Tadalafil-cs tab p / 20 mg of the film 1 pc


Tadalafil-cs tab p / 20 mg of the film 1 pc


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Active substance:
tadalafil – 20 mg
Kernel: Monohydrate lactose (milk sugar) – 100.2 mg; lactose monohydrate (laktopress) (milk sugar) – 123.0 mg; Microcrystalline cellulose – 53.0 mg; croscarmellose sodium (primelloza) – 17.0 mg; crospovidone (Kollidon CL-M) – 5,0 mg Crospovidone (Kollidon CL) – 2,0 mg giproloza extra thin (hydroxypropyl) – 5.0 mg; giproloza (hydroxypropyl) – 2.0 mg; Sodium stearyl fumarate – 2.0 mg; sodium lauryl sulfate – 0.8 mg;
Coating: Opadry II 85F240037 Pink – 10 mg (polyvinyl alcohol, partially hydrolyzed – 4.0 mg of titanium dioxide, E 171 – 2,236 mg; macrogol (polyethylene glycol 3350) – 2.02 mg talc – 1.48 mg iron oxide colorant (II) yellow E 172 – 0.143 mg iron oxide coloring agent (II) red E 172-0,121 mg).
Tablets, film-coated pinkish-orange, round, biconvex. The cross-sectional core tablet white or nearly white.
– Increased sensitivity to tadalafil or any substance included in the formulation;
– In case of receiving the preparations containing any organic nitrates;
– The use by persons under 18 years of age;
– The presence of contraindications to sexual activity in patients with diseases of the cardiovascular system: myocardial infarction within the past 90 days, unstable angina, occurrence of angina attack during intercourse, chronic heart failure class II and higher NYHA classification in the last 6 months, uncontrollable arrhythmia, hypotension (blood pressure less than 90/50 mm Hg), uncontrolled hypertension, ischemic stroke within the last 6 months;
– The loss of vision due nearterialnoy anterior ischemic optic neuropathy (irrespective of an inhibitor reception PDE-5);
– Simultaneous use with doxazosin, with other PDE5 inhibitors, with other treatment options for erectile dysfunction, guanylate cyclase stimulants such as riotsiguat;
– Application of patients with chronic renal failure (creatinine clearance less than 30 mL / min);
– lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
Since there is no sufficient data in patients with severe hepatic insufficiency (class C by Child-Pugh classification), caution should be exercised when administering the drug Tadalafil- NW this group of patients.
Care must be exercised when administering the drug Tadalafil- SZ patients taking alpha] adrenoblokatory, since simultaneous use of these drugs may result in symptomatic hypotension in some patients.
In the application of a single dose of tadalafil is not observed symptomatic hypotension while the use of tamsulosin, selective alpha] A-blocker (see. See “The interaction with other drugs”).
The drug Tadalafil NW should be used with caution in patients with a predisposition to priapism (for sickle cell anemia, multiple myeloma or leukemia), or in patients with anatomical deformation of the penis (angulation, cavernous fibrosis or Peyronie’s disease). Also, caution should be exercised at the same time taking with inhibitors isoenzyme CYP3A4 (ritonavir, saquinavir, ketoconazole, itraconazole, clarithromycin, erythromycin, grapefruit juice), antihypertensive drugs, inhibitors of 5-alpha reductase.
Diagnosis of erectile dysfunction should include the identification of potential primary cause corresponding medical examination and determination of treatment.
20 mg
Erectile disfunction.
Lower urinary tract symptoms in patients with benign prostatic hyperplasia (for a dosage of 5 mg).
Erectile dysfunction in patients with lower urinary tract symptoms on a background of benign prostatic hyperplasia (for a dosage of 5 mg).
Interaction with other drugs
The effect of other drugs on tadalafil
Tadalafil is mainly metabolized with isoenzyme CYP3A4. Selective inhibitor of isozyme CYP3A4 ketoconazole (400 mg daily) to increase exposure of a single dose of tadalafil (AUC) for 312% and Cmax by 22%, and ketoconazole (200 mg daily) to increase exposure of a single dose of tadalafil (AUC) for 107% and a Cmax at 15% relative to the AUC and Cmax values ​​for only one of tadalafil.
Ritonavir (200 mg twice daily), an inhibitor of isozyme CYP3A4, 2C9, 2C19 and 2D6, increases the exposure of a single dose of tadalafil (AUC) for 124% without changing Stach. Despite the fact that the specific interactions has not been studied, one can assume that other HIV protease inhibitors such as saquinavir, as well as inhibitors of isoenzyme CYP3A4, such as erythromycin, clarithromycin, itraconazole and grapefruit juice may increase the concentration of tadalafil in plasma blood. The role of vectors (e.g., P-glycoprotein) in the distribution tadalafil unknown. There is a possibility of drug interactions mediated by inhibition of transporters. Isozyme selective inducer of CYP3A4, rifampicin (600 mg daily), reduces the exposure of a single dose of tadalafil (AUC) by 88% and Cmax by 46% relative AUC and Cmax values ​​for only one of tadalafil. It can be assumed that the concurrent use of other inductor isoenzyme CYP3A4 (such as phenobarbital, phenytoin or carbamazepine) should also reduce the concentration of tadalafil in plasma ..
Simultaneous reception of antacid (magnesium hydroxide / aluminum hydroxide) and tadalafil reduces the rate of absorption of tadalafil without changing AUC for tadalafil.
Increased gastric pH as a result of receiving blocker histamine H2-receptor nizatidine had no effect on the pharmacokinetics of tadalafil.
The safety and efficacy of a combination of tadalafil with other treatments for erectile dysfunction or other PDE5 inhibitors have not been studied, so the use of such combinations is not recommended.
Effect of tadalafil on other drugs
It is known that tadalafil enhances hypotensive effects of nitrates. This is due to the additive effect of nitrates and tadalafil on the metabolism of nitric oxide II (N0) and cGMP. Therefore, the use of tadalafil in patients receiving nitrates is contraindicated.
Tadalafil has no 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 isozymes CYP1A2, CYP3A4, CYP2C9, CYP2C19, CYP2D6, CYP2E1. Tadalafil has no clinically significant effect on AUC S-warfarin or R-warfarin. Tadalafil did not affect the action of warfarin on prothrombin time.
Tadalafil potentsirket not increase bleeding duration ringing reception acetylsalicylic acid.
Tadalafil has a systemic vasodilating properties and can enhance the effect of antihypertensive drugs, aimed at lowering blood pressure. Additionally, patients taking multiple antihypertensive agents whose hypertension poorly controlled, there was a slightly greater blood pressure reduction. The vast majority of patients, this reduction was not associated with hypotensive symptoms. Patients treated with antihypertensive drugs and receiving tadalafil, should be given appropriate clinical recommendations. There was no significant reduction in blood pressure priodnovremennom use of tadalafil in healthy volunteers and selective alpha1-blocker tamsulosin.
The simultaneous use of tadalafil with doxazosin contraindicated. In applying tadalafil healthy volunteers who took doxazosin (4-8 mg per day), alpha] adrenoblokator were increased hypotensive effect of doxazosin. Some patients experienced symptoms associated with a decrease in blood pressure, including syncope.
Simultaneous reception riotsiguata with inhibitors of PDE5, including tadalafil, contraindicated because riotsiguat enhances the hypotensive effect of PDE-5 inhibitors.
drug interaction studies and tadalafil inhibitors of 5- alpha reductase has been conducted, during their simultaneous reception caution.
Tadalafil causes increase ethinyl estradiol bioavailability when taken orally.
A similar increase in bioavailability can be expected while taking terbutaline, however, the clinical consequences are not established.
Tadalafil did not affect the concentration of alcohol, as well as alcohol does not affect the concentration of tadalafil. At high doses of alcohol (0.7 g / kg) receiving tadalafil does not cause a statistically significant reduction in the average blood pressure value. Some patients experienced postural dizziness and orthostatic hypotension. When receiving tadalafil in conjunction with lower doses of alcohol (0.6 g / kg) decrease in blood pressure were not observed, and dizziness occurred with the same frequency as that at reception of alcohol.
Tadalafil has no clinically meaningful effect on the pharmacokinetics or pharmacodynamics of theophylline.
With single assignment tadalafil healthy volunteers at a dose of 500 mg and patients with erectile dysfunction – repeatedly to 100 mg / day, adverse effects were the same as in the application of lower doses. In case of overdose should be carried out standard symptomatic treatment. Hemodialysis tadalafil virtually displayed.
pharmachologic effect
Pharmacological group:
A treatment for erectile dysfunction – a PDE5 inhibitor
Tadalafil is a reversible, selective inhibitor of specific phosphodiesterase type 5 (PDE-5) is a cyclic guanosine monophosphate ut (cGMP). When sexual stimulation causes local release of nitric oxide, inhibition of PDE5 tadalafil leads to an increase in cGMP concentration in the corpus cavernosum penis. The consequence of this is the relaxation of smooth muscles of arteries and blood flow to the tissues of the penis that causes erections. Tadalafil has no effect in the absence of sexual stimulation.
Studies in vitro have shown that tadalafil is a selective inhibitor of PDE5. PDE5 is an enzyme found in corpus cavernosum smooth muscle, smooth muscle in blood vessels internal organs, skeletal muscle, platelets, kidneys, lungs and cerebellum. Effects of tadalafil for PDE5 is more active than other phosphodiesterase. Tadalafil is 10,000 times more potent against PDE5 than against PDE 1, PDE-2, PDE 4 and PDE 7, which are localized in the heart, brain, blood vessels, liver, leukocytes, skeletal muscle, and in other organs. Tadalafil 10,000 times more active blocks PDE5 than PDE-3 – enzyme that is found in the heart and blood vessels. This selectivity for PDE5 as compared to PDE-3 is significant, because 3-PDE is an enzyme participating in the reduction of the heart muscle. Furthermore, tadalafil is about 700 times more active against PDE5 than against PDE-6 found in the retina and is responsible for fotoperedachu. Tadalafil also exhibits effect of 9000 times more potent for PDE5 compared with its effect on PDE-8, PDE-9 and PDE-10 and 14 times more potent for PDE5 compared to PDE-11. Tissue distribution and physiological effects of inhibiting PDE-8 – PDE-11do not yet been elucidated. Tadalafil improves erection and increases the possibility of full sexual intercourse.
Tadalafil in healthy individuals does not cause significant changes in systolic and diastolic blood pressure compared to placebo in the supine position (mean maximum decrease of 1.6 / 0.8 mm Hg, respectively) and standing (mean maximum decrease of 0, 2 / 4.6 mm Hg, respectively). Tadalafil does not cause significant changes in heart rate. Tadalafil does not cause changes in the recognition of colors (blue / green), due to its low affinity PDE-6. In addition, there is no effect of tadalafil on visual acuity, electroretinogram, intraocular pressure and pupil size.
In order to assess the effect of daily administration of tadalafil in spermatogenesis was conducted several studies. None of the studies was not observed undesirable effects on sperm morphology and motility. In one study showed a reduction in the average sperm concentration as compared to placebo. Decrease of sperm concentration was associated with a higher incidence of ejaculation. Furthermore, there was no adverse effect on the average concentration of the sex hormones, testosterone, luteinizing hormone and follicle-stimulating hormone while taking Cialis, compared to placebo.
The improvement of erection in patients with erectile dysfunction of all severities when taking tadalafil once a day.
The mechanism of action in patients with benign prostatic hyperplasia (BPH)
The inhibition of PDE5 tadalafil, resulting in increased cGMP concentration in the corpus cavernosum of the penis, is also observed in the smooth muscle of the prostate, bladder and blood vessels that supply blood to them. Relaxation of vascular smooth muscle leads to an increased blood perfusion in these organs, and, as a consequence, to a decrease in severity of symptoms of BPH. Relaxation of smooth muscle of prostate and bladder may further exacerbate vascular effects.
After oral administration of tadalafil is rapidly absorbed. The average maximum concentration (Cmax) in plasma reached a mean of 2 hours after ingestion.
The rate and extent of absorption of tadalafil are not dependent on food intake, so the drug Cialis-NW can be used regardless of the meal. Reception hours (morning or evening) does not affect the rate and 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 of the area under the curve “concentration-time» (AUC) increased in proportion to dose. Equilibrium plasma concentrations are reached within 5 days while taking the drug once a day.
The pharmacokinetics of tadalafil in patients with erectile dysfunction is similar to the pharmacokinetics of the drug in patients without erectile dysfunction.
The average volume of distribution is approximately 63 liters, indicating that tadalafil is distributed in body tissues. At therapeutic concentrations, 94% of tadalafil in plasma is associated with proteins.
Protein binding is not changed by impaired renal function.
In healthy volunteers, less than 0.0005% of the administered dose was found in semen.
Tadalafil is mainly metabolized involving CYP3A4 isoenzyme of cytochrome P450. The main circulating metabolite is metilkateholglyukuronid. This metabolite on kraiyney least 13000 times less active against PDE5 than tadalafil. Consequently, the concentration of this metabolite is not clinically significant.
In healthy volunteers the average clearance of tadalafil ingestion of 2.5 l / h, and the average half-life – 17.5 hours. Tadalafil is excreted mainly in the form of inactive metabolites, mainly through the intestine (about 61% of the dose) and, to a lesser extent, the kidneys (approximately 36% of the dose).
Special groups paiientov
Age over 65 years
Healthy volunteers aged 65 years and older have a lower clearance tadalafil ingestion, resulting in an increase vploschadi under the curve “concentration-time” by 25% as compared with healthy volunteers aged 19 to 45 years. This difference is not clinically significant and does not require a dose adjustment.
kidney failure
In patients with renal insufficiency mild (creatinine clearance of 51 to 80 ml / min) and moderate (creatinine clearance of 31 to 50 ml / min), as well as in patients with end stage renal failure, hemodialysis, tadalafil exposure (AUC) is approximately doubled. In patients on hemodialysis, Cmax was 41% higher compared with healthy volunteers. Excretion of tadalafil using gemodialza is negligible.
Liver failure
The pharmacokinetics of tadalafil in patients with mild to moderate hepatic insufficiency (class A and B for the classification of Child-Pugh) is comparable to that in healthy volunteers. For patients with severe hepatic insufficiency (class C by Child-Pugh classification) data are insufficient. In appointing the drug Tadalafil NW in patients with severe hepatic impairment previously necessary to conduct a risk assessment and the use of the drug.
Patients with diabetes mellitus patients with diabetes during treatment with tadalafil area under the curve “concentration-time” is less than about 19%, compared to healthy volunteers. This difference does not require dose adjustment.
Pregnancy and breast-feeding
The drug Tadalafil-NW is not intended for use in women.
Conditions of supply of pharmacies
On prescription.
side effects
The most common adverse events in patients with erectile dysfunction and BPH are headache and dyspepsia, and back pain, myalgia.
According to the WHO classification all the reactions distributed in the body system and frequency of development: very common (> 1/10); often (> 1/100, 1/1000, 1U0000,
Violations by the immune system:
Uncommon: hypersensitivity reactions.
Rare: angioedema.
Disorders of the nervous system:
Common: headache.
Uncommon: dizziness.
Редко: инсульт (в том числе острое нарушение мозгового кровообращения (ОНМК) по геморрагическому типу), обморок, транзиторные ишемические атаки, мигрень, эпилептические припадки, транзиторная амнезия.
Violations by the organ of vision:
Нечасто: нечеткость зрительного восприятия, болевые ощущения в глазном яблоке.
Редко: нарушение полей зрения, припухлость век, конъюнктивальная гиперемия, неартериальная передняя ишемическая оптическая нейропатия, окклюзия сосудов сетчатки.
Нарушения со стороны органа слуха и лабиринтные нарушения:
Нечасто: звон в ушах.
Редко: внезапная потеря слуха.
Violations of the heart:
Нечасто: ощущение сердцебиения, тахикардия.
Редко: инфаркт миокарда, желудочковые нарушения ритма , нестабильная стенокардия.
Violations by vessels:
Часто: «приливы» крови к лицу.
Нечасто: снижение артериального давления, повышение артериального давления.
Violations of the respiratory system, thorax and mediastinum:
Часто: заложенность носа.
Нечасто: одышка, носовое кровотечение.
Disorders of the gastrointestinal tract:
Часто: диспепсия.
Нечасто: боль в животе, гастроэзофагеальный рефлюкс, диарея у пациентов старше 65 лет, рвота, тошнота..
Violations of the skin and subcutaneous tissue disorders:
Нечасто: сыпь.
Редко: крапивница, синдром Стивенс-Джонсона, эксфолиативный дерматит, гипергидроз (повышенная потливость).
Violations by musculoskeletal and connective tissue disorders:
Часто: боль в спине, миалгия, боль в конечностях.
Violations of the kidneys and urinary tract:
Нечасто: гематурия.
Violations by the genitals and breast:
Нечасто: длительная эрекция.
Редко: приапизм , гематоспермия, кровотечение из полового члена.
Общие расстройства:
Нечасто: боль в груди, периферический отек, усталость.
Редко: отек лица, внезапная сердечная смерть.
Наблюдались у пациентов, ранее имеющих сердечно-сосудистые факторы риска. Однако невозможно точно определить связаны ли эти явления непосредственно с этими факторами риска, с тадалафилом, с сексуальным возбуждением, или с комбинацией этих или других факторов.
Побочные реакции, выявленные при постмаркетинговом применении, не наблюдавшиеся в ходе клинических плацебо-контролируемых исследований.
Чаще наблюдались, когда тадалафил применялся у пациентов, уже принимающих гипотензивные средства.
special instructions
Сексуальная активность имеет потенциальный риск для пациентов с сердечно-сосудистыми заболеваниями. Поэтому лечение эректильной дисфункции, в том числе с препаратом Тадалафил-СЗ, не следует проводить у мужчин с такими заболеваниями сердца, при которых сексуальная активность не рекомендована.
Имеются сообщения о возникновении приапизма при применении ингибиторов ФДЭ-5, включая тадалафил. Пациенты должны быть проинформированы о необходимости немедленного обращения за медицинской помощью в случае возникновения эрекции, продолжающейся 4 часа и более. Несвоевременное лечение приапизма ведет к повреждению тканей полового члена, в результате чего может наступить необратимая импотенция.
Безопасность и эффективность комбинации препарата Тадалафил-СЗ с другими ингибиторами ФДЭ-5 и видами лечения эректильной дисфункции не изучались. Поэтому применение подобных комбинаций не рекомендуется. Как и другие ФДЭ-5 ингибиторы, тадалафил обладает системными сосудорасширяющими свойствами, что может приводить к транзиторному снижению артериального давления. Перед назначением препарата Тадалафил-СЗ врачи должны тщательно рассмотреть вопрос, не будут ли пациенты с сердечно-сосудистым заболеванием подвергаться нежелательному воздействию за счет таких сосудорасширяющих эффектов. Неартериальная передняя ишемическая оптическая нейропатия (НАПИОН) является причиной нарушения зрения, включая полную потерю зрения. Имеются редкие постмаркетинговые сообщения о случаях развитии НАПИОН, по времени связанных с приемом ингибиторов ФДЭ-5. IN
настоящее время невозможно определить, существует ли прямая связь между развитием НАПИОН и приемом ингибиторов ФДЭ-5 или другими факторами. Врачи должны рекомендовать пациентам в случае внезапной потери зрения прекратить прием тадалафила и обратиться за медицинской помощью. Врачи также должны сообщить пациентам, что у людей, перенесших НАПИОН, повышен риск повторного развития НАПИОН. Пациенты с предполагаемым диагнозом ДГПЖ должны пройти обследование для исключения рака предстательной железы.
Эффективность препарата Тадалафил-СЗ у пациентов, перенесших хирургическую операцию на органах малого таза или радикальную нейросберегающую простатэктомию, неизвестна.
Influence of control transport and other mechanisms
В период лечения препаратом Тадалафил-СЗ необходимо соблюдать осторожность при вождении автотранспорта и занятиями другими потенциально опасными видами деятельности, требующими повышенной концентрации внимания и быстроты психомоторных реакций.
Storage conditions
In the dark place at a temperature not higher than 25 ° C.
Keep out of the reach of children.
Dosing and Administration
For ingestion.
Применение препарата Тадалафил-СЗ по показанию эректильная дисфункция (ЭД)
Для пациентов с частой сексуальной активностью (более двух раз в неделю): рекомендованная частота приема – ежедневно, один раз в сутки 5 мг, в одно и то же время, вне зависимости от приема пищи. Суточная доза может быть снижена до 2,5 мг (1/2 таблетки 5 мг) в зависимости от индивидуальной чувствительности.
Для пациентов с нечастой сексуальной активностью (реже двух раз в неделю): рекомендовано назначение препарата Тадалафил-СЗ в дозе 20 мг, непосредственно перед сексуальной активностью согласно инструкции по медицинскому применению препарата.
Максимальная суточная доза препарата Тадалафил-СЗ составляет 20 мг.
Применение препарата Тадалафил-СЗ по показанию ДГПЖ или ЭД/ДГПЖ.
Рекомендуемая доза препарата Тадалафил-СЗ при применении один раз в сутки составляет 5 мг; препарат следует принимать приблизительно в одно и то же время дня, независимо от времени сексуальной активности. Продолжительность лечения устанавливается врачом индивидуально.
У пациентов с почечной недостаточностью легкой степени тяжести (клиренс креатинина от 51 до 80 мл/мин) и умеренной степени тяжести (клиренс креатинина от 31 до 50 мл/мин) коррекция дозы не требуется. У пациентов с тяжелой степенью почечной недостаточностью (клиренс креатинина
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg


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