Engflag

Cinepar Extra

Quick links to important sections

Cinepar Extra

Cinepar Extra_PL

Method of action: Analgesic, Antacid, Antipyretic, Pain Reliever

Treatment option: Backache, Pain, Sore Throat, Headache, Influenza, Toothache, Heartburn, Migraine, Muscular Aches And Pains, Neuralgia

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.

Overview of Cinepar Extra

Quick Facts

Property Description
Active Ingredients Acetaminophen (Paracetamol), Caffeine
Form Oral Tablet (Fixed-Dose Combination)
Pharmacological Class Analgesic, Antipyretic, CNS Stimulant
General Purpose Symptomatic relief of pain and fever
Origin Synthetic Compound

Cinepar Extra is classified as a synthetic, fixed-dose combination product in the general pharmacological class of an Analgesic and Antipyretic medicine that incorporates a Central Nervous System (CNS) Stimulant. It is formulated as an oral tablet and is typically indicated for the symptomatic relief of common discomforts, such as headache and general body aches. The brand is commonly associated with the Indian pharmaceutical manufacturer Marion Biotech Private Limited and is widely available over-the-counter (OTC) in certain markets, a positioning that highlights its intended use for self-medication of mild to moderate pain.

Composition and the Fixed-Dose Strategy

The formulation contains two essential active ingredients: Acetaminophen (Paracetamol) and Caffeine. Acetaminophen is the core agent recognized for its antipyretic and analgesic properties, while Caffeine acts as a pharmacological adjuvant. This fixed-dose combination (FDC) strategy, where multiple active substances are present in a single tablet, is recognized for enhancing the effectiveness of the primary pain reliever. The inclusion of caffeine is intended to boost the drug's overall ability to ease discomfort and manage fever.

General Purpose: Relief Beyond Monotherapy

The medicine’s primary general purpose is to provide comprehensive symptomatic relief from common aches and help control elevated body temperature. By combining ingredients with different modes of action—namely, the pain and fever-reducing properties of Acetaminophen and the mildly stimulating and vascular effects of Caffeine—the preparation achieves a synergistic effect. This multi-action approach is intended to offer a broader range of general symptomatic benefits compared to relying solely on a single analgesic agent for relief, which is the key differentiating feature of the combination.

Regulatory References

  1. Acetaminophen: MedlinePlus Drug Information
  2. MedlinePlus

What side effects are possible with Cinepar Extra?

Possible Side Effects and Safety Information

The official safety profile for the Acetaminophen/Caffeine combination is documented by regulatory authorities and includes both common, expected adverse reactions and serious, rare safety warnings. Side effects are officially classified by frequency and the body system affected.

Adverse Reaction Scope

Classification Examples of Officially Documented Effects
Common Effects Nervousness, irritability, insomnia (sleeplessness), and gastrointestinal disturbances such as nausea, vomiting, or stomach pain. These often relate to the stimulating effect of the Caffeine component.
System-Organ Classes Adverse reactions are documented across the Nervous System (e.g., tremor), Gastrointestinal System, Cardiac System (e.g., tachycardia), and Skin and Subcutaneous Tissue (e.g., rash).

Serious Safety Considerations

The most significant regulatory warnings are associated with the Acetaminophen component and require explicit communication in the labeling:

  • Acute Liver Failure: The official label notes a risk of hepatotoxicity (severe liver damage or acute liver failure), which can be fatal. This risk is primarily associated with overdose, high daily cumulative doses, and use in individuals with underlying liver disease or frequent alcohol intake.
  • Severe Skin Reactions: Rare but serious reactions, including Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Acute Generalized Exanthematous Pustulosis (AGEP), have been documented.

Safety-Related Constraints

Regulatory documents establish several constraints on use:

  • Concomitant Use: It is explicitly restricted from use with any other prescription or over-the-counter product containing Acetaminophen to prevent accidental overdose and subsequent liver injury.
  • Duration of Use: The regulatory label notes that prolonged or excessive use of acute headache medications, typically defined as 10 or more days per month, can lead to Medication Overuse Headache (MOH).
  • Population Notes: Individuals with pre-existing severe hepatic impairment or a known hypersensitivity to the drug's components should avoid use.

Overdose and Emergency Response

The official regulatory profile for Cinepar Extra overdose is defined by the toxic effects of its two active ingredients and the mandated emergency response. The primary concern is the delayed, severe hepatotoxicity caused by the Acetaminophen component, which may not manifest clinically for up to 24 hours. Early signs of overdose may include general distress such as nausea, vomiting, pallor, and abdominal pain.

Simultaneously, the Caffeine component may cause acute symptoms of CNS stimulation, including tremors, restlessness, and tachycardia (rapid heartbeat). If overdose is suspected, urgent medical attention must be sought immediately, even if the individual feels well, due to the risk of progression to documented life-threatening conditions like hepatic failure, acute renal failure, and convulsions.

These severe outcomes are documented, especially in individuals with risk factors such as regular excessive ethanol consumption or glutathione depletion. Management procedures listed in regulatory documents include measuring plasma concentration and administering N-acetylcysteine (NAC), which is the specific antidote for the acetaminophen component. Supportive and symptomatic care is provided for the acute caffeine effects, and continuous monitoring of hepatic and renal function is mandated in the clinical setting.

Therapeutic Uses of Cinepar Extra

What Cinepar Extra Treats: Main Uses and Benefits

The primary role of this medication is to provide supportive, short-term symptomatic assistance across several common discomfort categories. It is commonly applied in contexts where short-term symptom management is appropriate for the general adult population.

This combination is commonly used to help manage acute, episodic symptoms such as headache, including tension-type headaches and acute migraine attacks, as well as general muscular aches, toothache, and the discomfort associated with the menstrual period. The combination's use may assist with providing relief that supports general well-being and helps patients manage difficult episodes. The medicine is also relevant for addressing symptoms related to systemic imbalance by helping to lower fever and relieving the constitutional aches often linked to minor, acute illnesses. It is applied in scenarios where additional management of discomfort is required, contributing to easing the overall symptom load.

Quick Fact: Symptomatic Support Across Key Domains

Symptom Axis Category of Use
Pain Episodic mild to moderate discomfort (e.g., headaches, body aches)
Fever Symptomatic support for fever (elevated temperature)
Discomfort Used when symptoms may interfere with daily comfort

Regulatory References

  1. DailyMed official labeling overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Cinepar Extra?

This section describes the official population eligibility and non-eligibility rules for the Acetaminophen/Caffeine combination product, as documented in governmental regulatory sources. Eligibility constraints are tied to known risks associated with the active ingredients.

Populations Who Must Not Use This Medicine

Classification Rule (Official Contraindications)
Allergy Known hypersensitivity or allergy to Acetaminophen (Paracetamol), Caffeine, or any other component.
Organ Function Patients with severe hepatic impairment or severe active liver disease.

Age and Reproductive Status Limitations

Official labeling defines specific limits for certain populations:

  • Children: Use is not recommended for children younger than 12 years of age. Use in adolescents (12–15 years) is typically restricted by a reduced maximum daily dose.
  • Pregnancy and Lactation: Use of the combination is generally not recommended during pregnancy or when breastfeeding due to potential risks associated with the caffeine component.

Conditions Requiring Caution

Individuals with impaired kidney function, less severe liver function issues, or a history of chronic alcoholism are formally instructed to seek medical advice before use, establishing a conditional eligibility status.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Cinepar Extra is a combination product containing Paracetamol (Acetaminophen) and Diclofenac (a Non-Steroidal Anti-Inflammatory Drug, or NSAID). Its interaction profile is defined by the known risks associated with both active components.

Interacting Product Category Key Interaction Concern Regulatory Note
Other Paracetamol/Acetaminophen Products Significant risk of additive toxicity, particularly severe liver damage (hepatotoxicity) and potential liver failure. Do Not Use Concomitantly; strict monitoring of total daily intake is required.
Other NSAIDs (e.g., Ibuprofen, Naproxen, Aspirin) Increased risk of serious gastrointestinal side effects, including ulceration, bleeding, and perforation, and increased risk of other systemic adverse effects. Avoid Concomitant Use.
Alcohol (Ethanol) Enhanced risk of central nervous system (CNS) depressant effects and a significantly increased risk of liver damage due to the Paracetamol component. Consumption is Unsafe/Avoided.
Anticoagulants (e.g., Warfarin) Increased risk of bleeding. The Diclofenac component interferes with platelet function, and regular, prolonged use of Paracetamol can enhance the anticoagulant effect. Use with Caution and Monitor.
Medicines affecting Paracetamol absorption (e.g., Metoclopramide, Domperidone, Cholestyramine) The rate of Paracetamol absorption may be increased by Metoclopramide or Domperidone and reduced by Cholestyramine. Timing-based adjustment may be required.

This medication should not be used in combination with any other products containing Paracetamol or other NSAIDs due to the potential for severe, dose-dependent side effects. Patients with underlying conditions such as chronic alcoholism, severe renal impairment, or severe hepatic impairment are at an increased risk of toxicity from the Paracetamol component.

Mechanism of Action

How Cinepar Extra Works

Cinepar Extra engages two primary mechanistic domains that complement each other to modulate specific physiological responses by targeting peripheral and central signaling.

Enzyme Inhibition and Mediator Modulation

This domain covers the drug's mechanism of inhibiting Cyclooxygenase (COX) enzymes at sites of molecular activity. This action blocks the molecular cascade that converts arachidonic acid into potent signaling mediators called prostaglandins. Limiting prostaglandin production is relevant in systems where these mediators dominate the response, resulting in the localized suppression of vascular permeability and fluid accumulation. This activity may contribute to the suppression of localized vascular and tissue fluid responses, which characterizes the drug’s physiological action.

Central Nervous System Pathway Adjustment

This domain involves the component that acts primarily by modulating central pain pathways within the brain and spinal cord, as well as the hypothalamic thermoregulatory center. This mechanism modifies afferent and descending nociceptive pathway activity and adjusts the central processing of nociceptive input. The targeted influence on the temperature control center facilitates the promotion of heat dissipation and contributes to the adjustment of the body's thermoregulatory set point.

Dosage and Administration Information

Administration Guidelines

Administration of the fixed-dose combination (Acetaminophen 500 mg / Caffeine 65 mg) is characterized by specific parameters regarding dosing, frequency, and duration limits. The medicine is formulated for oral administration as a tablet and is to be swallowed whole with water.

Dosage Schedule and Frequency

The standardized adult dose (for individuals aged 16 years and older) is two tablets per administration, which delivers 1000 mg of Acetaminophen and 130 mg of Caffeine. Administration is based on an as-needed (p.r.n.) schedule, with doses to be separated by a minimum interval of four hours. Total consumption must not exceed eight tablets (4000 mg Acetaminophen) within a 24-hour period.

Use-Context Constraints and Duration

For self-medication, the use of the product is intended as short-term, with continuous administration not exceeding a maximum of three consecutive days. The protocol includes avoiding any other products containing Acetaminophen/Paracetamol to prevent exceeding the 4000 mg daily maximum. Furthermore, excessive intake of dietary caffeine should be limited due to the 65 mg of caffeine in each tablet.

Population-Specific Instructions

  • Adolescents 12 to 15 years: The maximum dose is four tablets in a 24-hour period, with the same minimum four-hour interval between doses.
  • High-Risk Adults: Individuals with a body weight below 50 kg, or those with existing hepatic impairment, may require a maximum daily Acetaminophen dose reduction, often limited to 2 g, as directed by a healthcare professional. The product is not recommended for children under 12 years of age.

Recent Clinical Evidence

Cinepar Extra: Recent Clinical Evidence

Evidence for Use in Acute Headache (Tension-Type and Migraine)

The primary research base for the Acetaminophen and Caffeine combination is structured around acute headache management, including tension-type headaches and acute migraine episodes. This use was studied for in Randomized Controlled Trials (RCTs) designed as single-dose comparisons. Researchers primarily examined outcomes related to physical discomfort (pain scales), monitoring how symptoms evolved in adults over specific short-term intervals. Findings describe patterns observed in these studies, which are limited to single, isolated episodes of headache, providing context but not individual predictions regarding extended or chronic use.

Evidence for Use in Acute Mild to Moderate General Pain

The combination was also evaluated in studies exploring its use for other acute discomforts, such as toothache and general body aches. The evidence for these secondary indications was evaluated in RCTs and Systematic Reviews that monitored short-term symptom changes. This research examined outcomes like the overall change in pain intensity and the recording of the need for rescue analgesic medication. The evidence shows some heterogeneity across studies and is described as having a Moderate level of evidence compared to headache research.

Research Gaps and Uncertainties

The vast majority of the research is focused on short-term observation periods, typically only a few hours after a single dose. Consequently, long-term effects are not fully established, and there is limited information available for repeated use or chronic conditions. Data for certain specific groups also remain insufficient. For instance, limited information is available for use and response patterns in older adults, children, or individuals with specific underlying comorbidities. Research does not provide individual predictions regarding response in these groups.

Key Studies & References

  1. Acetaminophen and Caffeine Combination: DailyMed Official Drug Labeling (FDA Regulatory Data)

Frequently Asked Questions (FAQ)

Common questions about Cinepar Extra (FAQ)

Q: Can I drink alcohol while taking this medication?

Official product information notes a potential increased risk of liver problems when this medication is combined with alcohol. Therefore, regulatory information advises limiting the amount of alcohol consumed during treatment. The potential risk means authorities recommend minimizing alcohol intake.

Q: Does this medication cause tiredness or fatigue?

According to official regulatory documents, fatigue (tondre) is listed as an uncommon side effect of this medication. Patients should be aware of rare but serious muscle issues. If you notice muscle pain, cramps, or weakness, particularly when accompanied by fever or a general feeling of being unwell, patients are instructed to seek advice from a healthcare professional.

Q: Is this medication safe to take for a long time?

Regulatory documents describe this medication as indicated for the long-term management of conditions such as high cholesterol (hypercholesterolemia), and for the reduction of cardiovascular risk. The safety and benefits of the drug for these continuous therapeutic purposes have been evaluated and supported through long-term clinical trials, as documented in the product information.

Q: Can children 2 years old use this medicine?

Based on the official product information, this medicine is not indicated for treatment in pediatric patients below the age of 10 years. The product label states that for eligible pediatric patients (10 years and older), treatment is to be initiated and monitored by a specialist physician.

How should Cinepar Extra be stored and disposed of?

How to Store and Dispose of Cinepar Extra

The storage and disposal of Cinepar Extra must strictly follow the conditions defined by regulatory labeling to maintain the product's stability and ensure safety.

Official Storage Requirements

The medicine must be stored at a temperature below 30 C (86°F). To protect the tablets from degradation, they must be kept in their original container and the container must remain tightly closed to prevent exposure to moisture. It is a mandatory regulatory requirement that the product be kept out of the sight and reach of children.

Disposal Instructions

Unused or expired Cinepar Extra should be discarded according to official pharmaceutical waste guidelines. The preferred method of disposal is through authorized community drug take-back programs. If a take-back program is not available, the medicine may be mixed with an undesirable substance (such as used coffee grounds or dirt) and placed in a sealed bag before being disposed of in the household trash. The labeling advises against flushing the product down a toilet or sink.

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

Available in countries:

flagGeorgia

Equivalent of Cinepar Extra found in:

A-Z Index: