Expiration date: 12/2025

Structure and Composition:

Controlled release tablets, coated tablets. One tablet contains active substance:

Tamsulosin hydrochloride 0.4 mg

Excipients: Macrogol 8000 - 7000000 macrogol 40 mg - 200 mg Magnesium stearate - 1.2 mg

shell: Opadry Yellow 03F22733 (Valium - 69.536%, macrogol 8000 - 13.024%, iron oxide yellow dye - 17.44%)

in a blister pack made of laminated PVC foil and aluminum foil 10 pcs. In the paper cartons 1 or 3 blisters.

Description pharmaceutical form:

Round biconvex film coated tablet, from yellow to brownish-yellow embossed on one side "04".

Pharmacokinetics:

Suction. Omnic Ocas is a tablet with controlled release through the gel matrix using a non-ionic type. This formulation provides a long and slow release of the tamsulosin and sufficient exposure to weak variations of tamsulosin in plasma concentration for 24 hours.

Tamsulosin tablets Omnic Ocas absorbed in the intestine. The absorption is estimated to be 57% of the administered dose. Food intake has no influence on the drug absorption. Tamsulosin is characterized by linear pharmacokinetics. After a single oral administration of the tablets on an empty stomach Omnic Ocas Cmax of tamsulosin in plasma is reached after an average of 6 hours. In the equilibrium state, which is achieved by the 4th day of admission, the concentration of tamsulosin in plasma reaches its maximum value after 4-6 hours both fasting and after meal. Cmax in plasma increased from about 6 ng / ml after the first dose to 11 ng / ml at steady state. The lowest concentration of tamsulosin in plasma is 40% of the maximum concentration in plasma glucose after a meal. There are large individual differences among patients against drug concentration in plasma following a single dose and multiple dose.

Distribution. Binding to plasma proteins - about 99%, Vd is small (about 0.2 l / kg).

Metabolism. Tamsulosin is slowly metabolized in the liver with the formation of less active metabolites. Most of tamsulosin in plasma is presented in unmodified form. Tamsulosin ability to induce liver microsomal enzyme activity is virtually absent (experimental data).

When liver failure is not required correction mode.

Withdrawal. Tamsulosin and its metabolites are primarily excreted in the urine, with approximately about 4-6% of the drug is excreted unchanged form.

T1 / 2 of tamsulosin in tablets with Omnic Ocas single dose and at steady state - 19 and 15 hours, respectively.

Description of the pharmacological actions:

Tamsulosin is a specific competitive blocker of postsynaptic alpha1-adrenoceptor & especially subtypes & alpha1A and & alpha1D, responsible for relaxation of smooth muscles of the prostate, bladder neck and prostatic urethra. Ocas Omnic 0.4 mg in the dosage increases the maximum speed of urination, and decreases the tonus of smooth muscle of prostate and urethra, enhancing the flow of urine and thus reducing the severity of voiding symptoms. Omnic Ocas also reduces the severity of symptoms of the filling, the development of which an important role is played by detrusor overactivity.

When long-term therapy is retained influence on the severity of the symptoms of the filling and emptying, reducing the risk of acute urinary retention and the need for surgical intervention.

Blockers & alpha1A-adrenergic receptors can reduce blood pressure by reducing peripheral resistance. Using drugs Omnic Ocas in a daily dose of 0.4 mg of clinically significant reductions in blood pressure were observed.

Indications:

Benign prostatic hyperplasia (treatment of micturition disorders).

Contraindications:

• hypersensitivity to tamsulosin or any other component of the preparation
  
• orthostatic hypotension
  
• severe hepatic insufficiency.
  

With care - chronic renal failure (Cl creatinine <10 ml / min), severe hepatic impairment, hypotension.

Side effect:

Side effects	Frequently (&ge1%, <10%)	Not frequently (&ge0,1%, <1%)	Rarely (&ge0,01%, <0,1%)	Very rarely (<0,01%)
From the CCC		palpitations, orthostatic hypotension
On the part of the digestive tract		constipation, diarrhea, nausea, vomiting
General state		asthenia
From the nervous system	dizziness (1,3%)	headache	fainting
Reproductive system		ejaculation disorders		priapism
From the side of respiratory, thoracic and mediastinal disorders		rhinitis
Skin and subcutaneous tissue		rash, pruritus, urticaria	angioedema

Described isolated cases of intraoperative iris instability (narrow pupil syndrome) during cataract surgery, which increase the risk of complications during and after surgery.

Drug Interactions:

In the appointment of tamsulosin with atenolol, enalapril, nifedipine or theophylline interactions were found. In an application with cimetidine was a slight increase in tamsulosin plasma concentrations of furosemide - decline, but it does not require changes in the dose Omnic Ocas, since the concentration of the drug remains within the normal range. Diazepam, propranolol, trichloromethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin does not alter tamsulosin free fraction in human plasma in vitro. In turn, serves as tamsulosin free fractions of diazepam, propranolol, trichlormethiazide and chlormadinone.

In in vitro studies found no interaction at the level of hepatic metabolism with amitriptyline, salbutamol, glibenclamide and finasteride. Diclofenac and Warfarin may increase the elimination rate of tamsulosin.

Co-administration of other blockers & alpha1-adrenergic receptors may cause hypotensive effect.

Dosage and administration:

Inside, regardless of the meal, 1 table. 1 time per day. Duration of application is not limited to, a drug administered in the form of continuous therapy. The tablet should be taken as a whole, it can not be chewed since it can affect the sustained release of the active substance.

Overdose:

Symptoms: reduced blood pressure, compensatory tachycardia.

Treatment: symptomatic. Blood pressure and heart rate can recover when taking sick horizontal position. If no effect is possible to apply means which increase the bcc and, if necessary, vasoconstrictors. It is necessary to monitor renal function. It is unlikely that dialysis would be effective, since tamsulosin extensively bound to plasma proteins.

To prevent further absorption of the drug it is advisable to gastric lavage, activated charcoal and an osmotic laxative.

Precautionary measures:

As with other alpha1-blockers &, in the treatment of drug Omnic Ocas in some cases, decrease in blood pressure may occur, which in rare cases may cause fainting. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lie down and remain in that position for as long as these symptoms persist.

Withdrawal is absent.

Special instructions:

When surgery for cataracts in patients receiving the drug may develop iris syndrome intraoperative instability eyes (narrow pupil syndrome), it is necessary to consider surgery for preoperative patient preparation and conduct of operations.

Before starting the therapy with Omnic Ocas, the patient must be examined in order to exclude the presence of other diseases that can cause similar symptoms as benign prostatic hyperplasia. Before you start treatment and regularly during therapy should be performed digital rectal examination and, if necessary, determination of prostate specific antigen.

In renal failure does not require dose changes.

Effects on ability to drive and use machines

Information about the negative impact on the ability to drive vehicles and engage in potentially dangerous activities available. However, due to the possibility of dizziness, to determine the individual response of the patient should refrain from activities that require high concentration and psychomotor speed reactions, including driving vehicles.