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Antidol 15

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Antidol 15

Antidol 15_EN

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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 Antidol 15

Property Description
Active ingredient Paracetamol and Codeine
Form Oral tablet, capsule, or soluble tablet
Pharmacological class Opioid/Non-opioid Analgesic Combination; Antipyretic
General purpose Relief of mild to moderate pain and reduction of fever
Origin Synthetic (Paracetamol) and Semi-synthetic (Codeine)

What Type of Medicine is Antidol 15?

Antidol 15 is defined as a fixed-dose combination (FDC) medicine, which is classified under the broad group of opioids in combination with non-opioid analgesics. Its primary formulation is designed to serve the general therapeutic purpose of providing enhanced relief for mild to moderate pain and reducing fever. The combination of codeine and paracetamol is used for acute pain management, where the combined ingredients are intended to achieve a reduction in short-term pain intensity.

What is the Composition and Form of Antidol 15?

The composition of Antidol 15 integrates two active pharmaceutical ingredients: Paracetamol (Acetaminophen) and Codeine (typically as the phosphate hemihydrate salt). Paracetamol is a synthetic p-aminophenol derivative, while Codeine is a semi-synthetic derivative of an opium alkaloid and is classified as an opioid analgesic. This combination product is typically prepared as an oral dosage form, most commonly supplied as a tablet or capsule, and is intended for the oral route of administration.

How Does the Codeine-Paracetamol Combination Work?

The efficacy of Antidol 15 stems from its dual action, wherein each component targets the pain response using a different mechanism. Codeine acts centrally, altering the pain threshold, while Paracetamol acts primarily by inhibiting the chemical synthesis of prostaglandins that mediate pain signals, providing both pain and fever reduction. This combined strategy is designed to deliver a synergistic effect, meaning the overall pain relief is greater than the simple sum of the individual components' effects. This mechanism supports the use of Antidol 15 in situations requiring robust symptomatic relief.

Regulatory References

  1. NICE Guideline on Codeine and Paracetamol for Acute Pain
  2. MedlinePlus (NIH) Information on Acetaminophen and Codeine

What side effects are possible with Antidol 15?

Possible Side Effects and Safety Information for Antidol 15

Antidol 15, a combination medicine containing paracetamol (acetaminophen) and codeine phosphate, carries safety risks primarily related to the effects of its active ingredients on the liver and respiratory system.

Key serious adverse reactions include life-threatening respiratory depression (slow or shallow breathing), which is most critical during treatment initiation or dose increase, and severe liver damage or failure, typically linked to exceeding the recommended dose or concurrent use of alcohol.

Safety Restrictions and Contraindications

  • Duration of Use: This medicine should not be taken for more than three consecutive days to limit the risk of codeine dependence and medication-overuse headache.
  • Concomitant Use: It must not be taken with other medicines containing paracetamol or codeine. Co-administration with sedatives (e.g., benzodiazepines) is strongly cautioned against due to the severe risk of profound sedation, respiratory depression, coma, and death.
  • Contraindications: Use is contraindicated in patients with severe liver or kidney failure, acute respiratory depression, or known hypersensitivity to the components.

Population-Specific Safety Considerations

  • Children and Adolescents: The medicine is not recommended for children under 12 years of age. Codeine is also restricted in adolescents (12–18 years) with existing respiratory impairment (such as severe lung disease or obstructive sleep apnea) due to increased risk of morphine toxicity.
  • High-Risk Patients: Caution and monitoring are required for elderly, frail patients, or those with existing conditions like asthma (avoid during acute attacks), head injuries, chronic liver disease (especially alcoholic liver disease), or a history of substance abuse.

Patients should immediately stop the medicine and seek emergency medical attention if symptoms such as confusion, severe drowsiness, slow or shallow breathing, or persistent nausea and vomiting occur.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with Antidol 15 is governed by the combined, distinct toxicities of its two components: the potential for acute respiratory depression from Codeine and the risk of delayed hepatic failure from Paracetamol.

Documented Manifestations:

Early signs may include nausea, vomiting, and excessive sweating. Signs of opioid toxicity can manifest as profound somnolence, miosis (pinpoint pupils), and critically slow or shallow breathing. The most severe outcome from the paracetamol component is hepatic necrosis, which is a life-threatening complication that may present with signs of liver injury, such as jaundice, after the initial symptoms subside.

Required Emergency Actions:

Immediate medical attention must be sought in all cases of suspected overdose, even if no initial symptoms are present, due to the documented risk of delayed, severe liver damage. Contacting emergency services is specifically required if signs of severe opioid toxicity occur, such as respiratory arrest, profound confusion, or coma.

Mandated Management:

Regulatory documents confirm the administration of specific antidotes: N-acetylcysteine for paracetamol toxicity and Naloxone for reversing opioid effects. Treatment often involves hospital observation, continuous monitoring of vital signs, and blood testing to assess plasma drug concentration and liver function.

Therapeutic Uses of Antidol 15

What Antidol 15 Treats: Main Uses and Benefits

Antidol 15 is generally considered relevant for managing symptoms related to physical discomfort and supporting relief for elevated body temperature. The combination is commonly used to help with mild to moderate pain in contexts marked by increased discomfort or tension.

The medication is applicable within clinical settings that involve acute or disruptive symptom patterns, such as severe toothache, episodic migraine headache, and significant musculoskeletal pain. It also helps address localized discomfort like back pain, muscle pain, and period pain (dysmenorrhea), and provides supportive relief for pain associated with concurrent fever from the cold or flu.

Applied in scenarios where additional management of discomfort is required, the medication contributes to easing the overall symptom load when symptoms interfere with daily functioning. It offers symptomatic relief that supports general well-being during symptomatic phases.

Quick Fact: Relief for Moderate Pain
Symptom Category: Symptoms related to heightened physiological activity and physical discomfort.
Key Scenarios: Post-dental procedures, acute musculoskeletal episodes, and pain accompanied by fever.
Patient Benefit: Provides support that helps ease the overall symptom burden.

Regulatory References

  1. NIH MedlinePlus Drug Information overview

Eligibility and Restrictions for Use

Eligibility Profile: Who Can and Cannot Use Antidol 15?

This section summarizes the official eligibility status for Antidol 15 (Codeine/Paracetamol 15 mg/500 mg) based on authoritative government regulatory documentation.

Antidol 15 is contraindicated (must not be used) in several populations due to the risks associated with codeine, specifically:

  • Children under 12 years of age for all indications.
  • All breastfeeding women.
  • Individuals known to be CYP2D6 ultra-rapid metabolisers of codeine, due to the risk of life-threatening toxicity.
  • Paediatric patients (0–18 years) who have undergone tonsillectomy or adenoidectomy for obstructive sleep apnoea.
  • Patients with severe hepatic or severe renal impairment or respiratory depression.

Restricted or Conditional Use:

  • Adolescents (12 to 18 years) are eligible only for acute moderate pain that is not relieved by non-opioid analgesics alone.
  • The elderly and patients with underlying conditions such as chronic alcoholism, head injuries, or compromised respiratory function require special caution and may be advised against use. The safety and efficacy for all children under 12 is not established.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents define the interaction profile of Antidol 15, focusing on potential metabolic and pharmacodynamic conflicts. Co-administration is contraindicated with Monoamine Oxidase Inhibitors (MAOIs), or within 14 days of stopping MAOI treatment, and with certain Mixed Agonist/Antagonist Opioid Analgesics (e.g., buprenorphine, nalbuphine), which could reduce analgesic effectiveness.

Pharmacokinetic and Pharmacodynamic Interactions

Interaction Type Interacting Substances/Classes Documented Effect on Exposure Regulatory Note
Metabolic CYP2D6 Inhibitors (e.g., quinidine, paroxetine) Decreases active metabolite (morphine) plasma concentration. May result in reduced analgesic efficacy.
Metabolic CYP3A4 Inducers (e.g., rifampin, phenytoin) Decreases codeine and morphine levels. Potential for decreased efficacy.
Pharmacodynamic CNS Depressants (e.g., benzodiazepines, alcohol) Additive depressant effects. Risk of profound sedation and respiratory depression.

Co-use with alcohol is explicitly restricted due to the high risk of severe CNS and respiratory depression. The paracetamol component necessitates caution with Warfarin (anticoagulants), as prolonged co-administration may require a reduction in the anticoagulant dosage. Furthermore, substances that decrease gastric emptying may decrease paracetamol absorption, while agents like Metoclopramide are documented to increase its absorption. Population-specific cautions note an increased risk of respiratory depression in elderly, frail, or debilitated patients, and those with severe hepatic or renal impairment.

Mechanism of Action

Central Modulation of Pain and Temperature Signals

Antidol 15's mechanism begins with the paracetamol component, which acts as an inhibitor of cyclooxygenase (COX) enzymes primarily within the central nervous system (CNS). This reduces the synthesis of the mediator, prostaglandin E2 ( PGE2), directly in the brain and spinal cord, influencing the body's thermoregulation and central nociceptive pathways.

mu-Opioid Receptor Agonism for Signal Blockade

The codeine component requires metabolism into the active substance, morphine, which then acts as an agonist on the central mu-opioid receptors (mu- OR). By engaging this system, the drug directly interferes with and inhibits the transmission of pain signals up the spinal cord, which contributes to central analgesia and concurrent suppression of the cough reflex.

Complementary Dual-Mechanism Analgesia

The drug leverages a synergistic dual-mechanism, combining paracetamol's central chemical modulation of PGE2 with morphine's direct neuronal blockade via mu- OR agonism. This approach targets nociception at multiple, independent points within the CNS, leading to dual-pathway modulation of the body's pain signaling dynamics.

Dosage and Administration Information

How to Use Antidol 15

Antidol 15 (Paracetamol/Codeine 500 mg/15 mg) is administered via the oral route as a tablet, capsule, or soluble form. The medication is used on an as-needed (PRN) basis for pain relief, rather than a continuous fixed schedule.

Standard Dosing and Administration

Instruction Detail
Route of Administration Oral route only.
Unit Dose 1 to 2 tablets or capsules (containing 500 mg Paracetamol and 15 mg Codeine per unit).
Frequency and Timing May be taken up to four times per day, with a minimum interval of 4 to 6 hours between doses.
Maximum Daily Dose Do not exceed 8 tablets (which corresponds to 4000 mg of paracetamol) in a 24-hour period.
Course Duration Use for acute pain is generally restricted to a maximum of 3 consecutive days without specific medical review.

Administration Context and Adjustments

Standard tablets and capsules are typically swallowed whole with water. Soluble tablets require complete dissolution in a glass of water before ingestion. Administration may occur with or without food. Use of the codeine component is contraindicated in children under 12 years of age. Furthermore, a reduced dose or extended interval (e.g., 8 hours) is often utilized for older adults or patients with existing liver or kidney impairment. If a dose is missed, the next dose is only taken if required and the minimum 4-to-6-hour interval has passed, ensuring the daily maximum is not exceeded.

Recent Clinical Evidence

Research evidence / Overview of studies for Antidol 15

Evidence for Use in Mild to Moderate Acute Pain

Research has explored its application in populations with mild to moderate acute pain. The evidence base includes systematic reviews and pooled analyses of numerous randomized controlled trials (RCTs). These studies were used in research examining short-term or episodic symptom patterns, particularly in adult populations experiencing acute discomfort following events like dental procedures or minor surgery.

The outcomes research examined were participant-reported changes in short-term pain intensity and the time measurement related to the need for supplemental pain medication. Research explored patterns observed when the combination was studied against paracetamol used alone in examining the time to recurrence of discomfort.

Research on Symptom Relief and Fever Reduction

Antidol 15 is relevant in trials assessing short-term symptom patterns associated with elevated body temperature. Research related to the paracetamol component has examined outcomes linked to temporary changes in elevated body temperature. The main research concentration for the combination remains on the study of pain symptoms associated with fever.

Long-Term Studies and Follow-Up Duration

The research base for the paracetamol and codeine combination is concentrated on acute pain models. This means follow-up durations were typically very limited, often assessing single-dose performance over a period of a few hours. This concentration on episodic and short-term changes means that information for long-term outcomes is limited. The evidence derived from these settings provides context for acute, temporary pain relief but does not determine whether an individual will respond similarly over continuous or repeated long-term use.

Research Gaps and Areas of Uncertainty

Research highlights that certain factors introduce variability and uncertainty into the findings. Due to natural genetic variation in the population, individuals convert codeine into its active form at different rates. This variability was associated with patterns of differing patient-reported outcomes. The evidence is derived from single-dose, controlled settings, and there is a research gap concerning the broader effects of this medicine on long-term functional outcomes or activity level. The current research provides context but not individual predictions, and long-term effects are not fully established.

Key Studies & References Codeine - StatPearls (General Pharmacological Context and Special Populations)

Frequently Asked Questions (FAQ)

Common questions about Antidol 15 (FAQ)

Q: What are the common side effects of this medication?

A: According to the official product information and clinical studies, the most commonly reported adverse reactions associated with Antidol 15 include reactions such as nausea and headache. Regulatory documents contain a full list of all observed side effects, which can be found in the 'Possible side effects and safety information' section of the leaflet.

Q: Can I drink alcohol while taking this medicine?

A: Official warnings in the regulatory documents indicate that avoiding or limiting alcohol consumption is advisable while using Antidol 15. This is due to the potential for the medicine to increase the risk of specific central nervous system effects, such as dizziness or increased drowsiness, when combined with alcohol.

Q: How should I store this medication?

A: The official product labeling provides specific storage instructions. Antidol 15 is generally intended to be stored at controlled room temperature, typically between 20 C and 25 C (68 F and 77 F). The labeling indicates that the medication should be protected from moisture, direct heat, and light.

Q: Does this medication cause weight gain?

A: Studies and official information list weight gain as an adverse reaction reported in connection with Antidol 15. This reaction has been observed in clinical trials or during post-marketing surveillance, with a reported frequency that is indicated as common or uncommon.

Q: Is this medicine safe to use for children under 12?

A: According to the authorized prescribing information, Antidol 15 is not indicated or studied for use in children under 12 years of age. The patient information leaflet contains details regarding the specific age groups for which this medicine has been approved and its appropriate usage.

Q: What should I do if I miss a dose?

A: The official product instructions describe a procedure for missed doses: if a dose is missed, taking it as soon as it is remembered is indicated. If it is nearly time for the next scheduled dose, skipping the missed dose is advised. The information explicitly cautions against taking a double dose to compensate for the missed one.

How should Antidol 15 be stored and disposed of?

How to Store and Dispose of Antidol 15

Official regulatory guidelines define specific conditions for storing and disposing of Antidol 15, which contains codeine.

Storage Requirement Official Regulatory Condition
Temperature Store at a temperature not above 25°C
Protection Keep in the original package to protect from light and moisture
Child Safety Must be kept out of the sight and reach of children

Storage above the maximum temperature may compromise stability. Due to the presence of an opioid, secure storage is mandated. The preferred method for disposing of unused or expired Antidol 15 tablets is returning them to an authorized drug take-back program. If a program is unavailable, follow specific household trash disposal procedures, ensuring the tablets are mixed with an undesirable substance, sealed, and personal information is removed from the label.

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

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