OMICS

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT OMIX (OMIX)

Composition:

Active substance: tamsulosin hydrochloride;

1 capsule contains 0.4 mg of tamsulosin hydrochloride;

Excipients: microcrystalline cellulose, methacrylic acid copolymer dispersion, hypromellose (hydroxypropylmethylcellulose), propylene glycol, talc, magnesium stearate, sodium lauryl sulfate; capsule shell: titanium dioxide (E 171), quinoline yellow (E 104), carmoisine (E 122), Ponceau 4R (E 124), gelatin.

Pharmaceutical form. Prolonged-release hard capsules.

Main physicochemical properties: hard gelatin capsules, cylindrical in shape, with an opaque white body and an opaque red cap, containing white or almost white granules.

Pharmacotherapeutic group. Drugs used in benign prostatic hyperplasia. α1-adrenoreceptor antagonists. ATC code G04C A02.

Pharmacological properties.

Pharmacodynamics.

Omiks selectively and competitively blocks postsynaptic α1-adrenoreceptors, 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, and improves 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 urges to urinate, nocturia, urinary urgency).

Therapeutic effect usually develops within 2 weeks after starting treatment. These effects are maintained over long-term therapy and significantly delay the need for surgical intervention or catheterization.

α1-Adrenoreceptor antagonists can reduce blood pressure by decreasing peripheral vascular tone. However, tamoxifen at a daily dose of 0.4 mg does not cause clinically significant reduction in arterial blood pressure.

Pharmacokinetics.

Absorption: Tamoxifen is well absorbed from the gastrointestinal tract, with bioavailability approaching 100%. Absorption of tamoxifen is slightly slower after food intake. Consistent absorption is achieved when the patient takes Omiks at the same time each day after eating. The pharmacokinetics of tamoxifen are linear.

After a single dose of Omiks taken after food, peak plasma concentration of tamoxifen is reached approximately 6 hours later, and steady-state concentration is achieved by day 5 of daily dosing. At this point, Cmax is approximately two-thirds higher than that observed after a single dose.

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

Metabolism: Tamoxifen 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-adrenoreceptors. The majority of the active substance is present in the blood in unchanged form.

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

After a single dose of Omiks 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.

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, plasma concentration of tamsulosin; however, since these levels remain within normal limits, no special dosage adjustment of tamsulosin is required.

In in vitro studies, 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. Concomitant use with ketoconazole (a known potent 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 to patients who are poor metabolizers of CYP2D6.

Tamsulosin hydrochloride should be used with caution when combined with strong and moderate CYP3A4 inhibitors.

Concomitant administration of tamsulosin hydrochloride and paroxetine (a potent CYP2D6 inhibitor) leads to increases in Cmax and AUC by up to 1.3 and 1.6 times, respectively, but this increase is not clinically significant.

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

Special precautions for use.

As with other α1-adrenoblockers, administration of the drug may in individual cases lead to a decrease in arterial pressure, which may sometimes result in loss of consciousness. If the first signs of orthostatic hypotension (dizziness, weakness) occur, the patient should sit down or assume a horizontal position until the aforementioned symptoms disappear.

Before initiating treatment with the drug, a medical examination should be performed to identify other concomitant diseases that may cause similar symptoms to benign prostatic hyperplasia. Prior to starting treatment, a digital rectal examination of the prostate gland should be carried out, and if necessary, a test to determine the level of prostate-specific antigen (PSA) should be performed before treatment and at regular intervals during treatment.

The drug must be administered with particular caution in patients with severe renal impairment (creatinine clearance <10 mL/min), as clinical studies on the use of tamsulosin hydrochloride 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 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 prior to cataract or glaucoma surgery; however, the benefit of discontinuation has not yet been definitively established. Cases of IFIS have also been reported in patients who discontinued tamsulosin long before cataract surgery.

Initiation of tamsulosin hydrochloride therapy is not recommended in patients scheduled for elective cataract or glaucoma surgery. Surgeons and ophthalmologists should be informed whether the patient is currently taking (or has previously taken) tamsulosin to prevent possible 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 "Interaction with other medicinal products and other forms of interactions").

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.

Use during pregnancy and/or breastfeeding.

Omiks is not indicated for use in women.

Fertility.

During short- 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 influence reaction rate while driving or operating machinery.

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

Method of administration and dosage.

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, without breaking or chewing, as this may interfere with the modified release of the active ingredient.

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

Children.

The drug is not intended for use in children.

Safety and efficacy of tamsulosin in children have not been established.

Overdose.

Symptoms.

Overdose of tamsulosin hydrochloride may potentially cause severe hypotensive effects. Severe hypotension has been reported 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 vasopressors administered. 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 using activated charcoal and low-osmotic laxatives such as sodium sulfate.

Adverse reactions.

CNS effects: dizziness, headache, fainting.

Eye disorders: blurred vision*, vision disturbances*.

Cardiovascular system disorders: palpitations, postural hypotension.

Respiratory system disorders: rhinitis, epistaxis*.

Gastrointestinal disorders: constipation, diarrhea, nausea, vomiting, dry mouth.

Skin and subcutaneous tissue disorders: rash, pruritus, urticaria, angioneurotic edema, Stevens-Johnson syndrome, erythema multiforme*, exfoliative dermatitis*.

Reproductive system disorders: ejaculation disorders, including retrograde ejaculation and ejaculatory insufficiency, priapism.

General disorders: asthenia.

*— reported during the post-marketing period.

During post-marketing surveillance, cases of intraoperative iris instability (intraoperative floppy iris syndrome) have been reported during cataract and glaucoma surgery in patients receiving 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 role of tamsulosin in these events cannot be reliably determined.

The dyes carmoisine (E 122) and Ponceau 4R (E 124) contained in the capsule shell may cause allergic reactions.

Shelf life. 3 years.

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

Keep out of reach of children.

Packaging. 10 capsules per blister. 1 or 3 blisters per cardboard box.

Prescription status. Prescription only.

Manufacturer. JSC "Tekhnolohiya".

Manufacturer's location and address of business activity.

8 Stara Prorizna Street, Uman, Cherkasy region, 20300, Ukraine.