Nidol

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Nidol

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.

Overview of Nidol

What is Nidol? (Overview)

Property Description
Active Ingredients Codeine, Ibuprofen
Form Oral Film-Coated Tablet
Pharmacological Class Combination Analgesic (Opioid / NSAID)
General Purpose Relief of acute moderate pain
Origin Synthetic

What Type of Pain Reliever is Nidol?

Nidol is a brand name for a fixed-dose combination analgesic, a single pharmaceutical preparation engineered to provide comprehensive pain relief by combining two distinct pharmacological classes. This medicine is defined by its two primary active ingredients: the opioid Codeine and the Nonsteroidal Anti-inflammatory Drug (NSAID), Ibuprofen. The physical form of Nidol is typically an oral film-coated tablet, a conventional, synthetic preparation designed for systemic delivery following ingestion.

Unlike single-agent analgesics, which rely on one mechanism, Nidol employs a dual-action approach. The combination of an opioid and an NSAID is clinically recognized for its ability to address pain that is not adequately managed by non-opioid medications alone. Both active components are chemically synthetic compounds, and their fixed inclusion in the tablet form allows for standardized and convenient oral administration, often intended for short-term use.

Understanding Nidol's Dual-Action Composition

The composition of Nidol is based on the synergy between the two active substances, which target pain through different mechanisms within the body. Codeine, present as Codeine phosphate hemihydrate, acts centrally on the nervous system to modify the patient's perception of pain signals, resulting in diminished pain sensation. Conversely, Ibuprofen exerts a peripheral effect by inhibiting the creation of pain- and inflammation-causing chemicals at the site of injury or irritation. Combination analgesics, particularly those pairing an opioid with an NSAID, are recognized to demonstrate efficacy in managing acute pain compared to the respective monotherapies. This formulation is designed to be more effective at easing discomfort than using one ingredient alone.

This pairing of a centrally acting agent with a peripherally acting agent distinguishes Nidol from many other common pain relievers, providing both anti-inflammatory properties and a substantial analgesic effect. The fundamental goal of incorporating both substances into the formulation is to optimize relief by tackling both the pain response in the brain and the underlying physical symptoms of inflammation and fever.

The General Purpose of This Combination Analgesic

The general purpose of Nidol is to achieve stronger pain relief for acute moderate pain when standard pain medications, such as ibuprofen alone, are insufficient. This combination is classified within the pharmacological group of opioids in combination with non-opioid analgesics. This classification confirms the medicine's role in addressing pain by leveraging the properties of both an opioid and a non-opioid substance. This unique formulation allows the medicine to target various components of the pain experience, including the sensory perception of discomfort and the physical symptoms of inflammation, thereby serving as an effective option for typical short-term pain management, such as post-operative pain or musculoskeletal injury pain.

Regulatory References

  1. European Medicines Agency (EMA)

What side effects are possible with Nidol?

Possible Side Effects and Safety Information

The safety profile of this medicine is derived from the risks associated with its dual components: an opioid (Codeine) and an NSAID (Ibuprofen). Officially documented adverse reactions are categorized by frequency and the body system affected, consistent with regulatory standards.


Adverse Reactions and Frequencies

Adverse reactions are formally classified by incidence, reflecting data from regulatory documentation:

  • Uncommon (May affect up to 1 in 100 people): Includes gastrointestinal disturbances such as nausea, abdominal pain, dyspepsia, and mild hypersensitivity reactions like skin rash.
  • Rare to Very Rare: Serious events are classified in this range, including gastrointestinal haemorrhage and perforation, severe hypersensitivity reactions (e.g., anaphylaxis, SJS), acute renal failure, and liver disorder.

Commonly documented effects associated with the nervous system include dizziness and drowsiness.


Safety Considerations and Restrictions

Official labeling addresses specific population risks and exposure patterns:

  • Duration-Related Risks: The risks of tolerance, dependence, and opioid use disorder are officially noted to be associated with repeated administration and prolonged regular use. Withdrawal syndrome may occur upon cessation.
  • Critical Safety Events: The potential for respiratory depression is a serious, known risk, particularly when codeine treatment is initiated or the dose is increased.
  • Population Notes: Regulatory documents specify that older adults have an increased risk of adverse reactions, particularly gastrointestinal events. The medicine is contraindicated in children under 12 years and in individuals who are known to be CYP2D6 ultra-rapid metabolizers.

Overdose and Emergency Response

An overdose of the combination analgesic Nidol involves simultaneous toxicity risks from its two active components, Codeine and Ibuprofen. Official regulatory information mandates that immediate emergency medical treatment must be sought, even if the person appears asymptomatic, due to the potential for life-threatening outcomes.

Manifestations of overdose are documented according to the specific toxicological profile of each ingredient. Overexposure to the opioid component (Codeine) may result in severe Central Nervous System (CNS) depression and life-threatening respiratory depression, characterized by slow or shallow breathing, profound sedation, stupor, and eventual loss of consciousness or coma. Severe hypotension and seizures are also documented. The NSAID component presents risks including acute gastrointestinal disturbances, such as severe stomach pain and gastrointestinal bleeding, as well as potential acute kidney failure.

The required emergency procedures are officially defined. Management involves supportive and symptomatic treatment, including hospital monitoring of vital signs. The opioid component’s severe depressive effects may be specifically addressed by the administration of Naloxone, which is listed in official procedures. Regulatory guidance highlights special population considerations, particularly the documented risk of fatal overdose in children from the opioid ingredient, and increased risk of GI/renal injury in elderly patients.

Therapeutic Uses of Nidol

What Nidol Treats: Main Uses and Benefits

The codeine and ibuprofen combination is commonly used in situations involving certain distressing symptoms where pain intensity has become challenging and may not be sufficiently managed by standard non-opioid medications alone.

This combination of active ingredients is applied in addressing symptom clusters that may become intense or disruptive, such as severe headaches, migraines, neuralgia, back pain, rheumatic discomfort, and pain associated with acute musculoskeletal injuries. It is generally relevant for managing symptoms related to inflammatory or irritative states. The combination provides symptomatic relief that helps patients cope more steadily with difficult episodes and contributes to easing the overall symptom load when symptoms escalate temporarily.

It may be applied in contexts involving heightened systemic burden following events like dental procedures (toothache) or during surgical recovery. The combination generally contributes to easing the overall symptom load for short-term management.


Quick Fact: Relief for Acute Moderate Pain

The medication may assist in symptom stabilization and is aimed at supporting general comfort during symptomatic phases when short-term symptomatic assistance is needed for discomfort that interferes with daily comfort.

Eligibility and Restrictions for Use

Who Can and Cannot Use Nidol?

Eligibility for Nidol (Codeine/Ibuprofen) is determined by official regulatory criteria, primarily related to age, physiological status, and underlying health conditions, reflecting the risks of both the opioid and NSAID components. The medicine is generally permitted for adults and children aged 12 years and over for short-term, acute moderate pain that is not adequately relieved by non-opioid medications alone.


Absolute Contraindications (Must Not Use)

  • Children younger than 12 years of age.
  • Adolescents under 18 who have undergone tonsillectomy or adenoidectomy for obstructive sleep apnoea.
  • Breastfeeding mothers.
  • Patients known to be CYP2D6 ultra-rapid metabolizers.
  • Patients with severe respiratory depression, active gastrointestinal bleeding or peptic ulceration, or gastrointestinal obstruction.
  • Patients with severe renal, hepatic, or heart failure.

Conditional Restrictions

Use is restricted or not recommended in patients with severe hepatic impairment, severe renal impairment, and in pregnant women from 20 weeks gestation onward. Caution is required when prescribing to older adults and adolescents (12-18) with compromised respiratory function.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Nidol (Nimesulide) is defined by its effects on drug metabolism and its additive actions with certain drug classes, as documented in official regulatory labeling.

Pharmacodynamic and Contraindicated Interactions

Nidol must not be co-administered with other systemic NSAIDs or oral anticoagulants, as these combinations significantly increase the risk of gastrointestinal bleeding and hemorrhage. The drug can also diminish the efficacy of antihypertensive agents, including ACE inhibitors and diuretics, by inhibiting renal prostaglandin synthesis. The co-administration with corticosteroids or SSRIs carries an increased risk of gastrointestinal adverse effects.

Pharmacokinetic Interactions and Exposure

Nidol is documented as an inhibitor of the CYP2C9 enzyme, which can lead to clinically significant increases in the plasma concentrations of co-administered drugs that are substrates of this enzyme, such as Phenytoin and certain anticoagulants. Clearance of renally eliminated drugs, notably Lithium and Methotrexate, is reduced, potentially resulting in elevated exposure and toxicity of these agents. For Methotrexate, this interaction is particularly pronounced.

Product and Timing Constraints

Absorption of Nidol may be delayed when taken with food. Combining Nidol with alcohol increases the risk of gastrointestinal toxicity. If low-dose Aspirin (Acetylsalicylic Acid) is required for cardiovascular prophylaxis, official labeling advises taking Nidol at least two hours after the immediate-release Aspirin to minimize pharmacodynamic interference. Interaction consequences may be more severe in the elderly and in patients with impaired renal or hepatic function.

Mechanism of Action

How Nidol Works: Mechanism of Action

Nidol's pharmacodynamic action is centered on its role as a selective inhibitor of the enzyme Cyclooxygenase-2 (COX-2). The drug preferentially targets and binds to the active site of the COX-2 enzyme, thereby preventing the conversion of arachidonic acid into prostaglandins (specifically pro-inflammatory eicosanoids). This molecular event modifies an early and essential step in the biochemical cascade that typically amplifies localized cellular responses. The consequence of this primary interaction is the modulation of local signaling intensity within affected tissues.

This mechanism results in distinct physiological adjustments. The reduced concentration of prostaglandins leads to a decrease in chemical signaling that modulates nociceptor activity and contributes to the containment of fluid leakage from local blood vessels. Primarily exerted at the peripheral level where COX-2 is induced, this targeted intervention modifies the regulatory feedback loop dynamics within the physiological systems.

Dosage and Administration Information

Nidol is administered through the oral route and is supplied as a film-coated tablet that must be swallowed whole with water. The medicine is typically taken with, or immediately after, food or a drink of milk to mitigate potential gastrointestinal effects.

The standard adult regimen involves taking one or two tablets (corresponding to 200 mg or 400 mg of Ibuprofen) as required. Doses are typically spaced every four to six hours, and a minimum interval of four hours is maintained between administrations. The total consumption must not exceed a maximum of six tablets in any 24-hour period, which limits the total daily Ibuprofen intake to 1200 mg.

The use of this combination product is limited to a maximum duration of three consecutive days. This follows the principle that the lowest effective dose should be used for the shortest possible time. Furthermore, the product is not to be used in children under 12 years of age. If a dose is missed, it is taken when remembered, unless the next dose is almost due; a double dose must never be taken. Concurrent administration with any other product containing codeine or other Nonsteroidal Anti-inflammatory Drugs (NSAIDs) is to be avoided.

Recent Clinical Evidence

Research evidence / Overview of Studies for Nidol

Evidence for Use in Acute Moderate Pain

Research involving the combination of Ibuprofen and Codeine has primarily relied on short-term Randomized Controlled Trials (RCTs) and comprehensive Systematic Reviews to explore its use in evaluating outcomes related to episodes of acute moderate pain. These trials were applied in studies examining patient-reported experiences of pain. Researchers investigated outcomes related to physical discomfort, focusing on how symptoms change over defined time intervals. Specifically, studies monitored measures like the time to the onset of analgesic action and the total measured outcomes related to perceived discomfort over several hours.

Findings describe patterns observed in these studies, where measured outcomes related to perceived discomfort were generally reported. The research so far describes that the studies primarily monitored adults experiencing high-intensity, short-duration pain. However, results apply only to the populations studied and only for short-term use.

Evidence for Use in Post-Operative Pain

The evidence base for the use of this combination in post-operative settings, such as following dental procedures or minor surgery, is founded on rigorous study types. RCTs and subsequent Meta-analyses have been central to this research. These studies were often conducted during periods of increased symptom activity following the procedure, observing responses over defined time intervals. Research examined patient-reported outcomes describing perceived discomfort and the proportion of patients achieving specific thresholds for measured changes in perceived discomfort.

Studies report how symptoms evolved in the observed populations, where findings consistently described patterns in outcomes related to pain intensity measures during the immediate recovery phase. The primary limitation here is that follow-up durations were limited to the immediate post-operative period (often less than 24 hours), which suggests the results apply only to that acute phase.

What Is Still Uncertain About Nidol Research

Several research limitations are noted in the overall evidence landscape. The primary uncertainty is the limited information for long-term outcomes data, as follow-up durations were consistently limited to short, acute periods. This means the research provides context only for acute assessment, not for prolonged use. Data for certain groups, such as frail older adults or individuals with specific comorbidities, remain insufficient. Furthermore, comparative evidence is lacking against some alternative pain management strategies.

Key Studies & References Codeine for Acute Dental Pain and Acute Pain Related to Dental Procedures

Frequently Asked Questions (FAQ)

Common questions about Nidol (FAQ)

Q: What is the primary way Nidol works in the body?

A: Nidol works by targeting and blocking specific COX enzymes, which are known to play a role in the body's inflammatory response. Official product information indicates this action helps to reduce both pain and inflammation. By temporarily inhibiting these enzymes, Nidol limits the production of certain substances that cause swelling and discomfort.

Q: Does Nidol interact with common painkillers like paracetamol (acetaminophen)?

A: Regulatory documents state that using Nidol simultaneously with other non-steroidal anti-inflammatory drugs (NSAIDs) is generally not recommended due to increased risks. However, official sources typically do not list a specific, strong interaction with paracetamol (acetaminophen) when used as directed. Regulatory sources generally emphasize the importance of discussing all medication use with a qualified healthcare provider.

Q: Can I take Nidol with food, or does it need to be taken on an empty stomach?

A: Official product information indicates that Nidol is typically administered with or immediately following a meal. Taking the medicine with food is a common practice that helps to minimize the possibility of stomach irritation and gastrointestinal side effects. This approach is often used to help reduce the potential for digestive discomfort.

Q: What should I do if I miss a dose of Nidol?

A: Official product labeling contains specific instructions regarding missed doses, which typically recommend taking a missed dose if remembered soon after, or skipping it if the next dose is near. These instructions are detailed in the 'How to Use Nidol' section. Official guidance advises against taking a double dose to compensate for a missed dose.

Q: How long does it typically take for Nidol to start relieving pain?

A: Studies and official information indicate that Nidol generally starts to work relatively quickly to reduce pain and inflammation, though the exact timing can vary among individuals. The full therapeutic effect is typically observed when the medication is taken consistently as directed by the prescribing information. This ensures the sustained relief that is often documented in research.

Q: Is it safe to drink alcohol while taking Nidol?

A: Regulatory documents generally state that alcohol consumption should be limited or avoided while using this medication. This guidance is in place because both Nidol and alcohol can independently irritate the stomach lining. Combining them may increase the potential risk of gastrointestinal side effects, such as upset or bleeding.

Q: Can Nidol be crushed or chewed, or must the tablet be swallowed whole?

A: Official product information specifies that Nidol tablets are intended to be swallowed whole with fluid. The medication label indicates that the tablets should not be crushed, chewed, or split, unless the product is specifically designed to be divided. This administration method is necessary for the medication to be released and absorbed as intended.

Q: Does Nidol cause drowsiness or affect my ability to drive?

A: According to the official product information, Nidol may cause side effects such as dizziness, drowsiness, or visual disturbances in some people. If a person experiences these effects, the official labeling advises against performing tasks that require full alertness, like driving or operating heavy machinery. Patients should note how the medicine affects them personally.

How should Nidol be stored and disposed of?

How to Store and Dispose of Nidol?

The official storage and disposal guidelines for Nidol (Codeine/Ibuprofen) are defined by two key regulatory concerns: maintaining product stability and mitigating the risks associated with the opioid component.


Storage Requirements

Condition Requirement
Temperature Store below 30^circC.
Environment Keep in a cool, dry place, away from heat, moisture, and direct sunlight.
Packaging Keep the tablets in the original pack to ensure stability throughout the 3-year shelf life.
Safety It is mandatory to keep Nidol out of the sight and reach of children, preferably in a locked cabinet, to prevent accidental ingestion.

Official Disposal Instructions

The proper disposal of unused or expired Nidol must follow rules for controlled substances. The best method is to utilize a drug take-back program or an authorized collection site. If a take-back option is unavailable, the disposal of this opioid-containing medicine should follow specific government guidance, which may include flushing or mixing with an unappealing substance and sealing in a bag before discarding in household trash, as specified by the national medicines authority.

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

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