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Dehace retard

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Dehace retard

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Method of action: Analgesic

Treatment option: Pain, Cancer

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.

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Overview of Dehace retard

Dehace retard is a medication specifically classified as an opioid analgesic designed for the management of persistent pain, delivered in a specialized prolonged-release tablet form. The medication's overarching purpose is to provide controlled analgesia by modulating pain signals within the central nervous system.


Property Description
Active ingredient Dihydrocodeine hydrogentartrate
Form Prolonged-release tablet (Sustained-release)
Pharmacological class Opioid analgesic
Common use Pain relief (Analgesia)
Origin Semi-synthetic opioid derivative

Dihydrocodeine: Classification and Origin of the Active Ingredient

Dehace retard’s primary component is Dihydrocodeine hydrogentartrate, classifying it as a Monopräparat due to its single active substance. This substance is identified as a semi-synthetic opioid derivative, chemically manufactured from the natural opium alkaloid, codeine. The drug is clinically recognized for its central action, belonging to the opioid analgesic class. This class of substances works by altering the way the brain and spinal cord perceive and respond to pain signals. This means the medicine centrally decreases the intensity of pain signals experienced by the patient.

The Specialized Prolonged-Release Tablet Formulation (Retard)

The medication is specifically presented as an oral prolonged-release tablet, often marketed using the descriptor "retard" to emphasize its unique delivery system. The sustained-release technology utilizes a controlled matrix engineered to regulate the dissolution rate of the active ingredient over an extended duration. This design is a key differentiating factor, enabling the drug to maintain consistent therapeutic levels. Modified-release formulations are designed to achieve steady concentrations of the drug over an extended time. The sustained-release design helps ensure that the analgesic effect lasts longer and is more consistent between doses.

Regulatory References

  1. European Medicines Agency (EMA)
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What side effects are possible with Dehace retard?

Possible Side Effects and Safety Information

Dehace retard (dihydrocodeine prolonged-release) is an opioid medication and carries a risk profile typical of this class of drugs. The officially documented side effects involve various body systems, most commonly the gastrointestinal and central nervous systems.

Common and Clinically Significant Adverse Reactions

The most frequently reported adverse reactions include constipation, nausea, vomiting, dizziness, and somnolence (drowsiness). These effects are generally classified as common. Less common effects involve the nervous system, such as headaches or confusion.

Serious and Safety Considerations

Serious risks associated with dihydrocodeine, as documented in regulatory sources, center on two main areas:

  • Respiratory Depression: This is a potentially life-threatening complication where breathing becomes shallow and slow. The risk is heightened when the medicine is combined with other central nervous system (CNS) depressants, including alcohol or benzodiazepines.
  • Dependence and Addiction: The medication carries a high risk for the development of physical and psychological dependence and abuse. Official documents advise that abrupt discontinuation after prolonged use can lead to withdrawal symptoms, necessitating a gradual dose reduction.

Population-Specific Warnings

Caution is advised and dose adjustment may be required in specific populations. These include elderly patients, and individuals with underlying conditions such as severe renal or hepatic impairment, impaired respiratory function (e.g., severe COPD or asthma), head injuries, or increased intracranial pressure. Use during pregnancy and breastfeeding is generally restricted due to the potential for fetal dependence and adverse effects on the infant. The risk of breathing-related disorders, such as sleep apnea, is also acknowledged, often in a dose-dependent manner.

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Overdose and Emergency Response

Overdose and when to seek help

This section summarizes the official overdose profile for Dihydrocodeine (Dehace retard) as documented in governmental regulatory sources.

Overdose Scope

Category Official Regulatory Statements
Documented overdose presentations Overdose is characterized by profound CNS depression progressing to stupor or coma. Clinical signs documented include pinpoint pupils (miosis), severe hypotension, and bradycardia.
Physiological systems affected (as stated in label) The primary concern is the respiratory system (risk of apnoea or respiratory arrest), the Central Nervous System (loss of consciousness), and the Cardiovascular system.
Dose-related or exposure-related factors (if applicable) The prolonged-release formulation contains a large drug quantity, posing a greater risk for overdose and death. Crushing or chewing the tablet can lead to the rapid absorption of a potentially fatal dose.
Population-specific overdose notes (if applicable) Accidental ingestion, especially by children, may result in a fatal outcome. Elderly or debilitated patients are at an increased risk of life-threatening respiratory depression.
Emergency-response statements (as written in official documents) Management requires the administration of an opioid antagonist (naloxone). Supportive measures include maintaining a patent airway, providing breathing support, and monitoring vital signs.
When immediate medical help is required (label-derived phrasing only) Seek immediate medical attention for suspected overdose. Call emergency services at once if signs of slowed or difficult breathing, severe sleepiness, or inability to wake up occur.

Overdose Classifications (High-Level)

Category Official Regulatory Phrasing
Severity classification (as defined in official documents) Life-threatening respiratory depression; fatal overdose; severe CNS depression progressing to coma.
Regulatory basis (EMA / FDA / etc.) Prescribing Information (FDA), Summary of Product Characteristics (EMA/HPRA), NIH/MedlinePlus.
Overdose-context constraints (as defined in official documents) The large dose in the prolonged-release matrix mandates specific awareness of the risk of rapid absorption upon improper use.

Connection to the Overall Overdose Profile

Official regulatory documents define the overdose profile for Dihydrocodeine primarily by the risk of profound CNS and respiratory depression. This toxicity mandates immediate intervention, with governmental instructions explicitly directing the use of an opioid antagonist and specific supportive care measures. The official guidance emphasizes that the prolonged-release design creates an inherent risk of fatality if the tablet is misused or accidentally ingested by vulnerable populations.

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Therapeutic Uses of Dehace retard

What Dehace Retard Treats: Main Uses and Benefits

Dehace retard is primarily applied for the daily management of persistent pain that is classified as moderate to severe, used in conditions where symptoms are opioid-responsive and require supportive symptom management appropriate for long-term conditions. The prolonged-release formulation is applied when sustained symptomatic relief throughout the day is needed, which helps ease the overall symptom burden and supports general well-being during symptomatic phases.


Therapeutic Scope and Indications

This medication is relevant across symptomatic domains where additional support is needed, including supportive relief for symptoms related to chronic severe pain, assists in addressing acute severe pain episodes following injury or surgery, and symptomatic assistance in palliative care for distressing manifestations. These manifestations may include severe breathlessness (dyspnea) and persistent coughing. It is commonly used in adults and adolescents (typically over 12 years of age) to address symptom patterns that create noticeable interference with functional stability.


Quick Fact: Symptomatic Relief

The prolonged-release formulation is relevant for easing symptoms and helps maintain a consistent level of comfort throughout the day, supporting patients during episodes of heightened discomfort by easing the overall symptom load.

Regulatory References

  1. New Zealand Data Sheet for DHC CONTINUS®
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Eligibility and Restrictions for Use

Dehace retard, a prolonged-release opioid analgesic, has strict eligibility criteria defined by government regulatory agencies. The rules establish who may use the medicine and who is formally prohibited from use.

Populations for Whom Use is Contraindicated

Use of Dehace retard is absolutely prohibited (contraindicated) in the following groups:

  • Children younger than 12 years of age.
  • Children younger than 18 years of age following tonsillectomy and/or adenoidectomy surgery.
  • Patients with severe respiratory depression, severe chronic obstructive lung disease (COPD), or during an acute asthma attack.
  • Patients with known or suspected gastrointestinal obstruction (e.g., paralytic ileus).
  • Individuals with rare hereditary problems such as galactose intolerance or total lactase deficiency.

Conditional Use and Restrictions

For certain populations, use is conditional and requires caution or dose modification, based on official labeling:

Population/Condition Eligibility Status (Regulatory Labeling)
Severe Renal Dysfunction Conditional use; dose reduction is typically required.
Impaired Hepatic Function Conditional use; dose reduction is typically required.
Elderly or Debilitated Patients Conditional use; initiate at the lowest possible dose.
Pregnancy/Lactation Not recommended for regular use (due to risk of neonatal withdrawal and excretion in breast milk).

Use also requires caution in patients with conditions such as raised intracranial pressure, hypothyroidism, biliary tract disorders, or a history of opioid dependence. The medicine is generally indicated for use in adults and adolescents over 12 years of age.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Dihydrocodeine prolonged-release tablets defines specific constraints and restrictions for co-administration with other substances.

Interaction Type Interacting Categories & Formal Outcome
Contraindicated Combinations Co-administration is formally prohibited with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of stopping MAOI therapy. The medicine is also contraindicated in cases of acute alcoholism.
Pharmacodynamic Interactions CNS Depressants (e.g., benzodiazepines, other opioids, hypnotics) cause an additive CNS depressant effect, officially increasing the risk of profound sedation and severe respiratory depression. Serotonergic drugs carry an officially documented risk of Serotonin Syndrome.
Pharmacokinetic Interactions CYP2D6 Inhibitors (e.g., fluoxetine, quinidine) may increase dihydrocodeine plasma concentration but decrease the active metabolite, dihydromorphine, potentially leading to reduced analgesic efficacy. CYP3A4 Inhibitors may increase dihydrocodeine levels, raising the risk of opioid toxicity.

The interaction profile is structured around these critical domains. The official labeling notes that alcohol may enhance the sedative effects and may compromise the integrity of the prolonged-release formulation. Furthermore, elderly or debilitated patients are noted to have a heightened susceptibility to the additive respiratory depressant effects from CNS depressant co-administration, requiring use with caution in these populations.

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Mechanism of Action

Central μ-Opioid Receptor Agonism

The action of Dihydrocodeine is defined by its selective engagement as a full agonist at the μ-opioid receptors (MOR), which are inhibitory G-protein coupled receptors found on neurons throughout the central nervous system. This molecular interaction initiates an internal cascade, leading to the activation of inhibitory Gi/o proteins and fundamentally altering the cell's signaling capacity.

Inhibition of Nociceptive Signal Transmission

Activation of the MOR modulates ion channel function, specifically by promoting the efflux of K^+ ions and inhibiting the influx of Ca^2+ ions. This dual effect results in neuronal hyperpolarization (reduced excitability) and presynaptic inhibition (suppressed neurotransmitter release). This cascade diminishes the transmission of ascending nociceptive signals along central neural pathways and shapes the drug's physiological effect profile.

Modulation of Central Reflex Systems

The mechanism extends to other nuclei in the brainstem, including the region responsible for regulating the cough reflex. MOR activation in these areas leads to a central dampening of the excitability required to trigger the reflex, illustrating that the mechanism modulates the activity of involuntary physiological processes.

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Dosage and Administration Information

Dehace retard is formulated for use as an oral medication, specifically as a prolonged-release tablet to ensure consistent drug delivery over an extended period. Proper administration preserves the drug’s sustained-release properties. To maintain this profile, the tablet must be swallowed whole and should never be crushed, chewed, or dissolved.

The schedule consists of administration twice daily, maintaining an interval of approximately twelve hours between doses. The starting regimen for adults is typically 60 mg per dose, with the dosage adjusted to a maintenance level within the recognized range. The maximum total daily dose is generally capped at 240 mg.

Long-term administration and discontinuation follow specific parameters. For persistent conditions, the drug is used over an extended duration, and treatment involves a gradual dose reduction (tapering) when treatment is concluded. Furthermore, dosage adjustment (reduction or extended interval) is required for patients with renal or hepatic impairment, and treatment for older adults starts at the lower end of the standard dosing range. If a dose is missed, the next dose is taken at the usual time without doubling the amount.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Dehace Retard

Evidence for Use in Chronic Moderate to Severe Pain

Research examining the prolonged-release formulation of dihydrocodeine was studied for its application in conditions marked by functional limitations, particularly chronic pain that is moderate to severe. The primary evidence was evaluated in short-term Randomized Controlled Trials (RCTs), where the formulation was compared with an inactive substance (placebo) or other active comparator treatments. The clinical trials research examined outcomes related to physical discomfort, including measurements of pain intensity using standardized scales, and outcomes reflecting daily functioning or activity level in adults and older adults.

Short-term trial reports described measurements related to changes in these measures during the defined treatment period. While studies explored differences between the prolonged-release and immediate-release forms, findings were mixed regarding any significant advantage for the prolonged-release tablet across all measured outcomes. Long-term effects are not fully established by high-quality RCTs, as follow-up durations were limited in most controlled studies.

Evidence for Use in Cancer Pain and Other Symptoms

The evidence landscape for using this medication for cancer-related pain is primarily built on Observational Studies and Post-Marketing Surveillance data. These studies were used in research exploring how symptoms change over time in patients requiring opioid pain relief. Research describes how the drug was used and how patients reported their overall patient-reported outcomes describing perceived discomfort and total symptom burden.

The medication was also studied for its potential application in managing severe breathlessness (dyspnea). Research in this area is mostly derived from studies of systemic opioids in general, and comparative evidence is lacking specifically for the prolonged-release formulation for this use. Sample sizes were modest in many of the dedicated trials, and evidence quality varies across studies when comparing high-level RCTs with observational data.

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Frequently Asked Questions (FAQ)

Common questions about Dehace retard (FAQ)


Q: How quickly does Dehace retard usually start working?

According to the official product information, this is a prolonged-release medicine formulated to provide consistent relief over an extended period, which is typically 12 hours. Regulatory documents focus on the duration and consistency of the effect rather than specifying a precise time for the initial onset of action.


Q: Can Dehace retard cause changes in mood or anxiety?

Official labeling confirms that some patients may experience changes in mood, including dysphoria (a state of dissatisfaction) and confusional states, listed as uncommon side effects. Additionally, if the medicine is stopped abruptly after prolonged use, anxiety and agitation are officially recognized as potential symptoms of withdrawal.


Q: Is it safe to drive after taking Dehace retard?

Regulatory warnings state that this medicine may cause drowsiness and impair cognitive function. Official regulatory advice notes that driving or operating machinery should be avoided if these side effects are experienced. Official product information emphasizes compliance with all local guidance regarding driving while using opioid medication.


Q: Are there any foods or drinks I should avoid while on Dehace retard?

The most critical restriction in the official documents is alcohol, as it may increase the effects of sedation and the risk of respiratory depression. Some official patient information also suggests caution or avoidance of Grapefruit Juice due to potential effects on how the body processes the medicine.


Q: Is Dehace retard a controlled substance?

Yes, official drug information confirms that the active ingredient, dihydrocodeine, is an opioid analgesic with a high potential for abuse and dependence. For this reason, it is classified as a controlled substance (often Schedule II or III in the U.S.), meaning its distribution and use are strictly monitored by governmental bodies.


Q: Is the 'retard' formulation designed to reduce side effects?

The prolonged-release ('retard') design is primarily intended to maintain consistent drug levels over a 12-hour period and provide steady pain relief. By avoiding the high peak concentrations that occur with immediate-release versions, this formulation is engineered in a way that may help reduce the incidence of certain concentration-dependent side effects.


Q: Can Dehace retard be prescribed for conditions other than its main use?

The main, officially approved indication is for the relief of severe pain. While research has examined the drug's use for managing other severe symptoms, such as breathlessness (dyspnea), official prescribing guidelines are strictly based on the approved pain indication.


Q: Is Dehace retard approved by the FDA?

Yes, the active ingredient, dihydrocodeine, is included in FDA-approved drug products that are listed on the U.S. National Library of Medicine’s DailyMed service. This confirms that the medication has met the requirements for regulatory approval and status in the United States.


Q: Do studies suggest Dehace retard is generally well-tolerated?

Regulatory summaries list several highly common side effects, including constipation, nausea, vomiting, dizziness, and drowsiness. Official sources clearly define the common incidence of these effects, and tolerability remains an individualized experience, and official guidance recommends reporting any side effects to a healthcare professional.


Q: Does Dehace retard contain lactose or gluten?

Official product information confirms that the tablet contains the excipient Lactose anhydrous. It is formally contraindicated for use in individuals with rare hereditary problems like galactose intolerance or total lactase deficiency. Gluten is not typically listed as a standard excipient or contraindication in the official documentation.


Q: Does Dehace retard contain steroids?

No, regulatory documentation identifies the single active ingredient as Dihydrocodeine hydrogentartrate, which is classified as an opioid analgesic. Official labeling does not list any steroid compounds in the composition of the medicine.


Q: Can I take Dehace retard with ibuprofen or Tylenol?

Official patient safety information indicates that this medicine is generally safe to take with common non-opioid pain relievers such as paracetamol (Tylenol) or ibuprofen. However, official warnings address the increased risks associated with combining it with other prescription painkillers that already contain an opioid.


Q: Does Dehace retard affect blood pressure?

Yes, official documentation lists the potential for a drop in blood pressure (hypotension) as an uncommon or serious side effect, particularly when moving from a sitting or lying position to standing. A rise in blood pressure is also a recognized symptom of opioid withdrawal.


Q: Is Dehace retard known to interact with herbal supplements?

Official patient safety information states that there is often not enough clinical information to definitively determine whether it is safe to take this opioid medicine with most herbal remedies and supplements. Official guidance notes that all supplements and remedies should be disclosed to a healthcare provider.


Q: Does Dehace retard interact with caffeine?

Regulatory information notes that the active ingredient, dihydrocodeine, is available in the U.S. as part of a combination product that includes caffeine and acetaminophen. This suggests that a direct, severe interaction between dihydrocodeine and caffeine is generally not expected in official contexts.

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How should Dehace retard be stored and disposed of?

How to Store and Dispose of Dihydrocodeine Prolonged-Release Tablets

Official regulatory guidelines strictly define the required storage and disposal of this opioid analgesic to maintain its stability and prevent unauthorized access.

Storage Requirements

Condition Type Requirement
Temperature Store below 25 C; Do not freeze.
Protection Store in the original package to protect from light and moisture.
Stability Do not take after the expiry date (EXP).
Child Safety Keep out of the sight and reach of children.

Disposal Instructions

Unused or expired tablets must be properly managed due to their nature as a controlled substance. The medicine should be returned to a pharmacy for proper disposal or taken to an authorized drug take-back location. If a take-back option is unavailable, specific regulatory guidance for certain narcotic medicines advises flushing down the toilet to prevent misuse. All disposal must comply with local regulations.

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

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