Caffetin

Quick links to important sections

Caffetin

Selected form

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 Caffetin

Caffetin is a combined analgesic drug intended for the symptomatic relief of mild to moderate discomfort, functioning as a non-prescription pain and fever reducer. Its fundamental identity is defined by the synergistic action of its four distinct active pharmaceutical ingredients.


Quick Facts

Property Description
Active Ingredients Paracetamol, Propyphenazone, Caffeine, Codeine
Form Tablet or Film-coated tablet
Pharmacological Class Analgesics and Antipyretics; Combined Analgesic Drug
Common Use Relief of mild to moderate pain and fever
Origin Synthetic combination product

Identity and Classification

Caffetin is classified as a Combined Analgesic Drug, which belongs to the broader pharmaco-therapeutic group of Analgesics and Antipyretics. This specific formulation is indexed under the Anatomical Therapeutic Chemical (ATC) code N02BE51, confirming its status as a paracetamol combination. This medicine is defined as a combination product, distinguishing it from single-agent preparations that rely on only one compound for a therapeutic effect. The general purpose is to address discomfort and elevated body temperature associated with common pain types, such as headache or muscle aches. This multi-compound strategy is clinically recognized for providing enhanced pain relief compared to its individual components alone.


Composition and Action Principles

The preparation is composed of four synthetic active ingredients, listed by their International Nonproprietary Names (INN): Paracetamol, Propyphenazone, Caffeine, and Codeine (as codeine phosphate sesquihydrate). Paracetamol is used for its analgesic and antipyretic effects. The overall structure utilizes two primary pain relievers and two adjuvants. The inclusion of Caffeine is utilized for its adjuvant effect to enhance the pain-relieving efficacy of the primary components; the addition of caffeine to standard analgesics is intended to improve pain relief. This means the mixture is effective in easing discomfort by boosting the action of the main pain-relieving agents. The medicine is manufactured in a solid dosage form—a tablet or film-coated tablet—intended for oral administration and systemic action. Concurrently, the Codeine component further contributes by modifying the central nervous system's perception of pain, ensuring the overall action provides comprehensive relief for mild to moderate discomfort.

Regulatory References

  1. Caffeine as an analgesic adjuvant for acute pain in adults (PMC)

What side effects are possible with Caffetin?

Possible Side Effects and Safety Information

This section summarizes the adverse effects and safety characteristics of this combined analgesic drug based strictly on official governmental regulatory product information (SmPC, FDA Labels, or equivalent). The classification and terminology reflect the official grouping of effects by System Organ Class (SOC) and frequency.


Officially Documented Adverse Reactions

The potential for adverse reactions is classified by their observed incidence in clinical use:

  • Common Reactions (May affect up to 1 in 10 people): Primarily impact the Nervous System and Gastrointestinal System. Manifestations include sedation, dizziness, nausea, and constipation.
  • Uncommon/Rare Reactions: May involve Hypersensitivity Reactions (e.g., skin rash), Blood and Lymphatic System disorders (e.g., agranulocytosis), or impacts on the Hepatobiliary System (e.g., elevated liver enzymes).
  • Frequency Not Known: This classification is often applied to reactions related to long-term use, such as drug dependence, withdrawal syndrome, and Medication Overuse Headache (MOH).

Serious Safety Constraints

Official labeling highlights severe risks, reflecting the complexity of a multi-component analgesic:

  • Serious Adverse Reactions: Life-threatening risks include Hepatotoxicity (severe liver damage) associated with the paracetamol component, and Respiratory Depression associated with the codeine component, particularly upon initiation or dose increase.
  • Time- and Duration-Related Patterns: The risk of physical and psychological dependence is a documented safety concern linked specifically to the long-term use of the codeine component.
  • Population-Specific Restrictions: The medication is officially contraindicated in several groups, including children under 12 years of age, individuals who are CYP2D6 ultra-rapid metabolizers, and patients with severe hepatic or renal impairment.

Overdose and Emergency Response

Overdose and When to Seek Help

An overdose of this combined analgesic is associated with serious and potentially fatal outcomes, reflecting the combined toxicities of its four components. Immediate medical attention is mandated by regulatory authorities following any suspected overdose, even if symptoms are not immediately apparent, due to the critical risk of delayed, severe liver damage.


Documented Clinical Manifestations

Initial manifestations often include paleness, nausea, vomiting, and abdominal pain. More severe presentations involve the central nervous system and cardiorespiratory function. These include extreme sleepiness, respiratory depression (slowed or difficult breathing), tachycardia (rapid heartbeat), confusion, muscle tremors, and convulsions.


Severe Outcomes and Management

The most severe regulatory-documented outcomes are fatal respiratory depression (linked to the Codeine component) and delayed hepatic failure (linked to the Paracetamol component), which may progress to coma or cardiac arrest. For emergency response, specific pharmacological antidotes are available: Acetylcysteine is used to manage the Paracetamol toxicity, and the opioid antagonist Naloxone is used to rapidly reverse severe respiratory depression caused by Codeine. Hospital monitoring of vital signs and laboratory testing of serum drug levels are required regulatory procedures. Increased risk of life-threatening respiratory depression is documented for children and the elderly.

Therapeutic Uses of Caffetin

What Caffetin Treats: Main Uses and Benefits

Caffetin is a combined analgesic drug commonly used to provide symptomatic relief for mild to moderate pain and reduce fever. This medication is applied across domains where additional symptomatic support is needed to address discomfort that may interfere with daily functioning.


Key Therapeutic Applications

This medication is generally used to help manage symptoms related to physical discomfort in various contexts. It is commonly used across conditions presenting with acute episodes such as tension-type headaches, discomfort during migraine episodes, and localized pain like a toothache. It plays a role in managing symptoms related to physical discomfort, helping to address general muscle pain (myalgia), pain associated with nerve pathways (neuralgia), and the predictable, cyclical discomfort of menstrual pain (dysmenorrhoea).

“Applied in scenarios where short-term symptomatic assistance is needed, the medication supports patients during difficult episodes by easing distress.”

Additionally, it assists with easing symptoms related to systemic imbalance by reducing fever and supports general well-being during symptomatic phases. Applied in contexts involving heightened systemic burden, the support provided helps patients cope more steadily with these episodes, contributing to easing the overall symptom load.

Quick Fact: Relief for Episodic Discomfort
Typical Use: Used to help with Pain (headache, muscle ache, toothache) and Fever associated with acute or recurrent episodes.
Patient Benefit: Provides supportive relief when symptoms interfere with routine activities.

Regulatory References

  1. Health Canada's Drug and Health Product Register

Eligibility and Restrictions for Use

Who Can and Cannot Use Caffetin?

Caffetin's eligibility is strictly governed by regulatory warnings and contraindications related to its active ingredients, specifically codeine and paracetamol.

Population Status Eligibility Rule
Allowed Use Approved for adults (18+ years) and adolescents ge 12 years for short-term, acute moderate pain not relieved by other single-agent analgesics alone.
Absolute Contraindications Prohibited for children younger than 12 years and all breastfeeding women. Use is also contraindicated in patients with severe hepatic or renal impairment, individuals identified as CYP2D6 ultra-rapid metabolizers, those with acute respiratory depression, or known hypersensitivity to any component.

The medicine is contraindicated in adolescents (under 18) who are recovering from tonsillectomy or adenoidectomy for sleep apnoea.

Use requires special caution and restricted prescribing in patients with pre-existing conditions such as non-severe hepatic or renal dysfunction, chronic alcoholism, or a history of drug dependence. Official documents also advise caution for older adults and patients with decreased respiratory reserve, chronic constipation, head injury, or raised intracranial pressure. During pregnancy, use is generally restricted and permitted only if clearly needed.

What should I know about interactions with other medicines?

The interaction profile for Caffetin, a combined analgesic drug, is structured by official regulatory documentation focusing on metabolic pathways, pharmacodynamic effects, and contraindications related to its four components.

Pharmacokinetic and Metabolic Interactions

Co-administration with CYP2D6 inhibitors (e.g., fluoxetine) is documented to increase Codeine plasma concentration while simultaneously decreasing the active metabolite morphine concentration, potentially resulting in reduced analgesic efficacy. Conversely, certain hepatic microsomal enzyme inducers (e.g., rifampicin, phenytoin) may enhance the hepatotoxicity risk associated with the Paracetamol component. Specific substances like Chloramphenicol have their elimination prolonged five-fold by Paracetamol. For the timing of administration, regulatory documents note that Colestyramine should not be taken within one hour of the Paracetamol component if maximal analgesic effect is required.

Pharmacodynamic and Substance Restrictions

The official profile includes a severe restriction against co-administration with Monoamine Oxidase Inhibitors (MAOIs), which is classified as a contraindicated combination requiring a 14-day separation period. A strong pharmacodynamic reinforcement occurs with Central Nervous System (CNS) depressants, including alcohol, which must be avoided due to the documented risk of profound sedation and respiratory depression. The Paracetamol and Propyphenazone components may also potentiate the effects of oral anticoagulants, increasing the risk of bleeding. The use of the Codeine component is formally contraindicated in children under 12 years of age and in individuals identified as ultra-rapid CYP2D6 metabolizers.

Mechanism of Action

Caffeine acts primarily through the non-selective antagonism of adenosine receptors A1 and A2 A within the central nervous system. Further mechanistic action includes the modulation of smooth muscle contractility via phosphodiesterase (PDE) inhibition, which elevates intracellular levels of cyclic AMP (cAMP). This interaction also induces cerebral vasoconstriction by blocking A2 receptors on cerebral vasculature.

Propyphenazone inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis. This inhibition reduces the local concentration of PGE2 and other pro-inflammatory mediators in peripheral tissue.

Paracetamol acts within the central nervous system to inhibit prostaglandin synthesis, a process potentially involving COX isozymes and modulation of descending serotonergic pathways. The antipyretic action is achieved specifically by inhibiting the synthesis of PGE2 within the hypothalamus, thereby resetting the body's thermoregulatory set-point.

Dosage and Administration Information

How to Use Caffetin — Administration Guidelines

This section describes usage parameters, detailing the administration route, dosing, and schedule.

Administration and Dosing

The route of administration is oral. The dosage regimen is specified according to age group and is intended for short-term use.

Population Single Dose Minimum Interval Max Daily Dose
Adults & Adolescents (16 years and older) 1 tablet (Max 2 tablets) 4 to 6 hours 8 tablets
Adolescents (12 to 15 years) 1 tablet 4 to 6 hours 4 tablets (for specific cold/flu formulations)
Children (< 12 years) Not recommended N/A N/A

Preparation and Procedural Rules

Preparation requirements vary by product form:

  • Film-coated tablets must be swallowed whole, typically with liquid.
  • Effervescent tablets must be dissolved completely in half a glass of water before administration.

Caffetin may be taken with or without food. Administration must not exceed the maximum dose limits or the required 4-to-6-hour interval. The maximum duration of administration is generally 3 days for fever or 4 days for pain; continued use beyond this period requires consultation with a healthcare professional.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Mechanism of Action Studies

Initial research focused on how the compound may affect certain biological targets, such as a specific neurotransmitter. This line of inquiry explored the compound’s potential role in influencing nerve signal transmission. Research focused on establishing whether this process may be associated with changes in the perception of pain.


Studies on Acute Pain Management

Research focused on examining patient outcomes in studies addressing acute pain. These trials often used standardized pain rating scales over a short period. Specifically, some studies reported that changes in measured parameters were evident during the initial 30 minutes post-administration in some trial participants. These investigations aimed to describe the compound's profile in the immediate post-treatment phase.


Studies on Chronic Pain and Long-Term Use

Long-term studies examined whether participants experienced a continued decrease in chronic pain markers over time. These trials tracked patient-reported measures over six months or more. The studies primarily aimed to collect data on long-term tolerability and safety rather than establishing definite causality in pain reduction.


Safety and Tolerability Data

This compound was investigated in clinical trials, and the data collected addressed its tolerability. Common adverse events noted in the trials included temporary dizziness and mild gastrointestinal discomfort, which researchers often described as short-lived.

  • Discontinuation Research: Studies examining the compound's discontinuation described that participants underwent a gradual dose reduction schedule to manage observed withdrawal effects. The research does not offer guidance on clinical practice but describes the observed outcomes.
  • Cardiovascular Findings: Clinical trials documented that participants with pre-existing heart conditions experienced certain adverse events at a higher rate; this information is part of the overall safety data.

Combination Therapy Research

Research also explored the compound’s possible interaction with specific cellular targets. Research has also explored the use of the compound alongside physical therapy, but the findings do not establish a definite conclusion regarding combined effects. The compound has been investigated in populations where standard approaches were not utilized or did not yield desired results, but the evidence is not conclusive.

Overall, the collective body of research to date has been descriptive of the compound's profile.

Frequently Asked Questions (FAQ)

Common questions about Caffetin (FAQ)

Q: How long does the primary effect of Caffetin typically last in the body?

Official dosing instructions specify that the minimum time between taking doses is generally 4 to 6 hours. This interval is established in regulatory documents to guide appropriate use and help prevent over-dosing, rather than being a guarantee of effective symptom relief duration.

Q: What should a patient look for if they suspect they have taken too much Caffetin?

If an overdose is suspected, official product information describes signs to look for, such as blurred vision, changes in consciousness, severe sleepiness, or a rapid/irregular heartbeat. These symptoms indicate that immediate medical attention is necessary.

Q: Can Caffetin affect blood pressure readings?

Official clinical data indicates that the use of this medicine may be associated with increased blood pressure (hypertension) and a faster heart rate (tachycardia) in some users. For individuals with pre-existing heart or blood pressure conditions, professional guidance is important.

Q: How does Caffetin compare to a generic version of the same ingredients?

Generic versions that contain the exact same active ingredients are required by regulatory authorities to be bioequivalent to the branded product. This means that a generic product is considered by regulators to be identical in dose, strength, route of administration, and performance.

Q: Are there any specific concerns for people with pre-existing stomach or ulcer issues?

Yes, official regulatory warnings advise that caution is necessary for patients with a history of peptic ulcers. Gastrointestinal issues, including a risk of gastric ulcer, have been documented as possible adverse reactions due to the product's components.

Q: What is the meaning of the term 'acute pain' in the context of Caffetin's use?

When used in the context of drug therapy, acute pain generally refers to pain that is short-term and results from a specific cause, such as injury or illness. Official documents indicate the medicine is intended for this type of pain, which often involves a short treatment period, rather than long-standing chronic pain.

Q: Does Caffetin interact with any medications for cold or flu symptoms?

Official warnings advise against taking Caffetin alongside other medicines that contain Paracetamol or stimulants, which are common ingredients in many cold and flu products. Using them together could lead to an excessive intake of certain ingredients and increase the risk of side effects like restlessness or high blood pressure.

Q: How long before an elective surgery should a person stop taking Caffetin?

The product contains components that can affect blood clotting. General regulatory guidance related to similar drug components often advises stopping use prior to surgery. However, only a healthcare provider can provide the individualized instructions necessary based on the specific procedure and patient history.

Q: Are there restrictions on consuming caffeinated beverages while taking Caffetin?

Yes, official regulatory warnings advise avoiding the excessive intake of caffeine from sources like coffee, tea, and energy drinks. This is because the product already contains caffeine, and exceeding recommended levels may increase the risk of side effects such as restlessness or insomnia.

Q: What official warnings are present regarding the use of Caffetin by people with asthma?

The product is officially contraindicated (prohibited) in patients whose asthma or bronchospasm (sudden tightening of the airways) is known to be triggered by aspirin or other NSAIDs. Caution is advised because bronchospasm may be precipitated in patients with a history of asthma or allergic disease.

Q: Can a patient with diabetes use Caffetin without concerns?

Official regulatory information advises caution for patients with pre-existing conditions, including diabetes. The caffeine component of the medicine can potentially affect blood glucose levels. Professional guidance is advised for use specific to the condition.

Q: What should be done if a patient experiences a new, unusual side effect?

Patients are advised to consult their healthcare provider if they experience any new or unusual adverse event. Official systems also allow patients to voluntarily report the effect directly to their country's drug regulatory agency (e.g., FDA or MHRA) to assist in monitoring drug safety.

Q: What is the average time Caffetin takes to be completely cleared from the body?

The time the components take to be completely cleared from the body is highly variable from person to person. Official information indicates that the rate depends on several factors, including genetics, smoking status, liver function, and other medications being taken. Regulatory information indicates that stating an average time is not feasible due to these variables.

How should Caffetin be stored and disposed of?

How to Store and Dispose of Caffetin

Caffetin must be stored according to the official regulatory instructions to maintain its quality and ensure safety. Store the medicine in a dry place where the temperature remains below 25°C.

Protect the tablets from light and moisture by keeping the blister strips inside the original outer carton. It is essential to keep Caffetin out of the sight and reach of children at all times. Do not use the medicine past the expiry date printed on the packaging.

When disposing of the medicine, do not throw away any unused tablets or expired packaging via household waste or wastewater. To protect the environment, dispose of the medicine by consulting your pharmacist on appropriate take-back programs or local regulations for discarding unused pharmaceutical products.

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

Available in countries:

Equivalent of Caffetin found in:

A-Z Index: