Cialis - June 17, 2019

How Much Does Cialis Cost: Cialis (5 mg) instructions for use, indications. (Other names Tadalafil)

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How Much Does Cialis Cost: Cialis (5 mg) instructions for use, indications. (Other names Tadalafil)

Cialis® (5 mg): instructions for use, indications. (Other names: Tadalafil)

Full description (Cialis® (5 mg)): use, composition, dosage, indications, contraindications, side effects. Other names: Tadalafil

Russian

азақша

Tradename

Cialis®

International non-proprietary name

Tadalafil

Dosage Form

Tablets, film coated, 5 mg

Composition

One tablet contains

active ingredient – tadalafil 5 mg,

excipients: lactose monohydrate 109.655 mg, lactose monohydrate (dry spray) 17.500 mg, hydroxypropyl cellulose (very fine) 2.800 mg, croscarmellose sodium 6.300 mg, hydroxypropyl cellulose 1.225, sodium lauryl sulfate 0.490 mg, microcrystalline cellulose (granule 102), and I / I applied to a cell. mg, magnesium stearate 0.880 mg. composition of the shell: Mix yellow dye (Y-30-12863-A) (lactose monohydrate, hydroxypropyl methylcellulose 2910, titanium dioxide (E171), triacetin, iron (III) yellow oxide (E172)) 8.750 mg. polishing: talc – traces.

Description

Almond-shaped tablets, with a biconvex surface, coated with a yellow color, marked “C 5” on one side.

Pharmacotherapeutic group

Preparations for the treatment of urological diseases. Other drugs for the treatment of urological diseases, including antispasmodics. Drugs for the treatment of erectile dysfunction. Tadalafil.

ATX code G04BE08

Pharmacological properties

Pharmacokinetics

Suction

After ingestion tadalafil is rapidly absorbed. The average maximum concentration (Cmax) in plasma is achieved on average 2 hours after ingestion. The speed and extent of absorption of tadalafil does not depend on food intake, so the drug can be taken regardless of food intake. The time of administration (in the morning or in the evening) has no clinically significant effect on the rate and extent of absorption.

Distribution

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The average volume of distribution is about 63 liters, which indicates that tadalafil is distributed in the tissues of the body. At therapeutic concentrations, 94% plasma tadalafil binds to proteins. Protein binding does not change with renal impairment. In healthy individuals, less than 0.0005% of the injected dose is found in semen.

Metabolism

Tadalafil is mainly metabolized with the participation of the cytochrome P450 CYP3A4 isoenzyme. The main circulating metabolite is methylcateholglucuronide, which is at least 13,000 times less active against PDE5 than tadalafil. Consequently, the concentration of this metabolite is not clinically significant.

Removal

In healthy individuals, the average clearance of tadalafil when taken orally is 2.5 l / h, and the average half-life is 17.5 hours. Tadalafil is excreted mainly in the form of inactive metabolites, mainly with feces (about 61% of the dose) and, to a lesser extent, with urine (about 36% of the dose).

The pharmacokinetics of tadalafil in healthy individuals is linear with respect to time and dose. In the dose range from 2.5 to 20 mg, the area under the concentration-time curve (AUC) increases in proportion to the dose. Equilibrium plasma concentrations are achieved within 5 days while taking the drug once a day.

The pharmacokinetics of tadalafil in patients with dysfunction of erection is similar to the pharmacokinetics of the drug in individuals without dysfunction of erection.

Special Populations

Elderly patients

In healthy elderly people (65 years and older) there is a lower clearance of tadalafil when taken orally, which leads to an increase in the area under the concentration-time curve (AUC) by 25% compared with healthy individuals aged 19 to 45 years . This difference is not clinically significant and does not require dose adjustment.

Patients with renal failure

In clinical studies, when prescribing tadalafil in a dose of 5 to 20 mg, the area under the concentration-time curve (AUC) almost doubled in patients with mild (creatinine clearance from 51 to 80 ml / min) or moderate (creatinine clearance from 31 to 50 ml / min) renal failure, as well as in patients with end-stage renal failure on dialysis. In patients on hemodialysis, Cmax was 41% higher than in healthy individuals. Hemodialysis has little effect on the elimination of tadalafil.

Patients with hepatic impairment

The pharmacokinetics of tadalafil in individuals with mild and moderate hepatic insufficiency is comparable to that in healthy individuals. There are limited clinical data on the safety of the drug in patients with severe hepatic insufficiency (class C according to the Child-Pugh classification). There are no data on the use of tadalafil once a day by patients with liver failure. In the case of the appointment of the drug in the mode of reception once a day, the attending physician should proceed from a careful individual assessment of the ratio of benefits and risks for the patient.

Patients with diabetes

In patients with diabetes mellitus, with the use of tadalafil, the area under the concentration-time curve (AUC) was approximately 19% less than in healthy individuals. This difference does not require dose adjustment.

Pharmacodynamics

Cialis ® improves erection and the possibility of successful sexual intercourse. The drug is valid for 36 hours. The effect appears already after 16 minutes after taking the drug in the presence of sexual arousal.

Cialis® is an effective, reversible selective inhibitor of specific phosphodiesterase type 5 (PDE5) cyclic guanosine monophosphate (cGMP). When sexual arousal causes local release of nitric oxide, inhibition of PDE5 by Cialis® leads to an increase in cGMP levels in the cavernous body of the penis. The result is a relaxation of smooth muscles of the arteries and blood flow to the tissues of the penis, which causes an erection. Cialis® has no effect in the absence of sexual stimulation.

Inhibition of PDE-5 by tadalafil, leading to an increase in cGMP concentration in the cavernous body of the penis, is also observed in the smooth muscles of the prostate gland, bladder and vessels that supply them to the blood. The resulting relaxation of vascular smooth muscle leads to an increase in blood perfusion in these organs, and, consequently, to a decrease in the severity of symptoms of the lower urinary tract benign prostatic hyperplasia (BPH). These vascular effects may be accompanied by inhibition of the activity of the afferent nerves of the bladder and relaxation of the smooth muscles of the prostate gland and the bladder.

In vitro studies have shown that Cialis® is a selective PDE5 inhibitor. PDE5 is an enzyme found in the smooth muscles of the cavernous body, in the smooth muscles of the vessels of the internal organs, in skeletal muscles, platelets, kidneys, lungs and cerebellum. The effect of Cialis® on PDE5 is more active than on other phosphodiesterase. Cialis® is 10,000 times more potent with PDE5 than with PDE1, PDE2, PDE4, and PDE7, which are located in the heart, brain, blood vessels, liver, leukocytes, skeletal muscle, and other organs. Cialis® is 10,000 times more active in blocking PDE5 than PDE3, an enzyme found in the heart and blood vessels. This selectivity for PDE5 over PDE3 is important because PDE3 is an enzyme involved in cardiac muscle contraction. In addition, Cialis® is approximately 700 times more active in relation to PDE5 than in relation to PDE6, an enzyme that is contained in the retina and is responsible for photo transmission. Cialis® also has an effect of 9,000 times more potent on PDE5 compared to its effect on PDE8, PDE9 and PDE10, and 14 times more powerful on PDE5 compared to PDE11. The distribution in tissues and the physiological effects of inhibition of PDE8 – PDE11 have not yet been elucidated.

Cialis® in healthy individuals does not cause significant changes in systolic and diastolic pressure in comparison with placebo in the prone position (the average maximum decrease is 1.6 / 0.8 mm Hg, respectively) and in the standing position (the average maximum decrease is 0.2 / 4.6 mm Hg. Art. respectively). Cialis® does not cause a significant change in heart rate.

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Cialis® does not cause color recognition changes (blue / green), which is explained by its low affinity for PDE6 compared to PDE5. In addition, Cialis® has no effect on visual acuity, electroretinogram, intraocular pressure, and pupil size.

Three studies were conducted on male patients in order to assess the potential impact on spermatogenesis of Cialis® 10 mg daily intake (one 6 month study) and 20 mg (one 6 month and one 9 month study). None of the studies observed an undesirable effect on the morphology of spermatozoa and their mobility. Two studies found a decrease in sperm concentration compared to placebo. In a 9-month study, a decrease in sperm concentration was associated with a higher frequency of ejaculation. The frequency of ejaculation during the 6-month study was not evaluated. In addition, there was no adverse effect on the average concentration of sex hormones, testosterone, luteinizing hormone and follicle-stimulating hormone when taking Cialis® 10 or 20 mg, compared with placebo.

Indications for use

erectile disfunction

signs and symptoms of benign prostatic hyperplasia

erectile dysfunction in patients with benign prostatic hyperplasia.

Sexual stimulation is necessary for the manifestation of the effect of tadalafil.

Cialis® is not intended for use by females.

Dosage and administration

For reception inside.

Erectile Dysfunction (ED)

The usual recommended dose is 10 mg before the intended sexual activity, regardless of the meal.

If taking 10 mg does not give the necessary response, then you may increase the dose to 20 mg of tadalafil. The frequency of the maximum dose – 1 time per day.

Cialis® 10 and 20 mg is intended for use before intended sexual activity and is not recommended for daily use. The drug should be taken at least 30 minutes before the intended sexual activity.

For patients with an expected frequent intake of Cialis® For patients with frequent sexual activity (more than 2 times per week), the recommended frequency of Cialis® is 5 mg 1 time per day, at the same time, regardless of the meal.

Patients can attempt sexual intercourse at any time within 36 hours after taking the drug in order to establish the optimal response time for taking the drug.

It is necessary to conduct a regular assessment of the appropriateness of prolonged daily intake of the drug.

Benign prostatic hyperplasia (BPH)

The recommended dose of Cialis® is 5 mg 1 time per day. The drug should be taken at about the same time, regardless of the time of sexual activity. The duration of treatment is determined by the doctor individually.

In patients with benign prostatic hyperplasia, accompanied by erectile dysfunction, the recommended dosage is 5 mg 1 time per day at approximately the same time.

In case of intolerance to patients with benign prostatic hyperplasia of Cialis® in a dosage of 5 mg, alternative treatment options should be considered.

Erectile Dysfunction and Benign Prostatic Hyperplasia (ED / BPH)

The recommended frequency of taking Cialis® is 5 mg 1 time per day, approximately at the same time.

Special Populations

Dose adjustment is not required in elderly patients (65 years and older), patients with mild and moderate renal failure, patients with diabetes.

For the treatment of erectile dysfunction in patients with hepatic insufficiency, the recommended dose of Cialis® as needed is 10 mg before the intended sexual activity, regardless of the meal. There are limited clinical data on the safety of Cialis® in patients with severely impaired liver function (class C on the Child-Pugh scale). In the case of the appointment of this drug, the attending physician should proceed from a careful individual assessment of the ratio of benefits and risks. There are no data on taking tadalafil in doses exceeding 10 mg in patients with hepatic insufficiency. In the case of the appointment of the drug in this group, the attending physician should proceed from a careful individual assessment of the ratio of benefits and risks for the patient.

Cialis® regimen 1 time per day for the treatment of erectile dysfunction or benign prostatic hyperplasia in patients with liver failure has not been studied.

Cialis® regimen 1 time per day at a dosage of 5 mg for the treatment of erectile dysfunction or benign prostatic hyperplasia is not recommended for patients with severe renal failure.

Children and teenagers under 18 years old

Cialis® is not used to treat erectile dysfunction in children and adolescents under 18 years of age.

Side effects

Adverse reactions occurring more often than in isolated cases are listed according to the following gradation: very often (ge; 10%); often (ge; 1%, 10%); sometimes (ge; 0.1%, 1%); rarely (ge; 0.01%, 0.1%); extremely rarely (0.01%), the frequency is unknown (it is impossible to estimate the frequency of occurrence of reactions from the available data).

Often

headache

nasal congestion

dyspepsia, gastroesophageal reflux

back pain, myalgia, pain in the limbs

tide / blood flow

Sometimes

hypersensitivity reactions

dizziness

blurred vision, pain in the eyeball

tinnitus

tachycardia, heart palpitations, hypotension2, hypertension

shortness of breath, nosebleeds

abdominal pain

rash, hyperhidrosis (excessive sweating)

hematuria, bleeding from the penis, hemospermia

chest pain1

Seldom

angioedema

How Much Does Cialis Cost: Cialis (5 mg) instructions for use, indications. (Other names Tadalafil)

stroke (including stroke in hemorrhagic type), syncope, transient ischemic attacks (TIA) 1, migraine3, seizures / convulsions, transient amnesia

visual disturbances, eyelid swelling, conjunctival hyperemia

non-arterial anterior ischemic optic neuropathy3 (NAPION), retinal vascular occlusion3

sudden hearing loss

myocardial infarction, unstable stenocardia3, ventricular arrhythmia3

urticaria, Stevens-Johnson syndrome 3, exfoliative dermatitis 3

prolonged erection, priapism3

swelling of the face3, sudden cardiac death1,3

1 Observed in patients with preexisting cardiovascular risk factors.

2 In most cases, it was observed in patients who have already taken antihypertensive drugs.

3 Adverse reactions reported during post-marketing studies and not observed in placebo-controlled clinical trials.

Patients who received Cialis® 1 time per day showed a slightly higher frequency of recorded changes on the ECG, primarily sinus bradycardia, compared with placebo. Most of the abnormalities on the ECG were not associated with adverse reactions.

There are limited data on the reactions of patients over 65 years old who received Cialis® for the treatment of erectile dysfunction or benign prostatic hyperplasia during clinical trials. In clinical studies, when taking 5 mg of the drug 1 time per day for the treatment of benign prostatic hyperplasia, dizziness and diarrhea were observed with greater frequency in patients older than 75 years.

Contraindications

hypersensitivity to tadalafil or to any substance included in the preparation

taking drugs containing any organic nitrates

the presence of contraindications to sexual activity in patients with diseases of the cardiovascular system: myocardial infarction in the last 90 days, unstable angina, the occurrence of angina during sexual intercourse, heart failure II-IV classes according to the classification of the New York Heart Association (NYHA), developed during the last 6 months, uncontrolled arrhythmia, arterial hypotension (BP less than 90/50 mm Hg), uncontrolled arterial hypertension, ischemic stroke during the last 6 months

loss of vision in one eye due to non-arterial anterior ischemic optic neuropathy (NAPION) (regardless of the connection with taking PDE5 inhibitors)

simultaneous administration of doxazosin, guanylate cyclase stimulants, such as riociguat, as well as medicines for the treatment of erectile dysfunction

frequent (more than 2 times a week) use in patients with chronic renal failure (CC less than 30 ml / min)

hereditary intolerance to galactose, Lapp-lactase deficiency and glucose-galactose malabsorption

severe renal failure

children and adolescents up to 18 years

Drug interactions

Effect of other drugs on Cialis®

Cialis® is mainly metabolized with the participation of the CYP3A4 enzyme. Taking ketoconazole selective CYP3A4 inhibitor, at a dose of 200 mg per day, increases the effect of the drug (AUC) (10 mg) by 2 times and Cmax by 15% compared with the same indicators with Cialis® monotherapy. Taking ketoconazole at a dose of 400 mg per day increases the effects of Cialis® (AUC) (20 mg) by 4 times and Cmax by 22%. Ritonavir, a protease inhibitor, 200 mg twice daily, an inhibitor of CYP3A4, CYP2C9, CYP2C19 and CYP2D6, increases the effect of Cialis® (20 mg) by 2 times without changing Cmax. Although specific interactions have not been studied, other protease inhibitors, such as saquinavir, as well as other CYP3A4 inhibitors, such as erythromycin, clarithromycin, itraconazole and grapefruit juice, should be taken with caution in conjunction with Cialis®, since an increase in plasma concentrations of the drug can be expected.

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There is the potential for drug interactions between Cialis® and transport proteins (for example, p-glycoprotein) mediated by inhibition of transporters.

Selective CYP3A4 inducer, rifampin (rifampicin, 600 mg per day), reduces the effects of a single dose of Cialis® (AUC) (10 mg) by 88% and Cmax by 46%, relative to AUC and Cmax values ​​with Cialis monotherapy. Reducing the effects of the drug may reduce the effectiveness of Cialis®; the magnitude of the decrease in efficacy is unknown. When taking the drug 1 time per day, you can expect a decrease in the effectiveness of Cialis® in the case of a joint appointment with rifampin. The simultaneous use of other inducers of CYP3A4, such as phenobarbital, phenytoin and carbamazepine, may also lead to a decrease in plasma Cialis® concentration.

Simultaneous administration of antacids (magnesium hydroxide / aluminum hydroxide) and Cialis® reduces the rate of absorption of the drug without changing the area under the pharmacokinetic curve (AUC) for Cialis®.

An increase in the pH of the stomach as a result of taking the histamine H2 receptor blocker nizatidine did not affect Cialis® pharmacokinetics.

The safety and efficacy of using Cialis® in combination with other PDE5 inhibitors or alternative methods of treating erectile dysfunction have not been studied, therefore, the use of such combinations is not recommended.

Effect of Cialis® on other drugs

It is known that Cialis® enhances the hypotensive effect of nitrates. The appointment of Cialis® to patients taking any form of organic nitrates is contraindicated. In the event of a life-threatening condition, when the prescription of nitrates is clinically justified, it is necessary to withstand the 48 hour interval after the last dose of Cialis®. In such conditions, nitrates should be used only under strict medical supervision with appropriate hemodynamic monitoring.

Cialis® does not have a clinically significant effect on the clearance of drugs whose metabolism proceeds with the participation of the cytochrome P450 isoenzyme. Studies have confirmed that Cialis® does not inhibit and does not induce cytochrome P450 isoforms, including CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9 and CYP2C19.

Cialis® has no clinically significant effect on the pharmacokinetics of S-warfarin or R-warfarin. Cialis® does not affect the effect of warfarin on prothrombin time.

Cialis® does not increase the duration of bleeding caused by acetylsalicylic acid.

Cialis® has systemic vasodilating properties and may enhance the action of antihypertensive drugs aimed at lowering blood pressure. In patients with insufficiently controlled arterial hypertension, who took several antihypertensive drugs, in which, a more pronounced decrease in blood pressure was noted. In the overwhelming majority of patients, a decrease in blood pressure was not accompanied by the development of hypotensive symptoms. Patients receiving antihypertensive medication and receiving Cialis® should be given appropriate clinical guidelines. Patients taking antihypertensive drugs should be warned about the possible risk of lowering blood pressure.

When Cialis® was used by healthy volunteers who took doxazosin alpha1-blocker (4-8 mg per day), a significant increase in the anti-hypertensive effect of doxazosin was observed. This effect lasts for at least twelve hours and can manifest by various symptoms, including syncope. Simultaneous use of Cialis® and doxazosin is not recommended.

According to the results of two clinical studies, no significant reduction in blood pressure was observed when Cialis® was used by healthy individuals taking selective alpha1-blockers tamsulosin and alfuzosin. Care must be taken when prescribing Cialis® to patients taking any alpha-blockers, especially elderly people. Treatment should begin with the minimum dosage and gradually adjust.

In clinical studies, the ability of tadalafil to enhance the hypotensive effect of antihypertensive drugs has been studied. The main classes of antihypertensive drugs have been studied, including calcium channel blockers (amlodipine), angiotensin-converting enzyme inhibitors (ACE) (enalapril), beta-adrenergic receptor blockers (metoprolol), thiazide diuretics (bendrofluazide), and angiotensin receptors blockers, angiotens, and thiazide diuretics (bendrofluazide) and blockers of angiotensol receptors, metoprolol, thiazide diuretics (bendrofluazide) and blockers of angiotensin receptors blockers and doses taken alone or in combination with thiazides, calcium channel blockers, beta blockers and / or alpha blockers). Tadalafil (10 mg, with the exception of studies of interactions with angiotensin II receptor blockers and amlodipine, in which a dose of 20 mg was used) did not have a clinically significant interaction with drugs of any of these classes. In a clinical pharmacological study, the interaction of tadalafil (20 mg), taken in combination with several (up to 4) classes of antihypertensive drugs, was studied. In patients taking several antihypertensive drugs, changes in blood pressure, measured on an outpatient basis, were correlated with measures to regulate pressure. In patients whose blood pressure was under careful drug regulation, its reduction was minimal, and was similar to that in healthy study participants. In patients whose blood pressure was not regulated, its decrease was greater, although this decrease did not lead to the appearance of hypotensive symptoms in most of the observed patients. In patients receiving co-prescribed antihypertensive drugs, Tadalafil 20 mg can cause a decrease in blood pressure, which (with the exception of alpha blockers, see above) is usually minimal and most likely does not lead to clinically significant manifestations. Analysis of the third phase of clinical trials showed no difference in the onset of side effects in patients taking tadalafil while taking antihypertensive drugs or in isolation. However, it is necessary to warn patients taking antihypertensive drugs about a possible decrease in blood pressure.

Cialis® (10 mg or 20 mg) did not affect the concentration of alcohol, nor did alcohol affect the concentration of Cialis®. Taking Cialis® did not increase the statistically significant reduction in the average blood pressure caused by alcohol at a dose of 0.7 g / kg, but some patients had postural dizziness and orthostatic hypotension. When taking Cialis® in combination with lower doses of alcohol (0.6 g / kg), arterial hypotension was not observed, and dizziness was noted with the same frequency as when taking one alcohol. Taking Cialis® (10 mg) did not increase the effect of alcohol on cognitive function.

In clinical studies comparing the simultaneous use of 5 mg of Cialis® and 5 mg of finasteride with a placebo and 5 mg of finasteride in the symptomatic treatment of prostate adenoma, no new adverse reactions were registered. Preclinical studies have shown an additional reducing effect on systemic arterial pressure with the combined use of PDE-5 inhibitors and riiiguata. In clinical studies, riociguat showed an increased hypotensive effect of PDE-5 inhibitors. In the studied groups of patients, no evidence of a favorable clinical effect with the combination of such drugs was obtained. Combined use of riociguat with PDE-5 inhibitors, including tadalafil, is contraindicated.

The combination of tadalafil and guanylate cyclase stimulants, such as riociguat, is not recommended because it can lead to symptomatic hypotension.

However, since there has been no formal study of the effects of drug interaction between Cialis® and 5-alpha reductase inhibitors, caution should be exercised when administered together.

Cialis® has no clinically significant effect on the pharmacokinetics or pharmacodynamics of theophylline (CYP1A2 substrate), a non-selective phosphodiesterase inhibitor, with the exception of a slight increase in heart rate (3.5 beats per minute). Despite the insignificant nature of this phenomenon, the possibility of an increase in heart rate must be taken into account while simultaneously prescribing Cialis® and theophylline.

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An increase in the bioavailability of ethinyl estradiol has been noted with Cialis®. A similar increase can be expected with oral administration of terbutaline, although the clinical effects have not been precisely established. Tadalafil (10 mg and 20 mg) does not increase the duration of bleeding caused by acetylsalicylic acid.

Clinical studies on the interaction of Cialis® with antidiabetic drugs have not been conducted.

special instructions

Cialis® is not intended for use in women!

Before starting drug therapy, it is necessary to study the history of the disease and conduct a physical examination of the patient to diagnose erectile dysfunction or benign prostatic hyperplasia and determine the potential causes of their occurrence.

Sexual activity has a potential risk for patients with cardiovascular disease. Before initiating erectile dysfunction therapy, physicians should take into account the patient’s cardiovascular status due to the presence of a certain degree of risk of developing cardiovascular pathology associated with sexual activity. Treatment of erectile dysfunction, including using Cialis®, should not be performed in men with heart diseases for which sexual activity is not recommended.

Like other PDE5 inhibitors, Cialis® has vasodilating properties, which can lead to a transient decrease in blood pressure, and, thus, enhances the hypotensive effect of nitrates.

Before prescribing Cialis® for the treatment of benign prostatic hyperplasia, the patient should be carefully examined for cardiovascular pathologies and in order to exclude prostate carcinoma.

Evaluation of erectile dysfunction should include identifying potential causes and appropriate treatment methods after proper medical examination. The effectiveness of Cialis® in patients who have undergone a non-nerve-saving radical prostatectomy or pelvic cavity surgery has not been established.

Myocardial infarction, sudden cardiac death, unstable angina pectoris, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, heart palpitations and tachycardia were observed in post-marketing and / or clinical studies in patients, most of whom had previously had cardiovascular risk factors. vascular diseases. However, it is not possible to establish with a high degree of certainty whether these phenomena are directly related to these risk factors, taking the drug, sexual arousal, or a combination of these or other factors.

In patients who receive antihypertensive drugs at the same time, the use of Cialis® can lead to a decrease in blood pressure. In the case of the appointment of a daily intake of tadalafil, the attending physician should consider the clinical situation in order to assess the possibility of dose adjustment of antihypertensive drugs.

Care must be taken when prescribing Cialis® to patients taking alpha1-blockers, since the simultaneous use of these drugs in some patients may lead to the development of symptomatic hypotension. Simultaneous administration of doxazosin and Cialis® is not recommended. According to the results of two clinical studies, no significant reduction in blood pressure was observed when Cialis® was used by healthy individuals who took selective tamsulosin alpha1A-blocker.

Visual impairment and cases of non-arterial anterior ischemic optic neuropathy (NAPION) were observed with Cialis® and other PDE5 inhibitors. NAPION causes visual impairment, including total loss of vision. At present it is impossible to determine whether there is a direct link between the development of NAPION and the intake of PDE5 inhibitors or other factors. The patient should be aware that in the event of a sudden loss of vision, he should stop taking Cialis® and immediately consult a doctor. Doctors should also inform patients that people who have had NAPION have an increased risk of re-developing this condition.

A sudden decrease or loss of hearing, which may be accompanied by tinnitus, has been reported in connection with the use of tadalafil. In this case, you should immediately consult a doctor.

Taking into account the increase in drug exposure (AUC), limited clinical experience and the inability to affect clearance through dialysis, taking Cialis® 1 time per day is not recommended for patients with severe renal failure.

Clinical data on the safety of a single dose of Cialis® in patients with severe hepatic insufficiency (Child-Pugh class C) are limited. The use of Cialis® in patients with liver failure 1 time per day for the treatment of erectile dysfunction or benign prostatic hyperplasia has not been studied. In the case of Cialis®, the attending physician should proceed from a careful individual assessment of the ratio of benefits and risks for the patient.

There are reports of the occurrence of priapism. Patients should be informed of the need to immediately seek medical help in the event of an erection lasting 4 hours or more. Late treatment of priapism leads to damage to the tissues of the penis, which can result in long-term loss of potency. Cialis® should be used with caution in patients with a predisposition to priapism (for example, in sickle cell anemia, multiple myeloma or leukemia) or in patients with anatomical deformation of the penis (for example, with angular curvature, cavernous fibrosis or Peyronie’s disease).

Care should be taken when prescribing Cialis® to patients taking potent inhibitors of CYP3A4 (ritonavir, saquinavir, ketoconazole, itraconazole and erythromycin), because while taking these drugs, there was an increase in the effects of Cialis® (AUC).

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The safety and efficacy of combining Cialis® with other PDE5 inhibitors and the treatment of erectile dysfunction has not been studied. Patients should be informed about the inadmissibility of taking Cialis® in such combinations.

Cialis® contains lactose in its composition. Patients with rare hereditary problems of galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption should not take Cialis®.

Data on the use of the drug in patients over 65 years old, receiving Cialis® in clinical trials for the treatment of erectile dysfunction or the treatment of benign prostatic hyperplasia, is limited.

Pregnancy

There are limited data on the use of tadalafil in pregnant women. As a precautionary measure, it is preferable to avoid taking Cialis® during pregnancy.

Lactation

Cialis® should not be used during breastfeeding.

Fertility

In some men, a decrease in sperm concentration was noted.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous machinery

Cialis® has a negligible effect on the ability to drive a vehicle or potentially dangerous machinery. Despite the fact that the incidence of dizziness while taking Cialis® is similar to that on the background of placebo, caution should be exercised during treatment while driving and doing other potentially hazardous activities that require increased concentration and psychomotor speed.

Overdose

Symptoms: When prescribing a single dose of Cialis® to 500 mg for healthy individuals and for patients with multiple dosages up to 100 mg per day, adverse events were similar to those observed when taking the drug in lower doses.

Treatment: In case of overdose, standard symptomatic treatment is necessary. Hemodialysis has a minor effect on Cialis® elimination.

Release form and packaging

On 14 tablets place in a blister strip packaging from a film of polyvinyl chloride and aluminum foil. On 1 or 2 planimetric packagings together with the instruction for medical application in the state and Russian languages ​​place in a cardboard pack.

Storage conditions

Store at room temperature no higher than 25 ° C.

Keep out of the reach of children!

Shelf life

3 years

Do not use after expiration date.

Pharmacy sales terms

On prescription

Name and country of the manufacturer

Lilly del Caribe Inc., Puerto Rico

Name and country of the packer

Lilly SA, Spain

Name and country of registration certificate holder

Eli Lilly East SA, Switzerland

The address of the organization that receives consumer complaints about the quality of products (goods) in the countries of Central Asia and Mongolia. Representative Office of Eli Lilly Vostok SA

Republic of Kazakhstan, 050059, Almaty, st. Ivanilov 21.

Tel: 8 (727) 2 447 447

fax: 8 (727) 2 442 851

Lilly_Safety_CARAGA@lilly.com

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