Omnik ocas

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT OMNIC OCAS

Composition:

Active substance: tamsulosin hydrochloride;

1 tablet contains 0.4 mg of tamsulosin hydrochloride;

Excipients: macrogol 8000, macrogol 7000000, magnesium stearate, purified water, Opadry Yellow 03F22733.

Pharmaceutical form. Prolonged-release tablets with oral controlled absorption system, coated with a film.

Main physicochemical characteristics: round, biconvex tablets coated with a yellow film coating, marked by embossing "04".

Pharmacotherapeutic group. Agents used in benign prostatic hyperplasia. α1-adrenergic receptor antagonists. ATC code G04CA02.

Pharmacological properties.

Pharmacodynamics.

Omnik Ocas selectively and competitively blocks postsynaptic α1-adrenoceptors, particularly α1A and α1D, located in the smooth muscle of the prostate gland, bladder neck, and prostatic urethra. This leads to reduced smooth muscle tone in the prostate gland, bladder neck, and prostatic urethra, resulting in improved urinary flow.

Simultaneously, symptoms of obstruction and irritation 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).

The ability of α1A-adrenergic blockers to reduce blood pressure is related to decreased peripheral resistance. Omnik Ocas at a daily dose of 0.4 mg does not cause clinically significant reduction in systemic arterial pressure (BP) in patients with arterial hypertension or in patients with normal baseline BP.

Pharmacokinetics.

Absorption. Omnik Ocas is an extended-release tablet with controlled release based on a matrix using a non-ionic gel. The Ocas formulation ensures prolonged and slow release of tamsulosin, resulting in plasma exposure with minimal fluctuations over 24 hours. After oral administration on an empty stomach, 57% of tamsulosin is absorbed in the intestine. The rate and extent of absorption of the drug in the extended-release tablet formulation are not altered when taken with a low-fat meal. However, absorption parameters increase by 64% and 149% (AUC and Cmax, respectively) when taken with a high-fat meal compared to administration on an empty stomach.

Tamsulosin exhibits linear pharmacokinetics.

After a single dose of Omnik Ocas administered on an empty stomach, the maximum plasma concentration of the active substance is observed after 6 hours. At steady state, achieved by the fourth day of treatment, peak plasma concentration occurs within 4–6 hours regardless of food intake. Peak plasma concentration increases from approximately

6 ng/mL after the first dose to 11 ng/mL at steady state.

As a result of prolonged release, the trough plasma concentration of tamsulosin reaches 40% of the maximum concentration, regardless of food intake.

Distribution. Plasma protein binding is 99%. The volume of distribution is low (approximately

0.2 L/kg).

Metabolism. Tamsulosin hydrochloride has a low first-pass effect and is slowly metabolized. The majority of the active substance circulates in the bloodstream unchanged. It is metabolized in the liver. In vitro data indicate that CYP3A4 and also CYP2D6 are involved in its metabolism, while other CYP isoenzymes have minimal influence on tamsulosin. Inhibition of metabolizing enzymes CYP3A4 and CYP2D6 may lead to increased exposure to tamsulosin hydrochloride (see sections "Special precautions", "Interaction with other medicinal products and other forms of interaction"). None of the metabolites is more active than the parent compound.

Elimination. Tamsulosin and its metabolites are primarily excreted by the kidneys, with 4–6% of the dose excreted unchanged. The elimination half-life of tamsulosin after a single dose and at steady state is 19 and 15 hours, respectively.

Clinical characteristics.

Indications.

Treatment of lower urinary tract symptoms associated with 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 have been conducted only in adults.

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

In vitro studies show that diazepam, propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glyburide, simvastatin, and warfarin do not affect the free fraction of tamsulosin in human plasma. Similarly, tamsulosin does not alter the levels of 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. Co-administration with ketoconazole (a known potent CYP3A4 inhibitor) resulted in an increase in AUC and Cmax by up to 2.8- and 2.2-fold, 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 concomitantly with strong and moderate CYP3A4 inhibitors.

Concomitant administration of tamsulosin hydrochloride and paroxetine (a strong CYP2D6 inhibitor) led to an increase in Cmax and AUC by 1.3- and 1.6-fold, respectively, but this increase 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 the medicinal product Omnic Ocas may in individual cases lead to a reduction in arterial pressure, which rarely may result in loss of consciousness. If symptoms of orthostatic hypotension occur (dizziness, weakness), the patient should sit or lie down immediately and remain in this position until the aforementioned symptoms subside.

Prior to initiating treatment with Omnic Ocas, 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 gland should be performed, and if necessary, a test to determine the level of prostate-specific antigen (PSA) should be carried out before treatment initiation and at regular intervals during treatment.

The drug should be administered with particular caution to patients with severe renal impairment (creatinine clearance <10 mL/min), as clinical studies in such patients have not been conducted.

In some patients receiving or who have previously received tamsulosin, intraoperative floppy iris syndrome (IFIS, a variant of intraoperative miosis) has been observed during cataract or glaucoma surgery, which may lead to an increased risk of complications during or after the procedure.

Generally, it is recommended to discontinue tamsulosin treatment 1–2 weeks prior to cataract or glaucoma surgery; however, the clinical benefit of such discontinuation has not yet been definitively established. Cases of IFIS have also been reported in patients who had discontinued tamsulosin long before cataract surgery.

Patients scheduled for elective cataract or glaucoma surgery should not initiate treatment with tamsulosin hydrochloride. To prevent potential complications associated with IFIS, surgeons and ophthalmologists should be informed whether the patient is currently taking or has previously taken tamsulosin.

Tamsulosin hydrochloride should not be co-administered with strong inhibitors of CYP3A4 in patients who are poor metabolizers of CYP2D6.

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

Occasionally, tablet residues may be observed in the feces.

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 with a prior history of sulfonamide allergy.

Use during pregnancy or breastfeeding

Omnic Ocas is not indicated for use in women.

Fertility

Ejaculation disorders have been reported during both short-term and long-term clinical studies with tamsulosin. Cases of ejaculation disorders, including retrograde ejaculation and impaired ejaculation, have been reported in the post-marketing period.

Ability to affect reaction speed when driving or operating machinery

No studies on the effect of the drug on the ability to drive or operate machinery have been conducted. However, patients should be warned about the possible occurrence of dizziness.

Method of administration and dosage.

The recommended dose is 1 tablet daily, regardless of food intake. The tablet should be swallowed whole, without breaking or chewing, as this may interfere with the prolonged and controlled release of the active ingredient. The duration of treatment is determined individually.

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

Children.

The drug is not intended for use in children.

The safety and efficacy of tamsulosin in children have not been evaluated.

Overdose.

Symptoms.

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

Treatment.

In case of acute drop in blood pressure 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 vasopressor agents 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 effective.

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

Side effects.

*Reported during the post-marketing period.

During post-marketing surveillance, cases of intraoperative iris instability of the eye (intraoperative floppy-iris syndrome) during cataract and glaucoma surgery have been reported in patients receiving tamsulosin (see section "Special precautions").

Post-marketing experience. In addition to the aforementioned adverse reactions, cases of atrial fibrillation, arrhythmia, tachycardia, and dyspnea have been reported. These cases were reported spontaneously, and the frequency of reporting as well as the role of tamsulosin in their occurrence cannot be reliably established.

Reporting of suspected adverse reactions

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

Shelf life. 3 years.

Storage conditions. Keep out of reach and sight of children.

Store at a temperature not exceeding 25 °C.

Packaging. 10 tablets per blister pack, 3 blister packs per cardboard box.

Prescription status. Prescription only.

Manufacturer. Delpharm Meppel B.V./Delpharm Meppel B.V.

Manufacturer's location and address of place of business.

Hogemaat 2, 7942 JG Meppel, the Netherlands/Hogemaat 2, 7942 JG Meppel, the Netherlands.

Marketing Authorization Holder. Astellas Pharma Europe B.V./Astellas Pharma Europe B.V.

Marketing Authorization Holder's location and address of place of business. Sylviusweg, 62, 2333 BE Leiden, the Netherlands/Sylviusweg, 62, 2333 BE Leiden, the Netherlands.