Brand Cialis online in Australia

What is brand Cialis used for?

Treatment of erectile dysfunction in adult men.

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

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

Conditions for which this medicine may be prescribed

• Erectile dysfunction
• Benign prostatic hyperplasia

Method of administration and dosage of the drug brand Cialis

Dose

Erectile dysfunction in adult men

In general, the recommended dose of Tadalafil Lilly 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. Tadalafil Lilly 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 Tadalafil Lilly (at least twice a week), taking one tablet per day, with lower doses of Tadalafil Lilly 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 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 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 demand administration, the recommended dose of Tadalafil Lilly 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 Tadalafil Lilly 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 Tadalafil Lilly 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 Tadalafil Lilly in the treatment of erectile dysfunction in the pediatric population is not justified.

Administration form

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

Possible side effects of brand Cialis

• Hypersensitivity reaction
• Angioedema
• Headache
• Feeling dizzy
• Stroke
• Syncope
• Transient ischemic attack
• Migraine
• Seizures
• Amnesia
• Blurry vision
• Eye pain
• Visual field defect
• Edema of the eyelids
• Conjunctival hyperemia
• Non-arteritic anterior ischemic optic neuropathy
• Retinal vascular occlusion
• Tinnitus
• Sudden hearing loss
• Tachycardia
• Palpitation
• Myocardial infarction
• Unstable angina
• Ventricular arrhythmia
• Redness
• Hypotension
• Hypertension
• Nasal congestion
• Dyspnoea
• Epistaxis
• Dyspepsia
• Abdominal pain
• Vomiting
• Sickness
• Gastroesophageal reflux
• Acne
• Hives
• Stevens-Johnson syndrome
• Exfoliative dermatitis
• Hyperhidrosis
• Back pain
• Myalgia
• Pain in the extremities
• Hematuria
• Prolonged erection
• Priapism
• Bleeding from the penis
• Hemospermia
• Chest pain
• Peripheral edema
• Tired
• Facial edema
• Sudden cardiac death
• Sinus bradycardia

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Summary of the safety profile

The most common side effects reported in patients taking Tadalafil Lilly 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 Tadalafil Lilly.

The reported side effects were transient and generally mild or moderate. Most headaches reported with Tadalafil Lilly 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 Tadalafil Lilly 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 (≥ 1/10), common (≥ 1/100, minus 1/10), rare (≥ 1/1000, minus 1/100), rare (≥ 1 / 10,000, minus 1 / 1000), very rare (minus 1 / 10,000) and frequency unknown (cannot be estimated from the available data).

Redness

Nasal congestion

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 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 are asked to report any suspected adverse reactions through the national reporting system listed in Appendix V.

Contraindications: when not to use this medicine?

• Hypersensitivity to tadalafil
• Contraindication for sexual activity.
• Myocardial infarction less than 3 months
• Angina that manifests during sex
• NYHA II-IV class heart failure in the last 6 months
• Alterations of the uncontrolled rhythm.
• Hypotension minus 90/50 mmHg
• Uncontrolled high blood pressure
• Stroke in the last 6 months
• Loss of vision in one eye due to non-arteritic anterior ischemic optic neuropathy
• Prostate cancer
• Severe kidney failure
• Galactose intolerance
• Lactase deficiency
• Glucose malabsorption syndrome
• Galactose malabsorption syndrome
• Excesive drinking

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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, Tadalafil Lilly is contraindicated in patients receiving nitrates in any form (see section Interactions with other medicinal products and other forms of interaction). Tadalafil Lilly should not be used in men with heart disease and 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 suffering from unstable angina or having angina pain during sexual 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.
• 6666666

Tadalafil Lilly 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)

Presentation of this medicine

Aluminum / PVC blisters in boxes of 28 film-coated tablets.

Appearance and shape

The tablets are light yellow in the shape of an almond, with the inscription | C 5 "on one side.

brand Cialis: its other forms

• brand Cialis 5 mg film-coated tablet, box of 84
• brand Cialis 10 mg film-coated tablet, box of 4
• brand Cialis 20 mg film-coated tablet, box of 4
• brand Cialis 20 mg film-coated tablet, box of 8
• brand Cialis 20 mg film-coated tablet, box of 12

Composition of the drug brand Cialis

* per unit dose Active ingredients: Tadalafil Thinners with known effects? : Tablet core: lactose monohydrate, film coating: lactose monohydrate Other excipients: croscarmellose sodium, hydroxypropyl cellulose, microcrystalline cellulose, sodium lauryl sulfate, magnesium stearate, hypromellose, triacetin, titanium dioxide, yellow iron oxide and talc Effects using machines

Tadalafil Lilly has a negligible influence on the ability to drive and use machines. Although the frequency of dizziness reported in the placebo group and the tadalafil group in clinical studies has been similar, patients should know how they react to Tadalafil Lilly before driving or using machines.

Warnings and precautions for use

• Reserved for men over 18
• History of pelvic surgery in men.
• Cardiovascular risk
• Visual abnormality
• Hearing loss
• Liver failure
• Priapism
• Anatomic malformation of the penis.
• Predisposition to priapism.

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Before treatment with Tadalafil Lilly

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 Tadalafil Lilly in patients who have had pelvic surgery or radical prostatectomy without preserving the nerve strips is unknown.

Cardiovascular damage

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, Tadalafil Lilly, 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 such as doxazosin, concomitant administration of Tadalafil Lilly 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 disorders.

Visual abnormalities and cases of NOIAN (anterior non-arteritic ischemic optic neuropathy) have been reported with Tadalafil Lilly and other PDE5 inhibitors. Observational data analyzes suggest an increased risk of acute NOIAN after administration of tadalafil or other PDE5 inhibitors in men with erectile dysfunction. This risk can affect all patients exposed to tadalafil. Therefore, patients should be advised that, in the event of a sudden visual defect, they should stop taking Tadalafil Lilly and seek immediate medical attention (see section 4.3).

Sudden decrease or loss of hearing.

Sudden hearing loss has been reported with the use of tadalafil. Although associated risk factors were present in some cases (such as age, diabetes, hypertension, or a history of hearing loss), patients should be advised to stop taking tadalafil and seek immediate medical attention in the event of a sudden decrease or loss. of hearing.

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 Tadalafil Lilly is not recommended in patients with severe renal impairment.

There are limited clinical data on the safety of the single dose of Tadalafil Lilly 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 Tadalafil Lilly 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.

Tadalafil Lilly 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

Tadalafil Lilly 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).

Tadalafil Lilly and other treatments for erectile dysfunction.

The efficacy and safety of the combination of Tadalafil Lilly 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 Lilly contains lactose. Patients with hereditary galactose intolerance, Lapp lactase deficiency, or glucose or galactose malabsorption should not take this medicine.

Mechanism of action: how does it work?

Pharmacotherapeutic group: urological, drugs used in erectile dysfunction, ATC code: G04BE08.

Mechanism of action

Tadalafil is a selective and reversible inhibitor of phosphodiesterase type 5 (PDE5), specific for cyclic guanosine monophosphate (cGMP). When sexual stimulation causes local nitric oxide release, PDE5 inhibition by tadalafil leads to increased cGMP levels in the corpora cavernosa. This results in relaxation of smooth muscles and blood flow to the tissues of the penis, allowing an erection to be obtained. Tadalafil has no effect in the treatment of erectile dysfunction in the absence of sexual stimulation.

The effect of PDE5 inhibition on cGMP concentration in the corpora cavernosa is also observed in the smooth muscles of the prostate and bladder and in its vascularization. This results in vascular relaxation, resulting in increased blood perfusion, which could be the mechanism by which symptoms of benign prostatic hyperplasia are reduced. To these vascular effects could be added the inhibition of the afferent nervous activity of the bladder and the relaxation of the smooth muscles of the prostate and the bladder.

Pharmacodynamic effects

In vitro studies have shown that tadalafil is a selective PDE5 inhibitor. PDE5 is an enzyme found in the smooth muscles of the corpora cavernosa, vascular and visceral smooth muscles, skeletal muscles, platelets, kidneys, lungs, and cerebellum. The effect of tadalafil is greater in PDE5 than in other phosphodiesterases. The effect of tadalafil

it is more than 10,000 times more potent in PDE5 than in PDE1, PDE2, and PDE4, enzymes found in the heart, brain, blood vessels, liver, and other organs. The effect of tadalafil is more than 10,000 times more powerful in PDE5 than in PDE3, an enzyme found in the heart and blood vessels. This selectivity for PDE5 compared to PDE3 is important because PDE3 is involved in cardiac contractility. Furthermore, tadalafil is approximately 700 times more potent in PDE5 than in PDE6, an enzyme present in the retina that is responsible for phototransduction. Tadalafil is also more than 10,000 times more powerful in PDE5 than in enzymes PDE7 to PDE10.

Clinical efficacy and safety

Tadalafil administered to healthy subjects showed no significant difference, compared to placebo, in systolic and diastolic blood pressure at bedtime (mean maximum decrease of 1.6 / 0.8 mm Hg, respectively), systolic and diastolic blood pressure while standing (average maximum fall of 0.2 / 4.6mm Hg, respectively), nor significantly altered heart rate.

In a study to assess the effects of tadalafil on vision, the Farnsworth-Munsell 100 color test did not detect any change in color distinction (blue / green). This result is consistent with the low affinity of tadalafil for PDE6 compared to PDE5. In all clinical studies, changes in color vision were rarely reported (minus 0.1%).

Three studies in men have been conducted to assess the potential effect of Tadalafil Lilly 10 mg (one 6-month study) and 20 mg (6-month study and 9-month study), administered daily, on spermatogenesis. In two of these studies, there was a decrease in sperm count, as well as a decrease in sperm concentration, related to tadalafil treatment, but it is not likely to be of clinical significance. These effects have not been associated with

changes in other parameters, such as sperm motility and morphology, as well as FSH (follicle-stimulating hormone) level.

Erectile dysfunction

Three clinical studies evaluated the response period to Tadalafil Lilly on demand in 1054 patients on an outpatient basis. Tadalafil statistically significantly improves erectile function and the possibility of having successful sexual relations up to 36 hours after taking it, as well as the possibility that patients obtain and maintain sufficient erections to have successful sexual relations. , from the 16th minute after taking the dose compared to placebo.

In a 12-week study of 186 patients (142 on tadalafil and 44 on placebo) with erectile dysfunction secondary to spinal cord injury, tadalafil significantly improved erectile function and led to an average percentage of sexual intercourse. successful per subject treated with tadalafil 10 or 20 mg (flexible dose, on request) of 48% in patients taking tadalafil compared to 17% in patients treated with placebo.

For the evaluation of tadalafil at doses of 2.5, 5 and 10 mg taken daily, three clinical trials were initially performed in 853 patients with erectile dysfunction of mild, moderate or severe severity, of various etiologies, ages (range 21-82) and different ethnic origins. In the two efficacy studies in the general population, the average percentage of successful intercourse attempts was 57 and 67% in the group of patients treated with Tadalafil Lilly 5 mg, 50% in the group of patients treated with Tadalafil Lilly 2.5 mg, compared to 31% and 37% with placebo. In the study of patients with erectile dysfunction secondary to diabetes, the mean percentage of successful sexual attempts was 41 and 46% in the group of patients treated with Tadalafil Lilly 5 mg and 2.5 mg, respectively, compared to 28% with placebo. Most of the patients in these three studies responded to pre-order therapy with PDE5 inhibitors. In a later study,

217 patients who had never been treated with PDE5 inhibitors were randomized to Tadalafil Lilly 5 mg taken daily versus placebo. The average percentage of successful attempts at sexual intercourse was 68% for patients taking Tadalafil Lilly compared to 52% for patients taking placebo.

Benign prostatic hyperplasia

Tadalafil Lilly has been studied in 4 12-week clinical studies in more than 1,500 patients with signs and symptoms of benign prostatic hyperplasia.

The improvement with Tadalafil Lilly 5 mg in the total score of the IPSS (International Prostate Symptom Score) questionnaire in the four studies was -4.8, -5.6, -6.1 and -6.3 compared to -2, 2, -3.6, -3.8 and -4.2 with placebo. Improvements in the total score of the IPSS questionnaire occurred from the first week. In one of the studies, which also included the administration of tamsulosin 0.4 mg as an active comparator, the improvements in the total IPSS questionnaire score with Tadalafil Lilly 5 mg, tamsulosin and placebo were respectively - 6, 3, -5.7 and -4.2 .

One of these studies evaluated the improvement of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia in patients with both pathologies. Improvements in the erectile function domain score of the International Erectile Function Index (IIEF) questionnaire and in the total score of the IPSS questionnaire in this study were 6.5 and - 6.1 with Tadalafil Lilly 5 mg, compared to 1.8 and -3.8 with placebo. The average percentage of successful sexual intercourse per subject was 71.9% with Tadalafil Lilly 5 mg compared to 48.3% with placebo.

Effect maintenance was assessed in the open phase in the extension phase of one of the studies in which it was demonstrated that the improvement in the total score of the IPSS questionnaire observed at 12 weeks was maintained for up to 1 year. additional treatment with Tadalafil Lilly 5 mg.

Pediatric population

A study with tadalafil has only been performed in the pediatric population in children with Duchenne muscular dystrophy and no evidence of efficacy has been found. The study was randomized into 3 parallel, double-blind, placebo-controlled groups, including 331 children aged 7 to 14 years with Duchenne muscular dystrophy who received concurrent corticosteroid treatment. The study included a 48-week double-blind period during which patients were randomized to receive tadalafil 0.3 mg / kg, tadalafil 0.6 mg / kg or placebo daily. The efficacy of tadalafil has not been demonstrated in terms of reducing the decrease in exercise capacity measured by distance traveled.

6 minutes, which was the main criterion. The average variation in distance traveled in 6 minutes at 48 weeks of treatment (least squares method) was -51.0 meters (m) in the placebo group, compared to -64.7 m in the tadalafil 0 group, 3 mg / kg (p = 0.307) and -59.1 m in the tadalafil 0.6 mg / kg group (p = 0.538). Furthermore, analysis of secondary criteria did not show any efficacy. The overall safety results in this study were generally consistent with the known safety profile of tadalafil and with the expected adverse reactions in a pediatric population with Duchenne muscular dystrophy receiving corticosteroids.

The Australian Medicines Agency has waived the obligation to present the results of studies carried out in all subgroups of the pediatric population in the treatment of erectile dysfunction. See the Dosage and Method of Administration section for information on pediatric use.

Interactions: do not take this medicine with ..

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 Tadalafil Lilly to patients receiving nitrates in any form is contraindicated (see section 4.3). Results of a clinical study

performed on 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 no longer detectable 48 hours after the last dose of tadalafil. Therefore, in a patient taking Tadalafil Lilly 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 last dose of Tadalafil Lilly 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 at the same time, tadalafil 20 mg 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.

Incompatibilities

Aimlessly.

How to react in case of 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.

brand Cialis: pregnancy, lactation and fertility

Tadalafil Lilly 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

Preclinical safety data section). As a precaution, it is best to avoid the use of Tadalafil Lilly 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 Lilly 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).