сialis 20mg

Сialis 20mg

Erectile Dysfunction

®

Benign Prostatic Hyperplasia

Cialis is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).

Erectile Dysfunction and Benign Prostatic Hyperplasia

Cialis is indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH).

Limitation of Use

[see Clinical Studies (14.3)]

Cialis Dosage and Administration

Do not split Cialis tablets; entire dose should be taken.

Cialis for Use as Needed for Erectile Dysfunction

  • The recommended starting dose of Cialis for use as needed in most patients is 10 mg, taken prior to anticipated sexual activity.
  • The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients.
  • Cialis for use as needed was shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising patients on optimal use of Cialis, this should be taken into consideration.

Cialis for Once Daily Use for Erectile Dysfunction

  • The recommended starting dose of Cialis for once daily use is 2.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.
  • The Cialis dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability.

Cialis for Once Daily Use for Benign Prostatic Hyperplasia

  • The recommended dose of Cialis for once daily use is 5 mg, taken at approximately the same time every day.
  • When therapy for BPH is initiated with Cialis and finasteride, the recommended dose of Cialis for once daily use is 5 mg, taken at approximately the same time every day for up to 26 weeks.

Cialis for Once Daily Use for Erectile Dysfunction and Benign Prostatic Hyperplasia

The recommended dose of Cialis for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity.

Use with Food

Cialis may be taken without regard to food.

Use in Specific Populations

Renal Impairment

Cialis for Use as Needed

  • Creatinine clearance 30 to 50 mL/min: A starting dose of 5 mg not more than once per day is recommended, and the maximum dose is 10 mg not more than once in every 48 hours.
  • Creatinine clearance less than 30 mL/min or on hemodialysis: The maximum dose is 5 mg not more than once in every 72 hours [see Warnings and Precautions (5.7) and Use in Specific Populations (8.7)].

Cialis for Once Daily Use

Erectile Dysfunction

  • Creatinine clearance less than 30 mL/min or on hemodialysis: Cialis for once daily use is not recommended [see Warnings and Precautions (5.7) and Use in Specific Populations (8.7)].

Benign Prostatic Hyperplasia and Erectile Dysfunction/Benign Prostatic Hyperplasia

  • Creatinine clearance 30 to 50 mL/min: A starting dose of 2.5 mg is recommended. An increase to 5 mg may be considered based on individual response.
  • Creatinine clearance less than 30 mL/min or on hemodialysis: Cialis for once daily use is not recommended [see Warnings and Precautions (5.7) and Use in Specific Populations (8.7)].

Hepatic Impairment

Cialis for Use as Needed

  • Mild or moderate (Child Pugh Class A or B): The dose should not exceed 10 mg once per day. The use of Cialis once per day has not been extensively evaluated in patients with hepatic impairment and therefore, caution is advised.
  • Severe (Child Pugh Class C): The use of Cialis is not recommended [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6)].

Cialis for Once Daily Use

  • Mild or moderate (Child Pugh Class A or B): Cialis for once daily use has not been extensively evaluated in patients with hepatic impairment. Therefore, caution is advised if Cialis for once daily use is prescribed to these patients.
  • Severe (Child Pugh Class C): The use of Cialis is not recommended [see Warnings and Precautions (5.8) and Use in Specific Populations (8.6)].

Concomitant Medications

Nitrates

[see Contraindications (4.1)]

Alpha-Blockers

ED[see Warnings and Precautions (5.6), Drug Interactions (7.1), and Clinical Pharmacology (12.2)]

BPH[see Warnings and Precautions (5.6), Drug Interactions (7.1), and Clinical Pharmacology (12.2)]

CYP3A4 Inhibitors

Cialis for Use as Needed[see Warnings and Precautions (5.10) and Drug Interactions (7.2)]

Cialis for Once Daily Use[see Warnings and Precautions (5.10) and Drug Interactions (7.2)]

Dosage Forms and Strengths

Four strengths of almond-shaped tablets are available in different sizes and different shades of yellow:

Contraindications

Nitrates

[see Clinical Pharmacology (12.2)]

Hypersensitivity Reactions

®[see Adverse Reactions (6.2)]

Warnings and Precautions

Evaluation of erectile dysfunction and BPH should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options.

Before prescribing Cialis, it is important to note the following:

Cardiovascular

Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatments for erectile dysfunction, including Cialis, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status. Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and seek immediate medical attention.

[see Contraindications (4.1) and Patient Counseling Information (17.1)]

Patients with left ventricular outflow obstruction, (e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators, including PDE5 inhibitors.

The following groups of patients with cardiovascular disease were not included in clinical safety and efficacy trials for Cialis, and therefore until further information is available, Cialis is not recommended for the following groups of patients:

  • myocardial infarction within the last 90 days
  • unstable angina or angina occurring during sexual intercourse
  • New York Heart Association Class 2 or greater heart failure in the last 6 months
  • uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension
  • stroke within the last 6 months.

[see Clinical Pharmacology (12.2)]

Potential for Drug Interactions When Taking Cialis for Once Daily Use

[see Drug Interactions (7.1, 7.2, 7.3)]

Prolonged Erection

There have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention.

Cialis should be used with caution in patients who have conditions that might predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease).

Effects on the Eye

[see Adverse Reactions (6.2)]

Physicians should consider whether their patients with underlying NAION risk factors could be adversely affected by use of PDE5 inhibitors. Individuals who have already experienced NAION are at increased risk of NAION recurrence. Therefore, PDE5 inhibitors, including Cialis, should be used with caution in these patients and only when the anticipated benefits outweigh the risks. Individuals with "crowded" optic disc are also considered at greater risk for NAION compared to the general population; however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including Cialis, for this uncommon condition.

Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical trials, and use in these patients is not recommended.

Sudden Hearing Loss

[see Adverse Reactions (6.1, 6.2)]

Alpha-blockers and Antihypertensives

[see Drug Interactions (7.1) and Clinical Pharmacology (12.2)]

[see Drug Interactions (7.1) and Clinical Pharmacology (12.2)]

ED

  • Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor. Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors.
  • In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest recommended dose.
  • In those patients already taking an optimized dose of PDE5 inhibitor, alpha-blocker therapy should be initiated at the lowest dose. Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking a PDE5 inhibitor.
  • Safety of combined use of PDE5 inhibitors and alpha-blockers may be affected by other variables, including intravascular volume depletion and other antihypertensive drugs.

[see Dosage and Administration (2.7) and Drug Interactions (7.1)]

BPH

  • The efficacy of the coadministration of an alpha-blocker and Cialis for the treatment of BPH has not been adequately studied, and due to the potential vasodilatory effects of combined use resulting in blood pressure lowering, the combination of Cialis and alpha-blockers is not recommended for the treatment of BPH. [see Dosage and Administration (2.7), Drug Interactions (7.1), and Clinical Pharmacology (12.2.)].
  • Patients on alpha-blocker therapy for BPH should discontinue their alpha-blocker at least one day prior to starting Cialis for once daily use for the treatment of BPH.

Renal Impairment

Cialis for Use as Needed

[see Use in Specific Populations (8.7)]

Cialis for Once Daily Use

ED

[see Use in Specific Populations (8.7)]

BPH and ED/BPH

[see Dosage and Administration (2.6), Use in Specific Populations (8.7), and Clinical Pharmacology (12.3)]

Hepatic Impairment

Cialis for Use as Needed

[see Use in Specific Populations (8.6)]

Cialis for Once Daily Use

[see Use in Specific Populations (8.6)]

Alcohol

[see Clinical Pharmacology (12.2)]

Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)

[see Drug Interactions (7.2)][see Dosage and Administration (2.7)]

Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies

The safety and efficacy of combinations of Cialis and other PDE5 inhibitors or treatments for erectile dysfunction have not been studied. Inform patients not to take Cialis with other PDE5 inhibitors, including ADCIRCA.

Effects on Bleeding

in vitro

Counseling Patients About Sexually Transmitted Diseases

The use of Cialis offers no protection against sexually transmitted diseases. Counseling patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered.

Consideration of Other Urological Conditions Prior to Initiating Treatment for BPH

Prior to initiating treatment with Cialis for BPH, consideration should be given to other urological conditions that may cause similar symptoms. In addition, prostate cancer and BPH may coexist.

Adverse Reactions

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Tadalafil was administered to over 9000 men during clinical trials worldwide. In trials of Cialis for once daily use, a total of 1434, 905, and 115 were treated for at least 6 months, 1 year, and 2 years, respectively. For Cialis for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively.

Cialis for Use as Needed for ED

In eight primary placebo-controlled clinical studies of 12 weeks duration, mean age was 59 years (range 22 to 88) and the discontinuation rate due to adverse events in patients treated with tadalafil 10 or 20 mg was 3.1%, compared to 1.4% in placebo treated patients.

see

Cialis for Once Daily Use for ED

In three placebo-controlled clinical trials of 12 or 24 weeks duration, mean age was 58 years (range 21 to 82) and the discontinuation rate due to adverse events in patients treated with tadalafil was 4.1%, compared to 2.8% in placebo-treated patients.

see

see

Cialis for Once Daily Use for BPH and for ED and BPH

see

Additional, less frequent adverse reactions (<1%) reported in the controlled clinical trials of Cialis for BPH or ED and BPH included: gastroesophageal reflux disease, upper abdominal pain, nausea, vomiting, arthralgia, and muscle spasm.

Back pain or myalgia was reported at incidence rates described in Tables 1 through 4. In tadalafil clinical pharmacology trials, back pain or myalgia generally occurred 12 to 24 hours after dosing and typically resolved within 48 hours. The back pain/myalgia associated with tadalafil treatment was characterized by diffuse bilateral lower lumbar, gluteal, thigh, or thoracolumbar muscular discomfort and was exacerbated by recumbency. In general, pain was reported as mild or moderate in severity and resolved without medical treatment, but severe back pain was reported with a low frequency (<5% of all reports). When medical treatment was necessary, acetaminophen or non-steroidal anti-inflammatory drugs were generally effective; however, in a small percentage of subjects who required treatment, a mild narcotic (e.g., codeine) was used. Overall, approximately 0.5% of all subjects treated with Cialis for on demand use discontinued treatment as a consequence of back pain/myalgia. In the 1-year open label extension study, back pain and myalgia were reported in 5.5% and 1.3% of patients, respectively. Diagnostic testing, including measures for inflammation, muscle injury, or renal damage revealed no evidence of medically significant underlying pathology. Incidence rates for Cialis for once daily use for ED, BPH and BPH/ED are described in Tables 2, 3 and 4. In studies of Cialis for once daily use, adverse reactions of back pain and myalgia were generally mild or moderate with a discontinuation rate of <1% across all indications.

[see Use in Specific Populations (8.5)]

Across all studies with any Cialis dose, reports of changes in color vision were rare (<0.1% of patients).

The following section identifies additional, less frequent events (<2%) reported in controlled clinical trials of Cialis for once daily use or use as needed. A causal relationship of these events to Cialis is uncertain. Excluded from this list are those events that were minor, those with no plausible relation to drug use, and reports too imprecise to be meaningful:

Body as a Whole

Cardiovascular

Digestive

Musculoskeletal

Nervous

Renal and Urinary

Respiratory

Skin and Appendages

Ophthalmologic

Otologic

Urogenital

Postmarketing Experience

The following adverse reactions have been identified during post approval use of Cialis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion either due to their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors.

Cardiovascular and Cerebrovascular[see Warnings and Precautions (5.1)]

Body as a Whole

Nervous

Ophthalmologic

[see Warnings and Precautions (5.4)]

Otologic[see Warnings and Precautions (5.5)]

Urogenital[see Warnings and Precautions (5.3)]

Drug Interactions

Potential for Pharmacodynamic Interactions with Cialis

Nitrates[see Dosage and Administration (2.7), Contraindications (4.1), and Clinical Pharmacology (12.2)]

Alpha-Blockers[see Dosage and Administration (2.7), Warnings and Precautions (5.6), and Clinical Pharmacology (12.2)]

Antihypertensives[see Warnings and Precautions (5.6) and Clinical Pharmacology (12.2)]

Alcohol[see Warnings and Precautions (5.9) and Clinical Pharmacology (12.2)]

Potential for Other Drugs to Affect Cialis

[See Dosage and Administration (2.7) and Warnings and Precautions (5.10)]

Antacids

H2 Antagonists (e.g. Nizatidine)

Cytochrome P450 Inhibitors

CYP3A4 (e.g., Ketoconazole)maxmax[see Dosage and Administration (2.7)]

Although specific interactions have not been studied, other CYP3A4 inhibitors, such as erythromycin, itraconazole, and grapefruit juice, would likely increase tadalafil exposure.

HIV Protease inhibitormaxmax[see Dosage and Administration (2.7)]

Cytochrome P450 Inducers

CYP3A4 (e.g., Rifampin)max

Potential for Cialis to Affect Other Drugs

Aspirin

Cytochrome P450 Substrates

CYP1A2 (e.g. Theophylline)

CYP2C9 (e.g. Warfarin)

CYP3A4 (e.g. Midazolam or Lovastatin)

P-glycoprotein (e.g. Digoxin)

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category B

Risk Summary

Animal Data

In a rat prenatal and postnatal development study at doses of 60, 200, and 1000 mg/kg, a reduction in postnatal survival of pups was observed. The no observed effect level (NOEL) for maternal toxicity was 200 mg/kg/day and for developmental toxicity was 30 mg/kg/day. This gives approximately 16 and 10 fold exposure multiples, respectively, of the human AUC for the MRHD of 20 mg.

Tadalafil and/or its metabolites cross the placenta, resulting in fetal exposure in rats.

Nursing Mothers

Cialis is not indicated for use in women.

Tadalafil and/or its metabolites were secreted into the milk in lactating rats at concentrations approximately 2.4-fold greater than found in the plasma.

Pediatric Use

Cialis is not indicated for use in pediatric patients. Safety and efficacy in patients below the age of 18 years has not been established.

Geriatric Use

[see Adverse Reactions (6.1)][see Clinical Pharmacology (12.3)]

Hepatic Impairment

[see Dosage and Administration (2.6) and Warnings and Precautions (5.8)]

Renal Impairment

max[see Dosage and Administration (2.6) and Warnings and Precautions (5.7)]

Overdosage

Single doses up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients. Adverse events were similar to those seen at lower doses. In cases of overdose, standard supportive measures should be adopted as required. Hemodialysis contributes negligibly to tadalafil elimination.

Cialis Description

221934

The chemical designation is pyrazino[1´,2´:1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol.

Cialis is available as almond-shaped tablets for oral administration. Each tablet contains 2.5, 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.

Cialis - Clinical Pharmacology

Mechanism of Action

Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle. This response is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cGMP in smooth muscle cells. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum. The inhibition of phosphodiesterase type 5 (PDE5) enhances erectile function by increasing the amount of cGMP. Tadalafil inhibits PDE5. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 by tadalafil has no effect in the absence of sexual stimulation.

The effect of PDE5 inhibition on cGMP concentration in the corpus cavernosum and pulmonary arteries is also observed in the smooth muscle of the prostate, the bladder and their vascular supply. The mechanism for reducing BPH symptoms has not been established.

in vitro

In vitroIn vitro

Pharmacodynamics

Effects on Blood Pressure

Tadalafil 20 mg administered to healthy male subjects produced no significant difference compared to placebo in supine systolic and diastolic blood pressure (difference in the mean maximal decrease of 1.6/0.8 mm Hg, respectively) and in standing systolic and diastolic blood pressure (difference in the mean maximal decrease of 0.2/4.6 mm Hg, respectively). In addition, there was no significant effect on heart rate.

Effects on Blood Pressure When Administered with Nitrates

[see Contraindications (4.1)]

see

[see Contraindications (4.1)]

Effect on Blood Pressure When Administered With Alpha-Blockers

[see Dosage and Administration (2.7) and Warnings and Precautions (5.6)]

Doxazosin

see

Blood pressure was measured manually at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours after tadalafil or placebo administration. Outliers were defined as subjects with a standing systolic blood pressure of <85 mm Hg or a decrease from baseline in standing systolic blood pressure of >30 mm Hg at one or more time points. There were nine and three outliers following administration of tadalafil 20 mg and placebo, respectively. Five and two subjects were outliers due to a decrease from baseline in standing systolic BP of >30 mm Hg, while five and one subject were outliers due to standing systolic BP <85 mm Hg following tadalafil and placebo, respectively. Severe adverse events potentially related to blood-pressure effects were assessed. No such events were reported following placebo. Two such events were reported following administration of tadalafil. Vertigo was reported in one subject that began 7 hours after dosing and lasted about 5 days. This subject previously experienced a mild episode of vertigo on doxazosin and placebo. Dizziness was reported in another subject that began 25 minutes after dosing and lasted 1 day. No syncope was reported.

In the second doxazosin study, a single oral dose of tadalafil 20 mg was administered to healthy subjects taking oral doxazosin, either 4 or 8 mg daily. The study (N=72 subjects) was conducted in three parts, each a 3-period crossover.

In part A (N=24), subjects were titrated to doxazosin 4 mg administered daily at 8 a.m. Tadalafil was administered at either 8 a.m., 4 p.m., or 8 p.m. There was no placebo control.

In part B (N=24), subjects were titrated to doxazosin 4 mg administered daily at 8 p.m. Tadalafil was administered at either 8 a.m., 4 p.m., or 8 p.m. There was no placebo control.

In part C (N=24), subjects were titrated to doxazosin 8 mg administered daily at 8 a.m. In this part, tadalafil or placebo were administered at either 8 a.m. or 8 p.m.

Blood pressure was measured by ABPM every 15 to 30 minutes for up to 36 hours after tadalafil or placebo. Subjects were categorized as outliers if one or more systolic blood pressure readings of <85 mm Hg were recorded or one or more decreases in systolic blood pressure of >30 mm Hg from a time-matched baseline occurred during the analysis interval.

Of the 24 subjects in part C, 16 subjects were categorized as outliers following administration of tadalafil and 6 subjects were categorized as outliers following placebo during the 24-hour period after 8 a.m. dosing of tadalafil or placebo. Of these, 5 and 2 were outliers due to systolic BP <85 mm Hg, while 15 and 4 were outliers due to a decrease from baseline in systolic BP of >30 mm Hg following tadalafil and placebo, respectively.

During the 24-hour period after 8 p.m. dosing, 17 subjects were categorized as outliers following administration of tadalafil and 7 subjects following placebo. Of these, 10 and 2 subjects were outliers due to systolic BP <85 mm Hg, while 15 and 5 subjects were outliers due to a decrease from baseline in systolic BP of >30 mm Hg, following tadalafil and placebo, respectively.

Some additional subjects in both the tadalafil and placebo groups were categorized as outliers in the period beyond 24 hours.

Severe adverse events potentially related to blood-pressure effects were assessed. In the study (N=72 subjects), 2 such events were reported following administration of tadalafil (symptomatic hypotension in one subject that began 10 hours after dosing and lasted approximately 1 hour, and dizziness in another subject that began 11 hours after dosing and lasted 2 minutes). No such events were reported following placebo. In the period prior to tadalafil dosing, one severe event (dizziness) was reported in a subject during the doxazosin run-in phase.

Blood pressure was measured manually pre-dose at two time points (-30 and -15 minutes) and then at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours post dose on the first day of each doxazosin dose, (1 mg, 2 mg, 4 mg), as well as on the seventh day of 4 mg doxazosin administration.

Following the first dose of doxazosin 1 mg, there were no outliers on tadalafil 5 mg and one outlier on placebo due to a decrease from baseline in standing systolic BP of >30 mm Hg.

There were 2 outliers on tadalafil 5 mg and none on placebo following the first dose of doxazosin 2 mg due to a decrease from baseline in standing systolic BP of >30 mm Hg.

There were no outliers on tadalafil 5 mg and two on placebo following the first dose of doxazosin 4 mg due to a decrease from baseline in standing systolic BP of >30 mm Hg. There was one outlier on tadalafil 5 mg and three on placebo following the first dose of doxazosin 4 mg due to standing systolic BP <85 mm Hg. Following the seventh day of doxazosin 4 mg, there were no outliers on tadalafil 5 mg, one subject on placebo had a decrease >30 mm Hg in standing systolic blood pressure, and one subject on placebo had standing systolic blood pressure <85 mm Hg. All adverse events potentially related to blood pressure effects were rated as mild or moderate. There were two episodes of syncope in this study, one subject following a dose of tadalafil 5 mg alone, and another subject following coadministration of tadalafil 5 mg and doxazosin 4 mg.

Tamsulosin

Blood pressure was measured manually at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours after tadalafil or placebo dosing. There were 2, 2, and 1 outliers (subjects with a decrease from baseline in standing systolic blood pressure of >30 mm Hg at one or more time points) following administration of tadalafil 10 mg, 20 mg, and placebo, respectively. There were no subjects with a standing systolic blood pressure <85 mm Hg. No severe adverse events potentially related to blood-pressure effects were reported. No syncope was reported.

In the second tamsulosin study, healthy subjects (N=39 treated; and 35 completed) received 14 days of once per day dosing of tadalafil 5 mg or placebo in a two-period crossover design. Daily dosing of tamsulosin 0.4 mg was added for the last seven days of each period.

Blood pressure was measured manually pre-dose at two time points (-30 and -15 minutes) and then at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours post dose on the first, sixth and seventh days of tamsulosin administration. There were no outliers (subjects with a decrease from baseline in standing systolic blood pressure of >30 mm Hg at one or more time points). One subject on placebo plus tamsulosin (Day 7) and one subject on tadalafil plus tamsulosin (Day 6) had standing systolic blood pressure <85 mm Hg. No severe adverse events potentially related to blood pressure were reported. No syncope was reported.

Alfuzosin

Blood pressure was measured manually at 1, 2, 3, 4, 6, 8, 10, 20, and 24 hours after tadalafil or placebo dosing. There was 1 outlier (subject with a standing systolic blood pressure <85 mm Hg) following administration of tadalafil 20 mg. There were no subjects with a decrease from baseline in standing systolic blood pressure of >30 mm Hg at one or more time points. No severe adverse events potentially related to blood pressure effects were reported. No syncope was reported.

Effects on Blood Pressure When Administered with Antihypertensives

Amlodipine

Angiotensin II receptor blockers

Bendrofluazide

Enalapril

Metoprolol

Effects on Blood Pressure When Administered with Alcohol

Alcohol and PDE5 inhibitors, including tadalafil, are mild systemic vasodilators. The interaction of tadalafil with alcohol was evaluated in 3 clinical pharmacology studies. In 2 of these, alcohol was administered at a dose of 0.7 g/kg, which is equivalent to approximately 6 ounces of 80-proof vodka in an 80-kg male, and tadalafil was administered at a dose of 10 mg in one study and 20 mg in another. In both these studies, all patients imbibed the entire alcohol dose within 10 minutes of starting. In one of these two studies, blood alcohol levels of 0.08% were confirmed. In these two studies, more patients had clinically significant decreases in blood pressure on the combination of tadalafil and alcohol as compared to alcohol alone. Some subjects reported postural dizziness, and orthostatic hypotension was observed in some subjects. When tadalafil 20 mg was administered with a lower dose of alcohol (0.6 g/kg, which is equivalent to approximately 4 ounces of 80-proof vodka, administered in less than 10 minutes), orthostatic hypotension was not observed, dizziness occurred with similar frequency to alcohol alone, and the hypotensive effects of alcohol were not potentiated.

Tadalafil did not affect alcohol plasma concentrations and alcohol did not affect tadalafil plasma concentrations.

Effects on Exercise Stress Testing

The effects of tadalafil on cardiac function, hemodynamics, and exercise tolerance were investigated in a single clinical pharmacology study. In this blinded crossover trial, 23 subjects with stable coronary artery disease and evidence of exercise-induced cardiac ischemia were enrolled. The primary endpoint was time to cardiac ischemia. The mean difference in total exercise time was 3 seconds (tadalafil 10 mg minus placebo), which represented no clinically meaningful difference. Further statistical analysis demonstrated that tadalafil was non-inferior to placebo with respect to time to ischemia. Of note, in this study, in some subjects who received tadalafil followed by sublingual nitroglycerin in the post-exercise period, clinically significant reductions in blood pressure were observed, consistent with the augmentation by tadalafil of the blood-pressure-lowering effects of nitrates.

Effects on Vision

Single oral doses of phosphodiesterase inhibitors have demonstrated transient dose-related impairment of color discrimination (blue/green), using the Farnsworth-Munsell 100-hue test, with peak effects near the time of peak plasma levels. This finding is consistent with the inhibition of PDE6, which is involved in phototransduction in the retina. In a study to assess the effects of a single dose of tadalafil 40 mg on vision (N=59), no effects were observed on visual acuity, intraocular pressure, or pupilometry. Across all clinical studies with Cialis, reports of changes in color vision were rare (<0.1% of patients).

Effects on Sperm Characteristics

Three studies were conducted in men to assess the potential effect on sperm characteristics of tadalafil 10 mg (one 6 month study) and 20 mg (one 6 month and one 9 month study) administered daily. There were no adverse effects on sperm morphology or sperm motility in any of the three studies. In the study of 10 mg tadalafil for 6 months and the study of 20 mg tadalafil for 9 months, results showed a decrease in mean sperm concentrations relative to placebo, although these differences were not clinically meaningful. This effect was not seen in the study of 20 mg tadalafil taken for 6 months. In addition there was no adverse effect on mean concentrations of reproductive hormones, testosterone, luteinizing hormone or follicle stimulating hormone with either 10 or 20 mg of tadalafil compared to placebo.

Effects on Cardiac Electrophysiology

cc

Pharmacokinetics

see

Absorptionmax

The rate and extent of absorption of tadalafil are not influenced by food; thus Cialis may be taken with or without food.

Distribution

Less than 0.0005% of the administered dose appeared in the semen of healthy subjects.

MetabolismIn vitro

Excretion

Geriatricmax[see Use in Specific Populations (8.5)]

Pediatric[see Use in Specific Populations (8.4)]

Patients with Diabetes Mellitusmax

Patients with BPHmax

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Mutagenesisin vitroin vitroin vivo

Impairment of Fertility

There were no treatment-related testicular findings in rats or mice treated with doses up to 400 mg/kg/day for 2 years.

Animal Toxicology and/or Pharmacology

Animal studies showed vascular inflammation in tadalafil-treated mice, rats, and dogs. In mice and rats, lymphoid necrosis and hemorrhage were seen in the spleen, thymus, and mesenteric lymph nodes at unbound tadalafil exposure of 2- to 33-fold above the human exposure (AUCs) at the MRHD of 20 mg. In dogs, an increased incidence of disseminated arteritis was observed in 1- and 6-month studies at unbound tadalafil exposure of 1- to 54-fold above the human exposure (AUC) at the MRHD of 20 mg. In a 12-month dog study, no disseminated arteritis was observed, but 2 dogs exhibited marked decreases in white blood cells (neutrophils) and moderate decreases in platelets with inflammatory signs at unbound tadalafil exposures of approximately 14- to 18-fold the human exposure at the MRHD of 20 mg. The abnormal blood-cell findings were reversible within 2 weeks after stopping treatment.

Clinical Studies

Cialis for Use as Needed for ED

The efficacy and safety of tadalafil in the treatment of erectile dysfunction has been evaluated in 22 clinical trials of up to 24-weeks duration, involving over 4000 patients. Cialis, when taken as needed up to once per day, was shown to be effective in improving erectile function in men with erectile dysfunction (ED).

Cialis was studied in the general ED population in 7 randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design, primary efficacy and safety studies of 12-weeks duration. Two of these studies were conducted in the United States and 5 were conducted in centers outside the US. Additional efficacy and safety studies were performed in ED patients with diabetes mellitus and in patients who developed ED status post bilateral nerve-sparing radical prostatectomy.

In these 7 trials, Cialis was taken as needed, at doses ranging from 2.5 to 20 mg, up to once per day. Patients were free to choose the time interval between dose administration and the time of sexual attempts. Food and alcohol intake were not restricted.

Several assessment tools were used to evaluate the effect of Cialis on erectile function. The 3 primary outcome measures were the Erectile Function (EF) domain of the International Index of Erectile Function (IIEF) and Questions 2 and 3 from Sexual Encounter Profile (SEP). The IIEF is a 4-week recall questionnaire that was administered at the end of a treatment-free baseline period and subsequently at follow-up visits after randomization. The IIEF EF domain has a 30-point total score, where higher scores reflect better erectile function. SEP is a diary in which patients recorded each sexual attempt made throughout the study. SEP Question 2 asks, “Were you able to insert your penis into the partner's vagina?” SEP Question 3 asks, “Did your erection last long enough for you to have successful intercourse?” The overall percentage of successful attempts to insert the penis into the vagina (SEP2) and to maintain the erection for successful intercourse (SEP3) is derived for each patient.

Results in ED Population in US Trialssee

Results in General ED Population in Trials Outside the USsee

In addition, there were improvements in EF domain scores, success rates based upon SEP Questions 2 and 3, and patient-reported improvement in erections across patients with ED of all degrees of disease severity while taking Cialis, compared to patients on placebo.

Therefore, in all 7 primary efficacy and safety studies, Cialis showed statistically significant improvement in patients' ability to achieve an erection sufficient for vaginal penetration and to maintain the erection long enough for successful intercourse, as measured by the IIEF questionnaire and by SEP diaries.

Efficacy Results in ED Patients with Diabetes Mellitussee

Efficacy Results in ED Patients following Radical Prostatectomysee

Results in Studies to Determine the Optimal Use of Cialis

Two studies were conducted to assess the efficacy of Cialis at a given timepoint after dosing, specifically at 24 hours and at 36 hours after dosing.

In the first of these studies, 348 patients with ED were randomized to placebo or Cialis 20 mg. Patients were encouraged to make 4 total attempts at intercourse; 2 attempts were to occur at 24 hours after dosing and 2 completely separate attempts were to occur at 36 hours after dosing. The results demonstrated a difference between the placebo group and the Cialis group at each of the pre-specified timepoints. At the 24-hour timepoint, (more specifically, 22 to 26 hours), 53/144 (37%) patients reported at least 1 successful intercourse in the placebo group versus 84/138 (61%) in the Cialis 20-mg group. At the 36-hour timepoint (more specifically, 33 to 39 hours), 49/133 (37%) of patients reported at least 1 successful intercourse in the placebo group versus 88/137 (64%) in the Cialis 20-mg group.

In the second of these studies, a total of 483 patients were evenly randomized to 1 of 6 groups: 3 different dosing groups (placebo, Cialis 10, or 20 mg) that were instructed to attempt intercourse at 2 different times (24 and 36 hours post-dosing). Patients were encouraged to make 4 separate attempts at their assigned dose and assigned timepoint. In this study, the results demonstrated a statistically significant difference between the placebo group and the Cialis groups at each of the pre-specified timepoints. At the 24-hour timepoint, the mean, per patient percentage of attempts resulting in successful intercourse were 42, 56, and 67% for the placebo, Cialis 10-, and 20-mg groups, respectively. At the 36-hour timepoint, the mean, per-patient percentage of attempts resulting in successful intercourse were 33, 56, and 62% for placebo, Cialis 10-, and 20-mg groups, respectively.

Cialis for Once Daily Use for ED

The efficacy and safety of Cialis for once daily use in the treatment of erectile dysfunction has been evaluated in 2 clinical trials of 12-weeks duration and 1 clinical trial of 24-weeks duration, involving a total of 853 patients. Cialis, when taken once daily, was shown to be effective in improving erectile function in men with erectile dysfunction (ED).

Cialis was studied in the general ED population in 2 randomized, multicenter, double-blinded, placebo-controlled, parallel-arm design, primary efficacy and safety studies of 12- and 24-weeks duration, respectively. One of these studies was conducted in the United States and one was conducted in centers outside the US. An additional efficacy and safety study was performed in ED patients with diabetes mellitus. Cialis was taken once daily at doses ranging from 2.5 to 10 mg. Food and alcohol intake were not restricted. Timing of sexual activity was not restricted relative to when patients took Cialis.

Results in General ED Population

The primary efficacy and safety study conducted outside the US included 268 patients, with a mean age of 56 years (range 21 to 78 years). The population was 86% White, 3% Black, 0.4% Hispanic, and 10% of other ethnicities, and included patients with ED of various severities, etiologies (organic, psychogenic, mixed), and with multiple co-morbid conditions, including diabetes mellitus, hypertension, and other cardiovascular disease. Ninety-three percent of patients reported ED of at least 1-year duration.

see

In the 6 month double-blind study, the treatment effect of Cialis did not diminish over time.

Efficacy Results in ED Patients with Diabetes Mellitussee

Cialis 5 mg for Once Daily Use for Benign Prostatic Hyperplasia (BPH)

[see Clinical Studies (14.4)]

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In each of these 2 trials, Cialis 5 mg for once daily use resulted in statistically significant improvement in the total IPSS compared to placebo. Mean total IPSS showed a decrease starting at the first scheduled observation (4 weeks) in Study K and remained decreased through 12 weeks.

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Efficacy Results in Patients with BPH initiating Cialis and Finasteride

see

In the 404 patients who had both ED and BPH at baseline, changes in erectile function were assessed as key secondary endpoints using the EF domain of the IIEF questionnaire. Cialis with finasteride (N=203) was compared to placebo with finasteride (N=201). A statistically significant improvement from baseline (Cialis/finasteride 13.7, placebo/finasteride 15.1) was observed at week 4 (Cialis/finasteride 3.7, placebo/finasteride -1.1; p<.001), week 12 (Cialis/finasteride 4.7, placebo/finasteride 0.6; p<.001), and week 26 (Cialis/finasteride 4.7, placebo/finasteride 0.0; p<.001).

Cialis 5 mg for Once Daily Use for ED and BPH

The efficacy and safety of Cialis for once daily use for the treatment of ED, and the signs and symptoms of BPH, in patients with both conditions was evaluated in one placebo-controlled, multinational, double-blind, parallel-arm study which randomized 606 patients to receive either Cialis 2.5 mg, 5 mg, for once daily use or placebo. ED severity ranged from mild to severe and BPH severity ranged from moderate to severe. The full study population had a mean age of 63 years (range 45 to 83) and was 93% White, 4% Black, 3% other races; 16% were of Hispanic ethnicity. Patients with multiple co-morbid conditions such as diabetes mellitus, hypertension, and other cardiovascular disease were included.

In this study, the co-primary endpoints were total IPSS and the Erectile Function (EF) domain score of the International Index of Erectile Function (IIEF). One of the key secondary endpoints in this study was Question 3 of the Sexual Encounter Profile diary (SEP3). Timing of sexual activity was not restricted relative to when patients took Cialis.

Cialis 5 mg for once daily use resulted in statistically significant improvements in the total IPSS and in the EF domain of the IIEF questionnaire. Cialis 5 mg for once daily use also resulted in statistically significant improvement in SEP3. Cialis 2.5 mg did not result in statistically significant improvement in the total IPSS.

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How Supplied/Storage and Handling

How Supplied

Cialis (tadalafil) is supplied as follows:

Four strengths of almond-shaped tablets are available in different sizes and different shades of yellow, and supplied in the following package sizes:

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Keep out of reach of children.

Patient Counseling Information

Nitrates

Physicians should discuss with patients the contraindication of Cialis with regular and/or intermittent use of organic nitrates. Patients should be counseled that concomitant use of Cialis with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke.

[see Contraindications (4.1) and Warnings and Precautions (5.1)]

Guanylate Cyclase (GC) Stimulators

Physicians should discuss with patients the contraindication of Cialis with any use of a GC stimulator, such as riociguat, for pulmonary arterial hypertension. Patients should be counseled that the concomitant use of Cialis with GC stimulators may cause blood pressure to drop to an unsafe level.

Cardiovascular Considerations

[see Warnings and Precautions (5.1)]

Concomitant Use with Drugs Which Lower Blood Pressure

[see Warnings and Precautions (5.6), Drug Interactions (7.1), and Clinical Pharmacology (12.2)]

Potential for Drug Interactions When Taking Cialis for Once Daily Use

[see Dosage and Administration (2.7), Warnings and Precautions (5.6), Drug Interactions (7.1, 7.2), Clinical Pharmacology (12.2), and Clinical Studies (14.2)]

Priapism

There have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Physicians should advise patients who have an erection lasting greater than 4 hours, whether painful or not, to seek emergency medical attention.

Sudden Loss of Vision

[see Warnings and Precautions (5.4) and Adverse Reactions (6.2)]

Sudden Hearing Loss

[see Adverse Reactions (6.1, 6.2)]

Alcohol

[see Warnings and Precautions (5.9), Drug Interactions (7.1), and Clinical Pharmacology (12.2)]

Sexually Transmitted Disease

The use of Cialis offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus (HIV) should be considered.

Recommended Administration

Physicians should instruct patients on the appropriate administration of Cialis to allow optimal use.

For Cialis for use as needed in men with ED, patients should be instructed to take one tablet at least 30 minutes before anticipated sexual activity. In most patients, the ability to have sexual intercourse is improved for up to 36 hours.

For Cialis for once daily use in men with ED or ED/BPH, patients should be instructed to take one tablet at approximately the same time every day without regard for the timing of sexual activity. Cialis is effective at improving erectile function over the course of therapy.

For Cialis for once daily use in men with BPH, patients should be instructed to take one tablet at approximately the same time every day.

Revision Date: 4/2016

Marketed by: Lilly USA, LLC
Indianapolis, IN 46285, USA

www.Cialis.com

Copyright © 2003, 2016, Eli Lilly and Company. All rights reserved.

CLS-0002-USPI-20160422

Patient Information

Cialis®(See-AL-iss)

(tadalafil) tablets

Read this important information before you start taking Cialis and each time you get a refill. There may be new information. You may also find it helpful to share this information with your partner. This information does not take the place of talking with your healthcare provider. You and your healthcare provider should talk about Cialis when you start taking it and at regular checkups. If you do not understand the information, or have questions, talk with your healthcare provider or pharmacist.

What Is The Most Important Information I Should Know About Cialis?

Cialis can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines.

take any medicines called “nitrates.”

  • Medicines called nitrates include nitroglycerin that is found in tablets, sprays, ointments, pastes, or patches. Nitrates can also be found in other medicines such as isosorbide dinitrate or isosorbide mononitrate. Some recreational drugs called “poppers” also contain nitrates, such as amyl nitrite and butyl nitrite.

Do not take Cialis if you take medicines called guanylate cyclase stimulators which include:

  • Riociguat (Adempas®) a medicine that treats pulmonary arterial hypertension and chronic-thromboembolic pulmonary hypertension.

Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are nitrates or guanylate cyclase stimulators, such as riociguat.

“Who Should Not Take Cialis?”

Tell all of your healthcare providers that you take Cialis. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took Cialis.

After taking a single tablet, some of the active ingredient of Cialis remains in your body for more than 2 days.“Can Other Medicines Affect Cialis?”

Stop sexual activity and get medical help right away if you get symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.

“What Are The Possible Side Effects Of Cialis?”

What Is Cialis?

Cialis is a prescription medicine taken by mouth for the treatment of:

  • men with erectile dysfunction (ED)
  • men with symptoms of benign prostatic hyperplasia (BPH)
  • men with both ED and BPH

Cialis for the Treatment of ED

ED is a condition where the penis does not fill with enough blood to harden and expand when a man is sexually excited, or when he cannot keep an erection. A man who has trouble getting or keeping an erection should see his healthcare provider for help if the condition bothers him. Cialis helps increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity. Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away.

Some form of sexual stimulation is needed for an erection to happen with Cialis.

Cialis does not:

  • cure ED
  • increase a man's sexual desire
  • protect a man or his partner from sexually transmitted diseases, including HIV. Speak to your healthcare provider about ways to guard against sexually transmitted diseases.
  • serve as a male form of birth control

Cialis is only for men over the age of 18, including men with diabetes or who have undergone prostatectomy.

Cialis for the Treatment of Symptoms of BPH

BPH is a condition that happens in men, where the prostate gland enlarges which can cause urinary symptoms.

Cialis for the Treatment of ED and Symptoms of BPH

ED and symptoms of BPH may happen in the same person and at the same time. Men who have both ED and symptoms of BPH may take Cialis for the treatment of both conditions.

Cialis is not for women or children.

Cialis must be used only under a healthcare provider's care.

Who Should Not Take Cialis?

Do not take Cialis if you:

  • take any medicines called “nitrates”.
  • use recreational drugs called “poppers” like amyl nitrite and butyl nitrite. (See “What Is The Most Important Information I Should Know About Cialis?”)
  • take any medicines called guanylate cyclase stimulators, such as riociguat.
  • are allergic to Cialis or ADCIRCA®, or any of its ingredients. See the end of this leaflet for a complete list of ingredients in Cialis. Symptoms of an allergic reaction may include:
  • rash
  • hives
  • swelling of the lips, tongue, or throat
  • difficulty breathing or swallowing

Call your healthcare provider or get help right away if you have any of the symptoms of an allergic reaction listed above.

What Should I Tell My Healthcare Provider Before Taking Cialis?

Only your healthcare provider and you can decide if Cialis is right for you.

  • have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack. Ask your healthcare provider if it is safe for you to have sexual activity. You should not take Cialis if your healthcare provider has told you not to have sexual activity because of your health problems.
  • have pulmonary hypertension
  • have low blood pressure or have high blood pressure that is not controlled
  • have had a stroke
  • have liver problems
  • have kidney problems or require dialysis
  • have retinitis pigmentosa, a rare genetic (runs in families) eye disease
  • have ever had severe vision loss, including a condition called NAION
  • have stomach ulcers
  • have a bleeding problem
  • have a deformed penis shape or Peyronie's disease
  • have had an erection that lasted more than 4 hours
  • have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia

Can Other Medicines Affect Cialis?

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Cialis and other medicines may affect each other. Always check with your healthcare provider before starting or stopping any medicines. Especially tell your healthcare provider if you take any of the following*:

  • medicines called nitrates (see “What Is The Most Important Information I Should Know About Cialis?”)
  • medicines called guanylate cyclase stimulators, such as riociguat (Adempas®), used to treat pulmonary hypertension
  • medicines called alpha blockers. These include Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), Uroxatral® (alfuzosin HCl), Jalyn® (dutasteride and tamsulosin HCl) or Rapaflo® (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. If Cialis is taken with certain alpha blockers, your blood pressure could suddenly drop. You could get dizzy or faint.
  • other medicines to treat high blood pressure (hypertension)
  • medicines called HIV protease inhibitors, such as ritonavir (Norvir®, Kaletra®)
  • some types of oral antifungals such as ketoconazole (Nizoral®), itraconazole (Sporanox®)
  • some types of antibiotics such as clarithromycin (Biaxin®), telithromycin (Ketek®), erythromycin (several brand names exist. Please consult your healthcare provider to determine if you are taking this medicine).
  • other medicines or treatments for ED.
  • Cialis is also marketed as ADCIRCA for the treatment of pulmonary arterial hypertension. Do not take both Cialis and ADCIRCA. Do not take sildenafil citrate (Revatio®) with Cialis.

How Should I Take Cialis?

  • Take Cialis exactly as your healthcare provider prescribes it. Your healthcare provider will prescribe the dose that is right for you.
  • Some men can only take a low dose of Cialis or may have to take it less often, because of medical conditions or medicines they take.
  • Do not change your dose or the way you take Cialis without talking to your healthcare provider. Your healthcare provider may lower or raise your dose, depending on how your body reacts to Cialis and your health condition.
  • Cialis may be taken with or without meals.
  • If you take too much Cialis, call your healthcare provider or emergency room right away.

How Should I Take Cialis for Symptoms of BPH?

For symptoms of BPH, Cialis is taken once daily.

  • Do not take Cialis more than one time each day.
  • Take one Cialis tablet every day at about the same time of day.
  • If you miss a dose, you may take it when you remember but do not take more than one dose per day.

How Should I Take Cialis for ED?

For ED, there are two ways to take Cialis - either for use as needed OR for use once daily.

Cialis for use as needed:

  • Do not take Cialis more than one time each day.
  • Take one Cialis tablet before you expect to have sexual activity. You may be able to have sexual activity at 30 minutes after taking Cialis and up to 36 hours after taking it. You and your healthcare provider should consider this in deciding when you should take Cialis before sexual activity. Some form of sexual stimulation is needed for an erection to happen with Cialis.
  • Your healthcare provider may change your dose of Cialis depending on how you respond to the medicine, and on your health condition.

OR

Cialis for once daily use is a lower dose you take every day.

  • Do not take Cialis more than one time each day.
  • Take one Cialis tablet every day at about the same time of day. You may attempt sexual activity at any time between doses.
  • If you miss a dose, you may take it when you remember but do not take more than one dose per day.
  • Some form of sexual stimulation is needed for an erection to happen with Cialis.
  • Your healthcare provider may change your dose of Cialis depending on how you respond to the medicine, and on your health condition.

How Should I Take Cialis for Both ED and the Symptoms of BPH?

For both ED and the symptoms of BPH, Cialis is taken once daily.

  • Do not take Cialis more than one time each day.
  • Take one Cialis tablet every day at about the same time of day. You may attempt sexual activity at any time between doses.
  • If you miss a dose, you may take it when you remember but do not take more than one dose per day.
  • Some form of sexual stimulation is needed for an erection to happen with Cialis.

What Should I Avoid While Taking Cialis?

  • Do not use other ED medicines or ED treatments while taking Cialis.
  • Do not drink too much alcohol when taking Cialis (for example, 5 glasses of wine or 5 shots of whiskey). Drinking too much alcohol can increase your chances of getting a headache or getting dizzy, increasing your heart rate, or lowering your blood pressure.

What Are The Possible Side Effects Of Cialis?

“What Is The Most Important Information I Should Know About Cialis?”

The most common side effects with Cialis are:

Call your healthcare provider if you get any side effect that bothers you or one that does not go away.

Uncommon side effects include:

An erection that won't go away (priapism). If you get an erection that lasts more than 4 hours, get medical help right away. Priapism must be treated as soon as possible or lasting damage can happen to your penis, including the inability to have erections.

Color vision changes, such a

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