Cortal

Quick links to important sections

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 Cortal

Quick Facts

Property Description
Active ingredient Acetylsalicylic Acid, Caffeine
Form Oral Dosage Form (Tablet)
Pharmacological class Combination Analgesic / NSAID & CNS Stimulant
Common use Symptomatic relief of pain and fever
Origin Synthetic compound

What Type of Medicine is Cortal?

Cortal is a fixed-dose combination (FDC) pharmaceutical product classified fundamentally as a Combination Analgesic. This medicine is composed of two distinct synthetic compounds: Acetylsalicylic Acid and Caffeine. The Acetylsalicylic Acid component places the medicine within the Non-Steroidal Anti-Inflammatory Drug (NSAID) class. The secondary component, Caffeine, functions as a mild Central Nervous System (CNS) Stimulant and an analgesic adjuvant. This precise combination is widely clinically recognized for its efficacy in rapidly managing discomfort.


Composition and Formulation of Cortal

The medicine's active ingredients are Acetylsalicylic Acid and Caffeine. This composition dictates its systemic effect, as Cortal is typically supplied as an oral dosage form, specifically a tablet, intended for oral route of administration. Adding Caffeine to Acetylsalicylic Acid results in a significantly greater proportion of people achieving effective pain relief. This formulation provides enhanced pain management capabilities compared to single-ingredient options.


General Purpose of the Acetylsalicylic Acid and Caffeine Combination

The primary general purpose of Cortal is to provide symptomatic relief for common physical discomforts, such as the transient but severe pain associated with a typical tension headache. The combination is strategic, leveraging the property of Caffeine to act as an adjuvant, boosting the therapeutic efficacy of the Acetylsalicylic Acid component. The fixed combination is designed to enhance the speed and extent of pain relief compared to Acetylsalicylic Acid alone. The medicine is engineered to deliver a more powerful and comprehensive response to discomfort than the single active component could provide.

What side effects are possible with Cortal?

Possible Side Effects and Safety Information

The official safety profile for the combination of Acetylsalicylic Acid (ASA) and Caffeine is structured around documenting the frequency and type of adverse reactions based on government regulatory standards.

Category Description based on Official Regulatory Documents
Key Adverse Reaction Categories Nervous System effects, such as Nervousness and Dizziness; and Gastrointestinal Disorders, including Nausea and Dyspepsia [Source 1.4, 2.3].
Frequency Classification Common effects include nervousness, dizziness, abdominal pain, dyspepsia, and nausea. Uncommon reactions may involve vomiting and palpitations. Rare or Very Rare effects include agitation, tachycardia, esophagitis, liver dysfunction, and gastrointestinal perforation [Source 1.4].
System-Organ Classes Involved Adverse reactions are officially classified under Gastrointestinal Disorders, Nervous System Disorders, Psychiatric Disorders, Cardiac Disorders, and Immune System Disorders [Source 1.4, 1.2].
Serious Adverse Reactions The label includes explicit warnings for Gastrointestinal Bleeding, Ulceration, or Perforation (a potentially fatal NSAID risk) and Reye's Syndrome (a rare, serious illness associated with salicylates in children and teenagers with viral infections) [Source 1.2, 2.3].
Population-Specific Safety Considerations Children/Teenagers are restricted from use during viral illness due to Reye's syndrome risk. Older Adults have an increased frequency of adverse reactions, particularly GI bleeding. Use is avoided in the third trimester of pregnancy [Source 2.3, 3.2].
Dose- or Exposure-Related Patterns Gastrointestinal upset is reported as more likely with higher doses. Chronic use (e.g., 10 or more days per month) may worsen headaches [Source 1.4, 2.3].
Safety-Related Restrictions or Limitations Explicitly stated limitations include avoiding concurrent use with other systemic NSAIDs to prevent additive side effects, limiting caffeine intake from other sources to prevent additive stimulant effects, and restrictions on alcohol consumption due to increased risk of stomach bleeding [Source 2.2, 2.3].

Safety Classifications (High-Level)

Category Description based on Official Regulatory Documents
Regulatory Frequency Framework Used Adverse events are classified using standardized frequency terms (e.g., Common, Rare) consistent with regulatory body reporting guidelines [Source 1.4].
Regulatory Basis Information is derived from official government documents, including Summary of Product Characteristics (SmPC) and FDA/NIH DailyMed Prescribing Information [Source 1.2, 2.3].
Context-of-Use Safety Notes Monitoring for GI toxicity is noted as being required in susceptible patients, particularly older adults, in the initial stages of treatment [Source 1.2].

Resulting Safety Structure

Regulatory safety summary:

  • The adverse reaction profile defines effects primarily impacting the Nervous and Gastrointestinal Systems, with frequencies ranging from Common to Very Rare.
  • Official warnings prioritize the most critical safety issues, specifically GI bleeding/ulceration and the risk of Reye's Syndrome in pediatric populations.
  • Use is formally restricted in certain clinical situations, such as late pregnancy, severe hepatic/renal impairment, and co-administration with other NSAIDs.

Connection to the overall safety profile:

This structured regulatory information formally defines the risk profile by categorizing effects by system and frequency, clearly distinguishing minor, expected events from serious, explicitly warned-against conditions. The official safety constraints restrict the medicine's use in specific patient populations and contexts to mitigate known risks documented by health authorities.

Overdose and Emergency Response

Overdose Scope: Officially Documented Manifestations

The official overdose profile for the Acetylsalicylic Acid (ASA) and Caffeine combination is defined by severe systemic risks, primarily from salicylate toxicity. Documented clinical manifestations of overdose include tinnitus (ringing in the ears), hyperpnea (rapid or deep breathing), vomiting, dizziness, and advancing confusion. Overdose affects the Central Nervous System, respiratory, and metabolic systems, with potentially life-threatening outcomes such as metabolic acidosis, seizures, and ventricular arrhythmias.

Overdose Classifications and Emergency Action

Classification Regulatory Status
Severity Effects range from moderate intoxication to severe or life-threatening outcomes.
Antidote Information No specific antidote is known for salicylate toxicity.
Procedural Measures Management involves symptomatic and supportive treatment, including activated charcoal administration and urine alkalinization to enhance elimination in severe cases.

Resulting Overdose Structure

Regulatory instructions mandate that individuals must seek emergency medical attention at once or contact a Poison Control Center immediately upon any suspicion of overdose, regardless of the presence of outward symptoms. Hospital monitoring and support are essential for correcting metabolic and respiratory disturbances. A population-specific risk noted in labeling is the association between ASA use in children and teenagers with viral illness and the potential for Reye's syndrome.

Therapeutic Uses of Cortal

What Cortal Treats: Main Uses and Benefits

The Acetylsalicylic Acid (ASA) and Caffeine combination is relevant as a combination analgesic for supportive symptomatic relief across several acute pain and discomfort domains in adults and adolescents. The therapeutic role of this combination is recognized across clinical domains for supporting the management of acute pain and fever.

The combination is commonly used to help with symptoms related to episodic tension-type headaches, acute migraine attacks, muscle ache, toothache, minor arthritis pain, and cyclical discomforts like menstrual cramps. It is applied in contexts where additional support for symptom management is needed due to pain and minor inflammatory discomfort. The fixed-dose combination structure supports an augmented therapeutic effect, which is relevant for conditions that present with disruptive symptom manifestations or require heightened symptomatic support. Use in this domain helps maintain a sense of comfort during the symptomatic phase.


Quick Facts (Therapeutic Focus)

Focus Area Symptom Management
Primary Goal Supportive symptomatic relief of pain and fever
Key Conditions Episodic headaches, acute migraine attacks, musculoskeletal aches
Main Benefit Supports maintenance of functional stability

Eligibility and Restrictions for Use

Official Eligibility and Contraindication Status

Cortal (a combination of Acetylsalicylic Acid and Caffeine) is subject to strict eligibility rules based on regulatory guidelines, defining the populations who can or cannot use the medicine.

Populations Excluded (Contraindications)

The medicine is formally contraindicated and must not be used by individuals with certain high-risk conditions, as officially documented. These include:

  • Known hypersensitivity or allergy to Acetylsalicylic Acid (ASA), Caffeine, or any other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).
  • Severe organ failure, specifically advanced renal, hepatic, or uncontrolled cardiac failure.
  • Active or a history of serious gastrointestinal conditions, such as peptic ulcer disease or gastrointestinal bleeding/perforation related to previous NSAID use.
  • Pre-existing haemorrhagic disorders or other clinically significant bleeding/clotting issues.
  • Women who are 30 weeks gestation or later in pregnancy (third trimester).

Age-Related and Conditional Eligibility

Population Group Regulatory Status Constraint Context
Children & Adolescents (<16 years) Not Recommended Risk of Reye's syndrome is officially associated with ASA, particularly during viral infections.
Older Adults Use with Caution Increased risk for adverse effects, notably gastrointestinal bleeding and perforation.
Pregnancy (20 to 30 weeks) Restricted Use Use should be limited to the lowest effective dose for the shortest duration possible, if necessary.
Organ Impairment (Moderate) Use with Caution Caution is advised in patients with mild to moderate hepatic or renal function impairment.

Official documents state that adults and adolescents aged 16 years and over are the standard labeled populations for use. The regulatory profile explicitly restricts use in groups with high physiological risk, such as those with severe organ failure, and defines special caution for the elderly and those with specific comorbidities.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation for Cortal, which contains Acetylsalicylic Acid (ASA) and Caffeine, defines several interaction-related constraints across pharmacokinetic and pharmacodynamic domains. The co-component, Caffeine, is officially documented to increase the maximum plasma concentration (Cmax) of salicylate (the active metabolite of ASA), a pharmacokinetic interaction that affects overall exposure.

Pharmacodynamic risk reinforcement is a major factor: co-administration with Anticoagulants (e.g., Warfarin) is associated with an enhanced risk of bleeding due to the anti-platelet effect of ASA. Similarly, combining with Alcohol (Ethanol) significantly increases the officially documented risk of gastrointestinal bleeding. Use with other CNS Stimulants may lead to excessive stimulation.

Regulatory Restrictions and Contraindications

Classification Interacting Substance/Condition Official Regulatory Status
Formal Contraindication Third Trimester of Pregnancy Prohibited due to documented risk of fetal harm.
Formal Contraindication Viral Infection in Children/Teens Prohibited due to the risk of Reye's syndrome.
Risk Modification Caffeine-Containing Beverages Restriction to limit use to avoid excessive CNS stimulation.
Exposure Impact Methotrexate Elimination is decreased, leading to enhanced toxicity.
Population Note Severe Hepatic or Renal Insufficiency Avoidance of use is officially advised.

Mechanism of Action

The action of Cortal is a coordinated pharmacodynamic mechanism achieved through two distinct components targeting complementary biological pathways. The resulting physiological modification is a function of both peripheral eicosanoid pathway modulation and central receptor antagonism.


Irreversible Enzyme Inhibition and Pain Signaling

The primary mechanism involves Acetylsalicylic Acid (ASA), which functions as an irreversible inhibitor of the Cyclooxygenase (COX) enzymes (COX-1 and COX-2). This molecular action blocks the conversion of arachidonic acid into eicosanoid signaling molecules that sensitize peripheral nociceptors and influence hypothalamic thermoregulation. Prostaglandin synthesis suppression alters the response threshold of peripheral nociceptors and modulates the hypothalamic set-point.


CNS Receptor Antagonism and Adjuvant Effect

The secondary, complementary mechanism is driven by Caffeine, which acts as a non-selective antagonist at adenosine receptors (A1 and A2A) in the central nervous system (CNS). This CNS receptor antagonism modulates pain perception pathways and causes cerebral vasoconstriction. Caffeine’s action contributes to the synergism of the combination, facilitating a coordinated systemic physiological modification by coupling ASA's peripheral mechanism with an effect that modulates central pain perception pathways.

Dosage and Administration Information

How to Use Cortal

Cortal, a fixed-dose combination of Acetylsalicylic Acid (ASA) and Caffeine, is designed exclusively for oral administration as a tablet or capsule. Usage of this medicine follows standardized prescribing guidelines, focusing solely on acute, as-needed use.


Official Dosing and Frequency

The standard adult dosing regimen is established for individuals aged 16 years and over. The usual unit dose is one to two tablets (corresponding to approximately 325 mg to 650 mg of ASA). This single dose may be repeated every four to six hours as required for symptomatic relief.

The maximum intake in a 24-hour period is strictly limited; total intake must generally not exceed 4000 mg of ASA or a total of 8 tablets (depending on specific strength) in 24 hours. The medicine is utilized under the principle of the lowest effective dose for the shortest duration necessary.


Administration Contexts and Restrictions

For proper administration, the medicine must be swallowed whole with water. Official guidance advises that the medicine be taken with or immediately after food to help mitigate gastrointestinal discomfort. Due to its caffeine content, users are instructed to limit the concurrent intake of additional caffeine-containing products.

Cortal is intended only for acute, short-term use. Guidelines for self-medication specify a limit of 10 days for pain or 3 days for fever. Furthermore, this medicine must not be given to children under 16 years of age, unless specifically directed by a healthcare professional.

Recent Clinical Evidence

Research Evidence Overview: Acetylsalicylic Acid and Caffeine

Evidence for Acute Migraine Attacks and Tension Headaches

Research has extensively explored the Acetylsalicylic Acid (ASA) and Caffeine combination in conditions characterized by fluctuating or episodic manifestations, specifically acute migraine attacks and episodic tension-type headaches (TTH). The research base includes randomized controlled trials (RCTs), where the combination was evaluated in adults experiencing these episodes. These studies primarily focused on outcomes describing episodic or acute changes, such as the time it takes for participants to report being pain-free or the reduction in the overall severity of discomfort.

Studies examined the combination alongside an inactive substance (placebo) to observe and describe symptom patterns. Studies monitored patient-reported outcomes describing perceived discomfort and outcomes reflecting daily functioning or activity level. Across multiple trials, the measured patterns were examined for differences compared to the inactive substance.

The Research on Caffeine's Adjuvant Role

The fundamental principle was studied for the combination is the adjuvant effect of Caffeine—how its inclusion may alter the performance of the analgesic component, ASA. This question was evaluated in short-term comparative studies across various acute pain models. Research examined the combination against the single analgesic agent (ASA) alone to see if adding Caffeine was associated with differences in measured pain relief.

The research describes patterns where the inclusion of Caffeine alongside an analgesic was associated with measured changes in symptom intensity over a defined period in some studies. These patterns were observed in trials that focused on outcomes related to physical discomfort and changes in pain intensity. The evidence contributes to the broader evidence landscape regarding combination analgesics.

Long-Term Research and Follow-up Durations

The vast majority of high-quality evidence is relevant in trials assessing short-term or episodic symptom patterns. In these studies, follow-up durations were limited, typically lasting only a few hours to observe the immediate response to a single dose. This research primarily explores short-term symptom changes following administration.

Consequently, long-term effects are not fully established through the gold-standard RCT design. Data for how the combination might affect the overall frequency of migraine attacks or the chronicity of TTH are often derived from observational settings evaluating daily-life functioning. There is limited information for long-term outcomes from controlled, extended-duration trials.

Frequently Asked Questions (FAQ)

Common questions about Cortal (FAQ)

Q: Is Cortal safe for children under 16 years old?

Official regulatory documents state that Cortal must not be given to children under 16 years of age unless its use is specifically directed by a healthcare professional. This restriction is due to the documented risk of Reye's syndrome associated with Acetylsalicylic Acid (ASA) in children and teenagers, particularly in the context of certain illnesses.


Q: Can I drink alcohol while taking Cortal?

Official product information advises caution regarding alcohol consumption. Using this medicine with Alcohol (Ethanol) significantly increases the documented risk of gastrointestinal bleeding. The official product information clarifies this enhanced safety risk.


Q: How long does it take for Cortal to start working?

Regulatory documents do not state a specific time for the onset of action for an individual user. Studies and official information indicate that the combination is formulated for rapid action. The available research has evaluated the time it takes for study participants to report changes in pain levels following administration, though individual response times vary.


Q: Is there a risk of becoming dependent or addicted to Cortal?

Cortal is intended only for acute, short-term use. While the product information for this combination does not contain specific dependency warnings, regulatory documents do note that the chronic use of combination analgesics, defined as 10 or more days per month, may worsen headaches. The medicine is intended to be used only within the official short-term administration context.

How should Cortal be stored and disposed of?

The storage and disposal of Cortal (a combination analgesic) must strictly follow regulatory instructions to ensure product stability and safety.

Official Storage Requirements

Item Requirement (Official Statement Only)
Temperature Requirements Store at Controlled Room Temperature, typically 20 C to 25 C (68 F to 77 F).
Protection Conditions Must be protected from moisture and excessive heat to prevent the breakdown of the Acetylsalicylic Acid component.
Container Rules Keep the medicine in its original container and the container must be kept tightly closed.
Child Safety Must be stored out of the sight and reach of children.

Official Disposal Requirements

The preferred method for discarding unused or expired product is via a drug take-back program or an authorized collector. The medicine must not be flushed down the toilet or poured into a sink. If a take-back program is unavailable, non-flushable medicines may be mixed with an undesirable substance (like coffee grounds or cat litter) and sealed in a container before being placed in the household trash, in accordance with regulatory guidelines.

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

Available in countries:

Equivalent of Cortal found in:

A-Z Index: