Prostagutt

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Prostagutt

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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 Prostagutt

What is Prostagutt? A Definition and Classification

Property Description
Active Ingredient Serenoa Repens Fructuum Extract
Form Soft Capsules (Oral)
Pharmacological Class Phytotherapeutic Agent, 5α-Reductase Inhibitor
Common Use Symptomatic relief for urinary tract issues
Origin Plant-derived (Saw Palmetto, Nettle)

What Type of Medicine is Prostagutt?

Prostagutt is classified as a phytotherapeutic agent, formally recognized as a licensed herbal medicinal product intended for oral administration in the form of soft capsules. The key active component is the standardized Serenoa repens fructuum extract, derived from the fruit of the dwarf palm (Serenoa repens). This classification assures adherence to specific pharmaceutical quality and manufacturing standards required in various European markets. Furthermore, Serenoa repens is recognized for its traditional use in addressing lower urinary tract symptoms, confirming the medicine's role in helping to ease urinary discomfort.

Composition and Source of Prostagutt Extracts

The medicinal activity of Prostagutt relies on the extract's lipophilic content, specifically its profile of key fatty acids and phytosterols. While the mono-preparation Prostagutt uno contains only the saw palmetto extract, the frequently utilized Prostagutt duo is a fixed combination product that also includes the Urtica dioica Radix Extract (nettle root extract). This dual-extract approach incorporates the combined properties of these botanicals. The anti-inflammatory properties of these extracts contribute to their general purpose. The final form is a soft capsule designed for the protected delivery of these lipid-soluble, plant-derived ingredients.

General Purpose of the Phytotherapeutic Agent

The overarching purpose of Prostagutt is to offer symptomatic relief for men experiencing discomfort and functional issues related to the prostate and urinary tract. Its general benefit centers on supporting the smooth flow of urine and minimizing the pressure that causes frequent or difficult urination, consistent with its classification as an agent for lower urinary tract symptoms (LUTS). Its presentation as a multi-component botanical option is intended for addressing the LUTS associated with benign prostate enlargement.

What side effects are possible with Prostagutt?

Possible Side Effects and Safety Information

The safety profile for Prostagutt, which contains extracts of Serenoa repens and Urtica dioica, is structured around a limited number of officially documented adverse reactions. These effects are primarily categorized by frequency and the body system affected, according to regulatory documents.


Official Adverse Reactions and Classification

The most frequently reported effects are typically categorized as Uncommon or Common in official labeling.

System-Organ Class Common Adverse Reactions Uncommon Adverse Reactions
Gastrointestinal Disorders Abdominal pain Nausea, Diarrhea, Stomach discomfort
Nervous System Disorders Headache Dizziness, Fatigue
Skin & Subcutaneous Disorders Skin rash, Pruritus, Urticaria

Adverse reactions classified as Not Known (frequency cannot be estimated from available data) include severe allergic reactions and reversible gynecomastia. Rare, but officially noted, serious safety events include the potential for acute hepatitis and the risk of Intra-operative Floppy Iris Syndrome (IFIS) during cataract surgery.


Population-Specific Safety Considerations

The medicine is contraindicated in individuals under 18 years of age. Furthermore, Prostagutt is not suitable for women (including during pregnancy or lactation) as it is intended exclusively for the adult male population and relevant safety data is absent for women. Caution is also advised for patients with known allergies to excipients, such as soy or peanuts.

These safety classifications provide a structured regulatory view, indicating that while most side effects are non-serious and infrequent, specific risks and population restrictions are formally documented and must be considered.

Overdose and Emergency Response

The official regulatory profile for Prostagutt is established by the safety characteristics of its herbal extracts, Serenoa repens and Urtica dioica Radix. Regulatory review, including the European Medicines Agency monograph for the main ingredient, notes that no case of overdose has been reported for the extract. Based on this, severe or life-threatening systemic outcomes are not explicitly documented in the prescribing information.

Documented Overdose Manifestations

Over-ingestion may potentially lead to a manifestation profile consistent with the medicine's documented adverse events. These documented effects are primarily localized and include gastrointestinal complaints and signs of hypersensitivity reactions, such as itching, skin rash, and hives (urticaria).

Emergency Actions and When to Seek Help

Management of a confirmed or suspected overdose is symptomatic and supportive, as the regulatory documents state that no specific antidote is known. The official labeling requires that medical attention be sought immediately for symptoms that indicate the underlying condition is worsening. These mandated triggers for urgent help include the appearance of blood in the urine (Haematuria), acute urinary retention (inability to empty the bladder), or the onset of cramps or severe pain when urinating. Additionally, patients are instructed to consult a doctor or pharmacist if there is doubt concerning the amount of medication taken.

Therapeutic Uses of Prostagutt

What Prostagutt Treats: Main Uses and Benefits

Prostagutt is generally considered relevant for the relief of lower urinary tract symptoms (LUTS), such as difficulty starting urination or a frequent need to urinate, associated with a benign enlarged prostate (BPH). It is applied in contexts where additional symptomatic support is needed for this condition.

This medication is commonly used to help with a range of distressing symptoms, including nocturnal frequency (nocturia), urinary urgency, and weak flow. The product is relevant for easing these manifestations and supports patients during difficult episodes of heightened discomfort.

It is considered relevant for supportive care in mild to moderate stages of BPH, contributing to easing the overall symptom load for conditions characterized by periods of heightened symptoms. The general patient-oriented benefit is applied to ease the impact of these urinary issues.

Quick Fact: Symptom Support for Nocturia
Contributes to better rest quality by managing the frequent urge to urinate at night.

Regulatory References

  1. European Medicines Agency public summary

Eligibility and Restrictions for Use

Official Eligibility and Contraindications

Regulatory documentation defines the population eligible to use Prostagutt (containing Serenoa repens and Urtica dioica extracts) based strictly on gender, age, and confirmed diagnosis.

Who is Eligible to Use Prostagutt:

  • Adult men with lower urinary tract symptoms (LUTS) that have been medically confirmed to be associated with benign prostatic hyperplasia (BPH).
  • Men who have first excluded serious underlying conditions, such as prostate cancer, as the medicine is not a substitute for diagnostic screening.

Contraindicated Populations (Must Not Be Used):

Population Group Regulatory Status
Women Contraindicated (The indication is male-specific and use is restricted to men only)
Children and Adolescents Contraindicated (Under 18 years of age; safety and efficacy are not established)
Hypersensitivity Contraindicated (To the active substances, peanuts, soy, or any excipients)
Pregnancy/Lactation Contraindicated/Not Applicable (Due to male-only indication)

Conditional Use Considerations:

Use requires caution for men planning surgical procedures, as regulatory warnings advise that the product may need to be discontinued due to a potential influence on bleeding time. There are no specific or explicit restrictions widely documented in regulatory labeling regarding use in patients with renal or hepatic impairment.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

The regulatory profile for Prostagutt is primarily defined by the absence of formally reported drug-drug interactions. Official regulatory documents state that no specific interactions with other medicinal products have been reported to date, and no dedicated studies have been conducted to assess interaction risk.

Documented Interaction Constraints

While general drug-drug interaction risk is not reported, a specific restriction exists related to a non-active ingredient in the medicine:

  • Excipient-Based Contraindication: Prostagutt contains hydrogenated soybean oil as an excipient in the capsule formulation. Use of the medicine is formally contraindicated if an individual has a known hypersensitivity to either peanuts or soybeans or any products derived from them. This restriction is classified based on the potential for an allergic reaction.

Pharmacokinetic and Co-Administration Information

The absence of documented data leads to the following regulatory statements:

  • Metabolic and Transporter Interactions: No specific pharmacokinetic interactions, such as those involving CYP enzymes or drug transporters, are formally documented or described in the official labeling.
  • Timing and Substance Constraints: No mandatory dose separation or specific timing requirements for co-administration are mandated with other medicines. Furthermore, no specific interaction patterns are documented concerning food, alcohol consumption, or other herbal products and supplements. The official information provides no basis for these types of constraints.

Mechanism of Action

The mechanistic action of Prostagutt involves modulation across the hormonal, dynamic, and inflammatory pathways relevant to prostate and lower urinary tract function.

Modulating Hormonal-Driven Growth

This mechanism involves the Serenoa repens extract acting as an inhibitor of the 5alpha-Reductase enzyme. Restricting the conversion of testosterone into the androgen Dihydrotestosterone (DHT), a key molecular stimulus for prostate cell proliferation, limits its effect on cellular growth. This enzymatic inhibition results in the modulation of the androgen-driven cellular proliferation cascade.

Modulating Smooth Muscle Tone

This domain is primarily executed by the Urtica dioica extract, which mechanistically modulates the involuntary smooth muscle tone surrounding the urethra. The extract's compounds act as antagonists on specific P2X1 Purinoceptors, resulting in the dampening of purinergic signaling that mediates smooth muscle contraction. This receptor antagonism results in a reduction in smooth muscle tone within the prostatic capsule and bladder neck.

Damping Inflammatory Pathways

Both extracts contribute to this mechanism by inhibiting the activation of the pro-inflammatory transcription factor NF-kappaB. Limiting the signaling cascade that produces inflammatory mediators like Interleukin-8 (IL-8) affects the processes that result in localized tissue oedema. This modulation influences the signaling patterns that control local tissue sensitivity and inflammatory responses within the prostate.

Dosage and Administration Information

How to Use Prostagutt

Prostagutt is administered orally and is available in the form of soft capsules. The usage instructions define specific dosing regimens based on the formulation, which must be adhered to for standardization. This medicine is generally intended for longer-term use and is not confined to a short, fixed duration, reflecting its role in managing persistent, underlying symptoms.

Official Dosing and Frequency

Administration frequency and the amount of active extracts vary depending on the specific product (uno or duo).

Formulation Dosing Regimen Daily Frequency
Prostagutt uno 1 soft capsule (320 mg Serenoa repens) Once daily
Prostagutt duo 1 soft capsule (160 mg S. repens / 120 mg U. dioica) Twice daily (morning and evening)

These standard regimens are established for these types of phytotherapeutic agents.

Administration Requirements

The soft capsule must be swallowed whole and unchewed with a sufficient amount of liquid, such as a glass of water. Intake is typically permitted independently of meals. If a scheduled dose is missed, standard instructions advise against taking a double amount to compensate; the patient should simply continue the regular schedule at the next designated time.

Use Constraints

The usage instructions include specific population constraints. The product is not suitable for use in children and adolescents under the age of 18, nor is it generally intended for use by women. These limitations define the approved scope of its administration.

Recent Clinical Evidence

Recent Clinical Evidence Overview

The active ingredients in Prostagutt are extracts from Saw Palmetto (Sabal serrulata) and Stinging Nettle root (Urtica dioica). Clinical evidence primarily focuses on the use of this fixed combination in men experiencing Lower Urinary Tract Symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH).

Core Research Findings

Multiple randomized controlled trials (RCTs) have been conducted to evaluate the effect of the combination extract on patient-reported symptoms. The primary measurement used across these studies is the International Prostate Symptom Score (I-PSS), which assesses the severity of urinary symptoms (e.g., frequency, urgency, incomplete emptying, and nocturia).

  • Symptom Change: RCTs and meta-analyses have reported a change in the I-PSS total score in patients receiving the combination treatment. One non-inferiority study found that the reduction in I-PSS score after 60 weeks of treatment with the combination was comparable to that seen with an alpha-blocker (Tamsulosin).
  • Quality of Life: Investigators have also measured the effect on Quality of Life (QoL) scores, typically assessed via the I-PSS QoL subscore, finding changes over the treatment period.

Safety Profile and Tolerability

Trials have consistently evaluated the drug's safety profile and tolerability, often comparing it against placebo or active reference drugs like Tamsulosin or Finasteride. Safety analysis generally focuses on the incidence of adverse events and the effect on sexual function.

Adverse Events (Reported) Study Focus
Gastrointestinal complaints General tolerability in RCTs
Mild nausea and headache Most frequently reported events
Sexual function changes Compared against active control drugs

Participants with specific conditions, such as severe allergies or acute urinary retention, were generally excluded from the primary clinical research. The long-term safety and effects extending beyond the primary study duration are often assessed through ongoing observational follow-up studies.

Frequently Asked Questions (FAQ)

Common questions about Prostagutt (FAQ)

Q: How does Prostagutt compare to just taking Saw Palmetto alone?

A: Prostagutt is often sold as a fixed combination product, meaning it contains two plant extracts: Saw Palmetto (Serenoa repens) and Nettle root (Urtica dioica). According to official documents, the two extracts are documented to have different, complementary mechanisms of action. For example, the nettle root extract is described as helping to modulate the smooth muscle tone in the urinary tract, which is a mechanism separate from that of Saw Palmetto alone.


Q: Is Prostagutt a prescription drug or can I buy it over the counter?

A: Prostagutt is typically classified as a non-prescription medicine. Instead, it is regulated as a licensed herbal medicinal product, often requiring purchase directly from a pharmacy. This classification is defined in the official regulatory documentation.


Q: How long does it typically take to start noticing any change after beginning Prostagutt?

A: Studies and official information indicate that this medicine is intended for longer-term use rather than immediate effect. Benefits are usually assessed after several months (e.g., three months) of continuous daily use. Therefore, any noticeable change is often not observed shortly after beginning the regimen.


Q: Is Prostagutt safe to take for a long period of time?

A: Official regulatory texts permit the use of this medicine for an unlimited duration, reflecting its intended role as a long-term therapy. Regulatory status requires that symptoms be regularly assessed and monitored by a healthcare professional while on the treatment.


Q: What are the major known interactions between Prostagutt and blood-thinning medications?

A: Official regulatory texts state that no specific drug-drug interactions have been reported to date. However, official warnings recommend that individuals planning surgery inform their physician due to a general potential for influence on bleeding time.


Q: Is it normal to feel no different after one week of taking Prostagutt?

A: Yes, it is not unexpected to feel no different after only one week. Official documentation indicates that the medicine is intended for longer-term use to manage symptoms. Therapeutic effects are generally assessed over a duration of several months in clinical studies, not after just one week.


Q: Does Prostagutt have any known effect on sexual function?

A: Clinical trials for Prostagutt specifically monitor the effect on sexual function. Adverse reactions related to sexual function are listed in regulatory summaries, with documented incidence rates varying across clinical studies. Examples include decreased libido.


Q: Is Prostagutt the same as Urorec or Tamsulosin?

A: No, these medicines are not the same. Prostagutt is classified by regulators as a phytotherapeutic agent (a licensed herbal medicine). Urorec (silodosin) and Tamsulosin are pharmacologically classified as alpha-blockers, which are synthetic drug classes.


Q: Are there any warnings about Prostagutt for people with liver conditions?

A: Official documentation advises caution regarding liver health, as regulatory adverse reaction summaries note the potential for a very rare, but serious, event called acute hepatitis. Caution is advised for those with hepatic impairment, and official warnings note the importance of medical supervision.


Q: Is it true that Prostagutt can help with hair loss?

A: The official and regulatory approved indication for Prostagutt is exclusively for offering symptomatic relief for men experiencing urinary tract symptoms associated with Benign Prostatic Hyperplasia (BPH). The approved purpose is not for treating hair loss; its indication is limited to LUTS associated with BPH.


Q: What is the difference between Prostagutt and Prostagutt Forte?

A: Prostagutt (often available as uno or duo) and Prostagutt Forte are different versions of the product. These versions typically vary in the exact strength or precise ratio of the active plant extracts (Serenoa repens and Urtica dioica) contained within the capsule.


Q: What is the shelf life of Prostagutt?

A: The official documentation requires the medicine to be used only until the expiry date printed on the packaging. This date represents the shelf life, which is determined during the regulatory licensing process based on the product’s stability data.


Q: How does Prostagutt work on the bladder?

A: The Nettle root extract (Urtica dioica) contained in the medication is described in regulatory texts as modulating the involuntary smooth muscle tone of the prostatic capsule and the bladder neck. This action is documented as contributing to the mechanism for managing LUTS.


Q: Are the side effects of Prostagutt usually mild?

A: The most frequently reported adverse reactions are typically classified as common or uncommon in regulatory documents and include non-serious effects like headache and gastrointestinal complaints. However, regulatory summaries also document very rare, serious events.


Q: Can Prostagutt be taken by people with high blood pressure?

A: Official regulatory documents do not list high blood pressure (hypertension) as a formal contraindication, a general warning, or a specific known interaction with the product.


Q: Has there been research on Prostagutt and its effect on prostate specific antigen (PSA) levels?

A: While clinical studies often monitor a range of factors, research focusing on the efficacy of Prostagutt primarily tracks changes in the International Prostate Symptom Score (I-PSS) and quality of life scores. The effect on PSA levels is typically not reported as a primary finding in the main efficacy trials.


Q: Is there a generic version of Prostagutt available?

A: Prostagutt is a registered brand name for a licensed herbal medicinal product that uses a specific fixed combination of plant extracts. Due to its unique formulation, a generic equivalent of the exact product is not available.


Q: Is Prostagutt known to affect sleep or cause drowsiness?

A: The official adverse reaction summary includes effects on the Nervous System. Specifically, side effects like Dizziness and Fatigue are listed, which could potentially impact a person's level of alertness or sleep patterns.


Q: Does Prostagutt require any specific follow-up tests or monitoring?

A: Official warnings state that men using the product require regular medical follow-up because the medicine is only intended to treat symptoms, not the underlying cause. This monitoring is to ensure serious underlying conditions, such as prostate cancer, have been excluded and to assess urinary symptoms.


Q: Who originally developed Prostagutt?

A: The official product labeling and regulatory submission documents identify the supplier and regulatory application holder as the developer and manufacturer of the product.


Q: Is Prostagutt approved for use in all countries?

A: The product is regulated as a licensed herbal medicinal product with approval in various European markets by agencies like the EMA. Regulatory approval status is determined by each nation's drug authority, so approval cannot be assumed for all global jurisdictions.


Q: Are there any reports of Prostagutt causing mood changes?

A: Official regulatory documentation provides a structured list of known and suspected adverse reactions. Mood changes or other psychological effects are not currently listed in the official safety profile for the medicine.


Q: Can Prostagutt affect the results of a prostate exam?

A: Official information emphasizes that while the drug treats symptoms, it must not interfere with or replace diagnostic procedures. Therefore, a physician is still required to perform regular diagnostic tests, such as a Digital Rectal Exam (DRE), and blood tests like PSA, to exclude serious underlying diseases.


Q: Does Prostagutt contain gluten or lactose?

A: The full list of inactive ingredients (excipients) in the product is provided in the official regulatory labeling. This list indicates that common allergens like gluten and lactose are not typically present among the flagged excipients.


Q: Can I stop taking Prostagutt suddenly?

A: Official documentation emphasizes that the medicine is generally intended for longer-term use for managing chronic symptoms. However, regulatory texts do not contain specific warnings or procedures that must be followed regarding the sudden cessation of the product.


Q: Is it okay to drive or operate machinery while taking Prostagutt?

A: The official guidance advises caution when driving or operating machinery, based on the potential for side effects like Dizziness and Fatigue that are listed in the adverse reaction summaries.


Q: Is there a risk of becoming dependent on Prostagutt?

A: Official safety documentation for the product does not list drug dependence, the risk of addiction, or withdrawal symptoms as known or suspected risks associated with the medicine.

How should Prostagutt be stored and disposed of?

Official Storage and Disposal Instructions

Prostagutt Duo capsules must be stored according to regulatory requirements to preserve product stability and ensure public safety. The medicine must not be stored above 30, C and should be stored in the original package to provide protection from light. This is essential for maintaining the integrity of the active plant extracts until the expiry date, after which the product must not be used.

Crucially, the medicine must be kept out of the sight and reach of children.

For disposal, regulatory documents explicitly state that the medicine must not be disposed of in wastewater or household waste. The official instruction for environmentally responsible and safe disposal is to ask your pharmacist how to dispose of any unused or expired product.

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

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