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Tadalafil 10 mg and 20 mg did not potentiate the increase in bleeding time caused by acetylsalicylic acid. There are limited data from the use of tadalafil in pregnant women. A risk to the suckling child cannot be excluded.

Effects were seen in dogs that might indicate impairment of fertility. Two subsequent clinical studies suggest that this effect is unlikely in humans, although a decrease in sperm concentration was seen in some men see sections 5.

Although the frequency of reports of dizziness in placebo and tadalafil arms in clinical trials was similar, patients should be aware of how they react to CIALIS before driving or using machines. The most commonly reported adverse reactions in patients taking CIALIS for the treatment of erectile dysfunction or benign prostatic hyperplasia were headache, dyspepsia, back pain and myalgia, in which the incidences increase with increasing dose of CIALIS.

The adverse reactions reported were transient, and generally mild or moderate. The majority of headaches reported with CIALIS once-a-day dosing are experienced within the first 10 to 30 days of starting treatment.

The table below lists the adverse reactions observed from spontaneous reporting and in placebo-controlled clinical trials comprising a total of patients on CIALIS and patients on placebo for on-demand and once-a-day treatment of erectile dysfunction and the once-a-day treatment of benign prostatic hyperplasia.

Stroke 1 including haemorrhagic events , Syncope, Transient ischaemic attacks 1 , Migraine 2 , Seizures 2 , Transient amnesia. Urticaria, Stevens-Johnson syndrome 2 , Exfoliative dermatitis 2 , Hyperhydrosis sweating.

A slightly higher incidence of ECG abnormalities, primarily sinus bradycardia, has been reported in patients treated with tadalafil once a day as compared with placebo. Most of these ECG abnormalities were not associated with adverse reactions. Data in patients over 65 years of age receiving tadalafil in clinical trials, either for the treatment of erectile dysfunction or the treatment of benign prostatic hyperplasia, are limited. In clinical trials with tadalafil taken on demand for the treatment of erectile dysfunction, diarrhoea was reported more frequently in patients over 65 years of age.

In clinical trials with tadalafil 5 mg taken once a day for the treatment of benign prostatic hyperplasia, dizziness and diarrhoea were reported more frequently in patients over 75 years of age. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via Ireland: Yellow Card Scheme, Website: Single doses of up to mg have been given to healthy subjects, and multiple daily doses up to mg have been given to patients.

Adverse events were similar to those seen at lower doses. In cases of overdose, standard supportive measures should be adopted, as required.

Haemodialysis contributes negligibly to tadalafil elimination. Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate cGMP -specific phosphodiesterase type 5 PDE5.

When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by tadalafil produces increased levels of cGMP in the corpus cavernosum. This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection.

Tadalafil has no effect in the treatment of erectile dysfunction in the absence of sexual stimulation. Tadalafil 5 mg - The effect of PDE5 inhibition on cGMP concentration in the corpus cavernosum is also observed in the smooth muscle of the prostate, the bladder and their vascular supply. The resulting vascular relaxation increases blood perfusion which may be the mechanism by which symptoms of benign prostatic hyperplasia are reduced.

These vascular effects may be complemented by inhibition of bladder afferent nerve activity and smooth muscle relaxation of the prostate and bladder. Studies in vitro have shown that tadalafil is a selective inhibitor of PDE5. PDE5 is an enzyme found in corpus cavernosum smooth muscle, vascular and visceral smooth muscle, skeletal muscle, platelets, kidney, lung, and cerebellum. The effect of tadalafil is more potent on PDE5 than on other phosphodiesterases.

Additionally, tadalafil is approximately fold more potent for PDE5 than for PDE6, an enzyme which is found in the retina and is responsible for phototransduction. Tadalafil administered to healthy subjects produced no significant difference compared to placebo in supine systolic and diastolic blood pressure mean maximal decrease of 1.

Three studies were conducted in men to assess the potential effect on spermatogenesis of CIALIS 10mg one 6-month study and 20mg one 6-month and one 9-month study administered daily. In two of these studies decreases were observed in sperm count and concentration related to tadalafil treatment of unlikely clinical relevance.

These effects were not associated with changes in other parameters, such as motility, morphology, and FSH. Three clinical studies were conducted in patients in an at-home setting to define the period of responsiveness to CIALIS on demand.

Tadalafil demonstrated statistically significant improvement in erectile function and the ability to have successful sexual intercourse up to 36 hours following dosing, as well as patients' ability to attain and maintain erections for successful intercourse compared to placebo as early as 16 minutes following dosing.

Tadalafil at doses of 2 to mg has been evaluated in 16 clinical studies involving patients, including patients with erectile dysfunction of various severities mild, moderate, severe , etiologies, ages range years , and ethnicities.

Most patients reported erectile dysfunction of at least 1 year in duration. For once-a-day evaluation of tadalafil at doses of 2. Most patients in these three studies were responders to previous on-demand treatment with PDE5 inhibitors. CIALIS was studied in 4 clinical studies of 12 weeks duration enrolling over patients with signs and symptoms of benign prostatic hyperplasia.

The improvements in total international prostate symptom score occurred as early as 1 week. In one of the studies, which also included tamsulosin 0. One of these studies assessed improvements in erectile dysfunction and signs and symptoms of benign prostatic hyperplasia in patients with both conditions.

The improvements in the erectile function domain of the international index of erectile function and the total international prostate symptom score in this study were 6. The mean per-subject proportion of successful sexual intercourse attempts was The maintenance of the effect was evaluated in an open-label extension to one of the studies, which showed that the improvement in total international prostate symptom score seen at 12 weeks was maintained for up to 1 additional year of treatment with CIALIS 5mg.

A single study has been performed in paediatric patients with Duchenne Muscular Dystrophy DMD in which no evidence of efficacy was seen.

The randomised, double—blind, placebo—controlled, parallel, 3—arm study of tadalafil was conducted in boys aged 7—14 years with DMD receiving concurrent corticosteroid therapy. The study included a 48—week double-blind period where patients were randomised to tadalafil 0. Tadalafil did not show efficacy in slowing the decline in ambulation as measured by the primary 6 minute walk distance 6MWD endpoint: In addition, there was no evidence of efficacy from any of the secondary analyses performed in this study.

The overall safety results from this study were generally consistent with the known safety profile of tadalafil and with adverse events AEs expected in a paediatric DMD population receiving corticosteroids. The European Medicines Agency has waived the obligation to submit the results of studies in all subsets of the paediatric population in the treatment of the erectile dysfunction. Tadalafil is readily absorbed after oral administration and the mean maximum observed plasma concentration C max is achieved at a median time of 2 hours after dosing.

Absolute bioavailability of tadalafil following oral dosing has not been determined. The rate and extent of absorption of tadalafil are not influenced by food, thus CIALIS may be taken with or without food. The time of dosing morning versus evening had no clinically relevant effects on the rate and extent of absorption. The mean volume of distribution is approximately 63 l, indicating that tadalafil is distributed into tissues.

Protein binding is not affected by impaired renal function. The major circulating metabolite is the methylcatechol glucuronide. This metabolite is at least 13,fold less potent than tadalafil for PDE5. Consequently, it is not expected to be clinically active at observed metabolite concentrations. The mean oral clearance for tadalafil is 2.

Tadalafil pharmacokinetics in healthy subjects are linear with respect to time and dose. Over a dose range of 2.

Steady-state plasma concentrations are attained within 5 days of once daily dosing. Pharmacokinetics determined with a population approach in patients with erectile dysfunction are similar to pharmacokinetics in subjects without erectile dysfunction. This effect of age is not clinically significant and does not warrant a dose adjustment.

Tadalafil exposure AUC in subjects with mild and moderate hepatic impairment Child-Pugh class A and B is comparable to exposure in healthy subjects when a dose of 10 mg is administered. There are no available data about the administration of once-a-day dosing of tadalafil to patients with hepatic impairment. There are no available data about the administration of doses higher than 10 mg of tadalafil to patients with hepatic impairment.

This difference in exposure does not warrant a dose adjustment. Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction. In the pregnant rat the AUC for calculated free drug at this dose was approximately times the human AUC at a 20 mg dose.

There was no impairment of fertility in male and female rats. See also section 5. Store in the original package in order to protect from moisture. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Detailed information on this medicinal product is available on the website of the European Medicines Agency http: This site uses cookies.

By continuing to browse the site you are agreeing to our policy on the use of cookies. Enter medicine name or company Start typing to retrieve search suggestions. Continue typing to refine. Back to top Eli Lilly and Company Limited contact details. Last updated on eMC: Show table of contents Hide table of contents 1.

Name of the medicinal product 2. Qualitative and quantitative composition 3. Marketing authorisation holder 8. Marketing authorisation number s 9. Date of revision of the text Legal category.

This information is intended for use by health professionals. Excipient with known effect: Each coated tablet contains 87 mg of lactose as monohydrate. Each 5 mg tablet contains 5 mg tadalafil. Each coated tablet contains mg of lactose as monohydrate.

Each 10 mg tablet contains 10 mg tadalafil. Each 20 mg tablet contains 20 mg tadalafil. For the full list of excipients, see section 6. The 5 mg tablets are light yellow and almond shaped tablets, marked 'C 5' on one side. The 10 mg tablets are light yellow and almond shaped tablets, marked 'C 10' on one side. The 20 mg tablets are yellow and almond shaped tablets, marked 'C 20' on one side. Treatment of erectile dysfunction in adult males.

Posology Erectile dysfunction in adult Men In general, the recommended dose is 10 mg taken prior to anticipated sexual activity and with or without food. The maximum dose frequency is once per day. The appropriateness of continued use of the daily regimen should be reassessed periodically.

Benign prostatic hyperplasia in adult men tadalafil 5 mg only The recommended dose is 5 mg, taken at approximately the same time every day with or without food. Special Populations Elderly Men Dose adjustments are not required in elderly patients. Men with Renal Impairment Dose adjustments are not required in patients with mild to moderate renal impairment. Men with Diabetes Dose adjustments are not required in diabetic patients. Paediatric population There is no relevant use of CIALIS in the paediatric population with regard to the treatment of erectile dysfunction.

Hypersensitivity to the active substance or to any of the excipients listed in section 6. The following groups of patients with cardiovascular disease were not included in clinical trials and the use of tadalafil is therefore contraindicated: Before treatment with CIALIS A medical history and physical examination should be undertaken to diagnose erectile dysfunction or benign prostatic hyperplasia and determine potential underlying causes, before pharmacological treatment is considered.

Decreased or sudden hearing loss Cases of sudden hearing loss have been reported after the use of tadalafil. Renal and hepatic impairment tadalafil 2. Priapism and anatomical deformation of the penis Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance. Transporters The role of transporters for example, p-glycoprotein in the disposition of tadalafil is not known.

Effects of Tadalafil on Other Medicinal Products Nitrates In clinical studies, tadalafil 5, 10 and 20 mg was shown to augment the hypotensive effects of nitrates. Anti-hypertensives including calcium channel blockers The co-administration of doxazosin 4 and 8 mg daily and tadalafil 5 mg daily dose and 20 mg as a single dose increases the blood pressure-lowering effect of this alpha-blocker in a significant manner.

Riociguat Preclinical studies showed an additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. Ethinylestradiol and terbutaline Tadalafil has been demonstrated to produce an increase in the oral bioavailability of ethinylestradiol; a similar increase may be expected with oral administration of terbutaline, although the clinical consequence of this is uncertain.

There have been rare reports of prolonged erections greater than 4 hours and priapism painful erections greater than 6 hours in duration for this class of compounds.

Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention. Cialis should be used with caution in patients who have conditions that might predispose them to priapism such as sickle cell anemia, multiple myeloma, or leukemia , or in patients with anatomical deformation of the penis such as angulation, cavernosal fibrosis, or Peyronie's disease.

Physicians should advise patients to stop use of all phosphodiesterase type 5 PDE5 inhibitors, including Cialis, and seek medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy NAION , a rare condition and a cause of decreased vision, including permanent loss of vision, that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors.

A similar study reported a consistent result, with a risk estimate of 2. Therefore, PDE5 inhibitors, including Cialis, should be used with caution in these patients and only when the anticipated benefits outweigh the risks.

Individuals with "crowded" optic disc are also considered at greater risk for NAION compared to the general population; however, evidence is insufficient to support screening of prospective users of PDE5 inhibitors, including Cialis, for this uncommon condition. Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical trials, and use in these patients is not recommended.

Physicians should advise patients to stop taking PDE5 inhibitors, including Cialis, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including Cialis. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see Adverse Reactions 6.

Physicians should discuss with patients the potential for Cialis to augment the blood-pressure-lowering effect of alpha-blockers and antihypertensive medications [see Drug Interactions 7. Caution is advised when PDE5 inhibitors are coadministered with alpha-blockers. PDE5 inhibitors, including Cialis, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated.

In some patients, concomitant use of these two drug classes can lower blood pressure significantly [see Drug Interactions 7. Consideration should be given to the following:. Because of insufficient information in patients with severe hepatic impairment, use of Cialis in this group is not recommended [see Use in Specific Populations 8. Cialis for once daily use has not been extensively evaluated in patients with mild or moderate hepatic impairment.

Therefore, caution is advised if Cialis for once daily use is prescribed to these patients. Patients should be made aware that both alcohol and Cialis, a PDE5 inhibitor, act as mild vasodilators. When mild vasodilators are taken in combination, blood-pressure-lowering effects of each individual compound may be increased. Therefore, physicians should inform patients that substantial consumption of alcohol e. Cialis is metabolized predominantly by CYP3A4 in the liver.

In patients taking potent inhibitors of CYP3A4 and Cialis for once daily use, the maximum recommended dose is 2. The safety and efficacy of combinations of Cialis and other PDE5 inhibitors or treatments for erectile dysfunction have not been studied.

PDE5 is found in platelets. Cialis has not been administered to patients with bleeding disorders or significant active peptic ulceration. Although Cialis has not been shown to increase bleeding times in healthy subjects, use in patients with bleeding disorders or significant active peptic ulceration should be based upon a careful risk-benefit assessment and caution. The use of Cialis offers no protection against sexually transmitted diseases.

Counseling patients about the protective measures necessary to guard against sexually transmitted diseases, including Human Immunodeficiency Virus HIV should be considered. Prior to initiating treatment with Cialis for BPH, consideration should be given to other urological conditions that may cause similar symptoms.

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

Tadalafil was administered to over men during clinical trials worldwide. In trials of Cialis for once daily use, a total of , , and were treated for at least 6 months, 1 year, and 2 years, respectively. For Cialis for use as needed, over and subjects were treated for at least 6 months and 1 year, respectively. In three placebo-controlled clinical trials of 12 or 24 weeks duration, mean age was 58 years range 21 to 82 and the discontinuation rate due to adverse events in patients treated with tadalafil was 4.

The following adverse reactions were reported see Table 2 in clinical trials of 12 weeks duration:. The following adverse reactions were reported see Table 3 over 24 weeks treatment duration in one placebo-controlled clinical study:.

In three placebo-controlled clinical trials of 12 weeks duration, two in patients with BPH and one in patients with ED and BPH, the mean age was 63 years range 44 to 93 and the discontinuation rate due to adverse events in patients treated with tadalafil was 3. Adverse reactions leading to discontinuation reported by at least 2 patients treated with tadalafil included headache, upper abdominal pain, and myalgia.

The following adverse reactions were reported see Table 4. Back pain or myalgia was reported at incidence rates described in Tables 1 through 4. In tadalafil clinical pharmacology trials, back pain or myalgia generally occurred 12 to 24 hours after dosing and typically resolved within 48 hours.

When medical treatment was necessary, acetaminophen or non-steroidal anti-inflammatory drugs were generally effective; however, in a small percentage of subjects who required treatment, a mild narcotic e. In the 1-year open label extension study, back pain and myalgia were reported in 5.

Diagnostic testing, including measures for inflammation, muscle injury, or renal damage revealed no evidence of medically significant underlying pathology. Across placebo-controlled studies with Cialis for use as needed for ED, diarrhea was reported more frequently in patients 65 years of age and older who were treated with Cialis 2. A causal relationship of these events to Cialis is uncertain.

Excluded from this list are those events that were minor, those with no plausible relation to drug use, and reports too imprecise to be meaningful:.

Body as a Whole — asthenia, face edema, fatigue, pain, peripheral edema. 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, gastroesophageal reflux disease, hemorrhoidal hemorrhage, rectal hemorrhage.

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.

Urogenital — erection increased, spontaneous penile erection. The following adverse reactions have been identified during post approval use of Cialis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

These events have been chosen for inclusion either due to their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors. Cardiovascular and Cerebrovascular — 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.

Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of Cialis without sexual activity.

Others were reported to have occurred hours to days after the use of Cialis and sexual activity. 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.

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 PDE5 inhibitors, including Cialis.

Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of NAION, including but not necessarily limited to: Otologic — Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including Cialis.

In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events.

In many cases, medical follow-up information was limited. 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.

Urogenital — priapism [see Warnings and Precautions 5. Nitrates — Administration of Cialis to patients who are using any form of organic nitrate, is contraindicated. In clinical pharmacology studies, Cialis was shown to potentiate the hypotensive effect of nitrates. 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 Dosage and Administration 2. Clinical pharmacology studies have been conducted with coadministration of tadalafil with doxazosin, tamsulosin or alfuzosin.

Clinical pharmacology studies were conducted to assess the effect of tadalafil on the potentiation of the blood-pressure-lowering effects of selected antihypertensive medications amlodipine, angiotensin II receptor blockers, bendrofluazide, enalapril, and metoprolol.

Small reductions in blood pressure occurred following coadministration of tadalafil with these agents compared with placebo. Alcohol — Both alcohol and tadalafil, a PDE5 inhibitor, act as mild vasodilators. Substantial consumption of alcohol e. Tadalafil did not affect alcohol plasma concentrations and alcohol did not affect tadalafil plasma concentrations.

H 2 Antagonists e. Nizatidine — An increase in gastric pH resulting from administration of nizatidine had no significant effect on pharmacokinetics.

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

Although specific interactions have not been studied, other HIV protease inhibitors would likely increase tadalafil exposure [see Dosage and Administration 2. Although specific interactions have not been studied, other CYP3A4 inducers, such as carbamazepine, phenytoin, and phenobarbital, would likely decrease tadalafil exposure.

No dose adjustment is warranted. 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. Aspirin — Tadalafil did not potentiate the increase in bleeding time caused by aspirin. Cytochrome P Substrates — Cialis is not expected to cause clinically significant inhibition or induction of the clearance of drugs metabolized by cytochrome P CYP isoforms.

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. 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.

Midazolam or Lovastatin — Tadalafil had no significant effect on exposure AUC to midazolam or lovastatin. Digoxin — Coadministration of tadalafil 40 mg once per day for 10 days did not have a significant effect on the steady-state pharmacokinetics of digoxin 0. There are no data with the use of Cialis in pregnant women to inform any drug-associated risks for adverse developmental outcomes. Surviving offspring had normal development and reproductive performance.

Based on the data from 3 studies in adult males, tadalafil decreased sperm concentrations in the study of 10 mg tadalafil for 6 months and the study of 20 mg tadalafil for 9 months.

This effect was not seen in the study of 20 mg tadalafil taken for 6 months. There was no adverse effect of tadalafil 10 mg or 20 mg on mean concentrations of testosterone, luteinizing hormone or follicle stimulating hormone. The clinical significance of the decreased sperm concentrations in the two studies is unknown. There have been no studies evaluating the effect of tadalafil on fertility in men [see Clinical Pharmacology Based on studies in animals, a decrease in spermatogenesis was observed in dogs, but not in rats [see Nonclinical Toxicology Cialis is not indicated for use in pediatric patients.

Safety and efficacy in patients below the age of 18 years have not been established. A randomized, double-blind, placebo-controlled trial in pediatric patients 7 to 14 years of age with Duchenne muscular dystrophy, who received Cialis 0. Of the total number of subjects in ED clinical studies of tadalafil, approximately 19 percent were 65 and over, while approximately 2 percent were 75 and over. However, in placebo-controlled studies with Cialis for use as needed for ED, diarrhea was reported more frequently in patients 65 years of age and older who were treated with Cialis 2.

No dose adjustment is warranted based on age alone. However, a greater sensitivity to medications in some older individuals should be considered. In subjects with end-stage renal disease on hemodialysis, there was a two-fold increase in C max and 2.

Exposure to total methylcatechol unconjugated plus glucuronide was 2- to 4-fold higher in subjects with renal impairment, compared to those with normal renal function. In patients on hemodialysis taking or mg tadalafil, there were no reported cases of back pain. Adverse events were similar to those seen at lower doses. In cases of overdose, standard supportive measures should be adopted as required. Hemodialysis contributes negligibly to tadalafil elimination.

Cialis tadalafil is a selective inhibitor of cyclic guanosine monophosphate cGMP -specific phosphodiesterase type 5 PDE5. Tadalafil has the empirical formula C 22 H 19 N 3 O 4 representing a molecular weight of The structural formula is:. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol. Cialis is available as almond-shaped tablets for oral administration. Each tablet contains 2. Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle.

This response is mediated by the release of nitric oxide NO from nerve terminals and endothelial cells, which stimulates the synthesis of cGMP in smooth muscle cells. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 by tadalafil has no effect in the absence of sexual stimulation.

The effect of PDE5 inhibition on cGMP concentration in the corpus cavernosum and pulmonary arteries is also observed in the smooth muscle of the prostate, the bladder and their vascular supply. The mechanism for reducing BPH symptoms has not been established. PDE5 is found in the smooth muscle of the corpus cavernosum, prostate, and bladder as well as in vascular and visceral smooth muscle, skeletal muscle, urethra, platelets, kidney, lung, cerebellum, heart, liver, testis, seminal vesicle, and pancreas.

Additionally, tadalafil is fold more potent for PDE5 than for PDE6, which is found in the retina and is responsible for phototransduction. PDE11 is an enzyme found in human prostate, testes, skeletal muscle and in other tissues e. The physiological role and clinical consequence of PDE11 inhibition in humans have not been defined. In addition, there was no significant effect on heart rate.

Therefore, the use of Cialis in patients taking any form of nitrates is contraindicated [see Contraindications 4. A study was conducted to assess the degree of interaction between nitroglycerin and tadalafil, should nitroglycerin be required in an emergency situation after tadalafil was taken. Subjects were administered a single dose of 0. The objective of the study was to determine when, after tadalafil dosing, no apparent blood pressure interaction was observed. In this study, a significant interaction between tadalafil and NTG was observed at each timepoint up to and including 24 hours.

At 48 hours, by most hemodynamic measures, the interaction between tadalafil and NTG was not observed, although a few more tadalafil subjects compared to placebo experienced greater blood-pressure lowering at this timepoint. After 48 hours, the interaction was not detectable see Figure 1.

Therefore, Cialis administration with nitrates is contraindicated. In such circumstances, nitrates should still only be administered under close medical supervision with appropriate hemodynamic monitoring [see Contraindications 4.

Six randomized, double-blinded, crossover clinical pharmacology studies were conducted to investigate the potential interaction of tadalafil with alpha-blocker agents in healthy male subjects [see Dosage and Administration 2.

In two studies, a daily oral alpha-blocker at least 7 days duration was administered to healthy male subjects taking repeated daily doses of tadalafil. Doxazosin — Three clinical pharmacology studies were conducted with tadalafil and doxazosin, an alpha[1]-adrenergic blocker.

Blood pressure was measured manually at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours after tadalafil or placebo administration. Severe adverse events potentially related to blood-pressure effects were assessed. No such events were reported following placebo.

Two such events were reported following administration of tadalafil. Vertigo was reported in one subject that began 7 hours after dosing and lasted about 5 days. This subject previously experienced a mild episode of vertigo on doxazosin and placebo. No syncope was reported. There was no placebo control. The placebo-subtracted mean maximal decreases in systolic blood pressure over a hour period after dosing in the placebo-controlled portion of the study part C are shown in Table 6 and Figure 3.

Doxazosin Study 2 Part C: Blood pressure was measured by ABPM every 15 to 30 minutes for up to 36 hours after tadalafil or placebo. Some additional subjects in both the tadalafil and placebo groups were categorized as outliers in the period beyond 24 hours.

In the period prior to tadalafil dosing, one severe event dizziness was reported in a subject during the doxazosin run-in phase. The results are shown in Table 7. All adverse events potentially related to blood pressure effects were rated as mild or moderate. Tadalafil or placebo was administered 2 hours after tamsulosin following a minimum of seven days of tamsulosin dosing. Blood pressure was measured manually at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours after tadalafil or placebo dosing.

No severe adverse events potentially related to blood-pressure effects were reported. Daily dosing of tamsulosin 0. Blood pressure was measured manually pre-dose at two time points and minutes and then at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours post dose on the first, sixth and seventh days of tamsulosin administration.

No severe adverse events potentially related to blood pressure were reported. Tadalafil or placebo was administered 4 hours after alfuzosin following a minimum of seven days of alfuzosin dosing. Blood pressure was measured manually at 1, 2, 3, 4, 6, 8, 10, 20, and 24 hours after tadalafil or placebo dosing. No severe adverse events potentially related to blood pressure effects were reported.

There was no effect of tadalafil on amlodipine blood levels and no effect of amlodipine on tadalafil blood levels. Subjects in the study were taking any marketed angiotensin II receptor blocker, either alone, as a component of a combination product, or as part of a multiple antihypertensive regimen.

Bendrofluazide — A study was conducted to assess the interaction of bendrofluazide 2. Alcohol and PDE5 inhibitors, including tadalafil, are mild systemic vasodilators. The interaction of tadalafil with alcohol was evaluated in 3 clinical pharmacology studies. In 2 of these, alcohol was administered at a dose of 0.

In one of these two studies, blood alcohol levels of 0. In these two studies, more patients had clinically significant decreases in blood pressure on the combination of tadalafil and alcohol as compared to alcohol alone. Some subjects reported postural dizziness, and orthostatic hypotension was observed in some subjects. The effects of tadalafil on cardiac function, hemodynamics, and exercise tolerance were investigated in a single clinical pharmacology study.

In this blinded crossover trial, 23 subjects with stable coronary artery disease and evidence of exercise-induced cardiac ischemia were enrolled. The primary endpoint was time to cardiac ischemia. Further statistical analysis demonstrated that tadalafil was non-inferior to placebo with respect to time to ischemia. Of note, in this study, in some subjects who received tadalafil followed by sublingual nitroglycerin in the post-exercise period, clinically significant reductions in blood pressure were observed, consistent with the augmentation by tadalafil of the blood-pressure-lowering effects of nitrates.

This finding is consistent with the inhibition of PDE6, which is involved in phototransduction in the retina. There were no adverse effects on sperm morphology or sperm motility in any of the three studies. The effect of a single mg dose of tadalafil on the QT interval was evaluated at the time of peak tadalafil concentration in a randomized, double-blinded, placebo, and active intravenous ibutilide -controlled crossover study in 90 healthy males aged 18 to 53 years.

A mg dose of tadalafil 5 times the highest recommended dose was chosen because this dose yields exposures covering those observed upon coadministration of tadalafil with potent CYP3A4 inhibitors or those observed in renal impairment.

Cialis 5 mg tablet

Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical trials, and use in these patients is not recommended. The dose is 5 mg once a day, but can be lowered to donde comprar viagra. Once a man has completed sexual activity, blood flow to his penis decreases, cialis 5 mg tablet, and his erection goes away. Benign prostatic hyperplasia in adult men tadalafil 5 mg only The recommended dose is 5 mg, taken at approximately the same time every day with or without food. Each 20 mg tablet contains 20 mg tadalafil. Tadalafil 20 mg at 8 p. Tadalafil administered to healthy subjects produced no significant difference compared to placebo in supine systolic and diastolic blood pressure mean maximal decrease of 1.

CIALIS is available as , 5, 10, and 20 mg film-coated tablets for oral use. Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section Cialis 5mg Tablets; Custom Tablet Quantity. Select. Warning. WARNING: You`ve selected a custom quantity of. This means you only want dispensed. Are you sure you only want to Cialis mg Tablets. $ (5 tablets) VIPPS Accredited & Certified Price: Cialis can be used at a lower dose once a day in men who intend to use it frequently (twice a week or more), based on the doctor’s judgement. The dose is 5 mg once a day, but can be lowered to mg once a day depending on how well it is tolerated.

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