Cialis tablets to increase potency and strengthen erections. Cialis: instructions for use Cialis 5 milligrams

Cialis is a drug (tablets) that belongs to the category of drugs for the treatment of urological diseases. The instructions for use highlight the following features:

Sold only with a doctor's prescription
During pregnancy: contraindicated
When breastfeeding: contraindicated
In childhood: contraindicated
For liver dysfunction: with caution
If renal function is impaired: with caution

Package

Cialis is a drug that helps relax the smooth muscles of the arteries, thereby increasing blood flow to the tissues of the penis and increasing the likelihood of achieving and maintaining an erection sufficient for sexual intercourse; in the absence of sexual arousal it is ineffective.

Release form and composition

The dosage form of Cialis is film-coated tablets:

2.5 mg: almond-shaped, filmy shell of light yellow-orange color; on one side there is an engraving - “C 2 1/2” (14 pcs in a blister, made of laminated Al foil and PVC/PE/PCTFE film; 1 or 2 blisters in a cardboard pack);
5 mg: almond-shaped, filmy shell of light yellow color; on one side there is an engraving “C 5” (14 pieces in a blister; 1 or 2 blisters in a cardboard pack);
20 mg: almond-shaped, yellow film coat; on one side there is an engraving - “C 20” (1 piece in a blister, 1 blister in a cardboard pack; 2 pieces in a blister, 1, 2 or 4 blisters in a cardboard pack).

Composition of 1 tablet:

active ingredient: tadalafil – 2.5/5/20 mg;
auxiliary components: hyprolose (hydroxypropylcellulose), lactose monohydrate, MCC (microcrystalline cellulose), croscarmellose sodium, sodium lauryl sulfate, magnesium stearate;
film coating: opadry yellow [triacetin, hypromellose, lactose monohydrate, titanium dioxide, iron oxide red (for 2.5 mg tablets), iron oxide yellow].

Pharmacological properties

Pharmacodynamics

Tadalafil is a reversible selective inhibitor of the specific PDE-5 (phosphodiesterase type 5) cGMP (cyclic guanosine monophosphate). During sexual arousal, local release of nitric oxide occurs, which leads to the suppression of PDE-5 by tadalafil and an increase in cGMP levels in the corpus cavernosum. As a result of this action, the smooth muscles of the arteries relax, and blood flows to the tissues of the penis, which leads to an erection. In the absence of sexual arousal, tadalafil does not show its effect.

PDE-5 is present not only in the smooth muscles of the corpus cavernosum, but also in skeletal muscles, in the walls of blood vessels of internal organs, lungs, kidneys, platelets and the cerebellum. Tadalafil has a much less active effect on other types of phosphodiesterases. Its effect on PDE-5 is 10,000 times stronger than on PDE-1, PDE-2, PDE-4 and PDE-7, which are localized in the brain, heart, liver, skeletal muscles, blood vessels, white blood cells and other organs. This selectivity of tadalafil is very important, since other phosphodiesterases (except PDE-5) are involved in vital processes occurring in the body. Tadalafil is 700 times more potent against PDE5 than PDE6, and 9000 times more potent against PDE5 than it is against PDE8, PDE9, and PDE10. Compared to PDE-11, the activity is 14 times higher.

Cialis improves erection and increases the likelihood of having full sexual intercourse.

In healthy individuals, there were no significant changes in blood pressure compared to placebo in the standing and lying position, as well as heart rate. Tadalafil does not affect visual acuity, color recognition, pupil size, intraocular pressure and electroretinogram.

The drug does not affect the morphology and motility of sperm. Only one study reported a decrease in mean sperm concentration compared to placebo, which was associated with increased ejaculation. Cialis also does not affect the average concentrations of sex hormones, follicle-stimulating hormone, luteinizing hormone and testosterone.

In the course of clinical studies, when using the drug once a day, an improvement in erection was observed in all degrees of severity of erectile dysfunction.

Pharmacokinetics

Tadalafil is rapidly absorbed after taking the tablets orally. The degree and rate of absorption do not depend on food intake, as well as the time of taking the drug (morning or evening). The maximum plasma concentration of tadalafil is achieved after approximately 2 hours.

The AUC (area under the concentration-time curve) of tadalafil in the dose range of 2.5–20 mg increases proportionally to the dose. After 5 days of daily single dosing of Cialis, steady-state plasma concentrations of tadalafil are achieved.

The pharmacokinetic parameters of the drug in patients with erectile dysfunction are similar to those in healthy individuals without erectile dysfunction.

Tadalafil is distributed in the tissues of the body. The average volume of distribution is about 63 liters. Tadalafil is 94% bound to plasma proteins (this figure does not change with impaired renal function). Less than 0.0005% of the dose taken is found in semen in healthy individuals.

As a result of the metabolism of tadalafil, methylcatechol glucuronide is formed (the main circulating metabolite). Its activity is 13,000 times lower than that of tadalafil, so the concentration of this metabolite has no clinical significance.

The half-life averages 17.5 hours. About 61% of the dose taken is excreted in feces and approximately 36% in urine (the drug is mainly excreted in the form of inactive metabolites).

Indications for use

Cialis is indicated for use in the treatment of erectile dysfunction in adult men.

Contraindications

Absolute:

simultaneous use with doxazosin and other drugs for the treatment of erectile dysfunction;
simultaneous use with drugs containing any organic nitrates;
pathologies of the cardiovascular system in which sexual activity of patients is undesirable [unstable angina, myocardial infarction during the last 3 months, ischemic stroke over the last 6 months, angina attacks during sexual intercourse, CHF (chronic heart failure) according to the NYHA classification - II- Class IV, arterial hypotension with a decrease in blood pressure (BP) ≤90/50 mm Hg. Art., uncontrolled arterial hypertension, uncontrolled arrhythmias];
optic nerve atrophy and vision loss due to acute ischemia of the anterior segment of the optic nerve (regardless of whether the condition is associated with the use of PDE-5 inhibitors);
chronic renal failure with CC (creatinine clearance) ≤30 ml/min with frequent (more than 2 times a week) use;
lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome;
children and adolescents up to 18 years of age;
hypersensitivity to tadalafil or other substances included in the drug.

Relative (Cialis is taken with caution due to the increased likelihood of complications):

severe liver failure class C on the Child-Pugh scale (there is insufficient research data on the use of the drug in this category of patients);
simultaneous use with α 1 -blockers (in some cases it can cause symptomatic arterial hypotension);
simultaneous use with antihypertensive drugs and strong inhibitors of the CYP3A4 isoenzyme (saquinavir, ritonavir, ketoconazole, erythromycin, itraconazole);
predisposition to priapism developing as a result of sickle cell anemia, leukemia, multiple myeloma;
anatomical deformation of the penis (cavernous fibrosis, Peyronie's disease, angular curvature).

When diagnosing erectile dysfunction, it is necessary to identify the main potential cause of the pathology in order to conduct an appropriate examination of the patient and determine treatment tactics and the most likely contraindications.

Instructions for use of Cialis: method and dosage

Cialis tablets are taken orally, regardless of food intake, but no later than 16 minutes before planned sexual activity.

frequent sexual activity (>2 times a week): 5 mg per day for 1 dose, at the same time; depending on individual tolerance of the drug, the daily dose may be reduced to 2.5 mg;
infrequent sexual activity (<2 раз в неделю): по 20 мг за 1 прием, непосредственно перед предполагаемой сексуальной активностью.

The maximum dose of tadalafil per day is 20 mg.

Within 36 hours of using Cialis, you can attempt sexual intercourse at any convenient time to determine the optimal response time to taking the pill.

Side effects

Side effects that occurred more often than in single episodes (according to the following gradation: ≥10% - very often; ≥1% -<10% – часто; ≥0,1–<1% – нечасто; ≥0,01–<0,1% – редко; <0,01% – очень редко; частота неизвестна – по имеющимся данным оценить частоту реакций невозможно):

nervous system: very often – headache; often – dizziness; rarely - stroke, including stroke (acute cerebrovascular accident) of the hemorrhagic type, TIA (transient ischemic attack) 1, transient amnesia, fainting 1, migraine 3, epileptic seizures;
organ of vision: infrequently – pain in the eyeball, blurred vision; rarely - swelling of the eyelids, impaired visual fields, non-arterial anterior ischemic optic neuropathy 3, injection of the vessels of the sclera of the eyeball, obstruction of the patency (occlusion) of the retinal vessels 3;
immune system: uncommon – allergic reactions;
organ of hearing and labyrinthine disorders: rarely - sudden deafness 2;
CVS (cardiovascular system): uncommon – tachycardia, sudden palpitations, increased blood pressure, decreased blood pressure (in patients taking antihypertensive drugs); rarely - ventricular arrhythmias 3, myocardial infarction, unstable angina 3;
respiratory system: often – dry nasal congestion; infrequently - shortness of breath; rarely – epistaxis (nosebleeding);
Gastrointestinal tract (gastrointestinal tract): often – indigestion; uncommon – gastroesophageal reflux, abdominal pain;
skin and subcutaneous tissue: uncommon – hyperhidrosis, rash; rarely – Stevens-Johnson syndrome 3, exfoliative dermatitis 3, urticaria;
musculoskeletal and connective tissue: often – myalgia, back pain;
genitals and mammary gland: rarely – priapism 3, prolonged erection;
general disorders: infrequently – chest pain 1; rarely - facial swelling 3, sudden cardiac death 1.3.

Notes

1 – recorded in patients with a history of cardiovascular risk factors. But it is not possible to reliably determine whether these reactions are directly related to previously observed risk factors, to the patient’s sexual arousal, to taking tadalafil, or to a combination of existing or other factors.

2 – sudden hearing loss was recorded in several cases during post-marketing and clinical studies of the use of all PDE-5 inhibitors, including tadalafil.

3 – adverse reactions recorded during post-marketing studies, but not observed in clinical placebo-controlled studies.

Overdose

When taking tadalafil in doses up to 500 mg per day once (in healthy individuals) and in doses up to 100 mg per day multiple times (in individuals with erectile dysfunction), the undesirable effects of Cialis were similar to the adverse reactions that occurred when taking lower doses.

In case of drug overdose, standard symptomatic therapy is prescribed. Hemodialysis is practically ineffective.

special instructions

There is evidence of cases of priapism due to the use of PDE-5 inhibitors, including tadalafil. Patients should be advised to seek immediate medical attention if they have an erection lasting more than 4 hours. Untimely treatment of priapism can lead to damage to the tissue of the penis, which can result in irreversible impotence.

NAPION (non-arterial anterior ischemic optic neuropathy) is a cause of visual impairment, up to its complete loss. There are rare data from post-marketing observations of episodes of development of NAPION associated in time with therapy with PDE-5 inhibitors. Today it is impossible to determine whether the development of NAPION directly depends on the use of PDE-5 inhibitors, or whether other factors influence it. Patients with sudden loss of vision should immediately stop taking tadalafil and seek help from specialists. It must be taken into account that if there is a history of NAPION, the risk of recurrence is increased.

There is no data on the effectiveness of Cialis in patients after pelvic surgery and/or radical neurosparing prostatectomy.

The incidence of dizziness during treatment with tadalafil and when taking placebo is the same. Despite this, during treatment you should be careful when driving vehicles and engaging in other potentially hazardous activities that require rapid psychomotor reactions and increased concentration.

Use during pregnancy and lactation

Cialis is used only in men. The drug is not intended for use in women.

Use in childhood

According to the instructions, Cialis is prohibited from being prescribed to children and adolescents under 18 years of age.

For impaired renal function

In case of severe renal failure, the use of Cialis is possible only in cases of extreme necessity and with extreme caution.

In patients with moderate renal failure (creatinine clearance 31–50 ml/min), back pain was reported more often than in patients with mild renal failure (creatinine clearance 51–80 ml/min) or healthy volunteers.

When creatinine clearance is 50 ml/min or less, Cialis is prescribed with caution.

For liver dysfunction

In case of severe liver failure, Cialis tablets are used with extreme caution and only in cases of extreme necessity.

Drug interactions

Cialis is metabolized mainly with the participation of the enzyme CYP3A4, resulting in an effect on tadalafil when used together with the following substances/drugs:

ketoconazole: enhances the effects of tadalafil;
ritonavir and presumably other HIV protease inhibitors (saquinavir) and CYP3A4 inhibitors (erythromycin and itraconazole): increase the activity of tadalafil;
rifampin (rifampicin): reduces the plasma concentration of tadalafil;
antacids (magnesium hydroxide, aluminum hydroxide): reduce the rate of its absorption without changing AUC;
nizatidine (H 2 antagonist, increasing the pH of gastric juice): has no effect on the pharmacokinetics of tadalafil;
other drugs for the treatment of erectile dysfunction: interaction with Cialis has not been studied, but the use of such combinations is not recommended.

The effect of tadalafil on other substances/drugs when used in combination:

nitrates: their hypotensive effect increases; Cialis therapy is contraindicated when using nitrates;
drugs metabolized with the participation of cytochrome P450 isoenzymes: tadalafil does not induce or inhibit cytochrome isoenzymes, and therefore does not have a clinically significant effect on the clearance of these drugs;
warfarin: tadalafil does not affect its effectiveness;
acetylsalicylic acid: the duration of bleeding does not increase;
antihypertensive drugs: due to the systemic vasodilatory properties of tadalafil, it is possible to enhance the effect of antihypertensive drugs aimed at lowering blood pressure; with such a combination, patients should be given appropriate recommendations for joint therapy;
tamsulosin (selective α 1 A-blocker): no significant decrease in blood pressure (when using tadalafil in healthy individuals) was observed;
doxazosin (α 1-adrenergic blocker): the hypotensive effect of doxazosin is enhanced, manifested by a decrease in blood pressure, up to fainting;
theophylline: there is no clinically significant effect on pharmacokinetics and pharmacodynamics;
ethanol: no mutual influence of alcohol (at a dose of up to 0.6 g/kg) with tadalafil was observed; high doses of alcohol (>0.7 g/kg) did not produce a significant decrease in mean blood pressure, but orthostatic hypotension and postural dizziness were recorded in some patients.

Analogs

Analogues of Cialis are: Afalaza, Viagra, Verona, Vizarsin, Viasan-LF, Zidena, Impaza, Yohimbine hydrochloride, Dynamico, Maxigra, Tornetis, Sirbida, Silafil, Sildenafil, Cialis Forte, Cialis Soft, Cialis Capsules, Olmax Strong, Rileys.

Terms and conditions of storage

Store at a temperature not exceeding 30 °C. Keep away from children.

Shelf life – 3 years.

Sooner or later in a man’s life, various disorders of sexual life arise. Moreover, pathologies can be observed at any age. This is especially true for men over 50 years of age. Absent or premature ejaculation is quite common in the modern world. In case of erectile dysfunction, doctors prescribe special selective inhibitors. These drugs include Cialis tablets. The drug is used for any character. What is Cialis, how does it work, and in what dosage should it be taken?

Cialis is used to treat erectile dysfunction in men. At the same time, the medicine does not affect libido levels. The main active component of Cialis is tadalafil. It is thanks to him that an erection not only occurs, but also lasts the required amount of time until the natural process of ejaculation.

In pharmacology, Cialis is included in the list of drugs that are photodiesterase type 5 inhibitors (PDE 5). This group of drugs eliminates the symptoms of impotence in men. The effectiveness of the drug is observed only in the case of normal sexual desire and desire of the man. Only with sexual stimulation and psychological mood will a full-fledged long-term erection occur after taking a Cialis tablet.

How does this drug work? Everything is very simple. Tadalafil releases nitric oxide in the blood, dilates blood vessels, and relaxes the smooth muscles of the pelvis. This accelerates the flow of blood to the cavernous bodies of the penis, which allows a full erection to occur. The outflow of blood from the penis will occur only during natural ejaculation.

Cialis: instructions for use

The instructions for use of Cialis indicate that the drug is relatively safe for the general health of men. Thus, tadalafil directly affects the smooth muscles of the pelvis, vessels and veins of the cavernous and cavernous bodies of the penis. At the same time, the effect of the main active substance does not apply to the entire cardiovascular system.

Taking the medicine does not change the composition and quality of sperm. Therefore, even with impotence, after taking the pill, men retain their reproductive function. Also, the drug does not disrupt hormonal levels and does not reduce testosterone levels. Tadalafil is well absorbed after oral administration. Also, the peak effectiveness of the drug does not depend on the amount and time of food intake. The instructions indicate that Cialis is prescribed to men with various erectile dysfunction:

Insufficient erection;
Absent erection;
Premature ejaculation.

Contraindications for use

Like any other selective inhibitor, Cialis has its contraindications for use. First of all, it should not be used by those young people who have an individual intolerance to tadalafil. Otherwise, life-threatening allergic reactions may occur. Men taking nitrates should not take the medication.

Cialis instructions also highlight the following factors prohibiting the use of tablets:

Age up to 18 years;
Female;
Severe heart and vascular diseases;
A stroke or myocardial infarction suffered in the last 3 months;
Heart failure of the second pit;
Arterial hypotension;
Predisposition to priapism;
Leukemia;
Multiple myeloma;
Marked curvature of the penis;
Peyronie's disease.

Cialis should be taken with extreme caution in case of severe pathologies of the liver and kidneys. Also, doctors do not advise taking any selective inhibitors simultaneously with any doses of adrenergic blockers (alpha).

Adverse reactions

Side effects occur very rarely. Basically, in 95% of cases, Cialis is tolerated easily and without consequences. Headaches may occur when taking the tablet. Also, some patients noted the development of back pain. A common side effect of Cialis is nasal congestion.

Other reactions include:

Facial redness;
Myalgia;
Visual impairment;
Increased sweating;
Nausea;
Dizziness.

If you are allergic to any group of medications, you should be careful when taking Cialis. A man may experience allergic reactions in the form of anaphylactic shock or Quincke's edema. Medicine has some data indicating that taking an increased dose of the pathogen sometimes provokes priapism. If a stable erection persists for more than 4 hours in a row, you should consult a doctor. The specialist will give an injection that will eliminate agitation. Priapism is often accompanied by pain in the penis, scrotum, and anus.

Cialis dosage 5 mg or 20 mg?

Both the original drug and the generic are available in two dosages: 5 and 20 milligrams. The time of erection and its duration also depend on the dosage. To begin with, doctors recommend taking 5 mg of tadalafil. Starting with the minimum dosage, you can establish the optimal, safe dose for a man. The instructions for use say that Cialis 5 mg can be used to treat erectile dysfunction in a course.

After five days of taking tablets with this dosage, the maximum concentration of tadalafil in the body is reached. Thus, a man can have sexual intercourse at any time. This stimulant is suitable for those who are used to leading an active sex life. And daily use of a 5 mg tablet eliminates mild symptoms of erectile dysfunction and has a beneficial effect on the psycho-emotional background. Thus, the minimum dose is allowed for use every day. A man is not subject to time limits and can enter into intimate relationships whenever he wants.

According to numerous reviews from men and recommendations from doctors, Cialis 20 mg is used for a single dose. This dosage allows one-time elimination of the symptoms of impotence, but does not cure it. Due to the high concentration of tadalafil, an erection occurs within 10-15 minutes after taking the medicine. The positive effect will last for 36 hours. Therefore, 20 mg of the drug can be taken no more than once every 2-3 days.

How to take Cialis?

Taking any dose of Cialis does not depend on food intake or time of day. The tablet is taken 15-20 minutes before the intended sexual intercourse. If 20 mg is used, you can take the tablet in advance. If a man is prescribed Cialis 5 mg daily, it is important to follow the same dosage time. So, for example, the drug is drunk every morning. Urologists advise periodically taking a course of 5 mg tablets in the presence of prostatitis or prostate adenoma to prevent erectile dysfunction.

Compatibility of Cialis with other medications

Cialis is a strong drug, and also synthetic. Therefore, it is important to consider its compatibility with other products. Only a doctor can help establish compatibility. It is strictly prohibited to prescribe any medications on your own. Otherwise there will be a negative impact.

Thus, this stimulant cannot be combined with Rifampicin and Erythromycin. This is due to the fact that these antibacterial drugs react with the components of the inhibitor. The simultaneous use of antibiotics and a pathogen can provoke an overdose of the active substance tadalafil. Also, you should not take Cialis with other stimulants, nitrates.

Is Cialis compatible with alcohol? Experts note their compatibility. A small amount of alcoholic beverages does not have a negative effect on the absorption and effects of the drug. But, excessive amounts of alcohol together with tadalafil cause headaches, migraines, and dizziness. If a man has heart, liver, or kidney diseases, Cialis and alcohol cannot be combined.

Some features of using Cialis

Doctors recommend taking a tablet of original Cialis or generic Cialis half an hour before sex. The tablet should not be swallowed; it should be washed down with plenty of water. But, if the drug is combined with alcohol, it is advised to put the tablet under the tongue and dissolve. It is better to avoid direct, direct contact of Cialis with alcohol.

When taking Cialis (reviews from men) for potency, a full erection occurs within 13 minutes after use. But the maximum period when an erection is achieved is 1 hour. Therefore, if there is no immediate excitement, there is no need to worry. It may be worth taking a course of therapy or increasing the dose of medication. If you take 5 mg of Cialis, the positive effect will last 13 hours. If a man takes 20 mg of Cialis, the duration of action increases to 36 hours. By stimulating arousal at this time, the man will achieve an erection and can engage in full sexual intercourse.

Doctors say that following the dosage and all recommendations will not cause the body to become addicted to tadalafil. Also, by following all the advice, you can avoid pressure surges, arrhythmia, and other consequences and harm. If a man is prescribed a course of treatment with Cialis, it can last 1-2 months. At the same time, a noticeable positive result occurs after 5 days of drinking the tablets.

Cialis: drug analogues

This drug has a sufficient number of analogues. All analogues have the same effect as the original. But the composition may differ slightly. Also, the analogue may contain another active substance. The most striking and widespread analogue of Cialis is Levitra. Taking Cialis or Levitra, which is better?

Levitra is intended for the treatment of erectile dysfunction. The main indication for its use is the absence of an erection with a strong desire. The main active ingredient is vardenafil. To achieve the fastest possible effect, it is recommended to use a 20 mg tablet of Levitra. Erection and arousal are achieved by relaxing smooth muscles, dilating blood vessels, and releasing nitric oxide. Thanks to active blood flow, the cavernous bodies of the penis quickly fill with blood, and the penis becomes erect.

Levitra tablet is taken half an hour before sex. It is allowed to take 1 tablet no more than once a day. Very rarely, men experience adverse reactions. If any do appear, they are minor: mild nausea, dizziness, headache. Therefore, in case of an allergy to tadalafil, Cialis can be safely replaced with Levitra.

Among other effective analogues of Cialis with an affordable price, the following medications and dietary supplements can be noted:

Speman;
Impaza;
Veromax;
Dynamic;
Tadaga;
Sealex;
Tadasoft.

Generic Cialis

Generic Cialis is intended for the treatment of impotence. Release form: tablets. All generics differ from the originals in that they have different excipients. But the main active ingredient is retained. Even such a minor difference makes generics cheaper and more accessible. This medicine is highly effective. And it will act just like the original. Therefore, most men prefer to use it.

Very often, the generic is prescribed for the treatment of sexual disorders at a young age, and not just in the elderly. When the process of ejaculation in a young man occurs already in the first minute of friction. Generic Cialis can cope with sexual disorders caused by various factors:

Poor nutrition;
sedentary lifestyle;
Alcohol abuse;
Overwork;
Excessive mental and physical stress.

Moreover, the pathogen is excellent for use in the prevention of impotence. It will also provide prevention of prostatitis, adenoma and prostate cancer. When using this drug, there is an increase in stamina, increased erection, prolongation of sexual intercourse, increased sensitivity of the genital organs, and normalization of blood circulation in the pelvic area.

An erection occurs within 15 minutes after consumption and persists throughout the day. Therefore, it is not necessary to use generic Cialis immediately before sexual intercourse. The minimum dosage of 5 mg is acceptable for use even with normal sexual life. So, the quality of sex will improve. The generic has the same contraindications as the original, since the active ingredient is similar.

The use of such a substitute with a small amount of alcohol is acceptable. But, if the doses of alcohol are high, taking a pill is simply useless - it will not have any effect. In addition, adverse reactions may increase. Also, doctors do not advise eating too fatty foods before or after using generic Cialis. Fat significantly reduces the absorption of tadalafil, making it less effective.

In this article you can read the instructions for use of the drug Cialis. Reviews of site visitors - consumers of this medicine, as well as the opinions of specialist doctors on the use of Cialis in their practice are presented. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Analogues of Cialis in the presence of existing structural analogues. Use for the treatment of erectile dysfunction and restoration of potency in men. Composition and effect of alcohol on the pharmacokinetics of the drug.

Cialis- A drug for the treatment of erectile dysfunction. It is a reversible selective inhibitor of specific phosphodiesterase type 5 (PDE5) cGMP. When sexual arousal causes local release of nitric oxide, inhibition of PDE5 by tadalafil results in increased cGMP levels in the corpus cavernosum of the penis. The consequence of this is relaxation of the smooth muscles of the arteries and blood flow to the tissues of the penis, which causes an erection. Tadalafil (the active ingredient in Cialis) has no effect in the absence of sexual stimulation.

In vitro studies have shown that tadalafil is a selective PDE5 inhibitor. PDE5 is an enzyme found in the smooth muscles of the corpus cavernosum, in the smooth muscles of the vessels of internal organs, in skeletal muscles, platelets, kidneys, lungs, and cerebellum.

Cialis improves erection and the ability to have successful sexual intercourse.

The drug is effective for 36 hours. The effect appears within 16 minutes after taking the drug in the presence of sexual arousal.

Tadalafil in healthy individuals does not cause significant changes in systolic and diastolic blood pressure, compared with placebo, in the supine position (the average maximum decrease in blood pressure is 1.6/0.8 mm Hg, respectively) and standing (the average maximum decrease in blood pressure is 0.2/4.6 mm Hg .st. respectively). Tadalafil does not cause a significant change in heart rate.

Tadalafil does not cause changes in color recognition (blue/green), which is explained by its low affinity for PDE6. In addition, there was no effect of tadalafil on visual acuity, electroretinogram, intraocular pressure and pupil size.

Several studies have been conducted to evaluate the effect of daily tadalfil on spermatogenesis. No adverse effects on sperm morphology or motility were observed in any of the studies. One study found a decrease in mean sperm concentration compared to placebo. Decreased sperm concentration was associated with higher ejaculation frequency. In addition, tadalafil did not cause undesirable changes in plasma testosterone, LH and FSH compared to placebo.

Compound

Tadalafil + excipients.

Pharmacokinetics

After oral administration, Cialis is quickly absorbed. The speed and extent of absorption do not depend on food intake. The timing of drug administration (morning or evening) does not have a clinically significant effect on the rate and extent of absorption.

At therapeutic concentrations, 94% of tadalafil is bound to plasma proteins. In healthy individuals, less than 0.0005% of the administered dose was found in semen.

Tadalafil is excreted primarily in the form of inactive metabolites, mainly in feces (about 61%) and to a lesser extent in urine (about 36%).

Indications

erectile dysfunction.

Release forms

Film-coated tablets 2.5 mg, 5 mg and 20 mg.

Instructions for use and dosage regimen

The drug is taken orally, regardless of food intake.

Cialis is taken at least 16 minutes before intended sexual activity.

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

Side effect

headache;
backache;
myalgia;
dizziness;
nasal congestion;
flushes of blood to the face;
dyspepsia;
swelling of the eyelids;
Pain in the eyes;
conjunctival hyperemia;
hypersensitivity reactions (including rashes, urticaria and facial swelling, Stevens-Johnson syndrome and exfoliative dermatitis);
arterial hypotension (in patients who were already taking antihypertensive drugs);
hypertension;
hyperhidrosis (excessive sweating);
priapism and delayed erection;
blurry vision;
non-arterial anterior ischemic optic neuropathy;
retinal vein occlusion;
visual field impairment;
nose bleed;
myocardial infarction;
sudden cardiogenic death;
stroke;
chest pain;
tachycardia.

Contraindications

simultaneous use of drugs containing any organic nitrates;
use in persons under 18 years of age;
hypersensitivity to the components of the drug.

Use during pregnancy and breastfeeding

The drug is not intended for use in women.

special instructions

The drug should be prescribed with caution to patients with severe hepatic impairment (class C on the Child-Pugh scale), since there are no data from controlled clinical studies on the safety and effectiveness of Cialis in this category of patients.

Caution is required when prescribing Cialis to patients taking alpha1-blockers, such as doxazosin, since simultaneous use in some cases may lead to symptomatic hypotension. In a clinical pharmacology study in 18 healthy volunteers taking a single dose of tadalafil, no symptomatic hypotension was observed during concomitant administration of the alpha1-blocker tamsulosin.

Sexual activity has potential risks for patients with cardiovascular disease. Therefore, treatment of erectile dysfunction, incl. with the use of Cialis should not be carried out in men with heart diseases for which sexual activity is not recommended.

The potential risk of complications during sexual activity in patients with diseases of the cardiovascular system should be taken into account: myocardial infarction within the last 90 days; unstable angina or angina that occurs during sexual intercourse; chronic heart failure (functional class 2 and higher according to the NYHA classification), which developed within the last 6 months; uncontrolled heart rhythm disturbances; arterial hypotension (blood pressure less than 90/50 mm Hg) or uncontrolled arterial hypertension; stroke suffered within the last 6 months.

Cialis should be used with caution in patients with severe renal failure (creatinine clearance less than 30 ml/min), with moderate renal failure (creatinine clearance from 31 to 50 ml/min), in patients with a predisposition to priapism (for example, with sickle-shaped cellular anemia, multiple myeloma or leukemia) or in patients with anatomical deformation of the penis (eg, angulation, cavernous fibrosis or Peyronie's disease).

There are reports of priapism occurring with the use of PDE5 inhibitors, including Cialis. The patient should be informed of the need to immediately consult a doctor if an erection occurs that lasts 4 hours or more. Untimely treatment of priapism leads to damage to the tissue of the penis, which can result in long-term loss of potency.

The safety and effectiveness of the combination of Cialis with other types of treatment for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.

Like other PDE5 inhibitors, tadalafil has systemic vasodilatory properties, which may lead to a transient decrease in blood pressure. Before prescribing Cialis, physicians should carefully consider whether patients with existing cardiovascular disease would be adversely affected by these vasodilatory effects.

Non-arterial anterior ischemic optic neuropathy (NAION) causes visual impairment, including complete loss of vision. There are rare post-marketing reports of cases of the development of NAPION, temporally associated with the use of PDE5 inhibitors. It is currently impossible to determine whether there is a direct relationship between the development of NAPION and the use of PDE5 inhibitors or other factors. Doctors should advise patients to stop taking Tadalfil and seek medical help if sudden vision loss occurs. Patients should be warned that people who have had NAPI are at increased risk of developing the condition again.

Impact on the ability to drive vehicles and operate machinery

Despite the fact that the incidence of dizziness with placebo and Cialis is the same, during the treatment period patients should be careful when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug interactions

Effect of other drugs on tadalafil

When taking an antacid (magnesium hydroxide/aluminum hydroxide) and tadalafil simultaneously, the rate of absorption of the latter is reduced without changing its AUC.

An increase in gastric pH as a result of taking the histamine H2 receptor blocker nizatidine does not affect the pharmacokinetics of tadalafil.

Effect of tadalafil on other drugs

Cialis enhances the hypotensive effect of nitrates. This occurs as a result of the additive effect of nitrates and tadalafil on the metabolism of nitric oxide and cGMP. Therefore, the prescription of Cialis against the background of the use of nitrates is contraindicated.

Tadalafil does not have a clinically significant effect on the clearance of drugs whose metabolism occurs with the participation of cytochrome P450 isoenzymes. Studies have confirmed that tadalafil does not inhibit or induce the isoenzymes CYP3A4, CYP1A2, CYP2D6, CYP2E1, CYP2C9, CYP2C19.

Tadalafil does not have a clinically significant effect on the pharmacokinetics of S- and R-warfarin. Tadalafil does not affect the effect of warfarin on prothrombin time.

Cialis does not increase the duration of bleeding due to the action of acetylsalicylic acid.

Tadalafil has systemic vasodilatory properties and may enhance the effect of antihypertensive drugs aimed at lowering blood pressure. Additionally, slightly greater reductions in blood pressure were observed in patients taking multiple antihypertensive agents and whose hypertension was poorly controlled. In the vast majority of patients, these decreases were not associated with hypotensive symptoms. Patients treated with antihypertensive drugs and taking tadalafil should be given appropriate clinical advice.

There was no significant reduction in blood pressure when tadalafil was used concomitantly with the selective alpha1A-blocker tamsulosin.

When tadalafil was administered to healthy volunteers taking the alpha1-blocker doxazosin (8 mg per day), an increase in the hypotensive effect of doxazosin was observed. Some patients experienced dizziness. There were no cases of syncope. Lower doses of doxazosin have not been studied.

Cialis did not affect the concentration of ethanol (alcohol), nor did ethanol (alcohol) affect the concentration of tadalafil. At high doses of ethanol (0.7 g/kg), taking tadalafil did not cause a statistically significant decrease in mean blood pressure. Some patients experienced postural dizziness and orthostatic hypotension. When tadalafil was administered in combination with lower doses of ethanol (0.6 g/kg), arterial hypotension was not observed, and dizziness occurred with the same frequency as when taking alcohol alone.

Tadalafil does not have a clinically significant effect on the pharmacokinetics and pharmacodynamics of theophylline.

Analogues of the drug Cialis

Structural analogues of the active substance:

Tadaga (in gelatin capsules);
Tadajoy;
Tadarise;
Tadasoft.

Analogues in terms of therapeutic effect (potency regulators):

Afrodor 2000;
Veromax;
Verona;
Viagra;
Viasan-LF;
Vigrande;
Vizarsin;
Dynamic;
Zyden;
Impaza;
Yohimbine "Spiegel";
Yohimbine hydrochloride;
Levitra;
Maxigra;
Muse;
Rileys;
Sildenafil citrate;
Speman;
Speman forte;
Super Yohimbe-Plus;
Tentex forte;
Testalamin;
Himkolin;
Edex.

If there are no analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and look at the available analogues for the therapeutic effect.

Compound

active substance: 1 tablet contains tadalafil 20 mg;

excipients: lactose monohydrate, lactose monohydrate (dry spray), hydroxypropyl cellulose (EF very fine), croscarmellose sodium, sodium lauryl sulfate, microcrystalline cellulose (granulate 102), magnesium stearate (vegetable), Opadry II yellow dye mixture (32K12884), talc .

Description

Yellow, almond-shaped tablets with the designation “C 20” printed on them on one side.

pharmachologic effect

Tadalafil is a reversible selective inhibitor of cGMP-specific PDE-5. When sexual arousal causes local release of nitric oxide, inhibition of PDE5 by tadalafil leads to increased concentrations of cGMP in the corpus cavernosum of the penis. The consequence of this is the relaxation of the smooth muscles of the arteries and the flow of blood to the tissues of the penis, which causes an erection. Tadalafil has no effect in the absence of sexual arousal.

Research in vitro showed that tadalafil is a selective PDE5 inhibitor. PDE-5 is an enzyme found in the smooth muscle of the corpus cavernosum, vascular smooth muscle of the internal organs, skeletal muscle, platelets, kidneys, lungs and cerebellum. The effect of tadalafil on PDE-5 is more active than on other PDEs. Tadalafil is 10,000 times more potent against PDE-5 than against PDE-1, PDE-2, PDE-4 and PDE-7, which are localized in the heart, brain, blood vessels, liver, white blood cells, skeletal muscles and in other organs. Tadalafil is 10,000 times more potent at blocking PDE-5 than PDE-3, an enzyme found in the heart and blood vessels. This selectivity for PDE-5 over PDE-3 is important because PDE-3 is an enzyme involved in cardiac muscle contraction. In addition, tadalafil is approximately 700 times more active against PDE-5 than against PDE-6, which is found in the retina and is responsible for phototransmission. Tadalafil is also 9000 times more potent against PDE5 than it is against PDE8, PDE9 and PDE10, and 14 times more potent against PDE5 than it is against PDE11. The tissue distribution and physiological effects of PDE-8 - PDE-11 inhibition have not yet been clarified.

Tadalafil improves erection and increases the possibility of full sexual intercourse.

Tadalafil in healthy individuals does not cause significant changes in SBP and DBP compared to placebo in the supine position (average maximum decrease is 1.6/0.8 mm Hg, respectively) and in the standing position (average maximum decrease is 0.2/ 4.6 mmHg respectively). Tadalafil does not cause a significant change in heart rate.

Tadalafil does not cause changes in color recognition (blue/green), which is explained by its low affinity for PDE-6. In addition, there was no effect of tadalafil on visual acuity, electroretinogram, intraocular pressure and pupil size.

Several studies have been conducted to evaluate the effect of daily tadalafil on spermatogenesis. No adverse effects on sperm morphology or motility were observed in any of the studies. One study found a decrease in mean sperm concentration compared to placebo. Decreased sperm concentration was associated with higher ejaculation frequency. In addition, no adverse effects were observed on the mean concentrations of sex hormones, testosterone, LH and FSH when taking tadalafil compared to placebo.

The effectiveness and safety of Cialis ® (in doses of 2.5 mg and 5 mg) was studied in clinical studies. An improvement in erection was noted in patients with erectile dysfunction of all degrees of severity when taking tadalafil once a day. In the primary efficacy studies of tadalafil 5 mg, 62% and 69% of attempted intercourse were successful compared with 34% and 39% of patients taking placebo. Tadalafil 5 mg significantly improved erectile function during the 24 hours between doses.

The mechanism of action of tadalafil in patients with BPH is inhibition of PDE-5 by tadalafil, leading to an increase in the concentration of cGMP in the cavernous body of the penis, also observed in the smooth muscles of the prostate gland, bladder and the vessels that supply them. Relaxation of vascular smooth muscle leads to an increase in blood perfusion in these organs and, as a result, to a decrease in the severity of BPH symptoms. Relaxation of prostate and bladder smooth muscle may further enhance the vascular effects.

Pharmacokinetics

Suction. After oral administration, tadalafil is rapidly absorbed. The average Cmax in plasma is achieved on average 2 hours after oral administration. The rate and extent of absorption of tadalafil do not depend on food intake, so Cialis ® can be used regardless of food intake. Time of administration (morning or evening) had no clinically significant effect on the rate or extent of absorption.

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, AUC increases proportionally to the dose.

The pharmacokinetics of tadalafil in patients with erectile dysfunction are similar to the pharmacokinetics of the drug in individuals without erectile dysfunction.

Distribution. C ss in plasma are achieved within 5 days when taking the drug once a day.

The average V d is about 63 L, which indicates that tadalafil is distributed in the tissues of the body.

At therapeutic concentrations, 94% of tadalafil in plasma is protein bound.

In healthy individuals, less than 0.0005% of the administered dose was found in semen.

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

Excretion. 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 primarily in the form of inactive metabolites, mainly in feces (about 61% of the dose) and to a lesser extent degrees with urine (about 36% of the dose).

Special Populations

Elderly patients. Healthy elderly patients (65 years of age or older) had lower oral clearance of tadalafil, resulting in a 25% increase in AUC compared to healthy individuals aged 19 to 45 years. This difference is not clinically significant and does not require dose adjustment.

Patients with renal failure. In persons with mild to moderate renal impairment, no dose adjustment is required. Due to the increased tadalafil exposure (AUC), Cialis ® is not recommended for patients with severe renal impairment.

Patients with liver failure. The pharmacokinetics of tadalafil in individuals with mild to moderate hepatic impairment are comparable to those in healthy individuals. No data are available for patients with severe hepatic impairment (Child-Pugh class C). When prescribing Cialis ® to patients with severe liver failure, it is necessary to first assess the risks and benefits of using the drug.

Patients with diabetes. In patients with diabetes mellitus, while using tadalafil, the AUC was approximately 19% less than in healthy individuals. This difference does not require dose adjustment.

Indications for use

erectile dysfunction (ED);

lower urinary tract symptoms in patients with benign prostatic hyperplasia;

erectile dysfunction in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia.

Contraindications

hypersensitivity to tadalafil or any substance included in the drug;

taking medications containing any organic nitrates;

use in persons under 18 years of age;

the presence of contraindications to sexual activity in patients with cardiovascular diseases (myocardial infarction within the last 90 days, unstable angina, the occurrence of an attack of angina during sexual intercourse, chronic heart failure of classes II-IV according to the NYHA classification, uncontrolled arrhythmias, arterial hypotension (BP less than 90 /50 mmHg), uncontrolled arterial hypertension, ischemic stroke within the last 6 months);

loss of vision due to non-arterial anterior ischemic optic neuropathy (regardless of the connection with taking PDE-5 inhibitors);

simultaneous use of doxazosin, as well as drugs for the treatment of erectile dysfunction;

frequent (more than 2 times a week) use in patients with chronic renal failure (Cl creatinine<30 мл/мин);

lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Carefully: Since there are no data in patients with severe hepatic impairment (Child-Pugh class C), caution should be exercised when prescribing Cialis ® to this group of patients.

Caution should be exercised when prescribing Cialis ® to patients taking alpha 1-blockers, since concomitant use may lead to symptomatic hypotension in some patients. In a clinical pharmacology study in 18 healthy volunteers receiving a single dose of tadalafil, no symptomatic hypotension was observed during concomitant administration of the alpha-1A blocker tamsulosin (see Interactions).

Diagnosis of erectile dysfunction should include identifying the potential underlying cause, appropriate medical examination, and determining treatment options.

Cialis ® should be used with caution in patients with a predisposition to priapism (sickle cell anemia, multiple myeloma or leukemia) or with anatomical deformation of the penis (angular curvature, cavernous fibrosis or Peyronie's disease). Caution should also be exercised when taken concomitantly with potent inhibitors of the CYP3A4 isoenzyme (ritonavir, saquinavir, ketoconazole, itraconazole, erythromycin), and antihypertensive drugs.

Pregnancy and lactation

Cialis ® is not intended for use in women.

Side effect

The most common adverse events in patients with ED are headache and dyspepsia, as well as back pain, myalgia, flushing, and nasal congestion.

The most common adverse events in patients with ED/BPH are headache and dyspepsia, pain in the limbs, gastroesophageal reflux, and myalgia.

From the immune system: uncommon (≥0.1%,<1 %) — реакции гиперчувствительности.

From the nervous system: very often (≥10%) - headache; often (≥1%,<10%) - головокружение; редко (≥0,01%, <0,1 %) - инсульт (в т.ч. острое нарушение мозгового кровообращения (ОНМК) по геморрагическому типу), обморок 1 , транзиторные ишемические атаки 1 , мигрень 3 , эпилептический припадок, транзиторная амнезия.

From the organs of vision: uncommon (≥0.1%,<1%) - нечеткость зрительного восприятия, болевые ощущения в глазном яблоке; редко (≥0,01%, <0,1%) - нарушение полей зрения, припухлость век, инъецирование сосудов склеры глазного яблока, неартериальная передняя ишемическая оптическая нейропатия (НАПИОН) 3 , окклюзия сосудов сетчатки 3 .

Hearing and labyrinth disorders: rarely (≥0.01%,<0,1%) - внезапная потеря слуха 2 .

From the SSS side: uncommon (≥0.1%,<1 %) - ощущение сердцебиения, тахикардия, снижение АД (у пациентов, которые уже принимали гипотензивные средства), повышение АД; редко (≥0,01%, <0,1%) - инфаркт миокарда, желудочковые нарушения ритма 3 , нестабильная стенокардия 3 .

From the respiratory system: uncommon (≥0.1%,<1%) - заложенность носа, одышка; редко (≥0,01%, <0,1%) - носовое кровотечение.

From the gastrointestinal tract: often (≥1%,<10 %) - диспепсия; нечасто (≥0,1%, <1%) - боль в животе, гастроэзофагеальный рефлюкс.

For the skin and subcutaneous tissues: uncommon (≥0.1%,<1%) - сыпь, гипергидроз (повышенная потливость); редко (≥0,01%, <0,1%) - крапивница, синдром Стивенса-Джонсона 3 , эксфолиативный дерматит 3 .

From the musculoskeletal and connective tissue side: often (≥1%,<10%) - боль в спине, миалгия.

From the genital organs and breast: rarely (≥0.01%,<0,1%) - длительная эрекция, приапизм 3 .

Common disorders: uncommon (≥0.1%,<1 %) - боль в груди 1 ; редко (≥0,01%, <0,1%) - отек лица 3 , внезапная сердечная смерть 1,3 .

1 Observed in patients with 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 arousal, or a combination of these or other factors.

2 Sudden hearing loss has been reported in a small number of cases from post-marketing and clinical studies with all PDE5 inhibitors, including tadalafil.

3 Adverse reactions detected during post-marketing studies that were not observed during clinical placebo-controlled studies.

Overdose

When a single dose of tadalafil was administered to healthy individuals at a dose of up to 500 mg and to patients with ED - repeatedly up to 100 mg/day, the undesirable effects were the same as when using lower doses.

Treatment: in case of overdose, standard symptomatic treatment should be carried out. During hemodialysis, tadalafil is practically not excreted.

Interaction with other drugs

Effect of other drugs on tadalafil

Tadalafil is mainly metabolized with the participation of the CYP3A4 isoenzyme. A selective inhibitor of the CYP3A4 isoenzyme ketoconazole (400 mg/day) increases the AUC of tadalafil in a single dose by 312% and Cmax by 22%, and ketoconazole (200 mg/day) increases the AUC of tadalafil in a single dose by 107% and Cmax by 15% relative to AUC and Cmax values for tadalafil alone. Ritonavir (200 mg 2 times daily), an inhibitor of CYP3A4, 2C9, 2C19 and 2D6 isoenzymes, increases the AUC of tadalafil in a single dose by 124% without changing Cmax. Although specific interactions have not been studied, it can be assumed that other HIV protease inhibitors, such as saquinavir, as well as CYP3A4 inhibitors, such as erythromycin and itraconazole, increase the activity of tadalafil.

A selective inducer of the CYP3A4 isoenzyme, rifampicin (600 mg/day), reduces the exposure of a single dose of tadalafil (AUC) by 88% and Cmax by 46% relative to the AUC and Cmax values for tadalafil alone. It can be assumed that the simultaneous use of other inducers of the CYP3A4 isoenzyme should also reduce tadalafil plasma concentrations.

Concomitant use of an antacid (magnesium hydroxide/aluminum hydroxide) and tadalafil reduces the rate of absorption of tadalafil without changing the area under the pharmacokinetic curve for tadalafil. An increase in gastric pH as a result of taking the H2-histamine receptor blocker nizatidine did not affect the pharmacokinetics of tadalafil.

The safety and effectiveness of the combination of tadalafil with other types of treatment for erectile dysfunction have not been studied, so the use of such combinations is not recommended.

Tadalafil does not potentiate the increase in bleeding time caused by taking acetylsalicylic acid.

Effect of tadalafil on other drugs

Tadalafil is known to enhance the hypotensive effect of nitrates. This occurs as a result of the additive effect of nitrates and tadalafil on the metabolism of nitric oxide (NO) and cGMP. Therefore, the use of tadalafil while taking nitrates is contraindicated.

Tadalafil does not have a clinically significant effect on the clearance of drugs whose metabolism occurs with the participation of cytochrome P450. Studies have confirmed that tadalafil does not inhibit or induce the isoenzymes CYP1A2, CYP3A4, CYP2C9, CYP2C19, CYP2D6, CYP2E1.

Tadalafil does not have a clinically significant effect on the pharmacokinetics of S-warfarin or R-warfarin. Tadalafil does not affect the effect of warfarin on PT.

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

Tadalafil has systemic vasodilatory properties and may enhance the effect of antihypertensive drugs aimed at lowering blood pressure.

Additionally, patients taking multiple antihypertensive agents and whose hypertension was poorly controlled experienced a slightly greater reduction in blood pressure. In the vast majority of patients, this decrease was not associated with hypotensive symptoms. Patients treated with antihypertensive drugs and taking tadalafil should be given appropriate clinical advice.

There was no significant reduction in blood pressure with tadalafil in healthy subjects taking the selective alpha 1A blocker tamsulosin in two clinical studies.

Concomitant use of tadalafil with doxazosin is contraindicated. When tadalafil was administered to healthy volunteers taking doxazosin (4-8 mg/day), an alpha 1-blocker, an increase in the hypotensive effect of doxazosin was observed. Some patients experienced symptoms associated with decreased blood pressure, including syncope.

Tadalafil did not affect the concentration of alcohol, nor did alcohol affect the concentration of tadalafil. At high doses of alcohol (0.7 g/kg), taking tadalafil did not cause a statistically significant decrease in mean blood pressure. Postural dizziness and orthostatic hypotension have been observed in some patients. When taking tadalafil in combination with lower doses of alcohol (0.6 g/kg), no decrease in blood pressure was observed, and dizziness occurred with the same frequency as when taking alcohol alone.

Tadalafil does not have a clinically significant effect on the pharmacokinetics or pharmacodynamics of theophylline.

Features of application

Sexual activity has potential risks for patients with cardiovascular disease. Therefore, treatment of ED, incl. Cialis ® should not be used in men with heart disease for which sexual activity is not recommended.

There are reports of priapism with the use of PDE5 inhibitors, including tadalafil. Patients should be informed of the need to seek immediate medical attention if an erection occurs that lasts 4 hours or more. Untimely treatment of priapism leads to damage to the tissue of the penis, which may result in irreversible impotence.

The safety and effectiveness of Cialis ® in combination with other PDE5 inhibitors and ED treatments have not been studied. Therefore, the use of such combinations is not recommended.

Like other PDE5 inhibitors, tadalafil has systemic vasodilatory properties, which may lead to a transient decrease in blood pressure. Before prescribing Cialis ® , physicians should carefully consider whether patients with cardiovascular disease would be adversely affected by these vasodilatory effects.

NAPION causes visual impairment, including complete loss of vision. There are rare post-marketing reports of cases of the development of NAPION, temporally associated with the use of PDE-5 inhibitors. It is currently impossible to determine whether there is a direct relationship between the development of NAPION and the use of PDE5 inhibitors or other factors. Doctors should advise patients to stop taking tadalafil and seek medical help if sudden vision loss occurs. Doctors should also tell patients that people who have had NAPION have an increased risk of developing NAPION again.

Patients suspected of having BPH should undergo testing to rule out prostate cancer.

The effectiveness of Cialis ® in patients undergoing pelvic surgery or radical neurosparing prostatectomy is unknown.

Influence on the ability to drive a car and perform work that requires an increased speed of psychomotor reactions. Despite the fact that the incidence of dizziness with placebo and tadalafil is the same, during the treatment period it is necessary to exercise caution when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.