DOSAGE AND ADMINISTRATION

8.1 Pregnancy
2.3 Use in Special Populations
17.6 Vision
17.5 Priapism
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17.3 Concomitant Use with Drugs Which Lower Blood Pressure

8.1 Pregnancy

Patients should not use CIALIS if sex is inadvisable due to cardiovascular status (5.1). Use of CIALIS with alpha blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension (5.6, 5.9). If taking potent inhibitors of CYP3A4, dose should be adjusted: CIALIS for use as needed: ≤10 mg every 72 hours. For once daily use: dose not to exceed 2.5 mg (5.10). Patients should seek emergency treatment if an erection lasts >4 hours.

Food effect

Product	Dosage	Quantity + Bonus	Price
Cialis Black	80mg	30 + 2 Pills	89.11€ 84.87€
Cialis Professional	20mg	180 + 4 Pills	423.11€ 402.96€
Cialis Professional	20mg	20 Pills	78.33€ 74.60€
Cialis Generic	40mg	10 Pills	37.79€ 35.99€
Cialis Generic	10mg	360 + 10 Pills	388.49€ 369.99€
Cialis Generic	5mg	360 + 10 Pills	268.08€ 255.31€
Cialis Professional	40mg	60 + 2 Pills	262.32€ 249.83€
Cialis Generic	60mg	10 Pills	41.22€ 39.26€
Cialis Generic	40mg	360 + 10 Pills	477.87€ 455.11€
Cialis Professional	40mg	120 + 4 Pills	436.68€ 415.89€
Cialis Generic	40mg	180 + 10 Pills	277.29€ 264.09€
Cialis Super Active	20mg	270 + 30 Pills	661.49€ 629.99€
Cialis Generic	20mg	60 + 6 Pills	117.76€ 112.15€
Cialis Generic	10mg	20 Pills	48.23€ 45.93€
Cialis Generic	20mg	10 Pills	31.49€ 29.99€
Cialis Black	80mg	180 + 10 Pills	356.64€ 339.66€

2.3 Use in Special Populations

Improves erectile function compared to placebo up to 36 hours post dose (2.1).CIALIS for once daily use: 2.5 mg taken once daily, without regard to timing of sexual activity. May increase to 5 mg based upon efficacy and tolerability (2.1).CIALIS may be taken without regard to food (2.2).DOSAGE FORMS AND STRENGTHSTablets (not scored): 2.5 mg, 5 mg, 10 mg, 20 mg (3).CONTRAINDICATIONSWARNINGS AND PRECAUTIONSPatients should not use CIALIS if sex is inadvisable due to cardiovascular status (5.1).Use of CIALIS with alpha blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension (5.6, 5.9).If taking potent inhibitors of CYP3A4, dose should be adjusted: CIALIS for use as needed: ≤10 mg every 72 hours. For once daily use: dose not to exceed 2.5 mg (5.10).Patients should seek emergency treatment if an erection lasts >4 hours. Use CIALIS with caution in patients predisposed to priapism (5.3).Patients should stop CIALIS and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of Non Arteritic Ischemic Optic Neuropathy (NAION). Discuss increased risk of NAION in patients with history of NAION (5.4).Patients should stop CIALIS and seek prompt medical attention in the event of sudden decrease or loss of hearing (5.5).ADVERSE REACTIONSMost common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, and pain in limb (6.1, 6.2).To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or INTERACTIONSSee 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.Revised: 7/2009 CIALIS® is a phosphodiesterase 5 (PDE5) inhibitor indicated for erectile dysfunction (ED) (1.1).

How does tadalafil work (mechanism of action)?

CIALIS for use as needed: Starting dose: 10 mg up to once daily. Improves erectile function compared to placebo up to 36 hours post dose (2.1). CIALIS for once daily use: 2.5 mg taken once daily, without regard to timing of sexual activity. May increase to 5 mg based upon efficacy and tolerability (2.1). CIALIS may be taken without regard to food (2.2). CIALIS for use as needed: Starting dose: 10 mg up to once daily. Improves erectile function compared to placebo up to 36 hours post dose (2.1). CIALIS for once daily use: 2.5 mg taken once daily, without regard to timing of sexual activity.

Cialis 20mg is sometimes used off-label for other medical conditions.
The medication is designed to improve quality of life for men with ED.
Tadalafil acts by increasing blood flow during sexual arousal.
Cialis can be used with certain lifestyle adjustments for better results.
Patients should monitor their response and side effects.
Cialis 20mg might interact with certain antifungal medications.
It is sometimes prescribed alongside other ED treatment options.
The safety profile of Cialis is well established.
Cialis 20mg helps improve confidence in intimate moments.
The medication should not be shared with others.
It is crucial to follow the prescribed dosage.
Always report any adverse effects to your healthcare provider.

May increase to 5 mg based upon efficacy and tolerability (2.1). CIALIS may be taken without regard to food (2.2). Patients should not use CIALIS if sex is inadvisable due to cardiovascular status (5.1).

Parameter	Value	Description	Notes
Absorption Time	30-60 minutes	Time to reach peak plasma concentration	After oral intake
Half-life	17.5 hours	Duration of action	Prolonged effects possible
Peak Plasma Levels	Achieved in 2 hours	Time to maximum concentration	Variable per individual
Bioavailability	~84%	Proportion absorbed into bloodstream	When taken with food

Use of CIALIS with alpha blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension (5.6, 5.9).

17.6 Vision

If taking potent inhibitors of CYP3A4, dose should be adjusted: CIALIS for use as needed: ≤10 mg every 72 hours. For once daily use: dose not to exceed 2.5 mg (5.10). Patients should seek emergency treatment if an erection lasts >4 hours.

Future and research: Patents for brand Cialis have expired in many markets.
This has led to the availability of multiple generic tadalafil products.
Research continues on other potential uses for tadalafil.
Investigated for use in Raynaud's phenomenon, female sexual arousal disorder.
Studies on its effect in premature ejaculation have shown mixed results.
Research into its role in treating lower urinary tract symptoms (LUTS) continues.
New formulations (e.g., sublingual, topical) are under investigation for faster onset.
Long-term cardiovascular outcomes in specific populations are still being studied.
Personalized medicine may one day guide optimal PDE5 inhibitor selection.
Digital health tools are emerging to support ED diagnosis and treatment adherence.
Always rely on current, approved prescribing information for medical decisions.

Use CIALIS with caution in patients predisposed to priapism (5.3). Patients should stop CIALIS and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of Non Arteritic Ischemic Optic Neuropathy (NAION). Discuss increased risk of NAION in patients with history of NAION (5.4). Patients should stop CIALIS and seek prompt medical attention in the event of sudden decrease or loss of hearing (5.5). Most common adverse reactions (≥2%) include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, cialis chewable and pain in limb (6.1, 6.2). To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE1.1 Erectile Dysfunction2 DOSAGE AND ADMINISTRATION2.1 Erectile Dysfunction2.2 Use with Food2.3 Use in Special Populations2.4 Concomitant Medications3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Hypersensitivity Reactions5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular5.2 Potential for Drug Interactions When Taking CIALIS for Once Daily Use5.3 Prolonged Erection5.4 Eye5.5 Sudden Hearing Loss5.6 Alpha blockers and Antihypertensives5.7 Renal Insufficiency5.8 Hepatic Impairment5.9 Alcohol5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)5.11 Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies5.12 Effects on Bleeding5.13 Counseling Patients About Sexually Transmitted Diseases6 ADVERSE REACTIONS6.1 Clinical Studies Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Potential for Pharmacodynamic Interactions with CIALIS7.2 Potential for Other Drugs to Affect CIALIS7.3 Potential for CIALIS to Affect Other Drugs8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.3 Nursing Mothers8.4 Pediatric Use8.5 Geriatric Use8.6 Hepatic Impairment8.7 Renal Insufficiency10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility13.2 Animal Toxicology and/or Pharmacology14 CLINICAL STUDIES14.1 CIALIS for Use as Needed14.2 CIALIS for Once Daily Use16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Storage17 PATIENT COUNSELING INFORMATION17.1 Nitrates17.2 Cardiovascular Considerations17.3 Concomitant Use with Drugs Which Lower Blood Pressure17.4 Potential for Drug Interactions When Taking CIALIS for Once Daily Use17.5 Priapism17.6 Vision17.7 Sudden Hearing Loss17.8 Alcohol17.9 Sexually Transmitted Disease17.10 Recommended Administration*Sections or subsections omitted from the full prescribing information are not listed. Sections or subsections omitted from the full prescribing information are not listed. 2 DOSAGE AND ADMINISTRATION 2.1 Erectile DysfunctionCIALIS for Use as NeededThe 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.

Ingredient	Quantity Per Tablet	Function	Source
Tadalafil	20 mg	Main active component	Lilly Laboratories
Croscarmellose	1.5 mg	Disintegrant	Pharmaceutical Grade
Microcrystalline Cellulose	2 mg	Filling agent	Pharmaceutical Supplier
Magnesium Stearate	0.2 mg	Lubricant	Chemical Manufacturer

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.2.3 Use in Special PopulationsRenal InsufficiencyCIALIS for Use as NeededMild (creatinine clearance 51 to 80 mL/min): No dose adjustment is required.Moderate (creatinine clearance 31 to 50 mL/min): A starting dose of 5 mg not more than once per day is recommended, and the maximum dose should be limited to 10 mg not more than once in every 48 hours.Severe (creatinine clearance <30 mL/min and on hemodialysis): The maximum recommended 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 UseMild (creatinine clearance 51 to 80 mL/min): No dose adjustment is required.Moderate (creatinine clearance 31 to 50 mL/min): No dose adjustment is required.Severe (creatinine clearance <30 mL/min and on hemodialysis): CIALIS for once daily use is not recommended [see Warnings and Precautions (5.7) and Use In Specific Populations (8.7)].Hepatic ImpairmentCIALIS for Use as NeededMild or moderate (Child Pugh Class A or B): The dose of CIALIS should not exceed 10 mg once per day. The use of CIALIS once per day has not been extensively evaluated in patients with hepatic insufficiency 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 UseMild or moderate (Child Pugh Class A or B): CIALIS for once daily use has not been extensively evaluated in patients with hepatic insufficiency. 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)].2.4 Concomitant MedicationsAlpha BlockersWhen CIALIS is coadministered with an alpha blocker, patients should be stable on alpha-blocker therapy prior to initiating treatment with CIALIS, and CIALIS should be initiated at the lowest recommended dose [see Warnings and Precautions (5.6), Drug Interactions (7.1) and Clinical Pharmacology (12.2)].

17.5 Priapism

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)]. Mild or moderate (Child Pugh Class A or B): CIALIS for once daily use has not been extensively evaluated in patients with hepatic insufficiency.

Pulmonary arterial hypertension

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. Mild (creatinine clearance 51 to 80 mL/min): No dose adjustment is required. Moderate (creatinine clearance 31 to 50 mL/min): A starting dose of 5 mg not more than once per day is recommended, and the maximum dose should be limited to 10 mg not more than once in every 48 hours. Severe (creatinine clearance <30 mL/min and on hemodialysis): The maximum recommended 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)].

Lifestyle factors can influence both ED and BPH and the effectiveness of treatment.
Smoking damages blood vessels and can worsen erectile dysfunction.
Regular physical exercise improves cardiovascular health and blood flow.
A healthy diet (e.g., Mediterranean) supports vascular function.
Obesity is a risk factor for ED and can reduce testosterone levels.
Limiting alcohol consumption can improve erectile function.
Managing stress through techniques like meditation can be helpful.
Adequate, quality sleep is important for hormonal balance and overall health.
Treating underlying conditions like diabetes and hypertension is crucial.
Lifestyle changes can enhance the effectiveness of Cialis.
Discuss lifestyle modifications with your healthcare provider.

Moderate (creatinine clearance 31 to 50 mL/min): No dose adjustment is required.

Eli Lilly developed Cialis in the early 2000s.
Cialis 20mg doses should be taken approximately one hour before sexual activity.
The medication helps increase the blood flow only during arousal.
Cialis is not a cure but helps manage erectile dysfunction.
It is important to confirm kidney and liver health before use.
Cialis 20mg is sometimes used off-label for other conditions.
Overuse of Cialis can lead to adverse effects.
The medication should be kept out of reach of children.
Cialis 20mg is often preferred for its long-lasting effects.
The drug’s patent run out, making generics more available.
Patients should report any allergic reactions to their doctor.
Cialis can improve intimacy and confidence in men.

Severe (creatinine clearance <30 mL/min and on hemodialysis): CIALIS for once daily use is not recommended [see Warnings and Precautions (5.7) and Use In Specific Populations (8.7)]. Mild or moderate (Child Pugh Class A or B): The dose of CIALIS should not exceed 10 mg once per day. The use of CIALIS once per day has not been extensively evaluated in patients with hepatic insufficiency 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)].

Free Returns

To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Table of Contents FULL PRESCRIBING INFORMATION: CONTENTS*1 INDICATIONS AND USAGE1.1 Erectile Dysfunction2 DOSAGE AND ADMINISTRATION2.1 Erectile Dysfunction2.2 Use with Food2.3 Use in Special Populations2.4 Concomitant Medications3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Nitrates4.2 Hypersensitivity Reactions5 WARNINGS AND PRECAUTIONS5.1 Cardiovascular5.2 Potential for Drug Interactions When Taking CIALIS for Once Daily Use5.3 Prolonged Erection5.4 Eye5.5 Sudden Hearing Loss5.6 Alpha blockers and Antihypertensives5.7 Renal Insufficiency5.8 Hepatic Impairment5.9 Alcohol5.10 Concomitant Use of Potent Inhibitors of Cytochrome P450 3A4 (CYP3A4)5.11 Combination With Other PDE5 Inhibitors or Erectile Dysfunction Therapies5.12 Effects on Bleeding5.13 Counseling Patients About Sexually Transmitted Diseases6 ADVERSE REACTIONS6.1 Clinical Studies Experience6.2 Postmarketing Experience7 DRUG INTERACTIONS7.1 Potential for Pharmacodynamic Interactions with CIALIS7.2 Potential for Other Drugs to Affect CIALIS7.3 Potential for CIALIS to Affect Other Drugs8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.3 Nursing Mothers8.4 Pediatric Use8.5 Geriatric Use8.6 Hepatic Impairment8.7 Renal Insufficiency10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.2 Pharmacodynamics12.3 Pharmacokinetics13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility13.2 Animal Toxicology and/or Pharmacology14 CLINICAL STUDIES14.1 CIALIS for Use as Needed14.2 CIALIS for Once Daily Use16 HOW SUPPLIED/STORAGE AND HANDLING16.1 How Supplied16.2 Storage17 PATIENT COUNSELING INFORMATION17.1 Nitrates17.2 Cardiovascular Considerations17.3 Concomitant Use with Drugs Which Lower Blood Pressure17.4 Potential for Drug Interactions When Taking CIALIS for Once Daily Use17.5 Priapism17.6 Vision17.7 Sudden Hearing Loss17.8 Alcohol17.9 Sexually Transmitted Disease17.10 Recommended Administration*Sections or subsections omitted from the full prescribing information are not listed. Sections or subsections omitted from the full prescribing information are not listed. 2 DOSAGE AND ADMINISTRATION 2.1 Erectile DysfunctionCIALIS for Use as NeededThe 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.

Who should not use tadalafil?

Therefore, when advising patients on optimal use of CIALIS, this should be taken into consideration.2.3 Use in Special PopulationsRenal InsufficiencyCIALIS for Use as NeededMild (creatinine clearance 51 to 80 mL/min): No dose adjustment is required.Moderate (creatinine clearance 31 to 50 mL/min): A starting dose of 5 mg not more than once per day is recommended, and the maximum dose should be limited to 10 mg not more than once in every 48 hours.Severe (creatinine clearance <30 mL/min and on hemodialysis): The maximum recommended 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 UseMild (creatinine clearance 51 to 80 mL/min): No dose adjustment is required.Moderate (creatinine clearance 31 to 50 mL/min): No dose adjustment is required.Severe (creatinine clearance <30 mL/min and on hemodialysis): CIALIS for once daily use is not recommended [see Warnings and Precautions (5.7) and Use In Specific Populations (8.7)].Hepatic ImpairmentCIALIS for Use as NeededMild or moderate (Child Pugh Class A or B): The dose of CIALIS should not exceed 10 mg once per day. The use of CIALIS once per day has not been extensively evaluated in patients with hepatic insufficiency 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 UseMild or moderate (Child Pugh Class A or B): CIALIS for once daily use has not been extensively evaluated in patients with hepatic insufficiency. 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)].2.4 Concomitant MedicationsAlpha BlockersWhen CIALIS is coadministered with an alpha blocker, patients should be stable on alpha-blocker therapy prior to initiating treatment with CIALIS, and CIALIS should be initiated at the lowest recommended dose [see Warnings and Precautions (5.6), Drug Interactions (7.1) and Clinical Pharmacology (12.2)]. 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. Mild or moderate (Child Pugh Class A or B): CIALIS for once daily use has not been extensively evaluated in patients with hepatic insufficiency.

17.3 Concomitant Use with Drugs Which Lower Blood Pressure

Dose proportionality

Severe (creatinine clearance <30 mL/min and on hemodialysis): The maximum recommended 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)]. Moderate (creatinine clearance 31 to 50 mL/min): No dose adjustment is required. Severe (creatinine clearance <30 mL/min and on hemodialysis): CIALIS for once daily use is not recommended [see Warnings and Precautions (5.7) and Use In Specific Populations (8.7)]. Mild or moderate (Child Pugh Class A or B): The dose of CIALIS should not exceed 10 mg once per day. The use of CIALIS once per day has not been extensively evaluated in patients with hepatic insufficiency and therefore, caution is advised.