Instructions for Vezom modified-release tablets 6 mg + 0.4 mg blister No. 30
Composition
active ingredients: solifenacin succinate, tamsulosin hydrochloride;
1 tablet contains 6 mg of solifenacin succinate, equivalent to 4.5 mg of solifenacin, and 0.4 mg of tamsulosin hydrochloride, equivalent to 0.37 mg of tamsulosin;
excipients: mannitol (E 421), maltose, macrogol 7000000, macrogol 8000, magnesium stearate (E 470b), Opadry Red 03F45072*.
* Macrogol 8000, hypromellose (E 464), iron oxide red (E 172), purified water (not present in the finished product).
Dosage form
Modified-release tablets.
Main physicochemical properties: round tablets, coated with a red film shell, with embossed marking "6/0.4".
Pharmacotherapeutic group
Drugs used in urology. Alpha-adrenoblockers. ATX code G04C A53.
Pharmacological properties
Pharmacodynamics.
Vesomni is a combination medicine containing two active substances, solifenacin and tamsulosin. These active substances have independent and complementary mechanisms of action for the treatment of lower urinary tract symptoms (LUTS) in benign prostatic hyperplasia (BPH) with bladder filling symptoms.
Solifenacin is a selective competitive muscarinic receptor antagonist with no affinity for other receptors, enzymes, or ion channels. Solifenacin has the highest affinity for muscarinic M3 receptors and lower affinity for muscarinic M1 and M2 receptors.
Tamsulosin is an alpha1-adrenoceptor blocker. Tamsulosin selectively and competitively binds to postsynaptic alpha1-adrenoceptors, especially the alpha1A and alpha1D subtypes, which are responsible for relaxing the smooth muscles of the lower urinary tract.
Solifenacin relieves bladder filling symptoms (irritative symptoms) associated with the action of acetylcholine, which activates M3 cholinergic receptors in the bladder. Acetylcholine activates the contractile function of the bladder wall, which manifests itself in the form of urgent urges to urinate or urinary incontinence.
Tamsulosin improves voiding symptoms by increasing maximum urine flow rate, reduces symptoms of obstruction by relaxing smooth muscles of the prostate, bladder neck, and urethra, and improves bladder filling.
Pharmacokinetics.
A multiple-dose bioavailability study showed that the pharmacokinetics of Vesomni are comparable to the pharmacokinetics of solifenacin and tamsulosin co-administered.
Absorption.
After multiple doses of Vesomni, the time to reach maximum concentration tmax for solifenacin varied between 4.27 and 4.76 h in different studies, and for tamsulosin between 3.47 and 5.65 h, respectively. Maximum plasma concentration (Cmax) for solifenacin varied between 26.5 ng/ml and 32.0 ng/ml, and for tamsulosin between 6.56 ng/ml and 13.3 ng/ml. The area under the concentration-time curve for solifenacin ranged from 528 ng/h/ml to 601 ng/h/ml, and for tamsulosin between 97.1 ng/h/ml and 222 ng/h/ml. The absolute bioavailability of solifenacin was approximately 90%, while tamsulosin was absorbed at 70-79% of the administered dose.
A single dose of Vesomni has been studied with food, a low-fat meal, a low-calorie breakfast, and a high-fat meal and a high-calorie breakfast. A 54% increase in Cmax for tamsulosin was observed after a high-fat meal, a high-calorie breakfast, compared to fasting conditions, where AUC increased by 33%. The pharmacokinetics of solifenacin are not affected by a low-fat meal, a low-calorie breakfast, or a high-fat meal and a high-calorie breakfast.
Concomitant use of solifenacin and tamsulosin OCAS results in a 1.19-fold increase in Cmax and a 1.24-fold increase in AUC of tamsulosin compared to the AUC of tamsulosin OCAS alone. There is no evidence of an effect of tamsulosin on the pharmacokinetics of solifenacin.
Breeding.
After a single dose of Vesomni, the elimination half-life t1/2 of solifenacin ranged from 49.5 hours to 53 hours; of tamsulosin – from 12.8 hours to 14 hours.
Multiple administration of verapamil at a dose of 240 mg simultaneously with the drug Vesomni leads to an increase in solifenacin Cmax by 60% and AUC by 63%, while for tamsulosin Cmax increases by 115% and AUC by 122%. Changes in Cmax and AUC are not clinically significant.
Analysis of pharmacokinetic data from phase 3 clinical trials shows variability in the pharmacokinetics of tamsulosin depending on age, height and blood concentration of α1-acid glycoprotein. An increase in AUC is associated with an increase in α1-acid glycoprotein and age, while a decrease in AUC is associated with a decrease in height. In addition, an increase in gamma-glutamyltransferase is associated with high AUC values. These changes in AUC values are not clinically significant.
Information on the pharmacokinetics of the active substances of the combination medicinal product complements the pharmacokinetic properties of the medicinal product Vesomni.
Solifenacin.
The time to reach the maximum concentration tmax is independent of dose and ranges from 3 to 8 hours after multiple doses. The values of Cmax and AUC increase proportionally with dose from 5 to 40 mg. Absolute bioavailability is approximately 90%.
Distribution: The volume of distribution of solifenacin after intravenous administration of the drug is about 600 L. Approximately 98% of solifenacin is bound to plasma proteins, primarily α1-acid glycoprotein.
Biotransformation. Solifenacin is metabolized slowly, with a low first-pass effect. Solifenacin is extensively metabolized in the liver, mainly by CYP3A4. However, alternative metabolic pathways exist that may affect the metabolism of solifenacin. The systemic clearance of solifenacin is approximately 9.5 l/h. After oral administration, one pharmacologically active metabolite (4R-hydroxysolifenacin) and three inactive metabolites (N-glucuronide, N-oxide and 4R-hydroxy-N-oxide of solifenacin) were determined in plasma (in addition to solifenacin).
Elimination: After a single dose of 10 mg of 14C-labeled solifenacin, approximately 70% of the radioactivity was recovered in the urine and 23% in the feces within 26 days. In the urine, approximately 11% of the radioactivity was recovered as unchanged active substance, approximately 18% as the N-oxide metabolite, 9% as the 4R-hydroxy-N-oxide metabolite and 8% as the 4R-hydroxymetabolite (active metabolite).
Tamsulosin.
Absorption. For tamsulosin in the OCAS form, tmax is in the range of 4 to 6 hours after multiple doses of 0.4 mg/day. Cmax and AUC increase proportionally with dose from 0.4 to 1.2 mg. Absolute bioavailability is approximately 57%.
Distribution. The volume of distribution of tamsulosin after intravenous administration is about 16 L. Approximately 99% of tamsulosin binds to plasma proteins, primarily α1-acid glycoprotein.
Biotransformation. Tamsulosin has a low first-pass effect and is metabolized slowly. Tamsulosin is extensively metabolized in the liver, mainly by CYP3A4 and CYP2D6. The systemic clearance of tamsulosin is approximately 2.9 l/h. The majority of the administered tamsulosin is present in plasma as unchanged active substance. None of the metabolites were more active than the parent compound. Excretion. After a single dose of 0.2 mg of 14C-labeled tamsulosin, approximately 76% of the radioactivity was excreted in the urine and 21% in the feces after 1 week of treatment. Approximately 9% of the radioactivity was recovered in the urine as unchanged tamsulosin, approximately 16% as o-diethyl tamsulosin sulfate and 8% as o-ethoxyphenoxyacetic acid.
Elderly patients.
In clinical pharmacology and bioavailability studies, the age of patients ranged from 19 to 79 years. After administration of Vesomni, the highest concentrations were observed in elderly patients, although individual values were almost identical to those in younger patients. Vesomni can also be used in elderly patients.
Kidney failure.
Vesomni is used in patients with mild to moderate renal impairment, but caution should be exercised when used in patients with severe renal impairment.
The pharmacokinetics of Vesomni have not been studied in patients with renal impairment.
The data below reflect information on renal failure specific to each of the active ingredients of the drug.
Solifenacin.
AUC and Cmax of solifenacin in patients with mild and moderate renal impairment are not significantly different from those in healthy volunteers. In patients with severe renal impairment (creatinine clearance ≤ 30 ml/min), solifenacin exposure is significantly higher - an increase in Cmax of about 30%, AUC of more than 100% and t1/2 of more than 60%. A statistically significant relationship between creatinine clearance and solifenacin clearance was observed. Pharmacokinetics in patients undergoing hemodialysis have not been studied.
Tamsulosin.
The pharmacokinetics of tamsulosin were compared in 6 patients with mild to moderate renal impairment (30 ≥ creatinine clearance < 70 ml/min/1.73 m2) or moderate to severe renal impairment (< 30 ml/min/1.73 m2) and in 6 healthy subjects (creatinine clearance > 90 ml/min/1.73 m2). Changes in total plasma concentrations of tamsulosin were observed due to changes in binding to α1-acid glycoprotein, while the active concentration of tamsulosin hydrochloride and intrinsic clearance remained relatively stable. The pharmacokinetics of tamsulosin in patients with end-stage renal failure (creatinine clearance < 10 ml/min/1.73 m2) have not been studied.
Liver failure.
The drug Vesomni is used in patients with mild to moderate hepatic impairment, but is contraindicated in patients with severe hepatic impairment.
The pharmacokinetics of Vesomni have not been studied in patients with renal impairment.
The data below reflect information on hepatic insufficiency specific to each of the active ingredients of the drug.
Solifenacin.
In patients with moderate hepatic insufficiency (7-9 points on the Child-Pugh scale), the Cmax value does not change, AUC increases by 60%, t1/2 increases by half.
Pharmacokinetics in patients with severe hepatic impairment have not been studied.
The pharmacokinetics of tamsulosin were compared in 8 patients with moderate hepatic insufficiency (Child-Pugh score 7-9) and in 8 healthy subjects. Changes in the total plasma concentration of tamsulosin were observed due to changes in binding to α1-acid glycoprotein, the active concentration of tamsulosin hydrochloride did not change significantly, and the intrinsic clearance of inactive tamsulosin changed moderately (32%). The pharmacokinetics of tamsulosin in patients with severe hepatic insufficiency have not been studied.
Indication
Treatment of moderate to severe bladder filling symptoms (urinary urgency, increased frequency of urination) and bladder emptying symptoms (obstructive symptoms) associated with benign prostatic hyperplasia (BPH) in men who are not responding to monotherapy.
Contraindication
Hypersensitivity to the active substances or to any of the excipients. Hemodialysis. Severe hepatic impairment. Severe renal impairment in which potent inhibitors of cytochrome P450 (CYP) 3A4 are used, e.g. ketoconazole. Moderate hepatic impairment in which potent inhibitors of CYP3A4 are also used, e.g. ketoconazole.
Severe gastrointestinal diseases (including toxic megacolon), myasthenia gravis or angle-closure glaucoma and the presence of risks for the development of these diseases. History of orthostatic hypotension.
Interaction with other medicinal products and other types of interactions
Concomitant use of the drug with other drugs with anticholinergic action may cause a more pronounced therapeutic effect and side effects. The interval between taking such drugs should be approximately one week. The therapeutic effect of solifenacin may be reduced with simultaneous use of cholinergic receptor agonists.
Interactions with CYP3A4 and CYP2D6 inhibitors.
Co-administration of solifenacin with ketoconazole (a potent CYP3A4 inhibitor) at a dose of 200 mg/day resulted in a 1.4- and 2.0-fold increase in Cmax and AUC of solifenacin, while ketoconazole at a dose of 400 mg/day resulted in a 1.5- and 2.8-fold increase in Cmax and AUC of solifenacin.
When tamsulosin was co-administered with ketoconazole at a dose of 400 mg/day, a 2.2- and 2.8-fold increase in Cmax and AUC of tamsulosin, respectively, was observed.
Since co-administration with strong CYP2D6 inhibitors such as ketoconazole, ritonavir, nelfinavir and itraconazole may lead to increased exposure to both solifenacin and tamsulosin, Vesomni should be used with caution with strong CYP2D6 inhibitors. Vesomni should not be used concomitantly with strong CYP2D6 inhibitors in patients with a CYP2D6 poor metaboliser phenotype or who are already taking strong CYP2D6 inhibitors.
Concomitant use of Vesomni with verapamil (a moderate CYP3A4 inhibitor) resulted in an approximately 2.2-fold increase in Cmax and AUC of tamsulosin and an approximately 1.6-fold increase in Cmax and AUC of solifenacin. Vesomni should be used with caution with moderate CYP3A4 inhibitors.
When tamsulosin was co-administered with cimetidine, a weak CYP3A4 inhibitor (400 mg every 6 hours), there was a 1.44-fold increase in tamsulosin AUC, while Cmax was not significantly changed. Vesomni can be used concomitantly with weak CYP3A4 inhibitors.
Concomitant use of tamsulosin with paroxetine, a potent CYP2D6 inhibitor (20 mg daily), resulted in a 1.3- and 1.6-fold increase in tamsulosin Cmax and AUC, respectively. Vesomni can be used concomitantly with CYP2D6 inhibitors.
The effect of enzyme inducers on the pharmacokinetics of solifenacin and tamsulosin has not been studied. Since solifenacin and tamsulosin are metabolized by CYP3A4, pharmacokinetic interactions with CYP3A4 inducers (e.g. rifampicin) are possible, which may reduce the plasma concentrations of solifenacin and tamsulosin.
Other interactions.
Solifenacin.
Solifenacin may reduce the effects of drugs that stimulate gastrointestinal motility, such as metoclopramide and cisapride. In vitro studies with solifenacin have shown that solifenacin at therapeutic concentrations does not inhibit CYP1A1/2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 or 3A4, therefore no interactions are expected between solifenacin and drugs that are metabolized by these CYP enzymes. Solifenacin does not alter the pharmacokinetics of R-warfarin or S-warfarin or their effects on prothrombin time. Solifenacin has been shown to have little effect on the pharmacokinetics of digoxin.
Concomitant use of tamsulosin with other alpha1-adrenergic blockers may result in hypotensive effects. In in vitro studies, the free fraction of tamsulosin in human plasma was not altered by concomitant use of diazepam, propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin or warfarin. Tamsulosin does not alter the free fraction of diazepam, propranolol, trichlormethiazide or chlormadinone. Although diclofenac and warfarin may increase the rate of tamsulosin elimination. Concomitant use with furosemide results in a decrease in tamsulosin plasma levels, but as tamsulosin levels remain within the therapeutic range, concomitant use of tamsulosin and furosemide is acceptable. In vitro studies with tamsulosin have shown that at therapeutic concentrations tamsulosin has little or no inhibitory effect on CYP1A2, 2C9, 2C19, 2D6, 2E1 or 3A4. Therefore, no interactions are expected between tamsulosin and drugs metabolized by these CYP enzymes. There are no reports of interactions with tamsulosin when co-administered with atenolol, enalapril or theophylline.
Application features
Vesomni should be used with caution in patients with severe renal impairment, risk of urinary retention, gastrointestinal obstructive disorders; risk of decreased gastrointestinal motility, hiatal hernia/gastroesophageal reflux and/or concomitant use of drugs that may cause or exacerbate esophagitis (e.g. bisphosphonates), autonomic neuropathy.
Before starting treatment with Vesomni, other possible causes of frequent urination (heart failure or kidney disease) should be evaluated. In the presence of a urinary tract infection, appropriate antibacterial treatment should be prescribed.
In patients with risk factors for QT prolongation, such as pre-existing long QT syndrome and hypokalemia, QT prolongation and ventricular fibrillation (torsade de pointes) have been observed with solifenacin succinate.
Angioedema with airway obstruction has been reported in some patients treated with solifenacin succinate and tamsulosin. If angioedema occurs, Vesomni should be discontinued and the drug should be discontinued. Appropriate measures should be taken and appropriate treatment should be initiated.
Anaphylactic reactions have been reported in some patients treated with solifenacin succinate. If anaphylactic reactions occur, Vesomni should be discontinued and appropriate measures and treatment should be initiated.
As with other alpha1-adrenergic blockers, in rare cases, tamsulosin treatment may cause a decrease in blood pressure, which may rarely result in fainting. Patients starting treatment with Vesomni should be advised to sit or lie down at the first sign of orthostatic hypotension (dizziness, weakness) until the symptoms have resolved.
In some patients taking tamsulosin hydrochloride during cataract or glaucoma surgery or in case of previous treatment with tamsulosin hydrochloride, atonic pupil syndrome (IFIS, a variant of constricted pupil syndrome) has been observed. IFIS may increase the risk of ophthalmic complications during and after surgery. Therefore, it is not recommended to start treatment with Vesomni in patients who are scheduled for cataract or glaucoma surgery. Discontinuation of Vesomni 2 weeks before cataract or glaucoma surgery is theoretically considered beneficial, but the benefit of stopping treatment has not been reliably established. In the preoperative period, surgeons and ophthalmologists planning cataract or glaucoma surgery should ask patients whether they are currently taking or have previously taken Vesomni, in order to ensure that appropriate measures are taken to treat the possible occurrence of IFIS during surgery.
Vesomni should be used with caution when co-administered with moderate and potent CYP3A4 inhibitors (see section 4.5) and should not be administered in combination with potent CYP3A4 inhibitors, such as ketoconazole, in patients with a low CYP2D6 phenotype, or in patients taking potent CYP2D6 inhibitors, such as paroxetine.
The medicine contains mannitol, so it may have a mild laxative effect.
Use during pregnancy or breastfeeding
Vesomni is not indicated for use by women.
Fertility.
The effect of Vesomni on fertility has not been evaluated. Animal studies with solifenacin or tamsulosin have not shown harmful effects on fertility and early embryonic development.
Ejaculation disorders have been observed in short-term and long-term clinical trials of tamsulosin. Ejaculation disorders, retrograde ejaculation and ejaculation failure have been reported in the post-marketing period.
Ability to influence reaction speed when driving vehicles or other mechanisms
No studies on the effects of Vesomni on the ability to drive or use machines have been conducted. However, patients should be informed of the possibility of reactions such as dizziness, blurred vision, fatigue and (uncommon) increased drowsiness, which may adversely affect the ability to drive or use machines (see section "Adverse reactions").
Method of administration and doses
Adult men, including elderly men.
Take 1 tablet of Vesomni (6 mg/0.4 mg) once a day, regardless of meals. The maximum daily dose of Vesomni is 1 tablet (6 mg/0.4 mg). The tablets should be taken whole, not chewed or crushed.
Patients with renal impairment. The effect of renal impairment on the pharmacokinetics of Vesomni has not been studied. However, the effect on the pharmacokinetics of the individual active substances of the drug is well studied (see section "Pharmacokinetic properties"). Vesomni can be prescribed to patients with mild and moderate renal impairment (creatinine clearance > 30 ml/min). Patients with severe renal impairment (creatinine clearance ≤ 30 ml/min) should use the drug with caution and not exceed the maximum daily dose (see section "Special instructions").
Patients with hepatic impairment. The effect of hepatic insufficiency on the pharmacokinetics of Vesomni has not been studied. However, the effect on the pharmacokinetics of the individual active substances of the drug is well studied (see section "Pharmacokinetic properties"). Vesomni can be prescribed to patients with mild hepatic insufficiency (Child-Pugh score ≤ 7). Patients with moderate hepatic insufficiency (Child-Pugh score 7-9) should use the drug with caution and not exceed the maximum daily dose. Vesomni is contraindicated in patients with severe hepatic insufficiency (Child-Pugh score > 9).
Moderate and potent inhibitors of cytochrome P450 3A4. Vesomni should be used with caution in patients receiving concomitant treatment with moderate or potent CYP3A4 inhibitors (such as verapamil, ketoconazole, ritonavir, nelfinavir, itraconazole).
Children.
The drug is not intended for use in children and adolescents (under 18 years of age).
Overdose
Symptoms Overdose with the combination of solifenacin and tamsulosin can potentially lead to severe anticholinergic effects with the development of acute arterial hypotension. The highest doses taken accidentally during clinical studies corresponded to 126 mg of solifenacin succinate and 5.6 mg of tamsulosin hydrochloride. These doses were well tolerated, with moderate to mild dry mouth observed during 16 days of treatment.
Treatment.
In case of overdose of solifenacin and tamsulosin, the patient should take activated charcoal. Gastric lavage may be useful within the first hour after ingestion, but vomiting should not be induced.
Symptoms of overdose with solifenacin, as with other anticholinergic drugs, can be treated as follows:
severe anticholinergic effects on the central nervous system, hallucinations or other pronounced disorders: treatment with physostigmine or carbachol;
Convulsions or severe excitability: treatment with benzodiazepines;
respiratory failure: treatment with artificial respiration;
Tachycardia: symptomatic treatment if necessary. Beta-blockers should be used with caution as concomitant overdose of tamsulosin could potentially cause severe hypotension;
urinary retention: catheterization.
As with other antimuscarinic agents, in the event of overdose, special attention should be paid to patients with an established risk of developing QT prolongation (e.g. hypokalaemia, bradycardia and concomitant use of medicinal products that may prolong the QT interval) and relevant pre-existing cardiac disease (e.g. myocardial ischaemia, arrhythmia, heart failure).
Acute hypotension, which may occur with tamsulosin overdose, should be treated symptomatically. Since tamsulosin is highly bound to plasma proteins, hemodialysis is unlikely.
Side effects
Vesomni may cause mild to moderate anticholinergic adverse reactions. The most common adverse reactions were dry mouth (9.5%), constipation (3.2%) and dyspepsia (including abdominal pain, 2.4%). Other adverse reactions were commonly observed, such as dizziness (1.4%), blurred vision (1.2%), fatigue (1.2%) and ejaculation disorder (including retrograde ejaculation, 1.5%). The most serious adverse reaction to the drug observed during treatment with Vesomni in clinical studies was acute urinary retention (0.3%, uncommon). The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000), unknown (cannot be estimated from the available data).
| Frequency of adverse reactions observed during clinical trials Vesomni | Frequency of adverse reactions of individual active substances | |
Solifenacin 5 mg and 10 mg# | Tamsulosin 0.4 mg# | | |
| Infections and infestations | | | |
| Urinary tract infections | | Infrequently | |
| Cystitis | | Infrequently | |
| On the part of the immune system | | | |
| Anaphylactic reactions | | Unknown* | |
| Metabolism and digestion | | | |
| Decreased appetite | | Unknown* | |
| Hyperkalemia | | Unknown * | |
| From the psyche | | | |
| Hallucinations | | Very rare* | |
| Confusion of consciousness | | Very rare* | |
| Delirium | | Unknown* | |
| From the nervous system | | | |
| Dizziness | Often | Rarely* | Often |
| Drowsiness | | Infrequently | |
| Dysgeusia | | Infrequently | |
| Headache | | Rarely* | Infrequently |
| Faint | | | Rarely |
| From the organs of vision | | | |
| Blurred vision | Often | Often | Unknown* |
| Atonic pupil syndrome (IFIS, a variant of constricted pupil syndrome) | | | Unknown** |
| Dry eyes | | Infrequently | |
| Glaucoma | | Unknown* | |
| Vision impairment | | | Unknown* |
| Cardiovascular system | | | |
| Palpitation | | Unknown* | Infrequently |
| Ventricular flutter/fibrillation (torsade de pointes) | | Unknown* | |
| QT prolongation on electrocardiogram | | Unknown* | |
| Atrial fibrillation | | Unknown* | Unknown* |
| Arrhythmia | | | Unknown* |
| Tachycardia | | Unknown* | Unknown* |
| Vascular disorders | | | |
| Orthostatic hypotension | | | Infrequently |
| Respiratory system | | | |
| Rhinitis | | | Infrequently |
| Dry nose | | Infrequently | |
| Dyspnea | | | Unknown * |
| Dysphonia | | Unknown * | |
| Nosebleed | | | Unknown* |
| From the digestive system | | | |
| Dry mouth | Often | Very often | |
| Dyspepsia | Often | Often | |
| Constipation | Often | Often | Infrequently |
| Nausea | | Often | Infrequently |
| Abdominal pain | | Often | |
| Gastroesophageal reflux | | Infrequently | |
| Diarrhea | | | Infrequently |
| Dry throat | | Infrequently | |
| Vomiting | | Rarely* | Infrequently |
| Intestinal obstruction | | Rarely | |
| Rectal obstruction | | Rarely | |
| Non-obstructive intestinal obstruction | | Unknown* | |
| Abdominal discomfort | | Unknown* | |
| Liver and biliary tract disorders | | | |
| Liver disease | | Unknown* | |
| Pathological changes in liver test parameters | | Unknown* | |
| Skin and subcutaneous tissue disorders | | | |
| Itch | Infrequently | Rarely* | Infrequently |
| Dry skin | | Infrequently | |
| Rash | | Rarely* | Infrequently |
| Urticaria | | Very rare* | Infrequently |
| Quincke's edema | | Very rare* | Rarely |
| Stevens-Johnson syndrome | | | Very rare |
| Erythema multiforme | | Very rare* | Unknown* |
| Exfoliative dermatitis | | Unknown* | Unknown* |
| Photosensitivity | | | Unknown* |
| Musculoskeletal and connective tissue disorders | | | |
| Muscle weakness | | Unknown* | |
| Kidney and urinary tract disorders | | | |
| Urinary retention *** | Infrequently | Rarely | |
| Difficulty urinating | | Infrequently | |
| Kidney failure | | Unknown* | |
| Reproductive system and breast disorders | | | |
| Ejaculation disorders, including retrograde ejaculation and ejaculatory failure | Often | | Often |
| Priapism | | | Very rare |
| General disorders | | | |
| Often | Infrequently | |
| Peripheral edema | | Infrequently | |
| Asthenia | | | Infrequently |
# The table includes adverse reactions specific to solifenacin and tamsulosin, as listed in the summary of product characteristics of these medicinal products.
*Based on post-marketing experience. As these events were reported spontaneously in the post-marketing period, the frequency of events and causality cannot be reliably established.
** Based on post-marketing experience; observed during cataract and glaucoma surgery.
*** See section "Application features".
Safety of the drug Vesomni with long-term use.
The adverse reaction profile observed with treatment up to 1 year was similar to that reported in the 12-week study.
Elderly patients.
Vesomni is indicated for the treatment of moderate to severe bladder filling symptoms (urinary urgency, urinary frequency) and bladder emptying symptoms (obstructive symptoms) associated with benign prostatic hyperplasia (BPH) in elderly patients. Clinical studies have been conducted in patients aged 45 to 91 years, with a mean age of 65 years. Adverse reactions in elderly patients are similar to those in younger patients.
Expiration date
3 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 30 °C.
Keep out of reach of children!
Packaging
10 tablets in a blister. 1 or 3 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
Astellas Pharma Europe B.V.
Address
Hogemat 2, 7942 JM Meppel, Netherlands.
In case of side effects, please send information to the representative office of Astellas Pharma Europe B.V. at 04050, Kyiv, Pymonenka St., 13, building 7-V, office 41, tel. 044-490-68-25, fax: 044-490-68-26.
