Aceclo PLUS

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Aceclo PLUS

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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 Aceclo PLUS

Quick Facts

Property Description
Active Ingredients Aceclofenac and Paracetamol (Acetaminophen)
Form Oral Tablet (typically film-coated)
Pharmacological Class NSAID and Analgesic/Antipyretic Combination
Common Use Goal Relief from Pain and Inflammation
Origin Synthetic Pharmaceutical Drug

Aceclo PLUS: An Overview of the Drug Type

Aceclo PLUS is a synthetic Fixed-Dose Combination (FDC) medicine classified broadly as an Analgesic and Anti-inflammatory agent. It belongs to the therapeutic class of agents used to reduce pain and fever. This classification indicates the medicine is designed to act systemically (throughout the body) to alleviate discomfort and swelling. This combination of Aceclofenac and Paracetamol is widely recognized in clinical practice for its application in conditions where both pain and inflammation are primary symptoms.

What are the Active Ingredients in Aceclo PLUS?

The medicine contains two distinct active ingredients: Aceclofenac and Paracetamol (Acetaminophen). Aceclofenac is the Non-Steroidal Anti-Inflammatory Drug (NSAID) component, primarily responsible for targeting peripheral pain and inflammation. Paracetamol contributes a general pain-relieving (analgesic) and fever-reducing (antipyretic) action, acting primarily within the central nervous system.

The rationale behind the "PLUS" formulation is clinically recognized for achieving enhanced efficacy. Combining these drug classes is utilized for its application in acute pain relief. This means the medicine is designed to provide an additive effect, offering greater pain relief than either ingredient used alone.

The Goal: Comprehensive Relief from Pain and Swelling

The general purpose of Aceclo PLUS is to achieve more comprehensive symptomatic relief than a single-ingredient medication. By integrating an anti-inflammatory with a general pain reliever, the formulation provides a dual-action approach. This allows the medicine to simultaneously address both the painful sensation and its underlying physical cause—the swelling and irritation—setting a therapeutic expectation for robust and efficient comfort management.

What side effects are possible with Aceclo PLUS?

Possible Side Effects and Safety Information

The safety profile of Aceclo PLUS is derived from the established risks of its active ingredients, Aceclofenac and Paracetamol, as documented in official government regulatory labels. Undesirable effects are formally classified by frequency and the physiological system they affect.

Officially Documented Adverse Reactions by System

The most frequently reported events are related to the Gastrointestinal disorders system, often classified as Common. These include dyspepsia, abdominal pain, nausea, and diarrhoea. Elevated hepatic enzymes are also listed as a Common finding in investigations. Less common adverse reactions include flatulence, gastritis, and certain skin reactions like pruritus and rash.

Classification Examples of Officially Documented Effects
Common Dyspepsia, Abdominal pain, Nausea, Elevated hepatic enzymes, Dizziness
Uncommon Flatulence, Gastritis, Constipation, Urticaria, Increased blood urea/creatinine
Rare/Very Rare Gastrointestinal haemorrhage, Anaphylactic shock, Severe skin reactions, Renal failure

Serious Adverse Reactions and Safety Constraints

Official regulatory documents highlight the potential for serious adverse reactions, though they are classified as Rare or Very Rare. These include Gastrointestinal haemorrhage, ulceration, or perforation, and severe dermatological events such as Stevens-Johnson Syndrome (SJS). The highest risk for these severe skin reactions is documented to be early in the course of therapy.

Safety limitations explicitly stated in regulatory labels include the constraint that the medicine is contraindicated in patients with pre-existing severe heart, hepatic, or renal insufficiency. Specific caution is documented for older adults due to an increased frequency of adverse reactions, particularly severe gastrointestinal events. Additionally, the medicine is contraindicated during the third trimester of pregnancy.

Overdose and Emergency Response

The official regulatory documentation emphasizes the critical nature of overdose with Aceclo PLUS due to the potential for severe, delayed organ damage. The greatest hazard is the risk of serious hepatic toxicity, or liver failure, primarily attributable to the Paracetamol component. Initial symptoms may be non-specific, limited to signs such as nausea, vomiting, abdominal pain, pallor, or somnolence, with clinical evidence of severe liver damage potentially not becoming apparent until 12 to 72 hours following ingestion.

Because of this delayed and life-threatening risk, regulatory authorities mandate that emergency medical advice must be sought immediately following a suspected overdose, even if the individual feels well or displays no initial symptoms. Severe outcomes documented in official labeling include hepatic necrosis, acute renal failure, pancreatitis, cardiac arrhythmias, and metabolic acidosis.

Management requires immediate hospital referral for symptomatic and supportive measures. The specific antidote, N-acetylcysteine, must be administered promptly according to regulatory protocol, as its maximum protective effect is time-critical, typically obtained within eight hours of ingestion. Monitoring requirements include measuring plasma drug concentration and laboratory tests for hepatic and renal function. Special overdose considerations apply to individuals with chronic alcohol use or pre-existing severe hepatic or renal impairment.

Therapeutic Uses of Aceclo PLUS

Aceclo PLUS is utilized in the symptomatic management of conditions characterized by periods of heightened symptoms. It is applied across therapeutic domains where additional symptomatic support for pain and inflammation is appropriate.

Easing Symptoms of Inflammatory Joint Conditions

The medicine is considered relevant for managing conditions that present with systemic or localized discomfort, such as rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. It is used when groups of symptoms appear suddenly or fluctuate, and it supports the management of difficult episodes by easing physical distress.

Supporting Acute Musculoskeletal and Procedural Pain

Aceclo PLUS may be part of symptomatic management for acute musculoskeletal pain, pain from sprains and strains, and discomfort following dental procedures or dysmenorrhea. By addressing symptoms related to inflammatory or irritative states, it may assist with maintaining functional stability and contributes to improved comfort during periods of heightened symptoms.


Quick Fact: Focus on Pain and Inflammation
Universal Symptom Axes Pain, Swelling, and Fever
Universal Clinical Contexts Acute flare-ups and post-procedural discomfort
Core Therapeutic Benefit Offers supportive symptomatic relief
Condition Categories Inflammatory joint and musculoskeletal disorders

Eligibility and Restrictions for Use

Aceclo PLUS is primarily intended for use in the adult population who do not have any defined non-eligibility conditions. The drug is subject to strict regulatory rules based on pre-existing medical conditions and life stage, as defined in official prescribing information.

Eligibility Status Key Populations/Conditions
Absolute Contraindication (Must Not Use) Severe hepatic, renal, or heart failure; active peptic ulceration or recurrent gastrointestinal bleeding; history of NSAID-induced asthma or hypersensitivity; and the third trimester of pregnancy.
Not Recommended (Use is Limited) Children and adolescents (use is not established/not recommended due to lack of clinical data); women who are breastfeeding; and use during the first and second trimesters of pregnancy.
Restricted/Caution (Conditional Use) The elderly population and patients with mild to moderate hepatic, renal, or cardiac impairment require close surveillance. Caution is also advised for those with pre-existing conditions like uncontrolled hypertension or certain inflammatory bowel diseases.

Regulatory documents define these restrictions by establishing clear-cut contraindications for populations with active organ disease or specific allergic histories, reserving the medicine for patients whose profile is compatible with the known effects of the active ingredients.

What should I know about interactions with other medicines?

Aceclo PLUS contains two active ingredients, resulting in a regulatory interaction profile based on combined pharmacokinetic and pharmacodynamic constraints. Co-administration with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) is advised to be avoided due to an increased risk of adverse effects.

The combination significantly increases the hazard of bleeding. This risk is evident with Anticoagulants (such as Warfarin), where the enhancing effect raises the risk of hemorrhage. Similarly, co-administration with Corticosteroids, Antiplatelet agents, or SSRIs increases the risk of gastrointestinal ulceration or bleeding. The medicine’s components also interact with agents affecting blood pressure and fluid balance: combining with Diuretics, ACE Inhibitors, or ARBs may lead to a deterioration of renal function, particularly in dehydrated or elderly patients.

Metabolic and absorption-based interactions are documented. The elimination of substances like Lithium and Methotrexate may be decreased, potentially leading to increased plasma concentrations. Conversely, the absorption rate of Paracetamol is affected by agents like Metoclopromide (increased absorption speed) and Cholestyramine (decreased absorption). Furthermore, substances that induce hepatic enzymes, including Alcohol and the herbal product St. John's Wort, increase the toxicity hazard for the Paracetamol component. Timing restrictions are formally documented: NSAIDs must not be used for 8–12 days following Mifepristone administration.

Mechanism of Action

Aceclo PLUS is a fixed-dose combination that exerts influence across two distinct mechanistic domains to modulate key pathways associated with heightened physiological responses.### Peripheral Inhibition of Eicosanoid SynthesisThis domain focuses on the action of Aceclofenac, a non-steroidal compound. It acts by targeting the cyclooxygenase (COX) enzyme pathway, specifically influencing the COX-2 isoform. This enzyme-mediated signaling blockade is a key early molecular step that suppresses the synthesis of eicosanoids (e.g., prostaglandins)—lipid mediators involved in signaling cascades. The resulting physiological effect is the attenuation of excessive mediator activity within targeted peripheral pathways. ### Central Modulation of Nociceptive and Thermal SignalingThis domain primarily involves Paracetamol (Acetaminophen). Its mechanistic intent is largely central, engaging mechanisms that influence signaling patterns associated with nociception and thermoregulation within the central nervous system. It affects the central synthesis of prostaglandins and also influences the hypothalamic center. This action leads to the modification of early molecular steps that shape systemic physiological outcomes, engaging mechanisms that influence feedback regulation within targeted central pathways, resulting in predictable physiological adjustments, such as modulation of central signaling patterns without affecting peripheral inflammation significantly.

Dosage and Administration Information

Administration Method and Timing

Aceclo PLUS is designated for oral administration as a film-coated tablet. Administration typically involves swallowing the tablet entirely with a sufficient quantity of liquid; the tablet should not be chewed or crushed. The contextual timing for intake is generally with or immediately after food.


Dosing Standard and Frequency

The standard adult regimen involves taking one tablet twice daily, which limits the total daily dose of the Aceclofenac component to 200 mg. The guiding principle for the duration of use is to utilize the lowest effective dose for the shortest duration necessary to address symptoms.


Procedural Constraints and Adjustments

A key parameter is the avoidance of combination with other pain relievers: the medication is not used simultaneously with other products containing Paracetamol to prevent exceeding established maximum daily dosages. Furthermore, the combination is not recommended for use in children due to limited clinical data. For patients identified with hepatic (liver) impairment, the regimen is adjusted to one tablet taken once daily, which limits the Aceclofenac component to 100 mg per day.

Recent Clinical Evidence

Research evidence / Overview of studies for Aceclo PLUS


Evidence for Use in Chronic Inflammatory Joint Conditions

Research examining Aceclo PLUS has focused on its application in conditions characterized by fluctuating or episodic manifestations, such as acute flare-ups of Osteoarthritis. The evidence landscape includes both Randomized Controlled Trials (RCTs) and systematic reviews; research designs available for this combination have included comparisons to one of the active ingredients (like Aceclofenac) used alone.

Study Designs and Measured Outcomes

The trials were applied in studies examining patient-reported experiences and functional measures. Researchers examined outcomes related to physical discomfort using metrics like the Pain Intensity Difference (PID) and functional capacity tools, such as WOMAC scores. These studies were generally short-term, designed to observe how symptoms changed during periods of heightened symptom activity rather than assessing long-term disease progression.


Evidence for Use in Acute Musculoskeletal and Post-Procedural Pain

Aceclo PLUS was evaluated in research exploring short-term symptom changes associated with acute lower back pain and discomfort following minor post-operative procedures. The trials typically involved adult patient cohorts with symptoms associated with acute or disruptive episodes. Research designs included comparative studies that monitored responses over defined time intervals.

Research Contexts for Rapid Symptom Relief

Studies focusing on acute pain often examined symptoms that become more noticeable and where rapid symptomatic assessment is the primary focus. The outcomes examined included patient-reported pain intensity measured on scales like the Visual Analog Scale (VAS). For low back pain, studies also monitored symptom variability by including evaluations of muscle spasm. Systematic reviews report heterogeneity in the findings available for this combination across various acute musculoskeletal pain settings.


Long-Term Studies and Follow-up Durations

The available research describes short-term changes but does not characterize the long-term patterns of symptom evolution. Most of the core clinical trials had follow-up durations that were limited, with observation periods typically lasting only up to 7 or 10 days. These study designs are relevant in trials assessing short-term or episodic symptom patterns. The long-term effects of this specific fixed-dose combination are not yet fully established.

Key Studies & References

  1. Efficacy and tolerability of aceclofenac-paracetamol combination tablets in painful musculoskeletal conditions: A randomized controlled trial
  2. Non-steroidal anti-inflammatory drugs (NSAIDs) for chronic low back pain: a systematic review of randomized controlled trials

Frequently Asked Questions (FAQ)

Common questions about Aceclo PLUS (FAQ)


Q: How often can Aceclo PLUS typically be taken?

Regulatory documents describe the standard adult regimen as being administered twice daily. Overall guidance specifies that the medicine is typically used at the lowest effective dose for the shortest duration of time that is necessary to manage symptoms.

Q: If I miss a dose of Aceclo PLUS, what is the general recommendation?

General patient information describes a common approach where a dose may be taken as soon as remembered, unless it is already close to the next dose time, in which case the missed dose is typically left out. Official guidance stresses that taking two doses at once to compensate for a missed dose is not recommended.

Q: Is it okay to take Aceclo PLUS if I have a history of heart problems?

Official documents specify that the medication is contraindicated (should not be used) in the presence of severe heart failure. Professional consideration is advised before use in patients who have pre-existing risk factors for cardiovascular problems.

Q: Is Aceclo PLUS appropriate for people with diabetes?

Official regulatory labels advise that caution is necessary before beginning any long-term treatment in patients who have risk factors for cardiovascular disease, which includes diabetes mellitus. Close surveillance is often noted in official documents for use in these circumstances.

Q: How long does Aceclo PLUS stay in the body after the last dose?

Pharmacokinetic studies indicate that the anti-inflammatory component is well-absorbed after being taken orally. The highest concentration of the drug in the bloodstream is typically reached between one and three hours after the dose.

Q: Can Aceclo PLUS be taken while breastfeeding?

Official documents describe that the medication is generally not recommended for use while breastfeeding. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) like Aceclofenac may appear in breast milk in very low concentrations.

Q: Why are there warnings about kidney function and Aceclo PLUS?

Warnings about kidney function are present because the NSAID component may interfere with the physiological processes that support renal health. Because of this documented risk, the medication is contraindicated for people with severe kidney impairment.

Q: How quickly can someone expect to feel the effects of Aceclo PLUS?

General product information describes that the onset of symptomatic action, such as pain relief, often occurs within a few hours following ingestion. The anti-inflammatory component reaches its highest concentration in the bloodstream within 1 to 3 hours.

Q: Is Aceclo PLUS considered a strong pain medication?

The medication is officially classified as an Analgesic (pain reliever) and Anti-inflammatory agent. The combination is described as providing a dual-action approach intended for both pain relief and the reduction of swelling.

Q: Are there any long-term effects of taking Aceclo PLUS that I should know about?

For patients undergoing long-term treatment with products containing NSAIDs, official documents describe that regular monitoring of blood counts and tests related to renal and hepatic function is typically performed as a precautionary measure.

Q: Can Aceclo PLUS be used for relief from headache or fever?

In addition to conditions like arthritis, some product information also lists its use for issues such as headaches. The Paracetamol component is officially described as having antipyretic action, meaning it is noted to help reduce fever.

Q: What is the typical duration of pain relief provided by Aceclo PLUS?

The typical dosing instructions for this medicine usually specify a dosing interval of every 4 to 6 hours. This interval reflects the expected duration of the primary symptomatic action of the medication.

Q: Is it normal to feel a slight dizziness after taking Aceclo PLUS?

Dizziness is listed as a Common side effect in regulatory safety information. This classification indicates that it is a frequently reported and expected occurrence for some users of the medication.

Q: What should I do if I feel unusual side effects while on Aceclo PLUS?

Official guidance states that if a user experiences severe or worsening side effects, consulting a healthcare professional is described as appropriate. For common, milder effects such as nausea, the patient information often notes that taking the medicine with food may help.

Q: Are there specific food items or drinks that should be avoided with Aceclo PLUS?

Official regulatory documents explicitly state that the consumption of alcohol is not recommended while taking this medication. The rationale is that alcohol may increase the documented risk of stomach bleeding and potential liver toxicity.

Q: Is Aceclo PLUS ever used for conditions other than joint or muscle pain?

Yes, the labeled indications often include relief from pain and inflammation in a range of conditions. These can include dental pain, acute lower back pain, and discomfort following minor post-operative procedures.

Q: Can Aceclo PLUS be taken at the same time as cold or flu medicine?

Official guidance states that this medication should not be used concurrently with any other product that contains Paracetamol (acetaminophen). This is because Paracetamol is a very common ingredient in many cold and flu preparations.

Q: Are there different strengths of Aceclo PLUS available?

Products containing the active ingredients Aceclofenac and Paracetamol are available in various formulations and strengths. The widely documented combination is typically Aceclofenac 100 mg combined with Paracetamol 500 mg, and other variations are also available.

Q: Are there specific tests that doctors might run before using Aceclo PLUS?

Official documents describe that for patients using the NSAID component for long-term treatment, regular monitoring of blood counts and tests for renal (kidney) and hepatic (liver) function is typically noted as a precautionary measure.

Q: What does official guidance say about stopping Aceclo PLUS suddenly?

General guidance indicates that because the medication is typically prescribed for short-term use, cessation may occur when symptoms diminish. All decisions regarding changes to the regimen are described as needing discussion with a doctor.

Q: Is Aceclo PLUS appropriate for someone with high blood pressure?

Caution is advised for patients with existing high blood pressure (hypertension). The Non-Steroidal Anti-Inflammatory Drug (NSAID) component may increase blood pressure and could potentially interfere with the effectiveness of high blood pressure medications.

How should Aceclo PLUS be stored and disposed of?

The official labeling for Aceclo PLUS (Aceclofenac/Paracetamol tablets) specifies precise storage conditions necessary to maintain drug stability and ensure safety.

Storage Requirements

The tablets must be stored at room temperature, which is generally defined as below 30 C in official documentation. It is mandatory to keep the medicine in its original container and protected from both light and moisture. To prevent accidental ingestion, the product must be kept out of the sight and reach of children at all times.

Key Storage Constraint Requirement
Temperature Store below 30 C
Protection Protect from light and moisture

Disposal Instructions

Unused or expired Aceclo PLUS must be disposed of according to local regulations. The preferred method is using an authorized drug take-back program or collection site. If a take-back program is unavailable, and the medicine is not on the FDA's flush list, it may be discarded in the household trash after being mixed with an unappealing substance (like dirt or coffee grounds) and sealed in a container to prevent leakage and misuse.

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

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