Cialis 5 5mg FC tablets

CIALIS is indicated for the treatment of erectile dysfunction. In order for CIALIS to be effective, sexual stimulation is required. CIALIS is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia in adult males. CIALIS is not indicated for use by women.

Posology
Erectile dysfunction in adult men
The recommended maximum dose of tadalafil is 5 mg taken once a day at approximately the same time of day.
Benign prostatic hyperplasia
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.
Special populations
Elderly men
Dose adjustments are not required in elderly patients.
Men with renal impairment
Dosage adjustments are not required in patients with mild or moderate renal impairment. Once-a-day dosing of tadalafil, both for the treatment of erectile dysfunction or benign prostatic hyperplasia, is not recommended in patients with severe renal impairment.
Men with diabetes
Dose adjustments are not required in diabetic patients.
Paediatric population
CIALIS should not be used in children.
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). Previous experience of partial, sudden, temporary or permanent decrease or loss of vision in one or both eyes. 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 whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4). Previous experience of unilateral or bilateral decrease or loss of hearing with or without associated vestibular symptoms. The combination of tadalafil and guanylate cyclase stimulators, such as riociguat, is contraindicated because it may lead to symptomatic hypotension (see section 4.4). The following groups of patients with cardiovascular disease were excluded in clinical trials, and safety in these patients is unknown. Therefore, use of CIALIS is contraindicated in the following groups of patients:
u2022 Patients with myocardial infarction within the last 90 days.
u2022 Patients with unstable angina or angina occurring during sexual intercourse.
u2022 Patients with New York Heart Association Class 2 or greater heart failure in the last 6 months.
u2022 Patients with uncontrolled dysrhythmias, hypotension (< 90/50 mm Hg), or uncontrolled hypertension.
u2022 Patients with a stroke within the last 6 months.

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. Prior to initiating treatment with CIALIS for benign prostatic hyperplasia (BPH), patients should be examined to rule out the presence of carcinoma of the prostrate. 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, physicians 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. When tadalafil, as contained in CIALIS, was co-administered to healthy patients taking doxazosin (4 to 8 mg daily), there was an augmentation of the blood-pressure-lowering effect of doxazosin.
Vision
Nonarteritic anterior ischaemic optic neuropathy (NAION) is a cause of decreased vision including permanent loss of vision. There are postmarketing reports of NAION in temporal association with the use of all PDE5 inhibitors, including CIALIS. 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 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).
Renal and hepatic impairment
Due to increased CIALIS 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 medical practitioner.
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 PDE5 inhibitors or other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.

CIALIS does not inhibit or induce CYP450 isoforms, including CYP1A2, CYP3A4, CYP2C9, CYP2C19, CYP2D6 and CYP2E1.
Effects of other substances on tadalafil
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, and itraconazole and grapefruit juice should be co-administered with caution as they would be expected to increase plasma concentrations of tadalafil (see section 4.4). Consequently the incidence of the adverse reactions listed in section 4.8 might be increased.
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 patients 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 - 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)
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 4.4). In interaction studies performed in a limited number of healthy volunteers, these effects were not reported with alfuzosin or tamsulosin. However, caution should be exercised when using tadalafil in 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. Analysis of phase 3 clinical trial data showed no difference in 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 using machines.

Summary of the safety profile
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.
Tabulated summary of adverse reactions
The table below lists the adverse reactions observed from spontaneous reporting and in placebo controlled clinical trials (comprising a total of 8022 patients on CIALIS and 4422 patients on placebo) for on-demand and once-a-day treatment of erectile dysfunction and the once-a-day treatment of benign prostatic hyperplasia.
Frequency convention: very common (u2265 1/10), common (u2265 1/100 to < 1/10), uncommon (u2265 1/1 000 to < 1/100), rare (u2265 1/10 000 to < 1/1 000) and very rare (< 1/10 000) and not known (cannot be estimated from the available data).

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