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However, caution should be exercised when using tadalafil in duizeligheid patients treated with any alpha-blockers, and notably in the elderly. Treatments should be initiated at minimal dosage and progressively adjusted. In clinical pharmacology studies, the potential for tadalafil to augment the hypotensive effects of antihypertensive medicinal products was examined. Major classes of antihypertensive medicinal products were studied, including calcium-channel blockers (amlodipine angiotensin converting enzyme (ACE) inhibitors (enalapril beta-adrenergic receptor blockers (metoprolol thiazide diuretics (bendrofluazide and angiotensin ii receptor blockers (various types and doses, alone or in combination with thiazides, calcium-channel blockers, beta-blockers, and/or alpha-blockers). Tadalafil (10 mg, except for studies with angiotensin ii receptor blockers and amlodipine in which a 20 mg dose was applied) had no clinically significant interaction with any of these classes. In another clinical pharmacology study, tadalafil (20 mg) was studied in combination with up to 4 classes of antihypertensives. In subjects taking multiple antihypertensives, the ambulatory-blood-pressure changes appeared to relate to the degree of blood pressure control. In this regard, study subjects whose blood pressure was well controlled, the reduction was minimal and similar to that seen in healthy subjects. In study subjects whose blood pressure was not controlled, the reduction was greater, although this reduction was not associated with hypotensive symptoms in the majority of subjects. In patients receiving concomitant antihypertensive medicinal products, tadalafil 20 mg may induce a blood pressure decrease, which (with the exception of alpha-blockers - see above) is, in general, minor and not likely to be clinically relevant.

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Therefore, there is the potential of drug interactions mediated by honey inhibition of transporters. Cytochrome P450 inducers a cyp3A4 inducer, rifampicin, reduced tadalafil auc by 88, relative to the auc values for tadalafil alone (10 mg). This reduced exposure can be anticipated to decrease the efficacy of tadalafil; the magnitude of decreased efficacy is unknown. Other inducers of cyp3A4, such as phenobarbital, phenytoin, and carbamazepine, may also decrease plasma concentrations of tadalafil. 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. Therefore, administration of cialis to patients who are using any form of organic nitrate is contraindicated (see section.3). Based on the results of a clinical study in which 150 subjects receiving daily doses of tadalafil 20 mg for 7 days and.4 mg sublingual nitroglycerin at various times, this interaction lasted for more than 24 hours and was no longer detectable when. Thus, in a patient prescribed any dose of cialis (2.5 mg- 20 mg where nitrate administration is deemed medically necessary in 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 only be administered under close medical supervision with appropriate haemodynamic monitoring. 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. This effect lasts at least twelve hours and may be symptomatic, including syncope. Therefore, this combination is not recommended (see section.4). In interaction studies performed in a limited number of healthy volunteers, these effects were not reported with alfuzosin or tamsulosin.

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other medicinal products and other forms of interaction Interaction studies were conducted with 10 mg and/or 20 mg tadalafil, as indicated below. With regard to those interaction studies where only the 10 mg tadalafil dose was used, clinically relevant interactions at higher doses cannot be completely ruled out. Effects of Other Substances on Tadalafil Cytochrome P450 inhibitors Tadalafil is principally metabolised by cyp3A4. A selective inhibitor of cyp3A4, ketoconazole (200 mg daily increased tadalafil (10 mg) exposure (AUC) 2-fold and Cmax by 15, relative to the auc and Cmax values for tadalafil alone. Ketoconazole (400 mg daily) increased tadalafil (20 mg) exposure (AUC) 4-fold and Cmax. Ritonavir, a protease inhibitor (200 mg twice daily which is an inhibitor of cyp3A4, cyp2C9, cyp2C19, and cyp2D6, increased tadalafil (20 mg) exposure (AUC) 2-fold with no change in Cmax. Although specific interactions have not been studied, other protease inhibitors, such as saquinavir, and other cyp3A4 inhibitors, such as erythromycin, clarithromycin, itraconazole, and grapefruit juice, should be co-administered with caution, as they would be expected to increase plasma concentrations of tadalafil (see section.4). Consequently, the incidence of the adverse reactions listed in section.8 might be increased. Transporters The role of transporters (for example, p-glycoprotein) in the disposition of tadalafil is not known.

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Decreased or sudden hearing loss Cases of sudden hearing loss have been reported after the use of tadalafil. Although other risk factors were present in some cases (such as age, diabetes, hypertension and previous hearing loss history) patients should be advised to stop taking tadalafil and seek prompt medical attention in the event of sudden decrease or loss of hearing. Renal and hepatic impairment (tadalafil.5 mg and 5 mg) due to increased tadalafil exposure (auc limited clinical experience and the lack of ability to influence clearance by dialysis, once-a-day dosing of cialis is not recommended in patients with severe renal impairment. There is limited clinical data on the safety of single-dose administration of cialis in patients with severe hepatic insufficiency (Child-Pugh Class C). Once-a-day administration has not been evaluated in patients with hepatic insufficiency. If cialis is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. Hepatic impairment (tadalafil 10 mg and 20 mg) There is limited clinical data on the safety of single-dose administration of cialis in patients with severe hepatic insufficiency (Child-Pugh Class C). Priapism and anatomical deformation of the penis Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage arabia and permanent loss of potency may result. Cialis, should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or peyronie's disease) or in patients who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia). Use with cyp3A4 inhibitors caution should be exercised when prescribing cialis to patients using potent cyp3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin as increased tadalafil exposure (AUC) has been observed if the medicinal products are combined (see section.5). Cialis and other treatments for erectile dysfunction The safety and efficacy of combinations of cialis and other pde5 inhibitors or other treatments for erectile dysfunction have not been studied.

Cardiovascular Serious cardiovascular events, including myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischaemic attacks, chest pain, palpitations and tachycardia, have been reported either post marketing and/or in clinical trials. Most of the patients in whom these events have been reported had pre-existing cardiovascular risk factors. However, it is not possible to definitively determine whether these events are related directly to these risk factors, to cialis, to sexual activity, or to a combination of these or other factors. Tadalafil.5 mg and 5 mg - in patients receiving concomitant antihypertensive medicinal products, tadalafil may induce a blood pressure decrease. When initiating daily treatment with tadalafil, appropriate clinical considerations should be given to a possible dose adjustment of the antihypertensive therapy. In patients who are taking alpha1 blockers, concomitant administration of cialis may lead to symptomatic hypotension in some patients (see section.5). The combination of tadalafil and doxazosin is not recommended. Vision Visual defects and cases of naion have been reported in connection with the intake of cialis and other pde5 inhibitors. Analyses of observational data suggest an increased risk of acute naion in men with erectile dysfunction following exposure to tadalafil or other pde5 inhibitors. As this may be relevant for all patients exposed to tadalafil, the patient should be advised that in case of sudden visual defect, he should stop taking cialis and consult a physician immediately (see section.3).

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Cialis must not be used in men with cardiac disease for whom sexual activity is inadvisable. Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease. The following groups of patients with cardiovascular disease were not included in clinical trials and the use of tadalafil is therefore contraindicated: - patients with myocardial infarction within the last 90 days, - patients with unstable angina or angina occurring during sexual intercourse, - patients. Cialis is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (naion regardless of whether this episode was in connection or not with previous pde5 inhibitor exposure (see section.4). The co-administration of pde5 inhibitors, including tadalafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section.5). 4.4 Special warnings and precautions for use 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. Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Tadalafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section.1) and as such potentiates the hypotensive effect of nitrates (see section.3). The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following an appropriate medical assessment. It is not known if cialis is effective in patients who have undergone pelvic surgery or radical non-nerve-sparing prostatectomy. Tadalafil 5 mg - prior to initiating treatment with tadalafil for benign prostatic hyperplasia patients should be examined to rule out the presence of carcinoma of the prostate and carefully assessed for cardiovascular conditions (see section.3).

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Once-a-day dosing.5 or 5 mg tadalafil both for the treatment of erectile dysfunction or benign prostatic hyperplasia is not recommended in patients with severe renal impairment arabia (see sections.4 and.2). Men with Hepatic Impairment For the treatment of erectile dysfunction using on-demand cialis the recommended dose of cialis is 10 mg taken prior to anticipated sexual activity and with or without food. There is limited clinical data on the safety of cialis in patients with severe hepatic impairment (Child-Pugh class c if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician. There are no available data about the administration of doses higher than 10mg of tadalafil to patients with hepatic impairment. Once-a-day dosing both for the treatment of erectile dysfunction and benign prostatic hyperplasia has not been evaluated in patients with hepatic impairment; therefore, if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician (see sections.4 and.2). 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. Method of administration cialis is available.5, 5, 10, and 20 mg film-coated tablets for oral use. 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section.1. In clinical studies, tadalafil was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cgmp pathway. Therefore, administration of cialis to patients who are using any form of organic nitrate is contraindicated (see section.5). cialis tadalafil 5mg

In these patients, the recommended dose is 5mg taken once a day at approximately the same time of day. The dose may be decreased.5mg once a day based on individual tolerability. 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. For adult men being treated for both benign prostatic hyperplasia and erectile dysfunction the recommended dose is also 5 mg taken at approximately the same time every day. Patients who stearate are unable to tolerate tadalafil 5 mg for the treatment of benign prostatic hyperplasia should consider an alternative therapy as the efficacy of tadalafil.5 mg for the treatment of benign prostatic hyperplasia has not been demonstrated. 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. For patients with severe renal impairment, 10 mg is the maximum recommended dose.

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Clinical particulars.1 Therapeutic indications. Treatment of erectile dysfunction in adult males. In order for tadalafil to be effective for the treatment of erectile dysfunction, sexual stimulation is required. 5 mg bell's only: Treatment of the signs and symptoms of benign prostatic hyperplasia in adult males. Cialis is not indicated for use by women. 4.2 Posology and method of administration. 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. In those patients in whom tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried. It may be taken at least 30 minutes prior to sexual activity. The maximum dose frequency is once per day. Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use. In patients who anticipate a frequent use of cialis (i.e., at least twice weekly) a once daily regimen with the lowest doses of cialis might be considered suitable, based on patient choice and the physician's judgement.

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Each 10 mg tablet contains 10 mg tadalafil. Excipient with known effect: Each coated tablet contains 170 mg of lactose (as monohydrate). Each 20 mg tablet contains 20 mg tadalafil. Excipient with known effect: Each coated tablet contains 233 mg of lactose (as monohydrate). For the full list of excipients, see section.1. Pharmaceutical form, film-coated tablet (tablet). The.5 mg tablets are light orange-yellow and almond shaped tablets, marked 'c 2 ' on one side. 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.

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Cialis.5mg film-coated tablets - summary of Product Characteristics (SmPC) - (eMC). Skip to main content, start typing to retrieve search suggestions. When suggestions are available use up and down arrows to review and enter to select. Continue typing to refine. Advanced search back to top, active ingredient tadalafil. Legal Category, pOM: Prescription only medicine, this information is intended for use by health professionals. Name of the medicinal product. Cialis*.5 mg, 5 mg, 10 mg crema and 20 mg film-coated tablets. Qualitative and quantitative composition, each.5 mg tablet contains.5 mg tadalafil. Excipient with known effect: Each coated tablet contains 87 mg of lactose (as monohydrate). Each 5 mg tablet contains 5 mg tadalafil. Excipient with known effect: Each coated tablet contains 121 mg of lactose (as monohydrate).

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Alpha-blockers: ED: When cialis is coadministered with an alpha-blocker in patients being treated for ed, patients should be stable on alpha-blocker therapy prior to initiating treatment, and cialis should be initiated at the lowest recommended dose. Bph: cialis is not recommended for use in combination with alpha-blockers for the treatment of bph. Cyp3A4 inhibitors: cialis for use as needed: For patients taking concomitant potent inhibitors of cyp3A4, such as ketoconazole or ritonavir, the maximum recommended dose of cialis is 10 mg, not to exceed once every 72 hours. Cialis for once daily use: For patients taking concomitant potent inhibitors of cyp3A4, such as ketoconazole or ritonavir, the maximum recommended dose.5.

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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. Efficacy in ed (for use as needed). Important considerations, nitrates: Concomitant use of nitrates in any form is contraindicated.

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Efficacy in ed (once daily use) 5 mg, the recommended dose of cialis for once daily use is 5 mg, taken at approximately the same time every day. When therapy for bph is initiated with cialis and finasteride, the recommended dose of cialis for once daily use is 5 mg, taken at approximately the same time every day for up to 26 weeks. Efficacy in bph 5 mg, 10 mg,.

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Dosing recommendations 5 mg, the recommended dose of cialis for once daily use is 5 mg, taken at approximately the same time every day, without regard to timing of sexual activity. Efficacy in edbph.5 mg, 5 mg, the recommended starting dose of cialis for once daily use.5 mg, taken at approximately the same time every day, without regard to timing of sexual activity. The cialis dose for once daily use may be increased to 5 mg, based on individual efficacy and tolerability.

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