Cialis online in Australia

Use

Therapeutic indications

Treatment of erectile dysfunction in adult men.

Sexual stimulation is required for tadalafil to be effective in treating erectile dysfunction.

Treatment of signs and symptoms of benign prostatic hyperplasia in adult men. Cialis is not indicated in women.

Dosage and method of administration

Dose

Erectile dysfunction in adult men

In general, the recommended dose of Cialis is 10 mg to take before any planned sexual activity, during or after meals.

In patients for whom a 10 mg dose of tadalafil does not produce a sufficient effect, a 20 mg dose may be recommended. Cialis can be taken at least 30 minutes before any sexual activity.

The maximum frequency of administration is one dose per day.

Tadalafil 10 mg and tadalafil 20 mg are indicated for sexual intercourse, but are not recommended for prolonged daily use.

In patients planning frequent use of Cialis (at least twice a week), taking one tablet per day, with lower doses of Cialis may be considered appropriate, the decision depends on the patient's choice. and the doctor's opinion.

In these patients, the recommended dose is 5 mg taken daily, at approximately the same time of day. The dose can be reduced to 2.5 mg once a day, depending on individual tolerance.

The choice of daily dose should be reevaluated periodically.

Benign prostatic hyperplasia in adult men.

The recommended dose is 5 mg taken at approximately the same time of day, with or without food. In adult men treated for both benign prostatic hyperplasia and erectile dysfunction, the recommended dose is also 5 mg at approximately the same time of day.

Patients who do not tolerate 5 mg of tadalafil to treat an enlarged prostate should consider taking another treatment.

In fact, the efficacy of tadalafil 2.5 mg in benign prostatic hyperplasia has not been demonstrated.

Special populations

Old man

No dosage adjustment is necessary for older men.

Men with kidney failure

No dosage adjustment is necessary in patients with mild to moderate renal impairment. In patients with severe renal impairment, the maximum recommended dose is 10 mg as on-demand therapy.

A daily dose of 2.5 or 5 mg tadalafil is not recommended for the treatment of erectile dysfunction and benign prostatic hyperplasia in patients with severe renal impairment (see Warnings and precautions for use and pharmacokinetic properties).

Men with liver failure.

For the treatment of erectile dysfunction by on-demand administration, the recommended dose of Cialis is 10 mg to be taken before any planned sexual activity, during or without meals. In patients with severe hepatic impairment (Child-Pugh, class C), the clinical safety data are limited; therefore, if Cialis is prescribed, the prescribing physician should perform a careful individual benefit / risk assessment. In patients with hepatic impairment, there are no data available on the administration of doses greater than 10 mg of tadalafil.

Daily intake of Cialis for the treatment of erectile dysfunction and benign prostatic hyperplasia has not been evaluated in patients with hepatic impairment; Accordingly, the physician should carry out a careful individual benefit / risk assessment after prescription (see Warnings and Precautions for Use and Pharmacokinetic properties sections).

Men with diabetes

No dosage adjustment is necessary in diabetic patients.

Pediatric population

The use of Cialis in the treatment of erectile dysfunction in the pediatric population is not justified.

Administration form

Cialis is available in film-coated tablets, 2.5, 5, 10 and 20 mg, for oral use.

Prescription and delivery conditions

List I. Duration and special precautions for conservation

Conversation duration:

3 years.

Special precautions for storage:

Store in the original container to protect it from moisture. Do not store above 25 ° C.

Preclinical safety data

Non-clinical data from conventional studies of safety pharmacology, repeated-dose toxicology, genotoxicity, carcinogenesis, and reproductive functions did not reveal any particular risk to humans.

No signs of teratogenicity, embryotoxicity, or fetotoxicity were observed in rats or mice receiving up to 1000 mg / kg / day of tadalafil. In prenatal and postnatal developmental studies in rats, the no effect dose was 30 mg / kg / day. In the pregnant rat, the AUC corresponding to the product in free form at this dose was approximately 18 times higher than the AUC determined for a dose of 20 mg in humans.

No impairment of fertility was observed in male and female rats. In dogs that have received tadalafil daily for 6 to 12 months at doses of 25 mg / kg / day (representing an exposure at least 3 times greater [3.7 to 18.6] than that observed in humans at a single dose of 20 mg) and more, a regression of the epithelium of the seminiferous tubes has been observed, which leads to a decrease in spermatogenesis in some dogs. See also section Pharmacodynamic properties.

Incompatibilities

Aimlessly.

Employment precautions

Contraindications

Hypersensitivity to the active substance or to any of the excipients included in the Composition section.

In clinical trials, tadalafil has been shown to potentiate the hypotensive effect of nitrates. This would result from the combined effects of nitrates and tadalafil on the nitric oxide / cGMP pathway. Therefore, Cialis is contraindicated in patients receiving nitrates in any form (see section Interactions with other medicinal products and other forms of interaction).

Cialis should not be used in men with heart conditions for whom sexual activity is not recommended. Physicians should assess the potential cardiac risk of sexual activity in patients with a cardiovascular history.

Since groups of patients with the following cardiovascular history were not included in clinical trials, the use of tadalafil is contraindicated in:

• patients who have had a heart attack in the last 90 days,
• patients with unstable angina or angina pain during intercourse,
• patients who have had heart failure greater than or equal to class 2 of the NYHA classification (New York Heart Association) in the last 6 months,
• patients with uncontrolled arrhythmias, low blood pressure (minus 90/50 mm Hg), or uncontrolled high blood pressure,
• patients who have had a stroke in the past 6 months.
• Cialis is contraindicated in patients with vision loss in one eye due to non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether or not this event was associated with prior exposure to a PDE5 inhibitor (See Warnings and Precautions section of use).
• Concomitant administration of PDE5 inhibitors, such as tadalafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated due to the risk of symptomatic hypotension (see section Interactions with other medicinal products and other forms of interaction)

Pregnancy and lactation

Cialis is not indicated in women.

Pregnancy

There are limited data on the use of tadalafil in pregnant women. Animal studies do not show any adverse effects, direct or indirect, on the course of pregnancy, embryo / fetus development, delivery and postnatal development (see section Preclinical safety data). As a precaution, it is best to avoid the use of Cialis during pregnancy.

Breastfeeding

Available pharmacodynamic / toxicological data in animals have shown excretion of tadalafil in milk. A risk for breastfed children cannot be excluded. Cialis should not be used during lactation.

Fertility

Effects have been observed that may be an indicator of impaired fertility in dogs. Furthermore, two clinical studies suggest that these effects are unlikely in humans, despite a decrease in sperm concentration observed in some men (see sections Pharmacodynamic properties and preclinical safety data).

Warnings and precautions for use

Before treatment with Cialis

A medical history and clinical examination should be performed to diagnose erectile dysfunction or benign enlarged prostate and to determine its possible underlying causes before considering drug treatment.

Before starting any treatment for erectile dysfunction, doctors should take into account the cardiovascular status of their patients, sexual activity is accompanied by a certain cardiac risk. Tadalafil has vasodilatory properties, causing slight and transient reductions in blood pressure (see section Pharmacodynamic properties) and, as such, enhances the hypotensive effect of nitrates (see section Contraindications).

Before starting any treatment for benign prostatic hyperplasia with tadalafil, patients should be examined to exclude the presence of prostate cancer. Careful assessment of cardiovascular status should be carried out (see Contraindications section).

The evaluation of erectile dysfunction should include the search for possible underlying causes and the identification of a suitable treatment after an appropriate medical examination. The efficacy of Cialis in patients who have undergone pelvic surgery or radical prostatectomy without preserving the nerve strips is unknown.

Cardiovascular

Serious cardiovascular events such as myocardial infarction, sudden cardiac death, unstable angina, ventricular arrhythmia, ischemic strokes, and transient ischemic attacks, chest pain, palpitations, and tachycardia have been reported after marketing and / or during clinical trials. of the patients in whom these events were observed had pre-existing cardiovascular risk factors. However, it is not possible to determine with certainty whether these events are directly related to these risk factors, Cialis, sexual activity, a combination of these factors, or other factors.

In patients receiving antihypertensive medications, co-administration of tadalafil may cause a drop in blood pressure. The doctor should consider a possible adaptation of the antihypertensive therapy dose, when starting daily treatment with tadalafil.

In some patients receiving alpha1 blockers such as doxazosin, concomitant administration of Cialis may cause symptomatic hypotension (see section Interactions with other medicinal products and other forms of interaction). Therefore, the simultaneous administration of tadalafil and doxazosin is not recommended.

Ophthalmic

Visual abnormalities and cases of NOIAN (anterior non-arteritic ischemic optic neuropathy) have been reported with Cialis and other PDE5 inhibitors. The patient should be advised that in the event of a sudden visual defect, he should stop taking Cialis and seek immediate medical attention (see section 4.3).

Kidney and liver failure

Due to increased exposure to tadalafil (AUC), limited clinical experience, and the inability to change clearance on dialysis, daily intake of Cialis is not recommended in patients with severe renal impairment.

There are limited clinical data on the safety of the single dose of Cialis in patients with severe hepatic impairment (Child-Pugh Class C). Daily use for the treatment of erectile dysfunction or benign prostatic hyperplasia has not been evaluated in patients with hepatic impairment. If Cialis is prescribed, the prescribing physician should perform an individual risk / benefit assessment.

Priapism and anatomical malformation of the penis.

Patients with erections lasting 4 hours or more should be advised to seek immediate medical attention. If priapism is not treated right away, it can damage penile tissue and permanent impotence.

Cialis should be used with caution in patients with an anatomical deformation of the penis (such as angulation, sclerosis of the corpora cavernosa or Peyronie's disease) or in patients with conditions that predispose them to priapism (such as sickle cell anemia), multiple myeloma, or leukemia) .

Use with CYP3A4 inhibitors

Cialis should be prescribed with caution in patients using selective CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin); An increased exposure (AUC) to tadalafil has been observed in combination with these drugs (see section Interactions with other medicinal products and other forms of interaction).

Cialis and other treatments for erectile dysfunction.

The efficacy and safety of combining Cialis with other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied.

Patients should be instructed not to use such associations.

Lactose

Cialis contains lactose. Patients with hereditary galactose intolerance, Lapp lactase deficiency, or glucose or galactose malabsorption should not take this medicine.

Interaction with other medicinal products and other forms of interaction

Interaction studies with the 10 and / or 20 mg dose of tadalafil were performed as indicated below. With respect to interaction studies in which only the 10 mg dose was used, these do not exclude the possibility of clinically relevant interactions at higher doses.

Effects of other substances on tadalafil

Cytochrome P450 inhibitors

Tadalafil is mainly metabolized by CYP3A4. In the presence of a selective CYP3A4 inhibitor, ketoconazole (200 mg per day), the exposure (AUC) to tadalafil (10 mg) is multiplied by 2 and the Cmax was increased by 15% compared to the AUC and Cmax values seen with tadalafil alone. At a dose of 400 mg per day, ketoconazole increases the exposure (AUC) to tadalafil (20 mg) by 4 and increases the Cmax by 22%. Ritonavir, an antiprotease inhibitor of CYP3A4, CYP2C9, CYP2C19 and CYP2D6 (200 mg twice daily), doubles the exposure (AUC) to tadalafil (20 mg), without changing the Cmax. Although specific interactions have not been studied, other antiproteases, such as saquinavir, and other CYP3A4 inhibitors, such as erythromycin, clarithromycin, itraconazole, and grapefruit juice, should be administered with caution as they may increase plasma concentrations of tadalafil (see section 4.4). . Therefore, the incidence of the side effects listed in the Side Effects section may increase.

Carriers

The role of transporters (such as glycoprotein P) in the distribution phase of tadalafil is unknown. Therefore, there is a potential risk of drug interactions due to inhibition of the transporters.

P450 Cytochrome Inductors

CYP3A4-inducing rifampin decreases the AUC of tadalafil by 88% compared to the AUC determined for tadalafil alone (10 mg). This decrease may reduce the effectiveness of tadalafil; The value of this reduction is unknown. A decrease in plasma tadalafil concentrations cannot be ruled out when combined with other CYP3A4 inducers, such as phenobarbital, phenytoin, and carbamazepine.

Effects of tadalafil on other medicines.

Nitro derivatives

Clinical studies have shown that tadalafil (5, 10 and 20 mg) increases the hypotensive effects of nitrates. Therefore, the administration of Cialis to patients receiving nitrates in any form is contraindicated (see section 4.3). The results of a clinical study conducted in 150 patients who received daily doses of 20 mg of tadalafil for 7 days and 0.4 mg of sublingual trinitrine at various times showed that this interaction lasted for more than 24 hours and was not more detectable 48 hours after the last dose of tadalafil. Therefore, in a patient taking Cialis regardless of dose (2.5 mg - 20 mg), and in whom administration of a nitro derivative is considered necessary for life prognosis, a minimum delay of

They should be observed 48 hours after the last dose of Cialis, before administering a nitro derivative. In this case, nitrates should only be administered under strict medical supervision, including proper hemodynamic monitoring.

Antihypertensives (including calcium channel blockers)

Concomitant administration of doxazosin (4 mg and 8 mg daily) and tadalafil (5 mg daily dose and 20 mg single dose) significantly increases the hypotensive effect of this alpha-blocker.

This effect can last at least twelve hours and manifest as symptoms such as fainting.

Therefore this combination is not recommended (see section 4.4).

In interaction studies in a limited number of healthy volunteers, these effects have not been reported with alfuzosin and tamsulosin.

However, in patients treated with alpha-blockers, and particularly in the elderly, the use of tadalafil will be done with caution.

Treatments should be started with the minimum dose; and dose adjustment should be done gradually.

The possibility that tadalafil may increase the hypotensive effects of antihypertensive drugs has been evaluated in clinical pharmacology studies. The main classes of antihypertensive drugs have been studied, including calcium channel blockers (amlodipine), angiotensin-converting enzyme (ACE) inhibitors (enalapril), beta blockers (metoprolol), thiazide diuretics (bendroflumethiazide) and angiotensin II receptor antagonists (various types and doses, alone or in combination with thiazide diuretics, calcium channel blockers, beta blockers, and / or alpha blockers). No clinically significant effect has been observed after taking tadalafil (10 mg with the exception of studies with angiotensin II receptor antagonists and amlodipine, in which a 20 mg dose was used) in combination with treatment of either of these classes. In another clinical pharmacology study, tadalafil (20 mg) was studied in combination with up to 4 classes of antihypertensive drugs. In subjects taking multiple antihypertensive drugs, changes in ambulatory blood pressure appear to be correlated with the degree of control of blood pressure. In this sense, in the patients in this study with adequately controlled blood pressure, the decrease was minimal and similar to that observed in healthy volunteers. In patients whose blood pressure was not controlled, the decrease was greater, although it was not associated with hypotensive symptoms in most of them. In patients treated with antihypertensive drugs simultaneously, 20 mg of tadalafil may cause a decrease in blood pressure (with the exception of alpha-blockers, see above), generally less and without clinical consequences. Analysis of data from phase III clinical trials showed no difference in adverse events that occur in patients taking tadalafil with or without antihypertensive therapy. However, adequate clinical advice should be given to patients regarding the possibility of a decrease in blood pressure if treated concomitantly with antihypertensive drugs.

Riociguat

Preclinical studies have shown an increase in the systemic hypotensive effect when PDE5 inhibitors were combined with riociguat. In clinical studies, riociguat has been shown to increase the hypotensive effects of PDE5 inhibitors. No benefit of association has been demonstrated in the study population. Concomitant use of riociguat with PDE5 inhibitors, such as tadalafil, is contraindicated (see section 4.3).

5- alpha reductase inhibitors

In a clinical trial comparing the simultaneous administration of 5 mg of tadalafil and 5 mg of finasteride to placebo and 5 mg of finasteride to relieve the symptoms of benign prostatic hyperplasia, no new adverse effects were identified.

No drug interaction study has been conducted to evaluate the effects of tadalafil and 5-alpha reductase (5-ARI) inhibitors. Caution should be exercised when co-administering tadalafil and 5-ARI.

CYP1A2 substrates (eg theophylline)

A clinical pharmacological study of the concomitant administration of tadalafil 10 mg and theophylline (a non-selective phosphodiesterase inhibitor) has shown no pharmacokinetic interaction.

The only reported pharmacodynamic effect was a slight increase (3.5 beats / min) in heart rate.

Even if this effect were considered minor and of no clinical importance in this study, this effect should be taken into account in the case of concomitant administration of these drugs.

Ethinyl estradiol and terbutaline

Tadalafil has been shown to increase the oral bioavailability of ethinyl estradiol; A similar increase is expected with oral administration of terbutaline, although the clinical consequence of this increase is uncertain.

Alcohol

Alcohol concentrations (mean maximum blood concentration of 0.08%) were not affected by concomitant administration of tadalafil (10 or 20 mg). In particular, no change in tadalafil concentrations was observed three hours after concomitant administration of alcohol, alcohol was administered to promote its absorption (overnight fast and absence of food for up to 2 hours after drinking alcohol). Tadalafil (20 mg) does not increase the average drop in blood pressure due to alcohol (at a dose of 0.7 g / kg or approximately 180 ml of 40% alcohol [vodka] in an 80 kg man). Dizziness and orthostatic hypotension have been observed in some subjects.

When tadalafil was administered with lower doses of alcohol (0.6 g / kg), no hypotension was observed. Similarly, dizziness was as common as when drinking alcohol alone. Tadalafil (10 mg) does not increase the effect of alcohol on cognitive functions.

Drugs metabolized by cytochrome P450

Tadalafil is not expected to cause clinically relevant inhibition or induction of clearance of drugs metabolized by CYP450 isoforms. Studies have confirmed that tadalafil is not an inhibitor or inducer of CYP450 isoforms, including CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9 and CYP2C19.

CYP2C9 substrates (eg warfarin-R)

Tadalafil (10 mg and 20 mg) has no clinically relevant effect on exposure (AUC) to warfarin-S or warfarin-R (substrate CYP2C9), and does not affect warfarin-induced changes in prothrombin levels.

Acetylsalicylic acid

Tadalafil (10 mg and 20 mg) does not potentiate the increased bleeding time caused by acetylsalicylic acid.

Antidiabetic medications

No specific interaction study with antidiabetic treatments has been performed.

Caution

Undesirable effects

Summary of the safety profile

The most common side effects reported in patients taking Cialis for the treatment of erectile dysfunction or benign prostatic hyperplasia were: headache, dyspepsia, back pain and myalgia, the incidence of which increases with increasing dose of Cialis.

The reported side effects were transient and generally mild or moderate. Most headaches reported with Cialis taken daily occur within the first 10 to 30 days after the start of treatment.

Summary table of adverse reactions

The following table presents the undesirable effects observed in spontaneous reports and in placebo-controlled clinical trials (involving a total of 8,022 patients treated with Cialis and 4,422 patients on placebo) for on-demand treatment. and a daily dose of erectile dysfunction and a daily dose of benign prostatic hyperplasia.

Frequency convention: very common (plus = 1/10), common (plus = 1/100, minus 1/10), uncommon (plus = 1/1000, minus 1/100),

rare (plus = 1 / 10,000, minus 1/1000), very rare (minus 1 / 10,000) and frequency unknown (cannot be estimated from the available data).

Very common

Frequent

Rare

Rare

Immune system disorders.

Reactions

hypersensitivity

Quincke edema2

Nervous system disorders

Headache

Dizzying sensations

Stroke1 (including bleeding events), syncope,

Transient ischemic attacks1, migraine2 seizures2, transient amnesia

Eye conditions

Blurred vision, sensations described as eye pain

Visual field defect, eyelid edema, conjunctival hyperemia, non-arteritic anterior ischemic optic neuropathy (NOIAN) 2, occlusion

retinal vascular2

Ear and labyrinth disorders.

Tinnitus

Sudden loss of

audience

Heart conditions1

Tachycardia, palpitations

Myocardial infarction, unstable angina2,

Ventricular arrhythmia2

Vascular disorders

Redness

Hypotension3,

Hypertension

Respiratory, thoracic and mediastinal disorders.

Nasal congestion

Dyspnoea

Epistaxis

Gastrointestinal disorders.

Dyspepsia

Abdominal pain, vomiting, nausea, reflux

gastroesophageal

Skin and subcutaneous tissue disorders.

Eruption

Urticaria, Stevens-Johnson syndrome2, exfoliative dermatitis2, hyperhidrosis

(excessive sweating)

Musculoskeletal and connective tissue disorders.

Back pain

Myalgia, pain

ends

Kidney and urinary tract disorders.

Hematuria

Reproductive system and breast disorders.

Prolonged erections

Priapism, bleeding from the penis,

Hemospermia

General disorders and administration site conditions.

Chest pain 1,

Peripheral edema, fatigue

Facial Edema2, Death

sudden cardiac 1,2

Description of the specific side effects.

A slight increase in the incidence of ECG abnormalities, mainly sinus bradycardia, has been reported in patients treated with tadalafil once daily compared to placebo. Most of these ECG abnormalities have not been associated with any side effects.

Other special populations.

Data from clinical trials in patients over 65 years of age treated with tadalafil for erectile dysfunction or benign prostatic hyperplasia are limited. In clinical trials in patients treated with tadalafil on demand for erectile dysfunction, diarrhea has been reported more frequently in patients older than 65 years. In clinical studies in patients treated with tadalafil 5 mg daily for benign enlarged prostate, dizziness and diarrhea have been reported more frequently in patients older than 75 years.

Notification of suspected adverse reactions.

Notification of suspected adverse reactions after authorization of the medicinal product is important. Allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals are requested to report any suspected adverse reactions through the national reporting system listed in Appendix V.

Overdose

Single doses of up to 500 mg have been administered to healthy subjects and multiple doses of up to 100 mg per day have been administered to patients. Adverse events were similar to those observed at lower doses. In the event of an overdose, the usual symptomatic treatment measures should be implemented as necessary. The elimination of tadalafil by hemodialysis is insignificant.