Omnic, modified-release capsules 0.4mg, 100pcs

Composition

of 1 capsule. : tamsulosin hydrochloride 0.4 mgsupport 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

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

Treatment of dysuric disorders in benign prostatic hyperplasia.

Contraindications

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

Side effects

From the cardiovascular system: rarely-dizziness; in isolated cases – orthostatic hypotension, palpitation, tachycardia. From the central nervous system: in isolated cases – headache, asthenia. On the part of the reproductive system: rarely-retrograde ejaculation. From the digestive system: rarely-nausea, vomiting, diarrhea, constipation. Allergic reactions: in some cases-skin rash, pruritus, angioedema.

Interaction

When Omnik 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, but this does not require changing the dose of Omnik. When used concomitantly with Omnik, diclofenac and warfarin may slightly increase the rate of elimination of tamsulosin. Simultaneous use of Omnik with other alpha-1-blockers can lead to a marked decrease in blood pressure. No drug interactions were observed when Omnik was co-administered with atenolol, enalapril, or nifedipine. Diazepam, propranolol, trichloromethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin, and warfarin did not alter the free fraction of tamsulosin in 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 and finasteride.

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

No cases of acute tamsulosin overdose have been reported. However, theoretically, an overdose may lead to an acute decrease in blood pressure and compensatory tachycardia, in which case symptomatic therapy is necessary. Blood pressure and heart rate can be restored when a person assumes a horizontal position. In the absence of an effect, you can use drugs that increase the volume of circulating blood and, if necessary, vasoconstrictors. Kidney function should be monitored. Dialysis is unlikely to be effective, as tamsulosin is strongly bound to plasma proteins. To prevent further absorption of the drug, it is advisable to wash the stomach, take activated charcoal or an osmotic laxative, such as sodium sulfate.

Special instructions

Omnik should be used with caution in patients with a predisposition to orthostatic hypotension. At the first sign of orthostatic hypotension (dizziness, weakness), the patient should be seated or laid down. Before starting to use the drug, it is necessary to verify the diagnosis and exclude the presence of other diseases that may cause similar symptoms. Before starting and regularly during therapy, a digital rectal examination should be performed and, if necessary, the determination of prostate specific antigen (PSA).

Form of production

Modified-release capsules

Storage conditions

The drug should be stored out of the reach of children 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 adults, For men

Indications

Prostatic Hyperplasia