Certificate of conformity (COC) Cialis pills 5mg, 28pcs

Cialis pills 5mg, 28pcs

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Active ingredient:	Tadalafil
Dosage form:	Pills

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Categories: Genitourinary system, Impotence, Medication

Description
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Composition

1 film-coated tablet contains:

Tadalafil 5 mg

Auxiliary substances:

Lactose monohydrate 109.65 mg

Lactose Monohydrate (spray dried) 17.50 mg

Giprolose 1.22 mg

Giprolose (extra fine) 2.80 mg

Sodium Lauryl sulfate 0.49 mg

Microcrystalline cellulose 26.25 mg

Croscarmellose Sodium 11.20 mg

Magnesium stearate (vegetable) 0.88 mg.

Shell composition:

opadray yellow (Y-30-12863-A) 8.75 mg (lactose monohydrate 3.72 mg, hypromellose 2.59 mg, titanium dioxide 1.54 mg, triacetin 0.74 mg, iron oxide yellow dye 0.16).

Pharmacological action

Cialis is a treatment for erectile dysfunction (impotence, erectile dysfunction) in men and is part of a group of drugs called PDE-5 (phosphodiesterase type 5) inhibitors.

The drug dilates the blood vessels of the penis during sexual arousal. As a result, blood circulation in the penis increases, and this, in turn, contributes to the onset of a stable erection.

Indications

Erectile dysfunction.
Lower urinary tract symptoms in patients with benign prostatic hyperplasia.
Erectile dysfunction in patients with lower urinary tract symptoms associated with benign prostatic hyperplasia.

Contraindications

Hypersensitivity to tadalafil or to any substance that is part of the drug.
In the case of taking medications containing any organic nitrates.
Under 18 years of age.
Cardiovascular disease: myocardial infarction within the last 90 days, unstable angina, occurrence of angina during sexual intercourse, chronic heart failure II-IV class NYHA classification, uncontrolled arrhythmias, hypotension (BP less than 90/50 mm Hg. St. ), uncontrolled hypertension, ischemic stroke within the last 6 months.
Loss of vision due to non-arterial anterior ischemic optic neuropathy (regardless of its association with PDE5 inhibitors).
Simultaneous use of doxazosin, as well as medications for the treatment of erectile dysfunction.
Frequent (more than 2 times a week) use in patients with chronic renal failure ( creatinine clearance less than 30 ml / min).
Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

With caution:

Severe hepatic insufficiency (Child-Pugh class C).
Patients taking alpha-1 blockers.
Predisposition to priapism (in sickle cell anemia, multiple myeloma, or leukemia).
Anatomical deformity of the penis (angular curvature, cavernous fibrosis or Peyronie’s disease).
Concomitant use with powerful inhibitors of the CYP3A4 isoenzyme (ritonavir, saquinavir, ketoconazole, itraconazole, erythromycin), antihypertensive agents.

Interaction

Effect of other drugs on tadalafil

Tadalafil is mainly metabolized by the CYP3A4 isoenzyme. A selective inhibitor of the CYP3A4 isoenzyme ketoconazole (400 mg per day) increases the exposure of a single dose of tadalafil (AUC) by 312% and with max by 22%, and ketoconazole (200 mg per day) increases the exposure of a single dose of tadalafil (AUC) by 107% and with max by 15% relative to the AUC and values with max for tadalafil alone.

Ritonavir (200 mg twice daily), an inhibitor of the CYP3A4,2C9,2C19 and 2D6 isoenzymes, increases the exposure to a single dose of tadalafil (AUC) by 124% without changing the C max. Although specific interactions have not been studied, it can be assumed that other HIV protease inhibitors, such as saquinavir, as well as inhibitors of the CYP3A4 isoenzyme, such as erythromycin and intraconazole, 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 C max by 46%, relative to the AUC and C max values for tadalafil alone. It can be assumed that the simultaneous use of other inducers of the CYP3A4 isoenzyme should also reduce the concentration of tadalafil in plasma.

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 nizatidine H2-histamine receptor blockers did not affect the pharmacokinetics of tadalafil.

The safety and efficacy of combining tadalafil with other treatments 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 medications

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

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

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

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

Tadalafil has systemic vasodilating properties and may enhance the effect of antihypertensive drugs aimed at lowering blood pressure. Additionally, patients who took multiple antihypertensive medications 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 receiving antihypertensive medications and taking tadalafil should be given appropriate clinical recommendations.

No significant reduction in blood pressure was observed when tadalafil was administered to individuals taking the selective alpha-1 A-blocker tamsulosin.

Concomitant use of tadalafil with doxazosin is contraindicated. When using tadalafil in healthy volunteers taking doxazosin (4-8 mg per day), an alpha-1-adrenoblocker, an increase in the hypotensive effect of doxazosin was observed. Some patients experienced dizziness. No fainting spells were observed. The use of doxazosin in lower doses has not been studied.

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

Tadalafil has no clinically significant effect on the pharmacokinetics or Pharmacodynamics of theophylline.

How to take, course of use and dosage

For oral use.

For patients with frequent sexual activity (more than twice a week), the recommended frequency of use is 5 mg daily, once a day, at the same time, regardless of food intake. The daily dose can be reduced to 2.5 mg depending on individual sensitivity.
For patients with infrequent sexual activity (less than twice a week), it is recommended to prescribe the drug at a dose of 20 mg, immediately before sexual activity, according to the instructions for medical use of the drug. The maximum daily dose is 20 mg.

Overdose

Symptoms: when administered once to healthy volunteers at a dose of up to 500 mg and to patients with erectile dysfunction – repeatedly up to 100 mg/day, the undesirable effects were the same as when using the drug in lower doses.

Treatment: performing standard symptomatic therapy. During hemodialysis, tadalafil is practically not excreted.

Special instructions

Caution should be exercised when prescribing Cialis to patients taking alpha-1 blockers, as concomitant use may lead to symptomatic hypotension in some patients.

In a clinical pharmacology study,18 healthy volunteers who received a single dose of tadalafil did not experience symptomatic hypotension with simultaneous use of tamsulosin, an alpha-1-blocker. Diagnosis of erectile dysfunction should include identification of the potential underlying cause, appropriate medical examination, and determination of treatment options.

Sexual activity has a potential risk for patients with cardiovascular diseases. Therefore, treatment of erectile dysfunction, including with the drug Cialis, should not be carried out in men with heart diseases in which sexual activity is not recommended. Priapism has been reported with PDE5 inhibitors, including tadalafil.

Patients should be informed about the need to seek immediate medical attention in the event of an erection lasting 4 hours or more. Untimely treatment of priapism leads to damage to the tissues of the penis, which can lead to irreversible impotence.

The safety and efficacy of the combination of Cialis with other treatments for disorders have not been studied. Therefore, the use of such combinations is not recommended. Like other PDE5 inhibitors, tadalafil has systemic vasodilating properties, which can lead to a transient decrease in blood pressure.

Before prescribing Cialis, doctors should carefully consider whether patients with cardiovascular disease will be exposed to undesirable effects due to such vasodilating effects. Non-arterial anterior ischemic optic neuropathy (NAPION) is a cause of visual impairment, including complete loss of vision.

There are rare post-marketing reports of cases of NAPION development that are associated with the use of PDE-5 inhibitors. Currently, it is not possible to determine whether there is a direct relationship between the development of NAPION and the use of PDE5_ inhibitors or other factors.

Doctors should recommend that patients with sudden vision loss stop taking tadalafil and seek medical attention. Doctors should also inform patients that people who have had NAPION have an increased risk of developing NAPION again.

The efficacy of Cialis in patients undergoing pelvic surgery or radical neuroprotective prostatectomy is unknown.

Use in patients with impaired liver function: since there are no data for patients with severe hepatic insufficiency (Child-Pugh class C), caution should be exercised when prescribing the drug to this group of patients.

Influence on the ability to drive motor vehicles and manage mechanisms: despite the fact that the frequency of dizziness with placebo and tadalafil is the same, during treatment, caution should be exercised when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.