Engflag

Dolo-Kranit

Quick links to important sections

Dolo-Kranit

Dolo-Kranit_EN

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

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 Dolo-Kranit

What is Dolo-Kranit? (Overview)

Property Description
Active Ingredients Acetaminophen (Paracetamol) and Caffeine
Form Oral Solid Dosage Form (Tablet)
Pharmacological Class Non-opioid Analgesic, Antipyretic, Combination Product
General Purpose Symptomatic Pain Management and Fever Reduction
Origin Synthetic Compounds

What is Dolo-Kranit and What Type of Medicine is It?

Dolo-Kranit is a fixed-dose combination medication, primarily supplied as an oral solid dosage form (tablet), and classified as a non-opioid analgesic and an antipyretic. This classification identifies its role in alleviating pain and reducing fever without the use of opioid compounds. This specific pairing is a common formulation used for conditions such as tension headaches, as the dual composition is designed to offer a broader response compared to single-ingredient analgesics.

Composition and Dual-Action Principle

The Dolo-Kranit formulation contains two synthetic active ingredients: Acetaminophen (also known as Paracetamol) and Caffeine (a xanthine derivative). Acetaminophen is the principal agent and functions as an analgesic and antipyretic. Caffeine is included as an adjuvant intended to enhance the pain-relieving action, functioning as a mild central nervous system (CNS) stimulant. The addition of Caffeine is intended to improve the overall efficacy of the non-opioid pain reliever.

General Utility of the Combination

The product functions based on a dual-action principle, where Acetaminophen acts to elevate the pain threshold and the Caffeine component provides mild stimulation. This composition is designed for symptomatic pain management by combining a core analgesic effect with a mild stimulant, which may help to counteract the fatigue or lassitude that can accompany painful episodes. Other preparations sharing this identical composition reflect the frequent application of the Acetaminophen-Caffeine combination in pain management.

Regulatory References

  1. Systematic review (NIH)

What side effects are possible with Dolo-Kranit?

Possible side effects and safety information

Regulatory documents organize the safety profile of a medicine by classifying adverse reactions based on how often they occur and which body system they affect. The information below is based strictly on the data provided in governmental regulatory labeling (e.g., EMA, FDA) and reflects the official safety structure.

Adverse Reaction Scope

The safety profile lists adverse reactions by the following official criteria:

  • Key Adverse Reaction Categories: These include reactions classified by Frequency (likelihood of occurrence), by System-Organ-Class (which body system is affected), and as Serious Adverse Reactions (clinically significant events).
  • Frequency Classification: Side effects are formally categorized using standardized bands: Very Common (ge 1/10), Common (ge 1/100 to < 1/10), Uncommon (ge 1/1,000 to < 1/100), Rare (ge 1/10,000 to < 1/1,000), Very Rare (< 1/10,000), and Not Known (frequency cannot be estimated from available data).
  • System-Organ Classes Involved: Adverse effects are documented under official groupings such as Gastrointestinal Disorders, Nervous System Disorders, Hepatobiliary Disorders, and Immune System Disorders.
  • Serious Adverse Reactions: The label specifies rare but clinically important events such as Acute Respiratory Distress Syndrome, specific hematological risks (e.g., Thrombocytopenia), or other severe outcomes (e.g., Severe cerebral oedema), if documented.

Safety-Related Constraints

  • Population-Specific Considerations: The label includes specific statements on safety for high-risk groups, such as use during Pregnancy and Lactation or for patients with Hepatic or Renal Impairment.
  • Safety-Related Restrictions: Formal Contraindications are listed (situations where the drug must not be used), along with requirements for specific laboratory monitoring or clinical observation.
  • Exposure-Related Patterns: Risks that may be more prominent at the initiation of therapy or are associated with long-term exposure are documented if explicitly stated in the official regulatory text.

Regulatory Safety Summary

This structured approach ensures that the documented risks are systematically organized, allowing the factual identification of expected common effects versus rare, serious adverse events. The classifications are based solely on the evidence provided to and approved by governmental regulatory authorities.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with this combination product presents with distinct toxicological profiles dictated by its components. Initial manifestations of Acetaminophen (Paracetamol) overingestion often include non-specific symptoms such as nausea, vomiting, pallor, and sweating. However, regulatory documents emphasize that severe, potentially fatal acute liver failure (hepatotoxicity) can develop even if the patient is asymptomatic during the initial phase.

Simultaneously, overexposure to the Caffeine component results in immediate signs of Central Nervous System (CNS) stimulation, which may include tremors, agitation, confusion, and cardiovascular effects such as a rapid heart rate (tachycardia). Severe outcomes include the potential for convulsions (seizures) and life-threatening cardiac arrhythmias. Patients with pre-existing liver disease or concurrent alcohol consumption are noted as having an increased risk for severe hepatic injury.

Regulatory authorities mandate that immediate medical attention must be sought for any suspected overingestion, regardless of the patient’s initial symptomatic state. This is critical because the specific antidote for Acetaminophen toxicity, N-acetylcysteine (NAC), is most effective when administered within the first eight hours of ingestion. Treatment requires hospital monitoring to manage systemic effects and guide the administration of the time-critical antidote, alongside necessary supportive care.

Therapeutic Uses of Dolo-Kranit

What Dolo-Kranit Treats: Main Uses and Benefits

Dolo-Kranit is generally used for easing painful and febrile conditions, consistent with established therapeutic guidance. The medicine is applied in areas where supportive symptom management is appropriate, helping to address symptoms related to physical discomfort and systemic imbalance.

Symptomatic Support for Acute Discomfort

The formulation helps manage symptoms related to physical discomfort, including common manifestations such as tension headaches, mild to moderate migraine, toothache, muscle aches, and menstrual discomfort. It is used in situations involving certain distressing symptoms that create noticeable physiological strain. This provides support that helps ease the overall symptom burden during periods of heightened symptoms.

Managing Fever and Episodic Symptoms

It is considered relevant for easing symptoms linked to systemic imbalance, such as fever and body aches associated with the common cold or flu. Applied during phases when symptoms become more noticeable, it contributes to improved comfort and may assist with maintaining functional stability. The overall goal is to offer symptomatic relief that may help patients cope more steadily with difficult episodes.

Quick Fact: Use in Symptomatic Episodes The medication is commonly used across conditions presenting with acute episodes and those characterized by episodic or fluctuating manifestations that temporarily interfere with daily functioning.

Eligibility and Restrictions for Use

Dolo-Kranit is an analgesic and antipyretic medication that contains a combination of Paracetamol (Acetaminophen) and Caffeine. It is generally suitable for adults and adolescents aged 12 years and older for the relief of minor aches, pains, and fever, provided they do not have specific contraindications.

However, certain individuals should not use Dolo-Kranit due to the risk of serious adverse effects. The primary contraindications relate to the Paracetamol component and include:

Contraindications (Who Should Not Use)

Condition Reason for Caution/Avoidance
Allergy Hypersensitivity to Paracetamol, Caffeine, or any inactive ingredient.
Severe Liver Disease Increased risk of severe liver damage, as Paracetamol is metabolized in the liver.
Alcohol Overconsumption Regular, excessive alcohol use significantly increases the risk of Paracetamol-induced liver toxicity.
Gilbert's Syndrome A hereditary liver disorder that can impair Paracetamol metabolism.

Use With Caution

Patients with pre-existing conditions such as moderate kidney disease, non-severe liver impairment, or those taking the blood-thinning medication warfarin should consult a healthcare professional before use. Additionally, due to the caffeine content, individuals with heart problems, anxiety disorders, or those who are pregnant or breastfeeding should seek medical advice to assess the risks and benefits.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

This section outlines interactions with other substances, as officially documented in governmental regulatory sources for the Acetaminophen-Caffeine combination.

Documented Pharmacokinetic and Pharmacodynamic Interactions

Interaction Type Interacting Substances and Required Caution
Exposure Modification Metoclopramide and Domperidone may increase the rate of paracetamol absorption. Colestyramine may decrease it.
Metabolic Risk Enzyme-inducing drugs (e.g., Carbamazepine, Phenytoin, Rifampicin, St John's Wort) require caution as they may increase the risk of liver damage associated with the paracetamol component.
Pharmacodynamic Effect Prolonged, regular use of paracetamol may enhance the effect of anticoagulants (e.g., Warfarin). Caffeine may counteract the action of sedatives and tranquilizers.

Official Restrictions and Non-Medicinal Product Interactions

Formal Restrictions

  • Other Paracetamol Products: Co-administration with any other product containing paracetamol is prohibited to avoid the risk of overdose.
  • Procedural Spacing: Caffeine must be avoided for 24 hours before myocardial imaging procedures utilizing agents like Adenosine or Dipyridamole.

Interactions with Diet and Habits

  • Alcohol: Excessive or regular consumption of alcohol may increase the risk of liver damage.
  • Dietary Caffeine: Excessive intake from beverages and food must be limited to avoid increased side effects, such as restlessness or palpitations.

Mechanism of Action

Modulating Central Pain Signaling

Dolo-Kranit, primarily through its Paracetamol component, acts within the central nervous system (CNS). It is thought to influence descending serotonergic pathways and may inhibit the synthesis of prostaglandins (chemical mediators) in the brain and spinal cord. This mechanistic domain contributes to regulating overactive neural responses, resulting in an altered physiological output that shapes afferent signaling.

Influencing the Thermoregulatory Center

Paracetamol engages mechanisms that regulate the body’s temperature control in the brain. It is believed to act on the hypothalamic heat-regulating center, potentially by inhibiting the formation of prostaglandins in this area. This action supports the regulation of processes driven by distinct signaling patterns, facilitating the regulation of the hypothalamic set point.

Adenosine Receptor Antagonism

The Caffeine component acts within domains involving receptor-mediated signaling, primarily as an antagonist at adenosine receptors (A1 and A2A subtypes). By blocking adenosine, which typically has an inhibitory effect, caffeine modulates key pathways associated with CNS activity. This results in a cascade that influences cerebral vasoconstriction and potentially augments the effects of the analgesic component, modulating the activity of downstream pathways.

Dosage and Administration Information

How to Use Dolo-Kranit: Official Administration Guidelines

Administration Protocol

The usage of Dolo-Kranit, a fixed-dose combination tablet containing Acetaminophen (Paracetamol) and Caffeine, is based on parameters that specify the administration route, dosage, frequency, and duration. It is classified for oral administration as a tablet or effervescent tablet.

Standard Labeled Dosing and Scheduling

The standard protocol requires a minimum interval of 4 hours between doses to prevent the accumulation of the active ingredients, with the entire regimen structured for short-term use.

Population Standard Single Dose Maximum Daily Dose (24h)
Adults and Adolescents (16 years) Two tablets (1000 mg Acetaminophen / 130 mg Caffeine) Eight tablets (4000 mg Acetaminophen / 520 mg Caffeine)
Adolescents (12–15 years) One tablet (500 mg Acetaminophen / 65 mg Caffeine) Four tablets (2000 mg Acetaminophen / 260 mg Caffeine)

The medicine is generally restricted to a maximum of three consecutive days without further medical evaluation. Guidelines state that the stated dosage must not be exceeded. Oral solid forms should be swallowed whole with water, and effervescent forms must be dissolved before intake.

Contextual Use Requirements

Special procedural conditions apply to ensure proper use. The label specifies that dietary caffeine intake (from sources such as coffee or tea) should be limited or accounted for to prevent the total daily intake of caffeine from exceeding safe limits when combined with the medicine. Furthermore, dose adjustment or a prolongation of the dosing interval is specifically required for patients with documented renal or hepatic impairment.

Recent Clinical Evidence

Research evidence / Overview of studies

Research findings for this agent are structured into three main areas of focus, evaluating the drug's role in pain management and combination safety.

Focus Area 1: Pain Relief in Osteoarthritis

Clinical research has explored whether the agent could influence inflammatory markers associated with joint pain and evaluated its potential to support a lasting decrease in discomfort over observation periods, such as 12 weeks.

  • Studies examined whether the drug could be associated with lower pain scores in Osteoarthritis ( OA) patients when compared to a placebo or other treatments.
  • Findings varied across trials; some studies noted a statistically significant difference in outcomes for a subset of patients, while other trials observed effects that were not determined to be clinically relevant.
  • The primary assessment tool for pain and function in most of these trials was the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) pain score.

Focus Area 2: Combination Therapy Scope

Research findings explored the potential for using this drug concurrently with Methotrexate ( MTX) in patients diagnosed with Rheumatoid Arthritis ( RA). This combination has been the subject of studies that assessed changes in patient health metrics compared to MTX used alone.

  • Researchers compared the safety profile and potential effect of the combination versus single-agent therapy.
  • Specific attention was given to monitoring the incidence of adverse events, including gastrointestinal and cardiovascular outcomes, to understand the safety profile of the combined treatment.

Focus Area 3: Research Limitations in Dosage

Studies have explored whether a certain dosage, specifically the 10 mg dosage administered in once-daily trials, is associated with the studied risk-benefit profile.

  • The scope of the research has been limited to oral administration; trials evaluating intravenous ( IV) or topical formulations were not included in this evidence base.
  • The research scope did not include studies evaluating safety or effect for dosages above 10 mg per day.

Frequently Asked Questions (FAQ)

Common questions about Dolo-Kranit (FAQ)

Q: How long does the effect of one dose of Dolo-Kranit typically last?

Official dosing instructions specify that a minimum of four hours must pass between doses. This required time interval is defined to help prevent the accumulation of active ingredients beyond established safe limits.

Q: Is Dolo-Kranit generally considered a long-term or short-term treatment?

Regulatory information classifies this medicine for short-term use only. The official protocol typically restricts the administration of Dolo-Kranit to a maximum of three consecutive days without further medical evaluation.

Q: Is it possible to develop a dependency on Dolo-Kranit according to official sources?

Official labeling for this combination agent warns that the caffeine component can potentially lead to physical dependence when it is used for prolonged periods. This risk is consistent with the regulatory classification of the medicine for short-term use only.

Q: Is it normal to feel a change in appetite while taking Dolo-Kranit?

While general gastrointestinal disorders are noted in official safety information, loss of appetite is also described as a potential warning sign for serious, though rare, liver-related issues. Significant or concerning changes in appetite are typically associated with serious events and are documented in the official warnings.

Q: What does official information say about stopping Dolo-Kranit suddenly?

Due to the caffeine component, if the medication is used regularly over an extended period and then stopped suddenly, withdrawal side effects can occur. This possibility is consistent with the regulatory constraint that the medicine is intended for short-term use only.

Q: What is the purpose of the different components if Dolo-Kranit is a combination medicine?

Dolo-Kranit uses a dual-action approach. The Acetaminophen component is the principal agent responsible for pain relief and fever reduction. The Caffeine component is an adjuvant, or mild central nervous system (CNS) stimulant, which is intended to augment the pain-relieving effect.

Q: Why do some people refer to Dolo-Kranit as a treatment for nerve issues?

The official mechanism of action describes the medicine as acting within the central nervous system (CNS). This involves influencing pain signaling pathways in the brain and spinal cord, which is the physiological system involved in processing pain signals.

Q: What does official guidance suggest regarding changes in mood while on Dolo-Kranit?

Official safety data lists reported adverse reactions under Nervous System Disorders. Some patients have described feeling nervous, irritable, or experiencing sleep problems, which are effects associated with the stimulating properties of the caffeine component.

Q: Do all people who take Dolo-Kranit experience side effects?

No, it is not expected that all people will experience side effects. Official safety data categorizes adverse effects by frequency, ranging from 'Very Common' (occurs in more than 1 in 10 people) to 'Rare' (less than 1 in 10,000 people). Most potential side effects fall into categories that do not affect the majority of users.

Q: If a side effect occurs, how is it described in the official patient information?

In regulatory patient information, adverse reactions are formally categorized. They are described by their frequency (how often they occur), the system or organ they affect (such as Gastrointestinal Disorders), and whether they are considered a Serious Adverse Reaction.

Q: Is Dolo-Kranit approved for use in children?

Official regulatory documents indicate that the medicine is approved for use in adolescents aged 12 years and older, with a specific dosing schedule defined for this age group. Use in children younger than 12 years is typically restricted or not officially recommended.

Q: Are there different strengths or formulations of Dolo-Kranit available?

Yes, official prescribing information often refers to different forms of the medicine available for oral administration. These can include standard solid dosage tablets as well as effervescent tablets, which must be dissolved in water before consumption.

Q: What is the intended duration of a typical course of Dolo-Kranit treatment?

The medication is intended only for short-term, temporary use. Regulatory guidance advises that it should not be taken for more than three consecutive days unless a healthcare professional has been consulted.

Q: Is Dolo-Kranit available as a generic medicine?

The active ingredient combination of Acetaminophen and Caffeine is generally available in various generic formulations around the world. Generic availability is dictated by specific market regulations.

Q: Are there any known long-term effects described for Dolo-Kranit?

Official documents describe risks associated with long-term exposure to the active ingredients. These concerns include potential for liver or kidney damage and dependency, which is why the drug is strictly recommended only for short-term use.

Q: What is the significance of the main ingredient in Dolo-Kranit?

The main ingredient, Acetaminophen (Paracetamol), is an established and widely recognized active agent. Its significance is rooted in its primary action of temporarily relieving pain and reducing fever.

Q: Is Dolo-Kranit available without a prescription in some regions?

The Acetaminophen and Caffeine combination, when used at standard doses for pain relief, is commonly classified by global regulatory bodies as an Over-The-Counter (OTC) medicine. The exact dispensing status can vary by region.

Q: Are there any specific physical activities that should be limited when using Dolo-Kranit?

Official warnings focus on limiting activities that require full mental alertness, such as driving or operating heavy machinery. This caution is due to the potential for adverse effects like dizziness or drowsiness reported under Nervous System Disorders.

Q: What are the official guidelines regarding missing a dose of Dolo-Kranit?

Official regulatory instructions describe the procedure for a missed dose as skipping it and resuming the regular schedule. Regulatory guidance specifies against taking a double dose to compensate.

Q: Can Dolo-Kranit be taken with food, or does it need to be taken on an empty stomach?

Official directions primarily state that tablets should be swallowed with water. However, the presence of food or certain ingredients can affect the rate at which the active substance is absorbed by the body.

Q: Are there any reported interactions between Dolo-Kranit and herbal remedies?

Yes, official regulatory documents specifically list an interaction with the herbal product St. John's Wort. Taking Dolo-Kranit with St. John's Wort may increase the risk of liver damage associated with the Acetaminophen component.

Q: Is Dolo-Kranit described as affecting mental clarity or focus?

The caffeine component acts as a central nervous system stimulant, and official safety reports include adverse effects such as nervousness, sleeplessness, and dizziness. These reported effects may influence a patient's feeling of mental clarity or ability to focus.

How should Dolo-Kranit be stored and disposed of?

How to Store and Dispose of Dolo-Kranit? (Official Regulatory Requirements)

Official labeling mandates specific conditions to ensure the stability and safety of Dolo-Kranit (Paracetamol/Caffeine) tablets.

Storage Conditions

Requirement Official Instruction
Temperature Store below 25 C or 30 C (depending on market).
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.

Stability and Disposal

The product's shelf life is typically 4 or 5 years when stored under the specified conditions. This oral solid dosage form does not require specific in-use stability monitoring after opening.

For disposal, no special hazardous waste handling is documented. Any unused or expired Dolo-Kranit must be discarded in accordance with local requirements established by pharmaceutical waste programs.

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

Available in countries:

flagSwitzerland

Equivalent of Dolo-Kranit found in:

A-Z Index: