Sinafil

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Sinafil

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 Sinafil

Property Description
Active ingredient Tadalafil (INN)
Form Tablet (Film-coated, Oral dosage form)
Pharmacological class Phosphodiesterase type 5 (PDE5) inhibitor
General purpose Supports localized blood flow
Origin Synthetic compound

What Type of Medicine is Sinafil?

Sinafil is a medication containing the active ingredient Tadalafil, which is pharmacologically classified as a highly selective Phosphodiesterase type 5 (PDE5) inhibitor. This synthetic compound is recognized for its comparatively long-acting profile, which distinguishes its therapeutic window from other agents in its class. Tadalafil possesses a specific mechanism as a selective inhibitor.

Composition and Pharmaceutical Form of Sinafil

Sinafil is prepared as an oral dosage form, most commonly available as a film-coated tablet intended to be taken by mouth. The composition relies on the single active agent, Tadalafil, combined with solid excipients that form the structural base and vehicle of the tablet. The active ingredient's chemical structure is well-defined, characterizing the chemical and pharmaceutical quality of the substance.

General Purpose and Physiological Role of Sinafil

The general purpose of this type of medication is to support and enhance localized blood flow by promoting vasodilation in targeted tissues. It achieves this by temporarily blocking the PDE5 enzyme, which causes the relaxation of certain smooth muscles within the blood vessel walls. By inhibiting this enzyme, the drug facilitates the body's natural processes that increase circulation.

What side effects are possible with Sinafil?

Possible Side Effects and Safety Information

Sinafil, containing the active ingredient Tadalafil, has an officially documented safety profile based on government regulatory labeling (e.g., FDA Prescribing Information, EMA SmPC). This section details the potential adverse reactions and safety restrictions without providing dosage or usage instructions.

Frequency-Classified Adverse Reactions

Adverse reactions are classified by frequency of occurrence in regulatory documents. Common side effects (ge1/100 to <1/10) include headache, dyspepsia (indigestion), back pain, myalgia (muscle aches), flushing, and nasal congestion. Uncommon reactions (ge1/1,000 to <1/100) include dizziness, visual defects, and hypotension.

Serious Adverse Reactions and Warnings

Regulatory labeling highlights specific rare but clinically significant adverse reactions. These include: Priapism (a prolonged erection lasting more than four hours), Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) which can cause sudden vision loss, sudden hearing loss, and rare major cardiovascular events such as myocardial infarction or stroke. Immediate medical attention is required for serious reactions.

Safety Constraints and Special Populations

Official labeling includes specific restrictions. Sinafil is absolutely contraindicated for use with any form of organic nitrate (e.g., nitroglycerin) due to the risk of life-threatening hypotension. It is also not recommended for use in individuals with severe hepatic (liver) impairment or severe renal (kidney) impairment due to concerns over increased drug exposure.

Overdose and Emergency Response

Overdose Manifestations

Overdose with Sinafil (Tadalafil) is formally documented in regulatory prescribing information as an exaggeration of dose-related adverse reactions commonly observed at therapeutic doses. These documented manifestations may include an increased frequency or severity of headache, dyspepsia, back pain, myalgia, flushing, and nasal congestion.


Immediate Actions Required

Official regulatory sources mandate that patients seek immediate medical assistance for specific severe outcomes. These outcomes include:

  • A prolonged erection (priapism) lasting four hours or more.
  • Sudden decrease or loss of vision.
  • Sudden decrease or loss of hearing.

Patients must stop the medication and seek prompt medical attention if any of these life-threatening or tissue-damaging symptoms occur.


Overdose Management and Constraints

Management of an overdose involves adopting standard supportive measures and providing symptomatic and supportive treatment. Regulatory documents explicitly state that no specific antidote is known for Tadalafil overdose. Due to the drug’s high protein binding, hemodialysis contributes negligibly to elimination. Patients with existing renal or hepatic impairment are noted to have a potential for prolonged systemic exposure following overdose due to impaired clearance.

Therapeutic Uses of Sinafil

Sinafil (generic name sildenafil) is commonly used across therapeutic domains, applied in situations involving certain distressing symptoms, generally across conditions presenting with acute episodes of functional stress. It supports the management of conditions where symptoms may intensify temporarily, providing supportive relief when needed.

The two main categories of conditions for which Sinafil is relevant are erectile dysfunction (ED) and Pulmonary Arterial Hypertension (PAH). It is applied in addressing symptom clusters that create noticeable physiological strain in these areas.

In clinical scenarios where supportive relief is needed, Sinafil helps improve day-to-day comfort during symptomatic periods, including those involving physical discomfort and functional stability issues. This is often used during phases when symptoms become more noticeable and may assist with maintaining functional stability in scenarios where short-term symptomatic assistance is needed.

Quick Fact: Supports Management of Symptom Clusters that Interfere with Daily Functioning.

The medication contributes to easing the overall symptom load for patients, assisting with managing symptoms linked to organ-specific functional stress.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Who can and cannot use Sinafil?

Sinafil (Tadalafil) is officially indicated for use in adult men for conditions such as erectile dysfunction (ED) and benign prostatic hyperplasia (BPH), and in adult patients for pulmonary arterial hypertension (PAH). Regulatory authorities define eligibility by imposing strict prohibitions based on pre-existing medical conditions and concomitant medication use.

Contraindicated Populations

Use is absolutely contraindicated in patients taking any form of organic nitrate or a Guanylate Cyclase (GC) stimulator (e.g., riociguat). It is also prohibited for patients with a history of Non-arteritic Anterior Ischemic Optic Neuropathy (NAION) or those with severe, high-risk cardiovascular states, including myocardial infarction within the last 90 days or unstable angina.

Restrictions and Limitations

Population Group Regulatory Status
Severe Hepatic (Child-Pugh C) / Severe Renal Impairment Not Recommended (Limited data)
Pediatric Patients (under 18 for ED/BPH) Safety and efficacy Not Established
Pregnant or Lactating Women Not Recommended / Avoid Use
Anatomical Penile Deformation Use with Caution Required

The drug is formally not indicated for use in women for ED/BPH. Older adults (geriatric patients) do not require a dose adjustment based on age alone, though caution is generally advised.

What should I know about interactions with other medicines?

Sinafil Interactions with other medicines and products

Sinafil, which contains Tadalafil, is subject to specific interaction patterns detailed in official regulatory prescribing information. The co-administration of certain products is strictly prohibited due to potential adverse effects.


Formally Contraindicated Combinations

Interacting Product Category Restriction Basis
Organic Nitrates (All forms) Potentiation of severe hypotensive effects.
Guanylate Cyclase Stimulators (e.g., Riociguat) Risk of symptomatic hypotension.

Interactions Affecting Drug Exposure

Tadalafil is primarily metabolized by the CYP3A4 enzyme. Regulatory documents state that Potent CYP3A4 Inhibitors (e.g., Ketoconazole, Ritonavir) significantly increase Tadalafil exposure (AUC), while CYP3A4 Inducers (e.g., Rifampin) significantly decrease exposure.

Pharmacodynamic & Other Interactions

Co-administration with alpha-blockers (e.g., Doxazosin) and substantial amounts of alcohol is officially documented to pose a risk of additive blood pressure-lowering effects.

A specific regulatory constraint mandates that nitrates must not be administered until at least 48 hours have elapsed after the last Tadalafil dose. Furthermore, use is generally not recommended in patients with severe hepatic or renal impairment due to the potential for increased drug exposure and heightened interaction risk.

Mechanism of Action

Sinafil acts as a selective inhibitor of key enzymes in specific molecular cascades, mediating the cellular events required for smooth muscle relaxation and targeted vasodilation within certain physiological systems.


Selective Enzyme Inhibition

The compound targets and blocks phosphodiesterase type 5 (PDE5), an enzyme responsible for hydrolyzing cyclic guanosine monophosphate (cGMP). This action modulates the activity of cGMP-driven processes, where cGMP functions as a critical second messenger in signaling patterns related to vascular tone.


Modulation of the NO-cGMP Pathway

Sinafil’s inhibition of PDE5 prevents the degradation of cGMP, thereby extending the duration of action initiated by Nitric Oxide (NO). The drug’s effect on cGMP levels modifies early molecular steps, altering the intracellular environment necessary for the relaxation of vascular smooth muscle cells.


Regulation of Vascular Smooth Muscle Tension

The augmented concentration of cGMP initiates a molecular cascade that decreases intracellular calcium concentrations, resulting in a change in smooth muscle fiber tension and subsequent vasodilation. This effect promotes the alteration of vascular resistance in circulatory beds characterized by high expression of PDE5.

Dosage and Administration Information

Sinafil (Tadalafil) is exclusively administered via the oral route, primarily available as a film-coated tablet in strengths of 2.5 mg, 5 mg, 10 mg, and 20 mg. The medication may be taken with or without food, as food does not influence the rate or extent of absorption.


Dosing Schedule (Official Ranges) Frequency Pattern
As-Needed Use: Starting dose is 10 mg; may be adjusted to a maximum of 20 mg. Maximum frequency is once per day; the dose is taken prior to anticipated activity.
Once-Daily Use (Chronic): Starting dose is 2.5 mg to 5 mg (maximum dose) for chronic use. Taken once daily at approximately the same time each day.
PAH Use: The standard dose is 40 mg (typically two 20 mg tablets). Taken once daily; the 40 mg dose must not be divided over the course of the day.

The administration protocol establishes high-level modifications for specific patient populations. For individuals with severe renal impairment (creatinine clearance <30 mL/min), the maximum as-needed dose is restricted to 5 mg no more than once every 72 hours. Furthermore, once-daily use is generally not recommended in cases of severe renal or hepatic impairment. The instructions specify that the film-coated tablets should not be split. For daily regimens, if a dose is missed, it should be skipped, and the patient should resume the schedule with the next dose at the regular time. When used for BPH in combination with finasteride, the co-administration duration is generally limited to up to 26 weeks.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Sinafil (Tadalafil)


Evidence for use in Erectile Dysfunction (ED)

Research examined Sinafil in the context of Erectile Dysfunction (ED) through studies that were derived primarily from randomized, double-blind, placebo-controlled trials (RCTs). These short-term studies, along with later integrated analyses, were used in research exploring how symptoms change over time. The studies were applied in trials assessing short-term or episodic symptom patterns in adult men with varying degrees of ED severity, including those with conditions like diabetes and high blood pressure.

Researchers in these trials primarily monitored patient-reported outcomes, specifically tracking changes using validated questionnaires like the International Index of Erectile Function (IIEF-EF score) and patient diaries detailing successful sexual intercourse attempts. Findings describe patterns observed in the studies where reported measurements of function and success rates evolved in the observed populations compared to those receiving an inactive substance.


Evidence for use in Pulmonary Arterial Hypertension (PAH)

Research examined Sinafil in the context of Pulmonary Arterial Hypertension (PAH) through studies that were mainly established through major randomized, placebo-controlled trials. These studies focused on patients with functional limitations due to the condition, typically those classified as WHO Functional Class II or III. Research examined outcomes reflecting daily functioning or activity level, as well as the progression of the condition.

Studies included patients who were both new to treatment and those who were already receiving background therapy with other PAH medicines. Research exploring short-term symptom changes in these settings found that findings were mixed when comparing the different combination regimens examined across the PAH evidence landscape.


What is Still Uncertain About the Research for Sinafil

It is important to understand that research provides context but not individual predictions. The existing evidence highlights what is known—and what is still uncertain—about the medicine. Comparative evidence is lacking for many direct, head-to-head studies between Sinafil and other treatments in the same drug class for both PAH and ED.

Furthermore, long-term effects are not fully established beyond the period of the extension studies, meaning the data available for long-term outcomes for both indications remain insufficient. The results apply only to the populations studied and reflect the specific conditions under which they were conducted. More research is needed to better characterize very long-term functional changes.

Key Studies & References Tadalafil - FDA Verification Portal (Regulatory/Prescribing Information)

Frequently Asked Questions (FAQ)

Common questions about Sinafil (FAQ)


Q: How quickly does Sinafil start to work?

A: Official clinical data suggests that the action of the medicine begins relatively quickly. According to the official product information, the typical onset of action is observed within approximately 30 minutes following administration of the tablet.


Q: What is the typical duration of Sinafil's effects?

A: Pharmacological studies indicate that the effects of the active ingredient may last for an extended period. Because the medicine has a comparatively long elimination half-life, its therapeutic effects are described in official documents as potentially lasting up to 36 hours.


Q: Can Sinafil be taken with alcohol?

A: Official information states that consuming substantial amounts of alcohol when taking Sinafil may increase the potential for symptoms like dizziness and headache due to an additive effect on lowering blood pressure.


Q: What happens if I miss a dose of Sinafil?

A: For the once-daily regimen, regulatory documents specify that a missed dose should be skipped entirely. Regulatory documents state the schedule should be resumed with the next dose at the regular time. For the as-needed regimen, official documents advise against taking more than one dose in a single day.


Q: Does Sinafil affect fertility?

A: Reproductive studies in humans have generally suggested that the active ingredient is unlikely to have a negative impact on overall human fertility. However, official regulatory reports note that a small decrease in sperm concentration was observed in some men during clinical studies.


Q: Can taking too much Sinafil be harmful?

A: Taking more than the recommended amount is officially associated with an increased occurrence and severity of known side effects. Official warnings indicate that a prolonged erection lasting more than four hours is an emergency that requires immediate medical attention.


Q: Does Sinafil have any known allergic reactions?

A: Yes, official labeling notes that the medicine should not be used by individuals with a known serious hypersensitivity (allergic reaction) to the active substance or its components. Regulatory reports have included rare, severe hypersensitivity reactions, such as Stevens-Johnson syndrome.


Q: Is Sinafil the same as [similar drug name]?

A: Sinafil is classified as a Phosphodiesterase type 5 (PDE5) inhibitor. While other medicines exist in this same class and share a similar mechanism of action (how they work), Sinafil is characterized by its longer duration of action compared to some other medicines in the same class, according to pharmacological studies.


Q: Can women use Sinafil?

A: The medicine is not indicated for its use in erectile dysfunction or benign prostatic hyperplasia in women. However, a specific formulation containing the same active ingredient is approved for the treatment of Pulmonary Arterial Hypertension (PAH) in both men and women.


Q: Can Sinafil be taken with daily multivitamins?

A: Official drug interaction lists do not typically include an interaction with standard daily multivitamins. Official patient guides contain a general statement noting the importance of informing a healthcare professional of all concurrent medicines, including vitamins and supplements.


Q: What if Sinafil doesn't seem to work for me?

A: The official documentation emphasizes that the medicine is not appropriate for everyone and that its effectiveness can vary. Regulatory documentation suggests discussing the response to the medication and any potential lack of effect with a healthcare provider.


Q: Does Sinafil interact with herbal remedies?

A: Official resources advise patients to inform their healthcare professional of all concomitant medicines, including herbal remedies and supplements. The regulatory interaction list does not fully characterize the effects of combining the drug with all complementary or herbal medicines.


Q: Are there published patient guides for Sinafil?

A: Yes. Regulatory requirements, such as those set by the FDA, mandate that the medicine comes with an official Patient Information Leaflet or Patient Guide. This document provides important information for the user to read and follow.


Q: Does Sinafil interact with common pain relievers?

A: The official interaction list focuses primarily on heart and blood pressure medications. However, studies have been conducted on co-administration with aspirin, a common pain reliever, and found that it did not prolong bleeding time, according to official reports.


Q: Is Sinafil a controlled substance?

A: The active ingredient, Tadalafil, is not listed under the U.S. Controlled Substances Act. It is generally not classified as a controlled substance by major regulatory bodies, such as the Drug Enforcement Administration.


Q: Is there a maximum recommended usage period for Sinafil?

A: There is no general maximum recommended period for continuous use when the medicine is prescribed alone for its main indications. However, when used for Benign Prostatic Hyperplasia (BPH) in combination with finasteride, official instructions limit the co-administration duration to up to 26 weeks.


Q: What body systems does Sinafil primarily affect?

A: Due to its mechanism of action as a vasodilator, the medicine primarily affects the cardiovascular system (blood vessels). Official regulatory warnings also note the potential for rare, serious adverse events that affect the ocular system (eyes) and auditory system (ears).

How should Sinafil be stored and disposed of?

Official Storage and Handling

Tadalafil tablets (Sinafil) must be stored under conditions that maintain their stability and quality, as defined by regulatory bodies. The product requires storage at a temperature not exceeding 30 C (86 F). The medicine must also be protected from moisture and light, necessitating storage in its original container to preserve its integrity over the typical 36-month shelf life.

Child Safety and Disposal

It is a mandatory safety instruction that the medication be kept out of the sight and reach of children at all times. For disposal, any unused or expired product must be discarded in accordance with local regulations. To protect the environment, the medicine must not be disposed of via wastewater or household waste; individuals should consult a pharmacist or utilize authorized drug take-back programs.

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

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