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Flodart Plus

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Flodart Plus

Flodart Plus_EN

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Medically reviewed

Marina Burgos

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 Flodart Plus

Property Description
Active ingredient Dutasteride and Tamsulosin
Form Oral Capsule (Fixed-Dose Combination)
Pharmacological class 5-Alpha Reductase Inhibitor and Alpha-blocker
Common use Management of Benign Prostatic Hyperplasia (BPH)
Origin Synthetic

What Type of Medicine is Flodart Plus?

Flodart Plus is a synthetic, fixed-dose combination product specifically formulated for the long-term management of symptomatic Benign Prostatic Hyperplasia (BPH) in adult men. It is an oral capsule categorized as a dual-action Urologic agent. Pharmacological studies support the necessity of combining a 5-Alpha Reductase Inhibitor and an Alpha-blocker for comprehensive BPH management. This product offers patients the convenience of addressing two distinct pathological components of prostate enlargement with a single administration.

What Are the Active Components in Flodart Plus?

The core active ingredients in Flodart Plus are Dutasteride and Tamsulosin, typically present as the salt Tamsulosin Hydrochloride. Both ingredients are synthetic in origin and are combined to ensure simultaneous delivery of both therapeutic actions. The presence of two active agents in the single capsule distinguishes this product from monotherapies. The dosage form ensures both components are ready for oral intake alongside inert pharmaceutical excipients. Other similar combination products available under different trade names, such as Jalyn, contain the same two INNs.

What is the General Purpose of This Dual Therapy?

The general purpose of Flodart Plus is to manage and relieve the bothersome urinary symptoms associated with an enlarged prostate gland (BPH). Clinical consensus widely recognizes the benefit of a dual-therapy approach when symptoms are moderate to severe. By simultaneously providing a hormonal mechanism (reducing prostate size) and a muscular mechanism (promoting smooth muscle relaxation), the medication works to facilitate easier urine flow and aims to mitigate the progression of BPH symptoms over time.

Regulatory References

  1. Dutasteride and Tamsulosin Combination Drug Information

What side effects are possible with Flodart Plus?

Possible Side Effects and Safety Information

The safety profile for Flodart Plus, the fixed-dose combination of Dutasteride and Tamsulosin, is structured by official regulatory classifications, grouping documented adverse reactions by frequency and affected body systems. These classifications are derived from clinical trials and post-marketing surveillance data.

Frequency-Classified Adverse Reactions

Adverse reactions are formally classified by frequency in official regulatory documents:

  • Very Common (occurring in ge 1 in 10 users): Sexual function disorders, including impotence, decreased libido, and ejaculation disorders. These are typically observed during the initial phases of treatment.
  • Common (occurring in ge 1 in 100 users): Dizziness, postural hypotension (drop in blood pressure upon standing), asthenia (weakness), and breast changes such as gynecomastia (breast enlargement) and tenderness. Dizziness is often more frequent at the start of therapy.
  • Uncommon or Rare: Palpitations, syncope (fainting), headache, and skin reactions like rash and pruritus are uncommon. Angioedema (swelling of the face, tongue, or throat) is classified as rare, while Priapism (a prolonged, painful erection) and Stevens-Johnson Syndrome (a severe skin reaction) are very rare.

Documented Safety Constraints

Official labeling contains specific high-level restrictions and considerations:

  • Contraindications: The medicine is contraindicated in women and children, and in individuals with known hypersensitivity to the components. It is also contraindicated in patients with severe hepatic impairment (severe liver problems).
  • Surgical Risk: Exposure to the Tamsulosin component has been associated with the risk of Intraoperative Floppy Iris Syndrome (IFIS), which is a consideration for patients undergoing cataract surgery.
  • Handling: The capsule contents must not be handled by pregnant women due to the risk of exposure to Dutasteride. The capsule must not be crushed or chewed.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information describes overdose manifestations for Flodart Plus (Dutasteride and Tamsulosin) as primarily driven by the tamsulosin component, which can lead to severe cardiovascular effects.

Documented Overdose Manifestations and Risks

Feature Official Regulatory Statement
Primary Clinical Sign Acute and severe hypotension (low blood pressure)
Severe Outcomes Risk of syncope (collapse) and cardiovascular instability
Associated Symptoms Dizziness, weakness, and compensatory tachycardia (increased heart rate)
Antidote Status No specific antidote is known for the active components

Regulatory Mandate for Emergency Response

Urgent medical attention must be sought immediately for known or suspected overdosage, particularly if signs of severe hypotension or cardiovascular instability are present. Treatment is classified as symptomatic and supportive.

Regulatory documents outline procedures to manage the effects of overdose, including placing the patient in a supine position to attempt to restore blood pressure. Depending on the time of ingestion, measures to impede absorption, such as gastric lavage or administering activated charcoal, may be considered. If severe hypotension persists, interventions such as the use of volume expanders and vasopressors are described to stabilize cardiovascular function, with continuous hospital monitoring required until the patient is haemodynamically stable.

Therapeutic Uses of Flodart Plus

Main Uses of Flodart Plus

Flodart Plus is a combination medication primarily used to manage symptoms associated with benign prostatic hyperplasia (BPH), a non-cancerous enlargement of the prostate gland. This condition is common in aging men and can significantly impact quality of life by affecting urinary function.

The medication works through two distinct mechanisms to address the physical and functional aspects of prostate enlargement:

  • Relaxation of Smooth Muscle: One component acts by relaxing the smooth muscles in the prostate and the neck of the bladder. This reduction in muscle tension helps to open the urinary passage, making it easier to initiate urination and maintain a stronger flow.
  • Reduction of Prostate Volume: The second component targets the hormonal processes responsible for prostate growth. By inhibiting the conversion of testosterone into dihydrotestosterone (DHT)—the primary hormone driving prostate enlargement—it can lead to a gradual reduction in the physical size of the gland.

Therapeutic Benefits

The integration of these two mechanisms provides comprehensive management of BPH symptoms. Users may experience several clinical benefits over the course of treatment:

Improvement of Urinary Flow

By decreasing the resistance within the urethra, the medication helps alleviate the difficulty often associated with starting urination. It can also reduce the sensation of incomplete bladder emptying and diminish the frequency of the "stop-and-start" pattern known as hesitancy.

Reduction of Urinary Frequency

Many patients experience a decrease in the urgent need to urinate. This is particularly beneficial for managing nocturia, the condition of waking up multiple times during the night to urinate, which often leads to improved sleep patterns.

Long-term Management and Progression

Beyond immediate symptom relief, the ability of Flodart Plus to shrink the prostate gland addresses the underlying cause of the obstruction. This long-term approach can help stabilize the condition and reduce the likelihood of complications associated with progressive prostate growth, such as acute urinary retention or the eventual need for surgical intervention.

Eligibility and Restrictions for Use

Who Can and Cannot Use Flodart Plus?

This information reflects the official population eligibility and non-eligibility rules documented by regulatory authorities (e.g., FDA, EMA).

Flodart Plus (Dutasteride and Tamsulosin) is strictly approved for use only in adult males (aged 18 years and older) for the management of symptomatic Benign Prostatic Hyperplasia (BPH).

Contraindications and Restrictions

The medicine is contraindicated and must not be used in the following populations:

Classification Population or Condition
Gender/Age Females, children, and adolescents (under 18 years).
Reproductive Status Females who are pregnant or may become pregnant, due to the risk of male fetal harm.
Comorbidity Patients with severe hepatic impairment.
Allergy Known, clinically significant hypersensitivity to dutasteride, tamsulosin, or any component.

Conditional Use:

  • Mild to moderate hepatic impairment: Use requires caution.
  • Surgical Restriction: Initiation of therapy is not recommended for patients scheduled for cataract or glaucoma surgery.
  • Secondary Exposure: Males with a pregnant partner must use barrier contraception during treatment and for six months after the last dose, and patients must not donate blood during this time frame.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Flodart Plus, a combination of tamsulosin and dutasteride, has several documented interactions with other medications and product categories that affect its safety and exposure in the body. It is essential to understand these potential effects to minimize risks.

Do Not Combine (Contraindicated):

  • Strong CYP3A4 Inhibitors: Medications that are strong inhibitors of the CYP3A4 liver enzyme, such as the antifungal medicine ketoconazole, must not be taken with this product. This combination significantly slows the breakdown of tamsulosin, leading to a marked increase in its concentration and potential for side effects.
  • Other Alpha-Adrenergic Antagonists: Coadministration with other alpha-blocker medications is not recommended due to the high risk of symptomatic hypotension (significantly low blood pressure).

Use with Caution and Monitoring:

  • Moderate CYP3A4/CYP2D6 Inhibitors: Medicines such as erythromycin (an antibiotic) and paroxetine (an antidepressant) can also increase tamsulosin exposure. Caution is advised, especially in individuals known to be poor metabolizers of the CYP2D6 enzyme.
  • PDE-5 Inhibitors: Medications used for erectile dysfunction, like sildenafil, can cause an additive blood pressure-lowering effect when combined with this product, requiring caution due to the risk of hypotension.
  • Warfarin: Closer monitoring is advised if this product is taken concurrently with the anticoagulant warfarin.

Interaction-Related Non-Medicinal Constraints:

  • Pregnant Individuals: Women who are pregnant or may become pregnant should not handle the capsules due to the risk of absorption of dutasteride, which may harm a male fetus.
  • Blood Donation: Individuals taking Flodart Plus must not donate blood until at least six months after their last dose to prevent potential exposure of dutasteride to a pregnant blood recipient.

Mechanism of Action

Dual Mechanism Modulating the Static and Dynamic Components

Flodart Plus exerts its physiological effect through two independent mechanistic domains to achieve a dual modulation of the urinary outflow tract. The approach combines a hormonal mechanism focused on tissue volume reduction with an autonomic mechanism focused on functional relaxation, which together modulate key physiological processes.

Hormonal Pathway Suppression via Dual Enzyme Inhibition

Dutasteride acts as a dual inhibitor of the Type 1 and Type 2 5-alpha reductase (5AR) enzymes. This mechanistic domain targets the androgen pathway, profoundly suppressing the conversion of testosterone into the growth factor, dihydrotestosterone (DHT). The molecular cascade results in the sustained deprivation of the prostate gland's growth stimulus, leading to a reduction in prostatic volume.

Autonomic Receptor Blockade and Smooth Muscle Tone Modulation

Tamsulosin engages the mechanistic domain of autonomic receptor antagonism by selectively blocking Alpha-1a (alpha1A) adrenergic receptors in the smooth muscle of the prostatic stroma and bladder neck. This action antagonizes the sympathetic nervous system's signaling that triggers muscle contraction. The immediate physiological consequence is the functional relaxation of muscle tone in the urinary tract, decreasing outflow tract resistance without altering the underlying tissue structure.

Dosage and Administration Information

Instruction Map: How to use Flodart Plus — Official Administration Guidelines

This map consolidates the usage parameters for the fixed-dose combination of Dutasteride 0.5 mg / Tamsulosin 0.4 mg.

Administration Scope

Instruction Detail
Route of administration Oral use only.
Dosing schedule One capsule (0.5 mg/0.4 mg) is taken once daily.
Timing in relation to meals To be taken approximately 30 minutes after the same meal each day.
Preparation requirements The capsule must be swallowed whole; it must not be chewed or opened.
Age-group administration rules Contraindicated for use in children and adolescents (under 18 years of age).
Missed-dose rules If a dose is missed, treatment should be continued with the next scheduled daily dose; the following dose should not be doubled.
Special procedural conditions Women who are pregnant or who may become pregnant must not handle the capsules.

Instruction Classifications (High-Level)

Classification Detail
Administration method type Oral
Frequency pattern Daily (Once daily)
Regulatory basis Standardized labeling
Use-context constraints Fixed time relation to food and requirement for long-term management.

Resulting Procedural Structure

Official step sequence:

  • Take one capsule (0.5 mg/0.4 mg) once daily.
  • Consume the dose approximately 30 minutes after the same meal each day.
  • Swallow the capsule whole without crushing or opening it.

Connection to the overall use protocol (2–4 sentences): The official labeling defines a consistent oral administration regimen of one capsule per day, establishing a standardized pattern for long-term use. The explicit instructions regarding food timing and the requirement to swallow the capsule whole are structural components designed to ensure the proper absorption and handling of the fixed-dose combination product.

Recent Clinical Evidence

Research Evidence / Overview of studies for Flodart Plus

1. Evidence for the Management of Symptomatic BPH

Randomized Controlled Trials (RCTs) contribute to the research landscape exploring the use of this fixed-dose combination. The combination was evaluated in research exploring how symptoms change over time. Studies included comparisons against taking either active ingredient (dutasteride or tamsulosin) alone. The populations studied were adult men presenting with conditions characterized by fluctuating symptoms of Benign Prostatic Hyperplasia (BPH), specifically those with moderate-to-severe symptoms and an enlarged prostate gland.

Research examined a variety of outcomes reflecting daily functioning or activity level. Studies monitored changes in validated patient-reported outcomes describing perceived discomfort. Researchers also monitored functional measures like the maximum urinary flow rate (Qmax) and tracked anatomical measures, including the prostate's size and Prostate-Specific Antigen (PSA) levels.

2. Research on Reducing Disease Progression Risk

The combination was studied for its potential to affect the long-term course of BPH. This involved long-term, event-driven RCTs that focused on conditions associated with acute or disruptive episodes of BPH progression. Studies explored outcomes describing episodic or acute changes, specifically the incidence of a major BPH-related event. These outcomes included the need for BPH-related surgery or an episode of Acute Urinary Retention (AUR).

Research examined these progression endpoints over several years in adult men who were judged to be at a higher risk of BPH progression. Studies monitored the observed rate of these long-term events in the combination group versus the monotherapy groups. This evidence contributes to understanding symptom patterns related to the disease’s progression.

5. What is Still Uncertain About the Research Evidence

Despite the existence of large-scale RCTs, some limitations in the broader evidence landscape exist. Evidence quality varies across studies when evaluating certain functional measures, and some findings were mixed or showed statistical variability, known as heterogeneity. Furthermore, long-term effects are not fully established beyond the four-year study window, meaning there is limited information for long-term outcomes beyond this period. This research provides context but not individual predictions, and findings describe group patterns, not personal outcomes.

Frequently Asked Questions (FAQ)

Common questions about Flodart Plus (FAQ)

Q: How quickly does Flodart Plus start to work?

The time it takes to see relief depends on which part of the medication is working. The tamsulosin component, which relaxes muscle tissue, may begin to relieve urinary symptoms within the first few weeks of starting treatment. The dutasteride component, which aims to shrink the prostate gland, may take three to six months of continuous use before its full therapeutic benefits are generally observed in studies.

Q: Does Flodart Plus affect blood pressure?

Yes, Flodart Plus can cause a drop in blood pressure, known as postural hypotension, which is a risk associated with the tamsulosin component. Due to the risk of low blood pressure, caution is generally recommended when changing positions, such as rising quickly from a sitting or lying position. Official information notes that dizziness or light-headedness—symptoms of low blood pressure—is a common side effect.

Q: Can Flodart Plus interact with natural supplements?

Regulatory information specifies that Flodart Plus interacts with certain medicines that inhibit specific liver enzymes (CYP3A4/CYP2D6). While specific natural supplements may not be listed, any supplement known to affect these same enzymes could alter how the medicine is processed in the body. Consulting a healthcare provider about all supplements being taken is necessary.

Q: Does Flodart Plus help with the nighttime urination frequency?

Flodart Plus is officially indicated for managing the bothersome urinary symptoms associated with an enlarged prostate. These symptoms typically include increased frequency of urination, which extends to nighttime urination (known as nocturia). Clinical research on the dual therapy components tracks relief from these overall symptoms.

Q: Is Flodart Plus taken with or without food?

Official administration instructions state that the capsule must be taken approximately 30 minutes after the same meal each day. This timing ensures consistent absorption of the medicine in your body. Taking the capsule without food may lead to increased exposure of one of the active ingredients, which is why taking it consistently with food is necessary.

Q: What happens when you stop taking Flodart Plus?

This medication is designed for the long-term management of chronic BPH symptoms. If treatment is stopped, the therapeutic benefits, particularly the prostate-shrinking effect of dutasteride, will gradually be lost. Stopping the medication may lead to the return or worsening of symptoms associated with BPH, as the drug's benefits are lost. Any decision to stop treatment should involve a doctor.

Q: What are the long-term effects of taking Flodart Plus?

Clinical trials for Flodart Plus have evaluated the safety and efficacy of the combination therapy for up to four years. During this period, side effects and risks were monitored and documented. Official product information notes that the full safety profile and effects beyond this four-year period have not been fully established in controlled studies.

Q: Is it normal to feel dizzy when starting Flodart Plus?

Yes, dizziness is listed in official documentation as a common side effect. It is often reported more frequently during the initial period after beginning treatment. Caution is recommended when changing positions or moving quickly due to the risk of falls related to dizziness.

Q: Can Flodart Plus cause hair loss or changes?

One of the active components, dutasteride, is known to affect hormones related to hair growth. Some users of this medication or its components have reported hair-related side effects, including hair loss or, less commonly, an increase in hair growth. If you observe changes in hair growth, this should be discussed with a healthcare provider.

Q: Why do some people say Flodart Plus makes them tired?

Official safety data lists asthenia, which means weakness or a lack of energy, as a common side effect. This is the clinical term that patients often describe as general fatigue or feeling tired. This effect is one of the documented adverse reactions to the medication.

Q: Is it safe to drive while taking Flodart Plus?

Official warnings advise caution regarding driving or operating hazardous machinery, particularly when starting treatment. Because the drug can cause dizziness or light-headedness, patients should not drive until they understand how the medicine affects them.

Q: Are there generic versions of Flodart Plus available?

Flodart Plus is a specific brand name for the fixed-dose combination of the active ingredients dutasteride and tamsulosin. These two components are available under various other brand names and as generic combination products, depending on the regulatory region.

Q: Does Flodart Plus need to be stored in the refrigerator?

No, the medicine does not require refrigeration. Official storage instructions specify that it must be kept in its original container below 30°C and protected from excessive moisture, heat, and direct sunlight.

Q: Is it normal to see changes in semen while on Flodart Plus?

Yes. According to official documents, ejaculation disorders and a decreased amount of semen/sperm are listed as very common side effects of this medication. These changes are expected, particularly during the initial phase of treatment.

Q: Can Flodart Plus cause headaches?

Yes. Official safety data classifies headache as an uncommon side effect of Flodart Plus. If headaches are persistent or severe, this should be discussed with a healthcare provider.

Q: Can people with kidney issues take Flodart Plus?

The medicine is strictly contraindicated (must not be used) in patients with severe liver impairment. For those with kidney issues, regulatory documents advise that caution is necessary. Limited information is available regarding its safety or dosing in cases of severe kidney impairment.

Q: What if I experience nausea after taking Flodart Plus?

Nausea is sometimes reported in regulatory documents associated with the tamsulosin component or related products. If nausea is severe or persistent, it should be discussed with the prescribing doctor.

Q: Do I need regular check-ups while on Flodart Plus?

Yes, regular medical follow-up is necessary while taking this medication. Regulatory guidance specifically advises that doctors monitor prostate-specific antigen (PSA) levels, as the drug can affect these readings. Continued check-ups are also needed to assess the long-term effectiveness and safety of the treatment.

Q: Can I take other cold and flu medicines with Flodart Plus?

It is important to exercise caution. Many over-the-counter cold and flu medicines contain decongestants (sympathomimetics) which can potentially interact with the tamsulosin component. This interaction could worsen urinary symptoms or affect blood pressure. It is important to check the ingredients of cold medicines and discuss them with a healthcare provider before combining them with Flodart Plus.

Q: Can Flodart Plus affect my mood?

While the most common side effects listed are physical, the individual components of Flodart Plus have been associated with psychiatric side effects in post-marketing reports. If unexpected or concerning mood changes are experienced, they should be reported to a healthcare provider.

Q: Does Flodart Plus cause weight gain or loss?

Weight changes are not listed as a common or very common side effect in official regulatory documents. While rare effects on metabolism may exist, weight gain or loss is not a frequently reported adverse reaction to this medication.

Q: Can I stop taking Flodart Plus suddenly if I feel better?

Since this drug is prescribed for the long-term management of a chronic condition, you should not stop taking it suddenly. Discontinuing the medication on your own can lead to the return or worsening of your BPH symptoms. Any decision to stop treatment should be made only after consultation with a healthcare provider.

Q: Are there any dietary restrictions specifically for the dutasteride component?

No specific dietary restrictions are listed for the dutasteride component of the medicine. However, the tamsulosin component requires the entire capsule to be taken 30 minutes after the same meal each day to ensure proper and consistent absorption.

How should Flodart Plus be stored and disposed of?

How to Store and Dispose of Flodart Plus

The storage and handling of Flodart Plus (dutasteride and tamsulosin hydrochloride) must strictly adhere to regulatory requirements to maintain product stability and ensure safety.

Storage Conditions

Requirement Specifics
Temperature Store below 30°C.
Protection Protect from direct sunlight, moisture, and heat.
Packaging Keep in the original, tightly closed container and out of reach of children.

Special Handling and Disposal

Pregnant women or women who may become pregnant must not handle damaged or leaking capsules, as the dutasteride component can be absorbed through the skin. Any unused or expired medicine must be disposed of safely according to the instructions on the package or local guidelines, ensuring it is not consumed by pets or children.

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

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