WARNINGS AND PRECAUTIONS
For CIALIS for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively. In eight primary placebo-controlled Phase 3 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.
| Symptom | Management Approach | When to Seek Help |
|---|---|---|
| Headache | Over-the-counter pain relievers | Severe or persistent headache |
| Muscle pain | Rest, hydrate, consult doctor if severe | Severe muscle cramps |
| Flushing | Cooling measures, avoid hot drinks | If accompanied by dizziness |
| Indigestion | Antacids or dietary adjustments | Severe or prolonged indigestion |
When taken as recommended in the placebo-controlled clinical trials, the following adverse events were reported (see Table 1) for CIALIS for use as needed: In three placebo-controlled Phase 3 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. The following adverse events were reported (see Table 2) in clinical trials of 12 weeks duration: The following adverse events were reported (see Table 3) over 24 weeks treatment duration in one placebo-controlled Phase 3 clinical study: Back pain or myalgia was reported at incidence rates described in Tables 1 and 2. In studies of CIALIS for once daily use, events of back pain and myalgia were generally mild or moderate with a discontinuation rate of 0.3%.
- Discontinuation of Cialis is straightforward; just stop taking it.
- There is no known withdrawal syndrome or physical dependence.
- Underlying ED symptoms will return after stopping the medication.
- For BPH, urinary symptoms will likely revert to their previous state.
- Always inform your doctor if you plan to stop any chronic medication.
- They may want to monitor for the return of symptoms or adjust other treatments.
- If you experience an allergic reaction (rash, swelling, difficulty breathing), seek help.
- Serious allergic reactions to tadalafil are rare but possible.
- Have a list of your medications and allergies readily available for emergencies.
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. 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 — asthenia, face edema, fatigue, pain Cardiovascular — angina pectoris, chest pain, hypotension, myocardial infarction, postural hypotension, palpitations, syncope, tachycardia Digestive — abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, GGTP increased, loose stools, nausea, upper abdominal pain, vomiting Nervous — dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigo Ophthalmologic — blurred vision, changes in color vision, conjunctivitis (including conjunctival hyperemia), eye pain, lacrimation increase, swelling of eyelids Otologic — sudden decrease or loss of hearing, tinnitus The following adverse reactions have been identified during post approval use of CIALIS. The list cialis 10mg prescription does not include adverse events that are reported from clinical trials and that are listed elsewhere in this section. Cardiovascular and cerebrovascular — Serious cardiovascular events, including myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported postmarketing in temporal association with the use of tadalafil. It is not possible to determine whether these events are related directly to CIALIS, to sexual activity, to the patient's underlying cardiovascular disease, to a combination of these factors, or to other factors [see Warnings and Precautions (5.1)].
Warnings and Precautions
Alternatives for benign prostatic hyperplasia (BPH)
Body as a whole — hypersensitivity reactions including urticaria, Stevens-Johnson syndrome, and exfoliative dermatitis Nervous — migraine, seizure and seizure recurrence, transient global amnesia Ophthalmologic — visual field defect, retinal vein occlusion, retinal artery occlusion Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including CIALIS.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Cialis Generic | 60mg | 360 + 10 Pills | 570.52€ 543.35€ | |
| Cialis Professional | 20mg | 20 Pills | 78.33€ 74.60€ | |
| Cialis Soft Tabs | 20mg | 10 Pills | 39.03€ 37.17€ | |
| Cialis Original | 20mg | 76 + 4 Pills | 319.19€ 303.99€ | |
| Cialis Generic | 2.5mg | 60 + 4 Pills | 83.43€ 79.46€ | |
| Cialis Generic | 20mg | 10 Pills | 31.49€ 29.99€ | |
| Cialis Soft Tabs | 20mg | 120 + 6 Pills | 248.64€ 236.80€ | |
| Cialis Soft Tabs | 20mg | 30 + 4 Pills | 87.43€ 83.27€ | |
| Cialis Original | 20mg | 48 + 4 Pills | 224.69€ 213.99€ | |
| Cialis Generic | 10mg | 90 + 6 Pills | 146.17€ 139.21€ | |
| Cialis Original | 20mg | 120 + 8 Pills | 497.29€ 473.61€ | |
| Cialis Professional | 40mg | 120 + 4 Pills | 436.68€ 415.89€ |
It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient's underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors [see Warnings and Precautions (5.4) and Patient Counseling Information (17.6)]. Otologic — Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including CIALIS. It is not possible to determine whether these reported events are related directly to the use of CIALIS, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Warnings and Precautions (5.5) and Patient Counseling Information (17.7)]. Urogenital — priapism [see Warnings and Precautions (5.3)]. 7 DRUG INTERACTIONS 7.1 Potential for Pharmacodynamic Interactions with CIALISNitrates — Administration of CIALIS to patients who are using any form of organic nitrate, is contraindicated.
16.2 Storage
Cialis for ED and BPH
In a patient who has taken CIALIS, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should elapse after the last dose of CIALIS before nitrate administration is considered.
- Men with cardiovascular disease require careful evaluation before use.
- Sexual activity poses a cardiac risk for men with heart conditions.
- Your doctor may recommend a cardiac stress test before prescribing.
- Do not use if you have had a recent heart attack, stroke, or arrhythmia.
- It can cause a mild, temporary decrease in blood pressure.
- Combining it with other blood pressure-lowering drugs may amplify this effect.
- Report chest pain, dizziness, or nausea during sexual activity to your doctor.
- Nitrates are absolutely contraindicated due to risk of severe hypotension.
- This includes recreational amyl nitrite or nitrite "poppers."
In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring [see Contraindications (4.1), Dosage and Administration (2.4) and Clinical Pharmacology (12.2)].Alpha Blockers — Caution is advised when PDE5 inhibitors are coadministered with alpha blockers. Clinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin or tamsulosin [see Warnings and Precautions (5.6), Dosage and Administration (2.4) and Clinical Pharmacology (12.2)].Antihypertensives — PDE5 inhibitors, including tadalafil, are mild systemic vasodilators. Small reductions in blood pressure occurred following coadministration of tadalafil with these agents compared with placebo.
| 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 |
[See Warnings and Precautions (5.6) free samples of cialis in canada and Clinical Pharmacology (12.2)].Alcohol — Both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators.
- Use in pulmonary arterial hypertension (PAH) requires a different formulation.
- Adcirca is a brand of tadalafil approved specifically for PAH.
- Do not substitute Cialis 20mg for Adcirca without medical guidance.
- Inform surgeons or dentists you are taking tadalafil before any procedure.
- It may affect blood pressure during anesthesia.
- It is not recommended for men with retinitis pigmentosa or certain eye conditions.
- Priapism (prolonged erection) is a rare but serious side effect.
- Sudden decrease or loss of hearing has been reported with PDE5 inhibitors.
- These hearing changes may be accompanied by tinnitus or dizziness.
Substantial consumption of alcohol (e.g., 5 units or greater) in combination with CIALIS can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache.
Popular FAQ
Although specific interactions have not been studied, other CYP3A4 inducers, such as carbamazepine, phenytoin, and phenobarbital, would likely decrease tadalafil exposure. The reduced exposure of tadalafil with the coadministration of rifampin or other CYP3A4 inducers can be anticipated to decrease the efficacy of CIALIS for once daily use; the magnitude of decreased efficacy is unknown.7.3 Potential for CIALIS to Affect Other DrugsCytochrome P450 Substrates — CIALIS is not expected to cause clinically significant inhibition or induction of the clearance of drugs metabolized by cytochrome P450 (CYP) isoforms. Studies have shown that tadalafil does not inhibit or induce P450 isoforms CYP1A2, CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP2E1.CYP1A2 (e.g. Theophylline) — Tadalafil had no significant effect on the pharmacokinetics of theophylline. When tadalafil was administered to subjects taking theophylline, a small augmentation (3 beats per minute) of the increase in heart rate associated with theophylline was observed.CYP2C9 (e.g.
Canadian Brand Name
Warfarin) — Tadalafil had no significant effect on exposure (AUC) to S-warfarin or R-warfarin, nor did tadalafil affect changes in prothrombin time induced by warfarin. Nitrates — Administration of CIALIS to patients who are using any form of organic nitrate, is contraindicated. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring [see Contraindications (4.1), Dosage and Administration (2.4) and Clinical Pharmacology (12.2)]. Alpha Blockers — Caution is advised when PDE5 inhibitors are coadministered with alpha blockers. Tadalafil did not affect alcohol plasma concentrations and alcohol did not affect tadalafil plasma concentrations. [See Warnings and Precautions (5.9) and Clinical Pharmacology (12.2)].7.2 Potential for Other Drugs to Affect CIALIS[See Dosage and Administration (2.4) and Warnings and Precautions (5.10)].Antacids — Simultaneous administration of an antacid (magnesium hydroxide/aluminum hydroxide) and tadalafil reduced the apparent rate of absorption of tadalafil without altering exposure (AUC) to tadalafil.H2Antagonists (e.g.
14.2 CIALIS for Once Daily Use
It is not possible to determine whether these events are related directly to CIALIS, to sexual activity, to the patient's underlying cardiovascular disease, to a combination of these factors, or to other factors [see Warnings and Precautions (5.1)]. Body as a whole — hypersensitivity reactions including urticaria, Stevens-Johnson syndrome, and exfoliative dermatitis Nervous — migraine, seizure and seizure recurrence, transient global amnesia Ophthalmologic — visual field defect, retinal vein occlusion, retinal artery occlusion Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including CIALIS. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient's underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors [see Warnings and Precautions (5.4) and Patient Counseling Information (17.6)]. Otologic — Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including CIALIS. It is not possible to determine whether these reported events are related directly to the use of CIALIS, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Warnings and Precautions (5.5) and Patient Counseling Information (17.7)].
Off-label use for Cialis
Urogenital — priapism [see Warnings and Precautions (5.3)]. 7 DRUG INTERACTIONS 7.1 Potential for Pharmacodynamic Interactions with CIALISNitrates — Administration of CIALIS to patients who are using any form of organic nitrate, is contraindicated. In a patient who has taken CIALIS, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should elapse 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 [see Contraindications (4.1), Dosage and Administration (2.4) and Clinical Pharmacology (12.2)].Alpha Blockers — Caution is advised when PDE5 inhibitors are coadministered with alpha blockers. Clinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin or tamsulosin [see Warnings and Precautions (5.6), Dosage and Administration (2.4) and Clinical Pharmacology (12.2)].Antihypertensives — PDE5 inhibitors, including tadalafil, are mild systemic vasodilators. Nizatidine) — An increase in gastric pH resulting from administration of nizatidine had no significant effect on pharmacokinetics.Cytochrome P450 Inhibitors — CIALIS is a substrate of and predominantly metabolized by CYP3A4. Studies have shown that drugs that inhibit CYP3A4 can increase tadalafil exposure.CYP3A4 (e.g., Ketoconazole) — Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4, increased tadalafil 20 mg single-dose exposure (AUC) by 312% and Cmax by 22%, relative to the values for tadalafil 20 mg alone.
| Ingredient | Quantity per Tablet | Function |
|---|---|---|
| Tadalafil | 20 mg | Active ingredient |
| Microcrystalline cellulose | 50 mg | Fillers |
| Croscarmellose sodium | 10 mg | Disintegrant |
| Magnesium stearate | 5 mg | Lubricant |
Ketoconazole (200 mg daily) increased tadalafil 10-mg single-dose exposure (AUC) by 107% and Cmax by 15%, relative to the values for tadalafil 10 mg alone [see Dosage and Administration generic cialis soft 20mg (2.4)].Although specific interactions have not been studied, other CYP3A4 inhibitors, such as erythromycin, itraconazole, and grapefruit juice, would likely increase tadalafil exposure.HIV Protease inhibitor — Ritonavir (500 mg or 600 mg twice daily at steady state), an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil 20-mg single-dose exposure (AUC) by 32% with a 30% reduction in Cmax, relative to the values for tadalafil 20 mg alone. Ritonavir (200 mg twice daily), increased tadalafil 20-mg single-dose exposure (AUC) by 124% with no change in Cmax, relative to the values for tadalafil 20 mg alone. Although specific interactions have not been studied, other HIV protease inhibitors would likely increase tadalafil exposure [see Dosage and Administration (2.4)].Cytochrome P450 Inducers — Studies have shown that drugs that induce CYP3A4 can decrease tadalafil exposure.CYP3A4 (e.g., Rifampin) — Rifampin (600 mg daily), a CYP3A4 inducer, reduced tadalafil 10-mg single-dose exposure (AUC) by 88% and Cmax by 46%, relative to the values for tadalafil 10 mg alone. Although specific interactions have not been studied, other CYP3A4 inducers, such as carbamazepine, phenytoin, and phenobarbital, would likely decrease tadalafil exposure. The reduced exposure of tadalafil with the coadministration of rifampin or other CYP3A4 inducers can be anticipated to decrease the efficacy of CIALIS for once daily use; the magnitude of decreased efficacy is unknown.7.3 Potential for CIALIS to Affect Other DrugsCytochrome P450 Substrates — CIALIS is not expected to cause clinically significant inhibition or induction of the clearance of drugs metabolized by cytochrome P450 (CYP) isoforms. Studies have shown that tadalafil does not inhibit or induce P450 isoforms CYP1A2, CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP2E1.CYP1A2 (e.g.
Brand Name
Small reductions in blood pressure occurred following coadministration of tadalafil with these agents compared with placebo. [See Warnings and Precautions (5.6) free samples of cialis in canada and Clinical Pharmacology (12.2)].Alcohol — Both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators. Substantial consumption of alcohol (e.g., 5 units or greater) in combination with CIALIS can increase the potential for orthostatic signs and symptoms, including increase in heart rate, decrease in standing blood pressure, dizziness, and headache. Tadalafil did not affect alcohol plasma concentrations and alcohol did not affect tadalafil plasma concentrations. [See Warnings and Precautions (5.9) and Clinical Pharmacology (12.2)].7.2 Potential for Other Drugs to Affect CIALIS[See Dosage and Administration (2.4) and Warnings and Precautions (5.10)].Antacids — Simultaneous administration of an antacid (magnesium hydroxide/aluminum hydroxide) and tadalafil reduced the apparent rate of absorption of tadalafil without altering exposure (AUC) to tadalafil.H2Antagonists (e.g.
Dosing Modifications
Nizatidine) — An increase in gastric pH resulting from administration of nizatidine had no significant effect on pharmacokinetics.Cytochrome P450 Inhibitors — CIALIS is a substrate of and predominantly metabolized by CYP3A4. Studies have shown that drugs that inhibit CYP3A4 can increase tadalafil exposure.CYP3A4 (e.g., Ketoconazole) — Ketoconazole (400 mg daily), a selective and potent inhibitor of CYP3A4, increased tadalafil 20 mg single-dose exposure (AUC) by 312% and Cmax by 22%, relative to the values for tadalafil 20 mg alone. Ketoconazole (200 mg daily) increased tadalafil 10-mg single-dose exposure (AUC) by 107% and Cmax by 15%, relative to the values for tadalafil 10 mg alone [see Dosage and Administration generic cialis soft 20mg (2.4)].Although specific interactions have not been studied, other CYP3A4 inhibitors, such as erythromycin, itraconazole, and grapefruit juice, would likely increase tadalafil exposure.HIV Protease inhibitor — Ritonavir (500 mg or 600 mg twice daily at steady state), an inhibitor of CYP3A4, CYP2C9, CYP2C19, and CYP2D6, increased tadalafil 20-mg single-dose exposure (AUC) by 32% with a 30% reduction in Cmax, relative to the values for tadalafil 20 mg alone. Ritonavir (200 mg twice daily), increased tadalafil 20-mg single-dose exposure (AUC) by 124% with no change in Cmax, relative to the values for tadalafil 20 mg alone. Although specific interactions have not been studied, other HIV protease inhibitors would likely increase tadalafil exposure [see Dosage and Administration (2.4)].Cytochrome P450 Inducers — Studies have shown that drugs that induce CYP3A4 can decrease tadalafil exposure.CYP3A4 (e.g., Rifampin) — Rifampin (600 mg daily), a CYP3A4 inducer, reduced tadalafil 10-mg single-dose exposure (AUC) by 88% and Cmax by 46%, relative to the values for tadalafil 10 mg alone. Theophylline) — Tadalafil had no significant effect on the pharmacokinetics of theophylline. When tadalafil was administered to subjects taking theophylline, a small augmentation (3 beats per minute) of the increase in heart rate associated with theophylline was observed.CYP2C9 (e.g.
8.5 Geriatric Use
For CIALIS for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively. In eight primary placebo-controlled Phase 3 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. When taken as recommended in the placebo-controlled clinical trials, the following adverse events were reported (see Table 1) for CIALIS for use as needed: In three placebo-controlled Phase 3 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. The following adverse events were reported (see Table 2) in clinical trials of 12 weeks duration: The following adverse events were reported (see Table 3) over 24 weeks treatment duration in one placebo-controlled Phase 3 clinical study: Back pain or myalgia was reported at incidence rates described in Tables 1 and 2. In studies of CIALIS for once daily use, events of back pain and myalgia were generally mild or moderate with a discontinuation rate of 0.3%.
Choose what you want
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. 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 — asthenia, face edema, fatigue, pain Cardiovascular — angina pectoris, chest pain, hypotension, myocardial infarction, postural hypotension, palpitations, syncope, tachycardia Digestive — abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, GGTP increased, loose stools, nausea, upper abdominal pain, vomiting Nervous — dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigo Ophthalmologic — blurred vision, changes in color vision, conjunctivitis (including conjunctival hyperemia), eye pain, lacrimation increase, swelling of eyelids Otologic — sudden decrease or loss of hearing, tinnitus The following adverse reactions have been identified during post approval use of CIALIS. The list cialis 10mg prescription does not include adverse events that are reported from clinical trials and that are listed elsewhere in this section. Cardiovascular and cerebrovascular — Serious cardiovascular events, including myocardial infarction, sudden cardiac death, stroke, chest pain, palpitations, and tachycardia, have been reported postmarketing in temporal association with the use of tadalafil. Warfarin) — Tadalafil had no significant effect on exposure (AUC) to S-warfarin or R-warfarin, nor did tadalafil affect changes in prothrombin time induced by warfarin. Nitrates — Administration of CIALIS to patients who are using any form of organic nitrate, is contraindicated. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring [see Contraindications (4.1), Dosage and Administration (2.4) and Clinical Pharmacology (12.2)].
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Alpha Blockers — Caution is advised when PDE5 inhibitors are coadministered with alpha blockers.