Prostazan-vista

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PROSTAZAN-VISTA (PROSTAZAN-VISTA)

Composition:

Active substance: tamsulosin hydrochloride;

1 capsule contains 0.4 mg of tamsulosin hydrochloride;

Excipients: microcrystalline cellulose, 30% dispersion of methacrylic acid - ethyl acrylate copolymer (1:1) containing polysorbate 80 (approximately 2.8%), sodium lauryl sulfate (approximately 0.7%), triethyl citrate, talc;

coating of pellets: 30% dispersion of methacrylic acid - ethyl acrylate copolymer (1:1) containing polysorbate 80 (approximately 2.8%), sodium lauryl sulfate (approximately 0.7%), talc, triethyl citrate;

capsule shell composition: gelatin, indigotine (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172).

Pharmaceutical form. Modified-release hard capsules.

Main physicochemical properties: hard gelatin capsule with orange-colored body and olive-colored cap. The capsule is filled with pellets from white to almost white in color.

Pharmacotherapeutic group. Agents used in benign prostatic hyperplasia. α1-adrenergic receptor antagonists. ATC code G04C A02.

Pharmacological Properties.

Pharmacodynamics.

Tamsulosin selectively and competitively blocks postsynaptic α1-adrenoceptors, particularly α1A and α1D subtypes, located in the smooth muscle of the prostate gland, bladder neck, and prostatic urethra. This leads to reduced tone of the smooth muscle in the prostate gland, bladder neck, and prostatic urethra, thereby facilitating improved urinary flow. Simultaneously, obstructive and irritative symptoms associated with benign prostatic hyperplasia are reduced (difficulty initiating urination, weakened urinary stream, post-void dribbling, sensation of incomplete bladder emptying, frequent urination, nocturia, urinary urgency).

These effects are maintained over long-term treatment and significantly delay the need for surgical intervention or catheterization.

α1-Adrenoceptor antagonists can reduce blood pressure by decreasing peripheral vascular resistance. However, during clinical studies, tamsulosin did not produce clinically significant reductions in blood pressure.

Pharmacokinetics.

Absorption. Tamsulosin is well absorbed from the gastrointestinal tract, with a bioavailability of nearly 100%. Absorption of tamsulosin is slightly slower following food intake. Consistent absorption is achieved when the patient takes tamsulosin at the same time each day after eating. The pharmacokinetics of tamsulosin are linear in nature.

After a single dose of tamsulosin taken after food, peak plasma concentration of tamsulosin is reached approximately 6 hours later. Steady-state concentration is achieved by the fifth day of daily dosing. At steady state, Cmax is approximately two-thirds higher than that observed after a single dose.

Distribution. In males, tamsulosin is approximately 99% bound to plasma proteins. The volume of distribution of tamsulosin is low (approximately 0.2 L/kg).

Metabolism. Tamsulosin hydrochloride does not undergo a first-pass effect and is slowly metabolized in the liver, forming pharmacologically active metabolites that retain high selectivity for α1-adrenoceptors. The majority of the active substance in the blood remains unchanged.

Elimination. Tamsulosin and its metabolites are primarily excreted via urine. Approximately 9% of the administered dose is excreted as unchanged active substance.

After a single dose of tamsulosin taken after food and at steady-state plasma concentrations, elimination half-lives are approximately 10 and 13 hours, respectively.

Clinical characteristics.

Indications.

Treatment of functional disorders of the lower urinary tract due to benign prostatic hyperplasia.

Contraindications.

Hypersensitivity to tamsulosin hydrochloride, including drug-induced angioneurotic edema, or to any of the excipients; history of orthostatic hypotension; severe hepatic impairment.

Interaction with other medicinal products and other forms of interaction.

Interaction studies were conducted only in adults.

No drug interactions were observed when tamsulosin hydrochloride was administered concomitantly with atenolol, enalapril, nifedipine, or theophylline. Concurrent administration with cimetidine increases, while coadministration with furosemide decreases, plasma concentrations of tamsulosin; however, since these levels remain within the normal range, no special dosage adjustment of tamsulosin is required.

In in vitro studies, diazepam, propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin, and warfarin did not affect the free fraction of tamsulosin in human plasma. Similarly, tamsulosin did not alter the free fractions of diazepam, propranolol, trichlormethiazide, and chlormadinone in human plasma.

However, diclofenac and warfarin may increase the elimination rate of tamsulosin. Concomitant administration of tamsulosin hydrochloride with strong CYP3A4 inhibitors may lead to increased effects of tamsulosin hydrochloride. Concurrent use with ketoconazole (a known potent CYP3A4 inhibitor) resulted in a 2.8- and 2.2-fold increase in AUC and Cmax, respectively.

Tamsulosin hydrochloride should not be prescribed in combination with strong CYP3A4 inhibitors to patients who are poor metabolizers of CYP2D6.

Tamsulosin hydrochloride should be used with caution when administered in combination with strong and moderate CYP3A4 inhibitors.

Concomitant administration of tamsulosin hydrochloride and paroxetine (a strong CYP2D6 inhibitor) results in a 1.3- and 1.6-fold increase in Cmax and AUC, respectively, although this is not considered clinically significant.

Concomitant use with other α1-adrenoblockers may enhance the hypotensive effect.

Special precautions for use.

As with other α1-adrenergic blockers, administration of tamsulosin may in individual cases lead to a reduction in blood pressure, which may occasionally result in loss of consciousness. If early signs of orthostatic hypotension (dizziness, weakness) occur, the patient should remain in a sitting or lying position until the aforementioned symptoms subside.

Prior to initiating treatment with the medicinal product Prostasan-Vista, a medical examination should be performed to rule out other concomitant conditions that may cause symptoms similar to those of benign prostatic hyperplasia. Prior to starting treatment, a digital rectal examination of the prostate should be performed, and, if necessary, a test to determine the level of prostate-specific antigen (PSA) should be conducted before treatment initiation and at regular intervals during treatment. The drug should be administered to patients with severe renal impairment (creatinine clearance < 10 mL/min) with particular caution, as clinical studies on the use of tamsulosin in such patients have not been conducted.

In some patients who were taking or had taken tamsulosin, intraoperative floppy iris syndrome (IFIS, a variant of intraoperative miosis) has been observed during cataract and glaucoma surgery, which may lead to an increased risk of complications during or after such procedures.

Generally, it is recommended to discontinue tamsulosin treatment 1–2 weeks prior to cataract or glaucoma surgery; however, the benefit of such discontinuation has not yet been definitively established. The floppy iris syndrome has also been reported in patients who had discontinued tamsulosin long before undergoing cataract surgery. Patients scheduled for elective cataract or glaucoma surgery should not initiate treatment with tamsulosin hydrochloride. Surgeons and ophthalmologists should be informed whether the patient is currently taking (or has previously taken) tamsulosin in order to prevent potential complications associated with IFIS.

Tamsulosin hydrochloride should not be prescribed in combination with strong CYP3A4 inhibitors to patients who are poor metabolizers of CYP2D6.

Tamsulosin hydrochloride should be used with caution in combination with strong and moderate CYP3A4 inhibitors (see section "Interaction with other medicinal products and other forms of interaction").

Cases of allergic reactions to tamsulosin have been reported in patients with a history of allergy to sulfonamides. Caution should be exercised when administering tamsulosin hydrochloride to patients who have previously experienced allergic reactions to sulfonamides.

Important information about excipients.

This medicinal product contains less than 1 mmol/dose of sodium, i.e., essentially "sodium-free".

Use during pregnancy or breastfeeding.

Prostasan-Vista is not indicated for use in women.

Fertility.

During short- and long-term clinical studies of tamsulosin, ejaculation disorders were observed. Cases of ejaculation disorder, retrograde ejaculation, and insufficient ejaculation have been reported in the post-marketing period.

Ability to affect the speed of reactions when driving or operating machinery.

Studies on the effect of tamsulosin on the ability to drive or operate machinery have not been conducted. However, patients should be warned about the possible occurrence of drowsiness, blurred vision, dizziness, and syncope.

Method of Administration and Dosage

The recommended dose for adults is 1 capsule daily after breakfast or after the first meal. The capsule should be swallowed whole, without breaking or chewing, as this would interfere with the modified release of the active ingredient.

Dose adjustment is not required in patients with renal impairment. Dose adjustment is not required in patients with mild to moderate hepatic impairment. (See also section "Contraindications").

Children

The medicinal product should not be used in children.

Safety and efficacy of tamsulosin in children (under 18 years of age) have not been established.

Overdose

Symptoms

Overdose of tamsulosin hydrochloride may potentially cause severe hypotensive effects. Severe hypotension has been observed at various overdose levels.

Treatment

In case of acute hypotension due to overdose, supportive therapy should be administered to restore normal cardiovascular function (e.g., the patient should be placed in a supine position). If this measure is ineffective, infusion therapy should be initiated and vasopressors administered. Renal function should be monitored, and general supportive therapy provided. Due to the high degree of plasma protein binding of tamsulosin, hemodialysis is unlikely to be beneficial.

To prevent further absorption of tamsulosin, induced vomiting may be considered. In cases of significant overdose, gastric lavage with activated charcoal and low-osmotic laxatives such as sodium sulfate should be performed.

Side effects.

All side effects are listed by organ systems and frequency.

* Reported during the post-marketing period.

Cases of intraoperative iris instability of the eye (intraoperative floppy iris syndrome) during cataract and glaucoma surgery have been reported in patients taking tamsulosin during the post-marketing surveillance period (see section "Dosage and Administration"). Post-marketing experience. In addition to the aforementioned adverse reactions, cases of atrial fibrillation, arrhythmia, tachycardia, and dyspnea have been reported. As with other alpha-blockers, somnolence, dry mouth, and edema may occur. Since these cases were reported spontaneously, the frequency of reporting and the role of tamsulosin cannot be reliably established.

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after medicine authorization is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicine. Healthcare professionals and patients, as well as their legal representatives, should report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua

Shelf life. 3 years.

Storage conditions. Store at temperatures not exceeding 25 ºC in the original packaging. Keep out of reach of children.

Packaging. 10 capsules per blister, 3 blisters per cardboard box.

Prescription status. Prescription only.

Manufacturer. Sintrop Spain, S.L.

Manufacturer's address and location of its business operations.

C/Castello, no1, Sant Boi de Llobregat, Barcelona, 08830, Spain