Paracodina

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Paracodina

Method of action: Analgesic

Treatment option: Pain, Cancer

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 Paracodina

Quick Facts

Property Description
Active Ingredient Dihydrocodeine tartrate
Form Tablets, Oral Solution, Oral Drops
Pharmacological Class Opioid Analgesic, Antitussive
General Purpose Pain management and cough suppression
Origin Semi-synthetic (Codeine derivative)

Dihydrocodeine: Defining the Paracodina Entity and Type

Paracodina is a recognized prescription-only medicine whose identity is defined by its core active substance, dihydrocodeine, chemically prepared as the salt dihydrocodeine tartrate. As a semi-synthetic opioid, the compound is structurally a codeine derivative, providing specific pharmacological characteristics that differentiate it from natural opiates. This substance is clinically recognized for its reliable action on the central nervous system (CNS), confirming its placement within the opioid analgesic class.

Composition and Available Pharmaceutical Forms

The composition of Paracodina is based on the single active ingredient dihydrocodeine tartrate, making it a preparation without combined antipyretic components. It is formulated into several specific dosage form(s) suitable for oral administration, typically including tablets and liquid preparations such as an oral solution or oral drops. The availability of these forms ensures flexibility in delivery, with the active component suspended in an appropriate solid or aqueous vehicle.

General Purpose: Pain Management and Cough Suppression

The primary general therapeutic purpose of the dihydrocodeine entity is twofold: to provide effective pain relief and to serve as a strong antitussive. This dual functionality is supported by pharmacological studies confirming its ability to address both moderate-to-severe pain and centrally-mediated, persistent coughing. A typical use scenario involves providing symptomatic relief for a patient experiencing significant discomfort. Medicines containing this substance are utilized for treating moderate-to-severe pain, which requires a strong level of pain control.

Regulatory References

  1. dihydrocodeine
  2. dihydrocodeine tartrate
  3. semi-synthetic opioid
  4. codeine derivative
  5. central nervous system (CNS)
  6. opioid analgesic
  7. DrugBank Dihydrocodeine Profile
  8. tablets
  9. oral drops
  10. antitussive

What side effects are possible with Paracodina?

Possible Side Effects and Safety Information

The safety profile of dihydrocodeine tartrate is established by regulatory authorities, classifying potential adverse effects by frequency and the physiological systems affected.

Adverse Reaction Classifications

The majority of unwanted effects are classified within the Gastrointestinal and Nervous System domains, which are commonly observed. Effects are grouped as follows in official prescribing information:

Classification Examples of Documented Adverse Reactions
Very Common Nausea, Vomiting
Common Constipation, Dizziness, Headache, Somnolence (Drowsiness), Confusion, Sweating
Uncommon/Rare Bronchospasm, Orthostatic Hypotension, Hallucinations, Mood Changes

Serious Adverse Reactions and Safety Patterns

The most serious risk documented in regulatory warnings is Life-Threatening Respiratory Depression, which is noted to be greatest during the initiation of therapy or following a dose increase. Other serious adverse reactions include Circulatory Depression and severe allergic reactions such as Anaphylaxis.

Population and Duration Constraints

Specific safety considerations exist for certain patient groups. Older Adults may experience increased sensitivity to the depressant effects, and caution is required for patients with Renal or Hepatic Impairment due to altered clearance. The official label also notes the risk of developing Physical Dependence with regular, long-term use and the potential for Withdrawal Syndrome upon cessation. The substance is also associated with the potential for Opioid Addiction, Abuse, and Misuse, as explicitly stated in regulatory warnings.

Overdose and Emergency Response

Overdose and when to seek help

Regulatory authorities define a Dihydrocodeine overdose as a severe event centered on Central Nervous System (CNS) and respiratory depression. Documented clinical manifestations include profound sedation, stupor, progressing to an inability to wake up or coma. The most critical sign is severe, life-threatening respiratory depression, characterized by slow, shallow, or difficult breathing, which can lead to hypoxia, cardiovascular complications such as hypotension, and fatal outcomes including respiratory arrest. Other signs noted in official labeling include constricted pupils (miosis) and bluish discoloration of the skin or lips (cyanosis).

Action Mandated by Regulators

It is officially mandated to seek immediate emergency medical attention if any sign of overdose is suspected, or if breathing becomes compromised. This action is critical because accidental ingestion, particularly by children, is documented as potentially resulting in a fatal overdose. Management protocols described in regulatory documents require securing the airway and administering the opioid antagonist Naloxone to reverse the depressive effects. Supportive care, including the provision of oxygen and close monitoring of vital signs, is also required until the patient is stabilized. Specific populations, including the elderly and patients with chronic pulmonary issues, are noted to have an increased risk of severe outcomes.

Therapeutic Uses of Paracodina

What Paracodina Treats: Main Uses and Benefits

Paracodina is commonly used to help with moderate to severe physical discomfort and pain when symptoms are typically unresponsive to common non-opioid medications. Its therapeutic use is relevant for providing symptomatic support for heightened physical discomfort, which applies to managing intense acute episodes, such as those following surgery or trauma, or for providing ongoing support for chronic pain conditions.

It is applied in addressing symptom clusters that may become intense or disruptive, including persistent, severe coughing fits, moderate to severe pain, and manifestations related to severe breathlessness (dyspnea). “It contributes to support for heightened physical discomfort,” and plays a role in managing cough. This contributes to easing the overall symptom load during periods of heightened symptoms and assists with maintaining functional stability when symptoms are more noticeable.


Quick Fact: Relief for Key Symptom Domains
Targeted Symptoms: Pain, persistent cough, and severe breathlessness (dyspnea).
Typical Context: Acute episodes, post-operative recovery, and supportive palliative care.
Primary Benefit: Provides support that helps ease the overall symptom burden.

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Paracodina — official regulatory information

Paracodina (dihydrocodeine) eligibility is strictly defined by regulatory documents, focusing on absolute exclusions and populations requiring conditional use.

Category Official Regulatory Statement
Populations for whom use is allowed Adults and children 12 years of age and older under standard labeled conditions.
Populations for whom use is contraindicated Children younger than 12 years. Patients under 18 post-tonsillectomy/adenoidectomy. Patients with severe respiratory depression, severe bronchial asthma, severe cor pulmonale, paralytic ileus, or known hypersensitivity to dihydrocodeine.
Age-related eligibility rules Contraindicated in children under 12. Reduced dose is recommended for the elderly due to increased sensitivity.
Condition-specific eligibility rules Use requires caution and potential dose reduction for patients with hepatic impairment (liver problems) or severe renal dysfunction (kidney problems). Caution is also advised for those with raised intracranial pressure or history of opioid abuse.
Pregnancy and lactation eligibility status Not recommended during pregnancy due to the risk of foetal drug dependence. Not recommended during breastfeeding due to the risk of infant respiratory depression.

Eligibility Classifications (High-Level)

Category Official Regulatory Statement
Eligibility severity classification Contraindicated (Absolute non-eligibility), Not Recommended, Use with Caution (Restricted Use).
Regulatory basis Summaries of Product Characteristics (SmPC) and US Prescribing Information.
Eligibility-context constraints Age, Respiratory Status, Organ Function, and Reproductive Status.

The regulatory profile prohibits use in specific, high-risk groups, primarily defined by severe respiratory conditions and age limitations, while mandating cautious or restricted use for patients with impaired clearance (liver/kidney) or neurological compromise. These official statements rigidly define the safe and approved patient population.

What should I know about interactions with other medicines?

The official regulatory documentation for dihydrocodeine (Paracodina) details specific constraints regarding co-administration with other medicinal products and substances. A formal regulatory restriction exists against the concurrent use of Monoamine Oxidase Inhibitors (MAOIs). Co-administration is formally prohibited, and a minimum separation period of 14 days is required after the cessation of MAOI therapy to avoid the risk of severe pharmacodynamic effects such as hypertension or CNS excitation.

A significant pharmacodynamic interaction is documented with Central Nervous System (CNS) depressants, including but not limited to benzodiazepines, sedatives, hypnotics, and general anesthetics. This interaction involves an additive effect, officially increasing the risk of profound sedation, respiratory depression, coma, and severe adverse outcomes. Alcohol (Ethanol) is listed under this category due to its capacity to potentiate these additive CNS depressant effects. This risk is officially noted as heightened in elderly or debilitated patients.

The drug’s pharmacokinetic profile also contributes to documented interactions, primarily through the modulation of CYP450 enzymes. Substances that act as CYP2D6 inhibitors (e.g., fluoxetine, quinidine) can increase the plasma concentration of the dihydrocodeine parent drug while simultaneously reducing the exposure of its active metabolite. Similarly, both CYP3A4 inhibitors and CYP3A4 inducers are officially documented as altering dihydrocodeine exposure, either increasing it (inhibitors) or decreasing it (inducers). Co-administration with mixed agonist/antagonist opioids is officially advised against as it may reduce efficacy or precipitate withdrawal symptoms.

Mechanism of Action

Paracodina is a commercial form of dihydrocodeine, a semi-synthetic opioid. Its primary mechanism involves acting as an agonist at central nervous system mu-opioid receptors (MOR). This interaction is also significantly mediated by its active metabolite, dihydromorphine, formed via metabolism by the cytochrome P450 enzyme CYP2D6.

Binding of the agonist to the MOR, a G-protein coupled receptor, initiates a cascade by coupling to the inhibitory G-protein (Gi/Go subunit). This coupling inhibits the enzyme adenylate cyclase, leading to a reduction in the intracellular concentration of the second messenger cyclic AMP (cAMP). Simultaneously, the activated G-protein complex promotes the opening of potassium channels and the inhibition of voltage-gated calcium channels on the neuronal membrane.

This sequence of intracellular events results in neuronal hyperpolarization and a suppression of neurotransmitter release from presynaptic terminals, particularly in the ascending pain pathways of the spinal cord and brainstem. The system-level physiological consequence is the modulation of nociceptive signal transmission within the central nervous system.

Dosage and Administration Information

How to Use Paracodina: Official Administration Guidelines

Paracodina (dihydrocodeine) is administered exclusively via the oral route, utilizing dosage forms such as immediate-release tablets, prolonged-release tablets, or an oral solution. The official instructions define precise administration rules based on the formulation type and patient population.


Administration Principle Labeled Guidance (Adults)
Dosing Regimen (Immediate-Release) A typical single dose is 30 mg, taken as required, with a maximum of 180 mg over a 24-hour period.
Dosing Regimen (Prolonged-Release) The usual daily range is 60 mg to 120 mg, administered on a twice-daily schedule (every 12 hours). The total dose should not exceed 240 mg daily.
Intake Condition The medicine is generally advised to be taken with or soon after a meal or snack to help minimize potential stomach discomfort.
Administration Constraint Prolonged-release tablets must be swallowed whole and must not be broken, chewed, or crushed to ensure the controlled release of the active ingredient.
Special Population Adjustment Dose reduction is officially recommended for older adults and individuals with impaired kidney or liver function.

These labeled guidelines structure the proper procedural use of the drug by defining the maximum allowable daily dose and establishing the mandatory time interval for each type of formulation. The instructions also set explicit handling requirements, such as ensuring prolonged-release tablets remain intact, and mandate necessary dose modifications for specific patient populations like those with hepatic or renal impairment.

Recent Clinical Evidence

Recent Clinical Evidence: Dihydrocodeine (Paracodina)

Paracodina, which contains the opioid derivative dihydrocodeine (DHC), has been used historically for its antitussive (cough suppressing) and analgesic (pain relieving) properties. Clinical research related to its efficacy, particularly for cough, has been a subject of review by global regulatory and health bodies.

Evaluation of Efficacy

Clinical studies have explored DHC's activity, especially in the context of cough relief for various patient populations. Results from research focusing on DHC and its comparison to other antitussives indicate:

  • Cough Suppression: In studies evaluating cough severity, DHC has been associated with a decrease in cough scores over time in the study groups. The time profile of this observed change was reported to be similar to other antitussive treatments in comparative trials.
  • Evidence Gap: Systematic reviews have highlighted a lack of sufficient evidence from controlled trials to definitively support or oppose the widespread use of codeine or its derivatives as antitussive agents for certain conditions, such as chronic cough in children.

Tolerability Profile

Safety data is primarily derived from clinical experience and monitoring of adverse events in trials and post-marketing reports. Due to its classification as an opioid, the risk of respiratory depression (slowed breathing) and the potential for dependence or addiction are primary safety concerns associated with prolonged use.

Observed Events Clinical Context
Common Side Effects Nausea, vomiting, constipation, drowsiness, and dizziness are commonly reported.
Serious Risks Potential for physical/psychological dependence, respiratory depression (especially at high doses or in sensitive populations), and interactions with other Central Nervous System depressants (e.g., alcohol).

Note: Due to known risks, regulatory guidance often restricts the use of DHC-containing medications in specific sensitive populations, such as children under 12 years of age.

Frequently Asked Questions (FAQ)

Common questions about Paracodina (FAQ)


Q: Is Paracodina the same as codeine?

Dihydrocodeine, the active ingredient in Paracodina, is classified in official documents as a semi-synthetic opioid and a derivative of codeine. This means the substances are chemically related and share a similar structure and mechanism of action, but they are chemically distinct.

Q: What does 'opiate derivative' mean in relation to Paracodina?

The official product information identifies the active ingredient as a semi-synthetic opioid. This classification indicates that the substance is chemically prepared from natural opiates, like codeine, which originate from the opium poppy.

Q: Are there any long-term effects associated with using Paracodina?

Long-term, regular use of any opioid is associated with a risk of developing physical or psychological dependence, or addiction. Official warnings also note that prolonged use of opioids is associated with risks such as hormonal dysfunction and changes in central nervous system function.

Q: How is Paracodina different from similar cough suppressants?

Paracodina's active ingredient, dihydrocodeine, is an opioid that works centrally to address the cough reflex. It achieves this by acting directly on the cough center in the brain. Non-opioid suppressants, in contrast, utilize different pharmacological pathways to address coughing.

Q: Why do official documents state that Paracodina is for short-term use?

Official regulatory labels state that the medicine is intended for short-term use only. This restriction is advised due to the established risk of dependence and medication overuse headache when used for more than three consecutive days.

Q: What kind of cough is Paracodina approved to treat?

The medicine is approved as an antitussive, which means its purpose is to address coughing. Official prescribing information focuses on its use for persistent, centrally-mediated coughing, which is cough originating from the brain's cough center.

Q: Can Paracodina affect driving or operating machinery?

Yes, official product information indicates that dihydrocodeine may impair the mental and physical abilities required for potentially hazardous tasks. Official warnings state that due to the potential for impairment, activities such as driving a car or operating heavy machinery should be avoided if affected by drowsiness or dizziness.

Q: What should I know about taking Paracodina with antidepressants?

Regulatory documents state that dihydrocodeine is contraindicated for use with Monoamine Oxidase Inhibitors (MAOIs). The medicine also interacts with certain other antidepressants that inhibit the CYP2D6 enzyme, which can alter the drug's processing, potentially changing the body's exposure to the medicine or its active metabolite.

Q: Is there a maximum time frame for how long Paracodina should be used?

Yes, official regulatory constraints limit continuous use to no more than three days without a medical re-evaluation, due to the documented risk of dependence. This warning is in place to minimize the risk of developing addiction and overuse headache.

Q: Are there specific food items that interact with Paracodina?

While specific food-drug interactions are not widely highlighted in core regulatory documents, Official regulatory documents mention that the medicine is generally taken with or soon after food or a snack. This context is described to help reduce the potential for stomach discomfort.

Q: Why do some people experience constipation with Paracodina?

Constipation is listed as a common side effect in official safety documents for the active ingredient. This occurs because the dihydrocodeine works by slowing down the normal movement and activity of the digestive system.

Q: Can Paracodina be taken with common pain relievers like ibuprofen?

Co-administration with non-opioid pain relievers such as paracetamol or ibuprofen is not generally listed as restricted in available regulatory guidance. This means the combination is not typically contraindicated by official sources.

Q: How quickly can I expect Paracodina to start working?

Official regulatory documents do not state an exact time of onset for the drug's action. However, the drug is labeled for use at intervals typically ranging from 4 to 6 hours for immediate-release forms, which provides a general timeframe for the expected duration of the effect.

Q: Is Paracodina considered a controlled substance?

Yes, due to its classification as an opioid and semi-synthetic codeine derivative, the drug is regulated as a controlled substance or Drug of Dependence. This status means it is subject to specific legal requirements regarding prescribing, storage, and disposal.

Q: Is Paracodina known to interact with herbal supplements?

Regulatory bodies advise that there is insufficient evidence to confirm safety when the drug is taken alongside herbal remedies and supplements. In such cases, official guidance directs patients to seek advice from their prescribing doctor or pharmacist.

Q: How long does the effect of Paracodina usually last?

The duration of the expected effect depends on the specific formulation being used. For example, immediate-release forms are generally labeled for use at 4 to 6-hour intervals, while prolonged-release tablets are generally taken at 12-hour intervals, providing the labeled timeframe for the effect.

Q: What happens if I miss a scheduled time for Paracodina?

Official patient instructions provide specific guidance to skip the missed administration and take the subsequent dose at the regularly scheduled time. The guidance explicitly cautions against taking a double quantity to make up for the missed one.

Q: Does Paracodina show up on standard drug tests?

Yes, as dihydrocodeine is classified as an opiate, it may be detected in standard drug screenings for opiates. Regulatory and toxicology information indicates it can be detectable for up to 3 days after administration.

Q: Does the efficacy of Paracodina decrease with repeated use?

Official opioid warnings indicate that with repeated use, the body may develop a phenomenon known as tolerance. This means that over time, the initial dose may become less effective, which is a factor that can lead to increased dose requirements and risk of dependence.

Q: What should I do if I suspect an interaction between Paracodina and another drug?

Official patient information directs that if a person suspects an interaction between medicines, professional guidance should be immediately sought from the prescribing doctor or pharmacist.

How should Paracodina be stored and disposed of?

The storage and disposal of Paracodina (Dihydrocodeine Tartrate) are governed by official regulatory standards to ensure product stability and safety.

Official Storage Requirements

The medicine must be stored at a temperature not exceeding 25 C and kept in its original container to maintain its stability until the expiration date. Protection from light and moisture is required. Due to its classification as an opioid, Paracodina must be kept strictly out of the sight and reach of children to prevent fatal accidental ingestion. The use of the product is prohibited after the expiration date listed on the carton.

Disposal Instructions

Regulatory documents mandate that unused or expired Paracodina must not be thrown away in household waste or wastewater. Patients must consult their pharmacist for guidance on proper elimination procedures, which must comply with local regulations for pharmaceutical waste and controlled substances.

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

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