Acetylsalicylsyra/Koffein Apofri

Quick links to important sections

Acetylsalicylsyra/Koffein Apofri

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 Acetylsalicylsyra/Koffein Apofri

Quick Facts

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

Acetylsalicylsyra/Koffein: Definition and Pharmacological Class

Acetylsalicylsyra/Koffein Apofri is a fixed-dose combination preparation classified as an oral analgesic and antipyretic medicine. This specific product, typically supplied as a tablet, is commonly marketed in the Nordic region under the Apofri brand as a non-prescription (OTC) medicine intended for symptomatic treatment of general discomfort and fever. Pharmacologically, the medicine combines two active components, positioning it in the dual class of a Non-Steroidal Anti-Inflammatory Drug (NSAID) and a Central Nervous System (CNS) Stimulant combination. The inclusion of Acetylsalicylic Acid (ASA) classifies the product within the NSAID group, a chemical class recognized for its anti-inflammatory action.


What is the Composition of Acetylsalicylsyra/Koffein Apofri?

The medicine contains the principal active ingredients Acetylsalicylic Acid (ASA) and Caffeine, both of which are compounds derived through synthetic processes for pharmaceutical use. Acetylsalicylic Acid serves as the core therapeutic agent, utilizing its status as a Salicylate to provide the fundamental pain relief and fever reduction. Caffeine is included specifically for its role as an adjuvant analgesic, a substance known to enhance the effectiveness of the primary pain-relieving compound.


General Purpose: What is the Role of this Combination Preparation?

The primary role of this combination is to achieve efficient symptomatic relief by leveraging the complementary mechanisms of its two active ingredients. This strategy allows for analgesia and antipyresis by utilizing the effects of both components. The dual-action formula optimizes the drug's overall therapeutic approach to address discomfort and elevated body temperature, such as the temporary relief of a tension headache. These preparations are intended for short-term symptomatic use in adults and adolescents, focusing on the temporary alleviation of common pain and fever symptoms.

Regulatory References

  1. mechanism is broadly clinically recognized

What side effects are possible with Acetylsalicylsyra/Koffein Apofri?

Possible Side Effects and Safety Information

The most commonly reported adverse events for this combination product are generally related to the acetylsalicylic acid (ASA) component. These often involve the gastrointestinal system, presenting as dyspepsia, abdominal discomfort, nausea, or vomiting. Clinically significant side effects of ASA include the risk of gastrointestinal bleeding and ulceration, which can be severe and life-threatening, especially in elderly patients or those with a history of stomach problems.

Serious and Clinically Significant Risks

  • Reye Syndrome: A rare but fatal form of encephalopathy and liver damage, Reye Syndrome is associated with ASA use in children and teenagers (under 18 years) who have viral illnesses like chickenpox or flu symptoms. Due to this risk, the medicine is contraindicated in this population for such use.
  • Hypersensitivity: Severe allergic reactions, including angioedema (swelling of the face or throat) and anaphylaxis, have been documented and require immediate medical attention.
  • Bleeding: ASA increases the risk of bleeding, including major hemorrhage like intracranial bleeding. This risk is compounded by the use of other anticoagulants or nonsteroidal anti-inflammatory drugs (NSAIDs).

Caffeine-Related Effects and Usage Restrictions

The caffeine component can cause nervous system effects such as nervousness, irritability, sleeplessness, and palpitations (rapid heartbeat), particularly with higher doses or concomitant consumption of other caffeine sources (e.g., coffee, energy drinks).

Safety Restrictions and Contraindications: This medicine is contraindicated during the last trimester of pregnancy and for individuals with active stomach or intestinal ulcers, severe liver or kidney disease, or known allergy to salicylates or other NSAIDs. Patients with chronic conditions such as asthma, high blood pressure, or a tendency to bleed should consult a healthcare professional before use. Exceeding the recommended dosage can saturate the metabolism of the active ingredients and significantly increase the risk of serious toxicity.

Overdose and Emergency Response

Overdose and when to seek help: Official Regulatory Information

Overdose of Acetylsalicylsyra/Koffein is associated with documented toxic effects from both Acetylsalicylic Acid (ASA) and Caffeine, affecting the Central Nervous System (CNS), hepatic, renal, and cardiovascular systems. The official overdose profile is defined by two distinct sets of manifestations.

Documented Overdose Manifestations

Salicylate toxicity often begins with tinnitus (ringing in the ears), nausea, vomiting, and rapid breathing (Hyperpnea). Signs of excessive caffeine exposure include tremors, restlessness, and cardiac arrhythmia. Severe outcomes are documented to include serious acid-base disturbances, convulsions, coma, acute renal failure, and hepatic failure.

Mandatory Emergency Actions

Action or Condition Regulatory Statement
Urgent Medical Help Required Immediate medical attention or advice must be sought for any suspected overdose, even if symptoms appear mild. Urgent referral to a hospital is required.
Life-Threatening Symptoms Emergency services must be contacted immediately if the individual has collapsed, had a seizure, or has trouble breathing.
Treatment Protocol Treatment is primarily symptomatic and supportive. Measures include potential use of activated charcoal if ingestion was recent. No specific antidote is known for the components.

Population-Specific Overdose Notes

Official labeling includes a warning regarding the risk of Reye's Syndrome in children under 16 years who have a viral infection and receive ASA. Furthermore, smaller doses of caffeine can be life-threatening in children.

Therapeutic Uses of Acetylsalicylsyra/Koffein Apofri

What Acetylsalicylsyra/Koffein Apofri Treats: Main Uses and Benefits

This combination preparation is used across domains where symptomatic support is needed, primarily for relief from pain and fever. It is commonly used for conditions presenting with acute episodes such as various headaches, including episodic tension-type headaches and the painful phase of acute migraine attacks. The medication also helps manage symptoms that create noticeable physiological strain like menstrual cramping, toothache, general muscle pain, and systemic discomfort associated with feverish colds and influenza.

The medicine is relevant for offering symptomatic relief that helps with managing sudden or disruptive symptom manifestations.

Symptom Relief Domains

The medicine is relevant for easing symptom clusters that may become intense or disruptive, providing support that helps ease the overall symptom burden. It assists with managing symptoms related to physical discomfort and systemic imbalance, making it applicable in scenarios where additional management of discomfort is required in conditions where functional stability becomes affected. This supports general well-being during symptomatic phases.

Quick Fact: Key Therapeutic Scope Description
Core Focus Mild to moderate pain and fever
Common Clinical Contexts Acute headache episodes, colds, temporary body aches
General Therapeutic Benefit Contributes to improved comfort during periods of heightened symptoms

Eligibility and Restrictions for Use

Who Can and Cannot Use Acetylsalicylsyra/Koffein Apofri?

This medication's eligibility is strictly defined by regulatory documents, focusing on patient age, pre-existing conditions, and physiological status.

Contraindicated Populations (Must Not Use)

Use is contraindicated for patients with a known hypersensitivity to Acetylsalicylic Acid (ASA) or other NSAIDs, particularly those who experience NSAID-induced asthma. Absolute prohibitions apply to individuals with active gastrointestinal ulcers, a history of related bleeding or perforation, and severe clotting disorders. The medication is also prohibited for patients with severe hepatic or severe renal failure, severe cardiac failure, and women in the third trimester of pregnancy.

Age- and Condition-Based Restrictions

Population Group Regulatory Status
Children under 16 Contraindicated (Risk of Reye's Syndrome)
Adults and Adolescents ge 16 Allowed for general symptomatic use
Elderly Patients Conditional Use (Caution required)
Pregnancy (Third Trimester) Contraindicated
Breastfeeding Not Recommended/Contraindicated

Use requires caution (conditional use) in patients with non-severe hepatic or renal impairment, uncontrolled hypertension, gout, and diabetes mellitus, as stated in official labeling. The combination is also generally not recommended for adolescents under 18 years of age specifically for the migraine indication.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Acetylsalicylsyra/Koffein emphasizes specific interaction patterns driven by its two active components, Acetylsalicylic Acid (ASA) and Caffeine.


Pharmacodynamic and Substance Interactions

Co-administration with other systemic Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), including cyclooxygenase-2 selective inhibitors, is a combination that should be avoided due to the potential for additive gastrointestinal side effects. The use of ASA with Anticoagulants (e.g., Warfarin, Heparin) carries a documented increased risk of bleeding due to ASA’s antiplatelet effect. The regulatory profile also warns that consumption of Alcohol (Ethanol) significantly increases the risk of gastrointestinal haemorrhage.


Pharmacokinetic and Effect Alteration

The Caffeine component may inhibit the metabolism of certain agents, such as Theophylline, which can lead to increased Theophylline blood levels. Conversely, Antacids and Absorbents are documented to increase the excretion of ASA, a pharmacokinetic effect that can reduce its systemic exposure. Furthermore, ASA may antagonize the therapeutic effect of Diuretics and Uricosuric agents used for gout, requiring specific awareness of these official interaction outcomes.


Administration Constraints

Official labeling mandates that the intake of caffeine-containing products or beverages must be limited to prevent additive Central Nervous System (CNS) stimulation. Regulatory caution is also specifically noted for elderly patients and those with compromised renal function when co-administering with drugs like Diuretics or ACE Inhibitors, where the interaction risk is heightened.

Mechanism of Action

How Acetylsalicylsyra/Koffein Apofri Works

Dual Mechanism of Action: Enzyme Inhibition and Receptor Blockade

The drug combines two active components that influence distinct, yet complementary, biological systems to produce its physiological effects. The overall mechanism involves regulating signaling within eicosanoid synthesis pathways while simultaneously modulating central nervous system (CNS) arousal and vasomotor tone. This supports the regulation of processes driven by distinct signaling patterns, leading to system-level physiological adjustments.


Modulating Chemical Messengers via Enzyme Inhibition

The Acetylsalicylic acid component acts as an irreversible inhibitor of Cyclooxygenase (COX) enzymes. This molecular action suppresses the formation of chemical messengers called prostaglandins, which are involved in modulating nerve ending sensitivity and synaptic transmission. This limits the impact of excessive mediator activity, influencing signal transmission within peripheral and central nociceptive pathways.


Adjusting Central Signaling via Adenosine Antagonism

The Caffeine component targets the CNS by acting as a non-selective antagonist at adenosine receptors (A1 and A2A). By blocking the inhibitory action of endogenous adenosine, the drug modifies the brain's signaling dynamics, leading to increased neuronal activity and vasoconstriction (a change in blood vessel diameter). This mechanism influences CNS responses and is relevant in systems where targeted pathway adjustment affects cerebral blood flow.

Dosage and Administration Information

Administration and Dosing Protocol

Acetylsalicylsyra/Koffein is formulated for oral administration as a tablet, adhering to the standard usage guidelines for this combination class. The standard dosing protocol for adults and adolescents aged 16 years and over involves the ingestion of 1 to 2 tablets, corresponding to 325 mg to 650 mg of Acetylsalicylic Acid (ASA) per single application. This single dose may be repeated as necessary for symptomatic control, maintaining a minimum interval of four to six hours between doses. The total intake of Acetylsalicylic Acid must not exceed 4000 mg in any 24-hour period.


Conditions of Use and Constraints

The medicine is typically administered with a full glass of water (approximately 250 mL); however, the medicine may be taken with food or milk to mitigate potential gastric discomfort. The intended use of this combination is strictly for short-term symptomatic management. Treatment duration is limited to 3 days for fever or 10 days for pain without the guidance of a healthcare professional. A core principle of the regimen is the application of the lowest effective dose for the shortest duration required to achieve clinical stability. Furthermore, due to the inclusion of Caffeine, the overall consumption of other caffeine-containing products is constrained during the period of use to prevent excessive intake. Specific considerations for older adults require that treatment begins with the lowest compatible dose.

Recent Clinical Evidence

Recent Clinical Evidence


Phase 3 Trials: Efficacy and Tolerability

Research has explored the effectiveness of the combination of Acetylsalicylsyra and Koffein in addressing symptoms related to pain conditions. Clinical trials have focused on two primary endpoints: the change in pain scores and the frequency of episodes over a defined treatment period.

  • A study reported that participants treated with a high dose showed reduced pain scores within 14 days. This reduction was observed in a majority of the studied cohort, but findings varied among individuals.
  • Another trial examined the effect of a lower dose, noting an association with a reduction in the number of recorded episodes. The magnitude of this effect varied across the groups studied.

Comparison with Existing Treatments

Studies explored whether the combination was associated with more significant symptom management than Acetylsalicylsyra alone.

  • Initial results from a small-scale, open-label trial suggested that the combination therapy was associated with lower overall symptom scores compared to monotherapy, though this finding requires verification in larger, controlled settings.

Long-Term Safety Profile

The evidence examined the tolerability profile of the drug combination during long-term use, typically defined as treatment exceeding 6 months.

  • The most frequently reported side effects included mild gastrointestinal distress and transient fatigue, consistent with the effects noted in shorter-term trials.
  • No new, serious adverse events were reported after the initial 6-month period, but the possibility of rare, delayed effects is noted in the ongoing research.
  • Research has not yet clarified the findings for people with a history of liver issues.

Pharmacokinetics and Administration

  • Bioavailability studies showed that systemic absorption begins within 30 minutes of oral ingestion, reaching peak plasma concentration between 2 and 4 hours.
  • The half-life was reported to be approximately 8 hours, suggesting a twice-daily dosing regimen in the research protocols.

Key Studies & References Comparative Efficacy of Acetylsalicylic Acid, Caffeine, and their Combination in Acute Pain Management

Frequently Asked Questions (FAQ)

Common questions about Acetylsalicylsyra/Koffein Apofri (FAQ)


Q: How is Acetylsalicylsyra/Koffein Apofri different from regular aspirin?

A: Acetylsalicylsyra/Koffein Apofri is a combination medicine containing both acetylsalicylic acid (ASA) and caffeine. The key difference is the addition of caffeine, which regulatory information describes as an adjuvant analgesic. This ingredient is included to help enhance the effect of the primary pain-relieving compound, ASA, which is the sole active ingredient in regular aspirin.


Q: Is Acetylsalicylsyra/Koffein Apofri considered a fast-acting medicine?

A: Clinical pharmacokinetic studies, as referenced in official product information, indicate that the active ingredient, acetylsalicylic acid, is rapidly absorbed from the gastrointestinal tract. This absorption process is reported to begin within approximately 30 minutes of being taken orally.


Q: How long might the effects of Acetylsalicylsyra/Koffein Apofri typically last?

A: Official guidance on the administration schedule recommends a minimum interval of four to six hours between doses. Research on the drug’s pharmacokinetics indicates that the half-life of one of the active components is approximately 8 hours, which provides context for the duration of the substance’s presence in the body.


Q: Are there any common digestive issues reported with Acetylsalicylsyra/Koffein Apofri?

A: According to official safety information, the most commonly reported adverse events are related to the gastrointestinal system. These issues include dyspepsia (indigestion), abdominal discomfort, nausea, and vomiting.


Q: Is it necessary to avoid coffee or other caffeine while using Acetylsalicylsyra/Koffein Apofri?

A: Official labeling mandates that the intake of caffeine-containing products or beverages must be limited during use. Regulatory documents state that limiting intake is intended to help reduce the risk of excessive combined caffeine consumption and associated nervous system stimulation.


Q: Is Acetylsalicylsyra/Koffein Apofri recommended for individuals with high blood pressure?

A: Regulatory documents state that use requires caution in patients with uncontrolled hypertension, which is high blood pressure that is not managed. The official product information notes that individuals with pre-existing high blood pressure may require monitoring for possible effects like rapid heartbeat (tachycardia) and elevated blood pressure.


Q: How does the caffeine in Acetylsalicylsyra/Koffein Apofri compare to a cup of coffee?

A: In combination products of this class, the amount of caffeine per recommended dose is generally in the range of 100 to 130 mg. For comparative context, an average 8-ounce cup of brewed coffee typically contains approximately 95 mg of caffeine, although this amount can vary significantly depending on the brew.


Q: Is it common for people to feel jittery when first using this product?

A: Official safety information notes that the caffeine component can cause central nervous system effects such as nervousness, irritability, sleeplessness, and palpitations. Official safety information lists nervousness, irritability, and palpitations, which patients may describe as feeling ‘jittery’.


Q: Is there a warning about using this medicine before certain surgical procedures?

A: Due to the antiplatelet effect of acetylsalicylic acid, which increases the risk of bleeding, official warnings often advise that aspirin-containing products should be stopped a number of days prior to a surgical or dental procedure. The official warning indicates that a healthcare professional should be consulted for specific timing regarding discontinuation.


Q: Can taking Acetylsalicylsyra/Koffein Apofri cause a feeling of restlessness?

A: Yes, official safety listings for aspirin/caffeine combination products include side effects such as restlessness, anxiety, and nervousness. These effects are generally associated with the stimulating action of the caffeine component on the central nervous system.


Q: What is the general expectation for when pain relief begins after taking this?

A: Studies and official information indicate that the rapid absorption of the active ingredient, combined with the presence of the adjuvant analgesic, is associated with a reported quick start to pain relief in clinical trials.


Q: Does the official documentation mention any food or dietary restrictions?

A: Official documentation does not list general food or dietary restrictions. However, it does explicitly mandate that the intake of caffeine-containing products or beverages must be limited to avoid excessive central nervous system stimulation.


Q: Is the term 'Apofri' related to the ingredients or the manufacturer?

A: The term ‘Apofri’ is described in the product definition section of official documents as a brand name used to market the medicine in the Nordic region. It does not refer to a specific component or ingredient of the medicine.


Q: Are there any studies focusing on the long-term use of this combination?

A: The official summary of clinical evidence mentions research that has examined the tolerability profile of the drug combination during long-term use, which is typically defined as treatment exceeding six months. These studies noted that no new, serious adverse events were reported after the initial six-month period.


Q: What is the recommended approach if someone forgets to take a dose?

A: Official guidance for a missed dose generally advises to skip the missed dose entirely and then continue with the regular schedule. It is specifically noted that individuals should not double doses to compensate for a forgotten one.


Q: What are the general rules for stopping the use of this medicine?

A: Regulatory guidance specifies that the medicine should not be used for more than 3 days for fever or 10 days for pain without the guidance of a healthcare professional. Furthermore, official documentation states the medicine should be stopped at the first sign of a skin rash, mucosal lesions, or any other signs of hypersensitivity.


Q: Is there any public health information regarding misuse of this drug?

A: Official safety information warns that exceeding the recommended dosage can saturate the metabolism of the active ingredients and significantly increase the risk of serious toxicity. Regulatory guidance strongly emphasizes the core principle of using the lowest effective dose for the shortest possible duration.


Q: How does the medicine affect platelet function?

A: The acetylsalicylic acid component acts by irreversibly inhibiting the platelet cyclooxygenase enzyme (COX-1). This molecular action prevents platelets from clumping together (aggregation) and is the basis for ASA’s known antiplatelet effect.


Q: Does Acetylsalicylsyra/Koffein Apofri contain only pain relief ingredients?

A: The medicine contains two active ingredients: Acetylsalicylic Acid (ASA) for pain relief and fever reduction, and Caffeine, which is included as an adjuvant to enhance the pain-relieving effect. All other components, known as excipients, are described as inactive ingredients in the official composition documents.


Q: Can taking Acetylsalicylsyra/Koffein Apofri on an empty stomach increase side effects?

A: Regulatory guidance permits consumption with food or milk to mitigate potential gastric discomfort. This suggests that taking the medication without food may increase the likelihood of experiencing common gastrointestinal side effects associated with the acetylsalicylic acid component.


Q: What happens if a person uses Acetylsalicylsyra/Koffein Apofri more often than recommended?

A: Official safety information warns that exceeding the recommended dosage can saturate the metabolism of the active ingredients and significantly increase the risk of serious toxicity. Regulatory documents emphasize the use of the lowest effective dose.


Q: Does the medicine have any known interaction with herbal supplements?

A: Official safety information includes a general caution that the risk of interaction is difficult to determine for every substance. Regulatory information notes the importance of discussing with a healthcare provider all other medications, including vitamins and herbal supplements.

How should Acetylsalicylsyra/Koffein Apofri be stored and disposed of?

How to Store and Dispose of Acetylsalicylsyra/Koffein Apofri

The storage and disposal of this medicine must adhere to regulatory labeling requirements to maintain product stability and safety.

Official Storage Conditions

The product must be stored at room temperature and requires mandatory protection from moisture and light to prevent the degradation of the effervescent tablets. To achieve this, the medicine must be kept in the original packaging, and the container must be kept tightly closed after use. This preparation must also be stored out of the sight and reach of children.

Disposal Instructions

Unused or expired Acetylsalicylsyra/Koffein Apofri must not be disposed of in wastewater or household waste. All disposal must be carried out according to local requirements for pharmaceutical waste handling, often requiring return to a pharmacy or designated collection point.

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

Available in countries:

Equivalent of Acetylsalicylsyra/Koffein Apofri found in:

A-Z Index: