Cialis 20 Mg Film-Coated Tablets

CIALIS is indicated for the treatment of erectile dysfunction. In order for CIALIS to be effective, sexual stimulation is required.

Posology

Adult men The recommended maximum dose of CIALIS is 20 mg taken prior to anticipated sexual activity and without regard to food. CIALIS can be taken up to 36 hours and as early as 16 minutes prior to sexual activity. Patients may initiate sexual activity at various time points relative to dosing in order to determine their own optimal window of responsiveness. The maximum recommended dosing frequency is one tablet once per day.

Method of administration

CIALIS is for oral use.

A known hypersensitivity to the active substance, tadalafil, or to any of the excipients listed in section 6.1. Administration of CIALIS to patients who are using any form of organic nitrate 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 4.5). Patients with severe hepatic insufficiency (Child-Pugh Class C). The following groups of patients with cardiovascular disease were excluded 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 with New York Heart Association Class 2 or greater heart failure in the last 6 months.
• Patients with uncontrolled dysrhythmias, hypotension (< 90/50 mm Hg), or uncontrolled hypertension.
• Patients with a stroke within the last 6 months.

CIALIS is contraindicated in patients who have loss of vision in one or both eyes 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 4.4). The combination of tadalafil and guanylate cyclase stimulators, such as riociguat, is contraindicated because it may lead to symptomatic hypotension (see section 4.5).

Before treatment with CIALIS The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following an appropriate medical assessment before pharmacological treatment is considered. Medical practitioners should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease. Patients who experience symptoms upon initiation of sexual activity should be advised to refrain from further sexual activity and should report the episode to their medical practitioner. CIALIS has systemic vasodilatory properties that may result in transient decreases in blood pressure. Prior to prescribing CIALIS, medical practitioners should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects.

Cardiovascular Sexual activity carries a potential cardiac risk for patients with pre-existing cardiovascular disease. CIALIS should not be used in men with cardiac disease for whom sexual activity is inadvisable. Caution should be exercised when prescribing CIALIS to patients who are taking u03b1-1 blockers, such as prazosin and doxazosin, as simultaneous administration may lead to symptomatic hypotension in some patients (see section 4.5). When tadalafil, as contained in CIALIS, was co-administered to healthy subjects taking doxazosin (4 to 8 mg daily), an alpha-1-adrenergic blocker, there was an augmentation of the blood-pressure-lowering effect of doxazosin.

Vision There are postmarketing reports of NAION in temporal association with the use of all PDE5 inhibitors, including CIALIS. NAION is a cause of decreased vision including permanent loss of vision. An increased risk of acute NAION has been suggested from analyses of observational data in men with ED within 1 to 4 days of episodic PDE5 inhibitor (such as CIALIS) use. Medical practitioners should advise patients to stop use of CIALIS and seek medical attention in the event of a sudden loss of vision. Medical practitioners should also inform patients that individuals who have already experienced NAION should not use CIALIS or other PDE5 inhibitors again (see section 4.3).

Decreased or sudden hearing loss Medical practitioners should advise their patients to stop taking 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 section 4.8).

Hepatic 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). It is therefore contraindicated in patients with severe hepatic insufficiency (see section 4.3).

Renal impairment In a clinical pharmacology study, administration of CIALIS to patients with moderate renal failure (creatinine clearance = 31 to 50 ml/min) was less well tolerated in terms of back pain than in patients with mild renal failure (creatinine clearance = 51 to 80 ml/min) and healthy subjects.

Priapism and anatomical deformation of the penis Priapism has been reported with CIALIS. 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 and permanent loss of potency may result. CIALIS should be used with caution in patients who have conditions that might predispose them to priapism (such as sickle cell anaemia, multiple myeloma, or leukaemia), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronieu2019s disease).

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 4.5).

CIALIS and other treatments for erectile dysfunction The safety and efficacy of combinations of CIALIS and other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.

CIALIS contains lactose monohydrate Patients with the rare hereditary conditions of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption, should not take CIALIS.

CIALIS contains sodium CIALIS contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially u2018sodium-freeu2019.

Effects of other substances on CIALIS Cytochrome P450 inhibitors CIALIS is principally metabolised by CYP3A4. A selective inhibitor of CYP3A4, ketoconazole (400 mg daily), increased CIALIS 20 mg single-dose exposure (AUC) by 312 % and C max by 22 % and ketoconazole (200 mg daily) increased CIALIS 10 mg single-dose exposure (AUC) by 107 % and C max by 15 % relative to the AUC and C max values for CIALIS alone (see section 4.4). Ritonavir (200 mg twice daily) an inhibitor of CYP3A4, 2C9, 2C19 and 2D6, increased CIALIS single-dose exposure (AUC) by 124 % with no change in C max. Although specific interactions have not been studied, other HIV protease inhibitors, such as saquinavir, and other CYP3A4 inhibitors such as erythromycin, clarithromycin, itraconazole and grapefruit, should be co-administered with caution as they would likely increase CIALIS exposure (see section 4.4).

Cytochrome P450 inducers A selective CYP3A4 inducer, rifampicin (rifampicin 600 mg daily), reduced CIALIS single-dose exposure (AUC) by 88 % and C max by 46 %, relative to the AUC and C max values for CIALIS alone. It can be expected that concomitant administration of other CYP3A4 inducers will also decrease plasma concentrations of CIALIS. Other inducers of CYP3A4 such as phenobarbital, phenytoin and carbamazepine, may also decrease plasma concentrations of tadalafil.

Antacids Simultaneous administration of an antacid (magnesium hydroxide/aluminium hydroxide) and CIALIS reduced the apparent rate of absorption of CIALIS without altering exposure (AUC) to CIALIS.

H2-antagonists An increase in gastric pH resulting from administration of nizatidine, an H2-antagonist, had no significant effect on CIALIS pharmacokinetics.

Effects of CIALIS on other medicinal products Nitrates In clinical studies, CIALIS 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 4.3). Based on the results of a clinical study in which 150 subjects receiving daily doses of tadalafil 20 mg for 7 days and 0,4 mg sublingual nitroglycerin at various times, this interaction lasted for more than 24 hours and was no longer detectable when 48 hours had elapsed after the last tadalafil dose. Thus, in a patient prescribed any dose of CIALIS (2,5 mg to 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.

Antihypertensive medicines (including calcium channel blockers) When tadalafil (5 mg daily dose and 20 mg as a single dose), as contained in CIALIS, was co-administered to healthy subjects taking doxazosin (4 and 8 mg daily), an alpha[1]-adrenergic blocker, there was an augmentation of the blood-pressure-lowering effect of doxazosin. This effect lasts at least twelve hours and may be symptomatic, including syncope. Therefore this combination is not recommended (see section 4.4). 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) is, in general, minor and not likely to be clinically relevant. Analysis of phase clinical trial data showed no difference in 3 adverse events in patients taking tadalafil with or without antihypertensive medicinal products. However, appropriate clinical advice should be given to patients regarding a possible decrease in blood pressure when they are treated with antihypertensive medicinal products.

Riociguat Preclinical studies showed an additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors. There was no evidence of favourable clinical effect of the combination in the population studied. Concomitant use of riociguat with PDE5 inhibitors, including tadalafil, is contraindicated (see section 4.3).

CIALIS is not indicated for use by women.

Fertility 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 5.1 and 5.3).

CIALIS has negligible influence on the ability to drive or use machines. 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 operating machinery.

In cases of overdose, standard symptomatic and supportive measures should be adopted as required. Haemodialysis contributes negligibly to CIALIS elimination.