Zerodol-S

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Zerodol-S

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

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

Overview of Zerodol-S

Property Description
Active ingredient Aceclofenac, Serrapeptase (Serratiopeptidase)
Form Oral Tablet
Pharmacological class NSAID and Systemic Enzyme Agent
Common use General pain and inflammation management
Origin Synthetic (Aceclofenac) and Biological (Serrapeptase)

Classification and Combination Identity

Zerodol-S is defined as a Fixed-Dose Combination (FDC) medicine, formulated as an oral tablet, that contains two distinct active substances: Aceclofenac and Serrapeptase. This formulation is classified as a combination of a Non-Steroidal Anti-Inflammatory Drug (NSAID) and a Systemic Enzyme Agent.

The FDC design ensures that both therapeutic agents are delivered simultaneously, which is a differentiating characteristic compared to single-component NSAID medicines. Aceclofenac serves as the primary component for pain and inflammation reduction, while Serrapeptase provides an enzymatic action aimed at managing swelling. This dual mechanism addresses the two primary components of discomfort: pain and physical swelling.

Composition and Dual Therapeutic Action

The active components in this medicine feature distinct origins: Aceclofenac is entirely synthetic, derived as a phenylacetic acid derivative, while Serrapeptase is an enzyme of natural/biological origin, typically isolated through fermentation. The general purpose of the Zerodol-S tablet is to manage pain and swelling concurrently.

Aceclofenac works by dampening inflammatory signals through biochemical inhibition. In complement, the enzyme Serrapeptase is a proteolytic agent that assists in the breakdown of inflammatory proteins, providing an anti-exudative effect to help clear accumulated fluid. This combined action offers a more comprehensive approach to managing pain and inflammation than single-ingredient therapies.

Regulatory References

  1. Aceclofenac + Serratiopeptidase FDC Rationale (CDSCO)

What side effects are possible with Zerodol-S?

Possible Side Effects and Safety Information

The safety profile for Zerodol-S (a combination medicine containing aceclofenac and serratiopeptidase) is based on the documented adverse reactions and restrictions found in official government regulatory documents.

Adverse Reactions by Frequency and System-Organ Class

The most commonly documented adverse effects fall under Gastrointestinal disorders, with Common reactions including nausea, dyspepsia, and abdominal pain. Less frequent, or Uncommon, reactions include flatulence, vomiting, constipation, and ulcerative stomatitis. The potential adverse reactions span multiple System-Organ Classes including the Nervous System, Skin and Subcutaneous Tissue, Hepatobiliary, and Renal and Urinary systems.

Serious and Clinically Significant Adverse Reactions

Official regulatory sources note the possibility of serious adverse reactions, which are generally categorized as Rare or Very Rare. These include significant events such as gastrointestinal bleeding and ulceration, severe bullous skin reactions (e.g., Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis), severe hepatic reactions (including hepatitis), and severe hypersensitivity reactions like anaphylaxis and angioedema. Certain blood disorders, such as agranulocytosis and haemolytic anaemia, have also been documented.

Safety-Related Restrictions

Zerodol-S is subject to specific safety limitations. It is Contraindicated for use in patients with active peptic ulceration or hemorrhage, severe heart failure, severe renal impairment, or severe hepatic failure. A known history of hypersensitivity to the drug's components or other Non-Steroidal Anti-inflammatory Drugs (NSAIDs) is also a restriction. Additionally, use in the third trimester of pregnancy is contraindicated, and use in children and adolescents under 18 years is generally not recommended due to a lack of established safety data. The risk of adverse events, particularly those affecting the gastrointestinal tract, may increase with higher dosage and prolonged exposure.

Overdose and Emergency Response

Overdose and When to Seek Help

This information addresses the official regulatory profile for an overdose of Zerodol-S, focusing on the Aceclofenac component as detailed in authoritative government documents.

Documented Overdose Presentations

Suspected overdose may initially present with effects localized to the gastrointestinal tract and central nervous system. Common documented signs include epigastric pain, nausea, vomiting, dizziness, headache, and drowsiness.

Risk of Severe Systemic Outcomes

Ingestion of substantial quantities poses a risk of serious, potentially life-threatening systemic outcomes, including:

  • Renal Damage: Acute renal failure.
  • Hepatic Damage: Liver toxicity.
  • CNS Effects: Convulsions and coma.
  • Systemic: Metabolic acidosis, hypotension, and respiratory depression.

Emergency Action and Supportive Management

There is no specific antidote for Aceclofenac overdose. Management must be supportive and symptomatic. The official instructions require immediate action to prevent absorption, such as considering gastric lavage or treatment with activated charcoal.

When to Seek Urgent Medical Help:

It is strictly required to seek medical attention immediately or contact a poison control center for all suspected overdosages. Patients with pre-existing conditions, particularly the elderly, may be at a higher risk for severe complications from an overdose and require continuous observation and intensive care.

Therapeutic Uses of Zerodol-S

Zerodol-S is applicable within clinical settings that involve acute or disruptive symptom patterns, and is relevant for easing symptomatic relief in situations where discomfort arises from the dual presence of pain and active inflammation. It is applied across domains where additional symptomatic support is needed to address symptom clusters that may become intense or disruptive.

The medication is commonly used across conditions presenting with acute episodes. The conditions where symptoms may intensify temporarily and for which this medication is commonly used include inflammatory joint conditions such as rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis, as well as pain and swelling associated with soft tissue injuries, post-operative recovery, and localized states like dental inflammation.

The medication is generally used to manage symptoms that interfere with daily functioning, providing supportive relief that helps patients cope more steadily with symptom fluctuations.

“The combination helps improve day-to-day comfort during symptomatic periods, providing supportive relief when symptoms interfere with routine activities.”


Quick Fact: Relief for Pain and Swelling

Zerodol-S may be relevant in clinical settings that involve acute or unstable symptom patterns. It contributes to improved comfort during periods of heightened symptoms, and is relevant when supportive symptom management is appropriate.

Regulatory References

  1. Medicines and Healthcare products Regulatory Agency (MHRA) guidance

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Zerodol-S — Official Regulatory Information

This section outlines the officially documented population eligibility and restrictions for the Aceclofenac/Serrapeptase Fixed-Dose Combination, as stated in government regulatory documents.

Populations for whom use is allowed (as stated in label):

  • Adult patients (typically ge 18 years of age).

Populations for whom use is contraindicated:

  • Patients with severe hepatic failure, severe renal failure, or severe/established heart failure (NYHA Class II-IV or uncompensated).
  • Individuals with a history of allergic-type reactions (e.g., asthma, acute rhinitis, urticaria) induced by aspirin or other NSAIDs.
  • Patients with active or history of recurrent peptic ulcer/haemorrhage or history of GI bleeding related to previous NSAID therapy.
  • Patients with established ischaemic heart disease, peripheral arterial disease, or cerebrovascular disease.
  • Pregnancy during the third trimester.

Age-Related and Conditional Use Status

Age-related eligibility rules:

  • Children and adolescents (lt 18 years): Use is not recommended; safety and efficacy are not established in this population.
  • Older adults/Elderly patients: Use requires increased caution due to higher risk of adverse reactions.

Pregnancy and lactation eligibility status:

  • First/Second Trimester of Pregnancy: Not recommended unless strictly necessary, and use must be minimized.
  • Lactation/Breastfeeding: Not recommended.

Condition-specific eligibility rules:

  • Mild to moderate hepatic or renal impairment: Use requires caution and close medical surveillance.
  • Patients with uncontrolled hypertension or a history of bleeding disorders are advised caution or restricted use.

Connection to the overall eligibility profile: Regulatory documents define the eligible population as adults, establishing strict prohibitions based on the medicine's NSAID component. These constraints formally exclude populations with severe organ failure, established cardiovascular disease, active gastrointestinal or bleeding disorders, and women in the third trimester of pregnancy. Use in other special groups, such as the elderly or those with mild impairment, is strictly limited to conditional status with mandatory surveillance.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Zerodol-S, which contains Aceclofenac and Serrapeptase, is based primarily on the officially documented risks associated with the Non-Steroidal Anti-Inflammatory Drug (NSAID) component, Aceclofenac. These interactions are categorized by regulatory authorities based on the potential for increased toxicity, reduced effectiveness of co-administered drugs, or altered drug concentrations.

Formal Contraindications and Major Restrictions

Co-administration with other NSAIDs, including analgesic doses of Aspirin, is formally contraindicated due to a significantly increased risk of serious gastrointestinal adverse events. For Mifepristone, a mandatory time-separation rule applies: Zerodol-S must be avoided for 8–12 days following its use, as documented in prescribing information.

Interactions Affecting Clearance and Bleeding Risk

Official labeling documents interactions that affect drug levels and bleeding risk:

  • Anticoagulants and Antiplatelet Agents: The risk of bleeding and hemorrhage is officially documented as significantly increased due to pharmacodynamic reinforcement.
  • Lithium and Methotrexate: Zerodol-S can reduce the clearance of these medicines, potentially leading to increased plasma levels and a risk of toxicity, as noted in regulatory sources.
  • Diuretics, ACE Inhibitors, and ARBs: Combination with these agents may reduce their antihypertensive and diuretic effects while concurrently increasing the risk of nephrotoxicity (kidney toxicity).

This information is strictly based on governmental regulatory prescribing documentation.

Mechanism of Action

Zerodol-S is a fixed-dose combination product containing aceclofenac and serratiopeptidase, each exhibiting distinct pharmacodynamic mechanisms.

Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID) which acts as an inhibitor of the cyclooxygenase (COX) enzymes, particularly showing preferential selectivity for COX-2 over COX-1. This inhibitory interaction blocks the metabolism of arachidonic acid into prostanoids, specifically decreasing the intracellular synthesis and release of pro-inflammatory mediators such as prostaglandin E2 (PGE2) at the site of tissue damage or inflammation. The consequent systemic reduction in these lipid mediators modulates vascular permeability and the subsequent localized fluid accumulation.

Serratiopeptidase is a proteolytic enzyme that functions as a substrate-specific catalyst, hydrolyzing specific non-viable proteins and polypeptides. It targets macromolecules associated with localized tissue responses, including bradykinin, histamine, and fibrin. Its fibrinolytic action facilitates the breakdown of proteinaceous exudates and clotted byproducts formed at reactive tissue sites. This degradation process results in the thinning of surrounding fluid, supporting its reabsorption into the circulatory and lymphatic systems. The combined molecular and enzymatic actions result in the systemic modulation of inflammatory and exudative pathways.

Dosage and Administration Information

How to Use Zerodol-S

Zerodol-S is a fixed-dose combination medicine administered via the oral route as a film-coated tablet. The usage instructions focus on the standard dosing regimen and administration conditions to ensure proper use, based on the established profile for its primary component, Aceclofenac.


Official Administration Guidelines

Usage Parameter Instruction
Route of Administration Oral route, administered as a film-coated tablet.
Standard Dosing Schedule The standard total daily dose of the Aceclofenac component is 200 mg, given in two separate doses of 100 mg each.
Timing in Relation to Meals To be taken preferably with or after food.
Dosing Frequency Administered twice daily (b.i.d.) (one tablet in the morning and one in the evening).
Preparation & Handling The tablet must be swallowed whole with liquid and must not be crushed or chewed.

Use Protocol and Population Adjustments

Treatment with this medicine must follow the principle of using the lowest effective dose for the shortest duration necessary to manage symptoms, requiring periodic re-evaluation.

Dose Adjustments:

For adults with hepatic impairment (compromised liver function), the initial daily dose should be reduced to a total of 100 mg. The medicine is not recommended for use in children under 18 years of age due to insufficient data. For older adults (the elderly), no general modification to dose frequency is considered necessary, though the lowest effective dose principle remains paramount.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Zerodol-S (Aceclofenac + Serratiopeptidase)

Evidence for use in Musculoskeletal Pain and Inflammation

Research has explored whether the Zerodol-S combination is relevant in conditions characterized by fluctuating or episodic manifestations of joint and muscle discomfort. Studies primarily included adult patients diagnosed with chronic musculoskeletal conditions. These trials were typically short- to intermediate-term, with researchers monitoring outcomes related to physical discomfort and daily functioning or activity level over defined time intervals.

Studies reported measurements of how symptoms evolved during the study period. Some trials monitored changes in measured pain scores and descriptions of perceived joint mobility and stiffness against a placebo or another formulation used in research exploring how symptoms change over time. Because the follow-up durations were often limited to a few weeks, evidence contributes to understanding symptom patterns only for short-term and intermediate-term use.

Evidence for use in Post-operative and Trauma-related Pain

The Zerodol-S combination was evaluated in clinical trials focusing on conditions associated with acute or disruptive episodes, such as following minor surgical procedures or soft tissue injury. Research focused on short-term changes, with studies monitoring outcomes describing episodic or acute changes like pain intensity and localized swelling/oedema over the initial hours and days post-procedure. The studies were conducted during periods of increased symptom activity.

Studies measured changes for outcomes related to systemic or functional imbalance, such as the amount of swelling present. Trials reported how patient-reported outcomes describing perceived discomfort evolved in the observed populations during the short follow-up time. The data collected was typical of research exploring short-term symptom changes.

Understanding Long-Term Study Data and Follow-up

Research has focused mainly on measuring outcomes over the short to intermediate term, as studies observed responses over defined time intervals typically ranging from days to a few weeks. Because many of the trials for the combination were designed for acute or temporary conditions where symptoms may vary in intensity, comprehensive multi-year data is not available. This means that information regarding the maintenance of any described effects and long-term effects are not fully established.

What is Still Uncertain About the Research for Zerodol-S

While research has explored the product in both chronic and acute pain settings, evidence quality varies across studies, leading to some uncertainty. Sample sizes were modest in many focused trials, and follow-up durations were limited. Furthermore, comparative evidence is limited to fully explore the outcomes of this specific combination against the wide range of other single and combination pain-relief products. This means that the evidence highlights what is known — and what is still uncertain — about its specific profile.

Frequently Asked Questions (FAQ)

Common questions about Zerodol-S (FAQ)


Q: Is Zerodol-S the same as just taking a pain reliever?

A: Zerodol-S is classified as a Fixed-Dose Combination (FDC) medicine. This means it contains two distinct active ingredients: a non-steroidal anti-inflammatory drug (NSAID) for pain and inflammation, and a systemic enzyme (Serratiopeptidase). This dual composition is formulated to address both pain/inflammation and associated swelling, distinguishing it from single-ingredient pain relief medicines.


Q: What is the difference between Zerodol-S and Zerodol plain?

A: Official information defines Zerodol-S as containing both the NSAID component, Aceclofenac, and the enzyme component, Serratiopeptidase. While not explicitly named on the label, the term 'Zerodol plain' generally refers to the single-ingredient formulation that contains only Aceclofenac.


Q: Is Zerodol-S a prescription-only medicine?

A: Due to the potential for serious adverse reactions and the necessity for dose adjustments in specific patient populations (such as those with liver impairment), this type of medicine is typically subject to prescription-only status by regulatory bodies. Use is generally subject to professional medical supervision.


Q: Does Zerodol-S cause fluid retention or swelling?

A: Fluid retention, or oedema, has been reported in association with the NSAID component of the medicine. Official regulatory documents advise caution for patients with a history of heart failure or high blood pressure due to this potential effect.


Q: What kind of pain is Zerodol-S typically used for?

A: The medicine is officially indicated for the relief of pain and inflammation primarily associated with musculoskeletal conditions, such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It has also been cited in some regulatory documents for use in post-traumatic pain, low back pain, and dental pain.


Q: Does Zerodol-S cause drowsiness or affect alertness?

A: Regulatory documents list central nervous system effects such as dizziness and drowsiness as potential, though not always common, side effects. Patients are generally advised to monitor how the medicine affects their personal ability to perform tasks that require mental alertness.


Q: Is Zerodol-S safe to use long-term?

A: The official guidance for this class of medicine emphasizes using the lowest effective dose for the shortest duration necessary to control symptoms. Official safety information indicates the risk of serious adverse events may increase with prolonged exposure.


Q: Is it common to have dizziness after taking Zerodol-S?

A: Dizziness is documented in the official safety information as a potential side effect. Regulatory documents classify the frequency of documented side effects, so this information should be referenced against the official product labeling (e.g., 'common,' 'uncommon,' or 'rare') to determine how frequently it is reported.


Q: Are there any food restrictions while using Zerodol-S?

A: Official administration guidelines state the medicine should be taken preferably with or after food. Specific restrictions on particular food types beyond this general advice are not usually detailed across regulatory product documents.


Q: What happens if I forget to take Zerodol-S?

A: Regulatory patient information generally advises taking a missed dose as soon as remembered, unless it is almost time for the next scheduled dose. If so, the missed dose should be skipped, and the regular schedule should be resumed. Regulatory patient information typically advises against taking a double dose to compensate for the missed one.


Q: Has Zerodol-S been studied in the elderly population?

A: The medicine’s use requires increased caution in the elderly population due to an officially recognized higher risk of adverse reactions, particularly affecting the kidney, heart, and stomach. Regulatory guidance maintains that the lowest effective dose principle is important in this population.


Q: Is Zerodol-S recommended for nerve pain?

A: The medicine is primarily indicated for pain and inflammation related to musculoskeletal conditions and post-traumatic soft tissue injuries. Nerve pain (neuropathic pain) is not listed as a primary official indication in the regulatory documents for this specific NSAID/enzyme combination.


Q: Can Zerodol-S affect liver function tests?

A: Official safety information notes the possibility of severe hepatic reactions (liver issues) as a rare side effect. Due to this potential, regulatory guidance often requires close surveillance and monitoring of liver function, especially for patients taking this medicine for prolonged periods.


Q: Is it possible to develop a dependency on Zerodol-S?

A: Zerodol-S contains an NSAID and an enzyme, placing it outside the classification of medicines known to carry risks of dependency, such as opioid-based pain relievers. Dependency is not mentioned as a recognized risk in the official product labeling.


Q: Is Zerodol-S used for fever reduction?

A: The NSAID component (Aceclofenac) is classified as having anti-inflammatory and analgesic properties. While some NSAIDs also have an antipyretic (fever-reducing) effect, fever reduction is not consistently listed as a primary official indication for this specific combination product.


Q: Can Zerodol-S cause changes in mood?

A: The official list of documented adverse reactions includes specific effects on the nervous system. These documented effects are not limited to physical sensations like dizziness but also include mood changes such as nervousness and, rarely, depression.


Q: Is it necessary to have regular check-ups while taking Zerodol-S?

A: Due to the potential for serious side effects involving major organ systems (liver, kidney, gastrointestinal tract), regulatory documents advise close medical surveillance and monitoring for patients who may be taking this medicine for prolonged periods.


Q: Does Zerodol-S cause constipation or diarrhea?

A: Both constipation and diarrhea are listed as documented potential side effects within the gastrointestinal disorders class in the safety information. Constipation is often specifically listed as an 'Uncommon' adverse reaction.


Q: Is Zerodol-S recommended for sprains or minor injuries?

A: Official indications and documented uses include relief from pain and swelling in 'post-traumatic' conditions and 'soft tissue injuries.' This classification covers the general scope of sprains and minor acute injuries.


Q: Can Zerodol-S affect sleep?

A: Sleep disturbance is documented in official safety information, with effects such as insomnia (inability to sleep) and drowsiness (feeling sleepy) being listed as potential adverse reactions affecting the nervous system.


Q: Are there specific patient groups that need extra caution with Zerodol-S?

A: Yes, official safety documents specify that caution is mandatory for several groups. This includes the elderly, patients with mild-to-moderate heart, liver, or kidney impairment, and those with a history of hypertension or conditions that increase the risk of internal bleeding.


Q: Are there any known interactions between Zerodol-S and alcohol?

A: Official guidance advises against the consumption of alcohol while using this medicine. This is because alcohol consumption may increase the risk of specific serious side effects, particularly affecting the gastrointestinal tract (e.g., bleeding) and the liver.


Q: What are the described signs of a potential overdose with Zerodol-S?

A: Signs of a potential overdose are consistent with the NSAID class of medicines. Documented symptoms may include nausea, vomiting, headache, dizziness, drowsiness, and irritation of the stomach or intestines. It is advised to seek professional medical help immediately if an overdose is suspected.

How should Zerodol-S be stored and disposed of?

Official Storage and Disposal Requirements

Zerodol-S oral tablets must be stored strictly according to the conditions defined in official regulatory labeling to maintain their quality and stability.

Condition Requirement
Temperature Store below 25 C or 30 C, at controlled room temperature.
Environment Must be protected from light and moisture. Do not refrigerate or freeze.
Packaging Keep the medicine in its original container to safeguard it from environmental factors.
Child Safety Keep out of the sight and reach of children to prevent accidental ingestion.
Disposal Do not dispose of the tablets by flushing them down a toilet or pouring them into wastewater.

Unused or expired Zerodol-S must be discarded using a drug take-back program or by following specific household trash disposal procedures, as recommended by regulatory guidelines.

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

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