seek help


Overdose Scope

Element Official Regulatory Documentation Statement
Documented overdose presentations: Manifestations include nausea, vomiting, stomach pain, diarrhea, dizziness, drowsiness, headache, and ringing in the ears (tinnitus). Central nervous system effects such as agitation, confusion, or delirium may also occur.
Physiological systems affected: Gastrointestinal system (bleeding, ulceration), Renal system (acute renal failure), Hepatic system (liver failure), and Central Nervous System (seizures, coma).
Population-specific overdose notes: A large overdose can be harmful to all patients; however, elderly individuals are at a higher risk for serious gastrointestinal adverse events.

Immediate Actions and Management

Classification Element Official Regulatory Documentation Statement
When immediate medical help is required: Regulatory documents mandate individuals seek medical help right away or contact a poison control center if an overdose is suspected. Seeking emergency help is also required for severe reactions like anaphylaxis.
Antidote and management: No specific antidote is known for this drug class toxicity. Management relies strictly on symptomatic and supportive treatment.

Connection to the overall overdose profile: The official documents define the overdose profile by listing the full spectrum of potential manifestations, from common gastrointestinal symptoms to life-threatening end-organ toxicities. The profile dictates that, due to the absence of a specific antidote, urgent medical intervention and specialized hospital monitoring, including assessment of vital signs and blood tests, are required to manage potential severe effects.

Therapeutic Uses of A-Fenac Plus

What A-Fenac Plus Treats: Main Uses and Benefits

The medicine is generally used to provide supportive symptomatic relief for conditions that involve pain, inflammation, and fever. This preparation is utilized across domains where additional symptomatic support is needed to address discomfort arising from inflammatory or irritative states.

A-Fenac Plus is considered relevant for managing symptoms related to chronic conditions like rheumatoid arthritis and osteoarthritis, as well as acute episodes of discomfort. Its use is common in clinical scenarios involving sprains, strains, dental pain, severe acute gout, and menstrual cramps.

“The primary benefit is in providing symptomatic relief that offers support during difficult episodes, rather than treating the underlying condition itself.”

The preparation may assist with easing symptoms that create noticeable functional strain, such as joint swelling and stiffness. It also supports patients during episodes of heightened discomfort and may assist with generalized body aches and symptoms related to systemic imbalance when accompanied by elevated body temperature (fever), contributing to easing the overall symptom burden.


Quick Facts: Therapeutic Support

Domain Conditions / Contexts Symptom Relief
Chronic Arthritis, Ankylosing spondylitis Joint stiffness, persistent pain
Acute Trauma, Post-procedure, Gout Swelling, severe acute discomfort
Episodic Headaches, Dysmenorrhea, Fever Generalized aches, elevated temperature

Eligibility and Restrictions for Use

The eligibility for A-Fenac Plus is strictly defined by regulatory documents, which list several absolute prohibitions and necessary restrictions.

Eligibility Scope

Populations for Whom Use is Allowed Adults. Adolescents (12 or 14 years of age, depending on formulation).
Populations for Whom Use is Contraindicated Patients with known hypersensitivity to Diclofenac or other NSAIDs (e.g., aspirin-induced asthma). Active or history of recurrent gastrointestinal ulceration/bleeding. Severe hepatic, renal, or heart failure (NYHA Class II-IV). Established Ischemic Heart Disease or Cerebrovascular Disease. Use during the last trimester of pregnancy.
Age-Related Eligibility Rules Not established for most oral formulations in children younger than 12 years of age. Geriatric patients must use with caution at the lowest effective dose due to increased risk of serious adverse reactions.
Pregnancy and Lactation Status Contraindicated in the last trimester of pregnancy. Use requires careful consideration during lactation as the medicine passes into breast milk.

Eligibility-Related Restrictions

Use is not recommended in patients with uncontrolled hypertension or significant cardiovascular risk factors. Patients with mild to moderate hepatic or renal impairment require caution and medical supervision.

What should I know about interactions with other medicines?

A-Fenac Plus contains aceclofenac (an NSAID) and paracetamol. The risk of adverse effects may increase when taken with several other medications. Therefore, it is essential to inform your doctor or pharmacist about all prescription, over-the-counter, and herbal supplements you are currently taking.


Major Drug Interactions

Particular caution and medical supervision are required with the following:

  • Anticoagulants (e.g., warfarin) and Antiplatelet agents (e.g., aspirin): Increased risk of serious bleeding.
  • Other NSAIDs (e.g., ibuprofen, naproxen): Concurrent use is generally not recommended, as it offers no additional benefit and significantly raises the risk of gastrointestinal side effects and bleeding.
  • Lithium and Digoxin: A-Fenac Plus can increase the blood levels of these drugs, leading to potential toxicity.
  • Methotrexate: Taking this combination within 24 hours may increase the levels and toxicity of methotrexate, which can be severe.
  • Diuretics and Antihypertensives (e.g., ACE inhibitors, ARBs): NSAIDs can reduce the effectiveness of these medications and increase the risk of kidney damage, especially in patients who are elderly or dehydrated.
  • Corticosteroids and Selective Serotonin Reuptake Inhibitors (SSRIs): Increased risk of gastrointestinal bleeding or ulceration.
  • Alcohol: Concurrent use is strongly discouraged due to a significantly increased risk of liver damage from paracetamol and gastrointestinal bleeding from aceclofenac.

If you have a history of heart, kidney, or liver disease, your doctor may need to adjust your A-Fenac Plus dosage or recommend alternative treatments.

Mechanism of Action

A-Fenac Plus operates via a dual-compartment mechanism that utilizes the distinct actions of Diclofenac and Paracetamol to influence prostaglandin synthesis. The mechanism initiates interference with chemical signals that mediate nociception and thermoregulation.

The mechanism centers on the non-selective inhibition of cyclooxygenase ( COX) enzymes by Diclofenac in peripheral tissues. This blocks the synthesis of pro-inflammatory mediators like prostaglandin E2 ( PGE2), resulting in decreased signaling** of inflammatory PGE2 and reduced sensitization of peripheral nociceptors.

The Paracetamol component primarily acts within the brain and spinal cord, focusing on the selective reduction of PGE2 in the hypothalamus and other central pain structures. This CNS action initiates a cascade that influences the hypothalamic thermoregulatory center, while also producing a distinct effect that modulates central nociceptive processing.

The two components operate with mechanistic synergy by targeting PGE2 in two separate anatomical locations—the periphery and the CNS—through different enzymatic interactions. This dual-site action results in a coordinated influence on the systems responsible for nociception and thermoregulation.

Dosage and Administration Information

How to use A-Fenac Plus: Official Administration Guidelines

Administration of A-Fenac Plus, which contains the active ingredient Diclofenac, follows standardized protocols.

The general principle for administration is to use the lowest effective dose for the shortest duration necessary. The total daily dose for chronic conditions should generally not exceed 150 mg.


Standard Dosing and Procedural Requirements

Instruction Detail
Route of Administration The preparation is administered via the oral route (by mouth).
Dosing Schedule (Adults) Standard daily dosing for chronic use typically ranges from 100 mg to 150 mg, usually given in divided daily doses (two to four times daily), depending on the formulation.
Timing in Relation to Meals Immediate-release formulations should generally be taken on an empty stomach for optimal absorption. Delayed-release (enteric-coated) tablets may be taken with or without food.
Preparation Requirements Tablets must be swallowed whole with liquid. Delayed-release and extended-release tablets must not be crushed, chewed, or divided to preserve the controlled release mechanism.
Special Conditions Different oral formulations (e.g., immediate-release vs. delayed-release) are not interchangeable at the same milligram strength.

Use in Specific Populations

Guidelines indicate that older adult patients be managed using the lowest effective dose. For pediatric patients aged 14 years and older, the daily dose should not exceed 75 mg to 100 mg in divided doses. Specific dose adjustments are not explicitly established for mild to moderate renal or hepatic impairment.

Protocol for Missed Doses

If a dose is missed, it should be taken as soon as remembered. However, if it is close to the time of the next scheduled dose, the missed dose should be skipped, and the regular schedule should be continued; two doses should not be taken together.

Recent Clinical Evidence

Research evidence / Overview of Studies for A-Fenac Plus


Evidence for Use in Chronic Conditions: Osteoarthritis and Rheumatoid Arthritis

Research has explored how patient-reported symptoms evolve over defined time intervals for chronic symptoms like pain and joint stiffness. Randomized Controlled Trials (RCTs) and Systematic Reviews evaluated outcomes related to physical discomfort and assessed measures of physical function in adults and older adults with conditions such as Osteoarthritis (OA). Studies conducted during these defined time intervals reported measurements that described patterns of change in patient-reported pain intensity. Evidence contributes to the broader evidence landscape through observational data on the medication's use over longer periods in real-world settings. Long-term effects are not fully established by randomized studies, and comparative evidence is lacking for some other common pain medications.

Research also was studied for Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS). These studies monitored outcomes such as pain severity, joint swelling, and functional disability scores over periods of several months. Studies report how symptoms evolved, largely tracking measures of symptomatic relief. However, studies provide limited insight into whether the medication alters the progression of structural damage associated with these conditions.


Evidence for Use in Acute and Episodic Pain: Musculoskeletal Injuries and Dysmenorrhea

For Acute Low Back Pain (LBP) and other musculoskeletal injuries, research examined temporary physiological imbalance using short-term RCTs. These trials explored outcomes describing episodic changes and monitored patient-reported discomfort. Findings indicated that measured outcomes described patterns of change in pain over periods typically less than four weeks. The medication was evaluated in women experiencing Dysmenorrhea (painful menstrual cycles), with RCTs examining outcomes related to physical discomfort. Subgroup findings are uncertain, and comparative evidence against all newer, targeted treatments is uncertain.


What Research Shows Is Still Uncertain About A-Fenac Plus

Evidence highlights what is known—and what is still uncertain. A consistent limitation across many studies is that follow-up durations were limited, especially for acute pain scenarios. For chronic conditions, long-term effects are not fully established by randomized data. In some research scenarios, findings were mixed due to the highly heterogeneous nature of the study population, which means that evidence quality varies across studies. Evidence for certain groups, including the pediatric population and patients with complex, pre-existing conditions, remains insufficient, and subgroup findings are uncertain.

Frequently Asked Questions (FAQ)

Common questions about A-Fenac Plus (FAQ)


Q: What is the main difference between A-Fenac Plus and regular A-Fenac?

A: Official regulatory product information indicates that A-Fenac Plus is a combination preparation. This means it contains Diclofenac along with an additional active substance, Paracetamol (Acetaminophen). Regular A-Fenac typically refers to the single-ingredient formulation containing only Diclofenac.


Q: Is A-Fenac Plus considered a strong pain reliever?

A: A-Fenac Plus contains Diclofenac, which belongs to the class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). Regulatory classification indicates this medicine is used to influence the body's response to pain, inflammation, and stiffness associated with conditions like arthritis.


Q: Do you need a prescription for A-Fenac Plus?

A: This preparation is commonly supplied as a prescription-only medicine. Although some lower-strength versions of Diclofenac may be available without a prescription for short-term use, the 'Plus' combination typically requires professional oversight.


Q: How quickly can I expect A-Fenac Plus to start working?

A: The onset of action is influenced by the specific type of tablet formulation being used. For Diclofenac, absorption may start or peak between 1 to 4 hours after taking the tablet. If a delayed-release tablet is taken with food, the onset may take longer.


Q: How long does the effect of A-Fenac Plus typically last?

A: The Diclofenac component has a half-life of approximately one to two hours in the bloodstream, which is a measurement used to estimate how quickly the substance is cleared from the body. The duration of symptomatic relief can vary between individuals.


Q: Is A-Fenac Plus commonly used for headaches or migraines?

A: Official regulatory indications for Diclofenac-based preparations include their use for common types of pain, such as tension-type headaches and mild migraines. Official indications describe its use for pain related to conditions such as muscle injuries and arthritis.


Q: Are there any long-term effects associated with using A-Fenac Plus?

A: Regulatory warnings state that the risk of serious side effects, particularly relating to severe gastrointestinal injury or cardiovascular events, may increase with a longer duration of use. Official guidance describes the necessity of using the lowest effective dose for the shortest possible duration.


Q: Why is A-Fenac Plus sometimes given with food or milk?

A: Official sources describe that taking this preparation with food, milk, or an antacid is a method used to help address potential stomach irritation and gastrointestinal upset. This is because the Diclofenac component is a known cause of these side effects.


Q: Is it common to feel drowsy after taking A-Fenac Plus?

A: Official documents list central nervous system effects such as dizziness, headache, and vertigo as common side effects. While the term 'drowsiness' (somnolence) is not always listed as a common effect, the medication has been described as causing sleepiness in some individuals.


Q: Does A-Fenac Plus contain aspirin or acetaminophen?

A: A-Fenac Plus contains the active ingredients Diclofenac and Paracetamol, which is also widely known as Acetaminophen. This preparation does not contain Aspirin.


Q: Is there a risk of withdrawal symptoms when stopping A-Fenac Plus?

A: Neither Diclofenac nor Paracetamol are classified as controlled substances with dependence potential. Official product labeling does not include warnings about physical withdrawal symptoms when the medication is stopped.


Q: Can A-Fenac Plus affect blood pressure or heart rate?

A: Regulatory warnings state that Diclofenac may cause or worsen high blood pressure (hypertension). Severe hypertension and heart failure are also listed as very rare adverse reactions in official safety documents.


Q: Is it possible to develop a tolerance to the effects of A-Fenac Plus?

A: Because this medication is not an opioid, official regulatory documents do not include warnings about the potential for developing a tolerance to its pain-relieving effects in the same manner described for opioid medications.


Q: Can A-Fenac Plus be used for chronic pain conditions?

A: The preparation is approved for the management of chronic conditions, including the pain and inflammation associated with Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis. Regulatory documents state that use for these conditions should adhere to the principle of using the lowest possible dose.


Q: Is it possible for A-Fenac Plus to interact with vitamins or herbal supplements?

A: Official information emphasizes the importance of providing a healthcare provider with a complete list of all products being used, including vitamins and herbal supplements. These products may not be tested in the same way as prescription drugs and could potentially affect how the medicine works or increase the risk of side effects.


Q: Can A-Fenac Plus cause changes in mood or behavior?

A: Official regulatory documents list psychiatric disturbances, which include depression, insomnia, and irritability, as rare adverse reactions related to the Diclofenac component.


Q: Does A-Fenac Plus affect alertness or ability to drive?

A: Official warnings state that activities requiring full alertness, such as driving or operating machinery, should be undertaken with caution until a person is aware of how the medication affects them. This is due to the potential for side effects such as dizziness, drowsiness, or blurred vision.


Q: Can A-Fenac Plus cause swelling in the hands or feet?

A: Official regulatory documents have reported fluid retention, known as edema, and swelling of the skin as potential side effects. This fluid retention may visibly affect areas such as the hands and feet.


Q: Is A-Fenac Plus considered safe for people with diabetes?

A: The use of the Diclofenac component is described in regulatory warnings as requiring careful consideration by a healthcare professional in patients who have significant cardiovascular risk factors. Diabetes mellitus is specifically included as one of these risk factors.


Q: Is A-Fenac Plus approved for use in multiple countries?

A: Yes, preparations containing the active ingredients Diclofenac and Paracetamol are reviewed and regulated by numerous national drug agencies. These include the FDA, EMA, MHRA, and TGA, indicating broad international oversight.


Q: Do regulatory agencies have specific warnings about A-Fenac Plus?

A: Yes, regulatory agencies apply specific, high-level warnings concerning the potential for serious cardiovascular thrombotic events and severe gastrointestinal adverse events with the Diclofenac component. The guidance reinforces the principle that the lowest effective dose should be used for the shortest duration possible.


Q: Are there any studies confirming the effects of A-Fenac Plus in different age groups?

A: Studies have examined the effects of this preparation in adults, including older adults, particularly for chronic conditions like arthritis. However, official information notes that evidence for certain groups, such as the pediatric population, is considered insufficient or uncertain.


Q: Can A-Fenac Plus be used for nerve pain?

A: The approved uses are generally described in relation to inflammatory and nociceptive pain associated with conditions like arthritis, muscle pain, and headache. The approved uses do not explicitly list neuropathic pain as an indication.


Q: How is A-Fenac Plus eliminated from the body?

A: According to official product information, the active ingredients are predominantly processed and changed by the liver. The subsequent elimination of these substances from the body occurs mainly through the urine.


Q: Are the side effects generally temporary when starting A-Fenac Plus?

A: While the expected duration of every side effect is not specified, many common gastrointestinal and central nervous system complaints are reported in short-term studies. This suggests these effects are often temporary or related to starting treatment.


Q: What happens if A-Fenac Plus is taken on an empty stomach?

A: Taking immediate-release formulations on an empty stomach is often done to achieve optimal and faster absorption. Taking delayed-release tablets on an empty stomach, however, may result in reduced peak concentrations of the drug in the bloodstream.


Q: Why is it important to check the ingredients of other cold/flu remedies when taking A-Fenac Plus?

A: This is important because many cold and flu products contain Paracetamol (Acetaminophen) or other NSAIDs. Taking A-Fenac Plus concurrently with these products can lead to taking too much of the active ingredients, increasing the risk of serious side effects like liver damage or gastrointestinal bleeding.


Q: Is A-Fenac Plus available in different forms (e.g., tablet, liquid)?

A: While the 'Plus' combination is predominantly manufactured as an oral tablet, the Diclofenac component itself is available in several dosage forms. These include immediate-release and delayed-release tablets.

How should A-Fenac Plus be stored and disposed of?

How to Store and Dispose of A-Fenac Plus (Diclofenac/Paracetamol)

Official regulatory documentation mandates specific conditions for storing and handling A-Fenac Plus tablets to maintain their stability.

Storage Component Requirement
Temperature Store at a temperature not exceeding 30 C or at Controlled Room Temperature (20 C to 25 C).
Environmental Control The product must be protected from light and moisture and stored in a dry place.
Packaging Keep the container tightly closed. The medicine should be dispensed in a light-resistant container with a child-resistant closure.
Child Safety The medicine must be kept out of the sight and reach of children and pets.

Unused or expired A-Fenac Plus must be disposed of following local regulations for pharmaceutical waste.

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

Available in countries:

Equivalent of A-Fenac Plus found in:

A-Z Index: