Instructions for use Prostazan Uroplus modified-release tablets 6.4 mg No. 30
Composition
active ingredients: solifenacin succinate, tamsulosin hydrochloride;
1 tablet contains solifenacin succinate 6 mg and tamsulosin hydrochloride 0.4 mg; excipients: microcrystalline cellulose 200, polyethylene oxide 7000000, magnesium stearate, microcrystalline cellulose, calcium hydrogen phosphate, colloidal anhydrous silicon dioxide, croscarmellose sodium, red iron oxide (E 172);
film coating: Opadry red 03f250016: hypromellose, red iron oxide (E 172), macrogol, titanium dioxide (E 171).
Dosage form
Modified-release tablets.
Main physicochemical properties: round tablets, coated with a red film coating, with embossed markings.
Pharmacotherapeutic group
Drugs used in urology. Alpha-adrenoblockers. ATX code G04C A53.
Pharmacological properties
Pharmacodynamics.
Prostazan Uroplus is a combination drug containing two active ingredients – solifenacin and tamsulosin. These active ingredients have independent and complementary mechanisms of action for the treatment of lower urinary tract symptoms (LUTS) in benign prostatic hyperplasia (BPH) in the presence of bladder filling symptoms. Solifenacin is a selective competitive antagonist of muscarinic receptors, has no affinity for other receptors, enzymes or ion channels. Solifenacin has the highest affinity for muscarinic M3 receptors and a lower affinity for muscarinic M1 and M2 receptors.
Tamsulosin is an alpha1-adrenoceptor blocker. Tamsulosin selectively and competitively binds to postsynaptic alpha1-adrenoceptors, particularly 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 the drug are comparable to the pharmacokinetics of solifenacin and tamsulosin co-administered.
Absorption
After multiple dosing, 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 the drug was studied with food, a low-fat meal, a low-calorie breakfast, and a high-fat meal and a high-calorie breakfast. After a high-fat meal, a high-calorie breakfast, an increase in Cmax for tamsulosin by 54% was observed compared to taking the drug on an empty stomach, in which the AUC increased by 33%. The pharmacokinetics of solifenacin does not change with a low-fat meal, a low-calorie breakfast, or a high-fat meal and a high-calorie breakfast. The simultaneous use of solifenacin and tamsulosin leads to a 1.19-fold increase in Cmax of tamsulosin and an increase in AUC of tamsulosin by 1.24-fold compared to the AUC of tamsulosin in monotherapy. There are no indications of the effect of tamsulosin on the pharmacokinetics of solifenacin.
Breeding
After a single dose of the drug, 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 leads to an increase in Cmax and AUC of solifenacin by 60% and 63%, respectively, while Cmax and AUC of tamsulosin increase by 115% and 122%, respectively. Changes in Cmax and AUC are not clinically significant.
Solifenacin.
Absorption.
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 in the range 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 detected in plasma (in addition to solifenacin). Excretion. 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 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, 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 in the range of 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 is bound 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 the drug, the highest concentration values were observed in elderly patients, although individual values were almost completely consistent with those in younger patients. The drug can also be used in elderly patients.
Kidney failure.
Prostazan Uroplus is used in patients with mild to moderate renal insufficiency, but caution should be exercised when used in patients with severe renal insufficiency. The pharmacokinetics of Prostazan Uroplus have not been studied in patients with renal insufficiency. The data below reflect information on renal insufficiency specific to each of the active substances of the drug.
Solifenacin.
The AUC and Cmax of solifenacin in patients with mild to 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: the increase in Cmax is approximately 30%, AUC is more than 100% and t1/2 is 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 mL/min/1.73 m2 ≥ 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 tamsulosin concentrations 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 Prostazan Uroplus is used in patients with mild to moderate liver failure, but is contraindicated in patients with severe liver failure.
The pharmacokinetics of Prostazan Uroplus have not been studied in patients with hepatic insufficiency.
The data below reflect information on hepatic insufficiency specific to each of the active substances of the medicinal product.
Solifenacin.
Pharmacokinetics in patients with severe hepatic impairment have not been studied. Tamsulosin.
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 total plasma concentrations 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 for whom monotherapy has been ineffective.
Contraindication
- Hypersensitivity to the active substances or to any of the excipients.
- Hemodialysis.
- Severe liver failure.
- Severe renal failure in which potent cytochrome P450 (CYP) 3A4 inhibitors, such as ketoconazole, are used.
- Moderate liver dysfunction in which potent CYP3A4 inhibitors, such as ketoconazole, are also used.
- Severe gastrointestinal diseases (including toxic megacolon), myasthenia gravis or angle-closure glaucoma and the presence of risks for developing these diseases.
- History of orthostatic hypotension.
Interaction with other medicinal products and other types of interactions
The simultaneous use of Prostazan Uroplus 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 decrease 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 was observed, respectively. Since co-administration with potent CYP3A4 inhibitors such as ketoconazole, ritonavir, nelfinavir and itraconazole may lead to increased exposure to both solifenacin and tamsulosin, Prostasan Uroplus should be used with caution with potent CYP3A4 inhibitors. Prostasan Uroplus should not be used concomitantly with potent CYP3A4 inhibitors in patients with a phenotype characterized by poor CYP2D6 metabolism or in patients already taking potent CYP2D6 inhibitors.
Concomitant use of Prostasan Uroplus 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. Prostasan Uroplus 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), a 1.44-fold increase in tamsulosin AUC was observed, while Cmax did not change significantly. The drug Prostazan Uroplus can be used simultaneously 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 Cmax and AUC of tamsulosin, respectively. The drug 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 does not inhibit CYP1A1/2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 or 3A4 at therapeutic concentrations, and 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 and 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 decreased plasma levels of tamsulosin, 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
Prostazan Uroplus should be used with caution in patients with severe renal insufficiency, 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 therapy with Prostazan Uroplus, 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, Prostasan Uroplus should be discontinued and the drug should not be taken again. 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, Prostasan Uroplus should be discontinued and appropriate measures and treatment should be initiated.
As with other alpha1-adrenergic blockers, in some cases, tamsulosin treatment may cause a decrease in blood pressure, which may rarely result in fainting. Patients who have started treatment with Prostasan Uroplus should be advised to sit or lie down at the first signs of orthostatic hypotension (dizziness, weakness) until the symptoms disappear. In some patients who have taken tamsulosin hydrochloride during cataract or glaucoma surgery or who have received previous treatment with tamsulosin hydrochloride, atonic pupil syndrome (IFIS, a variant of constricted pupil syndrome) has been observed. IFIS syndrome may increase the risk of ophthalmic complications during and after surgery. Therefore, it is not recommended to start treatment with Prostasan Uroplus in patients who are scheduled for cataract or glaucoma surgery. Discontinuation of Prostasan Uroplus 2 weeks before cataract or glaucoma surgery is theoretically considered beneficial, but the benefit of discontinuation of 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 using or have previously taken Prostasan Uroplus to ensure that appropriate measures are taken to treat the possible occurrence of IFIS during surgery. Prostasan Uroplus should be used with caution when co-administered with moderate and strong CYP3A4 inhibitors (see section “Interaction with other medicinal products and other forms of interaction”), and should not be prescribed in combination with strong CYP3A4 inhibitors, such as ketoconazole, in patients with a low CYP2D6 phenotype, or in patients taking strong CYP2D6 inhibitors, such as paroxetine.
The medicine contains mannitol, so it may have a mild laxative effect.
Use during pregnancy or breastfeeding
The drug Prostazan Uroplus is not indicated for use by women. Fertility.
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 have been conducted on the effects of Prostazan Uroplus on the ability to drive or use machines. 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 the elderly.
Take 1 tablet of the drug Prostazan Uroplus (6 mg/0.4 mg) orally once a day, regardless of meals.
The maximum daily dose of the drug Prostazan Uroplus is 1 tablet (6 mg/0.4 mg).
The tablets should be swallowed whole, not chewed or crushed.
Patients with renal insufficiency. The effect of renal insufficiency on the pharmacokinetics of Prostazan Uroplus has not been studied. However, the effect on the pharmacokinetics of individual active substances of the drug is well studied (see the section "Pharmacokinetic properties"). The drug Prostazan Uroplus can be prescribed to patients with mild and moderate renal insufficiency (creatinine clearance > 30 ml/min). Patients with severe renal insufficiency (creatinine clearance ≤ 30 ml/min) should use the drug with caution and not exceed the maximum daily dose (see the section "Special instructions for use").
Patients with impaired liver function. The effect of hepatic insufficiency on the pharmacokinetics of Prostazan Uroplus has not been studied. However, the effect on the pharmacokinetics of individual active substances of the drug is well studied (see the section "Pharmacokinetic properties"). Prostazan Uroplus 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. For patients with severe hepatic insufficiency (Child-Pugh score > 9), the use of Prostazan Uroplus is contraindicated. Moderate and potent inhibitors of cytochrome P450 3A4. Prostazan Uroplus should be used with caution in patients who are concurrently receiving treatment with moderate or potent CYP3A4 inhibitors (such as verapamil, ketoconazole, ritonavir, nelfinavir, itraconazole).
Children.
The medicine 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 mild dry mouth observed during 16 days of treatment.
Treatment.
In case of drug overdose, the patient should take activated charcoal. Gastric lavage may be useful within the first hour after drug 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, haemodialysis is unlikely to be effective.
Adverse reactions
The drug may cause mild to moderate anticholinergic adverse reactions.
The most serious adverse reaction observed during treatment with solifenacin succinate/tamsulosin hydrochloride in clinical trials 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 (≥ 1000 to < 1/100); rare (≥ 1/10000 to < 1/1000), very rare (< 1/10000), unknown (cannot be estimated from the available data).
| Organ system classes | Frequency of adverse reactions observed during clinical trials of solifenacin succinate, tamsulosin hydrochloride | Frequency of side effects of individual active ingredients | |
| 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* | |
| From the side of metabolism, metabolism | | | |
| 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, thoracic and mediastinal disorders | | | |
| Rhinitis | | | Infrequently |
| Dry nose | | Infrequently | |
| Dyspnea | | | Unknown * |
| Dysphonia | | Unknown * | |
| Nosebleed | | | Unknown* |
| Gastrointestinal tract | | | |
| 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* | |
| Renal and urinary 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 and administration site conditions | | | |
| Fatigue | 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 solifenacin succinate/tamsulosin hydrochloride therapy 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.
Prostazan Uroplus 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 were 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.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions after the marketing authorisation of a medicinal product is an important procedure. This allows for continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals should report any suspected adverse reactions via the national reporting system.
Expiration date
2 years.
Storage conditions
This medicinal product does not require any special storage conditions. Keep out of the reach of children.
Packaging
10 tablets in a blister. 3 or 9 blisters in a pack.
Vacation category
According to the recipe.
Producer
Synthon Hispania SL
Location of the manufacturer and its business address.
C/Castello, no1, Sant Boi de Llobregat, Barcelona, 08830, Spain/ C/Castello, no1, Sant Boi de Llobregat, Barcelona, 08830, Spain
