Наклофен

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Наклофен

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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 Наклофен

What is Наклофен? (Diclofenac)

Наклофен is a medicinal product defined by its active pharmaceutical ingredient, Diclofenac, which is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). This systemic medication is designed to provide symptomatic relief from pain, inflammation, and fever by intervening in specific biological pathways.


Quick Facts: Foundational Identity

Property Description
Active Ingredient Diclofenac (Sodium/Potassium Salt)
Form Tablets, Injection Solutions, Suppositories, Gels
Pharmacological Class Non-Steroidal Anti-Inflammatory Drug (NSAID)
Chemical Origin Synthetic (Phenylacetic Acid Derivative)
General Purpose Anti-inflammatory, Analgesic, Antipyretic

What Type of Medicine is Наклофен?

Наклофен is a synthetic medicine derived from the phenylacetic acid derivatives family, a chemical structure utilized for its inhibitory effects on inflammation. The active substance, Diclofenac (typically as the sodium or potassium salt), functions as a non-narcotic agent designed to reduce the body's response to inflammatory stimuli. Its formulation is distinguished by the availability of specialized forms, such as enteric-coated tablets or the dual-release capsules known as Naklofen Duo, which modify the release profile compared to standard immediate-release preparations. The systemic forms are typically prescription-only (Rx) medications.


The Forms and General Purpose

Diclofenac is available across several dosage forms and corresponding routes of administration, allowing for delivery based on clinical need, such as an injection solution for rapid intervention or a transdermal gel for localized topical application. The overarching purpose of Наклофен is to exert anti-inflammatory, analgesic, and antipyretic actions, which is the foundational basis for its use in managing symptoms like persistent musculoskeletal pain and inflammation. The medication is designed to reduce inflammation and fever, helping to ease discomfort associated with these key symptoms.

What side effects are possible with Наклофен?

Possible Side Effects and Safety Information

Naclofen (Diclofenac) carries an officially documented safety profile, with potential adverse reactions classified by frequency and system-organ class in regulatory documents, such as the EMA Summary of Product Characteristics and the FDA Prescribing Information.

Common adverse reactions typically include gastrointestinal disturbances like nausea, vomiting, diarrhea, and abdominal pain, as well as central nervous system effects such as headache and dizziness. Increased liver enzymes (transaminases) are also commonly documented.

Classification System-Organ Class Examples
Rare Hypersensitivity reactions (anaphylaxis), gastrointestinal bleeding or ulceration, and hepatitis.
Very Rare Severe skin reactions (e.g., Stevens-Johnson syndrome), blood disorders (e.g., thrombocytopenia), and acute renal failure.

Serious warnings highlight the risk of cardiovascular thrombotic events, including myocardial infarction and stroke, and serious gastrointestinal ulceration, bleeding, and perforation, which can occur at any time. Regulatory data specifies that the risk of these serious events may increase with higher dosage and prolonged duration of use.

Safety is formally constrained for certain populations. The medicine is contraindicated in the late stages of pregnancy and in patients with established severe conditions, including severe heart failure (NYHA Class II-IV) and ischemic heart disease. Older adults are officially noted as being at a greater risk for serious adverse events.

Overdose and Emergency Response

Overdose and when to seek help

Overdose of Diclofenac (Наклофен) is defined by regulatory bodies through specific clinical and physiological manifestations. Documented signs of acute intoxication often involve the Gastrointestinal (GI) system, presenting as nausea, vomiting, abdominal pain, or diarrhea. Central Nervous System (CNS) effects may also occur, including drowsiness, dizziness, or disorientation.

Severe outcomes are formally recognized and include Acute Renal Failure, Hepatic Dysfunction (liver damage), and life-threatening Gastrointestinal Bleeding or perforation. In severe cases, high exposure may lead to neurological events such as seizures or coma. The elderly patient population is specifically noted in regulatory documentation as having a greater risk for serious GI events following high exposure.

There is no specific antidote known for Diclofenac overdose. The official guidance mandates that management is limited to symptomatic and supportive treatment. Therefore, regulators explicitly state that one must seek medical help right away if an overdose is suspected or has occurred. Immediate emergency help is also required for any severe, sudden-onset reactions, such as anaphylaxis. Continuous medical surveillance, including monitoring of vital signs and renal function, may be required.

Therapeutic Uses of Наклофен

What Наклофен Treats: Main Uses and Benefits

Naclofen (which contains the active ingredient diclofenac sodium) is classified as a non-steroidal anti-inflammatory drug (NSAID). This medication is commonly used to help manage symptoms related to inflammatory or irritative states and acute or chronic pain associated with a variety of conditions.

Diclofenac is indicated for relief of the signs and symptoms of conditions like osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It may assist with easing symptoms related to inflammatory or irritative states and localized discomfort, such as swelling, stiffness, and joint pain, which are common symptoms that interfere with daily functioning in these chronic conditions.

This medication is also considered relevant in clinical settings that involve acute or unstable symptom patterns, such as managing acute episodes of pain, including menstrual cramps. Its primary role is to provide supportive relief, used in situations involving certain distressing symptoms. This medication is often used during phases when symptoms become more noticeable. It contributes to easing the overall symptom burden during symptomatic periods and supports the patient during difficult episodes by easing distress.

Quick Fact: Relief for Symptoms related to inflammatory or irritative states

Eligibility and Restrictions for Use

The eligibility for using systemic Наклофен (Diclofenac) is strictly governed by regulatory classifications based on patient health status and life stage. The medicine is generally approved for Adults and certain Adolescents (typically over 14 years old), while Geriatric Patients are eligible but require enhanced medical caution and monitoring.

Diclofenac is contraindicated and must not be used by patients with a known hypersensitivity to NSAIDs, aspirin, or any component of the formulation. Absolute exclusion also applies to patients with active gastrointestinal ulceration, bleeding, or perforation, and those with established severe heart failure (NYHA Class II–IV), severe renal failure, or hepatic failure. Use is also prohibited in the setting of Coronary Artery Bypass Graft (CABG) surgery.

Regarding specific populations, use is contraindicated in the last trimester of pregnancy (starting at approx 30 weeks gestation) and is not recommended for women who are breastfeeding. Additionally, caution is mandated for patients with mild to moderate renal or hepatic impairment, or a history of GI issues, reflecting conditional use defined by organ function and comorbidities.

What should I know about interactions with other medicines?

Official Interaction Statements

  • Co-administration with Aspirin (analgesic doses) and other non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 selective inhibitors is explicitly restricted due to a documented, significantly increased risk of serious gastrointestinal events.
  • The strong CYP inhibitor Voriconazole is documented to increase the systemic exposure (AUC and Cmax) of Diclofenac, requiring monitoring according to the label.
  • Use with Anticoagulants (e.g., Warfarin) and Anti-platelet Agents increases the regulatory-documented risk of bleeding and may prolong Prothrombin Time.
  • Concomitant use with ACE Inhibitors, Angiotensin Receptor Blockers (ARBs), or Diuretics may diminish the antihypertensive or natriuretic effect of these medicines. In populations such as the elderly or those with renal impairment, this combination carries a labeled risk of deterioration of renal function.
  • Diclofenac can increase the plasma concentrations of Lithium, Digoxin, and Methotrexate, increasing the risk of toxicity for these co-administered medicines as stated in official labeling.
  • For specific fast-acting oral forms, administration with food is documented to reduce the medicine's effectiveness due to decreased and delayed absorption.
  • Alcohol consumption is listed as a factor that may increase the potential for serious gastrointestinal adverse events.

Connection to the Overall Interaction Profile

Regulatory documents establish that Diclofenac's interaction structure is defined by both additive pharmacodynamic effects and pharmacokinetic clearance inhibition. This profile mandates formal constraints, including contraindicated combinations with other anti-inflammatory drugs and specific restrictions related to a patient's renal status. The documentation further details conditions requiring administration timing consideration in relation to meals to ensure proper systemic exposure.

Mechanism of Action

1. Inhibition of Prostaglandin Synthesis

The primary mechanism involves the reversible inhibition of Cyclooxygenase (COX) enzymes, which are critical for converting arachidonic acid into prostanoids. By blocking the active sites of both COX-1 and COX-2, the drug directly limits the production of key inflammatory mediators, such as Prostaglandin E2 ( PGE2). This action initiates a molecular cascade that leads to the reduction in local inflammatory mediator signaling and modifies the hypothalamic thermoregulatory set-point.


2. Modulation of Nociceptor Hypersensitivity

The mechanism extends to the nociceptive signaling system by reducing local PGE2 concentrations near peripheral nerve endings (nociceptors). PGE2 typically lowers the activation threshold for these nerve endings, chemically inducing a state of sensitization. By suppressing PGE2 synthesis, the drug reduces this chemical sensitization, thereby decreasing the transmission of nociceptive signals sent from the tissue to the central nervous system, with action predominantly focused on peripheral nociceptive pathways.


3. Central Thermoregulatory Adjustment

The drug's mechanism includes action within the brain's hypothalamus, where PGE2 acts to pathologically elevate the body’s core temperature set-point during an immune response. By reducing the central synthesis of PGE2, the drug adjusts the hypothalamic thermoregulatory set-point to a physiological baseline. This specific central action is the mechanistic explanation for the modulation of body temperature.

Dosage and Administration Information

How to Use Наклофен — Administration Guidelines

Naclofen (diclofenac) is used at the lowest effective dose for the shortest duration necessary. The maximum recommended daily dose for all systemic forms is generally 150 mg.

Administration Details

Administration Scope Instruction
Route(s) of Administration Oral (tablets, capsules) and Parenteral (Intramuscular, Intravenous)
Oral Dosing Schedule 75 mg to 150 mg daily, taken in two or three divided doses.
Timing in Relation to Meals Oral tablets/capsules should be swallowed whole with liquid. Immediate-release forms are preferably taken before meals; prolonged-release forms may be taken with or after food.
Preparation Requirements Intravenous infusion requires dilution immediately before use with a compatible solution (e.g., 0.9% sodium chloride or 5% glucose) and buffering.
Age-Group Rules Not recommended for children under 14 years for oral use. Parenteral forms (IM/IV) are generally not recommended for those under 18 years. The lowest effective dose should be used for the elderly.
Missed-Dose Rules If a dose is missed, the standard procedure is to skip the missed dose and resume the normal schedule, to avoid exceeding the maximum daily dose.
Special Procedural Conditions Oral forms must be swallowed whole and not chewed, broken, or divided. Intramuscular injections must be administered as a deep intragluteal injection.

Procedural Structure

The protocol for administration requires all oral dosages to be taken without altering the pill structure to maintain the intended absorption. The dosing regimen is limited by a maximum daily threshold, with a focus on dividing the total amount throughout the day to sustain levels without excessive concentration. The overall use profile emphasizes limiting the treatment period to the shortest possible duration while restricting higher-dose or long-term systemic use to minimize potential risks.

Recent Clinical Evidence

Research Evidence / Overview of studies for Наклофен (Diclofenac)

Evidence for Use in Chronic Inflammatory Joint Conditions

The research base for studies related to osteoarthritis symptoms is primarily built upon short-term randomized controlled trials (RCTs). These studies explored how symptoms change over time by evaluating outcomes related to physical discomfort and outcomes reflecting daily functioning or activity level, such as pain severity and joint stiffness. Trials monitored patterns observed when comparing diclofenac to a placebo or other agents. However, existing studies provide limited insight into long-term outcomes. Long-term effects are not fully established from controlled trials, and the results apply only to the populations studied.

Evidence for Use in Systemic Inflammatory Diseases

Studies related to systemic inflammatory disease symptoms, such as rheumatoid arthritis and ankylosing spondylitis, rely on RCTs and systematic reviews. These studies focus on conditions involving periods of heightened symptoms, monitoring changes in clinical signs and patient-reported functional capacity. The trials reported on changes in symptoms linked to inflammatory or irritative states. Comparative evidence is lacking when research explores outcomes alongside more recently developed treatments for these systemic diseases.

Evidence for Use in Acute Pain and Musculoskeletal Issues

Research examined diclofenac for outcomes describing episodic or acute changes related to acute musculoskeletal discomfort (e.g., sprains) and acute episodes of pain. The evidence largely stems from short-term, placebo-controlled randomized trials that monitor metrics like the time and magnitude of measured pain reduction. The primary research characteristic is that follow-up durations were limited, typically a few days up to two weeks.

Summary of Research Limitations and Uncertainty

While short-term patterns are documented, certainty remains low in several areas. Long-term effects are not fully established from controlled data past the one-year mark, and evidence durability relies on observational studies. Data for certain groups remain insufficient; for instance, there is limited information available for pediatric populations. Additionally, evidence quality varies across studies, and research exploring comparative outcomes against other NSAIDs was associated with variable data.

Frequently Asked Questions (FAQ)

Common questions about Наклофен (FAQ)


Q: What is the main purpose of Наклофен?

A: Наклофен belongs to the Non-Steroidal Anti-Inflammatory Drug (NSAID) class. Its primary purpose, as described in official labeling, is to provide symptomatic relief by treating pain and reducing inflammation in the body.


Q: Is Наклофен the same kind of medicine as ibuprofen?

A: Both Наклофен (diclofenac) and ibuprofen are classified as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). They share a fundamental similarity in that their primary mechanism involves inhibiting Cyclooxygenase (COX) enzymes to reduce inflammation and pain.


Q: How quickly does Наклофен usually start working?

A: Regulatory data indicates that the onset of pain relief can vary depending on the specific formulation being used. For some fast-acting oral forms, the medicine begins to work relatively quickly. For chronic conditions like arthritis, the full therapeutic effect may only be noticeable after one or two weeks of consistent treatment.


Q: Is Наклофен considered a strong pain reliever?

A: The medicine is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID) and is used for the management of pain and inflammation. Its dosage ranges include therapeutic levels that are used to address both acute and chronic pain conditions, as noted in official documents.


Q: Can people who have high blood pressure use Наклофен?

A: Regulatory warnings state that NSAIDs, including this medicine, may lead to the development of new high blood pressure or worsen existing high blood pressure. Official documents advise that patients with hypertension should be treated only after careful consideration, and their blood pressure should be regularly monitored.


Q: Do I need a prescription to get Наклофен?

A: The availability of Наклофен depends on the regulatory region and the specific strength or formulation. Higher-dose systemic forms typically require a prescription, while lower-dose topical gels or specific low-dose oral formulations may be available without one for short-term use.


Q: What is the difference between Наклофен capsules and suppositories?

A: Capsules are a systemic dosage form administered orally, usually taken with a liquid. Suppositories are another systemic dosage form that is administered rectally. Suppositories are sometimes utilized, for example, at bedtime, to help manage pain and stiffness overnight.


Q: Does Наклофен cause sleepiness or drowsiness?

A: Yes, official regulatory documents list somnolence, which means drowsiness or sleepiness, as an uncommon side effect of the central nervous system that has been reported during use of this medicine.


Q: Is it better to take Наклофен in the morning or the evening?

A: Official documentation advises that the total daily dose should generally be taken in divided doses (two or three times daily). While there is no strict official preference for morning or evening administration, some regulatory labels suggest that a bedtime dose may help manage pain and stiffness that occurs during the night and morning.


Q: Does the onset of action differ between the tablet and liquid forms of Наклофен?

A: Regulatory data indicates that the onset of pain relief can vary depending on the specific formulation being used. Official pharmacokinetic data shows that the speed of absorption and the peak concentration in the body can also be influenced by the administration method and whether the medicine is taken with food.


Q: Is it true that taking a proton pump inhibitor might be suggested with Наклофен?

A: Yes. Regulatory-supported guidance notes that a proton pump inhibitor (a medicine used to reduce stomach acid) is often co-prescribed with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) like diclofenac. This approach is described in guidance as a way to help mitigate the risk of serious gastrointestinal adverse events for patients considered to be at a higher risk.


Q: Is there a maximum recommended period for continuous use of Наклофен?

A: Official safety advice consistently emphasizes that the medicine should be used for the shortest duration necessary to control symptoms. This is because the risks, particularly those related to the cardiovascular and gastrointestinal systems, may increase with both the dose and the length of time over which it is taken. Specific limits for short-term use may be stated on over-the-counter packaging.


Q: What makes Наклофен different from other NSAIDs?

A: Наклофен (diclofenac) is part of the Non-Steroidal Anti-Inflammatory Drug (NSAID) class, meaning it works similarly to others by inhibiting COX enzymes. Regulatory reviews have noted that its cardiovascular risk profile is considered similar to some selective NSAIDs. Its specific chemical structure, which includes two chlorine groups, is a feature that distinguishes it from other NSAIDs.


Q: Are headaches a potential side effect of Наклофен?

A: Yes, headaches are listed in regulatory documents as a common side effect of this medicine. This is based on reports from clinical trials and post-marketing surveillance data.


Q: Why is Наклофен sometimes prescribed for gout?

A: Наклофен is officially indicated in regulatory documentation for the treatment of inflammatory diseases and painful conditions. Specifically, the acute attacks of gout, which are characterized by severe inflammation, are included among the conditions for which this medicine is used.


Q: Can the topical gel form of Наклофен be used for back pain?

A: Topical forms of diclofenac are officially approved for the local, symptomatic relief of pain and inflammation. While the medicine is commonly indicated for joint conditions like knee osteoarthritis, the specific approval for back pain depends on the regulatory region and formulation.


Q: Is Наклофен suitable for managing menstrual pain?

A: Yes. Official regulatory documents and product labeling include the treatment of primary dysmenorrhoea (menstrual pain), as an indicated use for this medicine.


Q: Are there specific instructions for stopping Наклофен treatment?

A: Regulatory guidance emphasizes that treatment should utilize the lowest effective dose for the shortest duration. The official guidance emphasizes using the medicine to control symptoms, which aligns with the overall principle of using the medicine for the shortest duration necessary. There are no official instructions for a specific weaning or tapering process.


Q: How does Наклофен affect fever?

A: The medicine's mechanism of action, as described in regulatory documents, includes its ability to adjust the body's central temperature regulation center in the brain (the hypothalamic thermoregulatory set-point). This action is the pharmacological basis for its effect in helping to modulate an elevated body temperature (fever).


Q: What is the official information regarding Наклофен use during pregnancy?

A: Official labeling contains a strict warning not to use this medicine from the start of the 20th week of pregnancy. The warning indicates that use after this time has the potential to cause harm to the developing fetus, including the risk of fetal renal dysfunction and premature closure of the ductus arteriosus.


Q: Do official sources describe any severe allergic reactions to Наклофен?

A: Yes. Official warnings and precautions describe severe allergic reactions, including life-threatening anaphylactic reactions and severe skin reactions (like Stevens-Johnson syndrome). These reactions can potentially occur even in patients who have not previously taken the medicine.


Q: Are there any specific lab tests that should be monitored while on Наклофен?

A: Official documentation advises that certain functions should be periodically monitored, particularly during long-term use. This monitoring may include checks of liver function, kidney function, and blood counts, according to official guidance for long-term treatment.


Q: Is Наклофен effective for nerve pain?

A: The medicine is officially indicated for treating inflammatory and painful conditions. Its mechanism of action includes reducing the sensitivity of peripheral nerve endings, which are involved in sending pain signals. However, it is not listed specifically as a treatment for neuropathic pain (pain caused by nerve damage).


Q: Can Наклофен be used for children?

A: Official documentation specifies age restrictions based on the formulation. For example, some oral forms are generally not recommended for children under 14 years of age. Parenteral (injection) forms are generally not recommended for those under 18 years, as specified in regulatory documentation.


Q: What are the known interactions with herbal remedies?

A: While specific herbal remedies are often not listed individually in official documents, warnings caution against combining the medicine with any substance that could increase the risk of bleeding (like anticoagulants) or negatively affect the kidneys. This principle should be considered when evaluating herbal supplements.


Q: Is it normal to feel dizzy when starting Наклофен?

A: Yes. Dizziness is listed in official regulatory documents as a common side effect of the central nervous system that has been reported with the use of this medicine.


Q: Can patients with asthma use Наклофен?

A: Official labeling contains a contraindication which states the medicine should not be used in patients who have a history of asthma, hives (urticaria), or other allergic-type reactions that have occurred after taking aspirin or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).


Q: Can Наклофен be used for chronic pain, or just short-term issues?

A: Official documents list indications for both short-term use, such as acute pain relief, and long-term use, such as managing the symptoms of rheumatoid arthritis. However, for all uses, the emphasis is always on using the lowest effective dose for the shortest possible time.


Q: What are the regulatory instructions about driving or operating machinery while taking Наклофен?

A: Official instructions advise that patients who experience undesirable effects such as dizziness, somnolence (drowsiness), or disturbances in vision should not operate machinery or drive a vehicle.


Q: What is the official recommendation regarding Наклофен and breastfeeding?

A: Regulatory data indicates that the medicine passes into breast milk in small amounts. Some official authorities advise that, due to limited information on the effects on the infant, it may be preferable to use alternative medicines with more published safety data, particularly when nursing a newborn.


Q: What pain conditions is Наклофен most commonly used for, according to studies?

A: According to official indications, this medicine is commonly used for a range of inflammatory and painful conditions. These include the symptoms of rheumatoid arthritis, osteoarthritis, acute attacks of gout, and pain related to kidney stones or gallstones.


Q: Why do some people experience swelling while taking Наклофен?

A: Regulatory documents report that the Non-Steroidal Anti-Inflammatory Drug (NSAID) class of medicines is associated with fluid retention and edema (swelling). This is a known undesirable effect that has been reported with this medicine.


Q: What is the scientific evidence regarding Наклофен for joint inflammation?

A: The medicine is officially indicated for the symptomatic relief of pain and inflammation in joint conditions, such as osteoarthritis and rheumatoid arthritis. This is supported by clinical research evidence cited in regulatory documents.

How should Наклофен be stored and disposed of?

Storage and Disposal of Diclofenac (Naclofen)

Official regulations require diclofenac sodium (Naclofen) to be stored under Controlled Room Temperature conditions, specifically between 20° and 25°C (68° and 77°F). Maintaining product stability is mandatory, which necessitates protection from moisture and light. For this reason, the medication must be stored in a tight, light-resistant container.

Required Conditions

Condition Requirement
Temperature Controlled Room Temp (20°–25°C)
Environment Protect from moisture and light
Child Safety Keep out of the sight and reach of children

All medication must be kept out of the sight and reach of children. When the product is expired or unused, it must be discarded by following local regulatory requirements for pharmaceutical waste, and generally should not be placed in household trash or wastewater.

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

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