Cialis Daily online in Australia

Use

Therapeutic indications

Treatment of erectile dysfunction in adult men.

Sexual stimulation is required for tadalafil to be effective.

Cialis Daily is not indicated in women.

Dosage and method of administration

Dose

Erectile dysfunction in adult men

In general, the recommended dose is 10 mg to take before any planned sexual activity, with or without food.

In patients for whom a 10 mg dose of tadalafil does not produce a sufficient effect, a 20 mg dose may be recommended. Take 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 to use tadalafil frequently (at least twice a week), taking one tablet per day, with lower doses of tadalafil may be considered appropriate, the decision depends on the patient's choice and the opinion of the doctor.

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.

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. A daily dose of 2.5 mg or 5 mg tadalafil is not recommended in these patients with severe renal impairment (see sections 4.4 and 4.4).

Men with liver failure.

The recommended dose of tadalafil is 10 mg to take before any planned sexual activity, with or without food. In patients with severe hepatic impairment (Child-Pugh, class C), the clinical data on the safety of tadalafil are limited; therefore, in the event of prescription, the prescribing physician should make a careful individual assessment of the benefit / risk ratio. In patients with hepatic impairment, there are no data available on the administration of doses greater than 10 mg of tadalafil.

Daily use has not been evaluated in patients with hepatic impairment; Accordingly, the physician should perform 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 tadalafil in the treatment of erectile dysfunction in the pediatric population is not justified.

Administration form

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

Prescription and delivery conditions

List I.

Duration and special precautions for conservation

Shelf life: 2 years.

Special precautions for storage: This medicine does not require special storage conditions.

Preclinical safety data

Non-clinical data from conventional studies of safety pharmacology, repeated-dose toxicology, genotoxicity, carcinogenesis, and reproductive functions have revealed no 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, the administration of tadalafil is contraindicated in patients receiving nitrates in any form (see section Interactions with other medicinal products and other forms of interaction).

Tadalafil 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 who have angina 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.

Tadalafil is contraindicated in patients with vision loss in one eye due to anterior non-arteritic ischemic optic neuropathy (NAION), regardless of whether or not this event was associated with prior exposure to a PDE5 inhibitor (See Warnings and Precautions for Use section) .

Co-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 interactions).

Pregnancy and lactation

Cialis Daily is not indicated in women.

Pregnancy

There are limited data on the use of tadalafil in pregnant women. Animal studies do not reveal 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 using tadalafil during pregnancy.

Breastfeeding

Available pharmacodynamic / toxicological data in animals have shown excretion of tadalafil in milk. A risk for breastfed children cannot be excluded. Tadalafil 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 tadalafil

A medical history and clinical examination should be performed to diagnose erectile dysfunction and 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).

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 tadalafil 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, stroke, and transient ischemic attacks, chest pain, palpitations, and tachycardia have been reported after marketing and / or during clinical trials. Most patients in which these events were observed, they 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, tadalafil, sexual activity, a combination of these factors, or other factors.

In patients receiving antihypertensive drugs, concomitant administration of tadalafil may cause a decrease 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, concomitant administration of tadalafil 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 tadalafil and other PDE5 inhibitors. The patient should be advised that, in the event of a sudden visual defect, he should stop taking tadalafil and consult a doctor immediately (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 use of tadalafil is not recommended in patients with severe renal impairment.

There are limited clinical data regarding the safety of a single dose of tadalafil in patients with severe hepatic impairment (Child-Pugh Class C). Daily intake has not been evaluated in patients with hepatic impairment. If tadalafil 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 help. If priapism is not treated right away, it can damage penile tissue and permanent impotence.

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

Use with CYP3A4 inhibitors

Tadalafil should be prescribed with caution in patients using strong CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin); An increase in exposure (AUC) to tadalafil has been observed when combined with these drugs (see section Drug interactions and other forms of interaction).

Tadalafil and other treatments for erectile dysfunction.

The efficacy and safety of combining tadalafil with other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied. Patients should be instructed not to use such associations.

Lactose

Tadalafil 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 have been performed with the 10 mg and / or 20 mg dose of tadalafil, 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 values. and the observed Cmax for tadalafil alone. At the daily dose of 400 mg, ketoconazole increases the exposure (AUC) of tadalafil (20 mg) by 4 and increases the Cmax by 22%. Ritonavir, an antiprotease (200 mg twice daily) and CYP3A4, CYP2C9, CYP2C19 and CYP2D6 inhibitor, 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 co-administered. with caution as they may increase plasma tadalafil concentrations (see section 4.4). Therefore, the incidence of the side effects listed in section 4.8 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 mg, 10 mg, and 20 mg) increases the hypotensive effects of nitrates. Therefore, the administration of tadalafil 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 more than 24 hours and was not more detectable 48 hours after the last dose of tadalafil. Therefore, in a patient taking tadalafil 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 48 hours after the last dose of tadalafil 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 association with treatment of one or another of these classes. In another clinical pharmacology study, letadalafil (20 mg) was studied in combination with up to 4 classes of antihypertensive agents. In subjects taking multiple antihypertensive medications, changes in ambulatory blood pressure appear to be correlated with the degree of blood pressure control, and in this study in patients 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 a placebo and 5 mg of finasteride to alleviate 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-year-old man) kg) in some subjects Dizziness and orthostatic hypotension have been observed.

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 significant 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) does not have a clinically relevant effect on exposure (AUC) to warfarin-S or warfarin-R (CYP2C9 substrate), and does not affect changes in warfarin-induced prothrombin rate.

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 frequently reported adverse reactions in patients taking tadalafil for the treatment of erectile dysfunction or benign prostatic hyperplasia were: headache, dyspepsia, back pain and myalgia, the incidence of which increases with increasing tadalafil dose.

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

Summary table of undesirable effects

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 tadalafil and 4,422 patients on placebo) for on-demand treatment and daily intake of erectile dysfunction and daily treatment of benign prostatic hyperplasia.

Frequency convention: very common (≥1 / 10), common (≥1 / 100, minus 1/10), uncommon (≥1 / 1000, minus 1/100), rare (≥1 / 10,000, minus 1 / 1000), very rare (minus 1/10000) and frequency unknown (cannot be estimated from the available data).

Very common

Frequent

Rare

Rare

Immune system disorders.

Hypersensitivity reactions

Angioedema²

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, retinal vascular occlusion 2

Ear and labyrinth disorders.

Tinnitus

Sudden hearing loss

Heart conditions1

Tachycardia, palpitations

Myocardial infarction, unstable angina pectoris2, ventricular arrhythmia2

Vascular disorders

Redness

Hypotension3, hypertension

Respiratory, thoracic and mediastinal disorders.

Nasal congestion

Dyspnea, epistaxis

Gastrointestinal disorders.

Dyspepsia

Abdominal pain, vomiting, nausea, gastroesophageal reflux

Skin and subcutaneous tissue disorders.

Eruption

Urticaria, Stevens-Johnson syndrome2, exfoliative dermatitis2, hyperhidrosis (excessive sweating)

Musculoskeletal and connective tissue disorders.

Back pain, myalgia,

Pain in the extremities

Kidney and urinary tract disorders.

Hematuria

Reproductive system and breast disorders.

Prolonged erections

Priapism2, penile hemorrhage, hemospermia2

General disorders and administration site conditions.

Chest pain1, peripheral edema, fatigue

Facial edema2, sudden cardiac death1,2

(1) Most of the patients had pre-existing cardiovascular risk factors (see section 4.4).

(2) Adverse reactions not observed have been reported in placebo-controlled clinical trials during post-marketing surveillance.

(3) It is reported more frequently in patients taking tadalafil and already being treated with antihypertensive drugs.

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 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 trials 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 report any suspected adverse reaction through the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers.

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.

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