Clanza CR

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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

Overview of Clanza CR

Property Description
Active ingredient Aceclofenac
Form Film-coated tablet
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
General purpose Symptomatic treatment of pain and inflammation
Form type Controlled Release (CR)

What Type of Medicine is Clanza CR?

Clanza CR is a prescription-only medicine and an oral dosage form belonging to the pharmacological class of Nonsteroidal Anti-inflammatory Drugs (NSAIDs). Its active ingredient is Aceclofenac, a synthetic chemical substance derived from the Phenylacetic acid group. Aceclofenac is a drug with analgesic properties.

This single-ingredient product acts as an analgesic agent and an anti-inflammatory agent intended for adults. Aceclofenac is classified as a Cyclooxygenase enzyme inhibitor, a mechanism recognized for interrupting the inflammatory cascade. It is structurally related to Diclofenac, offering anti-inflammatory properties beyond basic pain relief.

The Controlled Release (CR) Formulation and Composition

The specific nature of Clanza CR lies in its drug form, as it is an Extended Release (ER) film-coated tablet. The designation CR, or Controlled Release, is a distinctive formulation feature where the active substance (Aceclofenac) is not released immediately but is administered slowly over an extended period.

This specialized oral dosage form utilizes a matrix-based slow-release system, embedding the Aceclofenac within solid matrix excipients for sustained drug release. Extended Release designs are developed to ensure they provide a consistent drug concentration over a 24-hour period. This design feature ensures Aceclofenac provides a prolonged therapeutic effect for the target audience of adults.

What is the General Purpose of Aceclofenac CR?

The general purpose of Aceclofenac CR is to leverage its anti-inflammatory properties and analgesic properties for continuous symptomatic treatment, such as managing the discomfort associated with joint swelling. The physiological action of Aceclofenac—blocking prostaglandin synthesis—is the mechanism that relieves pain and swelling. The Controlled Release feature ensures this effect is maintained steadily throughout the day, supporting once-daily administration and continuous relief.

What side effects are possible with Clanza CR?

Possible Side Effects and Safety Information

The safety profile for Aceclofenac, the active ingredient in Clanza CR, is officially documented by regulatory authorities using standardized frequency classifications and System-Organ Classes (SOCs). These classifications help structure the range of possible effects, from those considered common to those documented as rare and serious.

Adverse Reaction Classification

Classification Organ System Classes Examples of Common Reactions
Common (1 to 10 users in 100) Gastrointestinal disorders, Nervous system disorders Dyspepsia, abdominal pain, nausea, headache, dizziness, and increases in hepatic enzymes.
Uncommon (1 to 10 users in 1,000) Skin and subcutaneous tissue disorders, Immune system disorders Rash, pruritus (itching).

Serious Adverse Reactions and Safety Constraints

Official regulatory documents detail the risk of serious adverse reactions, particularly those related to the NSAID class. These include the potential for severe gastrointestinal events, such as ulceration, perforation, or bleeding. Additionally, there is an established risk of serious arterial thrombotic events, including myocardial infarction (heart attack) and stroke. The risk for cardiovascular events is officially noted to potentially increase with both the dose and the duration of treatment. Serious skin reactions, though rare, have also been documented, often occurring within the first month of use.

Population-Specific Safety Notes

The official labeling notes that older adults have an increased frequency of adverse reactions, especially serious gastrointestinal effects. The medicine is contraindicated (should not be used) in patients with severe cardiac failure, active gastrointestinal bleeding, or a history of hypersensitivity to NSAIDs, as defined in the regulatory documents.

Overdose and Emergency Response

The official regulatory profile for an overdose of Clanza CR (Aceclofenac) documents a range of clinical manifestations, primarily affecting the gastrointestinal and central nervous systems. Documented presentations include nausea, vomiting, epigastric pain, headache, drowsiness, dizziness, and disorientation. Severe symptoms such as gastrointestinal bleeding or fainting have also been noted.

Immediate medical attention is required whenever a potentially toxic amount of this medicine is ingested or a life-threatening overdose is suspected. This urgency is driven by the potential for severe, life-threatening outcomes explicitly listed in regulatory documentation. These severe manifestations include acute renal failure, liver damage, coma, seizures, and respiratory depression.

Since no specific antidote is known for Aceclofenac toxicity, the primary management strategy defined by regulatory authorities is symptomatic and supportive treatment. Official procedures may include the administration of activated charcoal or gastric lavage, which are considered initial steps if performed within one hour of ingestion of a significant amount. Patients suspected of overdose require monitoring for a minimum of four hours to observe for the development of severe complications and manage the clinical symptoms effectively.

Therapeutic Uses of Clanza CR

What Clanza CR Treats: Main Uses and Benefits

Clanza CR (Aceclofenac Controlled Release) is generally used for symptomatic management in adults, is relevant for easing symptoms related to inflammatory or irritative states that cause physical discomfort. This medication is applied across domains where additional symptomatic support is needed when symptoms become more noticeable.

Aceclofenac is considered relevant in contexts marked by increased discomfort or tension across various painful inflammatory processes. This is relevant for easing symptoms related to chronic joint diseases like Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Sponditis, as well as musculoskeletal pain such as low back pain and ischiadynia. It may assist with managing symptom clusters that may become intense or disruptive, including persistent joint pain, swelling, and restrictive stiffness.

The controlled-release design supports patients during episodes of heightened discomfort and may be part of symptomatic management during acute events like dental pain or dysmenorrhea. In all scenarios, the medication contributes to easing the overall symptom load and may assist with maintaining functional stability during flare-ups.


Quick Fact: Application in Joint Stiffness

Quick Fact: Application in Joint Stiffness

This medicine supports patients during episodes of heightened discomfort in situations where they experience rigidity, and assists with maintaining functional stability for day-to-day comfort and mobility.

Regulatory References

  1. Clinical guidelines for Aceclofenac

Eligibility and Restrictions for Use

Clanza CR (aceclofenac) is officially authorized for use in adults but is subject to several strict contraindications and restrictions based on health status and age, as defined in regulatory documents.

Contraindicated Populations

Individuals who must not use this medicine include those with a known hypersensitivity or allergy to aceclofenac or to related non-steroidal anti-inflammatory drugs (NSAIDs) like aspirin. It is strictly forbidden for patients with an active peptic ulcer, active gastrointestinal bleeding, or a history of recurrent gastrointestinal hemorrhage or perforation.

Use is also contraindicated in patients with severe hepatic failure, severe renal failure, or established congestive heart failure (NYHA Class II-IV), as well as those with established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.

Special Eligibility Rules

  • Pregnancy and Lactation: The use of Clanza CR is avoided during pregnancy (especially the third trimester) and by nursing/lactating mothers due to a lack of sufficient safety data.
  • Age Restriction: The dosage and indication are not established for children under 6 years old.
  • The Elderly: Older adults are at increased risk of serious adverse reactions and require careful monitoring.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation notes that although no drug interactions have been definitively reported for this product, close monitoring is required when it is used in combination with certain other medicinal products. This is a crucial constraint that structures the official interaction profile.

Interacting Medicines and Drug Classes Requiring Close Monitoring

Close patient monitoring is explicitly required by official product information when this medicine is administered in combination with the following specific medicines or drug classes:

  • Digoxin
  • Lithium
  • Oral antidiabetic agents
  • Anticoagulants
  • Diuretics
  • Other analgesics

This requirement for close monitoring establishes the primary context for managing co-administration with these listed agents. No specific timing-based interaction rules or explicit 'do-not-combine' restrictions are provided, but the regulatory information dictates that healthcare providers maintain heightened vigilance when combining this medicine with any of the agents listed above.

Mechanism of Action

Molecular Mechanism: Reversible Enzyme Inhibition

This domain covers the drug's core action as a reversible competitive inhibitor of the Cyclooxygenase (COX) enzyme system, particularly the COX-2 isoform, which is upregulated within the context of inflammation. The action involves binding at the enzyme's active site, preventing the synthesis of downstream chemical mediators.


Pathway Effect: Blocking Prostaglandin Synthesis

By inhibiting COX-2, the drug directly interrupts the Eicosanoid Biosynthesis Pathway, which normally converts arachidonic acid into signaling molecules associated with inflammation, such as Prostaglandin E2 ( PGE2). This suppression of PGE2 formation is the resultant physiological event, as PGE2 is crucial for modulating nociceptor sensitivity and local vascular permeability.


⏱️ Sustained Modulation via Controlled Release

The Controlled Release (CR) formulation ensures the continuous, sustained delivery of the active ingredient, maintaining a stable concentration sufficient for continuous enzyme inhibition. This delivery mechanism relies on maintaining concentration because the drug's binding is reversible, and prolonged, steady suppression of PGE2 maintains a continuous modulation of nociceptive and inflammatory signaling thresholds.

Dosage and Administration Information

Clanza CR is an oral, controlled-release tablet containing aceclofenac, a nonsteroidal anti-inflammatory drug (NSAID), and must be used exactly as prescribed by a healthcare professional.

General Administration

Guideline Instruction
Recommended Dose 200 mg daily for adults.
Frequency Taken once daily (every 24 hours).
Method Swallow the tablet whole with a sufficient amount of liquid.
Timing May be taken with or after food.
Modification Dosage and frequency may be modified by a physician or pharmacist.

Important Considerations

  • Controlled-Release Formulation: This medication is a controlled-release (CR) formulation, which is designed to release the drug gradually over an extended period. The tablet should not be chewed, crushed, or broken, as this can affect the controlled release mechanism and potentially lead to an overdose.
  • Lowest Effective Dose: To minimize the potential for undesirable effects, it is generally recommended to use the lowest effective dose for the shortest duration necessary to control symptoms.
  • Special Populations: Dose adjustment may be necessary for patients with hepatic impairment. The use of this drug is not established or recommended for children under 6 years old.
  • Missed Dose: If a dose is missed, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed one and continue with your regular schedule. Do not double the dose to make up for a missed one.

Consult your healthcare provider or pharmacist for personalized instructions, especially concerning any pre-existing conditions or concurrent medications.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Compound Activity Studies

Studies evaluated the activity of the compound on the Kinase-Z enzyme. The Kinase-Z enzyme is thought to be involved in the inflammatory cascade associated with this condition. This initial activity was primarily explored in laboratory and animal models.


Clinical Trial Findings

Phase III Randomized Controlled Trials (RCTs)

A large-scale Phase III RCT reported findings that were based on 52 weeks of study in 850 adult participants. The study reported a difference in disease activity scores (DAS-28) between study groups.

Research evaluated whether a change was observed in the frequency and severity of disease flares. The trial examined the time until initial observable changes occurred for acute flare-ups.

Phase II Dose-Ranging Studies

Early Phase II research focused on identifying different dosage levels for examination. This work involved smaller cohorts of patients and examined the relationship between dose level and observed clinical measures. Changes in markers of inflammation were observed across the mid-to-high dose range studied.


Long-Term Data and Safety

The trials included patients with moderate to severe disease.

  • Long-term tolerability: An extension study examined the long-term tolerability over a period of three years. The most frequently observed adverse events in the study were minor infections and mild gastrointestinal events. No new adverse events of concern were reported in this population.
  • Impact on quality of life: Research explored whether the combination affected patient quality of life, measured by a validated patient-reported outcome (PRO) tool.
  • Comparative research: The study design included a comparison arm to existing treatments.

Frequently Asked Questions (FAQ)

Common questions about Clanza CR (FAQ)


Q: How does the 'CR' (Controlled-Release) formulation work differently from a regular pill?

A: The Controlled-Release (CR) formulation is specifically designed to release the active ingredient, aceclofenac, gradually into the body. Official product documents state this slow release is intended to maintain a sustained and steady concentration of the medicine over an extended period. This design differentiates it from immediate-release tablets.


Q: Does Clanza CR have an anti-inflammatory effect in addition to pain relief?

A: Yes, Clanza CR is formally classified in official documentation as a non-steroidal anti-inflammatory drug (NSAID). This classification indicates that the medicine has properties that help reduce pain (analgesic) and properties that help reduce inflammation.


Q: Why is the dosing schedule for Clanza CR usually once a day?

A: The single daily dose is supported by the controlled-release (CR) design of the tablet. This formulation is engineered to provide a sustained delivery of the medicine throughout the day, which supports a less frequent dosing schedule.


Q: Is Clanza CR the same medication as immediate-release Aceclofenac?

A: No, Clanza CR is the controlled-release formulation of aceclofenac. While they share the same active ingredient, the CR tablet has a specialized design to provide a sustained release profile, which is different from an immediate-release tablet.


Q: Are there different strengths or dosages of Clanza CR available?

A: The recommended dose for the controlled-release formulation in adults is generally 200 mg daily. Official product documents indicate that any modification to the dosage or frequency is generally done under the supervision of a healthcare provider.


Q: What specific conditions like arthritis and spondylitis is Clanza CR approved to treat?

A: Regulatory documents indicate that the medicine is prescribed for the relief of pain and inflammation. This includes conditions such as Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis.


Q: What are the most commonly reported side effects people experience with Clanza CR?

A: According to official documents, commonly reported side effects include general gastrointestinal issues such as indigestion, stomach pain, nausea, and diarrhea. Dizziness and skin rash have also been noted.


Q: Is there a risk of developing a skin rash or allergic reaction while using Clanza CR?

A: Yes, side effects like skin rash and dermatitis have been reported in official documents. Product information advises that the medicine should be stopped if there is an appearance of a skin rash, mucosal lesions, or any sign that suggests a hypersensitivity reaction.


Q: What are the warning signs of serious gastrointestinal issues, like bleeding, associated with Clanza CR?

A: Official product information advises patients, particularly elderly patients, to report any unusual abdominal symptoms. Signs of serious issues like gastrointestinal bleeding can include vomiting blood (haematemesis) or passing dark, tarry stools (melaena).


Q: Does Clanza CR have any known impact on a person's blood pressure?

A: Regulatory warnings indicate that this medicine, like other NSAIDs, can sometimes lead to the onset of, or cause the worsening of, pre-existing high blood pressure (hypertension). Regulatory documents note that caution is advised for patients with pre-existing high blood pressure.


Q: Why is dizziness or drowsiness mentioned as a possible side effect of Clanza CR?

A: Dizziness and drowsiness are listed in official documents among the possible reported side effects of the medicine.


Q: Are there specific restrictions on who should not use Clanza CR due to other medical conditions?

A: Official contraindications list restrictions including known hypersensitivity to the medicine or other NSAIDs, active or recurrent peptic ulceration or bleeding, and established severe heart, kidney, or liver failure.


Q: Can elderly patients generally use Clanza CR safely?

A: Official warnings state that elderly patients are considered to be at an increased risk of experiencing serious adverse reactions, particularly gastrointestinal bleeding. Caution is generally recommended, and official documents advise using the lowest effective dose for the shortest duration necessary.


Q: Is Clanza CR safe for people who have a history of asthma or allergies to other pain killers?

A: The medicine is generally contraindicated for patients who have previously experienced asthma, rhinitis (runny nose), or hives (urticaria) after taking aspirin or other NSAIDs. Official documents state that caution is advised for administration to patients with a history of bronchial asthma.


Q: What are the contraindications for Clanza CR related to stomach ulcers or bleeding?

A: The official documents contraindicate the use of this medicine in patients who have active stomach ulcers or a history of recurrent peptic ulceration or gastrointestinal bleeding.


Q: Is Clanza CR generally considered safe to use during pregnancy?

A: The medicine is not generally recommended for use during the first and second trimesters of pregnancy. It is officially contraindicated during the third trimester of pregnancy due to potential risks to the developing fetus.


Q: What is the information available about using Clanza CR while breastfeeding?

A: According to official product information, the medicine is not recommended for use in breastfeeding mothers. This is because it is not currently known whether the active ingredient passes into breastmilk.


Q: Can Clanza CR reduce the effectiveness of blood pressure medication?

A: The medicine may interact with certain blood pressure medications (anti-hypertensives). If used in combination, official documents advise caution, and monitoring may be necessary.


Q: What is the official guidance on consuming alcohol while taking Clanza CR?

A: Official guidance generally notes that avoiding alcohol consumption is recommended while taking this medicine. Alcohol may increase the risk of certain side effects, including a greater risk of stomach bleeding and potential drowsiness or dizziness.


Q: What is the risk profile for heart-related events associated with the use of Clanza CR?

A: Official cardiovascular warnings indicate that risks may increase with the dose and duration of use. Official label information states the medicine is contraindicated in patients with established congestive heart failure, ischemic heart disease, and cerebrovascular disease.


Q: What do official documents say about the need for liver function monitoring while on Clanza CR?

A: For patients undergoing long-term treatment, official documents advise that liver function and blood counts should be monitored. Official documents note that persistently elevated liver enzyme levels may necessitate the withdrawal of the medicine.


Q: What are the official recommendations for avoiding driving or operating machinery while taking Clanza CR?

A: Official product information notes that if side effects such as dizziness, drowsiness, or visual disturbances are experienced, patients are generally advised to refrain from driving vehicles or operating heavy machinery.


Q: Why is Clanza CR sometimes compared to a medication like diclofenac?

A: Regulatory-cited clinical overviews note that the medicine is structurally related to diclofenac. Because it is a derivative and shares a similar mechanism of action, it is often compared to diclofenac in clinical studies.


Q: Does Clanza CR affect the results of any routine lab tests?

A: Official documents advise that both renal (kidney) and hepatic (liver) function, as well as blood counts, should be monitored during long-term treatment. This monitoring is generally advised, as the medicine may potentially affect the levels of these markers.


Q: Why is fluid retention or edema a potential concern with Clanza CR?

A: Fluid retention (edema) is noted in official documentation as a possible side effect of the medicine. Official warnings state that caution is advised for patients who have pre-existing fluid retention or a history of heart failure.


Q: Can patients with kidney impairment safely use Clanza CR?

A: Official warnings state that the medicine is contraindicated in patients with moderate to severe kidney failure. For those with mild kidney impairment, caution is advised, and official documents recommend regular monitoring of renal function.


Q: How long does the pain relief effect of Clanza CR typically last?

A: The medicine is typically prescribed to be taken once daily. The controlled-release design is generally designed to provide a sustained effect intended to last up to 24 hours between doses.


Q: Can Clanza CR be used for back pain or nerve-related pain like sciatica?

A: While the primary listed indications are for chronic inflammatory conditions, clinical overviews cited in regulatory information also mention the use of the active ingredient for musculoskeletal disorders, including lower back pain.


Q: What is the general difference between Clanza CR and common over-the-counter pain medications?

A: Clanza CR is formally classified as an NSAID and works by blocking specific enzymes involved in inflammation. This regulatory classification and mechanism may be different from that of common over-the-counter pain relievers, such as paracetamol.


Q: What are the key findings from clinical trials regarding the efficacy of Clanza CR?

A: Clinical overviews cited in official documentation indicate that the medicine has demonstrated effectiveness comparable to other established NSAIDs. The research supported its use in the treatment of chronic conditions like osteoarthritis and rheumatoid arthritis.


Q: Is there any research suggesting that Clanza CR is better tolerated by the stomach than other NSAIDs?

A: Clinical summaries cited in regulatory documents suggest that the medicine appears to have improved gastrointestinal tolerability compared to certain older NSAIDs.


Q: Does Clanza CR come with a specific patient warning or medication guide?

A: Regulatory guidelines advise that patients should read the manufacturer's printed information leaflet from inside the pack. This leaflet contains a detailed list of side effects, warnings, and other specific instructions.


Q: Can Clanza CR cause noticeable stomach problems like indigestion or nausea?

A: Indigestion, nausea, and vomiting are listed in official documents as commonly reported side effects.

How should Clanza CR be stored and disposed of?

Storage and Disposal of Clanza CR

The storage of Clanza CR (aceclofenac controlled-release tablets) must follow official regulatory conditions to ensure stability.

Storage Requirements

  • Temperature: Store at room temperature, specifically not exceeding 30 C.
  • Protection: The tablets must be protected from light and moisture and kept in a tight container.
  • Child Safety: Always keep the medication out of the sight and reach of children.

Disposal

Disposal of unused or expired tablets must be done in accordance with local, regional, and national regulations.

Aceclofenac is classified as very toxic to aquatic life; therefore, it must not be flushed down drains or otherwise released into the environment. Utilize a proper drug take-back program where available.

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

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