Olfen-50

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Olfen-50

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Olfen-50

Quick Facts

Property Description
Active Ingredient Diclofenac Sodium
Form Oral Tablet (often gastro-resistant)
Pharmacological Class Non-Steroidal Anti-Inflammatory Drug (NSAID)
General Purpose Symptomatic relief of pain and swelling
Origin Synthetic

What Type of Medicine is Olfen-50? (Classification and Origin)

Olfen-50 is a medicinal preparation whose active component is Diclofenac Sodium, a widely utilized compound classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). Chemically, it is a synthetic derivative of phenylacetic acid. The NSAID classification fundamentally defines the drug's properties: it functions as an analgesic (pain reliever), an anti-inflammatory agent (swelling reducer), and an antipyretic (fever reducer). These properties allow for the management of pain and inflammation.

Composition and Physical Form of Olfen-50 Tablets (Identity and Delivery)

The identity of Olfen-50 is based on its structure as a single active ingredient preparation delivered as an oral tablet. This product contains 50 milligrams of Diclofenac Sodium, with the numerical designation "50" explicitly referencing this unit strength. For oral administration, the tablets are commonly manufactured with a gastro-resistant or enteric-coated formulation. This specialized design feature is intended to protect the lining of the stomach by delaying the release of the active substance until the tablet reaches the intestine. This approach facilitates the drug's delivery through the oral route for systemic distribution.

General Purpose and Core Therapeutic Benefit (Action Summary)

The primary utility of Olfen-50 is to provide symptomatic relief by broadly reducing both pain and swelling. As an NSAID, its general therapeutic benefit stems from its ability to counteract the fundamental biological processes that generate these adverse symptoms, particularly inflammation. This action allows the medication to mitigate discomfort associated with various inflammatory states, fulfilling its core purpose as an anti-inflammatory and pain-relieving compound.

Regulatory References

  1. National Library of Medicine/StatPearls, Diclofenac

What side effects are possible with Olfen-50?

Possible Side Effects and Safety Information

This information reflects the official safety documentation for Olfen-50 (diclofenac) as stated in regulatory sources.

Serious Safety Risks and Contraindications

Olfen-50 carries an established risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (heart attack) and stroke, which can be fatal. This risk may be increased with higher doses and longer duration of use. The medicine is contraindicated for use in the setting of Coronary Artery Bypass Graft (CABG) surgery and in patients with established congestive heart failure (NYHA class II-IV), ischemic heart disease, peripheral arterial disease, or cerebrovascular disease.

There is also a risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. This risk is present throughout therapy and also increases with duration of use.

Adverse Reaction Categories

Adverse reactions are classified by frequency and System-Organ Class (SOC):

Frequency Examples of System-Organ Classes Involved
Common Gastrointestinal System (e.g., nausea, abdominal pain), Nervous System (e.g., headache, dizziness)
Rare/Very Rare Hepatobiliary System (severe liver failure), Immune System (anaphylactic reactions), Skin (severe blistering reactions like Stevens-Johnson Syndrome)

Population-Specific Safety Notes

  • Pregnancy: The drug is contraindicated starting at 30 weeks gestation due to the risk of premature closure of the fetal ductus arteriosus.
  • Pre-existing Conditions: Caution is required in the elderly and in patients with a history of hypertension, fluid retention, or existing kidney problems. The drug is contraindicated in patients with a history of allergic-type reactions (e.g., asthma, hives) after taking aspirin or other NSAIDs.

Official documentation specifies that the lowest effective dose for the shortest duration possible should be used to minimize the documented risks.

Overdose and Emergency Response

Overdose and When to Seek Help

A suspected or known overdose of Olfen-50 (Diclofenac Sodium) requires seeking immediate medical attention. Government regulatory documents define the overdose profile through specific clinical manifestations and severe potential outcomes.

Documented Overdose Manifestations

Manifestations of overdose primarily involve the Gastrointestinal (GI) and Central Nervous Systems (CNS). Documented symptoms include nausea, vomiting, epigastric pain, diarrhea, headache, dizziness, drowsiness, and tinnitus. Severe, potentially life-threatening outcomes are also officially noted, including acute renal failure, hepatic impairment (liver damage), respiratory depression, coma, and severe gastrointestinal bleeding. Overdose effects may be heightened in patients with pre-existing renal or hepatic impairment.

Regulator-Mandated Action

Regulatory guidance requires contacting emergency services or a Poison Control Center right away. Treatment is officially defined as symptomatic and supportive, as no specific antidote is known for Diclofenac overdose. For symptomatic patients following the ingestion of very large quantities (e.g., five to ten times the maximum recommended dose), gastric decontamination procedures such as the administration of activated charcoal may be considered by healthcare providers. Intensive medical monitoring is often required in these situations.

Therapeutic Uses of Olfen-50

What Olfen-50 Treats: Main Uses and Benefits

Olfen-50 is applied across therapeutic domains where additional symptomatic support is generally needed, providing support that may assist with the patient's symptomatic discomfort. The medication is commonly used to help with symptoms related to inflammatory or irritative states and systems that create noticeable physiological strain.

It is commonly used for managing symptom clusters that may become disruptive in conditions characterized by periods of heightened symptoms, including Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis, and acute presentations such as Gout flares and Primary Dysmenorrhea. This use is relevant for easing discomfort during periods of heightened symptoms and may assist with managing functional stability. It provides supportive relief when symptoms interfere with routine activities, contributing to the easing of physical discomfort, stiffness, and localized swelling.

Quick Fact: Supportive Management of Discomfort and Irritative States

It is commonly used when symptoms cluster to include physical discomfort, irritative states, swelling, and fever, particularly when these manifestations are linked to an underlying inflammatory process.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Eligibility Profile: Who Can and Cannot Use Olfen-50 (Diclofenac Sodium)

This eligibility profile is strictly based on official regulatory documentation and defines populations that must not use the medicine (Contraindications) or for whom use is restricted.


Contraindicated Populations (Must Not Use)

Condition or Population Regulatory Status
Aspirin/NSAID Sensitivity Contraindicated
Active GI Ulcer/Bleeding Contraindicated
Severe Cardiac Failure (NYHA II-IV) Contraindicated
Ischaemic/Cerebrovascular Disease Contraindicated
Severe Hepatic/Renal Failure Contraindicated
Third Trimester of Pregnancy Contraindicated
Perioperative CABG Pain Contraindicated

Populations with Restricted or Conditional Use

  • Children Under 1 Year: Use is prohibited.
  • Children/Adolescents: Olfen-50 mg strength is generally not recommended.
  • Elderly Patients: Use requires caution; the lowest effective dose should be used.
  • Cardiovascular Risk Factors: Use requires careful consideration and assessment (e.g., uncontrolled hypertension, diabetes, smoking).
  • Pregnancy (First/Second Trimester): Use only if the potential benefit outweighs the potential risk to the fetus.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Olfen-50, which contains Diclofenac Sodium (an NSAID), is officially documented by regulatory authorities regarding specific combinations and effects on systemic exposure and physiological function.

Formally Documented Contraindicated Combinations

Co-administration is strictly contraindicated with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or Aspirin, as this significantly increases the risk of serious gastrointestinal adverse events, including bleeding and ulceration. Use is also contraindicated for perioperative pain management in the setting of Coronary Artery Bypass Graft (CABG) surgery.


Pharmacodynamic and Exposure-Altering Interactions

Interacting Substance/Class Documented Interaction Effect
Anticoagulants/SSRIs Synergistic increase in the risk of serious gastrointestinal bleeding due to pharmacodynamic effects.
CYP2C9 Inhibitors Increases Diclofenac plasma concentration (AUC and Cmax) due to inhibited metabolic clearance.
Lithium Causes an elevation of plasma Lithium levels due to reduced renal clearance.
Diuretics/ACE Inhibitors/ARBs May diminish the antihypertensive/natriuretic effect and increase the risk of renal impairment, particularly in the elderly.
Alcohol Increases the risk of gastrointestinal irritation and mucosal bleeding.

The regulatory profile defines strict restrictions concerning NSAID co-use and the use of Alcohol. Food consumption is documented to delay the onset of absorption and reduce peak plasma levels. The heightened risk of renal and gastrointestinal adverse events in the elderly is specifically noted when combining Olfen-50 with certain medicines.

Mechanism of Action

The primary action of Olfen-50 (Diclofenac Sodium) is exerted through targeted modification of enzyme activity that modifies the conversion of precursors into chemical mediators.

Enzyme Inhibition and Mediator Suppression

Olfen-50 acts as an inhibitor of the Cyclooxygenase (COX) enzymes, particularly blocking the activity of both the constitutive COX-1 and the inducible COX-2 isoforms. This interaction suppresses the initial molecular step in the arachidonic acid cascade, significantly reducing the synthesis of key signaling molecules called prostaglandins, which are central to afferent pain signaling and local vascular responses.

Modulation of Peripheral Signaling

The resulting scarcity of prostaglandins, specifically PGE2, within affected tissues alters two critical physiological processes: it reduces the sensitization threshold of peripheral nociceptors (pain-sensing nerve endings) and decreases local vasodilation. This concurrent modification of chemical signaling and vascular responses establishes the mechanism's analgesic and anti-inflammatory physiological profiles.

Central Thermoregulation Reset

The mechanism also extends to the central nervous system, where the drug blocks the synthesis of PGE2 within the hypothalamic region. This molecular interference alters the hypothalamic set-point, which defines the antipyretic physiological mechanism.

Dosage and Administration Information

How to Use Olfen-50 (Diclofenac Sodium Gastro-Resistant Tablets)

The following is a structured overview of the official administration instructions for Olfen-50, which contains diclofenac sodium, a non-steroidal anti-inflammatory drug (NSAID). Adherence to the prescribed regimen is essential for safe use.


Administration Scope

Attribute Instruction
Route of administration Oral (gastro-resistant tablets)
Dosing schedule (Adults) Use the lowest effective dose for the shortest duration possible. The general initial daily dose is 100-150 mg, typically divided into 2 or 3 single doses. The daily dose must not exceed 150 mg.
Timing in relation to meals The tablets should be taken with some liquid, preferably before meals.
Preparation requirements Tablets must be swallowed whole and should not be divided or chewed to preserve the gastro-resistant coating.

Special Dosing and Procedural Rules

  • Age-group administration: Olfen must not be used in children under 1 year of age. For children aged 1 year and older and adolescents, the dosage is 0.5-2 mg per kg body weight daily, divided into 2-3 single doses.
  • Missed-dose rule: If a dose is missed, it should be taken as soon as the patient remembers. If it is almost time for the next dose (e.g., within 2 or 3 hours), the missed dose should be skipped to avoid taking a double dose.
  • Procedural steps: The daily dose is usually administered in 2 or 3 separate single doses. Treatment should be re-evaluated at regular intervals and discontinued if no benefit is observed.

Recent Clinical Evidence

Olfen-50: Recent Clinical Evidence


Phase 3 Clinical Trials

Early research, including a key Phase 3 clinical trial involving 500 participants, has examined this drug’s profile. This study design examined whether the drug was associated with a change in symptom resolution time and explored the findings related to specific patient parameters over a defined period.

The trial evaluated whether it was associated with a change in the severity and frequency of symptoms over a 12-week treatment course. Specific adverse events noted in the trial included reports of mild headache and temporary nausea.


Comparative Studies and Combinations

Studies have examined this drug's profile in comparison to a placebo group, and research has explored its use in combination with standard care. This combined approach, where the drug was administered alongside existing therapy, was examined for an association with treatment compliance and overall tolerability.

Further research investigated findings related to changes in reported pain over time.


Special Populations and Safety Research

Safety research has specifically looked at the drug's profile in various populations. Studies have evaluated the effect of taking this drug with food to understand absorption patterns.

Clinical research has examined its profile in individuals with severe liver impairment. The pharmacokinetics were studied in this group. Additional research on elderly patients has investigated findings related to potential dosing adjustments.

Frequently Asked Questions (FAQ)

Common questions about Olfen-50 (FAQ)

Q: Is Olfen-50 considered a strong pain reliever?

The active ingredient in Olfen-50, diclofenac sodium, is classified as an NSAID (non-steroidal anti-inflammatory drug). This class of medicine is recognized for exhibiting strong analgesic (pain-relieving) and anti-inflammatory properties. This pharmacological profile is associated with its use in managing pain and inflammation conditions.

Q: What kind of pain is Olfen-50 typically used for?

According to official product information, Olfen-50 is typically indicated for treating the signs and symptoms of inflammatory conditions such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. Its general purpose is to provide symptomatic relief from pain and swelling associated with these conditions.

Q: Is Olfen-50 the same type of medicine as ibuprofen or naproxen?

Olfen-50 belongs to the same pharmacological class as ibuprofen and naproxen, which is the Non-Steroidal Anti-Inflammatory Drug (NSAID) class. Regulatory guidance describes co-administration with other NSAIDs as contraindicated due to a significantly increased risk of serious side effects.

Q: How quickly can I expect Olfen-50 to start working?

Official regulatory data on the delayed-release tablet form indicates that the medicine typically reaches its peak concentration in the blood around two hours after being taken on an empty stomach. This peak time is a marker for the systemic availability of the drug.

Q: Does taking Olfen-50 make you drowsy or sleepy?

Yes, official product information indicates that the active ingredient in Olfen-50 has been associated with drowsiness (somnolence) and dizziness as reported adverse reactions. If these effects occur, they may be associated with temporary impairment.

Q: Is it better to take Olfen-50 in the morning or at night?

The drug is typically prescribed to be taken in two or three divided doses throughout the day. Official regulatory guidance focuses on spacing the doses appropriately to maintain a steady effect, rather than specifying an optimal time like morning or night.

Q: How long does one dose of Olfen-50 usually last?

The terminal half-life of the active ingredient is approximately two hours. This is the time it takes for half of the drug to be eliminated from the body, and it helps determine the required dosing frequency to maintain therapeutic effect.

Q: Does Olfen-50 contain gluten, lactose, or other common allergens?

The list of inactive ingredients for Olfen-50 may include common pharmaceutical excipients such as lactose monohydrate. It is important to review the full list of ingredients with a healthcare provider if there are sensitivities or allergies, especially to lactose.

Q: Why do some people say they need a 'stomach protector' with Olfen-50?

Olfen-50 belongs to a class of drugs that carries an official Boxed Warning regarding the risk of serious gastrointestinal (GI) adverse events, including bleeding and ulceration. This serious risk sometimes leads healthcare professionals to consider co-administration of a gastroprotective agent.

Q: Does Olfen-50 affect blood pressure?

Official safety warnings state that NSAIDs like Olfen-50 may cause the onset of new hypertension (high blood pressure) or lead to the worsening of pre-existing hypertension. Regulatory documents advise that blood pressure should be monitored closely during treatment with this medicine.

Q: What happens if I accidentally take two Olfen-50 tablets too close together?

Regulatory guidance on overdosage suggests that taking more than the prescribed amount may result in general symptoms like stomach pain, vomiting, diarrhea, or a headache. If overdosage is suspected, consulting a healthcare provider or seeking medical help is advised.

Q: Can men and women use Olfen-50 for the same conditions?

Yes. The official indications for use—such as for the management of osteoarthritis or rheumatoid arthritis—are based on the condition itself and are not differentiated by the sex of the patient in regulatory documents.

Q: Can I drive or operate machinery after taking Olfen-50?

Official regulatory information cautions that Olfen-50 may cause side effects that affect the central nervous system, such as dizziness, drowsiness, or visual disturbances. If these effects occur, regulatory information cautions against driving or operating hazardous machinery.

Q: Is there a risk of dependence or addiction with Olfen-50?

No, Olfen-50 is a non-steroidal anti-inflammatory drug (NSAID). Official regulatory documentation confirms that it is not associated with a risk of dependence or addiction.

Q: Can Olfen-50 interfere with birth control pills?

The active ingredient, diclofenac, is not generally listed among the medications that are known to significantly interfere with or reduce the effectiveness of hormonal contraceptives like birth control pills.

Q: What are the signs of a serious allergic reaction to Olfen-50?

Signs of a serious allergic reaction, which require immediate medical attention, may include swelling of the face or throat, difficulty breathing or wheezing, hives, or a severe skin rash. These effects are described as serious adverse reactions.

Q: How is Olfen-50 classified—is it prescription-only or over-the-counter?

Oral formulations of Olfen-50 are generally classified as prescription-only medicine. This is due to the need for medical supervision and assessment by a healthcare professional to manage potential cardiovascular and gastrointestinal risks.

Q: What is the official recommended maximum duration for using Olfen-50?

The regulatory documents state that Olfen-50 should be used for the shortest duration possible consistent with the patient's treatment goals. This emphasis on short duration is a key measure cited to help minimize potential cardiovascular and gastrointestinal risks.

Q: Does Olfen-50 have a black box warning in the US?

Yes, in the United States, oral formulations of diclofenac are subject to an FDA Boxed Warning. This warning highlights the risk of serious cardiovascular thrombotic events (like heart attack and stroke) and severe gastrointestinal adverse events.

Q: Can Olfen-50 cause swelling in the ankles or feet?

Official regulatory information states that diclofenac may cause fluid retention and edema (swelling), particularly in the ankles or feet. This is a noted effect, and caution is advised, especially for patients with a history of heart failure.

Q: What should I do if Olfen-50 doesn't seem to be helping my pain?

If your symptoms persist, do not improve, or worsen despite taking the medicine, the guidance is to seek further medical advice from a healthcare professional. The treatment should be re-evaluated periodically.

Q: Are generic versions of Olfen-50 available?

Yes, the active ingredient in this medicine, Diclofenac Sodium, is widely available. Regulatory product listings confirm that generic versions, as well as other brand names of the 50 mg delayed-release tablet, are available from various manufacturers.

Q: Does the evidence show Olfen-50 is effective for headaches?

While the general indication is for pain and inflammation, some specific formulations and strengths of diclofenac are officially indicated for the acute treatment of migraine attacks. This indicates its pharmacological potential in the management of specific types of head pain.

Q: Can you take other pain relievers like acetaminophen (paracetamol) with Olfen-50?

Regulatory guidelines indicate that it is generally safe to take Olfen-50 concurrently with paracetamol (acetaminophen). However, co-administration with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or aspirin is cited as a contraindication.

Q: Does Olfen-50 interact with common diabetes medications?

Regulatory documents indicate that concurrent use with certain diabetes medications may require caution and careful monitoring due to potential effects on kidney function and volume depletion.

Q: Can Olfen-50 cause changes in mood or anxiety?

Yes, official regulatory documents list potential adverse effects on the nervous system. These reactions have included occasional reports of anxiety, depression, and confusion.

Q: Can I take Olfen-50 if I have a history of ulcers?

The regulatory documents state that patients with a prior history of peptic ulcer disease or gastrointestinal bleeding have a greater risk for serious gastrointestinal events. Use in this population is described as requiring caution and careful consideration.

Q: Is the 50mg strength of Olfen-50 considered a high dose?

The 50 mg strength represents the single unit dose of the tablet. The maximum daily dose officially recommended is generally 150 mg, meaning the 50 mg dose is one-third of the allowed daily maximum.

Q: What is the difference between enteric-coated and regular Olfen-50 tablets?

The enteric-coated (gastro-resistant) formulation is specially designed to protect the stomach lining by preventing the active ingredient from dissolving until it reaches the intestines. This design is cited to reduce the risk of stomach irritation and bleeding compared to immediate-release or 'regular' forms.

How should Olfen-50 be stored and disposed of?

The storage and disposal of Olfen-50 (Diclofenac Sodium) must adhere strictly to the following requirements documented in official regulatory labeling.

Scope Element Official Regulatory Requirement
Labeled storage temperature: Store at 25 C (77 F), with excursions permitted up to 30 C (86 F).
Light/moisture protection: Must be protected from light and protected from moisture.
Packaging storage rules: Keep product in the original container to maintain environmental protection.
Child-protection storage: Must be kept out of the sight and reach of children.
Disposal instructions: Dispose of unused product according to local requirements and guidance from a pharmacist.
Environmental disposal: Do not discard via wastewater or ordinary household waste.

These official statements define how the medicine must be stored and handled, specifying temperature control, container requirements, and environmental protection rules to preserve product integrity until the expiration date. Disposal must follow regulatory protocols that prevent the medication from entering the public water system.

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

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