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Description
The instruction for medical use
of Omnik medicine Okas®
the Trade name
Omnik of Okas®
the International unlicensed
name Tamsulozin Lekarstvennaya
the Tablet form, with controlled release, coated, 0.4 mg
Structure
One tablet contains
active substance – a tamsulozin a hydrochloride of 0.4 mg,
excipients: macrogoal 8000, macrogoal 7000000, magnesium stearate
structure of a cover: opadray the yellow 03F22733
Description
of the Tablet of round shape, with a biconvex surface, coated yellow color, with an engraving 04 on one party.
Pharmacotherapeutic group
Drugs for treatment of urological diseases. Drugs for treatment of a benign hypertrophy of a prostate. Alpha adrenoblockers. Tamsulozin
Kod of automatic telephone exchange of G04 CA02
the Pharmacological
Omnik Pharmacokinetics properties Okas® represents a tablet with the prolonged release on the basis of a matrix with use of gel not of ionic type. The Okas form provides long and slow release of a tamsulozin that gives sufficient exposure with weak fluctuations within 24 hours.
Tamsulozin in shape Okas is soaked up in intestines, the bioavailability is 57% of the entered dose. Meal does not influence absorption of a tamsulozin. Tamsulozin is characterized by linear pharmacokinetics. After single dose inside on an empty stomach of 0.4 mg of drug its maximum concentration in plasma is reached on average in 6 hours. Equilibrium concentration is reached by 4th day of reception. Peak plasma concentration increases from about 6 ng/ml after the first dose to 11 ng/ml in an equilibrium state. Communication with proteins of plasma – about 99%, the volume of distribution small (about 0.2 l/kg).
Tamsulozin is slowly metabolized in a liver with formation of less active metabolites. The most part of a tamsulozin is provided in blood plasma in not changed form. The ability to induce activity of microsomal enzymes of a liver at a tamsulozin is practically absent.
In a liver failure the correction of the mode of dosing is not required.
Tamsulozin and his metabolites are mainly removed with urine, at the same time about about 4-6% of drug are allocated in not changed look.
Elimination half-life at single dose and in an equilibrium condition of Omnik of Окас® 0.4 mg makes 10 and 15 hours, respectively.
The pharmacodynamics
Omnik of Okas® – an alpha 1 adrenoblocker, is a specific competitive blocker of postsynaptic a1-adrenoceptors, especially a1a and a1D of subtypes. These receptors are located in smooth muscles of a prostate, a neck of a bladder and a prostatic part of an urethra. Tamsulozin is a prostatoselektivny blocker as (70% of the total number of receptors) in a prostate alfa1a-receptors are prevailing. Reduces a tone of smooth muscles of a prostate and an urethra, improving urine outflow. It leads to reduction of symptoms of obstruction and the irritation connected with a benign hyperplasia of a prostate.
At use of drug in a standard dosage of 0.4 mg in a daily dose Omnik of Okas® does not cause clinically significant lowering of arterial pressure.
Indications
– a benign hyperplasia of a prostate.
A route of administration and doses
Inside, on 1 tablet of 1 times a day irrespective of meal. The pill has to be taken entirely, it cannot be chewed.
The course of treatment is defined individually by the doctor. Appointment within 1-2 months with breaks for 1 month and more is recommended.
Side effects
– heartbeat, postural hypotension, orthostatic hypotension
– a constipation, diarrhea, nausea, vomiting
– an asthenia, dizziness, a headache
– disturbances of an ejaculation, a priapism
– rhinitis
In isolated cases
– orthostatic hypotension, tachycardia/heartbeat
In extremely exceptional cases
– can be observed reactions of hypersensitivity, skin rash, an itching, a Quincke’s disease, Stephens-Johnson’s Syndrome
– are described cases of intraoperative instability of an iris of the eye of an eye (syndrome of a narrow pupil) at operation for a cataract at patients a long time accepting tamsulozin
Contraindications
– hypersensitivity to a tamsulozin or any other component of drug
– orthostatic hypotension (including in the anamnesis)
– the profound liver failure
– with care – a heavy renal failure (clearance of creatinine less than 10 ml/min.)
– children’s and teenage age up to 18 years
Medicinal interactions
When assigning a tamsulozin together with atenolol, enalapril, nifedipine or theophylline of interactions it was revealed not. At simultaneous use with Cimetidinum some increase in concentration of a tamsulozin in blood plasma, with furosemide – decrease in concentration is noted, however it does not demand change of a dose of Omnik of Okas® as concentration of drug remains within normal range. Diazepam, propranolol, trikhlormetiazid, chlormadinon, amitriptyline, glibenclamide, simvastatin do not change free fraction of a tamsulozin in blood plasma. In turn, tamsulozin also does not change free fractions of diazepam, propranolol, a trikhlormetiazid and chlormadinon.
In researches the interaction at the level of hepatic metabolism with amitriptyline, salbutamol, glibenclamide and finasteridy was not revealed. Diclofenac and warfarin can increase the clearance rate of a tamsulozin.
Co-administration of other antagonists of a1-adrenoceptors can result in hypotensive effect.
Special instructions
As well as when using other a1-adrenoblockers, at treatment Omniky Okas® the lowering of arterial pressure which, in rare instances, can lead to an unconscious state in some cases can be observed. At the first symptoms of orthostatic hypotension (dizziness, weakness) the patient has to sit down or lay down and remain in this situation until signs do not disappear.
Before beginning therapy with the drug Omnik Okas®, it is necessary to exclude presence of other diseases which can cause the same symptoms, as well as a benign hyperplasia of a prostate. Before an initiation of treatment and regularly during therapy the manual rectal inspection and if it is required, definition of specific prostatic antigen (DOG) has to be carried out.
In a renal failure drug is used with care (control of clearance of creatinine lower than 10 ml/min.) in a standard dosage.
The feature of influence of medicine on ability to run the vehicle and potentially dangerous mechanisms
during treatment needs to be careful during the driving of motor transport and occupation other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.
Overdose
Symptoms: sharp lowering of arterial pressure, compensatory tachycardia.
Treatment: symptomatic. Arterial blood pressure and heart rate can be redeemed at acceptance by the patient of horizontal situation. In the absence of effect it is possible to apply the means increasing the volume of the circulating blood and if it is necessary, vasoconstrictors. It is necessary to control function of kidneys. The hemodialysis is inefficient as it tamsulozin intensively contacts proteins of plasma. For prevention of further absorption of drug the gastric lavage, intake of activated carbon and osmotic laxative, for example sulfate sodium is reasonable.
The form of release and packing
On 10 tablets place in blister strip packaging from a film from laminated by aluminum foil of a polyvinylchloride film and aluminum foil.
On 1 or 3 blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions at a temperature from 15 to 25 of 0C.
To store out of children’s reach!
3 years
not to use a period of storage after the expiration date specified on packing.
Prescription status
According to the prescription
the Name and the country
of the Astellas of Pharm B.V. Europe. manufacturing organization, Silviusveg 62, 2333 VE, Leiden, Netherlands
the Name and the country of the owner of the registration certificate
Astellas of Pharm B.V. Europe , Silviusveg 62, 2333 VE, Leiden, Netherlands
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods):
Representation Astellas of Pharm B.V. Europe in RK
Almaty, 050559, Al-Farabi Ave. 15, the Centre Party of Finland of Nurla Tau, zd 4B,
office No. 20 Phone number (727) 311-13-89 Fax (727) 311-13-90
www.astellas.ru
to Develop e-mail of astellas@com.kz
Additional information
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