Omnic, modified-release capsules 0.4mg, 30pcs

Composition

Active ingredient:

tamsulosin hydrochloride 0.4 mg;

Auxiliary substances:

MCC;

methacrylic acid copolymer (type C); polysorbate 80;

sodium lauryl sulfate;

triacetin;

calcium stearate;

talc;

gelatin;

indigotine;

titanium dioxide;

iron oxide yellow;

iron oxide red

Pharmacological action

Pharmaceutical group:

alpha 1-adrenoblocker.

Pharmaceutical action:

Omnik selectively and competitively blocks postsynaptic α1A-adrenoreceptors located in the smooth muscles of the prostate, bladder neck and prostatic part of the urethra, as well as α1D-adrenoreceptors mainly located in the bladder body. This leads to a decrease in the smooth muscle tone of the prostate, bladder neck and prostatic part of the urethra and improves detrusor function.

This reduces the symptoms of obstruction and irritation associated with benign prostatic hyperplasia. As a rule, the therapeutic effect develops 2 weeks after the start of taking the drug, although in some patients a decrease in the severity of symptoms is noted after taking the first dose.

The ability of Omnik to act on a1A-adrenoreceptors is 20 times greater than its ability to interact with a1B-adrenoreceptors, which are located in the smooth muscles of blood vessels. Due to this high selectivity, the drug does not cause any clinically significant reduction in systemic blood pressure both in patients with arterial hypertension and in patients with normal baseline blood pressure.

Indications

Dysuric disorders in benign prostatic hyperplasia (treatment).

Contraindications

• hypersensitivity to tamsulosin or any other component of the drug;
• orthostatic hypotension (including in the anamnesis);
• severe liver failure.

With caution — severe renal insufficiency (creatinine clearance

Side effects

Rarely — dizziness, retrograde ejaculation; in rare cases — orthostatic hypotension, tachycardia/palpitation, asthenia, headache.

From the gastrointestinal tract:  rarely — nausea, vomiting, diarrhea, constipation.

In extremely rare cases, hypersensitivity reactions (skin rash, pruritus, angioedema) may occur.

Interaction

When prescribing Omnik® No interactions were found with atenolol, enalapril, or nifedipine. When Omnika® was co-administered with cimetidine, there was a slight increase in the concentration of tamsulosin in blood plasma, and with furosemide-a decrease in the concentration (this does not require changing the dose of Omnika®, since the concentration of the drug remains within the normal range).

Diazepam, propranolol, trichloromethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin, and warfarin do not alter the free fraction of tamsulosin in human plasma in vitro. In turn, tamsulosin also does not alter the free fractions of diazepam, propranolol, trichloromethiazide, and chlormadinone.

In vitro studies showed no interaction at the level of hepatic metabolism with amitriptyline, salbutamol, glibenclamide, or finasteride.

Diclofenac and warfarin may increase the rate of tamsulosin elimination.

Concomitant use of other α1-adrenergic antagonists may lead to a decrease in blood pressure.

How to take, course of use and dosage

Inside.

 After breakfast, with water,1 capsule (0.4 mg) 1 time a day.

It is not recommended to chew the capsule, as this may affect the release rate of the drug.

Overdose

Symptoms:  theoretically, it is possible to develop an acute decline Blood pressure and compensatory tachycardia.

Treatment:  transfer of the patient to a horizontal position, gastric lavage, use of activated carbon or osmotic laxative (sodium sulfate); in the absence of an effect-the appointment of agents that increase the BCC, if necessary — vasoconstrictors; carrying out symptomatic therapy. Renal function should be monitored. The effectiveness of dialysis is unlikely.

Special instructions

As with other alpha-1 blockers, treatment with Omnik® may sometimes result in a decrease in the number of patients treated with the drug. Blood pressure, which can sometimes lead to fainting. At the first sign of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down and remain in this position until the signs disappear. During surgical interventions for cataracts while taking the drug, intraoperative instability of the iris (narrow pupil syndrome) may develop, which should be taken into account by the surgeon for preoperative preparation of the patient and during the operation.

Before starting therapy with Omnik®, the patient should be evaluated in order to exclude the presence of other diseases that may cause the same symptoms as benign prostatic hyperplasia. Before starting treatment and regularly during therapy, a digital rectal examination should be performed and, if necessary, prostate specific antigen (PSA) determination should be performed.

Form of production

Capsules

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

4 years

Active ingredient

Tamsulosin

Conditions of release from pharmacies

By prescription

Dosage form

long-acting capsules

Description

For men, For adults

Indications

Prostatic Hyperplasia