Faktu

Quick links to important sections

Faktu

Selected form

Method of action: Vasoprotective

Treatment option:

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 Faktu

Faktu: Definition and Classification as an Anorectal Preparation

Property Description
Active Ingredient Cinchocaine, Policresulen
Form Rectal Ointment, Suppository
Pharmacological Class Local Anesthetic and Astringent
Common Purpose Localized relief of discomfort and tissue support
Origin Synthetic

Faktu is classified as a specific combination anorectal preparation intended exclusively for topical application. The preparation is fundamentally defined by its synthesis of two distinct therapeutic compounds: a local anesthetic and a specialized astringent/tissue regenerator. This dual formulation places it in a unique category among topical treatments and is available commercially as a rectal ointment and a suppository.

Core Composition and Pharmacological Class

The preparation’s core efficacy is rooted in its dual active ingredients: Cinchocaine and Policresulen. Cinchocaine is categorized as an amide-type local anesthetic, a property of this compound. This synthetic compound is used to induce rapid, localized numbing. Policresulen is also a synthetic polycondensation product classified as an antiseptic and hemostatic agent. Policresulen specifically facilitates the restoration of damaged tissue by its selective coagulation property and supports capillary sealing in the affected area, a mechanism utilized in various topical treatments.

General Therapeutic Role and Dual-Action Benefit

The general therapeutic purpose of Faktu is to provide combined symptomatic relief and focused tissue support at the site of application. The medicine is broadly intended to manage local sensations of pain and burning while actively supporting the restoration and structural integrity of the anorectal lining. For instance, it is commonly used to ease the acute discomfort and tissue inflammation associated with perianal irritation. The formulation’s effectiveness in providing both immediate comfort and reparative support is a characteristic of these dual-mechanism topical preparations.

What side effects are possible with Faktu?

Possible Side Effects and Safety Information

The safety profile for Faktu (Cinchocaine/Policresulen) is primarily defined by local reactions at the application site, as classified in official regulatory documentation.


Adverse Reactions by Frequency

The most frequent adverse events are generally categorized as Common or Occasional, occurring at the administration site. Rare, but more clinically significant, events are related to systemic response.

Frequency Classification Officially Documented Adverse Reactions (System Organ Class)
Common / Occasional Localized temporary discomfort (e.g., burning, pruritus or itching) (General Disorders and Administration Site Conditions)
Isolated Cases / Rare Allergic contact sensitivity, manifesting as inflammatory skin changes like skin reddening (erythema) and vesicle formation (papules) (Skin and Subcutaneous Tissue Disorders)

Safety Constraints and Considerations

Faktu is contraindicated in individuals with a known hypersensitivity to Policresulen, Cinchocaine, or any excipients present in the formulation. This constraint addresses the risk of rare, but potentially serious, systemic allergic reactions (Immune System Disorders).

Localized symptoms, such as the initial sensation of burning or itching, are often noted in regulatory labeling as most noticeable at the start of treatment and typically resolve quickly. Regarding specific populations, the regulatory guidance states that use during pregnancy must be strictly indicated following an appropriate benefit-risk assessment. It is not currently known whether the active ingredients are excreted in breast milk.

Regulatory safety information structures the risk profile around local tolerability and the avoidance of use in sensitized individuals.

Overdose and Emergency Response

Overdose and When to Seek Help

The official overdose profile for Faktu (Cinchocaine and Policresulen) is defined by the risks associated with systemic exposure to its local anesthetic component, Cinchocaine. The risk of severe overdose primarily exists following accidental oral intake of the preparation, rather than from normal topical use.


Documented Manifestations and Actions

Category Official Regulatory Statement
Overdose Presentation Systemic effects of the local anesthetic are expected, potentially involving the Central Nervous System and Cardiovascular System. Early manifestations may include dizziness, headache, nausea, and loss of coordination
Severe Outcomes Severe systemic exposure may lead to life-threatening cardioneurological events, including severe cardiovascular depression, seizures, and cardiac arrest
Antidote No specific antidote is officially documented; management is supportive and symptomatic
Required Action In case of accidental oral intake, regulatory documents explicitly require the user to immediately call a Poison Center or doctor

The regulatory information establishes that the Cinchocaine component is classified as toxic if swallowed. Consequently, immediate medical attention is required if accidental ingestion or severe overuse of the preparation is suspected, due to the potential for serious systemic complications.

Therapeutic Uses of Faktu

Quick Facts

  • May offer support for the management of hemorrhoids (piles).
  • May assist in the care of anal fissures.
  • May provide relief of symptoms associated with anorectal conditions, such as itching and discomfort.

Faktu is a medicinal product considered for the local management of anorectal conditions. It may be used in the care of hemorrhoids, particularly those associated with discomfort or superficial bleeding.

The medication may also offer support in the management of other related conditions, including anal fissures and rhagades (minor injuries of the anal lining). Its application may provide relief from symptoms such as local discomfort, including itching, oozing, or minor pain, that may be associated with these conditions. Additionally, Faktu may assist in the management of wounds following certain proctological procedures.

Regulatory References

  1. BPOM therapeutic overview

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Faktu

The eligibility profile for Faktu (Policresulen + Cinchocaine) is strictly defined by population-exclusion and conditional-use criteria documented in government regulatory sources (e.g., SmPC).


Absolute Contraindications

Faktu must not be used by individuals with a known hypersensitivity to the active substances, Cinchocaine or Policresulen. Use is also strictly contraindicated in patients with an allergy to soya or peanuts due to the presence of excipients derived from soya beans. Furthermore, the medicine is contraindicated for children below 2 years of age.

Age-Related and Conditional Use Restrictions

Faktu is generally intended for adults (18 years and older). It is not recommended for children and adolescents under 18 due to insufficient data on safety and efficacy in these age groups. For older adults, safety and efficacy data have not been formally established.

Usage is conditional during pregnancy and lactation. The medicine must be used only when strictly indicated following risk assessment, as it is unknown if the active ingredients pass into breast milk or if human risk data is available.

Eligibility-Related Limitations

Caution is advised regarding use in patients with systemic infection, severe liver disease, or kidney disease, as data in these populations is limited or warrants special consideration. Use is also restricted based on a documented wool allergy due to certain excipients.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Faktu is a topical preparation containing Policresulen and Cinchocaine. Due to its application route (rectal) and negligible systemic absorption, the drug has a very restricted official interaction profile focusing primarily on local and chemical effects.


Documented Interaction Constraints

Official regulatory information emphasizes constraints related to local application and the chemical nature of Policresulen (an organic acid).

Interaction Type Constraint & Rationale
Local Co-administration Avoid using Faktu concurrently with other rectally applied local preparations. This is necessary due to the potential for chemical or physical incompatibility at the application site.
Chemical Incompatibility Alkaline substances, particularly soap, must be avoided in the treatment area. Policresulen is chemically incompatible with alkaline substances, which can lead to its inactivation.

Systemic Interactions

There are no clinically significant systemic drug-drug interactions documented in official labeling. This includes the absence of warnings regarding interactions mediated by liver enzymes (CYP450) or drug transporters, as the active ingredients do not reach sufficient concentrations in the bloodstream to cause these effects. Therefore, interactions with orally or parenterally administered medicines are generally not expected based on current regulatory data.

Mechanism of Action

How Faktu Works: Mechanism of Action

The pharmacological effect of Faktu results from the independent yet complementary actions of its two active ingredients, which target distinct physiological processes to alter signal transmission and tissue structure.


Peripheral Sensory Signal Blockade

This domain, driven by Cinchocaine, involves a rapid, reversible action on the voltage-gated sodium channels (Nav) found on peripheral nerve endings. By binding inside the channel pore, the mechanism physically blocks the necessary influx of sodium ions, thereby inhibiting the nerve's ability to propagate electrical signals. This precise mechanistic step leads directly to the physiological consequence of local sensory signal suppression by halting the transmission of nociceptive (sensory) signals.


Selective Tissue Modification and Capillary Sealing

The second core domain, facilitated by Policresulen, is characterized by selective protein coagulation. This chemical interaction precipitates proteins on the surface of damaged tissue and microvasculature, forming a protective surface film (coagulum). Simultaneously, its astringent property causes contraction of local tissue elements and small vessels. This mechanism induces local hemostasis through the mechanical sealing of compromised capillaries and facilitates tissue surface modification through the selective removal of non-viable cells, a process which allows for underlying epithelial proliferation.


Mechanistic Synergy

The combined mechanism results from the Cinchocaine mechanism creating rapid sensory signal blockade, which precedes the slower, more sustained tissue modification and structural sealing action of Policresulen, allowing this astringent process to occur following the suppression of afferent sensory signaling.

Dosage and Administration Information

Faktu is an anorectal preparation for administration via the topical and rectal routes. The medicine is supplied in two specialized dosage forms: a rectal ointment and a suppository, each containing a defined concentration of Policresulen and Cinchocaine.

Dosing and Administration

The standard administration protocol is defined by a progression from an initial, more frequent schedule to a maintenance phase. For both the ointment and the suppository forms, the starting application frequency is typically two to three times daily. This regimen is used for the management of the acute phase. As the treatment course progresses, the application frequency is generally reduced to once daily for continued management, though the final length of treatment is determined by a healthcare professional.

A critical procedural condition is that the product should be administered after a bowel movement to facilitate contact with the affected tissue. For internal rectal application of the ointment, the enclosed applicator or cannula is used. Suppositories are inserted deeply into the rectum.

In specific populations, use during pregnancy is typically limited to cases only when strictly indicated following professional consultation, reflecting a constraint on use rather than a dose modification. The product is for localized use and is never intended for oral administration.

Recent Clinical Evidence

Faktu: Recent Clinical Evidence

Clinical evidence for Faktu (a combination product containing Policresulen and Cinchocaine) primarily involves multicenter studies focused on its effectiveness and local tolerability in managing hemorrhoidal and other anorectal conditions.

Therapeutic Focus of Research

Studies have investigated Faktu for the management of symptoms associated with internal and external hemorrhoids, anal fissures, and anal rhagades. Research has also explored its use in supporting wound healing following proctological operations.

The combined actions of the active ingredients, Policresulen and Cinchocaine, form the basis of the investigational focus in these trials:

  • Policresulen: Studies have evaluated its local astringent, hemostatic (bleeding-stopping), and tissue-selective properties, which are thought to promote the cleaning and healing of affected tissue.
  • Cinchocaine: Research assesses its role as a local anesthetic to alleviate pain and itching, with effects generally observed shortly after application.

Efficacy and Tolerability Outcomes

Multicenter studies involving thousands of patients reported that physician-assessed outcomes and patient-rated satisfaction were high in the treatment of hemorrhoidal symptoms. A high percentage of patients achieved control of symptoms such as pain and itching, often within two to three weeks of consistent application.

Symptom Evaluated Research Observation
Pain/Itching Symptom control generally achieved within 2–3 weeks.
Bleeding Prompt control of minor bleeding reported due to hemostatic effects.
Local Side Effects Mild, temporary reactions (e.g., burning or irritation) were reported by a minority of participants, typically occurring at the start of treatment.

Key Studies & References

  1. World Health Organization Model List of Essential Medicines (Relevant section on local anesthetics and anti-haemorrhoidals)

Frequently Asked Questions (FAQ)

Common questions about Faktu (FAQ)

Q: Is Faktu considered a type of steroid or cortisone cream?

Official regulatory documents define Faktu by its two active compounds: a local anesthetic (Cinchocaine) and an astringent/tissue regenerator (Policresulen).

According to its official pharmacological classification, it is not considered a steroid or cortisone preparation.


Q: How frequently are allergic reactions to Faktu reported in clinical data?

Official safety reports categorize the most common local reactions, like temporary burning or itching, as uncommon (occurring in 1 in 100 to 1 in 1,000 treated patients).

Systemic allergic reactions are reported as very rare (less than 1 in 10,000 patients).


Q: How quickly do the effects of Faktu generally become noticeable?

Because Faktu contains Cinchocaine, a local anesthetic, official information indicates that the relief from pain and itching may begin shortly after application due to the local anesthetic component.

This rapid effect is due to the numbing action of the anesthetic ingredient.


Q: Is it expected that Faktu will provide immediate relief upon application?

The anesthetic component is described as acting rapidly to help suppress local sensory signals (numbing).

However, the full therapeutic benefit from the tissue-healing ingredients requires consistent use over several days or weeks.


Q: What does the evidence say about the maximum recommended duration of treatment with Faktu?

The final length of treatment is typically determined by a healthcare professional.

Some regulatory guidance advises against prolonged use beyond recommended periods, such as 7 days, unless professional re-evaluation is recommended.


Q: What is the general expectation for when maximum improvement might be observed with Faktu?

Clinical evidence indicates that symptom control is typically reported within two to three weeks of use.

The process of tissue healing facilitated by Policresulen may continue throughout the defined course of treatment.


Q: What does 'for topical use only' mean for a product like Faktu?

The classification 'topical use only' means the medicine is intended exclusively for application to the surface of the skin or rectum.

This constraint specifies that the product is never to be swallowed or administered orally.


Q: Is Faktu available without a prescription in some places?

The official regulatory status of Faktu varies depending on the country.

Regulatory portals in some major territories classify Faktu as a Prescription Drug (Rx).


Q: How is Faktu described in official patient information leaflets?

Official patient information leaflets describe the medicine's intended use, its active ingredients, and important safety details.

This typically includes warnings, possible side effects, storage instructions, and directions for administration.


Q: Are there any reports of long-term side effects associated with Faktu use?

Official safety advice includes a precaution to avoid prolonged use beyond the recommended duration.

This guidance indicates that use exceeding the recommended duration warrants professional assessment.


Q: Can Faktu cause drowsiness or affect alertness?

Regulatory safety information indicates that no interaction has been found or established regarding the ability to drive or operate machinery.

Overall, the medicine is not expected to cause drowsiness or affect alertness.


Q: Does consuming alcohol affect the documented action of Faktu?

According to official regulatory information, no interaction between Faktu and consuming alcohol has been found or established.


Q: What is the general guidance if an application of Faktu is missed?

Official guidance states that if an application is missed, the general recommendation is to apply the next dose at the usual time.

Treatment then continues as previously instructed by a healthcare professional.


Q: Are there studies that examine the effects of prolonged or long-term usage of Faktu?

Official safety advice recommends avoiding prolonged or excessive use of the product.

This constraint suggests that clinical research and efficacy focus is primarily on short-term use for the treatment of acute symptoms.


Q: What should a person do if they accidentally ingest a small amount of Faktu?

The product is strictly for external use and is not intended for oral consumption.

Official information indicates that consultation with a healthcare professional is appropriate if too much Faktu ointment has been used (overdose guidance).


Q: Is it normal for the color of the ointment to vary slightly between batches?

According to the official product information, the ointment’s color can range from white to light brown.

This description addresses natural variations in the product's appearance.


Q: Are there restrictions on driving or operating machinery while using Faktu?

Official safety advice states there are no known restrictions on driving or operating machinery.

This is because the medicine is applied locally, and significant systemic effects, such as impaired alertness, are generally not documented.


Q: Does Faktu contain any substances derived from animals, based on the ingredient list?

Regulatory documents list specific contraindications related to allergies, including hypersensitivity to excipients derived from soya, peanuts, and those linked to a wool allergy.

This information addresses the presence of these specific non-active ingredients based on the contraindications listed.


Q: What regulatory status does Faktu hold in major governmental territories like the EU or US?

The product’s status is determined by governmental health bodies in each territory.

Regulatory portals in some countries classify the medicine as a Prescription Drug (Rx).


Q: Is Faktu described as a preventative treatment for its indicated condition?

The product information states that the intended uses are for the treatment of existing conditions, such as hemorrhoids and anal fissures.

It is not described in official documents as a preventative treatment for the initial onset of these conditions.

How should Faktu be stored and disposed of?

How to Store and Dispose of Faktu?

Official Storage Conditions

Faktu must be stored according to regulatory requirements to ensure product stability. The ointment must not be stored above 30°C or 25°C (depending on the official label), while the suppositories must be kept below 25°C and must not be frozen. Both formulations must be stored in their original packaging and protected from direct light and moisture. It is a mandatory requirement to keep the medicine out of the sight and reach of children.

Disposal Instructions

Expired or unused Faktu must not be disposed of via household waste or flushed down wastewater. Consult a pharmacist to determine the correct local procedure, such as using an official drug take-back program, to discard the product.

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

Available in countries:

Equivalent of Faktu found in:

A-Z Index: