Oprimea

I N S T R U C T I O N for medical use of the medicinal product OMNIC® (OMNIC®)

Composition:

active substance: tamsulosin hydrochloride;

1 capsule contains 0.4 mg of tamsulosin hydrochloride;

excipients: microcrystalline cellulose, methacrylic acid copolymer (type A), polysorbates, sodium lauryl sulfate, triacetin, calcium stearate, talc, capsule shell: gelatin, indigo carmine (E 132), titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).

Pharmaceutical form. Modified-release hard capsules.

Main physicochemical properties: elongated-shaped capsules (size 2) with an orange body and olive-green cap, marked in black on the surface; the contents are granular, whitish-yellow powder.

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

Pharmacological Properties.

Pharmacodynamics.

Omnic® 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 tone of the smooth muscle of the prostate gland, bladder neck, and prostatic urethra, resulting in 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, urgency).

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

α1-adrenoceptor antagonists may reduce blood pressure due to decreased peripheral vascular tone. However, during clinical studies of Omnic®, no clinically significant reduction in arterial blood pressure was observed.

Pharmacokinetics.

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

After a single dose of Omnic® 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. The Cmax at steady state is approximately two-thirds higher than that observed after a single dose.

Distribution: In men, tamsulosin is approximately 99% bound to plasma proteins. The volume of distribution 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. Most of the active substance is present in the blood in unchanged form.

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

After a single dose of Omnic® taken after food and at steady-state plasma concentration, 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 angioedema, or to any of the excipients; history of orthostatic hypotension; severe hepatic impairment.

Interaction with other medicinal products and other forms of interactions.

Interaction studies have been performed 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, glibenclamide, simvastatin, and warfarin do not affect the free fraction of tamsulosin in human plasma. Similarly, tamsulosin does not alter the free fraction levels 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 inhibitors of CYP3A4 may lead to increased effects of tamsulosin hydrochloride. Concomitant use with ketoconazole (a known strong CYP3A4 inhibitor) resulted in increases in AUC and Cmax by up to 2.8 and 2.2 times, respectively.

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

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

Concomitant administration of tamsulosin hydrochloride and paroxetine (a strong CYP2D6 inhibitor) leads to increases in Cmax and AUC by up to 1.3 and 1.6 times, respectively, but 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-adrenoblockers, when using Omnic®, a decrease in arterial pressure may occur in individual cases, which sometimes may lead to loss of consciousness. If the first signs of orthostatic hypotension (dizziness, weakness) appear, the patient should assume a sitting or lying position until the aforementioned symptoms disappear.

Before starting treatment with Omnic®, a medical examination should be performed to rule out other concomitant diseases that may cause similar symptoms to benign prostatic hyperplasia. Prior to initiating therapy, 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 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 of Omnic® use in such patients have not been conducted.

In some patients who were taking or had previously taken tamsulosin, intraoperative floppy iris syndrome (IFIS, a variant of the small pupil syndrome) 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 before cataract or glaucoma surgery; however, the benefit of discontinuing tamsulosin 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 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 inhibitors of CYP3A4 to 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 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 prescribing tamsulosin hydrochloride to patients with a previous history of sulfonamide allergy.

Use during pregnancy and/or breastfeeding.

Omnic® is not indicated for use in women.

Fertility

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

Ability to affect reaction speed when driving or operating machinery.

Studies on the effect of the drug on the ability to drive or operate machinery have not been conducted. However, patients should be warned about the possibility of experiencing dizziness.

Dosage and Administration.

The recommended dose for adults is 1 capsule daily, taken after breakfast or after the first meal of the day. The capsule should be swallowed whole and not broken or chewed, 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 also not required in patients with moderate or severe hepatic impairment (see also "Contraindications").

Children.

The drug is not intended for use in children.

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

Overdose.

Symptoms.

Overdose with 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 initiated to restore normal cardiovascular function (e.g., the patient should be placed in a supine position). If this measure is ineffective, intravenous fluid therapy should be administered and vasopressor agents prescribed. Renal function should be monitored, and general supportive treatment provided. Due to the high degree of plasma protein binding of tamsulosin, hemodialysis is unlikely to be beneficial.

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

Adverse reactions.

*Occurred during the post-marketing period

Cases of intraoperative iris instability (intraoperative floppy-iris syndrome) during cataract and glaucoma surgery have been reported in patients taking tamsulosin (see section "Special precautions").

Post-marketing experience: In addition to the above-mentioned adverse reactions, cases of atrial fibrillation, arrhythmia, tachycardia, and dyspnea have been reported. Since these cases were reported spontaneously, the frequency of reporting and the causal relationship with tamsulosin use cannot be reliably established.

Reporting of suspected adverse reactions

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

Shelf life. 4 years.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Packaging. 10 capsules in a blister, 3 blisters in a cardboard box.

Prescription status. Prescription only.

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

Manufacturer's address. Hogemaat 2, 7942 JG Meppel, the Netherlands / Hogemaat 2, 7942 JG Meppel, the Netherlands.

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

Address of the Marketing Authorisation Holder. Sylviusweg, 62, 2333 BE Leiden, the Netherlands / Sylviusweg, 62, 2333 BE Leiden, the Netherlands.