FULL PRESCRIBING INFORMATION: CONTENTS*

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, 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. 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)]. 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 cialis tadalafil 20mg recommended dosing frequency is once per day in most patients.

Side Effect	Incidence Rate	Severity	Recommendations
Headache	Common	Mild	Hydrate, over-the-counter pain relief
Flushing	Common	Mild	Avoid hot environments
Nasal Congestion	Less common	Mild	Use decongestants cautiously
Back Pain	Less common	Mild	Seek medical advice if persists

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.

Mechanism of action

Are you currently using Tadalafil (Cialis, Adcirca, and others)?

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

Product	Dosage	Quantity + Bonus	Price
Cialis Generic	60mg	60 + 4 Pills	145.06€ 138.15€	Buy
Cialis Super Active	20mg	180 + 20 Pills	521.59€ 496.75€	Buy
Cialis Soft Tabs	20mg	180 + 8 Pills	353.17€ 336.35€	Buy
Cialis Professional	20mg	180 + 4 Pills	423.11€ 402.96€	Buy
Cialis Black	80mg	60 + 4 Pills	150.98€ 143.79€	Buy
Cialis Generic	40mg	360 + 10 Pills	477.87€ 455.11€	Buy
Cialis Super Active	20mg	120 + 16 Pills	382.15€ 363.95€	Buy
Cialis Generic	40mg	120 + 8 Pills	206.98€ 197.12€	Buy
Cialis Generic	5mg	20 Pills	41.99€ 39.99€	Buy
Cialis Super Active	20mg	30 + 6 Pills	128.09€ 121.99€	Buy
Cialis Black	80mg	180 + 10 Pills	356.64€ 339.66€	Buy
Cialis Soft Tabs	20mg	60 + 4 Pills	159.37€ 151.78€	Buy

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.

• 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.

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)].

What About Other ED Medications?

Mild 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.

Drug Label Information

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, 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.

What should I know about tadalafil before using it?

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. 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.

Report Side Effects

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. The maximum cialis tadalafil 20mg 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. When CIALIS is coadministered with an alpha blocker, patients should be soft cialis 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)]. 4 CONTRAINDICATIONS 4.1 NitratesAdministration of CIALIS to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated.

Brand Name	Manufacturer	Price (per 20mg tablet)	Certification	Notes
Cialis	Lilly	$30	FDA, EMA	Original branded drug
Tadalafil Generic	Multiple	$8 - $15	ISO-certified	Cheaper alternative
Adcirca	Lilly	Prescription only	FDA	For pulmonary hypertension
Tadylof	Local pharma	$10 - $12	Local cert	Generic version

In clinical pharmacology studies, CIALIS was shown to potentiate the hypotensive effect of nitrates. This is thought to result from the combined effects of nitrates and CIALIS on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2)].4.2 Hypersensitivity Reactionsis contraindicated in patients with a known serious hypersensitivity to tadalafil (CIALIS or ADCIRCA). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions (6.2)]. Administration of CIALIS to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. This is thought to result from the combined effects of nitrates and CIALIS on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2)]. is contraindicated in patients with a known serious hypersensitivity to tadalafil (CIALIS or ADCIRCA).

Related/similar drugs

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

Duration of action

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

Does Cialis increase the size of a man’s penis?

Therefore, caution is advised if CIALIS for once daily use is prescribed to these patients. When CIALIS is coadministered with an alpha blocker, patients should be soft cialis 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)]. 4 CONTRAINDICATIONS 4.1 NitratesAdministration of CIALIS to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, CIALIS was shown to potentiate the hypotensive effect of nitrates. This is thought to result from the combined effects of nitrates and CIALIS on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2)].4.2 Hypersensitivity Reactionsis contraindicated in patients with a known serious hypersensitivity to tadalafil (CIALIS or ADCIRCA). 5 WARNINGS AND PRECAUTIONS Evaluation of erectile dysfunction 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:5.1 CardiovascularPhysicians 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.

Side Effects

Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions (6.2)]. Administration of CIALIS to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. This is thought to result from the combined effects of nitrates and CIALIS on the nitric oxide/cGMP pathway [see Clinical Pharmacology (12.2)]. is contraindicated in patients with a known serious hypersensitivity to tadalafil (CIALIS or ADCIRCA). 5 WARNINGS AND PRECAUTIONS Evaluation of erectile dysfunction 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:5.1 CardiovascularPhysicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity.

Priapism and Your Cialis Dose

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.Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of CIALIS. In such a patient, who has taken CIALIS, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 48 hours should have elapsed after the last dose of CIALIS before nitrate administration is considered. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring. Therefore, patients who experience anginal chest pain after taking CIALIS should seek immediate medical attention.

Pulmonary arterial hypertension

Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and seek immediate medical attention.Physicians should discuss with patients the appropriate action in the event that they experience anginal chest pain requiring nitroglycerin following intake of CIALIS. In such a patient, who has taken CIALIS, where nitrate administration is deemed medically necessary for a life-threatening situation, at least 48 hours should have elapsed after the last dose of CIALIS before nitrate administration is considered.

• Comparison with other PDE5 inhibitors: Sildenafil (Viagra) and Vardenafil (Levitra).
• Key difference: Tadalafil's duration of action is much longer (up to 36 hours).
• Sildenafil and vardenafil typically last 4-5 hours.
• Tadalafil is less affected by food, especially high-fat meals.
• Sildenafil absorption is significantly delayed by a high-fat meal.
• Onset of action is similar for all (30-60 minutes), though sildenafil can be faster.
• Side effect profiles are similar, but tadalafil is more associated with back pain.
• Tadalafil is the only PDE5 inhibitor approved for daily use and for BPH.
• Choice depends on individual response, lifestyle, frequency, and cost.
• Do not take tadalafil within 24-48 hours of taking another PDE5 inhibitor.
• Consult a doctor to determine the most suitable medication.

In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring. Therefore, patients who experience anginal chest pain after taking CIALIS should seek immediate medical attention.