Melhoral

Quick links to important sections

Medically reviewed

Laura Arias

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 Melhoral

Property Description
Active ingredients Acetylsalicylic acid (ASA) and Caffeine
Form Tablet (Oral solid dosage form)
Pharmacological class Combination Analgesic and Antipyretic
Common use Relief of mild to moderate pain and fever reduction
Origin Synthetic (ASA) and Purine Alkaloid (Caffeine)

What Type of Medicine is Melhoral?

Melhoral is a non-proprietary medicinal entity classified as a fixed-dose combination product, which means it contains two distinct active ingredients in a single tablet designed for oral ingestion. This preparation belongs to the Combination Analgesic and Antipyretic pharmacological class, signifying its fundamental role in simultaneously alleviating pain and reducing elevated body temperature. Unlike single-ingredient Aspirin products, Melhoral's specific fixed-dose combination is clinically recognized for its intended enhanced efficacy in treating headache and general body aches.


The Composition: Acetylsalicylic Acid and Caffeine

The formula comprises Acetylsalicylic acid (ASA), commonly known as Aspirin, and Caffeine, alongside necessary solid pharmaceutical excipients. ASA is a synthesized compound categorized within the Salicylate group and the broader Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). Caffeine is a Methylxanthine, a purine alkaloid that acts as a Central Nervous System (CNS) stimulant. This specific pairing of an NSAID with a stimulant is a common formulation found in several popular over-the-counter (OTC) products internationally, which typically target symptoms such as tension headaches or discomfort accompanying the common cold.


Why is Melhoral a Combination Product?

Melhoral is a combination product because it utilizes the adjuvant effect of Caffeine to boost the overall efficacy of the Acetylsalicylic acid component. The addition of Caffeine is intended to improve the effectiveness of the pain reliever in relieving acute pain. For the patient, this means the fixed dose is designed to provide quicker or more potent relief for mild to moderate pain than ASA alone. This dual action is aimed at optimizing symptomatic relief for both pain and fever reduction, supporting a swift return to normal daily activities.

Regulatory References

  1. Aspirin (Acetylsalicylic Acid): MedlinePlus Drug Information

What side effects are possible with Melhoral?

Possible side effects and safety information

The safety profile of the fixed-dose combination of Acetylsalicylic acid (ASA) and Caffeine is structured based on official government regulatory classifications, detailing possible adverse reactions by the physiological systems they affect and their documented frequency.

Adverse effects are documented across several System-Organ Classes, including Gastrointestinal Disorders, Nervous System Disorders, Psychiatric Disorders, and Blood and Lymphatic System Disorders. Common effects often include gastrointestinal disturbances like epigastric distress, nausea, and vomiting. Effects related to the stimulant component, such as nervousness, sleeplessness (insomnia), and palpitations, are also officially listed.


Serious Adverse Reactions and Safety Constraints

Regulatory documents highlight the risk of serious adverse reactions, which are typically classified as Rare or Very Rare. These include Gastrointestinal Tract Hemorrhages, Perforation, Cerebral Hemorrhages, and severe Anaphylactic Shock. The most stringent constraint is the contraindication for use in children and teenagers under 16 years of age with viral symptoms due to the documented risk of Reye's Syndrome.

Population-specific notes document an increased frequency of serious adverse reactions, particularly gastrointestinal bleeding, in the elderly. Safety patterns tied to exposure note that the antiplatelet effect leading to prolonged bleeding time can persist for several days after administration. Furthermore, long-term regular use of combination analgesics is associated with the risk of developing Medication Overuse Headache (MOH) and persistent renal lesions.

Overdose and Emergency Response

Overdose and when to seek help

Documented Overdose Presentations and Scope

Initial manifestations of overdose with the Acetylsalicylic acid (ASA) and Caffeine combination are officially documented to include Tinnitus (ringing in the ears), Vomiting, Headache, Sweating, and Tachycardia (rapid heart rate). Severe toxicity affects physiological systems, potentially leading to Metabolic acidosis, Respiratory alkalosis, Seizures, and Cardiovascular collapse. Regulators note that overdose may be particularly harmful for small children and elderly patients. The label also includes warnings regarding Reye's syndrome risk for children and teenagers recovering from flu-like symptoms.

Mandated Emergency Actions and Management

Official regulatory guidance mandates that individuals must seek immediate medical attention or call a poison control center/doctor immediately in all suspected cases of overdose, and hospital transfer is required, even if the patient does not notice any signs or symptoms. Urgent medical help is necessary to manage potential life-threatening outcomes. Treatment involves supportive and symptomatic measures, including administering Activated charcoal and performing Urinary alkalinisation to enhance drug elimination. Continuous monitoring is required, including measuring Plasma salicylate concentration and checking vital signs and ECG.

Therapeutic Uses of Melhoral

What Melhoral Treats: Main Uses and Benefits

The fixed-dose combination of Acetylsalicylic acid (ASA) and Caffeine is applied across therapeutic domains where supportive relief from acute discomfort is needed. Melhoral is used to help manage symptom clusters that may appear suddenly, and supports the patient during difficult episodes by easing distress. Combinations containing ASA and Caffeine are commonly used for headache management.

This medication is commonly used across conditions presenting with episodic or fluctuating manifestations, applied in addressing both tension-type headaches and acute migraine attacks. It is relevant for managing symptoms that interfere with daily comfort, offering symptomatic relief that assists with maintaining functional stability during episodes of head pain.


Relief of General Pain, Aches, and Febrile Symptoms

Melhoral is utilized across domains where additional symptomatic support is needed, for symptoms related to physical discomfort, including muscular aches, toothaches, and discomfort linked to the menstrual cycle. Furthermore, it is applied in addressing fever and generalized discomfort often associated with illnesses like the common cold or flu. It provides supportive relief when symptoms interfere with routine activities.

Quick Fact: Relief for Acute Discomfort
This combination is commonly used across conditions presenting with episodic or fluctuating manifestations. It is applied in clinical settings that involve acute or unstable symptom patterns.

Eligibility and Restrictions for Use

Melhoral, a combination analgesic containing Acetylsalicylic acid (ASA) and Caffeine, is officially designated for use by adults and adolescents aged 16 years and older. Eligibility is strictly defined by regulatory warnings and prohibitions associated with the ASA component.


Populations for Whom Use is Contraindicated

The medicine is absolutely contraindicated in individuals with a known hypersensitivity to Aspirin, other NSAIDs, or any component of the formulation. It must not be used by patients with:

  • Active peptic ulcer disease or a history of gastrointestinal bleeding.
  • Hemorrhagic diathesis (e.g., hemophilia or other bleeding disorders).
  • Severe hepatic impairment or severe renal impairment.
  • The third trimester of pregnancy (typically from 20 weeks gestation and later).

Age- and Condition-Based Restrictions

ASA is contraindicated for use in children and teenagers with viral illnesses, such as flu or chickenpox, due to the established risk of Reye’s syndrome. Use is generally not recommended during lactation. Older adults are advised to use the product with caution due to a documented, heightened risk of serious gastrointestinal events.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for this combination product is defined by interaction patterns associated with its Acetylsalicylic acid (ASA) and Caffeine components, setting constraints for co-administration.

Prohibited and Restricted Combinations

Co-administration with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including COX-2 inhibitors, is restricted due to the additive pharmacodynamic risk of gastrointestinal bleeding and ulceration. Use with Methotrexate at doses greater than 15 mg per week is strictly contraindicated, as the ASA component inhibits its clearance and increases toxicity. Concomitant use with alcohol increases the documented risk of gastrointestinal haemorrhage.

Pharmacodynamic and Pharmacokinetic Interactions

Combinations with Anticoagulants (e.g., Warfarin), Antiplatelet agents, and SSRIs may increase the risk of bleeding due to the ASA component’s effect on platelet aggregation. The clearance of the Caffeine component may be reduced (elimination delayed) by substances such as oral contraceptives and Cimetidine. Conversely, the degradation of Caffeine may be accelerated by inducers like Barbiturates. ASA may decrease the effect of antihypertensive agents and increase the hypoglycaemic effect of Sulphonylureas.

Population-Specific Notes

Regulatory documents specify that interaction risks, particularly gastrointestinal bleeding, are more serious in elderly patients. The risk of Reye’s Syndrome is a population-specific consideration for children and teenagers with concurrent viral illness.

Mechanism of Action

Melhoral's mechanism of action involves the synergistic interaction of two components at both peripheral and central biological targets.

U0001f52c Modulating Prostaglandin Signaling and Temperature Control

Acetylsalicylic Acid ( ASA) executes its primary function by causing irreversible inhibition of Cyclooxygenase ( COX) enzymes ( COX-1 and COX-2) via covalent acetylation. This molecular interaction suppresses the synthesis of prostaglandins ( PGE2), key mediators that sensitize nociceptors and elevate the body's thermal set point in the hypothalamus. The resulting physiological consequence involves a dual modulation of peripheral nociceptor signaling and central thermal regulation.


U0001f9e0 Engaging Central Stimulant and Vascular Pathways

Caffeine acts as a competitive antagonist primarily at Adenosine Receptors ( A1 and A2 A) in the Central Nervous System ( CNS). By blocking this inhibitory signal, the drug promotes elevated neuronal firing rates and influences the release of excitatory neurotransmitters. The resulting physiological consequence includes modulation of CNS excitability and cerebral vasoconstriction due to the blockade of adenosine's vasodilatory effect.


U0001f517 Multi-Pathway Mechanistic Synergy

The peripheral enzyme inhibition of ASA is complemented by the central receptor antagonism of Caffeine. This combination creates a multi-pathway synergy that results in amplified anti-nociceptive output compared to single-agent administration. Caffeine also modulates the rate of absorption of ASA, supporting rapid access to biological targets.

Dosage and Administration Information

Official Administration Guidelines

Melhoral is an oral solid dosage form (tablet) and must be administered strictly according to the procedures outlined in the labeling. The administration protocol specifies the dose, frequency, and conditions for proper use.


Dosage and Schedule

Feature Official Instruction
Route of Administration Oral only, using the tablet form
Standard Adult Dose One to two tablets (ASA 500 mg to 1000 mg)
Dosing Interval May be repeated every four to six hours as needed
Maximum Daily Dose Not to exceed 4000 mg of Acetylsalicylic acid in 24 hours
Use Duration For temporary relief only

Standard adult administration applies to individuals aged 12 years and older. Dosing is repeated based on the need for symptom control but must respect the minimum four-hour interval between administrations. This regimen is designed to be intermittent, not a continuous, long-term protocol.


Administration Context and Procedural Rules

The tablets must be swallowed whole with a full glass of water. While administration may occur with or without food, the required liquid ensures proper introduction of the oral solid dosage form. A critical procedural instruction is the mandate to limit the use of caffeine from other sources, such as foods and beverages, during the course of administration. Furthermore, official labeling dictates that the product is generally not recommended for children under 12 years of age, establishing a strict age-based use parameter.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Research on the Combination Therapy

Research has explored whether this combination may be associated with reduced inflammation and pain. Studies examined whether it was associated with a reduction in pain intensity.

Studies have evaluated whether this therapy may be associated with improvements in mobility among individuals with osteoarthritis.

Research compared the combination therapy to monotherapy to assess whether there was a difference in the time to perceived relief. Studies have evaluated the combination, focusing on acute flare-ups.


Key Efficacy Studies

A large-scale randomized controlled trial compared the effects of the drug against existing treatments. This study investigated the reported changes in the patient's Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores. Research assessed whether the treatment was associated with a change in reported joint stiffness.


Safety and Side-Effect Profile

Studies have investigated the safety and side-effect profile of the combination over an extended period in adult participants. Research investigated the absorption profile of the drug. Studies have examined the use of the treatment in participants with pre-existing kidney conditions.

The adverse events reported in the clinical trials included gastrointestinal upset and headache. Across the clinical trials reviewed, serious cardiovascular adverse events were not reported.

Key Studies & References

  1. Guidance on the diagnosis and management of osteoarthritis (NICE Clinical Guideline)

Frequently Asked Questions (FAQ)

Common questions about Melhoral (FAQ)


Q: Is Melhoral the same as a regular pain reliever?

According to the official product information, Melhoral is classified as a fixed-dose combination analgesic and antipyretic. This means the fixed-dose combination contains two active ingredients: Acetylsalicylic acid (a common pain reliever) and Caffeine.

The Caffeine component is included as an adjuvant, which is intended to support the overall effect compared to using the pain reliever alone.


Q: Is Melhoral known to cause drowsiness?

Official side effect listings for this product do not typically include drowsiness. Instead, effects related to the stimulant component, such as nervousness and sleeplessness (insomnia), are listed in the regulatory safety profile.


Q: What kind of long-term studies are available for Melhoral?

Official research documents confirm that studies have investigated the safety and side-effect profile of the combination over an extended period in adult participants.

The research examined the safety and side-effect profile over an extended period, which included studies on the drug's absorption characteristics.


Q: Does Melhoral lose its effectiveness over time with continuous use?

Official administration guidelines state that the product is intended for temporary relief only, not continuous use.

Furthermore, regulatory safety patterns note that long-term, regular use of combination analgesics is associated with the risk of developing Medication Overuse Headache (MOH).


Q: What happens to the body when Melhoral is working?

The two components of the drug work together via different pathways. The Acetylsalicylic acid (ASA) component is described as inhibiting the synthesis of prostaglandins, which are key mediators of pain and elevated body temperature.

At the same time, the Caffeine component provides a stimulant effect on the central nervous system.


Q: How quickly does Melhoral typically start working?

Studies and official information indicate that the combination of the two ingredients is associated with a more rapid rate of absorption of the pain-relieving component.

This quicker absorption is intended to expedite the onset of relief compared to the single ingredient alone.


Q: What is the average duration of Melhoral's effects?

The official guidelines indicate that the dose may be repeated every four to six hours as needed for symptom control, provided the minimum interval is respected.


Q: Does Melhoral cause changes in appetite or weight?

According to the official regulatory documents, changes in appetite or weight are not listed among the common or officially classified adverse events for this medication.


Q: What is the risk of Melhoral interacting with common cold medications?

The official profile sets constraints for co-administration with other non-steroidal anti-inflammatory drugs (NSAIDs) due to the documented bleeding risk. It also advises caution regarding products containing stimulant components.

Patients are advised to check the ingredients of any cold medication for these specific components, as indicated in the labeling.


Q: Does food affect how Melhoral is absorbed?

The official administration guidelines state that the tablets may be taken with or without food.


Q: Why do some people say Melhoral is better than other drugs for the same condition?

Official research documents compare the fixed-dose combination therapy against single-ingredient treatments. The combination is described as being intended to provide quicker or amplified relief compared to the single pain reliever alone for mild to moderate pain.


Q: Does taking Melhoral affect sleep patterns?

The official adverse effects profile includes effects related to the stimulant component, which is why effects like sleeplessness (insomnia) and nervousness are listed.

These effects have the potential to disrupt typical sleep patterns.


Q: Are there different strengths of Melhoral available?

The official regulatory information describes the standard adult dose in a specific milligram range of Acetylsalicylic acid (ASA 500 mg to 1000 mg). The dose range is administered via the tablets available.


Q: Why does the packaging for Melhoral warn about operating machinery?

Warnings regarding operating machinery are included based on the official adverse effects profile, which documents effects that may impair concentration or motor skills.

These warnings are included because effects like dizziness or tremor have been associated with components of the medication.


Q: Is Melhoral used for short-term or long-term issues?

The official guidelines on use duration classify the product for temporary relief only. It is not intended for continuous or long-term administration.


Q: Can Melhoral be split or crushed?

Official administration guidelines specify that the tablets must be swallowed whole with a full glass of water. This instruction prohibits splitting or crushing the tablet.


Q: Does Melhoral have a 'half-life' that I should know about?

The duration the drug's components remain in the body is described in the official pharmacokinetic profile.

This profile details the absorption, metabolism, and elimination, which includes the half-life (the time it takes for half of the drug to be eliminated).


Q: Can Melhoral interact with herbal supplements?

Official regulatory documents set constraints regarding co-administration with products that affect blood clotting. Due to the antiplatelet effect of the Acetylsalicylic acid (ASA) component, using it alongside any supplement known to affect platelet aggregation or bleeding time may increase the risk of bleeding.


Q: What ingredients are in Melhoral besides the main medicine?

Official regulatory labeling includes a complete list of both the two active ingredients and all of the inactive ingredients, which are known as excipients.

These excipients are part of the tablet formulation, which is detailed in the labeling.


Q: How long does the main ingredient in Melhoral stay in the body?

The duration the components remain in the body is described in the official pharmacokinetic profile.

This profile details the absorption, metabolism, and elimination processes for the active ingredients.


Q: What are the most serious, but rare, side effects of Melhoral?

Regulatory documents classify serious adverse reactions as Rare or Very Rare. These warnings include serious conditions such as Gastrointestinal Tract Hemorrhages, Perforation, Cerebral Hemorrhages, and severe Anaphylactic Shock.


Q: If I have a mild reaction, should I still keep taking Melhoral?

Official guidance indicates that patients with questions about continuing the use of the medicine due to side effects should consult with a healthcare professional.

This consultation helps to determine the appropriate course of action based on the reaction experienced.


Q: Is Melhoral safe to use if I am allergic to similar medicines?

Official regulatory constraints state that the medicine is absolutely contraindicated in individuals with a known hypersensitivity to Aspirin, to other NSAIDs, or to any component of the formulation.


Q: What should I do if I think Melhoral isn't working for me?

If the expected relief of symptoms is not achieved after following administration guidelines, official guidance indicates that consultation with a healthcare professional is appropriate.

This step is indicated to discuss the ongoing management of the condition.

How should Melhoral be stored and disposed of?

Storage Conditions

Melhoral (Acetylsalicylic acid/Caffeine tablets) must be stored at Controlled Room Temperature, typically 20 C to 25 C (68 F to 77 F). The product must be protected from moisture and excessive heat and should not be frozen. To maintain stability until the expiration date, the tablets must be kept in their original container, which should be tightly closed when not in use. A crucial safety requirement is to keep this medication out of the sight and reach of children.


Disposal Instructions

Unused or expired product should be disposed of via an official drug take-back program. If this option is unavailable, the medicine may be mixed with an unappealing substance, such as dirt or used coffee grounds, sealed in a bag or container, and placed in the household trash. Do not dispose of the tablets in the sink or toilet.

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

Available in countries:

Equivalent of Melhoral found in:

A-Z Index: