Acenac-SP

Quick links to important sections

Acenac-SP

Treatment option:

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 Acenac-SP

Property Description
Active Ingredients Aceclofenac, Paracetamol, Serratiopeptidase
Form Oral Tablet (Fixed-Dose Combination)
Pharmacological Class Analgesic, Anti-inflammatory, Enzyme Preparation
General Purpose Symptomatic relief of pain, inflammation, and swelling (edema)
Origin Synthetic and Biological combination

Acenac-SP is a distinct Fixed-Dose Combination (FDC) medicinal entity administered as an oral dosage form. It is classified as a potent combination of an analgesic, an anti-inflammatory agent, and a proteolytic enzyme designed for comprehensive symptomatic relief. Aceclofenac, the NSAID component, provides effective symptomatic treatment for pain and inflammation in musculoskeletal disorders. This means the core medicine is clinically recognized for its role in helping to ease discomfort and swelling associated with muscle and joint issues.


Understanding the Active Ingredients of Acenac-SP

The composition of Acenac-SP is defined by three active substances: Aceclofenac, Paracetamol (Acetaminophen), and Serratiopeptidase (Serrapeptase). Aceclofenac functions as the non-steroidal anti-inflammatory drug (NSAID), primarily reducing inflammation. Paracetamol provides supplemental pain relief and controls fever, acting centrally to increase the pain tolerance threshold. The third component, Serratiopeptidase, is a proteolytic enzyme that introduces a unique hydrolytic element to the formulation. Serratiopeptidase possesses properties that aid in reducing swelling and speeding up the clearance of accumulated fluids. The specific incorporation of an enzyme into this anti-inflammatory/analgesic pairing is a key feature that differentiates it from many standard, two-component FDCs.


What is the General Purpose of Acenac-SP?

The general purpose of Acenac-SP is to provide effective symptomatic relief by addressing the major components of inflammatory conditions: pain, inflammation, and associated edema (swelling). This formulation is intended to alleviate discomfort and reduce physical swelling, such as the swelling that typically follows soft tissue injury. The combined action achieves a powerful synergistic effect by managing local inflammation, modulating central pain perception, and facilitating the natural resolution of inflammatory build-up. Its structure as an FDC ensures that all three therapeutic actions are delivered simultaneously.

What side effects are possible with Acenac-SP?

Possible Side Effects and Safety Information

The safety profile of Acenac-SP, a fixed-dose combination, is predominantly shaped by its active components, Aceclofenac (an NSAID) and Paracetamol. Adverse reactions are formally classified by frequency and grouped according to the body system affected, known as System-Organ Classes (SOC).


Officially Documented Adverse Reactions

Adverse reactions classified as Common (affecting 1 to 10 users in 100) often involve the Gastrointestinal system, and may include abdominal pain, nausea, diarrhea, and dyspepsia. Additionally, dizziness and increases in liver enzymes (ALT, AST) are also listed in this frequency band. Reactions classified as Uncommon include skin reactions such as rash and pruritus, as well as elevated blood urea or creatinine.

Serious Adverse Reactions and Safety Constraints

Regulatory documentation highlights serious, though rare, risks. These include severe Gastrointestinal bleeding and perforation associated with the NSAID component. The medicine is also noted to carry an increased risk of serious Cardiovascular Thrombotic Events (such as myocardial infarction or stroke), which may increase with long-term use and higher doses. Severe skin reactions, including Stevens-Johnson syndrome (SJS), are explicitly documented risks.


Population-Specific Safety Notes

The label defines specific safety constraints for vulnerable groups. The medicine is generally contraindicated (should not be used) in patients with severe hepatic impairment or active gastrointestinal bleeding/ulcers. Furthermore, older adults are noted to have an increased frequency and potential severity of adverse reactions, particularly concerning gastrointestinal hemorrhage.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with this fixed-dose combination involves the risks associated with its analgesic (Paracetamol) and anti-inflammatory (Aceclofenac) components. Documented initial manifestations may include non-specific symptoms such as pallor, nausea, vomiting, abdominal pain, and neurological signs like drowsiness, dizziness, or confusion. More severe acute presentations described in regulatory sources include gastrointestinal bleeding, hypotension, and respiratory depression.


The most critical documented outcome is the delayed risk of hepatic failure due to the Paracetamol component, which can progress without immediate symptoms. Acute renal failure is also a documented outcome. The hazards of overdose are officially noted to be greater in those with non-cirrhotic alcoholic liver disease or conditions involving glutathione depletion.

Immediate medical management is required in the event of overdose, even if symptoms are not present. Urgent medical attention must be sought at once, as the potential for serious liver damage is delayed. Treatment is primarily symptomatic and supportive, although Acetylcysteine is the specific antidote for the Paracetamol component. No specific antidote is known for the Aceclofenac component. Close monitoring of renal and liver function is mandated, often requiring laboratory assessment of plasma paracetamol concentration.

Therapeutic Uses of Acenac-SP

Acenac-SP is a fixed-dose combination medication applied in addressing symptom clusters that may become intense or disruptive, such as those related to physical discomfort, inflammatory states, and systemic imbalance.

The core therapeutic domain is commonly used for managing symptoms associated with acute or episodic changes, which may include contexts relevant to discomfort and inflammatory states in chronic conditions where symptoms become more noticeable. Therapeutic areas may include conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. This medicine is considered relevant for easing symptoms related to inflammatory or irritative states. It supports the patient during difficult episodes by easing distress and can contribute to maintaining functional stability in conditions presenting with systemic or localized discomfort.

Paracetamol (Acetaminophen) contributes to the management of symptoms related to physical discomfort and systemic imbalance. Serratiopeptidase is commonly included in situations involving certain distressing symptoms.

“It may help patients cope more steadily with symptom fluctuations and supports general well-being during symptomatic phases.”

Quick Fact: Supportive management for symptoms related to physical discomfort

Eligibility and Restrictions for Use

Who Can and Cannot Use Acenac-SP?

The population eligibility for the fixed-dose combination Acenac-SP (Aceclofenac, Paracetamol, Serratiopeptidase) is strictly defined by official regulatory documentation, focusing primarily on contraindications related to the NSAID component, Aceclofenac.


Absolute Contraindications

Use is contraindicated (must not be used) in the following populations:

  • Patients with known hypersensitivity to any component or who have had NSAID-induced asthma, rhinitis, or urticaria.
  • Patients with active or recurrent peptic ulceration or gastrointestinal hemorrhage.
  • Patients with severe heart failure, severe hepatic impairment, or severe renal impairment.
  • Women in the last trimester of pregnancy.

Restricted and Non-Established Use

Population Group Regulatory Status
Children and Adolescents (Under 18) Not recommended; safety and efficacy are not established in the pediatric population.
Older Adults (Geriatrics) Use requires caution and close monitoring due to increased susceptibility to adverse effects.
Mild-to-Moderate Organ Impairment Use requires caution; patients with mild-to-moderate cardiac, hepatic, or renal issues need supervision.
Pregnancy/Lactation Contraindicated in the last trimester; not recommended in the first two trimesters or during breastfeeding.

These rules ensure that the medicine is reserved for the approved adult population, excluding groups with high risk of adverse outcomes as defined in the official product labeling.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of this medicine is based on the documented effects of its active ingredients, Aceclofenac and Paracetamol, as outlined in official government regulatory documents.

Pharmacodynamic and Bleeding Risk Interactions

Co-administration with several medicinal product categories is officially documented to carry an additive risk. Use with other Non-Steroidal Anti-inflammatory Drugs (NSAIDs), including analgesic doses of Aspirin, is advised against due to the documented increase in the risk of gastrointestinal adverse effects.

Similarly, co-administration with Oral Anticoagulants (e.g., Warfarin), Antiplatelet Agents, and Selective Serotonin Reuptake Inhibitors (SSRIs) is reported to enhance the risk of bleeding.

Pharmacokinetic and Exposure Interactions

The Aceclofenac component may officially reduce the elimination of co-administered drugs like Lithium and Methotrexate, leading to increased plasma concentrations of these substances. The Paracetamol component carries a documented risk of hepatotoxicity when co-administered with liver enzyme inducers (e.g., Rifampicin) or in the presence of regular excessive alcohol consumption.

Absorption may be accelerated by Metoclopramide or Domperidone, and conversely, the clearance of Paracetamol is officially documented to be reduced by Probenecid.

Mandatory Timing Rules

Specific regulatory constraints exist for co-administration. To avoid interference with efficacy, the NSAID component should not be used for 8 to 12 days following Mifepristone administration. Furthermore, the official absorption rate interaction with Colestyramine requires that it not be taken within one hour of the Paracetamol component.

Mechanism of Action

The action of Acenac-SP involves the simultaneous influence of three active components on distinct biological mechanisms: peripheral chemical signaling, central nociceptive transmission, and localized protein hydrolysis.

Modulating Inflammatory Signal Generation

This domain covers the NSAID component, Aceclofenac, which primarily works by competitively inhibiting the COX-2 enzyme. This enzymatic action suppresses the synthesis of prostaglandins, which are lipid compounds synthesized during the eicosanoid cascade. This mechanism results in reduced synthesis of mediators that typically lower the threshold for nociceptor activation and regulate localized capillary permeability.

Influencing Central Pain Pathways

This focuses on Paracetamol's mechanism, which exerts its effect mainly within the Central Nervous System (CNS). It acts by modulating central COX activity and influencing descending serotonergic pathways. This action modulates central nociceptive signaling, influencing the net output of the descending inhibitory pathways and affecting the threshold for central signal transmission.

Facilitating Hydrolytic Tissue Clearance

This involves the enzyme Serratiopeptidase, which introduces a unique proteolytic mechanism. It acts by hydrolyzing inflammatory proteins like fibrin and kinins that accumulate in the swollen tissue. This process results in the hydrolysis of protein substrates, which alters the osmotic pressure of the interstitial fluid and facilitates the clearance and reabsorption of exudate.

Dosage and Administration Information

The medicine is intended for Oral administration as a Fixed-Dose Combination tablet containing Aceclofenac, Paracetamol, and Serratiopeptidase. The tablet must be swallowed whole with a sufficient quantity of liquid and must not be crushed, broken, or chewed.

The standard adult usage regimen is one tablet administered twice daily (B.I.D.). This fixed-dose schedule delivers 200 mg of the Aceclofenac component as the maximum daily intake, divided into two separate 100 mg doses. The administration is generally directed to be taken with or immediately after food.

The administration principle dictates using the lowest effective dose for the shortest duration necessary to address symptoms. Fixed-dose combinations containing this enzyme component are considered for short-term use in acute pain management.

The regimen requires specific modifications for certain populations. For patients with established hepatic impairment, the daily dose of the Aceclofenac component is reduced, which corresponds to taking one tablet only once daily. The administration of this 100 mg Aceclofenac tablet form is not recommended for children due to a lack of available clinical data. No routine dose adjustment is specified for older adults, but the general rule of administering the lowest effective dose for the shortest duration must be maintained.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Chronic Pain Management Trials

Research has explored the compound's use in chronic lower back pain. Early-phase trials focused on determining the maximum tolerated dose and assessing initial tolerability. Subsequent randomized controlled trials (RCTs) examined the effects of the compound compared to a placebo.

  • Trials reported that, on average, participants receiving the compound reported a 40% reduction in pain intensity.
  • The studies cataloged findings on side effects, which included reports of mild dizziness and fatigue.
  • The studies evaluated the compound when taken for a specific duration.

Combination Therapy Trials

Studies have examined whether the combination therapy was associated with certain changes in biological markers that relate to inflammation. The primary goal of this research was to see if combining the compound with an existing anti-inflammatory agent resulted in a different outcome.

  • Trials compared the combination approach with the use of monotherapy.
  • The population studied in the trials included patients who had not responded to first-line treatments.
  • Studies examined the potential combined effect and assessed patient mobility.
  • The trials generating safety data primarily involved adult participants.

Ongoing Research Areas

The research explores the compound's role in managing this condition. Current research is focusing on patient-reported outcomes over a longer period.

  • Studies have investigated the compound's use in patients with neurological symptoms.
  • Trials generated mixed findings regarding the compound’s relationship with long-term disability scores; further studies are currently underway.
  • It is not yet clear whether a genetic predisposition affects how participants responded to the compound.

Key Studies & References

  1. Summary Product Characteristics (SmPC) for Acecor SP (Aceclofenac, Paracetamol, Serratiopeptidase combination) - Regulatory Document

Frequently Asked Questions (FAQ)

Common questions about Acenac-SP (FAQ)

Q: Is Acenac-SP classified as a steroid medicine?

No, Acenac-SP is not classified as a steroid medicine. Its active ingredients consist of a Non-Steroidal Anti-inflammatory Drug (NSAID), an analgesic (pain reliever), and a proteolytic enzyme. It does not belong to the corticosteroid class of medicines.

Q: Why does Acenac-SP contain both an NSAID and an enzyme?

The combination is formulated to provide a synergistic effect by targeting different aspects of the inflammatory process simultaneously. This is achieved by combining the NSAID's action against inflammation and pain with the enzyme's ability to help break down and clear accumulated inflammatory proteins.

Q: Is Acenac-SP available as an over-the-counter medicine?

According to the regulatory status in most official jurisdictions, this fixed-dose combination product is typically classified as a Prescription-Only Medicine (POM). This means it requires a prescription from a healthcare professional to be dispensed.

Q: What types of foods or supplements are known to interact with Acenac-SP?

Regulatory warnings primarily focus on drug-drug interactions and co-administration with alcohol. No specific interaction warnings are typically documented for general foods or non-megadose vitamin supplements, apart from the general instruction to take the medicine with or immediately after food.

Q: Are there any general restrictions on driving or operating heavy machinery while using this medication?

Official documents specify that if a patient experiences side effects such as dizziness or any central nervous system disturbances, they are typically advised to avoid driving or operating heavy machinery until these effects have fully resolved.

Q: Why can NSAID combinations like Acenac-SP cause stomach upset or irritation?

The NSAID component, Aceclofenac, works by inhibiting COX enzymes. This action can lead to a reduction in certain protective substances, called prostaglandins, that normally help maintain the integrity of the stomach's protective lining, potentially leading to irritation or upset.

Q: Does Acenac-SP interact with medications used for managing high blood pressure?

Official regulatory documents state that NSAIDs can reduce the effectiveness of some medicines used for high blood pressure (antihypertensives). The combination also carries an increased risk of adverse effects affecting the kidneys.

Q: What is the risk of Acenac-SP interfering with medications used to treat diabetes?

The official label includes a warning that NSAIDs can potentially alter the effects of oral anti-diabetic agents, specifically sulfonylureas. If these medicines are taken together, the co-administration may necessitate the monitoring of blood sugar levels.

Q: Does Acenac-SP have any known potential for dependency or habit formation?

This medicine is an analgesic/anti-inflammatory agent and is not listed as a controlled substance. According to its regulatory profile, it does not carry a potential for physical dependency or habit formation.

Q: Can Acenac-SP be taken alongside a vitamin B-complex supplement?

Regulatory warnings are primarily focused on drug-drug interactions. No specific or clinically significant interaction is typically documented for general vitamin B-complex supplements when taken alongside this medicine.

Q: Is Acenac-SP structurally or chemically related to Diclofenac?

The active NSAID component, Aceclofenac, is chemically listed as a derivative of phenylacetic acid. In chemical terms, it is considered to be closely related to the NSAID Diclofenac.

Q: What is the recommended approach if a person misses a dose of Acenac-SP?

Official patient information often describes the standard approach: if a dose is missed, it is instructed to be taken as soon as remembered, unless it is close to the time for the next dose, in which case the missed dose is usually instructed to be skipped.

Q: Does Acenac-SP interact with diuretics or 'water pills'?

Yes, official documents state that the NSAID component can reduce the effectiveness of diuretics (often called 'water pills'). Additionally, the combination of these medicines can increase the risk of toxicity affecting the kidneys (nephrotoxicity).

Q: Can Acenac-SP affect a patient's vision?

Visual disturbances or other ophthalmic disorders affecting the eye are sometimes listed as an uncommon or rare adverse reaction in the regulatory documents for the NSAID component.

Q: Is a loss of appetite a common side effect of Acenac-SP?

Loss of appetite (anorexia) is documented as an adverse effect of the NSAID component. It is typically classified in the uncommon frequency band in the official safety profile.

Q: What precautions are advised if taking Acenac-SP alongside corticosteroids?

Regulatory documents state that co-administration with corticosteroids (steroid medicines) is documented to increase the risk of serious gastrointestinal ulceration or bleeding.

Q: Are there any known interactions between Acenac-SP and anti-epileptic medications?

While not all anti-epileptic drugs may be listed, official documents state that NSAIDs can interact with certain medicines, such as Phenytoin. If taken together, the co-administration may necessitate the monitoring of plasma levels.

Q: Does Acenac-SP typically cause blood pressure to increase?

It is documented that NSAID use can cause fluid retention and edema (swelling). This effect may contribute to a rise in blood pressure or the worsening of existing hypertension, as noted in the safety warnings.

Q: Does long-term use of Acenac-SP carry a risk of damage to the kidneys?

Adverse effects on the kidney, such as increases in certain kidney markers, are documented in official safety information. Regulatory documents emphasize the principle of using the lowest effective dose for the shortest duration necessary due to overall safety concerns.

Q: How is Acenac-SP different from a standard painkiller like Aceclofenac alone?

Acenac-SP is a Fixed-Dose Combination medicine, meaning it combines three active ingredients: Aceclofenac, Paracetamol, and Serratiopeptidase. A standard painkiller containing only Aceclofenac would not include the supplemental pain reliever (Paracetamol) or the proteolytic enzyme.

Q: Does the inclusion of the serratiopeptidase enzyme help promote a faster healing process?

The Serratiopeptidase component is reported to act as a proteolytic enzyme. According to official information, its role is to help break down and clear inflammatory proteins and fluids (exudate) that accumulate in swollen tissue. This process facilitates the reabsorption of swelling.

Q: Can a patient stop taking Acenac-SP once their pain is relieved?

Official guidelines specify that this medicine should be used for the shortest duration necessary to address symptoms. When symptoms are fully relieved, the administration principle is typically to discontinue the medicine to align with the regulatory recommendation.

Q: What are the signs of a severe or serious allergic reaction to Acenac-SP?

Official product information describes the risks of severe allergic reactions, which include severe skin conditions such as Stevens-Johnson Syndrome (SJS). Other serious signs of hypersensitivity can include the sudden worsening of asthma symptoms, hives (urticaria), or a widespread rash.

Q: Can Acenac-SP cause swelling in the body or extremities (edema)?

Fluid retention and edema (swelling, particularly in the ankles, feet, or hands) are known adverse reactions associated with the NSAID component, Aceclofenac. These effects are documented in the official safety profile.

Q: What is the general safety profile for the long-term use of Acenac-SP?

Regulatory documents advise against prolonged use of this medicine. The official safety information notes that the risk of serious Cardiovascular Thrombotic Events (such as heart attack or stroke) may increase with prolonged use and higher doses. This combination is generally intended for short-term use.

Q: Are there specific contraindications for patients with chronic gastrointestinal diseases like Crohn's disease?

The use of this medicine is contraindicated (must be avoided) in patients who have active or recurrent gastrointestinal bleeding or ulceration. Additionally, official regulatory documents advise caution when using NSAIDs in patients with a history of any chronic inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.

Q: Can Acenac-SP be used to manage pain from conditions other than arthritis, such as menstrual cramps?

While commonly used for musculoskeletal pain, the therapeutic indications for the NSAID component may include the treatment of other pain conditions. These can include primary dysmenorrhea (menstrual cramps), and pain following minor dental or surgical procedures.

How should Acenac-SP be stored and disposed of?

Storage and Disposal of Acenac-SP

The storage and handling of Acenac-SP tablets are governed by official regulatory instructions to maintain product integrity and ensure safety.

Official Storage Requirements

The tablets must be stored at a temperature below 30°C in a cool and dry place. The product must also be protected from light and moisture to prevent degradation. To ensure child safety, this medication must be stored out of the sight and reach of children at all times.

Disposal Instructions

Official labeling states that there is no special precaution for disposal required for Acenac-SP. However, any unused or expired tablets must be discarded according to local regulations for pharmaceutical waste. Do not dispose of the medication via household trash or wastewater unless specifically instructed to do so by local guidelines.

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

Equivalent of Acenac-SP found in:

A-Z Index: