Seractil

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Seractil

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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.

Overview of Seractil

Seractil is a pharmaceutical preparation whose active ingredient, Dexibuprofen, is defined as a highly purified, single-component medicine belonging to the class of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). It is administered orally via film-coated tablets to provide relief from pain, inflammation, and fever.


Quick Facts

Property Description
Active ingredient Dexibuprofen (S(+)-ibuprofen)
Form Film-coated tablets
Pharmacological class Nonsteroidal Anti-Inflammatory Drug (NSAID)
Common purpose Provides analgesia, anti-inflammatory, and antipyretic effects
Origin Synthetic, purified single-isomer derivative of ibuprofen

Identity, Composition, and Origin

Seractil is classified as a propionic acid derivative within the broader NSAID category. Its active component, Dexibuprofen, is chemically the S-enantiomer of ibuprofen, which is the molecular form responsible for the anti-inflammatory and pain-relieving effects. As the active enantiomer, Dexibuprofen works by blocking an enzyme that produces prostaglandins, substances involved in inflammation and pain. This substance is delivered as a single-component product in an oral dosage form, typically as a film-coated tablet.

This composition is chemically distinct from conventional ibuprofen, which is typically manufactured as a racemate—a mixture containing both active and largely inactive enantiomers. Seractil, by isolating only the specific, therapeutic component, is considered a single-isomer NSAID.

General Purpose and Action

The fundamental purpose of Seractil is to provide symptomatic relief by broadly addressing the processes that lead to physical discomfort. The mechanism involves interrupting the cycle of pain and inflammation at the biochemical level. Dexibuprofen is effective for managing general acute symptoms, such as the fever associated with inflammatory responses. By suppressing prostaglandin synthesis, the medicine enables the body to reduce the intensity of the inflammatory response, offering effective symptomatic relief.

Regulatory References

  1. European Medicines Agency (EMA) Referral

What side effects are possible with Seractil?

Possible Side Effects and Safety Information

Seractil (dexibuprofen) is a non-steroidal anti-inflammatory drug (NSAID) whose safety profile, as defined by regulatory bodies, includes risks characteristic of this drug class. Adverse reactions are classified by frequency and system-organ class.


Adverse Reaction Scope

Classification Examples of Affected System-Organ Classes
Common Gastrointestinal disorders (e.g., nausea, vomiting, abdominal pain)
Rare to Very Rare Severe acute hypersensitivity reactions, severe skin reactions, severe hematologic changes

Serious Adverse Reactions

The most clinically significant adverse reactions documented in regulatory sources include gastrointestinal bleeding, ulceration, or perforation, which can be fatal. Seractil, like other NSAIDs, may also be associated with a small increased risk of arterial thrombotic events (e.g., myocardial infarction and stroke), particularly when used at high doses and for prolonged periods. Severe, potentially fatal skin reactions, such as Stevens-Johnson syndrome, have also been reported rarely.

Safety Restrictions and Limitations

  • Contraindications: Seractil is strictly contraindicated in patients with active gastrointestinal bleeding or ulceration, severe heart failure, severe kidney or liver disease, and in the last trimester of pregnancy (from the beginning of the 6th month).
  • Population-Specific: Elderly patients and those with a history of gastrointestinal ulcers or cardiovascular risk factors (e.g., hypertension, diabetes, high cholesterol) are at higher risk for serious complications and may require regular safety monitoring.
  • Exposure Pattern: The risk of serious gastrointestinal and cardiovascular events is explicitly documented to increase with increasing dose and duration of treatment. It is recommended to use the lowest effective dose for the shortest necessary period.

Overdose and Emergency Response

The official labeling for the active ingredient in Seractil (Dexibuprofen) details the potential manifestations and mandated emergency actions required in the event of an overdose. Documented presentations often involve gastrointestinal disturbances such as nausea, vomiting, and abdominal pain, along with Central Nervous System (CNS) effects like drowsiness, dizziness, headache, and nystagmus.

Severe outcomes are explicitly documented in regulatory sources and necessitate urgent medical attention. These complications include progression to coma, generalized seizures, acute renal failure, and cardiovascular shock or significant hypotension.

Due to the risk of serious outcomes, regulatory guidance requires immediate action: Get medical help or contact a Poison Control Center right away if an overdose is suspected. This immediate action is mandatory regardless of initial symptom severity. Management is strictly supportive, as no specific antidote is known for this Nonsteroidal Anti-Inflammatory Drug (NSAID) overdose. Treatment focuses on symptomatic and supportive care, with hospital observation often required for a minimum of four to six hours to monitor for signs of serious complications. Official notes also confirm that elderly patients are at a heightened risk for severe outcomes, particularly gastrointestinal bleeding.

Therapeutic Uses of Seractil

Seractil (Dexibuprofen) is relevant when supportive symptom management is appropriate for conditions presenting with systemic or localized discomfort associated with specific acute or chronic inflammatory states. The medicine is generally used to help address symptom clusters that may become intense or disruptive, especially those related to inflammatory or irritative states. The therapeutic applications for Dexibuprofen are similar to those for racemic ibuprofen.

The medication is commonly used for musculoskeletal pain, symptomatic relief of joint stiffness in conditions where symptoms may intensify temporarily, like osteoarthritis, management of recurrent cyclical pain (dysmenorrhoea), and relief of mild to moderate pain following minor surgical or dental procedures.

Managing Discomfort and Maintaining Stability

The primary benefit is supportive, assisting with maintaining functional stability in situations where patients experience heightened discomfort and the symptoms interfere with daily functioning. It is applied in scenarios where additional management of discomfort is required, contributing to easing the overall symptom load.

Quick Fact: Relief for Inflammation and Pain

Context Benefit
Symptom Cluster Pain, stiffness, swelling, and fever.
Typical Use Acute pain episodes and symptomatic management of recurrent/chronic pain.
Core Benefit Contributes to easing the overall symptom load during periods of heightened discomfort.

Eligibility and Restrictions for Use

Seractil (Dexibuprofen) eligibility is strictly defined by regulatory authorities based on age, physiological status, and underlying health conditions.

Contraindications (Must Not Use)

Official labeling mandates that Seractil must not be used in patients with a known hypersensitivity to any NSAID or to the active ingredient. Absolute non-eligibility applies to those with an active gastrointestinal ulcer or a history of GI bleeding/perforation, severe renal dysfunction, severely impaired hepatic function, or severe heart failure. It is also contraindicated for women from 20 weeks of pregnancy onward.

Age and Conditional Eligibility

Seractil is generally approved for use in adults. For the pediatric population, use is not recommended for children under eight years of age as safety and efficacy are not established in this group. Older adults are eligible but require close monitoring due to an increased frequency of adverse reactions.

High doses (e.g., ge 1200 mg/day) should be avoided in patients with established cardiovascular disease (e.g., stroke or ischemic heart disease). Caution is explicitly required for patients with bronchial asthma or a history of inflammatory bowel disease.

What should I know about interactions with other medicines?

The interaction profile of Seractil (Dexibuprofen) is defined by its class as an NSAID, resulting in several officially documented restrictions and monitoring requirements with co-administered substances, as stated in government regulatory documents.

Documented Interaction Patterns

Contraindicated Combinations

  • Other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Co-administration with other NSAIDs, including selective cyclooxygenase-2 (COX-2) inhibitors and high-dose salicylates, is generally contraindicated due to a significantly increased pharmacodynamic risk of gastrointestinal bleeding and ulceration.
  • High-Dose Methotrexate: The concomitant use of Methotrexate at doses of 15 mg/week or more is prohibited, as Dexibuprofen reduces its renal clearance, leading to elevated plasma levels and potential toxicity.

Interactions Affecting Drug Concentrations

  • CYP2C9 Inhibitors: Substances classified as potent CYP2C9 inhibitors (e.g., Fluconazole, Voriconazole) may increase the plasma concentration and total systemic exposure (AUC) of Dexibuprofen.
  • Lithium and Digoxin: Dexibuprofen can decrease the renal clearance of both Lithium and Digoxin, resulting in increased serum concentrations of these medicines. Regulatory labels require monitoring of serum levels if co-administered.

Interactions Affecting Bleeding and Renal Function

  • Oral Anticoagulants and Antiplatelet Agents: There is a documented increased pharmacodynamic risk of hemorrhage when Dexibuprofen is combined with anticoagulants (e.g., Warfarin) and antiplatelet agents (e.g., Ticlopidine).
  • Antihypertensives and Diuretics: Dexibuprofen may reduce the efficacy of diuretics and certain blood pressure medicines, such as ACE inhibitors. This combination carries an increased risk of acute renal injury, particularly in elderly or volume-depleted patients.

Timing-Based Administration Rules

  • Low-Dose Aspirin: Dexibuprofen may interfere with the antiplatelet effect of low-dose aspirin. When co-administration is necessary, regulatory documents require a specific separation of doses to ensure the preservation of aspirin's desired effect.

Mechanism of Action

Mechanism of Action: Dexibuprofen

Dexibuprofen is a reversible non-selective inhibitor that exerts its action by blocking the active sites of the Cyclooxygenase ( COX-1 and COX-2) enzymes. This molecular interaction prevents the conversion of Arachidonic Acid into Prostanoids, primarily suppressing the synthesis of Prostaglandin E2 ( PGE2) —a key chemical mediator involved in nociceptive and thermoregulatory signaling.

The PGE2 suppression results in a dual modulation of the nervous system. Peripherally, the reduction in PGE2 concentration desensitizes nociceptors (pain-transmitting nerves), reducing the excitability of peripheral pain pathways. Centrally, the mechanism involves reducing PGE2 synthesis in the hypothalamus, which is the physiological event required to reset the elevated body temperature set-point back to a regulated state.

As the active S-enantiomer, Dexibuprofen achieves direct enzyme inhibition, bypassing the metabolic conversion required by racemic ibuprofen. However, the non-selective mechanism is constrained by the unavoidable suppression of homeostatic functions mediated by constitutive COX-1 (e.g., gastric protection).

Dosage and Administration Information

Seractil is administered via the oral route as a film-coated tablet, available in multiple strengths, including 200 mg, 300 mg, and 400 mg. The dosing strategy centers on using the lowest effective dose for the shortest duration necessary to control symptoms, a principle applied to Nonsteroidal Anti-Inflammatory Drugs.

The recommended daily adult dosage typically ranges from 600 mg to 900 mg of dexibuprofen, divided into up to three single doses per day. For acute conditions or exacerbations, the dose may be temporarily increased, but the maximum daily dose must not exceed 1200 mg. During chronic use, the dosage should be adjusted to the lowest effective maintenance dose.

The tablets may be taken with or without a meal, though taking them with food can help reduce gastrointestinal irritation. However, consuming the medicine alongside a meal may lead to a slightly later onset of action. If a dose is forgotten, the instruction is to take the next dose as scheduled and not to take a double dose to make up for the missed one.

Special consideration is given to specific patient populations. For older adults and individuals with mild to moderate renal or hepatic impairment, treatment should be initiated at a reduced starting dose or the lower end of the dosage range. Furthermore, specific pediatric dosing regimens exist for children from eight to eighteen years old. The score line found on some tablets is solely to facilitate swallowing, and is not intended to divide the tablet into equally precise doses.

Recent Clinical Evidence

Research Evidence: Overview of Studies for Seractil (Dexibuprofen)


Evidence for Use in Osteoarthritis and Related Pain

This section will summarize the available randomized controlled trials and clinical studies that examined the drug in research exploring outcomes related to physical discomfort and inflammation linked to joint conditions (osteoarthritis) and other musculoskeletal issues. Research has primarily focused on conditions marked by functional limitations in the hip or knee joints, which often involve periods of heightened symptoms. The studies monitored patient-reported outcomes describing perceived discomfort and movement ability over defined time intervals.

The findings from these controlled settings describe patterns observed in the studies where participants assigned the medication provided different reports on pain intensity and functional measures when compared to control groups. Some trials explored the use of the study drug compared to other non-steroidal anti-inflammatory drugs (NSAIDs) and reported that the findings describe group patterns where the measured changes in reported pain outcomes across groups were observed, and different rates of gastrointestinal events were also tracked in the study reports.


Evidence for Use in Acute Pain Conditions

This section will outline the structure of short-term clinical research, including trials and observational data, focusing on studies that evaluated the drug in conditions involving acute, non-chronic pain. Research examined the drug in specific conditions associated with acute or disruptive episodes, such as pain related to menstruation (primary dysmenorrhea) and post-operative pain. Outcomes describing episodic or acute changes were the primary focus, and studies were conducted during periods of increased symptom activity.

In these acute research scenarios, the findings describe patterns observed in the symptoms of the study populations were noted when compared to control groups. However, follow-up durations were limited by the nature of acute pain research, which means long-term outcomes in these settings are not characterized due to limited research. The sample sizes were modest in some of the pain models studied, which suggests that the results apply only to the populations studied.


Long-Term Studies and Follow-up

Research in chronic conditions has been studied for up to a year, providing insight into intermediate-term use. These studies describe patterns related to the reported incidence of adverse events, particularly concerning the gastrointestinal tract, over the period of observation. However, class-level data for high-dose NSAIDs, which include similar drugs, suggests an association with an increased risk of serious cardiovascular events may be observed with long-term use. Long-term effects are not fully established beyond the intermediate follow-up for most patients.


What is Still Uncertain About Seractil (Dexibuprofen)

Comparative evidence is lacking for many direct head-to-head comparisons with all other available NSAIDs, making it difficult to fully contextualize the findings. Subgroup findings are uncertain for many groups not well-represented in the main trials. Furthermore, the study results reflect the specific conditions under which they were conducted (e.g., highly controlled environments) and research does not determine whether an individual will respond similarly in a real-world setting. Limited information is available regarding its research focus and safety profile in younger populations (children and adolescents).

Key Studies & References

  1. Efficacy and long-term safety of dexibuprofen [S(+)-ibuprofen]: a short-term efficacy study in patients with osteoarthritis of the hip and a 1-year tolerability study in patients with rheumatic disorders
  2. The effects and safety of dexibuprofen compared with ibuprofen in febrile children caused by upper respiratory tract infection

Frequently Asked Questions (FAQ)

Common questions about Seractil (FAQ)


Q: How long does it take for Seractil to start working?

Studies and official information indicate that for acute pain, Seractil (dexibuprofen) has a relatively fast onset of action. In clinical trials, measurable pain relief for many patients was observed within the first 1 to 3 hours after a dose.


Q: If I have high blood pressure, is Seractil safe for me to take?

Regulatory information advises caution for individuals with cardiovascular risk factors, including high blood pressure (hypertension), diabetes, or high cholesterol. It is important to discuss your medical history with a doctor or pharmacist, as the product label recommends that treatment should not exceed the lowest effective dose or necessary duration for these patients.


Q: Can I split the Seractil tablet to take a half dose?

According to the official product information, the score line on the tablet is present only to make the tablets easier to swallow. It is not intended for dividing the tablet to create a precise smaller dose. Splitting the tablet does not guarantee an exact, accurately measured dose.


Q: What should I do if I experience a serious side effect like severe stomach pain or rash?

Official patient information directs that if you experience signs of a serious problem, such as difficulty breathing, swelling of the face, severe rash, or signs of bleeding like vomiting blood or passing black stools, you should discontinue use immediately and seek prompt medical attention. These symptoms could indicate a severe allergic reaction or serious internal bleeding.


Q: What are the different strengths or dosages Seractil is available in?

Seractil is manufactured as film-coated tablets in several strengths, including 200 mg, 300 mg, and 400 mg. The selection of a starting strength and the determination of the overall daily intake must be discussed with a healthcare professional.


Q: Can children or teenagers take Seractil?

Official labeling states that Seractil is not recommended for children under 8 years of age. For children and adolescents from 8 to 18 years old, use is allowed for certain conditions, but specific dosing regimens apply, which should be determined and advised by a healthcare professional.

How should Seractil be stored and disposed of?

The storage and disposal of Seractil (dexibuprofen) must follow the instructions provided in the official product information to ensure its stability and safe handling.

Storage Requirements

Condition Requirement (Official Statement)
Temperature Do not store above 25 °C.
Packaging Store in the original package.
Stability The shelf life is 3 years in the blister packaging.
Handling Keep out of the sight and reach of children.

Disposal Instructions

Do not use this medicine after the expiry date printed on the packaging. Medicines should not be disposed of through wastewater or household waste. Any unused medicinal product or waste material must be disposed of in accordance with local requirements to help protect the environment. You should return expired or unused tablets to your pharmacist for safe disposal.

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

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