Olfen UNO

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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 Olfen UNO

Quick Facts

Property Description
Active ingredient Diclofenac (e.g., Diclofenac sodium)
Form Hard capsule (Prolonged-release)
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common purpose Systemic relief from pain and inflammation
Origin Synthetic compound

What Type of Medicine is Olfen UNO?

Olfen UNO is a medicinal product classified as a Nonsteroidal Anti-inflammatory Drug (NSAID) that is used for systemic relief of pain and inflammation. Its active ingredient is Diclofenac, a synthetic compound belonging chemically to the phenylacetic acid derivatives group. Diclofenac functions primarily as a Cyclooxygenase (COX) inhibitor, meaning it works to intercept the biological process responsible for producing the key chemical mediators of pain, fever, and inflammation. Diclofenac is categorized as an analgesic and anti-inflammatory agent in the ATC classification system.

This confirms that the medicine's fundamental role is to reduce both pain and inflammation simultaneously. The efficacy of Diclofenac for its anti-inflammatory properties is widely clinically recognized and supported by extensive pharmacological studies.

Composition: Olfen UNO and its Diclofenac Component

The composition of Olfen UNO features Diclofenac as the single active ingredient contained within a hard capsule. This medicine is designed for oral administration, allowing for efficient absorption into the bloodstream where the Diclofenac exerts its therapeutic action. Diclofenac belongs to the class of NSAIDs which help reduce inflammation, pain, and fever. This indicates that the drug's general purpose is to provide relief across these three symptomatic areas.

The Sustained-Release Distinction (UNO Formulation)

The defining characteristic of Olfen UNO is its specialized prolonged-release or sustained-release formulation, a key differentiating factor from standard immediate-release Diclofenac products. This means the Diclofenac is released slowly from the capsule’s internal extended-release matrix into the body over a sustained period of time. This particular design aims to maintain consistent and stable levels of the active ingredient in the system, a feature pharmacologically designed to offer greater consistency. Consequently, the long-lasting therapeutic effect provided by this mechanism is intended to offer more consistent systemic relief compared to conventional, immediate-release forms. Olfen UNO is typically designated as a prescription-only medicine (Rx), underscoring its role in professionally managed care.

What side effects are possible with Olfen UNO?

Possible Side Effects and Safety Information

Olfen UNO, which contains the active substance diclofenac, is associated with specific, serious safety risks common to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), particularly affecting the gastrointestinal and cardiovascular systems.

Serious and Clinically Significant Adverse Reactions

Systemic use of diclofenac carries an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (heart attack) and stroke, which can be fatal. This risk may increase with high doses and prolonged duration of use. Furthermore, NSAIDs can cause serious gastrointestinal (GI) adverse events, such as bleeding, ulceration, or perforation of the stomach or intestines, which may also be fatal and can occur without prior warning symptoms.

Rare, but severe, reactions involving the liver, kidneys, and immune system have also been documented. These include severe hepatic reactions, kidney function disorders, and life-threatening allergic reactions, such as anaphylaxis and serious skin reactions.

Safety Restrictions and Contraindications

Use of this medicine is contraindicated in individuals with established congestive heart failure (NYHA Class II-IV), ischaemic heart disease, peripheral arterial disease, or cerebrovascular disease. It is also contraindicated in patients with active gastrointestinal bleeding or ulceration, a history of NSAID-related GI bleeding, or severe liver, kidney, or heart failure. Diclofenac should be avoided during the third trimester of pregnancy due to the risk of fetal harm.

Caution is required in patients with significant risk factors for cardiovascular events (e.g., high blood pressure, high cholesterol, diabetes, or smoking). The recommended regulatory practice is to use the lowest effective dose for the shortest duration necessary to control symptoms.

Overdose and Emergency Response

Overdose and When to Seek Help

This section describes the officially documented clinical manifestations and required emergency actions in the event of an overdose with Diclofenac, the active ingredient in Olfen UNO, based strictly on government regulatory labeling.


Documented Clinical Manifestations

Overdose manifestations, as described in regulatory documents, may include Central Nervous System (CNS) effects such as headache, stupor, drowsiness, excitement, dizziness, and seizures.

System Documented Signs/Symptoms
CNS Stupor, Drowsiness, Excitement, Seizures
Gastrointestinal Vomiting, Nausea, Abdominal pain
Other Hyperventilation, Disorientation

Severe Outcomes and Emergency Actions

Regulatory information highlights the potential for severe or life-threatening systemic outcomes, including acute renal failure, hepatic damage (liver injury), hypotension (low blood pressure), and respiratory depression.

Official guidance mandates that individuals seek immediate medical attention by contacting a physician, poison control center, or hospital emergency department for a suspected overdose. The management of Diclofenac overdose is primarily symptomatic and supportive, as there is no specific antidote known.

For a recent substantial overdose, hospital observation and official procedures such as gastric lavage or activated charcoal may be required. Overdose severity is officially documented as being potentially greater in patients with existing renal impairment or hepatic dysfunction.

Therapeutic Uses of Olfen UNO

What Olfen UNO Treats: Main Uses and Benefits

Olfen UNO is commonly used to provide systemic symptomatic relief for conditions involving inflammatory or irritative processes. The extended-release form is relevant for easing the symptoms related to physical discomfort and stiffness that are characteristic of these long-term conditions. It primarily supports patients managing chronic inflammatory diseases such as osteoarthritis and rheumatoid arthritis, conditions like ankylosing spondylitis, and painful spinal syndromes.

“The medication’s role is to provide consistent support, assisting with symptoms that create noticeable functional strain.”

This medication is also relevant for managing acute manifestations, including extra-articular rheumatic disorders like tendonitis and bursitis, discomfort arising following trauma or surgical procedures, and intense episodes such as acute gout attacks and primary dysmenorrhea. Its use in these symptom-driven clinical presentations may assist patients with coping more steadily with difficult episodes.


Quick Fact: Relief for Inflammation and Stiffness

The formulation provides a long-lasting effect, which is relevant when supportive symptom management is appropriate for chronic pain and morning stiffness, supporting the patient during episodes of heightened discomfort and assisting with maintaining functional stability.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Olfen UNO (Diclofenac prolonged-release) eligibility is defined by official regulatory criteria, primarily applying to adults 18 years of age and older. The safety and effectiveness of this prolonged-release formulation are not established for use in pediatric patients (under 18 years).

Use is contraindicated for several populations, including individuals with a known hypersensitivity to diclofenac or other NSAIDs (such as aspirin-sensitive asthma). It is also prohibited for patients with active gastrointestinal ulceration or bleeding, severe cardiac failure (NYHA class II–IV), severe hepatic or renal insufficiency, and for pain management following Coronary Artery Bypass Graft (CABG) surgery.

The medicine is restricted or must be avoided in other high-risk groups. This includes patients with a recent myocardial infarction (MI) or advanced renal disease, unless the regulatory body determines the benefit outweighs the risk. Use must be avoided entirely during the third trimester of pregnancy due to the risk of fetal harm. Extreme caution is officially advised for older adults and individuals with a prior history of GI bleeding.

What should I know about interactions with other medicines?

Olfen UNO, which contains diclofenac, a Non-Steroidal Anti-Inflammatory Drug (NSAID), can interact with many other medicines. Always inform your doctor or pharmacist about all prescription and non-prescription drugs, supplements, and herbal remedies you are taking.

️ Medicines That Increase Risk of Bleeding or Gastrointestinal Side Effects

Combining Olfen UNO with certain medicines significantly increases the risk of serious side effects, such as gastrointestinal bleeding or ulcers. These include:

  • Other NSAIDs: Aspirin, ibuprofen, or naproxen. Concurrent use should be strictly avoided as it provides no additional benefit but greatly increases risk.
  • Anticoagulants (Blood Thinners): Such as warfarin or rivaroxaban.
  • Antiplatelet agents: Such as clopidogrel.
  • Corticosteroids (e.g., prednisone, hydrocortisone).
  • SSRIs (Selective Serotonin Reuptake Inhibitors) and SNRIs (Serotonin-Norepinephrine Reuptake Inhibitors).

Medicines Whose Effects May Be Altered

Diclofenac can affect how your body handles other drugs, potentially altering their effectiveness or increasing their toxicity:

  • Blood Pressure Medicines: ACE inhibitors, Angiotensin II Receptor Blockers (ARBs), and Beta-blockers; diclofenac may reduce their blood pressure-lowering effect and increase the risk of kidney problems.
  • Diuretics (Water Pills): Diclofenac may reduce their effect.
  • Lithium and Methotrexate: Diclofenac can increase the blood levels of these drugs, leading to increased toxicity and side effects. Close monitoring is essential.
  • Ciclosporin or Tacrolimus: Increased risk of kidney damage.

Avoid alcohol consumption while taking Olfen UNO, as it raises the risk of stomach bleeding.

Mechanism of Action

Molecular Action: Enzyme Inhibition and Pathway Interruption

Olfen UNO's action begins at the molecular level through non-selective competitive inhibition of the Cyclooxygenase (COX) enzymes, specifically both COX-1 and COX-2. By occupying the active site of these enzymes, the drug prevents them from producing prostaglandins—chemical mediators that regulate inflammation, nociception, and thermoregulation.


Physiological Consequence: Modulation of Peripheral Signaling

The resulting reduction in prostaglandin synthesis acts to modulate peripheral nociceptive signaling and the inflammatory cascade. This mechanism contributes to the regulation of exaggerated physiological responses by reducing the sensitization of peripheral nerve endings, which transmit nociceptive signals, and limiting the localized increase in vascular permeability that drives localized fluid accumulation. The effect is primarily peripheral, focused on the source of the chemical signals.


Mechanistic Scope: Physiological Process Modulation

The drug engages mechanisms designed for the physiological process modulation of heightened responses, including modulation of the thermoregulatory set point and acute inflammation. This action is mechanistically constrained to influencing chemical signaling and is mechanistically unable to alter structural abnormalities or the progression of primary tissue changes.

Dosage and Administration Information

How to Use Olfen UNO: Official Administration Guidelines

This section outlines the specific instructions for the proper administration and dosing of prolonged-release diclofenac.


Administration and Dosing Schedule

Parameter Official Instruction
Route of Administration Oral (swallowing the capsule/tablet).
Dosage Form Prolonged-release hard capsule or tablet.
Standard Daily Dose Typically 100 mg to 150 mg of diclofenac sodium.
Frequency Generally once daily (for the 100 mg or 150 mg strength).
Maximum Daily Dose Must not exceed 150 mg per day for the prolonged-release formulation.

Procedural Instructions and Constraints

Olfen UNO must be swallowed whole with a liquid. It is a critical instruction that the prolonged-release capsule or tablet must not be crushed, broken, or chewed. This is necessary to ensure the active ingredient, diclofenac, is released slowly over the intended period, maintaining the approved therapeutic window.

Administration may be done with or without food, though some product labels suggest taking the dose with or after a meal.

Dosing Principle: A standard principle for all Nonsteroidal Anti-inflammatory Drugs (NSAIDs) is to use the lowest effective dose for the shortest duration possible consistent with the treatment goals.

Population-Specific Guidance: The prolonged-release formulations (e.g., 100 mg) are not suitable for use in children and adolescents. While dose adjustments are generally not required for patients with mild to moderate kidney impairment, specific recommendations for severe liver impairment are limited; in these cases, the lowest effective dose must be considered.

Recent Clinical Evidence

Research evidence / Overview of Studies for Olfen UNO


Evidence for Use in Chronic Inflammatory Joint Conditions

Research involving the active component in Olfen UNO was conducted to explore its use in conditions characterized by fluctuating or episodic manifestations, such as osteoarthritis (OA), rheumatoid arthritis (RA), and ankylosing spondylitis (AS). These studies primarily involved numerous Randomized Controlled Trials (RCTs). The main focus of this research examined outcomes related to physical discomfort and outcomes reflecting daily functioning or activity level, using tools like pain scales and functional index questionnaires.

Studies, which have been classified as providing a High level of evidence certainty, examined outcomes related to the component’s use in these chronic conditions. Research describes that scores related to patient-reported outcomes describing perceived discomfort and functional measures were monitored over defined time intervals in the observed populations during the trials.

Despite the extensive research base, the long-term effects are not fully established by the primary efficacy trials. There is also limited information for long-term outcomes when comparing the specific prolonged-release formulation directly against immediate-release forms.


Evidence for Use in Acute and Exacerbated Musculoskeletal Pain

The active component was also evaluated in research exploring conditions associated with acute or disruptive episodes, such as acute low back pain and pain stemming from sprains and strains. This research largely consists of short-term RCTs that focused on episodes where symptoms become more noticeable. These studies explored outcomes describing episodic or acute changes, primarily focusing on how quickly patients experienced changes in pain intensity and the time required to reach a specific level of relief.

Findings generally contribute to the broader evidence landscape related to outcomes linked to inflammatory or irritative states in acute settings. However, when research specifically examined temporary physiological imbalance in conditions like acute low back pain, findings were inconsistent across different studies, particularly concerning the acceleration of recovery time.


Key Studies & References

  1. Anatomical Therapeutic Chemical (ATC) Classification System: M01AB05 (Diclofenac)
  2. Diclofenac Extended-Release Tablet Drug Information (MedlinePlus / NIH)

Frequently Asked Questions (FAQ)

Common questions about Olfen UNO (FAQ)


Q: Is Olfen UNO meant for short-term pain relief or long-term conditions?

Official indications describe its use for both acute pain and chronic conditions such as osteoarthritis and rheumatoid arthritis. Regulatory guidelines emphasize the principle of using the lowest effective dose for the shortest duration possible, which is standard regulatory advice for all NSAIDs.


Q: What are the most common side effects people report with Olfen UNO?

The most frequently reported adverse effects described in official product documents are generally gastrointestinal disturbances. These common issues may include non-serious symptoms like nausea, abdominal pain, indigestion (dyspepsia), and gas.


Q: Does Olfen UNO commonly cause stomach upset, ulcers, or heartburn?

Official documentation states that general gastrointestinal effects, such as stomach upset or indigestion (dyspepsia), are common. Official labeling also includes regulatory warnings about the potential for serious gastrointestinal events, like bleeding or ulceration, which may occur without prior symptoms.


Q: Can taking Olfen UNO affect my liver or kidney function?

Official labeling describes that use of the medicine can cause elevations of liver enzymes in some patients. In rarer instances, it may be associated with more severe hepatic reactions or affect renal (kidney) function, particularly in individuals who already have pre-existing kidney issues.


Q: Is it normal to feel slightly dizzy or drowsy when using Olfen UNO?

Official product information indicates that adverse reactions affecting the nervous system can occur, including dizziness or somnolence (drowsiness). Regulatory sources advise exercising caution if these effects are experienced, particularly when performing skilled tasks.


Q: Can Olfen UNO be used safely during pregnancy or while breastfeeding?

According to official documents, the use of diclofenac is contraindicated (prohibited) during the third trimester of pregnancy due to the risk of fetal harm. Use during the first and second trimesters, as well as while breastfeeding, is generally described in official documents as not recommended.


Q: Is Olfen UNO generally suitable for people over the age of 65?

While the medicine is indicated for adults, official documents advise extreme caution for patients over 65 years old. This is primarily due to an increased regulatory risk for serious adverse effects in the older population, particularly concerning gastrointestinal bleeding and kidney function.


Q: Does Olfen UNO interact with certain antidepressants or psychiatric medications?

Official drug documents describe interactions with certain psychiatric medications, specifically those classified as SSRIs or SNRIs. Concurrent use with these agents is described as increasing the risk of gastrointestinal bleeding, and regulatory warnings describe caution as necessary in this context.


Q: Are there any specific official monitoring recommendations for people using Olfen UNO long-term?

Official recommendations for chronic or long-term use include routine monitoring. These measures often involve checking blood pressure and performing periodic kidney function tests for specific patient groups to monitor for potential issues.


Q: Are there any serious long-term safety risks linked to taking Olfen UNO?

Official warnings state that the serious risks of cardiovascular events (like heart attack or stroke) and gastrointestinal bleeding/ulceration described in regulatory documents are stated to increase with the duration of use. Regulatory documentation requires the use of the shortest duration possible to control symptoms.


Q: What signs of an allergic reaction are described in official warnings for Olfen UNO?

Official documentation describes that signs of a serious, life-threatening allergic reaction, known as anaphylaxis, may include difficulty breathing or swallowing. Other symptoms described are swelling of the face, tongue, or throat, as well as hives or a severe skin rash.


Q: Is there a known risk of dependence or addiction with Olfen UNO?

Olfen UNO contains diclofenac, which is classified as a non-opioid Nonsteroidal Anti-inflammatory Drug (NSAID). Official regulatory labeling for this medicine does not include warnings or statements regarding dependence, abuse, or addiction.


Q: Does Olfen UNO carry a 'black box warning' from regulatory bodies like the FDA?

The US Food and Drug Administration (FDA) label for diclofenac does include a Boxed Warning (sometimes called a black box warning). This warning highlights the risk of serious cardiovascular thrombotic events and serious gastrointestinal adverse events associated with the medicine.


Q: How long does it typically take for the pain relief effects of Olfen UNO to start?

Olfen UNO is a prolonged-release formulation, meaning the active ingredient is released slowly over time. Official pharmacokinetic data indicates that the peak concentration of the active ingredient in the bloodstream is typically reached after several hours following oral administration.


Q: What is the usual duration of effect for Olfen UNO?

The medicine is designed as a prolonged-release formulation intended to provide a sustained therapeutic effect. Because of this design, official dosing instructions typically prescribe the medicine to be taken once daily.


Q: What should be done if a dose of Olfen UNO is occasionally missed? (General guideline)

Official documentation generally advises that if a dose is missed, it should be taken as soon as the patient remembers, unless it is close to the time for the next scheduled dose. It is a general regulatory warning that two doses should not be taken at the same time to make up for a missed dose.


Q: Are there any dietary supplements that are generally restricted while using Olfen UNO?

Official labeling advises caution with supplements that are known to affect bleeding time due to the NSAID component. For example, some patient leaflets warn about supplements like Ginkgo biloba. Official resources advise users to inform their healthcare provider about all supplements being taken.


Q: Are there any restrictions on driving or operating machinery mentioned in the official safety information?

Because adverse reactions such as dizziness, drowsiness, or visual disturbances are possible, official documentation advises caution. Regulatory documentation specifies caution regarding driving or operating machinery if these effects are experienced.


Q: Can Olfen UNO cause increased sensitivity to sunlight?

Official side effect profiles describe an increased sensitivity to light, known as photosensitivity, as a possible adverse reaction. While generally uncommon, this effect is listed in the documentation.


Q: Is it true that prolonged use of Olfen UNO can impact fertility?

Official documentation describes that diclofenac may potentially impair female fertility. This effect is generally described as reversible upon cessation of the medication, but it is a factor noted in regulatory materials.


Q: What is the maximum number of consecutive days Olfen UNO is generally advised to be used for?

Regulatory guidelines consistently adhere to the principle of using the lowest effective dose for the shortest duration possible. This principle typically translates to short-term use for acute pain conditions.


Q: Does Olfen UNO contain any common allergens like gluten or lactose?

Official documentation contains a mandatory list of all inactive ingredients (excipients). This part of the regulatory document specifies if the formulation contains common substances like lactose, gluten, or other known allergens for patient safety.


Q: Are there any known side effects that occur when stopping Olfen UNO after regular use?

Since diclofenac is a non-opioid medicine, official regulatory documents do not list or warn about specific withdrawal symptoms or side effects that occur upon the cessation of its use.


Q: What are the general guidelines for using Olfen UNO for gout flares?

Official indications for diclofenac include the use for acute attacks of gout. The standard regulatory principle for NSAIDs, including for this condition, is to use the lowest effective dose for the shortest duration required to control symptoms.


Q: What is the difference between an NSAID and a simple analgesic like acetaminophen?

Official resources describe Nonsteroidal Anti-inflammatory Drugs (NSAIDs) as having anti-inflammatory, pain-relieving, and fever-reducing properties. By contrast, simple analgesics like acetaminophen (paracetamol) primarily offer pain relief and fever reduction but are described as generally lacking significant anti-inflammatory effects.

How should Olfen UNO be stored and disposed of?

Storage & Disposal Requirements for Olfen UNO

Official regulatory documents define specific conditions for storing and disposing of Olfen UNO to maintain its stability and protect the environment.

Storage Conditions

Requirement Official Instruction
Temperature Store below 30 C (thirty degrees Celsius).
Protection Keep in the original package to protect from moisture.
Access Keep out of the sight and reach of children.
Expiration Do not use after the expiry date (EXP) stated on the packaging.

Disposal Instructions

Medicines should not be disposed of via wastewater or household waste, as this helps protect the environment. When the medication is no longer needed, it must be disposed of according to a pharmacist's guidance or local regulations for pharmaceutical waste.

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

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