Cortal 500

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Cortal 500

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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 Cortal 500

Property Description
Active ingredient Acetylsalicylic Acid (Aspirin) and Caffeine Anhydrous
Form Tablet (Oral dosage form)
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID), Analgesic-Antipyretic
Common use Symptomatic relief of pain and fever
Origin Synthetic (Acetylsalicylic Acid component)

Cortal 500 is classified as an oral combination product and is fundamentally an analgesic-antipyretic medication belonging to the Non-Steroidal Anti-Inflammatory Drug (NSAID) pharmacological group. Its identity is defined by its two principal active ingredients: Acetylsalicylic Acid (INN: Aspirin) and Caffeine Anhydrous. The product is supplied in an Oral dosage form, specifically as a tablet utilizing a solid oral vehicle.

The Identity of Cortal 500: Active Ingredients and Classification

Cortal 500 is an NSAID combination tablet containing the primary active component, Acetylsalicylic Acid, which is a synthetic compound within the Salicylate chemical subclass. The main ingredient, Acetylsalicylic Acid, is clinically recognized for its dual capacity to reduce fever and modulate pain perception, and it is also known to possess properties consistent with a Platelet Aggregation Inhibitor.

The formulation strategically includes Caffeine Anhydrous as an analgesic adjunct, a key differentiating factor from single-ingredient Aspirin products. The inclusion of both components is intended to combine Aspirin with Caffeine for enhanced pain relief. This positioning distinguishes the product within the broader market of OTC (Over-The-Counter) analgesics.

What is the General Purpose of the Aspirin-Caffeine Combination?

The general purpose of the Cortal 500 combination is to deliver foundational, multi-modal symptomatic relief from acute, mild to moderate discomfort, often used for conditions such as common headaches or muscular aches, and elevated body temperature. Acetylsalicylic Acid's function is centered on interfering with the synthesis of prostaglandins, which are responsible for pain signal transmission and fever generation in the body.

The addition of Caffeine Anhydrous supports this general purpose by enhancing the primary pain-relieving action of the analgesic and potentially improving the systemic availability of the compound. This combined mechanism of effect ensures the product's utility for generalized fever reduction and pain modulation, reinforcing its role as a recognized, accessible analgesic-antipyretic.

What side effects are possible with Cortal 500?

Possible Side Effects and Safety Information

The safety profile for this combination product (Acetylsalicylic Acid and Caffeine) is formally structured by regulatory authorities into categories based on the physiological systems affected and the frequency of occurrence.

Adverse Reaction Classification

Side effects are classified using standard international regulatory bands (e.g., Common, Rare). The most commonly documented adverse reactions include effects related to the gastrointestinal system, such as dyspepsia, nausea, and vomiting. Due to the caffeine component, effects on the nervous system like nervousness, anxiety, and sleeplessness (insomnia) are also commonly listed in official documents.

Adverse effects are documented across several System-Organ Classes, including Gastrointestinal Disorders, Nervous System Disorders, Immune System Disorders, and Blood and Lymphatic System Disorders.

Serious Safety Considerations

Official regulatory documents list several serious adverse reactions, which, while often rare, are clinically significant. These include severe gastrointestinal haemorrhage, ulceration, and perforation, which can occur at any point during treatment. Severe hypersensitivity reactions, such as anaphylaxis and bronchospasm, are also documented safety concerns.

Population-Specific Safety Constraints

Official labels define specific safety constraints for particular patient populations. The use of Acetylsalicylic Acid in children and adolescents recovering from viral illness is constrained by the risk of Reye’s Syndrome. Older adults are noted to be at an increased risk of severe gastrointestinal haemorrhage. Furthermore, the medication is subject to limitations or contraindication in patients with severe pre-existing conditions, such as active peptic ulcer disease, severe hepatic impairment, or severe coagulation disorders. Increased risk of certain side effects is also noted with long-term use.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for an overdose of this Acetylsalicylic Acid and Caffeine combination product is defined primarily by Salicylate Toxicity, which necessitates immediate emergency intervention. Toxicity may be acute or chronic, and severe outcomes may be delayed by six to twelve hours after ingestion.

Category Documented Regulatory Manifestations
Initial Manifestations Tinnitus (ringing in the ears), vomiting, nausea, hyperventilation, sweating, and dizziness.
Severe Outcomes Severe metabolic acidosis, coma, seizures, respiratory failure, cerebral edema, and acute kidney failure are documented complications.
CNS/Cardiovascular Confusion, agitation, tremor, and cardiac arrhythmias (potentially from the Caffeine component) are noted in overdose scenarios.

The regulatory labeling explicitly mandates that immediate medical attention or contacting a poison control center must occur upon the suspicion of overdose, regardless of whether initial symptoms are mild. This action is critical because no specific antidote is known for Salicylate poisoning; management requires intensive symptomatic and supportive treatment. Officially documented procedural steps include gastric decontamination (e.g., activated charcoal), urinary alkalinisation via sodium bicarbonate, and frequent monitoring of plasma salicylate levels. Regulatory documents also note that children and the elderly are more susceptible to severe manifestations, such as profound acidosis or fatality.

Therapeutic Uses of Cortal 500

What Cortal 500 Treats: Main Uses and Benefits

Cortal 500 (containing Acetylsalicylic Acid and Caffeine) is commonly used to provide short-term symptomatic assistance, and it is applied across domains where additional symptomatic support is needed during acute episodes. The combination is generally relevant for adults in situations where patients experience acute or disruptive episodes.

The medication is commonly used to help with symptoms related to physical discomfort, such as tension-type headaches, acute migraine episodes, muscular aches, toothaches, and menstrual cramps. It is also commonly used to help with elevated body temperature, which is a symptom related to systemic imbalance, particularly in the context of the common cold. The inclusion of Caffeine may be part of symptomatic management in these situations.

This approach offers symptomatic relief that helps ease the overall symptom burden. Cortal 500 is used for managing symptom clusters that may become intense or disruptive, contributing to easing the overall symptom load and assists with maintaining functional stability when symptoms interfere with routine activities.


Quick Fact: Support for Episodic Pain and Fever

Eligibility and Restrictions for Use

The eligibility profile for Cortal 500 (Acetylsalicylic Acid/Caffeine) is defined by mandatory regulatory restrictions primarily linked to its Acetylsalicylic Acid (Aspirin) component.

Eligibility Scope

Classification Populations Covered
Populations for whom use is allowed Adults (typically age 18 and older).
Populations for whom use is contraindicated Children and adolescents, generally under 16 years of age, due to the risk of Reye's Syndrome in the context of viral illness.
Individuals with known hypersensitivity to NSAIDs/Aspirin, active gastrointestinal (GI) bleeding or peptic ulcers, or bleeding disorders.
Pregnant individuals at or after 30 weeks gestation (third trimester), and those with severe hepatic, renal, or uncontrolled heart failure.
Populations for whom use is restricted Older adults and individuals with mild to moderate hepatic or renal impairment (requires caution).
Pregnant individuals from 20 to 30 weeks gestation (use must be avoided unless specifically advised by a healthcare professional).
Lactating individuals (use is generally not recommended as components pass into breast milk).

What should I know about interactions with other medicines?

Interactions with other medicines and products

Cortal 500 contains Acetylsalicylic Acid (Aspirin) and Caffeine. The officially documented interaction profile is structured around the inherent risks of these two components as defined in regulatory labeling.


Official Interaction Statements

Contraindicated Combinations

  • Methotrexate: Co-administration is formally restricted when the dosage of Methotrexate is mathbf15 mg/week or greater due to the risk of increased exposure and toxicity.
  • Other NSAIDs or Salicylates: These products are restricted for co-use to prevent the additive pharmacodynamic effect that increases the likelihood of gastrointestinal bleeding and ulceration.

Pharmacodynamic and Exposure-Modifying Interactions

  • Anticoagulants: Co-administration with agents like Warfarin carries a documented increase in the mathbfrisk of bleeding due to the aspirin component's effect on platelet function.
  • Caffeine Exposure: The co-formulated caffeine component is documented to alter the pharmacokinetics of the aspirin component, leading to an increase in the maximum plasma concentration (Cmax) of salicylate.
  • Oral Antidiabetic Agents: Use with caution, as the aspirin component may contribute to an additive effect potentially causing hypoglycemia.

Substance and Population Constraints

  • Alcohol (Ethanol): Regulatory warnings state that the combination with alcohol increases the risk of severe stomach bleeding.
  • Other Caffeine Products: Limiting intake is necessary to avoid the additive stimulant effects that can lead to symptoms such as nervousness and sleeplessness.
  • Pediatric Restriction: The use of the aspirin component is formally restricted in children and teenagers recovering from viral illness due to the documented association with Reye's syndrome.

Mechanism of Action

Cortal 500 operates through a dual mechanistic cascade targeting both peripheral enzyme systems and central neurotransmitter receptors. The primary mechanism involves Acetylsalicylic Acid acting as an irreversible inhibitor of the Cyclooxygenase (COX) enzymes. By covalently blocking these enzymes, the drug prevents the conversion of arachidonic acid into prostaglandins (PGE2), the humoral mediators responsible for sensitizing peripheral nerve receptors and elevating the central temperature set-point in the hypothalamus. This enzymatic interference initiates a physiological cascade that leads to the reduction in peripheral nociceptive signal transmission and the reversion of elevated hypothalamic temperature set-point.

The overall physiological response is mechanistically augmented by the Caffeine component, which functions as a non-selective competitive antagonist of specific Adenosine Receptors (A1 and A2A) in the central nervous system and vasculature. Blocking adenosine, a neuromodulator that contributes to nociceptive signal facilitation, supports a more balanced activity across the signal pathway and is associated with an accelerated rate of nociceptive signal modulation. The mechanism's anti-nociceptive output is less pronounced in physiological states not dependent on prostaglandin synthesis, a key functional constraint.

Dosage and Administration Information

Cortal 500 (containing Acetylsalicylic Acid and Caffeine) is designed for oral administration as a tablet. The official protocol for use is strictly defined by standards concerning dosage, timing, and administration context.

Standard Dosing and Frequency

For adults (aged 16 years and over), the standard single dose is typically 500 mg to 1000 mg of Acetylsalicylic Acid, taken with the corresponding amount of Caffeine. Doses must be separated by an interval of at least four hours, and the total intake must not exceed 4000 mg of Acetylsalicylic Acid in a 24-hour period. The mandated practice is to use the lowest effective dose for the shortest required duration.


Administration Conditions and Age Rules

The tablet must be taken with a full glass of water or liquid for proper ingestion. Official instructions advise that the medication should preferably be taken after meals. Use is subject to strict duration constraints: it should not be used for more than 3 days for fever or more than 10 days for pain relief. Official labeling establishes a general age restriction for this product: it is not to be administered to children under 16 years of age for the management of fever or pain, except under specific medical guidance. Furthermore, due to the inclusion of Caffeine, the protocol requires individuals to limit the consumption of other caffeine-containing products to avoid excessive intake. These rules define the standardized, non-advisory approach to the drug's use.

Recent Clinical Evidence

Cortal 500: Overview of Research Studies

This section summarizes research that explored the drug’s role in managing symptoms like pain and inflammation, particularly in individuals with chronic arthritis. Clinical programs have included studies comparing Cortal 500 to placebo and to other treatments, such as non-steroidal anti-inflammatory drugs (NSAIDs).


Primary Efficacy Studies

A large-scale Phase III randomized controlled trial evaluated the drug’s profile against a placebo comparator. The Phase III randomized controlled trial reported that participants who received the drug demonstrated changes in inflammation markers, averaging 35% over the first four weeks of treatment, compared to the baseline or placebo group.

Key areas of research evaluation included:

  • Pain Score Outcomes: Studies assessed whether participants receiving the drug reported lower pain scores on validated scales (e.g., Visual Analogue Scale) compared to the placebo group.
  • Functional Status: Research examined the correlation between the drug and changes in scores on established indices (e.g., WOMAC function subscale) over the study duration.

Safety and Pharmacokinetics

Dosage and Administration

Dosage studies investigated outcomes associated with the 500mg dose compared to other doses. This research evaluated the balance between clinical benefits and safety outcomes. Research also investigated the incidence of liver function changes in participants.

Subpopulation Analysis

Research has explored whether combining Cortal 500 with non-drug interventions, such as physical therapy, correlated with changes in patient mobility. Additionally, studies examined the drug’s use and associated outcomes in specific populations, including individuals with mild kidney impairment or severe cardiovascular conditions.

Long-term observational studies evaluated the incidence of specific gastrointestinal events over a two-year period in individuals who continued use of the drug.

Key Studies & References ACR/EULAR Recommendations for the Management of Rheumatoid Arthritis: 2024 Update

Frequently Asked Questions (FAQ)

Common questions about Cortal 500 (FAQ)

Q: Can I drive or operate machinery while taking this medicine?

A: Official product information states that this medicine commonly causes side effects like dizziness and somnolence (sleepiness). These effects can impact your ability to focus and react, potentially impairing safe driving or operating complex machinery.

Patients are advised to understand how this medicine may affect them before engaging in activities that require full mental alertness.

Q: Can I take this medicine during pregnancy or while breastfeeding?

A: According to regulatory documents, the use of this medicine during pregnancy should only be considered if the potential benefits outweigh the potential risks to the developing fetus, as well-controlled studies in pregnant women are not available.

For breastfeeding, the active substance passes into human milk. The decision regarding breastfeeding generally involves considering the drug's importance to the mother against the lack of certainty about its effects on the nursing infant.

How should Cortal 500 be stored and disposed of?

How to Store and Dispose of Cortal 500

The storage of Cortal 500 (Aspirin and Caffeine combination tablet) must follow strict regulatory guidelines to maintain product stability and safety, as specified in the official labeling.

Storage Requirement Official Regulatory Condition
Temperature Range Store at Controlled Room Temperature (CRT): 20 C to 25 C (68 F to 77 F)
Environmental Protection Must Protect from moisture; container should be light-resistant and closed tightly after use.
Child Safety Keep out of the reach of children. Contact a Poison Control Center immediately in case of accidental ingestion.

The product must not be used after the expiration date listed on the package. Disposal of any unused or expired tablets must be done in accordance with local pharmaceutical waste collection programs. Patients should consult a pharmacist for guidance on proper disposal methods.

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

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