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Dafalgan C

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Dafalgan C

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Treatment option:

Medically reviewed

Marina Burgos

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.

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Overview of Dafalgan C

Property Description
Active Ingredients Paracetamol (Acetaminophen), Codeine (Codeine phosphate)
Form Oral Solid Dosage (Tablet, Effervescent Tablet)
Pharmacological Class Non-opioid/Opioid Combination Analgesic
Common Use Symptomatic relief of moderate pain and fever
Origin Synthetic

What Type of Medicine is Dafalgan C?

Dafalgan C is classified as a compound analgesic pharmaceutical preparation, which is a fixed-dose combination product designed to achieve a synergistic therapeutic effect greater than that of its individual components. It falls into the Non-opioid/Opioid Combination Analgesic class, positioning it for the symptomatic treatment of moderate pain and elevated body temperature (fever). This dual-component approach is clinically recognized for providing superior analgesia compared to monotherapy with Paracetamol alone. The consensus among medical experts is that this combination is useful when a standard, single-ingredient pain reliever is not strong enough to manage discomfort.

Active Ingredients and Drug Form

The preparation contains two synthetic active ingredients: Paracetamol (an aniline derivative and non-opioid analgesic) and Codeine (an opioid analgesic that functions as a pro-drug). These components are delivered in an oral solid dosage form, often available as an effervescent tablet or standard tablet, intended for oral administration. The effervescent tablet form is a differentiating feature, often providing rapid disintegration compared to traditional solid tablets. Due to the inclusion of Codeine, which is categorized pharmacologically as an opium alkaloid derivative, Dafalgan C is consistently designated as a prescription-only medicine.

The General Purpose of this Combination

The general purpose of combining these substances is to leverage analgesic synergy, providing enhanced pain relief by targeting the central nervous system through two distinct pathways. Paracetamol reduces fever and pain signals centrally, while Codeine modulates pain perception by activating opioid receptors. This dual-action mechanism makes the medicine a highly effective choice for managing moderate pain and providing antipyretic benefits, a strategy supported by pharmacological studies demonstrating the combination's therapeutic advantage over its individual constituents.

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What side effects are possible with Dafalgan C?

Possible side effects and safety information

The official safety profile of this Paracetamol/Codeine combination is structured around two main risk areas: potential hepatotoxicity from the Paracetamol component and risks associated with opioid exposure from the Codeine component.

Adverse Reaction Scope

The most commonly documented adverse reactions, classified as Common, primarily involve the Gastrointestinal System (e.g., nausea, vomiting, constipation) and the Nervous System (e.g., drowsiness, dizziness). Less frequent reactions documented in regulatory documents include respiratory depression, skin rashes, and urinary retention. Very Rare serious cutaneous reactions have been reported in association with Paracetamol-containing products.

Serious Safety Risks

Official regulatory labeling, including Boxed Warnings in some regions, highlights the potential for acute liver failure related to Paracetamol, which can be fatal. The Codeine component carries a risk of life-threatening or fatal respiratory depression, particularly at the initiation of therapy or following a dose increase. Furthermore, there is an established risk of developing physical dependence, abuse, and misuse associated with the opioid content.

Population-Specific Safety Constraints

Specific populations face constraints due to increased vulnerability. The product is contraindicated in children younger than 12 years of age for any pain management and is generally restricted in adolescents. It is also contraindicated in women who are breastfeeding and in individuals known to be CYP2D6 ultra-rapid metabolizers. Caution is officially recommended for patients with existing severe hepatic or renal impairment or those with compromised respiratory function.

This regulatory data emphasizes that patient physiology and the context of use are critical factors influencing the overall risk profile.

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Overdose and Emergency Response

Overdose and When to Seek Help

Dafalgan C contains paracetamol (acetaminophen), which is the primary risk factor in an overdose. Taking more than the recommended dose can cause severe liver damage, which may lead to liver failure and death if not treated promptly. Symptoms of paracetamol poisoning often do not appear immediately, making early medical intervention essential, even if you feel well.

Immediate medical help must be sought if you or someone else has taken more than the maximum recommended dose. Contact emergency services or go to the nearest hospital emergency department right away. Take the medicine packaging with you.

Phase Onset Symptoms
Early First 24 hours Often none, or mild non-specific symptoms such as nausea, vomiting, stomach pain, loss of appetite, and paleness.
Later 24 to 72 hours Signs of liver damage, including pain in the upper right side of the abdomen, dark urine, and jaundice (yellowing of the skin and eyes).

The maximum recommended daily dose for adults is typically 4 grams of paracetamol. N-acetylcysteine (NAC) is the specific antidote for paracetamol poisoning, and its effectiveness is greatest when administered within the first eight hours of overdose. Vitamin C (ascorbic acid) components in the product are generally not associated with severe, life-threatening toxicity; excessive intake may cause gastrointestinal upset, such as diarrhea.

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Therapeutic Uses of Dafalgan C

Enhanced Relief for Moderate Acute Discomfort

The combination is commonly used to help manage moderate pain in situations where additional symptomatic support is needed. This combination is relevant for short-term symptomatic relief in situations where additional management of discomfort is required. It is commonly applied for conditions such as musculoskeletal aches, post-dental procedure pain, tension headaches, and menstrual discomfort (dysmenorrhea). A therapeutic benefit is offering supportive relief when symptoms interfere with routine activities, generally contributing to easing the overall symptom load.

“Applied across domains where additional symptomatic support is needed,” this medication is relevant when symptoms become temporarily overwhelming.

Quick Fact: Relevant for Acute Episodic Pain

Supportive Management of Pain-and-Fever Clusters

The combination is also relevant in contexts involving symptoms related to systemic discomfort, which include elevated body temperature (fever) and generalized discomfort. It is commonly used in conditions that involve the co-occurrence of fever and body aches, such as flu-like symptoms. This supportive management helps patients cope more steadily with symptom fluctuations and may assist with maintaining functional stability during symptomatic phases.

Regulatory References

  1. European Medicines Agency guidance on codeine combinations
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Eligibility and Restrictions for Use

Dafalgan C contains paracetamol (acetaminophen) and ascorbic acid (Vitamin C), and its use is generally safe for many adults and adolescents. However, due to the paracetamol component, certain medical conditions and concurrent drug use require caution or contraindicate its use.

Contraindications (Should Not Use)

Condition Rationale
Allergy Known hypersensitivity to paracetamol, ascorbic acid, or any other ingredient.
Severe Organ Impairment Severe liver or severe kidney failure, as paracetamol is primarily metabolized and excreted by these organs.
Children Generally not recommended for children under the age of 16 without medical advice, as dosing should be strictly weight-based.

Precautions (Use with Caution/Medical Advice)

Consult a healthcare professional before use if you have any of the following:

  • Mild to Moderate Liver or Kidney Issues: Reduced organ function may necessitate a lower dose or less frequent administration.
  • Chronic Alcohol Consumption: Regular, heavy alcohol use increases the risk of paracetamol-induced liver toxicity.
  • Severe Malnutrition/Low Weight: These factors increase the risk of hepatotoxicity due to low glutathione reserves.
  • G6PD Deficiency: High doses of ascorbic acid can cause hemolysis in individuals with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency.
  • Kidney Stone History: High doses of Vitamin C may increase the risk of oxalate kidney stone formation.

Pregnancy and Breastfeeding: Paracetamol is often considered the first-choice pain reliever, but it should be used at the lowest effective dose and for the shortest possible duration. Consult a doctor before use.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation requires careful assessment of concurrent use with specific medications and substances due to potential interactions involving the product’s active component, acetaminophen/paracetamol.

Interacting Medicinal Product Categories

Category Interaction Constraint
Oral Anticoagulants (e.g., Warfarin) Acetaminophen may potentiate the effect of oral anticoagulants, leading to an increased risk of bleeding. Close and frequent monitoring of the International Normalized Ratio (INR) is necessary if these products are used concomitantly, particularly with prolonged use or higher dosages.
Other Acetaminophen/Paracetamol Products Concomitant use with any other medicinal product containing acetaminophen or paracetamol is strictly restricted to prevent accidental overdose and subsequent severe liver damage (hepatotoxicity).

Substance and Population-Specific Restrictions

Severe liver damage may occur with the use of this medicine in individuals who consume three or more alcoholic drinks per day. The use of acetaminophen is cautioned or contraindicated in patients with underlying liver disease or chronic alcoholism due to an increased risk of toxicity. The constraints emphasize that the total daily intake of acetaminophen from all sources must not exceed the maximum recommended dose.

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Mechanism of Action

Modulating Pain Signals via Central Opioid Receptor Agonism

Codeine functions as a pro-drug, metabolically converting to Morphine which acts as an agonist on the mu-Opioid Receptor ( MOR) in the CNS. This interaction triggers a cascade that causes neuronal hyperpolarization and limits the release of pain-signaling neurotransmitters. The resulting physiological effect is the dampening of nociceptive signal transmission across supraspinal and spinal structures.


Inhibiting Central Prostaglandin and Cannabinoid Pathways

Paracetamol primarily acts by inhibiting Cyclooxygenase ( COX) enzymes within the CNS, reducing the synthesis of Prostaglandin E2 ( PGE2) in the hypothalamus. Simultaneously, its metabolite AM404 modulates the endocannabinoid system, increasing the central pain threshold. This mechanism results in two key physiological outcomes: the resetting of the hypothalamic thermal set-point (facilitating heat dissipation) and a non-opioid increase in the central pain threshold.


Mechanistic Synergy and Genetic Constraint

The combined formulation leverages complementary analgesic pathways. However, the action of the Codeine component is physiologically constrained by CYP2D6 genetic polymorphism. Individuals with low CYP2D6 activity exhibit a reduced metabolic conversion to the active metabolite, Morphine.

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Dosage and Administration Information

How to Use Dafalgan C: Official Administration Guidelines

This section outlines the administration and dosing instructions for products containing the active ingredient found in Dafalgan C, based strictly on standard pharmaceutical documentation.

Administration and Dosage Rules

Scope Official Regulatory Instruction
Route of Administration Oral.
Preparation Requirements Effervescent tablets must be fully dissolved in a glass of water before drinking. Oral liquid forms must be measured with the dosing device provided.
Dosing Interval A minimum of 4 hours must elapse between doses for all populations.
Maximum Total Daily Dose Must not exceed 4000 mg (4 grams) in a 24-hour period for adults and adolescents weighing 50 kg or more.

Age-Specific Instructions

  • Adults and Adolescents (ge 50 kg): The typical single dose is 500 mg to 1000 mg. The dose may be repeated every 4 to 6 hours as needed.
  • Children (Under 12 Years): Dosing is generally determined by body weight (typically 10 mg/kg to 15 mg/kg per dose). Children must not exceed 4 doses in any 24-hour period. Dosage for infants under 3 months is highly restricted and subject to specific guidelines.

Procedural Conditions

Do not take this medicine with any other product containing Paracetamol (Acetaminophen) to prevent accidental overdose. If a dose is missed, continue with the next scheduled dose; do not take a double dose to compensate.

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Recent Clinical Evidence

Research evidence / Overview of Studies for Dafalgan C

The research evidence for the combination of Paracetamol and Codeine is highly structured, focusing on patterns of symptoms in specific populations and over defined, typically short, periods. Studies help show what has been observed so far, providing context but not individual predictions.


Evidence for Use in Moderate Acute Pain Relief

Research examined the combination in contexts involving outcomes related to physical discomfort during conditions associated with acute or disruptive episodes, such as pain after dental or minor surgical procedures. The evidence is derived from randomized controlled trials (RCTs) and systematic reviews that focused on adult populations. The short-term acute setting was assigned a High evidence level by regulatory bodies, reflecting findings from studies focused on the first few hours post-ingestion. While research provides insight into short-term changes, long-term effects are not fully established, and there is limited information for continuous use extending beyond 24 hours.


Evidence for Use in Managing Chronic Nociceptive Pain

The combination was evaluated in settings involving conditions characterized by fluctuating or episodic manifestations, such as pain associated with osteoarthritis. Studies monitored outcomes reflecting daily functioning or activity level in adults over multi-dose protocols. Findings were sometimes mixed across studies. Due to constrained follow-up durations, this evidence is often described as having a Moderate or Low quality label. Research gaps exist for longer-duration observation.


Durability of Effect and Long-Term Follow-up

The definitive data that research describes is based on studies conducted during periods of increased symptom activity and observed over short, defined time intervals. The evidence base is not structured to describe the durability of patterns observed over many months or years, meaning the long-term effects are not fully established.


Evidence in Special Populations

The research primarily was observed in the general adult population, meaning data for certain groups remain insufficient. This excludes pediatric populations (children under the age of 12) and individuals with specific, known genetic factors. Research exploring these groups is limited.


Synthesis of Evidence Quality and Research Gaps

The strongest available evidence is associated with the short-term, acute pain trials in adults. Conversely, the evidence for chronic pain indications is often assigned a Moderate or Low quality label. Key limitations include that sample sizes were modest in some analyses, and comparative evidence is lacking against specific alternative pain management strategies. This means research provides context about what is known — and what is still uncertain — about the combination.

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Frequently Asked Questions (FAQ)

Common questions about Dafalgan C (FAQ)

Q: What is the main difference between Dafalgan C and regular paracetamol?

Dafalgan C is an effervescent product that combines Paracetamol (the active pain reliever and fever reducer) with Vitamin C (Ascorbic Acid). Regular paracetamol products may differ by not including Vitamin C or the effervescent formulation. Official product information describes the exact composition of this specific medicine.

Q: Can Dafalgan C be used for tension headaches?

The active ingredient, Paracetamol, is officially indicated for the symptomatic treatment of mild to moderate pain. This general category of pain may include various types of headaches, such as tension headaches. It is used to help manage the discomfort associated with these conditions.

Q: Is Dafalgan C considered an anti-inflammatory drug?

Official product information indicates that the active ingredient, Paracetamol, primarily works in the central nervous system (brain and spinal cord). Its mechanism of action does not involve the strong anti-inflammatory actions characteristic of medicines known as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

Q: How quickly should I expect Dafalgan C to start working?

The effervescent form is generally associated with a quicker rate of absorption of the active ingredient compared to conventional solid tablets. This increased rate of absorption may potentially lead to a more rapid onset of pain relief.

Q: How long does the effect of Dafalgan C usually last?

The recommended minimum dosing interval in official guidelines is typically 4 to 6 hours, which generally aligns with the expected duration of the effect. The medicine should be taken as described in the official instructions.

Q: Is it common to feel jittery or restless after taking Dafalgan C?

According to official regulatory documents, jitteriness or restlessness are not typically listed among the common or frequent side effects of the active ingredient. Patients should be aware that all medicines can have possible side effects, though most are rare.

Q: Can Dafalgan C be taken on an empty stomach?

The active ingredient in this medicine may generally be taken with or without food. Taking the medicine with food is not typically required for absorption or efficacy, though individual tolerance may vary.

Q: Does Dafalgan C interact with common pain relievers like ibuprofen?

Official warnings strongly advise against taking this medicine concurrently with any other product containing Paracetamol. Co-administration with other types of pain relievers requires review based on individual health conditions and potential interaction risks.

Q: Are there specific foods or drinks to avoid when using Dafalgan C?

Official regulatory labeling indicates that caution is advised regarding the use of alcohol. Chronic or heavy consumption of alcohol combined with the active ingredient is associated with an increased risk of severe liver damage.

Q: Can people with high blood pressure use Dafalgan C?

The effervescent formulation contains sodium, which may be a factor for consideration by individuals who are on a controlled or low-sodium diet, such as those managing high blood pressure. The full composition is listed in the official product information.

Q: Is Dafalgan C suitable for older adults?

Dosage adjustment is generally not required for the elderly population based solely on age, according to official guidelines for the active ingredient. However, official product information indicates that consideration is advised for older adults who have existing severe kidney or liver problems.

Q: What are the most common side effects of Dafalgan C?

Official regulatory documents indicate that the medicine is generally well tolerated when used according to directions. Rare, serious effects reported include hypersensitivity reactions (allergies) and blood-related disorders. A full list of possible effects is found in the official safety information.

Q: Can Dafalgan C cause stomach upset or nausea?

Gastrointestinal symptoms such as nausea and vomiting have been reported as possible side effects in official documents. These are potential, though usually uncommon, effects that may occur with some medicines.

Q: Does Dafalgan C interact with alcohol?

Regulatory warnings state that the combination of the active ingredient with heavy alcohol consumption is associated with an increased risk of severe liver damage. This specific risk is detailed in the official safety information.

Q: Why is Dafalgan C sometimes recommended for flu-like symptoms?

The active ingredient, Paracetamol, is officially indicated for the symptomatic treatment of both fever and pain. Since both fever and pain are common symptoms of flu-like conditions, the medicine is used to help manage these forms of discomfort.

Q: Is Dafalgan C safe to use for a long period?

Official guidelines generally advise that prolonged use of the active ingredient should be avoided without professional review. This is recommended to ensure continued safety and to monitor for any potential organ damage associated with long-term use.

Q: Is Dafalgan C available only by prescription?

Products containing this active ingredient are often classified as over-the-counter medicines in many countries and are available for purchase without a prescription. Availability and permissible pack size can vary based on local regulatory limits.

Q: Can Dafalgan C be used for period pain?

The active ingredient is formally indicated for the symptomatic treatment of mild to moderate pain. This indication is broad and is inclusive of many types of pain, such as common menstrual discomfort.

Q: What are the signs of an allergic reaction to Dafalgan C?

Signs of a serious hypersensitivity (allergic) reaction are detailed in official labeling. These may include the sudden appearance of a skin rash, itching, or swelling of the face, throat, or lips, and difficulty breathing.

Q: Does the 'C' in Dafalgan C refer only to the Vitamin C component?

Yes, the letter 'C' in the product name refers to the inclusion of Vitamin C (Ascorbic Acid) in the formulation. This ingredient is listed alongside the primary active pharmaceutical ingredient, Paracetamol.

Q: Can Dafalgan C be taken at the same time as cold and flu medication?

Regulatory warnings advise that Dafalgan C should not be taken concurrently with any other medicine containing Paracetamol to prevent the risk of accidental overdose. It is necessary to check the ingredients of all other medications before use.

Q: Are there any specific warnings for people with kidney issues using Dafalgan C?

Official product information indicates that consideration is advised for individuals with existing severe kidney impairment. The kidneys are one of the main organs responsible for processing this medicine.

Q: Is Dafalgan C a non-sedating medicine?

Official regulatory documents do not commonly list sedation as a frequent or common side effect. The active ingredient is generally regarded as having no or negligible influence on alertness.

Q: Can Dafalgan C be taken before driving or operating machinery?

Official labeling generally states that the active ingredient, when taken as directed, has no or negligible influence on a person's ability to drive or operate machinery.

Q: What are the major reasons someone would be advised not to use Dafalgan C?

The medicine is contraindicated (not to be used) primarily for individuals with a known hypersensitivity (allergy) to the active ingredient or any other component in the product. It is also typically contraindicated in cases of severe liver disease.

Q: How does the effervescent form of Dafalgan C compare to tablets?

The effervescent form is designed to ensure the active ingredient is fully dissolved when consumed. This allows the medicine to be absorbed more rapidly than conventional solid tablets, which is associated with a potentially quicker onset of action.

Q: Are there documented cases of Dafalgan C causing liver problems?

Official regulatory warnings emphasize that exceeding the recommended dose of Paracetamol is associated with a risk of severe liver damage. Consideration is advised for those with existing liver conditions or chronic alcoholism.

Q: Is it known whether Dafalgan C is safe to use while breastfeeding?

Regulatory documents state that Paracetamol can be used during breastfeeding if taken at the recommended doses, as only very small amounts appear in breast milk.

Q: How should Dafalgan C be stored correctly?

Official labeling provides specific storage instructions, which typically include keeping the medicine out of the sight and reach of children and storing it below a specified temperature to maintain its stability.

Q: What is the role of paracetamol in Dafalgan C?

Paracetamol is the primary component responsible for the therapeutic effects, acting as a pain reliever (analgesic) and fever reducer (antipyretic). It works mainly in the central nervous system to inhibit the synthesis of certain pain-signaling compounds.

Q: Why is Dafalgan C not recommended for children under a certain age?

Official guidelines state that dosing for children is determined based on body weight. Adult-strength dosage forms are generally not recommended for young children due to the concentration of the active ingredient.

Q: Can Dafalgan C be used to reduce fever?

According to its therapeutic indications, the active ingredient, Paracetamol, is specifically indicated for its antipyretic action (meaning it helps to reduce fever).

Q: Does Dafalgan C contain sodium, and is that a concern for some people?

Effervescent products frequently contain sodium (e.g., Sodium Bicarbonate) as an excipient. The sodium content is a factor for consideration by patients who are on a controlled or sodium-restricted diet.

Q: Is it common for Dafalgan C to cause dizziness?

Official regulatory documents indicate that dizziness may be reported as a possible side effect of the active ingredient. Patients should note that side effects are usually uncommon when the medicine is taken as directed.

Q: Can I take Dafalgan C if I have a history of asthma?

Official documents sometimes note that consideration is necessary for individuals with asthma who have a known history of sensitivity to aspirin or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

Q: What precautions should be taken if I am already taking blood thinners with Dafalgan C?

Regulatory warnings indicate that Paracetamol may interact with certain blood-thinning medicines (oral anticoagulants). Professional monitoring is advised if both medicines are taken concurrently for prolonged periods.

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How should Dafalgan C be stored and disposed of?

How to Store and Dispose of Dafalgan C?

Official regulatory documents define strict rules for the storage and disposal of this medicine, focusing on product stability and public safety.

Storage Constraints

The medicine must not be stored above 25°C and should be kept in a cool, dry place. To maintain stability and prevent degradation, the tablets must remain in their original package to protect them from both light and moisture. Due to the presence of Codeine, a crucial safety requirement is to keep this medicine out of the sight and reach of children at all times.

Disposal Rules

When the product is expired or unused, it must be disposed of safely according to pharmaceutical waste guidelines. Do not throw the medication into household trash, wastewater, or flush it down the toilet. The official instruction is to return the unused product to a pharmacist or a recognized drug take-back program for proper disposal.

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

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