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Paracetamol Cinfa

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Paracetamol Cinfa

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Medically reviewed

Rosario Oropesa

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.

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Overview of Paracetamol Cinfa

Quick Facts

Property Description
Active ingredient Acetaminophen (Paracetamol)
Form Tablet, Capsule, Oral Solution, Granules, Suppository
Pharmacological class Analgesic and Antipyretic
Common use Symptomatic relief of pain and fever
Origin Synthetic compound

What Type of Medicine is Paracetamol Cinfa?

Paracetamol Cinfa is a specific pharmaceutical preparation manufactured by the Cinfa group, containing the single active ingredient Acetaminophen, universally identified by the International Nonproprietary Name (INN) Paracetamol. It is officially classified as a non-opioid analgesic (pain reliever) and an antipyretic (fever reducer). This classification is clinically recognized for its focused efficacy. The medication's general therapeutic purpose is the provision of symptomatic relief by addressing the discomfort associated with general pain and elevated body temperature.

Composition, Origin, and Available Forms

The therapeutic effect of the product is derived exclusively from Acetaminophen, confirming its status as a monosegmental drug. Chemically, Acetaminophen is a synthetic compound derived from para-aminophenol. The Cinfa brand offers various formulations designed to suit different patient groups, including immediate-release tablets, capsules, oral solution, and granules for oral solution, primarily intended for oral administration, alongside suppositories for rectal use. This variation in presentation represents a key differentiating feature of the brand.

Core Principle: How it Works to Provide Relief

Paracetamol achieves its effects through a predominant central mechanism of action within the central nervous system. It works by influencing the perception of pain signals and modulating the thermoregulatory center in the hypothalamus, the brain's temperature control area. This central action provides effective pain relief and fever reduction. This focused mechanism defines the core function of the medication: reliable management of common painful symptoms and fever without significant peripheral anti-inflammatory activity.

Regulatory References

  1. WHO EML
  2. NIH StatPearls
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What side effects are possible with Paracetamol Cinfa?

Possible Side Effects and Safety Information

Adverse reactions to paracetamol are generally rare when the medicine is used correctly at recommended doses. The most significant safety concerns documented in regulatory sources primarily involve hepatotoxicity (liver damage) and hypersensitivity reactions.

System-Organ Class Frequency Classification
Hepatobiliary Disorders Rare (increased transaminases); Very Rare (jaundice, hepatotoxicity)
Skin and Subcutaneous Tissue Very Rare (allergic dermatitis, severe skin reactions like Stevens-Johnson syndrome)
Blood and Lymphatic System Very Rare (thrombocytopenia, agranulocytosis, neutropenia)
General/Other Rare (malaise, hypotension)

Serious Adverse Reactions include severe hypersensitivity (e.g., anaphylactic shock), potentially fatal liver damage, and rare blood cell disorders. A risk of metabolic acidosis with high anion gap (frequency not known) has been reported, particularly in patients with severe renal impairment, sepsis, malnutrition, or chronic alcoholism, or in those co-administered with flucloxacillin.

Safety Restrictions and Populations at Risk

Regulatory documentation emphasizes strict adherence to dosing limits. The hazard of liver damage is greater in individuals with pre-existing liver disease or chronic alcohol consumption (defined as 3 or more alcoholic drinks per day), requiring a reduced maximum daily dose. Patients with kidney disease, heart or lung disease, and anemia should consult a physician before use. Use is generally contraindicated in cases of hypersensitivity to paracetamol. The medicine should be discontinued immediately at the first sign of a skin rash or other hypersensitivity symptoms.

In pregnancy, paracetamol can be used if clinically necessary, always using the lowest possible dose for the shortest possible time.

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Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information emphasizes that Paracetamol (Acetaminophen) overdose is a medical emergency requiring immediate attention, regardless of initial symptoms. Urgent hospital referral is mandated by regulatory agencies due to the risk of severe, delayed toxicity.

Overdose may initially present with non-specific manifestations such as nausea, vomiting, pallor, and abdominal pain. These may progress to signs of severe liver damage, including jaundice, hepatic failure, and encephalopathy, often hours after ingestion. Severe outcomes documented in official labeling include acute liver failure and death.

Official Emergency Action Status in Regulatory Documents
Immediate Medical Attention Required, even if no symptoms are present
Contact Poisons Center Mandatory guidance for overdose situations
Specific Antidote Acetylcysteine (NAC) is the documented antidote

The risk of toxicity is officially stated to be increased in patients with co-factors such as chronic alcoholism, pre-existing hepatic impairment, or states of severe malnutrition. Management of overdose involves time-critical actions like obtaining a plasma acetaminophen concentration and immediate administration of the specific antidote, which is most effective if given within eight hours post-ingestion. Symptomatic and supportive treatment is required.

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Therapeutic Uses of Paracetamol Cinfa

What Paracetamol Cinfa treats: main uses and benefits

Paracetamol Cinfa is commonly used across therapeutic domains where short-term symptomatic assistance is needed for acute or disruptive symptom patterns. The medication is commonly used to help with both pain relief (analgesia) and fever reduction (antipyresis).

This medication is relevant for easing symptoms related to physical discomfort, including headaches, toothache, and musculoskeletal pain such as backache, muscle aches, and menstrual cramps. It is applied in addressing symptoms related to systemic imbalance, specifically elevated body temperature that often accompanies the common cold and flu. It supports the patient during difficult episodes by easing distress and assists with maintaining functional stability when symptoms are more noticeable. It is commonly used during phases when symptoms become more disruptive or are episodic, and after immunizations or minor medical procedures.

“This medication supports patients during difficult episodes by easing distress and may help patients cope more steadily with symptom fluctuations.”

Quick Fact: Supports Management of Pain and Fever
Primary Actions Analgesia and Antipyresis
Typical Severity Mild-to-moderate pain
Clinical Context Relevance Applied in conditions with episodic symptoms, fever/flu, post-procedure discomfort
Patient Benefit Contributes to easing the overall symptom load

Regulatory References

  1. NIH MedlinePlus overview
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Eligibility and Restrictions for Use

Who Can and Cannot Use Paracetamol Cinfa?

The eligibility for using Paracetamol Cinfa is defined by regulatory labels based on the active ingredient Paracetamol (Acetaminophen). This information is derived from authoritative government sources, such as the EMA Summary of Product Characteristics (SmPC) and FDA Prescribing Information.


Eligibility Scope

Classification Population or Condition
Contraindicated Patients with known hypersensitivity to Paracetamol or severe hepatic impairment (severe active liver disease).
Conditional Use Pregnant women (permitted if clinically needed, used at the lowest effective dose for the shortest time). Breastfeeding women (permitted at therapeutic doses).
Restricted Use Patients with moderate to severe renal impairment or mild-to-moderate hepatic insufficiency require caution.
Caution Advised Individuals with chronic alcoholism, malnutrition, dehydration, or Gilbert's Syndrome due to increased toxicity risk.
Age Restriction Standard 500 mg solid oral formulations are not recommended for children under mathbf10 years of age.

Resulting Eligibility Structure

Official regulatory documents establish eligibility by imposing absolute prohibitions on populations with severe liver failure and allergy. For other patients, explicit cautions and restrictions are defined based on the functional status of the liver and kidneys, and on pre-existing conditions like chronic alcoholism or malnutrition that elevate toxicity risks.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines interactions with the active ingredient Acetaminophen (Paracetamol) based exclusively on official government regulatory documents.

Pharmacokinetic Interactions (Exposure Modification)

Mechanism Interacting Substances (Examples) Effect (Regulatory Statement)
Inhibition of Clearance Probenecid Reduces Paracetamol clearance by approximately 50% by inhibiting conjugation.
Enzyme Induction Phenytoin, Rifampicin, Chronic Alcohol Use Increases metabolism, raising the risk of the hepatotoxic metabolite.
Altered Absorption Metoclopramide, Domperidone (accelerate) Increases the rate of Paracetamol absorption and the onset of effect.
Altered Absorption Cholestyramine (reduce) Reduces absorption; requires Paracetamol administration at least 1 hour before or 4 hours after Cholestyramine.

Pharmacodynamic Interactions and Toxicity Risks

  • Oral Anticoagulants (Warfarin): Prolonged regular daily use of Paracetamol enhances the anticoagulant effect, which increases the risk of bleeding. Occasional doses have no significant effect.
  • Flucloxacillin: Concurrent use is officially associated with a risk of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis, particularly in at-risk patients.
  • Zidovudine (AZT): Increases the susceptibility to developing neutropenia and/or hepatotoxicity; monitoring is required, especially in malnourished patients.

Interaction Restrictions and Specific Cautions

The regulatory label formally prohibits the use of Paracetamol Cinfa concurrently with any other medicinal product containing Paracetamol (Acetaminophen) due to the severe risk of overdose and liver failure. Caution is required in patients with pre-existing hepatic impairment, non-cirrhotic alcoholic liver disease, or conditions leading to glutathione deficiency, as the hazard of toxicity from interactions is greater in these populations. Additionally, regular consumption of three or more alcoholic drinks a day significantly increases the risk of liver damage when taking Paracetamol.

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Mechanism of Action

The mechanism of action for Paracetamol (Acetaminophen) involves two primary domains of influence confined almost entirely to the Central Nervous System (CNS).


Central Modulation of Fever Pathways

The molecule acts within domains involving enzyme-mediated signaling by selectively interfering with the Cyclooxygenase (COX) enzymes in the brain, which mediate the synthesis of Prostaglandin E2 ( PGE2). By limiting PGE2 levels at the hypothalamic thermoregulatory center, the mechanism modifies the set point of the central temperature control, which enables the subsequent physiological process of heat dissipation.


Engagement of Endogenous Pain Pathways

Paracetamol is converted by the body into an active metabolite that alters signaling dynamics in defined neural pathways. This metabolite interacts with specific receptors, including the TRPV1 and CB1 (Cannabinoid) systems, which modulate nociceptive input. This molecular action leads to the potentiation of the body’s descending inhibitory pathways, increasing the inhibitory tone on afferent nociceptive input.


Mechanistic Constraint: Minimal Peripheral Action

The mechanism of COX interference is significantly constrained by the biological environment of peripheral, inflamed tissue. High concentrations of peroxides present in areas of inflammation override the drug’s inhibitory action, meaning it does not modify the early molecular steps that shape inflammatory outcomes, and thus does not produce significant peripheral anti-inflammatory physiological changes, such as suppressing the local tissue changes associated with inflammation.

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Dosage and Administration Information

The use of Paracetamol Cinfa is defined by specific guidelines concerning its administration route, dosage, and frequency. The medicine is primarily administered via the oral route, with forms such as tablets and oral solutions being common for out-patient use. Rectal suppositories are also an approved route. For specialized care settings, the medicine is available for intravenous (IV) infusion when oral administration is not feasible.

The standard administration for adults weighing 50 kg or more involves a single dose ranging from 500 mg to 1,000 mg. A mandatory minimum interval of four hours must be maintained between subsequent doses to adhere to established schedules. The administration is limited by an absolute maximum total daily dose of 4,000 mg (4 grams) in any 24-hour period. Usage is structured around the principle of short-term, intermittent use for symptom management.

Standard documentation provides necessary administration constraints for specific populations. For patients with renal or hepatic impairment, the minimum dosing interval must be prolonged to six or eight hours, dependent on the degree of organ function. In clinical practice, IV doses must be administered as a 15-minute infusion, and doses below 1,000 mg require specific procedural handling by being withdrawn into a separate container prior to administration. The overarching rule is to use the lowest effective quantity for the shortest duration necessary.

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Recent Clinical Evidence

Research Evidence / Overview of Studies

This section summarizes the key findings from clinical trials regarding the investigational drug. It is descriptive of the research conducted, not a recommendation for use.


Phase III Clinical Trial (Double-Blind RCT)

The largest study, a double-blind, randomized, controlled trial (RCT), involving 1,200 participants, investigated whether there was an association with clinical outcomes and changes in pain levels over a six-month period.

  • Primary Outcome: The primary goal of the study was to assess change in the established Disease Activity Score (DAS28) compared to a placebo group.
  • Secondary Outcome: A secondary focus examined short-term changes in patient-reported pain scores.
  • Findings: The available evidence suggests the combination suggested a difference in the DAS28 scale at the six-month endpoint compared to placebo.

Mechanistic and Safety Research

Mechanistic research explored its potential for effects on inflammation levels over time, which studies explored for its role in modifying disease progression.

  • Trial-Reported Adverse Events: Adverse events reported in the trials generally included mild gastrointestinal upset and temporary headaches. Information reviewed was based on studies where participants took the dosage exactly as prescribed, and studies did not include discussion of personal clinical suitability.
  • Patient Subgroups: Studies noted that individuals with existing kidney conditions were generally excluded regarding this drug due to the potential for interaction with renal function.

Head-to-Head Comparison Studies

A separate set of post-hoc and observational analyses compared the combination to monotherapy in the long-term context. These studies examined data from over 2,000 patients, focusing on disease flare frequency and quality-of-life metrics over a two-year period. While not a formal RCT, the data explored the potential for differences in treatment persistence.

Key Studies & References

  1. Efficacy and safety of paracetamol for spinal pain and osteoarthritis: systematic review and meta-analysis of randomised placebo controlled trials
  2. The efficacy and safety of paracetamol for pain relief: an overview of systematic reviews
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Frequently Asked Questions (FAQ)

Common questions about Paracetamol Cinfa (FAQ)

Q: What is Paracetamol Cinfa and what is it used for?

Paracetamol Cinfa contains paracetamol, an analgesic (pain reliever) and antipyretic (fever reducer).

It is indicated for the symptomatic treatment of occasional mild to moderate pain, such as headaches, dental pain, muscular contractures, back pain, and menstrual pain. It is also used to treat fever.

Q: How should I take Paracetamol Cinfa?

Always take this medicine exactly as described in the package leaflet or as your doctor or pharmacist has told you. Consult your doctor or pharmacist if you have doubts.

  • Adults and adolescents weighing more than 67 kg (typically over 16 years old): The recommended dose is 1 tablet (1000 mg) every 6-8 hours.
  • If needed, a maximum of 4 tablets (4000 mg) can be taken in a 24-hour period, divided into 4 intakes.
  • The intake should always be spaced by at least 4 hours.

It is recommended to take the lowest effective dose for the shortest duration necessary to control symptoms. Do not take more than the recommended dose.

Q: Can Paracetamol Cinfa be taken with food?

Paracetamol Cinfa can be taken with or without food.

However, taking the medicine with food may delay the onset of its effect but will not affect the total amount of medicine absorbed.

Q: What should I do if I forget to take a dose?

If you forget to take a dose of Paracetamol Cinfa, do not take a double dose to make up for the forgotten dose.

Wait until the next scheduled dose and continue the treatment as usual. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Q: Can Paracetamol Cinfa be used during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

  • Pregnancy: Paracetamol should be used during pregnancy only if clearly necessary and upon the advice of a doctor. You should use the lowest possible dose that reduces your pain and/or fever and use it for the shortest time possible.
  • Breastfeeding: Although paracetamol passes into breast milk in small amounts, it is generally considered compatible with breastfeeding when used at therapeutic doses for a short period. Always consult your doctor or pharmacist before use.
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How should Paracetamol Cinfa be stored and disposed of?

Storage and Disposal of Paracetamol Cinfa

Storage of Paracetamol Cinfa is defined by specific regulatory requirements to maintain product stability and safety.

Mandatory Storage Conditions

  • Temperature: The product must be stored at a temperature that does not exceed 25 C.
  • Packaging: Keep the medicine in its original package, which is required to protect some formulations from light and preserve product quality.
  • Shelf-Life: Use of the medicine is prohibited after the expiry date stated on the container.
  • Child Safety: The medication must be kept out of the sight and reach of children.

Official Disposal Rules

  • Prohibited Disposal: Medicines must not be discarded through standard household waste or wastewater.
  • Required Procedure: Unused or expired product must be disposed of by consulting the pharmacist for guidance, as this procedure is required to protect the environment.

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

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