10 OVERDOSAGE

For once daily use: dose not to exceed 2.5 mg (5.10).

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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. Patients should seek emergency treatment if an erection lasts >4 hours.

• The global market for ED drugs is substantial, with Cialis being a major product.
• Marketing and direct-to-consumer advertising have increased awareness.
• Stigma around ED has decreased, leading more men to seek treatment.
• Cialis 20mg is sometimes used off-label for other conditions.
• Off-label use should only be undertaken under direct medical supervision.
• Research continues on new applications for PDE5 inhibitors.
• Adherence to prescribed dosing is crucial for safety and effectiveness.
• Keep all medications out of reach of children and pets.
• Dispose of unused or expired medication through a take-back program.

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, 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.

• Men with spinal cord injuries may benefit from PDE5 inhibitors like Cialis.
• Efficacy can be lower in this population but is still significant for many.
• Men with prostatectomy for prostate cancer often experience ED.
• Cialis can be part of a penile rehabilitation program post-surgery.
• Such programs aim to preserve erectile tissue health during recovery.
• Use after prostatectomy should be carefully timed and monitored by a urologist.
• Other treatments like vacuum devices or injections may be combined.
• A multidisciplinary approach often yields the best long-term results.
• Never initiate such a regimen without specialist supervision.

Sections or brand cialis canadian pharmacy 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.

Question	Answer
Can I take Cialis daily?	Usually not; consult your doctor for daily use plans
Is Cialis 20mg safe for everyone?	No, contraindicated in some conditions; see doctor
How long does the effect last?	Up to 36 hours depending on individual factors
Can I drink alcohol with Cialis?	Moderate alcohol is generally safe; excessive alcohol can increase side effects

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.

Product	Dosage	Quantity + Bonus	Price
Cialis Professional	20mg	60 + 2 Pills	183.83€ 175.08€	Buy
Cialis Generic	10mg	120 + 6 Pills	178.49€ 169.99€	Buy
Cialis Generic	20mg	20 Pills	54.72€ 52.11€	Buy
Cialis Black	80mg	10 Pills	43.27€ 41.21€	Buy
Cialis Generic	2.5mg	60 + 4 Pills	83.43€ 79.46€	Buy
Cialis Generic	10mg	10 Pills	31.41€ 29.91€	Buy
Cialis Generic	5mg	90 + 6 Pills	115.91€ 110.39€	Buy
Cialis Generic	2.5mg	30 + 4 Pills	51.95€ 49.48€	Buy
Cialis Black	80mg	270 + 10 Pills	502.88€ 478.93€	Buy
Cialis Generic	40mg	270 + 10 Pills	382.19€ 363.99€	Buy
Cialis Professional	20mg	30 Pills	104.57€ 99.59€	Buy
Cialis Original	20mg	34 + 2 Pills	183.99€ 175.23€	Buy

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.

Parameter	Value	Description
Absorption Rate	Peak plasma levels in 2 hours	Fast absorption
Bioavailability	~36%	Percentage of dose reaching circulation
Half-life	17.5 hours	Duration of action
Elimination	Mainly via feces	Metabolism primarily by CYP3A4

CIALIS for use as needed was shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising cialis tadalafil 10 mg 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.

What to avoid

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).

Incidence not known

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 brand cialis canadian pharmacy subsections omitted from the full prescribing information are not listed. 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.

Step	Instruction	Notes
Taking the Tablet	Swallow whole with water	Do not crush or split
Timing	Take at least 30 minutes before activity	Can be taken up to 36 hours before
Daily Limit	Do not exceed once per day	Risks of overdose

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)].

5.1 Cardiovascular

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)].

Patient resources

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 cialis tadalafil 10 mg patients on optimal use of CIALIS, this should be taken into consideration. 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. 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)].

5.9 Alcohol

When 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)]. 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). Hypersensitivity reactions have been cialis 10mg pills reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions (6.2)].

Long-term use

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. 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. 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. When 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)]. 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). Hypersensitivity reactions have been cialis 10mg pills 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).

• Hepatic impairment (Child-Pugh Class A or B) limits the maximum dose to 10mg.
• In severe hepatic impairment (Child-Pugh Class C), use is not recommended.
• Concomitant use with alcohol can increase the risk of orthostatic hypotension.
• Symptoms include dizziness, lightheadedness, and fainting upon standing.
• Operating machinery or driving should be avoided until you know your response.
• Visual disturbances (blue tinge, blurred vision) are possible but uncommon.
• These are due to mild inhibition of PDE6 in the retina.
• The effects are temporary and reversible.
• Permanent visual damage is extremely rare.

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.

Proper Use

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. 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)].

ED dosage for occasional use

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. Therefore, caution is advised if CIALIS for once daily use is prescribed to these patients. 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.