Omnic capsules with modified release 0,4 mg, No. 10

Benign prostatic hyperplasia.

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

Inside - 400 mcg 1 time / day (after breakfast).

Active ingredient: tamsulosin hydrochloride - 400 mcg

Excipients : microcrystalline cellulose - 281.2 mg, copolymer of methacrylic acid and ethyl acrylate - 42.5 mg, polysorbate 80 - 1 mg, sodium lauryl sulfate - 0.3 mg, triacetin - 1.1 mg, talc - 0.8 mg, calcium stearate - 0.4 mg.

The composition of the capsule shell *: gelatin - 62.8 mg, titanium dioxide - 0.89 mg, indigo carmine - 0.004 mg, iron dye yellow oxide - 0.5 mg, iron dye red oxide - 0.04 mg.

* an identification code is applied to the capsule in black ink, which contains iron oxide black oxide (E172) and shellac.

Hypersensitivity to tamsulosin.

Description:

Capsules with modified release, hard gelatinous, size No. 2, orange body marked '701' and a graphic image of the company's trademark, olive green cap marked '0.4'; the contents of the capsules are granules from white to white with a light yellow shade.

Composition:

Active ingredient: tamsulosin hydrochloride - 400 mcg

Excipients : microcrystalline cellulose - 281.2 mg, copolymer of methacrylic acid and ethyl acrylate - 42.5 mg, polysorbate 80 - 1 mg, sodium lauryl sulfate - 0.3 mg, triacetin - 1.1 mg, talc - 0.8 mg, calcium stearate - 0.4 mg.

The composition of the capsule shell *: gelatin - 62.8 mg, titanium dioxide - 0.89 mg, indigo carmine - 0.004 mg, iron dye yellow oxide - 0.5 mg, iron dye red oxide - 0.04 mg.

* an identification code is applied to the capsule in black ink, which contains iron oxide black oxide (E172) and shellac.

Clinical and pharmacological group: A drug used for urination disorders associated with benign prostatic hyperplasia. Alpha1-blocker

Pharmaco-therapeutic group: Alpha1-blocker

pharmachologic effect

Blocker? 1-adrenergic receptors; a remedy for the symptomatic treatment of benign prostatic hyperplasia.

Selectively blocks postsynaptic ? 1A-adrenergic receptors of smooth muscles of the prostate gland, bladder neck, prostatic urethra. As a result, the tone of the smooth muscles of these formations decreases, and the outflow of urine is facilitated. At the same time, the symptoms of obstruction and irritation associated with benign prostatic hyperplasia are reduced. The therapeutic effect appears approximately 2 weeks after the start of treatment.

The ability to block ?1B-adrenergic receptors of vascular smooth muscles is much less pronounced in tamsulosin, therefore the effect on systemic blood pressure is insignificant.

Pharmacokinetics

After oral administration, tamsulosin is rapidly and almost completely absorbed from the gastrointestinal tract. After a single oral intake of 400 ?g, the Cmax of the active substance in plasma is reached after 6 hours.

Plasma protein binding - 99%. Vd is insignificant and amounts to 0.2 l / kg.

Tamsulosin is slowly metabolized in the liver with the formation of pharmacologically active metabolites that retain a high selectivity for ?1A-adrenergic receptors. Most of the active substance is present in the blood unchanged.

T1 / 2 of tamsulosin with a single dose - 10 hours, terminal T1 / 2 is - 22 hours. It is excreted by the kidneys, 9% - unchanged.

Indications

Benign prostatic hyperplasia.

Dosage regimen

The method of application and dosage regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly observe the compliance of the used dosage form of a particular drug with the indications for use and the dosage regimen.

Inside - 400 mcg 1 time / day (after breakfast).

Side effect

From the side of the cardiovascular system: rarely - dizziness, orthostatic hypotension, palpitations.

From the side of the central nervous system: headache, asthenia are possible.

From the reproductive system: rarely - retrograde ejaculation.

Contraindications for use

Hypersensitivity to tamsulosin.

Application for violations of liver function

Use with caution in patients with severe liver dysfunction.

Application for impaired renal function

In patients with impaired renal function, changes in the dosage regimen are not required.

special instructions

Use with caution in patients prone to arterial hypotension, with severe liver dysfunction.

Before starting tamsulosin therapy, the patient should be examined for other diseases that can cause the same symptoms as benign prostatic hyperplasia. Before starting treatment and regularly during therapy, a digital rectal examination should be performed and, if required, the determination of a specific antigen of the prostate. In patients with impaired renal function, changes in the dosage regimen are not required.

Influence on the ability to drive vehicles and use mechanisms

During the period of treatment, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Drug interactions

With the simultaneous use of tamsulosin with cimetidine, there was a slight increase in the concentration of tamsulosin in the blood plasma, and with furosemide, a decrease in the concentration; with other? 1-blockers - a pronounced increase in the hypotensive effect is possible.

Diclofenac and indirect anticoagulants slightly increase the rate of tamsulosin elimination.

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 change the free fractions of diazepam, propranolol, trichloromethiazide and chlormadinone.

In vitro studies, no interaction was found at the level of hepatic metabolism with amitriptyline, salbutamol, glibenclamide and finasteride.

Other? 1-blockers, acetylcholinesterase inhibitors, alprostadil, anesthetics, diuretics, levodopa, antidepressants, beta-blockers, slow calcium channel blockers, muscle relaxants, nitrates and ethanol can increase the severity of the hypotensive effect.

Storage conditions.

Store at a temperature not exceeding 25 ? C. Keep out of the reach of children.

Shelf life

3 years. Do not use after the expiration date printed on the package

Vacation conditions

Dispensed by prescription.