Perofen 400

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Perofen 400

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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 Perofen 400

What is Perofen 400?

Perofen 400 is an oral medication containing 400 mg of ibuprofen, an active substance belonging to the class of drugs known as non-steroidal anti-inflammatory drugs (NSAIDs). These medications are primarily used to manage pain and reduce inflammation.

Mechanism of Action

The active ingredient works by inhibiting the production of prostaglandins, which are lipid compounds in the body that act as chemical messengers. Prostaglandins are released in response to injury or certain diseases and are responsible for signaling pain, inducing fever, and causing swelling and inflammation. By reducing the synthesis of these compounds, Perofen 400 helps to alleviate these symptoms.

Primary Uses

Perofen 400 is typically utilized for the relief of various types of mild to moderate pain. Common applications include:

  • Musculoskeletal pain: Including backaches and minor aches associated with arthritis.
  • Headaches: Such as tension headaches and migraines.
  • Dental pain: Discomfort following dental procedures or toothaches.
  • Menstrual cramps: Relief of primary dysmenorrhea.
  • Fever reduction: Temporary management of an elevated body temperature.

Pharmacological Properties

As a 400 mg formulation, this medication is categorized as a higher-strength over-the-counter or prescription-strength dose, depending on local regulations. It is absorbed into the bloodstream through the gastrointestinal tract, reaching peak plasma concentrations relatively quickly to provide systemic relief from discomfort and inflammatory responses.

Regulatory References

  1. Model List of Essential Medicines

What side effects are possible with Perofen 400?

Possible Side Effects and Safety Information

Perofen 400, which contains the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen, is associated with mandatory warnings from regulatory authorities regarding its serious potential risks.

Serious Adverse Reactions and Warnings

Official labeling contains Boxed Warnings concerning two major organ systems:

  • Cardiovascular Thrombotic Events: NSAIDs may increase the risk of serious, potentially fatal, cardiovascular thrombotic events, including myocardial infarction and stroke. This risk may increase with higher doses or longer duration of use. The drug is contraindicated for use immediately before or after coronary artery bypass graft (CABG) surgery.
  • Gastrointestinal Risk: NSAIDs increase the risk of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events may occur at any time without warning symptoms, and the risk is higher in older adults.

Common Adverse Reactions

The most common adverse reactions generally involve the gastrointestinal system, including nausea, dyspepsia (indigestion), vomiting, abdominal pain, flatulence, constipation, and diarrhea.

Population-Specific and Dose-Related Concerns

The lowest effective dose should be used for the shortest possible duration to minimize risk. Use is generally contraindicated in the third trimester of pregnancy due to potential harm to the fetus. Caution is advised in patients with pre-existing conditions such as hypertension, heart disease, kidney or liver disease, and in those over 60 years of age, who are at a higher risk for serious GI complications.

Overdose and Emergency Response

Overdose and When to Seek Help

This information describes the official overdose profile for Perofen 400 (Ibuprofen) as documented in government regulatory sources, detailing the potential manifestations and mandatory emergency actions.


Documented Overdose Manifestations

An overdose of Ibuprofen is associated with a range of documented effects, often involving the gastrointestinal and central nervous systems. Common manifestations include nausea, vomiting, abdominal pain, headache, drowsiness, and ringing in the ears (tinnitus).

Severe Outcomes

Serious or life-threatening outcomes can occur, particularly with massive ingestion. These documented complications include seizures (convulsions), CNS depression leading to stupor or coma, metabolic acidosis, and damage to the kidneys, potentially leading to acute renal failure. Hypotension (low blood pressure) has also been reported in severe cases.


Mandatory Emergency Actions

Regulatory authorities explicitly require users to seek immediate medical attention for any suspected overdose of Perofen 400. It is mandatory to contact a Poison Control Center right away. This instruction applies even if the person appears well or is initially asymptomatic after ingesting a large amount, as symptoms or severe complications like acute renal failure may be delayed. There is no specific antidote for Ibuprofen overdose; management is limited to supportive care and continuous monitoring of vital signs and renal function in a clinical setting.

Therapeutic Uses of Perofen 400

What Perofen 400 Treats: Main Uses and Benefits

Perofen 400 (Ibuprofen) is a relevant medication used to provide symptomatic relief across multiple domains of discomfort. It is applicable in contexts where short-term assistance is needed to ease the overall burden of symptoms. The medication is commonly used to address pain, inflammation, and fever, helping manage conditions characterized by episodic or fluctuating symptoms.


Symptom Relief and Application

Perofen 400 is relevant for easing symptoms that interfere with daily comfort across three main areas. It provides supportive relief for acute and recurrent pain patterns such as headaches, toothaches, and menstrual cramping. It is also applied in conditions marked by heightened physiological responses, specifically addressing the discomfort, swelling, and stiffness associated with musculoskeletal injuries, sprains, and symptomatic flares of chronic conditions like arthritis. Additionally, it assists patients during systemic imbalance by helping to manage elevated body temperature and general body aches from the common cold or flu.

“This application is relevant when supportive symptom management is appropriate to help maintain a sense of stability.”


Quick Fact: Relief for Acute Pain and Inflammation

The medication is commonly used for acute episodes including pain after minor dental procedures, discomfort from soft tissue injuries, and is relevant for easing discomfort during painful menstrual periods. This assistance may contribute to improved comfort during symptomatic periods.

Regulatory References

  1. NIH MedlinePlus Drug Information overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Perofen 400?

The eligibility for using Perofen 400 (Ibuprofen 400 mg) is determined by official regulatory criteria, defining groups who may use the medicine and those for whom it is contraindicated.

Eligibility Summary

Classification Population Status
Eligible Use Adults and Adolescents 12 years of age and older.
Conditional Use Older adults, patients with mild-to-moderate renal or hepatic impairment, and women in the first or second trimester of pregnancy.
Contraindicated Use Individuals who must not use the medicine.

Official Contraindications

Perofen 400 is strictly contraindicated (must not be used) under several conditions, based on regulatory labeling:

  • Hypersensitivity: A history of allergic reactions to Ibuprofen, aspirin, or any other Non-Steroidal Anti-Inflammatory Drug (NSAID).
  • Gastrointestinal Status: The presence of active or recurrent peptic ulcer or bleeding in the stomach or intestines.
  • Organ Failure: Diagnosis of severe heart failure (NYHA Class IV), severe renal failure, or severe hepatic failure.
  • Pregnancy: Use during the third trimester of pregnancy is prohibited due to risk to the fetus.

Note: The 400 mg strength is generally not recommended for children under 12 years of age.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Perofen 400 (Ibuprofen) is documented in regulatory labeling to interact with several drug classes, potentially leading to altered drug exposure or increased risk of adverse events.

Contraindications and Restrictions

Use of Perofen 400 is formally contraindicated for treating peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. Co-administration with other NSAIDs or Aspirin at doses above 75 mg daily is advised against due to the additive risk of adverse reactions, particularly gastrointestinal events.

Clinically Significant Interaction Patterns

Interaction Mechanism Interacting Substances Official Outcome Statement
Reduced Clearance (Pharmacokinetic) Lithium, Methotrexate Increases plasma levels and risk of toxicity.
Additive Toxicity Risk (Pharmacodynamic) Warfarin, Oral Corticosteroids, SSRIs Increases risk of gastrointestinal bleeding/ulceration.
Therapeutic Antagonism (Pharmacodynamic) ACE Inhibitors, Diuretics May diminish the anti-hypertensive or diuretic effect.
Metabolic Inhibition (Pharmacokinetic) CYP2C9 Inhibitors May increase Ibuprofen plasma exposure.

Administration Timing Requirement

An interaction exists with low-dose, immediate-release Aspirin that may interfere with its anti-platelet activity. Regulatory documents state that this interaction is mitigated if Ibuprofen is administered at least 2 hours after the Aspirin dose. Concomitant use with Alcohol is restricted due to a documented increase in the risk of serious gastrointestinal bleeding. The Elderly are noted in labeling to be at greater risk for adverse reactions resulting from interactions with certain drugs, such as diuretics.

Mechanism of Action

The action of Perofen 400 (Ibuprofen) results from its intervention in the body's Arachidonic Acid Cascade, specifically targeting the enzymes that produce key signaling molecules. The drug's mechanism is defined by three interconnected physiological domains.

Blocking the Cyclooxygenase Enzyme System

Perofen 400 is a non-selective, reversible inhibitor of the Cyclooxygenase (COX) enzymes (both COX-1 and COX-2). By temporarily blocking the active sites of these enzymes, the drug restricts the initial step in synthesizing prostaglandins ( PGE2) and other eicosanoids, which are significant physiological mediators.

Modulating Central Thermoregulatory Signaling

The reduction of Prostaglandin E2 ( PGE2) specifically within the central nervous system, particularly in the hypothalamus, addresses the biological trigger for the upward shift in body temperature. This action helps to modulate the central thermoregulatory set point, which allows the thermoregulatory set point to be returned toward basal temperature.

Modulating Peripheral Sensory and Vascular Responses

At the sites of tissue distress, the drug's mechanism leads to the desensitization of peripheral nociceptor nerve endings by reducing the surrounding concentration of PGE2. Furthermore, the reduced prostanoid levels attenuate local vasodilation and vascular permeability, thereby reducing the fluid leakage and nerve sensitization associated with the local physiological response.

Dosage and Administration Information

How Perofen 400 is Used: Standard Administration Guidelines

Perofen 400, an oral tablet formulation of Ibuprofen, is administered as a systemic treatment. The administration route for this formulation is oral, with the tablet intended to be swallowed whole.

Usage protocols follow the principle of employing the lowest effective dose for the shortest duration necessary to manage symptoms.


Administration Scope

Instruction Category Standard Guideline
Route of Administration Oral
Timing in Relation to Meals May be taken with or after food or milk to improve gastric tolerability.
Frequency Pattern As-needed; minimum interval between doses is 4 to 6 hours.
Duration Constraint Usage is limited to 10 days for pain or 3 days for fever, unless directed by a healthcare professional.

Labeled Dosing Regimens (Adults)

Usage Context Standard Dosing Range
Short-Term Relief (Pain/Fever) 200 mg to 400 mg per single dose. Maximum daily dose for this use is generally 1200 mg in a 24-hour period.
Chronic Inflammatory Use Total daily dose is typically 1200 mg to 3200 mg, administered in divided doses.

Population-Specific Guidance

Instructions for older adults (geriatric patients) involve the use of the lowest effective dose for the shortest possible duration. Similarly, patients with existing renal or hepatic impairment utilize the lowest possible dose, with function monitored as necessary. These parameters establish the framework for appropriate administration.

Recent Clinical Evidence

Recent Clinical Evidence


Summary of Clinical Trials

Research has explored the effect of this fixed-dose combination on symptoms and lung function in individuals with Chronic Obstructive Pulmonary Disease (COPD). Trials evaluated whether the frequency of acute flare-ups was lower compared to monotherapy with Drug A or placebo. Research has focused on its use in addressing chronic symptoms. Investigations have also included whether the combination was associated with differences in patient-reported relief when flare-ups occurred.

Components Studied in Combination

The combination includes two components that were studied for their distinct roles in COPD management:

  • Drug A (Short-Acting Beta-2 Agonist): Research examined whether this component contributed to a difference in immediate symptoms.
  • Drug B (Long-Acting Muscarinic Antagonist): Research examined the association between this component and measures of airway maintenance, inflammation, and spasm prevention.

Evaluations measured changes in bronchospasm markers over the long term, and their relationship to respiratory health. The fixed-dose combination of Drug A and Drug B has been the primary focus of these efficacy and safety studies.


Efficacy and Safety Profile

Clinical research has investigated the profile of this combination therapy:

  • Efficacy: Studies measured changes in forced expiratory volume in one second (FEV1), a key measure of lung function, and differences in the severity of COPD symptoms, such as breathlessness and coughing.
  • Safety: The safety profile was characterized by comparing adverse event incidence rates against placebo and Drug A alone. Research assessed this combination when used for ongoing symptom management in COPD. The tolerability and utility of which have been evaluated in clinical trials for adult patients, with additional studies examining the effect on patient breathing and the quality of life outcomes.

Frequently Asked Questions (FAQ)

Common questions about Perofen 400 (FAQ)


Q: How long can a person generally use Perofen 400 before consulting a doctor?

A: According to official product information for short-term, over-the-counter use, the duration is typically limited. Regulatory documents state that use is generally limited to a maximum of 10 days for pain or 3 days for fever, unless explicitly advised otherwise by a healthcare professional for specific conditions.

Q: Is fatigue or drowsiness listed as a possible side effect of Perofen 400?

A: Official labeling lists several possible central nervous system effects. These can include dizziness, somnolence (which means drowsiness), and feelings of fatigue. Although the reported incidence for some of these effects may be low, regulatory documents include them as reported possibilities.

Q: What are the signs of an allergic reaction to Perofen 400?

A: Regulatory labeling includes an allergy alert, noting that severe allergic reactions can occur. Signs can include common allergy symptoms like hives or facial swelling, but also more serious reactions like asthma (wheezing), shock, and the appearance of skin reddening, rash, or blisters.

Q: Is Perofen 400 safe to use during pregnancy, according to official guidelines?

A: Regulatory guidelines strongly advise avoiding use of this type of medicine from 20 weeks gestation onward due to the risk of problems affecting the developing fetal kidneys. Use is prohibited after 30 weeks. Use between 20-30 weeks should be limited to the lowest dose for the shortest duration possible, as described in official guidelines.

Q: Is it true that Perofen 400 can sometimes affect the liver?

A: Official documents include warnings about the risk of hepatotoxicity (liver damage), though this is classified as a rare risk. Regulatory labeling notes that abnormal liver function tests are a possible adverse reaction, indicating the drug's known association with the liver system.

Q: Does Perofen 400 have any impact on blood pressure?

A: Yes, regulatory information indicates that this type of medicine may have an impact on the cardiovascular system. Elevated blood pressure (hypertension) and fluid retention (edema) have been reported in association with NSAID therapy.

Q: How quickly do people typically start to feel the effects of Perofen 400?

A: Pharmacological summaries often state that the drug typically begins working to relieve pain within an hour after it is swallowed. The concentration of the medicine in the blood, which relates to its peak activity, is often reached within one to two hours.

Q: What is the average duration of action for Perofen 400?

A: The effective activity of the medicine generally aligns with its dosing frequency. Official dosing instructions typically specify that a dose may be repeated every 4 to 6 hours while symptoms persist, which indicates the general duration of its action for symptom relief.

Q: What is the difference between Perofen 400 and a typical over-the-counter pain reliever?

A: Perofen 400 is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID), which means its action is to relieve pain, lower fever, and reduce inflammation. Other common over-the-counter pain relievers, such as acetaminophen, primarily target pain and fever but do not have significant anti-inflammatory action.

Q: Is Perofen 400 known by a different name in other countries?

A: Yes, the substance contained in Perofen 400 is Ibuprofen, which is the internationally recognized name for the active ingredient. This substance is widely available and is sold around the world under numerous regional brand names.

Q: Are there any common foods or drinks that should be avoided while using Perofen 400?

A: Regulatory documents restrict the concomitant use of alcohol due to a documented increase in the risk of serious gastrointestinal bleeding. No other common foods or drinks are consistently restricted across major labels.

Q: What kind of studies support the use of Perofen 400 for pain relief?

A: The drug's approval is supported by a significant body of clinical studies confirming its efficacy as an analgesic and anti-inflammatory agent. The World Health Organization (WHO) includes Ibuprofen on its Model List of Essential Medicines for the symptomatic relief of pain, inflammation, and fever.

Q: Does taking Perofen 400 regularly cause dependency?

A: Ibuprofen is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). Based on its pharmacological classification, it is not generally classified as a drug with a significant potential for physical addiction or dependence, unlike pain relievers in the opioid class.

Q: What happens if a person misses a dose of Perofen 400?

A: Official instructions describe that this medicine is typically taken as needed for symptoms. Guidance generally focuses on adhering to the minimum time interval between doses, such as 4 to 6 hours.

Q: Is there information on using Perofen 400 while breastfeeding?

A: Authoritative medical sources indicate that Ibuprofen is generally noted as compatible for use in nursing mothers. This is due to the low levels of the drug found in breast milk and its established safety profile for infants at these concentrations.

Q: Do studies suggest Perofen 400 is effective for common tension headaches?

A: Official indications describe the drug for the relief of minor aches and pains. This category generally includes common symptoms such as headaches.

Q: What are the official recommendations regarding alcohol consumption while using Perofen 400?

A: The use of Perofen 400 with alcohol is generally restricted or advised against in regulatory documents. This is due to the documented increase in the risk of serious gastrointestinal bleeding when the two are combined.

Q: Can Perofen 400 be used by people who have mild kidney problems?

A: Caution is advised in patients with any degree of renal (kidney) impairment. Regulatory guidelines stipulate that the lowest effective dose should be used and that renal function should be monitored by a healthcare provider, especially when the medicine is used long-term or in those with pre-existing issues.

Q: Can Perofen 400 cause changes in sleep patterns?

A: Official labeling lists certain central nervous system adverse reactions that can affect sleep. These include both somnolence (drowsiness) and insomnia (difficulty sleeping) as possible effects.

Q: Is there a generic version of Perofen 400 available?

A: Yes, the active ingredient in the medicine is Ibuprofen. This compound is one of the most widely used pain relievers globally and is available as a common, lower-cost generic medication in many regulatory markets worldwide.

Q: How is Perofen 400 described in official prescribing information regarding pain relief?

A: Official prescribing information describes Perofen 400 (Ibuprofen) for the symptomatic relief of mild to moderate pain. It is also indicated for its use in various inflammatory conditions.

Q: Does Perofen 400 interfere with birth control pills?

A: Ibuprofen is not typically described as interfering with the efficacy of hormonal contraceptives, meaning it generally will not reduce their effectiveness. However, combining it with certain hormonal components may increase the risk of elevated potassium levels, which sometimes requires monitoring.

Q: What are the official restrictions on driving or operating machinery while using Perofen 400?

A: Regulatory guidelines describe that driving or operating machinery may be affected, as it may cause effects such as dizziness or sleepiness. Patients are cautioned against driving until the individual effect of the medicine is known.

Q: Can people with a history of heart conditions use Perofen 400?

A: Regulatory documents advise caution. Severe heart failure (NYHA Class IV) is listed as a contraindication, meaning it must not be used. Patients with a history of heart disease, hypertension, or risk factors for cardiovascular events should be treated with careful consideration, using the lowest possible doses and avoiding high doses.

Q: What does official data say about the long-term use of Perofen 400?

A: Official data emphasizes that use should be limited to the shortest possible duration and the lowest effective dose. The risk of serious side effects, particularly cardiovascular and gastrointestinal issues, is noted to be higher with high doses or long-term use.

Q: Is it normal to feel a mild burning sensation after taking Perofen 400?

A: Gastrointestinal side effects are common with this class of medication and officially reported symptoms include heartburn, epigastric pain (pain above the stomach), and abdominal distress. A mild burning sensation is consistent with the officially reported symptom of heartburn or epigastric pain.

How should Perofen 400 be stored and disposed of?

Storage and Disposal Requirements for Perofen 400 (Ibuprofen)

Perofen 400 (Ibuprofen) must be stored strictly according to regulatory standards to maintain its effectiveness. The medication should be kept at a controlled room temperature, defined as 20 to 25 C (68 to 77 F). The tablets must be protected from heat, moisture, and light, and should be dispensed in a tight container.

Handling and Disposal

It is mandatory to keep the product out of the sight and reach of children.

When disposing of unused or expired medicine, regulatory requirements state it must not be thrown away via wastewater or household waste. Disposal must be performed according to local requirements for pharmaceutical waste.

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

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