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Omol Extra

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Omol Extra

Omol Extra_L

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 Omol Extra

Quick Facts

Property Description
Active ingredient Paracetamol (Acetaminophen) and Caffeine
Form Tablet (Oral)
Pharmacological class Analgesic, Antipyretic, and CNS Stimulant Combination
Common use Relief of pain and fever
Origin Synthetic Compounds

What Type of Medicine is Omol Extra and How is it Classified?

Omol Extra is a combination analgesic and antipyretic medicine designed for the relief of minor to moderate pain and fever. It is classified as a synthetic combination product that pairs a non-opioid pain reliever with a Central Nervous System (CNS) stimulant. This dual classification reflects its dual mechanism and is a standard formulation for managing common discomforts.

This medication's general purpose is the temporary and effective management of acute discomfort. This is a common solution utilized when a patient needs relief from symptoms like a headache or general aches that may be accompanied by mild fatigue.

Composition, Type, and Form of Omol Extra

The medicine contains two active ingredients: Paracetamol and Caffeine. Omol Extra is an oral medication provided in a solid tablet form. The key differentiating feature of this composition is the inclusion of Caffeine, which functions as an adjuvant (helper ingredient).

The addition of Caffeine to common pain relievers, like Paracetamol, is intended to enhance the proportion of people who achieve good relief from acute pain. This establishes that the unique benefit of Omol Extra lies in the synergy achieved by its components.

What is the Core Benefit of This Combination?

The primary benefit of Omol Extra is its synergistic effect, created by combining a pain-fighting agent with a stimulant. While the Paracetamol component targets the core symptoms of pain and fever, the Caffeine component works to strengthen the overall analgesic effect. This strategic formulation offers enhanced relief by providing both pain-fighting and fever-reducing properties in one single dose, making it a high-value option for general discomfort.

What side effects are possible with Omol Extra?

Possible side effects and safety information

The official safety profile for the Paracetamol and Caffeine combination is structured around the established risks of its two active components, categorized by regulatory bodies based on frequency and affected system-organ classes.

Adverse Reaction Classifications

Side effects are generally categorized into those linked to the Paracetamol component and those linked to the Caffeine component. Certain severe reactions are classified as Very Rare, meaning they occur in fewer than 1 in 10,000 patients. This group includes serious hypersensitivity events, such as anaphylaxis and severe cutaneous reactions like Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), as documented in regulatory labeling. Blood disorders like thrombocytopenia are also considered Very Rare.

Reactions linked to the stimulant properties of Caffeine—including nervousness, palpitation, insomnia, restlessness, and anxiety—are commonly reported but their exact frequency is often officially classified as Not Known, as it cannot be accurately estimated from available data. These effects primarily involve the Nervous System and Cardiac System Organ Classes.

Critical Safety Considerations

Hepatotoxicity (liver damage/failure) is the most critical serious adverse reaction, particularly associated with taking more than the recommended dose. Regulatory constraints explicitly note an increased risk of this serious reaction when the medicine is used with other Paracetamol-containing products or in individuals with hepatic impairment or chronic excessive alcohol consumption. Furthermore, the safety profile notes that severe liver damage may not become apparent until 12 to 48 hours after ingestion of an overdose.

Population Constraints are noted in official labeling. For example, use is generally not recommended during pregnancy due to the caffeine component, and caution is noted for asthmatics sensitive to NSAIDs, who may have an increased risk of bronchospasm.

Overdose and Emergency Response

The official regulatory profile for Omol Extra overdose focuses primarily on the severe, time-dependent toxicity of Paracetamol (Acetaminophen) combined with the acute CNS and cardiac effects of Caffeine.

Overdose Scope

Domain Official Regulatory Statements
Documented overdose presentations Initial symptoms are often absent or non-specific, including nausea, vomiting, and sweating. Later signs of hepatic damage can include jaundice and abdominal pain. The caffeine component may cause tachycardia, anxiety, and seizures [1.1, 1.6].
Physiological systems affected (as stated in label) Overdose risk involves the Hepatic (acute liver failure), Neurological (encephalopathy, seizures), Cardiovascular (cardiac arrhythmias), and Metabolic systems [1.3, 2.7].
Dose-related or exposure-related factors (if applicable) Ingestion of doses exceeding the maximum recommended limit carries the risk of severe liver damage. The efficacy of the antidote is highly dependent on the time elapsed since ingestion [3.2].
Population-specific overdose notes (if applicable) Individuals with factors like chronic alcohol misuse or malnutrition are noted to have an increased susceptibility to severe hepatic injury [1.4].
Emergency-response statements (as written in official documents) Seek immediate medical attention or call Poison Help immediately upon any suspicion of overdose [1.7, 1.2].
When immediate medical help is required (label-derived phrasing only) Required immediately following any known or suspected overdose, regardless of the patient's current symptomatic state [1.7].

Overdose Classifications (High-Level)

Classification Official Regulatory Statements
Severity classification (as defined in official documents) Classified with potential for severe and possibly fatal outcomes, specifically acute liver failure [1.5, 1.6].
Regulatory basis (EMA / FDA / etc.) Based on official labeling and public health warnings from authorities, including the FDA and NIH [1.7, 1.1].
Overdose-context constraints (as defined in official documents) Treatment is constrained by the 8 to 10-hour critical window for optimal effectiveness of the antidote Acetylcysteine [2.3].

Resulting Overdose Structure

Official overdose statements:

  • Overdose carries a risk of delayed but severe acute liver failure and immediate risk of seizures or cardiac events [1.6, 2.7].
  • Immediate medical attention must be sought, and Poison Help should be contacted immediately [1.7].
  • The antidote Acetylcysteine is the specific treatment for toxicity, and it is most effective when administered within 8 hours of acute ingestion [2.1].
  • Management protocols include initial measures like activated charcoal administration and mandatory monitoring of liver function tests and vital signs [1.4, 3.1].

Connection to the overall overdose profile (2–4 sentences): Regulatory documents define the overdose profile by focusing on the time-critical nature of toxicity, necessitating immediate emergency intervention. The documented potential for delayed, catastrophic liver failure requires that medical help be sought following any overdose, even if the patient is currently asymptomatic. The entire regulatory framework directs rapid assessment and procedural measures to implement the specific antidote within the documented treatment window [2.3].

Therapeutic Uses of Omol Extra

The core therapeutic function of Omol Extra is providing symptomatic relief across key domains of discomfort and fever. It is indicated for application in contexts where additional symptomatic support is needed to address mild to moderate pain and fever. The medicine is commonly used to help with symptoms related to physical discomfort, including headache, muscle pain, backache, toothache, and period pain. The medication is designed to provide support that helps ease the overall symptom burden during periods of heightened symptoms.

The medicine is relevant for managing symptom clusters that interfere with daily comfort and is used during phases when symptoms become more noticeable, such as those associated with colds and flu. The medicine assists with maintaining functional stability and contributing to improved symptom management, particularly when facing pronounced symptoms. This supports the patient during difficult episodes by easing the overall symptom load.

Quick Fact: Symptom Management Focus
Primary Target Mild to moderate acute pain and fever
Key Benefit Supports symptom management during episodes
Typical Context Headaches, cold/flu, muscle aches

Regulatory References

  1. Health Products Regulatory Authority (HPRA) overview

Eligibility and Restrictions for Use

Official Eligibility: Who Can and Cannot Use Omol Extra?

The official eligibility profile for Omol Extra (Paracetamol/Caffeine) is strictly defined by regulatory authorities and centers on age, underlying health status, and known allergies.

Contraindicated Populations

This medication is contraindicated (must not be used) in patients with a known hypersensitivity to Paracetamol, Caffeine, or any excipients. Furthermore, Omol Extra is prohibited for use in patients currently taking any other medicinal product containing Paracetamol, to prevent the risk of overdose and subsequent liver damage.

Age and Condition Restrictions

Age Group or Condition Regulatory Status
Children under 12 years Not recommended or Not suitable
Adults (16 years and over) Standard use permitted
Adolescents (12 to 15 years) Permitted but with a restricted maximum daily dose
Pregnancy and Breastfeeding Not recommended
Hepatic or Renal Impairment Use requires caution and professional oversight

Use also requires specific caution in individuals with conditions such as chronic alcoholism, severe malnutrition, or certain metabolic disorders like Gilbert's Syndrome. These restrictions ensure the medicine is only used by populations for whom its safety and eligibility profile has been established.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines documented interaction patterns for the Paracetamol and Caffeine combination, strictly based on government regulatory information.

Interaction Type Specific Interacting Substance Regulatory Outcome Documented
Contraindicated Other Paracetamol-containing products Prohibited due to the risk of exceeding the dose threshold for hepatotoxicity.
Pharmacodynamic Warfarin and other Coumarins Enhanced anticoagulant effect is documented with prolonged regular Paracetamol use.
Pharmacokinetic Probenecid, Isoniazid Reduces Paracetamol clearance, increasing plasma exposure.
Enzyme Induction Phenytoin, Carbamazepine, Rifampicine Accelerate Paracetamol metabolism, increasing the risk of toxic metabolite formation.
Stimulant Effects Sedatives, Tranquilizers Caffeine exerts an antagonistic pharmacodynamic effect against CNS depressants.
Absorption Rate Metoclopramide, Domperidone Accelerate the speed and extent of Paracetamol absorption.
Timing Rule Cholestyramine Reduces Paracetamol absorption, requiring separation of administration.

Interaction Constraints and Substance Restrictions The administration of Paracetamol must be separated from Cholestyramine (at least 1 hour before or 4 hours after) to prevent reduced absorption. Co-administration of Zidovudine (AZT) is cautioned due to increased risk of neutropenia. Furthermore, regular, chronic consumption of alcohol (ethanol) is documented as a risk factor for Paracetamol-induced liver damage, and excessive dietary caffeine should be avoided due to the potential for compounded adverse effects.

Regulatory documents define the product’s interaction profile based on pharmacokinetic modification (e.g., clearance reduction by Probenecid) and pharmacodynamic effects (e.g., enhanced anticoagulant risk). This structure establishes specific constraints, including prohibition of other Paracetamol products.

Mechanism of Action

Central Modulation of Pain and Temperature Signaling

The action involves the Paracetamol component, which modulates processes by inhibiting cyclooxygenase (COX) enzymes, primarily in the central nervous system (CNS). By reducing the synthesis of prostaglandin E2 ( PGE2) in the spinal cord and hypothalamus, the drug modifies core body signals, resulting in the suppression of nociceptive signaling and the promotion of heat loss mechanisms, which adjusts the hypothalamic set point for thermoregulation.

Antagonism of Inhibitory Adenosine Receptors

This mechanism is driven by Caffeine, which functions as a non-selective antagonist on adenosine receptors ( A1 and A2 A) throughout the CNS. By blocking the natural inhibitory effects of adenosine, the drug supports the regulation of other neurotransmitters, resulting in increased central nervous system (CNS) arousal and wakefulness.

Concurrent Modulation of Physiological Systems

The two distinct mechanisms operate concurrently. Caffeine's blockade of adenosine receptors also promotes cerebral vasoconstriction (a decrease in the diameter of blood vessels in the brain), which complements the central analgesic effect of Paracetamol, contributing to the overall effect profile of the combination by modulating both chemical and vascular components of the pain signaling pathway.

Dosage and Administration Information

Omol Extra is a combination medicine explicitly designated for oral administration as a solid tablet. Its application is governed by constraints on dosage, time frequency, and total duration, as established by standard prescribing protocols.

Administration Principles and Dosage

The medicine is supplied in a tablet form containing 500 mg of Paracetamol and 65 mg of Caffeine. The tablets must be swallowed whole with water and should not be chewed. For adults and adolescents aged 16 years and over, the standard single dose is 2 tablets, which is equivalent to 1000 mg of Paracetamol. Doses are administered intermittently, every 4 to 6 hours, as required for symptom management, ensuring that the interval between successive doses is never less than four hours.

The total consumption is specified as limited, with the maximum recommended dose for this group not to exceed 8 tablets (4000 mg Paracetamol / 520 mg Caffeine) in any 24-hour period.

Duration and Specific Population Use

Omol Extra is intended for short-term use. Guidelines indicate that continuous consumption should not extend beyond 3 days. A procedural constraint related to its composition is the requirement to limit the intake of dietary caffeine (e.g., coffee, tea) to avoid exceeding the daily limit provided by the maximum tablet dose.

For younger populations, specific dosage adjustments apply. Children between the ages of 12 and 15 years should receive 1 tablet per dose, with their total daily consumption not exceeding 4 tablets in a 24-hour period. The medicine is not recommended for administration to children under 12 years of age.

Recent Clinical Evidence

Om ol Extra: Recent Clinical Evidence

The evidence for the combination of Paracetamol and Caffeine is based on clinical research, as described in regulatory and scientific literature, that has studied its application in acute symptom contexts. This section summarizes the types of studies conducted and where the current research has limitations.

Evidence for Acute Pain Relief

Research has examined the combination for application in conditions associated with acute pain, such as mild to moderate general pain. The evidence relies on systematic reviews and meta-analyses that consolidate findings from many Randomized Controlled Trials (RCTs). Researchers monitored outcomes related to symptom intensity change and explored the proportion of participants reporting defined levels of symptom change in acute pain models. The research foundation is concentrated on single-dose and short-term evaluation, meaning follow-up durations were limited to acute timeframes of four to six hours. This focus provides limited insight into extended or chronic daily application.

Evidence for Relief of Headaches and Migraines

The combination was evaluated in research for primary headache disorders, including tension-type headache and acute migraine symptoms. Dedicated, multi-centre RCTs have been used to examine outcomes reflecting daily functioning and the measurement of pain intensity. Findings describe patterns related to symptom changes during the short-term observation of primary headache episodes.

Evidence in Specific Patient Populations and Research Gaps

The main body of evidence was observed in a broad group of healthy adult and adolescent patients. Studies have also explored findings in specific pain models like post-operative dental pain and menstrual pain. However, data for certain groups remain insufficient. For instance, few data are available that specifically research examined the application of the combination in older adult populations (e.g., subjects over 65 years of age). Consequently, subgroup findings are uncertain for some demographic areas. The overall evidence highlights that long-term effects are not fully established, as research primarily involves short-term studies.

Key Studies & References HPRA Product Information: Summary of Product Characteristics (SmPC) for combination analgesic (e.g., Panadol Extra/Omol Extra equivalent document)

Frequently Asked Questions (FAQ)

Common questions about Omol Extra (FAQ)

Q: Can Omol Extra be used to treat a fever?

According to the official product information, Omol Extra is indicated for the treatment of pain. The official indications focus on the treatment of pain.

Q: Does Omol Extra contain caffeine?

Yes, official product information indicates that Omol Extra contains caffeine. Caffeine is included in the formulation as a component intended to support the pain-relieving action.

Q: Is Omol Extra suitable for children?

Regulatory documents state that Omol Extra is indicated for use in adults and adolescents over a certain age and weight. Use in younger children is not covered by the official indications for this product.

Q: Can I take Omol Extra if I am pregnant or breastfeeding?

Official information advises that Omol Extra should only be used during pregnancy or breastfeeding if a doctor or pharmacist considers it absolutely necessary. Use is typically advised only when a healthcare professional determines it is absolutely necessary. Any use should follow the guidance to take the lowest effective dose for the shortest possible duration.

Q: What kind of pain can Omol Extra treat?

The official product information states that Omol Extra is indicated for the short-term treatment of moderate pain. This indication includes headaches, migraine attacks, muscle pain, menstrual pain, and dental pain.

Q: How long can I use Omol Extra for pain relief?

According to the official product information, this medicine is for short-term use only. If pain or fever continues for more than three days, consultation with a doctor is recommended.

How should Omol Extra be stored and disposed of?

How to Store and Dispose of Omol Extra

Official regulatory guidelines strictly define the conditions necessary to maintain the stability and safety of Omol Extra tablets. The product must be stored at a temperature below 30 C.

Storage Requirements

  • Protection: The medicine must be protected from both light and moisture, meaning it must be kept in the original container or packaging.
  • Child Safety: It is mandatory to store Omol Extra out of the sight and reach of children.

Disposal Instructions

Expired or unused Omol Extra should be disposed of according to local pharmaceutical waste regulations. The product must not be thrown into wastewater (e.g., flushed down the toilet or poured down the sink).

The preferred method of disposal is returning the medicine to a pharmacist or utilizing a registered drug take-back program.

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

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