VESOMNI PILLS 6MG + 0.4MG

Indications

- treatment of filling symptoms (irritative symptoms), moderate to severe (urge to urinate, frequent urination), and emptying symptoms (obstructive symptoms) associated with benign prostatic hyperplasia in men.

Dosage and administration

Adults over the age of 18, as well as older patients

Inside, 1 tab. 1 time / day, regardless of the meal.

The pill must be taken whole, it can not be chewed, because This may affect the prolonged release of the active substance.

Side effect

Vesomnia can cause side effects associated with the m-anticholinergic action of solifenacin, often mild or moderate severity. The most frequently reported side effects of dry mouth (9.5%), constipation (3.2%) and dyspepsia (including 2.4% pain in the abdomen) were reported during the conduct of clinical trials with Vesomni. Other common adverse reactions include dizziness (1.4%), blurred vision (1.2%), fatigue (1.2%), and ejaculation disorders (including retrograde ejaculation - 1.5%). Acute urinary retention (0.3%, rare) is the most serious side effect that was observed during the treatment with Vesomni during clinical studies.

In the table below, the column "Frequency of adverse reactions when taking Vesomni" reflects the adverse reactions recorded during a clinical study of the drug Vesomni.

The columns "frequency of occurrence of undesirable reactions of solifenacin and tamsulosin" reflect unwanted reactions that were reported in relation to individual components (data from drug instructions solifenacin 5 and 10 mg and Tamsulosin 0.4 mg, respectively), and which can potentially occur when taking the drug Vesomni.

The frequency of adverse reactions is determined as follows: very often (≥1 / 10); often (≥1 / 100 to <1/10); infrequently (≥1 / 1000, up to <1/100); rarely (≥1 / 10,000 to <1/1000); very rarely (<1/10 000), unknown (impossible to estimate based on available data).

* - observed after registration of the drug. Due to the fact that the data were obtained by the method of spontaneous messages in the post-registration period, determining the frequency and causal relationship with taking tamsulosin and solifenacin is difficult.

Vesomny Long Term Safety Data

The types and frequency of adverse reactions that were observed during the treatment for 1 year with Vesomni, coincided with the data that were observed during the 12-week study. The drug was well tolerated and there were no specific adverse reactions associated with prolonged use of the drug.

Contraindications

- hypersensitivity to the active substances or any of the auxiliary substances;

- hemodialysis;

- severe liver failure;

- severe renal insufficiency or moderate hepatic insufficiency with simultaneous treatment with strong inhibitors of the CYP3A4 isoenzyme, for example, Ketoconazole ;

- the presence of severe gastrointestinal diseases (including toxic megacolon), myasthenia and angle-closure glaucoma;

- orthostatic hypotension;

- children's age up to 18 years (lack of data on efficiency and safety).

Carefully

Patients should be carefully prescribed with:

- severe renal failure;

- the risk of urinary retention;

- gastrointestinal obstructive diseases;

- risk of reduced gastrointestinal motility;

- with hernia of the esophageal orifice of the diaphragm, gastroesophageal reflux, and patients who are simultaneously taking drugs (for example, bisphosphates) that can cause or strengthen esophagitis;

- with autonomic neuropathy;

- in patients with such risk factors as the syndrome of lengthening the QT interval and hypokalemia, prolongation of the QT interval and tachycardia of the "pirouette" type were observed.

Anaphylactic reaction was noted in some patients who received treatment with solifenacin after registering the drug. With the development of Anaphylactic reactions , the treatment should be stopped and appropriate treatment should be carried out.

Like using other alpha1-adrenergic blockers, in the treatment with tamsulosin, in some cases, a decrease in blood pressure can be observed, which in rare cases can lead to fainting. At the first sign of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down and remain in this position until the signs disappear.

In some patients taking or previously taking tamsulosin hydrochloride,during surgery but the development of the syndrome of intraoperative instability of the iris of the eye (narrow pupil syndrome), which can lead to complications during surgery or in the postoperative period, was noted during cataract and glaucoma. It is not recommended to start Vesomni therapy in patients who are scheduled for cataract or glaucoma surgery. The expediency of discontinuing Vesomni therapy 1-2 weeks before cataract or glaucoma surgery has not yet been proven. During the preoperative examination of patients, the surgeon and the ophthalmologist should consider whether this patient is accepting or accepting Vesomni. This is necessary to prepare for the development of the syndrome of intraoperative instability of the iris.

Vesomni should be used with caution in combination with strong and moderate CYP3A4 inhibitors, for example, Verapamil , ketoconazole, ritonavir, nelfinavir, itraconazole. The drug should not be used in patients with metabolic imbalance of CYP2D6 isoenzyme in combination with strong inhibitors of CYP3A4 or strong inhibitors of CYP2D6, for example, paroxetine.

Patients with renal failure

Vesomni can be used in patients with mild to moderate renal insufficiency, but should be used with caution in patients with severe renal insufficiency.

Patients with liver failure

Vesomny can be used by patients with mild hepatic impairment (Child-Pugh score ≤7). Patients with moderate hepatic insufficiency (7–9 points on the Child-Pugh scale) should take the drug with caution. Patients with severe hepatic insufficiency (score on the Child-Pugh scale above 9) use Vesomni contraindicated.

Use during pregnancy and lactation

The impact of Vesomny on reproductive function has not been studied. Animal studies have not revealed a direct adverse effect of solifenacin or tamsulosin on fertility or embryo / fetus development.

Pregnancy and lactation

Vesomni preparation is intended for use only in males.

Application for violations of the liver

The drug is used with caution in patients with moderate liver failure (7-9 points on the Child-Pugh scale).

For patients with severe liver failure (Child-Pugh score above 9), use of the drug is contraindicated.

Application for violations of kidney function

Vesomni can be used in patients with mild to moderate renal insufficiency, but should be used with caution in patients with severe renal insufficiency.

The drug is contraindicated in patients with severe renal insufficiency or moderate hepatic insufficiency with simultaneous treatment with strong inhibitors of the CYP3A4 isoenzyme, for example, ketoconazole.

Use in children

The drug is contraindicated in children and adolescents under the age of 18 years.

special instructions

Influence on ability to drive vehicles and mechanisms

Studies on the effects of Vesomni on the ability to drive and engage in potentially hazardous activities have not been conducted. However, the patient should be informed about the possible occurrence of dizziness, blurred vision, fatigue and less sleepiness, which can adversely affect the ability to drive and work with mechanisms.

Overdose

Overdose with a combination of solifenacin and tamsulosin may be accompanied by severe m-holinoblokiruyuschimi violations along with acute hypotension. The highest dose that was taken by chance during a clinical trial was 126 mg solifenacin and 5.6 mg tamsulosin. This dose was well tolerated, it was noted the only undesirable phenomenon - dry mouth weak degree of severity for 16 days.

Treatment

In cases of overdose, you should appoint activated charcoal, wash the stomach, but should not induce vomiting. As in cases of overdose of other m-cholinoblockers, the symptoms should be treated as follows:

- with severe m-anticholinergic effects of central action (hallucinations, severe excitability) - physostigmine or Activated carbon ;

- for convulsions or marked irritability - benzodiazepines;

- in respiratory failure - artificial respiration;

- with tachycardia - symptomatic treatment as needed. Beta-blockers should be used with caution, since a simultaneous overdose with tamsulosin can potentially lead to severe hypotension;

- during acute urinary retention - catheterization.

As in the case of overdose of other m-cholinoblockers, special attention should be paid to patients with an established risk of lengthening the QT interval (ie, with hypokalemia, bradycardia and while taking medications that cause lengthening of the QT interval) and patients with heart disease (myocardial ischemia, arrhythmias, chronic heart failure).

Severe hypotension that may occur after a tamsulosin overdose should be treated symptomatically. It is unlikely that dialysis will be effective, because tamsulosin is intensively bound to plasma proteins .

Drug interaction

Interaction with inhibitors of CYP3A4 and CYP2D6

The simultaneous use of solifenacin and ketoconazole (200 mg / day), a potent inhibitor of the CYP3A4 isoenzyme, caused a twofold increase in the AUC of solifenacin, and at a dose of 400 mg / day - a threefold increase.

The simultaneous use of tamsulosin with ketoconazole at a dosage of 400 mg / day leads to an increase in Cmax and tamsulosin AUC 2.2 and 2.8 times respectively.

Simultaneous reception of Vesomni with verapamil (moderate inhibitor of CYP3A4) leads to an increase in Cmax and tamsulosin AUC 2.2 times and C increasemax and the AUC of solifenacin is approximately 1.6 times.

The simultaneous administration of tamsulosin with a strong inhibitor of CYP2D6 paroxetine (20 mg / day) leads to an increase in Cmax and tamsulosin AUC 1.3 and 1.6 times, respectively.

Since solifeiatsin and tamsulosin are metabolized by CYP3A4 isoenzyme, pharmacokinetic interactions with inducers of CYP3A4 isoenzyme (for example, rifampicin) are possible.

Other interactions

Solifenacin

- Solifenacin can reduce the effect of drugs that stimulate GI motility, for example, Metoclopramide and cisapride.

- In vitro studies have shown that at therapeutic concentrations, solifenacin does not inhibit CYP1A1 / 2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 or 3A4 isoenzymes. Therefore, it is unlikely that solifenacin will change the clearance of drugs metabolized by these iso-CYP enzymes.

- The administration of solifenacin ns caused changes in the pharmacokinetics of R-warfarin or S-warfarin or their effect on prothrombin time.

- The administration of solifenacin does not affect the pharmacokinetics of Digoxin .

Tamsulosin

- Simultaneous appointment of other α blockers1-adrenoreceptors can lead to a hypotensive effect.

- Diazepam, propranolol, trichlormethiazide, chlormadinone, Amitriptyline , Diclofenac , glibenclamide, Simvastatin and Warfarin do not change the free fraction of tamsulosin in human plasma in vitro. In turn, tamsulosin also does not change the free fractions of diazepam, propranolol, trichloromethiazide and chlormadinone. Diclofenac and warfarin may increase the rate of elimination of tamsulosin.

- When used simultaneously with Furosemide , a slight decrease in concentration is noted, but this does not require a dose change, since the drug concentration remains within the normal range.

- In vitro studies have shown that at therapeutic concentrations, tamsulosin does not inhibit CYP1A1 / 2, 2C9, 2C19, 2D6, 2E1 or 3A4 isoenzymes. Therefore, it is unlikely that tamsulosin will change the clearance of drugs metabolized by these iso-SUR enzymes.

- When prescribing tamsulosin together with Atenolol , Enalapril or theophylline interactions, ns was detected.

Pharmacy sales terms

The drug is available on prescription.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not higher than 30 ° C.