Talis

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Talis

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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 Talis

Talis is a fixed-dose combination drug product formulated for oral administration, containing two distinct synthetic active pharmaceutical ingredients: Metaclazepam Hydrochloride and Tadalafil. This specific combination design ensures the simultaneous delivery of both agents, which is intended for addressing co-morbid conditions in appropriate adult patients. The convenience of this single-tablet approach distinguishes it from separate, co-administered therapies.

The Dual Pharmacological Classification of Talis

Talis is categorized into two pharmacological classes, reflecting its dual action. The Metaclazepam Hydrochloride component functions as an anxiolytic belonging to the benzodiazepine derivative class. Metaclazepam is a 1,4-benzodiazepine characterized by its selectivity for anxiolytic effects. This component is intended to offer central moderation and calmness.

The second component, Tadalafil, is classified as a Phosphodiesterase type 5 (PDE5) inhibitor. Its mechanism involves the relaxation of smooth muscle tissue through the inhibition of the PDE5 enzyme. This component is designed to provide peripheral vascular modulation.

General Therapeutic Purpose of the Combination

The overarching purpose of the Talis formulation is to provide a dual-action therapeutic effect by targeting both central and peripheral physiological systems in tandem. The product is utilized in scenarios where a patient requires the calming, tension-reducing properties of the anxiolytic alongside the flow-enhancing, smooth muscle relaxing properties of the PDE5 inhibitor. This fixed-dose approach is designed to support adult patients whose clinical needs require concurrent central moderation and vascular modulation through a unified treatment.

What side effects are possible with Talis?

Possible Side Effects and Safety Information

The following information summarizes the safety profile of Talis (Tadalafil) as documented in official regulatory sources. It is not patient advice.

Common Adverse Reactions

The most frequently reported adverse reactions (ge 2%) involve the central nervous system, musculoskeletal system, and gastrointestinal tract, and include headache, dyspepsia (indigestion), back pain, myalgia (muscle pain), nasal congestion, flushing, and pain in limb. These effects are often more common at higher dose strengths.

Serious and Clinically Significant Risks

Regulatory documents emphasize several serious adverse reactions:

  • Cardiovascular Risks: Due to its vasodilatory properties, Talis can cause transient decreases in blood pressure. The drug is contraindicated for patients concurrently using any form of organic nitrate or guanylate cyclase stimulators (e.g., riociguat), as this combination may lead to severe hypotension.
  • Vision Loss (NAION): Cases of sudden decrease or loss of vision in one or both eyes, which may be a sign of Non-Arteritic Ischemic Optic Neuropathy (NAION), have been reported in temporal association with this class of drugs.
  • Hearing Loss: Sudden decrease or loss of hearing, sometimes accompanied by dizziness and ringing in the ears (tinnitus), has been reported.
  • Priapism: Prolonged erections (lasting over 4 hours) and painful erections (priapism, lasting over 6 hours) have occurred. Immediate emergency medical attention is required to prevent permanent tissue damage.

Safety Restrictions and Limitations

Use of Talis is not recommended in patients with a history of myocardial infarction within the last 90 days, stroke within the last 6 months, unstable angina, or uncontrolled blood pressure. Use is also not recommended for patients with severe hepatic impairment, or for once-daily dosing in those with severe renal impairment or on dialysis. Caution is advised in patients with conditions predisposing them to priapism or with anatomical deformation of the penis.

Overdose and Emergency Response

Overdose and When to Seek Help

The overdose profile for Talis is defined by the risks associated with excessive levels of its two active components, requiring specific emergency actions mandated by regulatory bodies.

Overdose Component Documented Manifestations
Anxiolytic (Metaclazepam) Central Nervous System (CNS) depression, including somnolence, confusion, lethargy, ataxia, and slurred speech. Severe outcomes include respiratory depression and coma.
PDE5 Inhibitor (Tadalafil) Exaggerated common effects like headache, flushing, myalgia, and clinically significant hypotension (low blood pressure).

In cases of suspected overdose, seek immediate medical attention or contact emergency services. Urgent medical help is required for life-threatening symptoms, such as compromised respiration or profound symptomatic hypotension. The official regulatory approach for management is symptomatic and supportive treatment, with a mandatory focus on monitoring vital signs and cardiac function.

While the label for the anxiolytic component states that a specific antagonist, flumazenil, may be considered, its use requires caution due to the documented risk of precipitating seizures. For the Tadalafil component, regulatory documents confirm that no specific antidote is known. Hospital monitoring may be required due to the potential for delayed onset of severe effects.

Therapeutic Uses of Talis

What Talis Treats: Main Uses and Benefits

Talis is applied across domains where additional symptomatic support is needed, relevant in contexts marked by increased discomfort or tension. This fixed-dose combination is used when groups of symptoms create noticeable functional strain.

The Tadalafil component within this combination is utilized to assist in several key areas. The formulation is considered relevant where symptoms are linked to organ-specific functional stress and signs of increased neurological or muscular activity. This medication is primarily used for managing erectile dysfunction, providing supportive relief for benign prostatic symptoms (LUTS), and offering assistance in pulmonary arterial hypertension (PAH).

Key Therapeutic Focus

This medication addresses challenging symptom clusters related to both physical impairment and emotional tension, such as difficulty with function alongside performance-related anxiety. It helps address groups of symptoms that create noticeable functional strain, including urinary urgency, frequency, and difficulties with flow, as well as activity-related functional discomfort in PAH. The medication contributes to easing the overall symptom load and may assist with maintaining functional stability and general well-being.

“The medication contributes to easing the overall symptom load, and may assist with maintaining functional stability.”

Quick Fact: Relief for Functional Strain Talis is commonly used across conditions presenting with acute episodes, where symptomatic support is appropriate for managing co-existing physical limitation and central psychological tension.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Talis — Official Regulatory Information

This section outlines the officially documented eligibility and non-eligibility rules for the use of Talis, based on governmental regulatory prescribing information for its components (Tadalafil and Metaclazepam).

Category Official Regulatory Status
Populations for whom use is allowed Adult patients for the treatment of established labeled conditions.
Populations for whom use is contraindicated Patients using any form of organic nitrate or Guanylate Cyclase (GC) Stimulators (e.g., riociguat). Patients with a known serious hypersensitivity to either active ingredient. Patients with Myasthenia Gravis or severe respiratory insufficiency.
Populations for whom use is not recommended Patients for whom sexual activity is inadvisable due to cardiovascular status. Those with a recent history of myocardial infarction (within 90 days) or stroke (within 6 months). Patients with uncontrolled hypotension or hypertension.
Organ and Comorbidity Restrictions Use is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) or severe renal impairment ( CrCl < 30 mL/min) for once-daily use. Caution is advised for those with conditions predisposing to priapism or a history of Non-Arteritic Ischemic Optic Neuropathy (NAION).
Age and Reproductive Status Pediatric patients (under 18 years): Use is not established and not indicated. Pregnant and breastfeeding women: Use is generally avoided or not recommended.

The drug is intended for use only in adults, as safety and efficacy have not been established in the pediatric population. The profile imposes strict exclusions for patients with certain cardiovascular conditions and those taking specific medications, reflecting the risk classification defined in regulatory documents.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Talis, a fixed-dose combination containing Metaclazepam and Tadalafil, is determined by the specific interaction constraints of both active components, as documented in regulatory information.

Formal Restrictions and Contraindicated Combinations

Co-administration of the Tadalafil component with Organic Nitrates (e.g., nitroglycerin, isosorbide dinitrate) is officially contraindicated. This combination is prohibited due to the substantial risk of potentiating hypotensive effects, potentially leading to severe symptomatic hypotension. Similarly, co-administration with Guanylate Cyclase (GC) Stimulators (e.g., riociguat) is also contraindicated.

Documented Pharmacokinetic Alterations

The Tadalafil component is primarily cleared via the CYP3A4 enzyme system. Potent CYP3A4 Inhibitors (e.g., ketoconazole, ritonavir) are documented to significantly increase Tadalafil exposure (AUC). Conversely, Potent CYP3A4 Inducers (e.g., rifampicin) are stated to cause a reduction in Tadalafil exposure.

Additive Pharmacodynamic Effects

Concomitant use with other CNS Depressants, including opioids and alcohol, may result in additive CNS depressant effects due to the Metaclazepam component. The combination with alpha-blockers carries a documented risk of additive blood pressure-lowering effects.

Timing and Population Considerations

The official label mandates that if a life-threatening situation requires nitrate administration, at least 48 hours must have elapsed since the last dose of the Tadalafil component. Additionally, the use of the Tadalafil component is generally not recommended in patients with severe hepatic or renal impairment due to the potential for increased exposure.

Mechanism of Action

Enzyme Inhibition and Molecular Cascade

The drug’s primary action is the selective competitive inhibition of the Phosphodiesterase type 5 (PDE5) enzyme. This enzyme normally breaks down cyclic Guanosine Monophosphate (cGMP), a signaling molecule. By blocking PDE5, Talis prevents the inactivation of cGMP, causing this molecule to accumulate within specific cells.

Modulation of Smooth Muscle Tone

The buildup of cGMP maintains the signal for smooth muscle relaxation in the walls of blood vessels and certain other tissues. This molecular cascade leads to a decrease in the tension of these muscles, which operates within systems where specific mediators like Nitric Oxide (NO) are involved in the regulation of vascular dynamics.

Localized Vascular and Physiological Adjustment

The resulting relaxation of vascular smooth muscle causes the blood vessels to widen, a process known as vasodilation. This targeted action alters regional blood flow and tissue perfusion, which results in localized changes in vascular resistance and tissue hemodynamics.

Dosage and Administration Information

Talis is a fixed-dose oral tablet and its administration is defined by instructions regarding route, frequency, and dose adjustments. The medicine is taken orally and the tablet must be swallowed whole for proper administration. The tablet may be taken with or without food, allowing flexible timing in relation to meals.

Labeled Dosing Regimens and Frequency

The usage patterns are structured around two distinct schedules. The first is a once-daily, continuous schedule intended for chronic conditions. When following this regimen, the medicine must be taken at approximately the same time every day to maintain consistent levels. The daily dose for the Tadalafil component ranges from 5 mg up to 40 mg, depending on the use pattern. Notably, the 40 mg dose is to be taken as a single unit and not divided over the course of the day.

The second pattern is an as-needed, episodic schedule for situational use. For this approach, the dose of the Tadalafil component starts at 10 mg, within an established range between 5 mg and a maximum of 20 mg per dosing occasion. The frequency for this use is limited to no more than once per day.

Population and Procedural Rules

Dosage adjustments are an integral part of the use protocol. In patients with renal or hepatic impairment, standard protocols involve a modification of the dose, often involving a reduction or avoidance in severe cases. For the continuous daily regimen, if a dose is missed, it should be taken when remembered, but two doses should not be taken concurrently.

Recent Clinical Evidence

Research evidence / Overview of Studies for Talis

The research base for Talis, a fixed-dose combination, is built upon clinical studies involving its two active components, Metaclazepam and Tadalafil. This evidence highlights what has been observed in controlled trials and what areas still require further research.


Evidence for Use in Erectile Dysfunction (ED)

Research explored outcomes related to physical discomfort in ED, focusing primarily on the Tadalafil component. Researchers studied adult men with conditions characterized by functional limitations in several short-term Randomized Controlled Trials (RCTs). These trials measured outcomes reflecting daily functioning and activity level using standardized scales and patient-reported outcomes describing perceived discomfort. The existing evidence for the fixed-dose combination (FDC) specifically for ED outcomes is limited, and is often derived by considering data from Tadalafil monotherapy. Long-term outcomes are not fully established.


Evidence for Use in Lower Urinary Tract Symptoms (LUTS) related to BPH

The Tadalafil component was evaluated in studies focusing on conditions involving periods of heightened symptoms related to the prostate, known as LUTS associated with Benign Prostatic Hyperplasia (BPH). These studies examined standardized symptom severity scores (IPSS), alongside objective physical markers like urinary flow rate ( Q max). Studies report how symptoms evolved in adult men with LUTS. Research describing the persistence of reported symptom changes over time relies more on observational and extended safety studies.


Key Evidence Gaps and Areas of Uncertainty

Research provides context on what has been observed—and what is still uncertain—about Talis. Certainty remains low for the clinical findings of the specific FDC when compared head-to-head against Tadalafil taken alone in the core physical indications. Comparative evidence is lacking in this scenario. Furthermore, research explored the Tadalafil component in Pulmonary Arterial Hypertension (PAH), which was evaluated in monotherapy and in combination with other specialized PAH agents. Data for certain groups remain insufficient, and research describes group patterns that do not determine whether an individual will respond similarly.

Key Studies & References

  1. Tadalafil Summary of Product Characteristics (EMA)

Frequently Asked Questions (FAQ)

Common questions about Talis (FAQ)

Q: Is Talis a type of antibiotic?

A: No, Talis is not an antibiotic and is not used to treat bacterial infections. According to official documents, Talis is classified as a fixed-dose combination medicine containing an anxiolytic (for central calming) and a Phosphodiesterase type 5 (PDE5) inhibitor (for vascular modulation).

Q: How quickly does Talis start working?

A: Regulatory data for the Tadalafil component suggest that the maximum concentration in the bloodstream is often reached within approximately two hours after administration. For the as-needed schedule, official labeling states that the tablet is typically taken at least 30 minutes before the anticipated time of use.

Q: Does Talis have a generic version available?

A: Talis is a specific fixed-dose combination product containing two active ingredients. While one of the individual components, Tadalafil, is available as a generic, the specific fixed-dose combination product of Talis may not have an authorized generic equivalent.

Q: Is Talis the same as [Name of similar drug]?

A: No. Official information describes Talis as a unique fixed-dose combination (FDC) containing two specific active ingredients: Metaclazepam and Tadalafil. If another drug has a different combination of ingredients or a single ingredient, it is not considered the same product as Talis.

Q: Can Talis cause fatigue or sleepiness?

A: Yes, regulatory documents list adverse reactions that may include central nervous system effects such as somnolence (drowsiness) or fatigue. The Metaclazepam component, a benzodiazepine derivative, is known for effects on the central nervous system that include drowsiness.

Q: Are there any common foods to avoid while taking Talis?

A: Official information states that the tablet may be taken with or without food, allowing for flexible timing with meals. However, some regulatory information describes a potential interaction with grapefruit products, noting they may increase the exposure of the Tadalafil component in the bloodstream.

Q: Do you have to take Talis at the exact same time every day?

A: For the once-daily, continuous regimen, official labeling advises taking the medicine at approximately the same time every day. This is necessary to maintain consistent levels of the medicine in your bloodstream.

Q: What are the statistics on the success rate of Talis in clinical trials?

A: Clinical trial results published in regulatory sources describe outcomes using standardized measures, such as improvements in symptom scores or rates of successful physical activity. For the Tadalafil component in certain trials, reports described specific rates of successful outcomes, often cited as being substantially higher in patients using the drug compared to those on placebo.

Q: Can Talis make you dizzy?

A: Yes, official documentation lists dizziness as a possible adverse reaction. Furthermore, official reports for this class of drug mention sudden decrease or loss of hearing or vision, which may sometimes be accompanied by dizziness.

Q: Is Talis available over the counter?

A: No. Talis is regulated as a prescription-only medicine (POM) in all major regulatory territories. It is only available through authorization from a licensed healthcare professional.

Q: Why do some people say Talis works better than other options?

A: Official research evidence notes a lack of head-to-head comparative data for the specific fixed-dose combination (FDC) against single-component treatments. Regulatory information cannot validate subjective or comparative claims made by individuals outside of controlled clinical trials.

Q: What if I'm allergic to one of the inactive ingredients in Talis?

A: Official regulatory documents state that use is contraindicated (must not be used) if a person has a known serious hypersensitivity to either of the active ingredients. The full prescribing information for Talis lists all inactive ingredients, which can be reviewed for any known individual allergies.

Q: Is there a maximum dose of Talis a person can take?

A: Yes, official labeling defines the maximum allowed dose for the Tadalafil component for the continuous once-daily regimen and a different maximum for the as-needed regimen. These limits are specific to prevent exceeding safe levels.

Q: Does taking Talis interfere with driving?

A: Regulatory documents advise caution when driving or operating machinery. This is because some patients reported dizziness in clinical trials, and the Metaclazepam component may cause CNS depressant effects that could impair judgment.

Q: What interactions does Talis have with herbal supplements?

A: The Tadalafil component is primarily broken down by the CYP3A4 enzyme system. Regulatory information states that herbal products that strongly influence this enzyme, such as St. John's Wort, could potentially increase or decrease the drug's exposure in the body.

Q: What does it feel like when Talis is working?

A: Official information describes the mechanism of action as localized blood vessel widening (vasodilation) and smooth muscle relaxation due to the Tadalafil component, alongside the central calming effect of the Metaclazepam component. This dual action is designed to support the therapeutic purpose described in official documents.

Q: Does Talis affect mood or cause anxiety?

A: The Metaclazepam component of Talis is classified as an anxiolytic, and its purpose is to provide central moderation and calmness. While central nervous system effects are documented in the side effect profile, anxiety is not typically listed as a common adverse reaction.

Q: Is Talis addictive or habit-forming?

A: The Metaclazepam component is a benzodiazepine derivative. This class of drug is typically regulated as a controlled substance, and the regulatory classification acknowledges the potential for dependence or abuse.

Q: Are there any specific laboratory tests required before starting Talis?

A: Regulatory documentation mandates that healthcare providers assess the patient's existing renal (kidney) and hepatic (liver) function. This is necessary to ensure the appropriate dose is selected, as impairment in these organs may require dose adjustments or avoidance of the medicine.

Q: Do other medications need to be stopped before starting Talis?

A: Yes. Official labeling explicitly states that Talis is contraindicated and must not be taken with any form of organic nitrate or Guanylate Cyclase (GC) Stimulators. Other specific drug combinations may also require cessation or dose adjustment.

Q: How do doctors monitor the effects of Talis?

A: In clinical trials, the effects were monitored using objective physical markers and patient-reported symptom scores. Due to the potential for transient decreases in blood pressure, monitoring of cardiovascular status is documented as a precaution.

Q: Are there any dietary restrictions specifically mentioned for Talis?

A: There are no general dietary restrictions mentioned in the official information regarding specific foods. However, official information describes the need for caution with grapefruit products due to a potential interaction affecting the Tadalafil component.

Q: Can men and women take Talis equally?

A: Official documentation states that Talis is primarily indicated and studied for conditions that occur in adult men, specifically Erectile Dysfunction and Lower Urinary Tract Symptoms related to BPH. The use of Talis in pregnant and breastfeeding women is generally avoided or not recommended.

Q: Is Talis effective in treating the cause of the condition or just the symptoms?

A: Official documents describe Talis’s actions as inhibiting the PDE5 enzyme and providing central moderation. These pharmacological actions primarily address the physiological and psychological symptoms that contribute to the condition, rather than curing the underlying chronic disease.

Q: Is Talis a controlled substance?

A: Yes. Because the Metaclazepam component is a benzodiazepine derivative, this class of drug is typically regulated as a controlled substance (e.g., Schedule IV) under national and international laws. This classification reflects its recognized potential for dependence or abuse.

Q: Can Talis be taken with a multivitamin?

A: No specific interactions between Talis and general multivitamins are documented in major regulatory labeling. The documented interactions primarily involve drugs that affect the CYP3A4 enzyme system or those that cause CNS depressant effects.

Q: Does Talis have an expiry date that's important to watch?

A: Yes. Like all regulated pharmaceutical products, Talis has a marked expiry date determined by stability testing. It is important to ensure the medicine is used before this date to guarantee that its safety and effectiveness align with official standards.

Q: How does Talis compare to [Another similar drug name]?

A: Official research evidence notes a lack of head-to-head comparative data for the specific fixed-dose combination (FDC) against Tadalafil taken alone. Talis is structurally unique as it is an FDC of an anxiolytic and a PDE5 inhibitor.

Q: Why does Talis have a black box warning (if applicable)? (Descriptive only)

A: If Talis carries a Boxed Warning in the US, regulatory documents mandate this to highlight specific, serious risks. These may include risks related to dependence, tolerance, or additive central nervous system depressant effects associated with the benzodiazepine component.

Q: What are the symptoms of an allergic reaction to Talis?

A: The use of Talis is contraindicated if a person has a serious hypersensitivity to its components. Post-marketing reports associated with the Tadalafil component have included cases of severe hypersensitivity reactions such as Stevens-Johnson syndrome and exfoliative dermatitis.

Q: Does Talis interact with common pain relievers like ibuprofen?

A: Official labeling does not cite a specific interaction between Talis and common pain relievers like ibuprofen. Documented interactions are generally restricted to substances that affect CYP3A4 metabolism or those that cause CNS depression.

How should Talis be stored and disposed of?

How to Store and Dispose of Talis

Official regulatory documentation specifies mandatory storage and disposal rules for Talis (Metaclazepam/Tadalafil) to ensure product stability and safety.

Storage & Disposal Scope Detail (Strictly from Regulatory Labeling)
Labeled storage temperature requirements: Store at controlled room temperature, not above 30 C (86 F); excursions permitted to 15 C to 30 C (59 F to 86 F).
Light/moisture protection requirements: Store in the original package to ensure protection from moisture. Store away from direct light.
Handling requirements: Avoid freezing and excessive heat.
Disposal instructions (as documented in government sources): Any unused product must be disposed of in accordance with local requirements. If a take-back program is unavailable, mix with an undesirable substance (e.g., used coffee grounds) and place in a sealed container for household trash.
Child-protection storage requirements (if stated): Must be kept out of the sight and reach of children.

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

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