Cinopal

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Cinopal

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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 Cinopal

Property Description
Active ingredient Fenbufen
Form Capsule or tablet (oral)
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
Common purpose Relief from pain, inflammation, and fever
Origin Synthetic (phenylalkanoic acid derivative)

1. Cinopal: Definition and Pharmacological Classification

Cinopal is a prescription medication whose active substance is Fenbufen, and it is formally classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). Fenbufen is a synthetic compound belonging to the phenylalkanoic acid derivative chemical group. A key characteristic distinguishing this active substance is its function as a prodrug, which means the administered molecule itself is initially inert and must be metabolized by the body into its pharmacologically active therapeutic form, biphenylacetic acid. This conversion process contributes to the compound's established duration of activity. The mechanism operates through a targeted action against the inflammatory cascade.


2. Composition, Form, and General Therapeutic Purpose

Cinopal is formulated as a single-ingredient product intended for oral administration, typically supplied as a capsule or tablet. The general therapeutic purpose of Cinopal is centered on its ability to provide relief from symptoms associated with inflammation and pain, such as the discomfort experienced in rheumatic conditions. This benefit is achieved by its core function: the selective inhibition of cyclooxygenase (COX) enzymes. By interfering with this process, Cinopal reduces the local biological synthesis of prostaglandins, which are key mediators that trigger pain, swelling, and fever. The medication is characterized by its combined analgesic (pain-relieving), anti-inflammatory, and antipyretic (fever-reducing) action. This fundamental, three-fold action makes the medication useful for mitigating the physical symptoms of various painful inflammatory states.

Regulatory References

  1. MedlinePlus

What side effects are possible with Cinopal?

Possible Side Effects and Safety Information

The official safety profile of Fenbufen (Cinopal) is detailed in regulatory documents, which classify potential adverse reactions primarily by frequency and the body system affected, consistent with its classification as a Non-Steroidal Anti-Inflammatory Drug (NSAID).

Officially Classified Adverse Reactions

The label notes that certain neurological and psychiatric disturbances are common, including dizziness, headache, depression, and numbness. Adverse reactions reported as less common predominantly involve the Gastrointestinal system, covering symptoms such as vomiting, diarrhea, abdominal pain, heartburn, and reports of black stool.

Serious Reactions and Systemic Safety

Serious adverse reactions listed in regulatory summaries include potentially life-threatening conditions typical of the NSAID class, such as Acute Renal Failure and other severe kidney disorders like interstitial nephritis. The label also documents rare but severe skin reactions, including Toxic Epidermal Necrolysis (TEN). Furthermore, the product documentation notes transient elevations of liver transaminases (SGOT/SGPT) and alkaline phosphatase, which were occasionally observed during the first four weeks of therapy.

Safety-Related Restrictions

Fenbufen is explicitly contraindicated for individuals with known hypersensitivity to the drug or other NSAIDs, and its use is contraindicated during lactation. Safety notes also highlight potential consequences when used with other agents, such as an increased risk of convulsions with quinolones or the enhancement of the anticoagulant effect of coumarins.

Overdose and Emergency Response

Overdose of Fenbufen, the active substance in Cinopal, may present with recognized clinical signs, primarily involving the gastrointestinal and nervous systems. Documented manifestations can include nausea, vomiting, abdominal pain, drowsiness, dizziness, and headache. Regulatory warnings state that ingestion of acutely toxic amounts carries the risk of severe and potentially life-threatening outcomes, specifically due to systemic organ toxicity.

The most serious complications documented for this Non-Steroidal Anti-Inflammatory Drug (NSAID) class involve the gastrointestinal tract (including bleeding, ulceration, and perforation), the renal system (acute renal failure), and the hepatic system (hepatotoxicity or liver damage). Additionally, severe central nervous system effects, such as seizures, and serious cardiovascular thrombotic events are risks noted in the regulatory profile.

Due to the severity of these potential outcomes, regulatory documents mandate that all individuals with suspected over-ingestion must seek immediate medical attention. Emergency services must be contacted immediately if signs of life-threatening complications occur, such as severe GI symptoms, seizures, or sudden cardiovascular symptoms. Management is strictly defined as symptomatic and supportive treatment, as no specific antidote is known for Fenbufen. Procedures to reduce absorption, like activated charcoal, may be used. Hospital monitoring and observation are required to assess for delayed onset of severe systemic effects, which can be heightened in patients with existing renal or hepatic impairment.

Therapeutic Uses of Cinopal

What Cinopal Treats: Main Uses and Benefits

Cinopal is commonly used to help manage symptoms related to inflammatory or irritative states across several therapeutic domains. This medication is used to address symptom clusters that may become intense or disruptive, particularly those linked to inflammatory states. Its application is centered on clinical indications involving joint and musculoskeletal discomfort.

Cinopal is generally used to help with conditions characterized by periods of heightened symptoms in the joints, such as rheumatoid arthritis and osteoarthritis. It is relevant for easing symptom clusters that may become intense or disruptive, such as the persistent triad of pain, stiffness, and inflammation. By easing these symptoms, the medication contributes to improved comfort and assists with maintaining functional stability during periods when chronic symptoms are more noticeable.

It is also considered relevant for easing intense episodic manifestations, such as those seen in acute gouty arthritis, and pain following musculoskeletal incidents like sprains or tendinitis. Cinopal helps address groups of symptoms that interfere with daily functioning, including common presentations like backache and other musculoskeletal disorders. Furthermore, it is commonly used to help with symptoms related to systemic imbalance, including fever.


Quick Fact: Relief for Joint Pain, Stiffness, and Musculoskeletal Discomfort

Eligibility and Restrictions for Use

Who Can and Cannot Use Cinopal?

Cinopal (Fenbufen) eligibility is determined by official regulatory documents based on patient health status and demographic factors. The medicine is primarily intended for use by Adults.

Contraindicated Populations

Use is strictly prohibited in the following groups:

  • Patients with known hypersensitivity to Fenbufen or cross-sensitivity to aspirin or other NSAIDs.
  • Individuals with active or recurrent peptic ulceration or gastrointestinal bleeding.
  • Patients diagnosed with severe renal, hepatic, or heart failure.
  • Pregnant women in the third trimester and those who are lactating/breastfeeding.

Restricted and Non-Recommended Use

Cinopal is generally not recommended for children under 14 years old due to insufficient data. Use is permitted only with extreme caution and monitoring for patients with mild-to-moderate organ impairment, a history of asthma or chronic dyspepsia, and for elderly patients, who are at higher risk for adverse reactions according to regulatory guidelines. These official rules ensure the medicine is reserved for patient groups where the labeled risk profile is deemed acceptable.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines the officially documented interaction patterns for Cinopal (Fenbufen) with other substances, based on governmental regulatory sources. As a Non-Steroidal Anti-Inflammatory Drug (NSAID), its interaction profile requires specific restrictions and cautions.

Documented Pharmacodynamic and Exposure Interactions

The regulatory labeling identifies interactions that can lead to altered drug exposure or reinforced pharmacological effects:

  • Anticoagulants (Coumarins): Co-administration may result in a reinforced anticoagulant effect, a pharmacodynamic interaction that significantly increases the risk of hemorrhage and bleeding.
  • Quinolone Antibiotics (e.g., Enoxacin, Ofloxacin): Concomitant use is documented to carry a risk of convulsions, a serious central nervous system pharmacodynamic interaction.
  • Aspirin (Acetylsalicylic acid): The combination is officially noted to cause a decreased serum concentration of Fenbufen, altering the exposure of the active substance.

Interaction-Related Restrictions and Cautions

Formal restrictions documented in prescribing information designate certain uses as prohibited combinations:

  • Other NSAIDs: Cinopal is formally contraindicated with other Non-Steroidal Anti-Inflammatory Drugs due to the cumulative risk of severe adverse effects.
  • Population Note: The official labeling advises increased awareness regarding potential renal toxicity risk in elderly patients, as their physiological status may heighten the clinical significance of drug exposure alterations.

No specific time-separation requirements are mandated in the official labeling for co-administered medicines, and no explicit restrictions regarding food, alcohol, or herbal products are documented.

Mechanism of Action

Inhibition of Cyclooxygenase (COX) Enzymes

Cinopal, which acts as a prodrug, is converted in the body to its active metabolite, biphenylacetic acid (BPAA). BPAA functions as a non-selective inhibitor of the cyclooxygenase (COX) enzymes, targeting both COX-1 and COX-2 isoforms. This interaction involves blocking the enzymatic capacity of COX to convert arachidonic acid into various eicosanoid signaling molecules, thereby initiating the drug's primary mechanism of action.

Modulation of the Arachidonic Acid Cascade

The inhibition of COX fundamentally interferes with the Arachidonic Acid Cascade, resulting in decreased synthesis of prostaglandins. Prostaglandins are lipid mediators that play key roles in regulating afferent nociceptor sensitization, modulating hypothalamic thermoregulation, and governing peripheral vascular permeability. The resulting mechanistic effect modulates three core physiological functions—nociception, inflammation, and thermoregulation—by adjusting activity within these targeted processes.

Dosage and Administration Information

How to Use Cinopal: Official Administration Guidelines

Cinopal (Fenbufen) is prescribed for oral administration in the form of a tablet or capsule, following specific parameters for timing and dosage. The standard administration framework includes the following details:

Instruction Detail
Route of administration Oral (via tablet or capsule form).
Dosing schedule Typical total daily dose is 900 mg, often divided and administered as 300 mg in the morning and 600 mg in the evening. The daily dose range is generally 600 mg to 1000 mg.
Timing in relation to meals Must be taken with or immediately after food.
Age-group administration rules Use is not recommended for children and adolescents under 14 years of age.

The primary administration method is oral, with a twice-daily frequency pattern being the standard schedule for divided doses. The protocol is structured to ensure the daily dose is administered in portions across the day, which supports its intended duration of activity. The requirement to take the dose with food serves as a critical use-context constraint defining proper administration.

Official Step Sequence:

  • Step 1: The dosage form (tablet or capsule) is administered orally.
  • Step 2: The dose must be taken with or immediately following food.
  • Step 3: The total daily dose is divided and administered in a twice-daily schedule (b.i.d.).

This established framework governs the approach to using Cinopal, setting clear expectations for the route, timing, and dosage limits.

Recent Clinical Evidence

Cinopal: Recent Clinical Evidence

Overview of Clinical Research

Research has explored the putative mechanism of action. A body of research has examined effects related to specific physical and psychological measures. The primary focus of the clinical trial data involved measuring changes in the severity and frequency of specific symptoms over periods ranging from 4 to 12 weeks.

Safety and tolerability data from studies examined short-term use (up to 6 months).

Key Efficacy Findings

The majority of studies were randomized, placebo-controlled trials that examined the use of the drug as a monotherapy.

Symptom Management and Severity

  • Studies have examined the quality of life in relation to the drug’s administration.
  • Research evaluated pain scores over the study duration.
  • Studies investigated the onset of change in key symptoms, with changes observed in a subset of participants.
  • Evaluations showed changes in symptom frequency were noted in patient groups involved in the studies.

Comparative Studies

One comparative study examined the drug in relation to older treatments that are available for similar conditions. This research looked at the rate of change in an established symptom-rating scale between the two groups over a 10-week period. The trial results provided observational data on differences in the symptom score between the treatments.

Long-term and Combination Data

Use in Combination with Other Treatments

Research evaluated whether the use of the drug alongside a non-pharmacological intervention is associated with differences in symptom score relative to the drug used alone. The combined approach was evaluated for its impact on patient adherence and overall physical function. It is not yet clear whether this combination approach yields predictable changes for individuals. Overall, research evaluated whether the combination approach was associated with observed differences in patient outcomes.

Extended Follow-Up Research

Data on long-term outcomes (beyond 6 months) remain limited. Extended follow-up studies were conducted to monitor for potential delayed changes or effects on general health markers. These studies are continuing to examine if the initial changes seen in short-term trials are maintained over periods of one year or more.

Key Studies & References

  1. A narrative review of Phase II and III clinical trials for the pharmacological treatment of Fibrodysplasia Ossificans Progressiva

Frequently Asked Questions (FAQ)

Common questions about Cinopal (FAQ)

Q: Does Cinopal treat the cause of the disease or just the symptoms?

Cinopal's active ingredient works by inhibiting the synthesis of prostaglandins in the body. Prostaglandins are natural chemicals that act as mediators of pain, inflammation, and fever. According to regulatory documents, the drug's mechanism of action is intended to provide relief from these symptoms rather than curing the underlying cause of the condition itself.

Q: Is Cinopal generally used for short-term or long-term treatment?

Clinical data summarized in official sources primarily supports the use of Cinopal for short-term treatment, generally up to six months. As with all Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), regulatory agencies advise general caution for cumulative risks associated with extended use, as long-term safety data are limited.

Q: What are the signs of a serious allergic reaction to Cinopal?

Official warnings highlight the risk of serious hypersensitivity reactions to the drug. These reactions can manifest as severe skin conditions, such as Toxic Epidermal Necrolysis (TEN), or symptoms like difficulty breathing, or swelling of the face, throat, or tongue.

Q: Are there any known long-term side effects associated with Cinopal use?

Official research data on outcomes beyond six months are limited. However, as Cinopal is classified as an NSAID, it carries warnings regarding cumulative long-term risks common to this class. These risks include potentially severe effects on the gastrointestinal system, cardiovascular system, and kidneys.

Q: Can Cinopal affect my sleep, causing insomnia or drowsiness?

The product's safety profile lists neurological disturbances such as dizziness and depression as common effects. Other central nervous system effects, including both insomnia (difficulty sleeping) and somnolence (drowsiness), have also been noted in official product information.

Q: Can Cinopal be taken with common pain relievers like ibuprofen or acetaminophen?

Co-administration is formally contraindicated with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as ibuprofen, due to the cumulative risk of severe adverse effects. However, regulatory documents do not list explicit restrictions for use with acetaminophen (paracetamol).

Q: How quickly should I expect to feel the effects of Cinopal after starting treatment?

According to pharmacokinetic properties described in official regulatory summaries, the active substance is rapidly absorbed following oral administration. Peak blood concentrations of the active substance are typically reached within approximately 70 minutes after the dose is taken.

Q: Why might a patient be prescribed a lower starting dose of Cinopal?

The initial dose may be individualized by the prescriber. Official guidelines indicate that a lower starting dose may be considered for populations at higher risk for adverse reactions. This includes elderly patients or individuals with mild-to-moderate impairment of the liver or kidneys.

Q: Is Cinopal considered a controlled substance or narcotic?

Cinopal (Fenbufen) is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). Official regulatory frameworks do not list Cinopal as a scheduled, controlled substance, or narcotic.

Q: Does Cinopal typically cause changes in body weight?

Official adverse reaction summaries do not list specific weight changes as a common or less common effect. However, product information for this drug class notes that the medication may be associated with fluid retention in some patients.

Q: Is it safe to drink alcohol while I am taking Cinopal?

Regulatory guidance describes a general caution regarding the concurrent use of NSAIDs and alcohol. This caution is due to the potential for increased risk of gastrointestinal blood loss and irritation.

Q: How long does Cinopal stay in your system after the last dose?

The active substance, biphenylacetic acid, and its related metabolites are eliminated from the body over time. Official pharmacokinetic data reports that the elimination half-life ranges from approximately 10 to 17 hours.

Q: Does Cinopal affect my ability to drive or operate machinery?

The official product information notes potential effects on the ability to drive or operate machinery. This is due to the common side effects of dizziness and other neurological disturbances.

Q: What does official guidance say about the risk of becoming dependent on Cinopal?

Cinopal is not classified as a controlled substance. Official regulatory guidance does not list addiction or dependence as a known risk associated with its use.

Q: Does Cinopal contain gluten or lactose?

Information regarding the presence of specific inactive ingredients like gluten, lactose, or other excipients is detailed in the official package leaflet. This detail is listed in the Summary of Product Characteristics (SmPC) under the section for excipients.

Q: What happens if I take more Cinopal than instructed?

Taking more than the prescribed amount is considered an overdose and can lead to adverse effects. Symptoms can include severe headache, dizziness, nausea, vomiting, or ringing in the ears. In rare, severe cases, overdose can lead to seizures or decreased consciousness.

Q: What is the risk of overdose with Cinopal according to regulatory sources?

Official regulatory sources define the risks of overdose, especially with large ingestions. These risks include serious conditions common to the NSAID class such as multi-organ dysfunction, acute renal failure, and shock.

Q: Does Cinopal impact fertility in men or women?

Official information notes that, as with other NSAIDs, the drug has the potential to inhibit prostaglandin-mediated reproductive processes in women. This inhibition may temporarily impair fertility. The product label does not specifically note effects on male fertility.

How should Cinopal be stored and disposed of?

How to Store and Dispose of Cinopal (Fenbufen)

Official regulatory guidelines strictly define the conditions necessary for storing and disposing of Cinopal.

Storage Requirements

The medicine must be stored in a dry, cool, and shaded area under conditions typically associated with Controlled Room Temperature (20 C to 25 C / 68 F to 77 F). The product must be kept in its tightly closed original container and requires explicit protection from light and moisture. All medicine must be kept out of the sight and reach of children and pets, and should be stored locked up.

Disposal Instructions

Disposal must adhere to local and national regulations to prevent environmental contamination. Unused or expired Cinopal should not be flushed down the toilet or poured into drains, as it must not be allowed to enter sewers, surface, or ground water. The recommended method is to use official drug take-back programs. If this is unavailable, the medicine should be mixed with an unappealing substance, sealed in a bag, and disposed of with household trash; all personal information on the label must be scratched out beforehand.

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

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