Proflosin 30s 0.4 mg modified-release capsules

The instruction for medical use of Proflosin® medicine the Trade name of Proflosin® the International unlicensed name Tamsulozin Lekarstvennaya the Capsule form with the modified release Structure One capsule contains the Kernel of granules active agent – a tamsulozina a hydrochloride of 0.4 mg excipients: microcrystalline cellulose, copolymer of methacrylic acid and ethyl acrylate (1:1) 30 of % dispersion **, triethyl citrate, talc, water the Cover of granules cleaned *** copolymer of methacrylic acid and ethyl acrylate (1:1) 30 of % dispersion **, triethyl citrate, talc, water the Indigo carmine capsule Lid cleaned **** Structure of a cover of the capsule ferrous oxide red (E 172), ferrous oxide yellow (E 172), the titan dioxide (E 171), gelatin - FD& Blue No. 2 (E 132), ferrous oxide black (E 172), ferrous oxide yellow (E 172), the titan dioxide (E 171), the Structure blackened gelatin, as a percentage Syrup with shellac of 45% (esterified, 20% in ethanol) 1, ferrous oxide black (E 172), alcohol of N - the butyl 1 Water purified 1, propylene glycol, the dehydrogenated ethanol 1, isopropyl alcohol 1, Ammonium hydroxide of 28% 2 ** - 30% dispersion of copolymer of methacrylic acid and ethyl acrylate contains 2.8% of polysorbate 80 and 0.7 of % of sodium of lauryl sulfate, *** - **** - partially is removed in the course of drying of granules before achievement of values of 2-4% completely 1 (Dehydrogenated) ethanol, alcohol of N - butyl is removed in the course of production, the water purified and isopropyl alcohol are volatile components and there are no 2 Ammonium on the capsule hydroxide, used for adjustment rn, there is at undetectable quantities a Description Solid gelatin capsules with the body of orange color and a cover of olive color. On a top of the body and a lid about one black line is put. On a lid black ink printed the TSL 0.4 code. Contents of capsules – granules of white or almost white color Pharmacotherapeutic group Drugs for treatment of urological diseases. Drugs for treatment of a benign hypertrophy of a prostate. Alpha adrenoblockers. Tamsulozin. ATH G04CA02 code the Pharmacological Tamsulozin Pharmacokinetics Absorption properties is quickly soaked up in digestive tract at almost full bioavailability. Meal just before prescribing of this drug slows down absorption process. Stability of absorption of a tamsulosin can be reached by regular reception of a tamsulozin after a breakfast. The linear dependence is inherent to pharmacokinetics of a tamsulozin. The maximum concentration of drug in plasma are reached approximately six hours later after reception of a single dose of a tamsulozin on a full stomach. Stable concentration in plasma are established for the fifth day of regular reception, on reaching the maximum concentration of drug, approximately on two thirds of the single dose exceeding the maximum concentration after reception. In spite of the fact that these data were obtained for elderly patients, the similar result should be expected also at patients of younger age. Between patients big individual differences of concentration of a tamsulozin of plasma are noted, both at single, and at multiple dose of drug. Distribution Tamsulozin more than for 99% contacts proteins of plasma and the volume of distribution of drug is small (about 0.2 l/kg). Biotransformation Tamsulozin is poorly metabolized at the first passing through a liver. The prevailing quantity of a tamsulosin is in plasma in not changed look. Tamsulozin is exposed to metabolism in a liver. Metabolites of a tamsulozin have smaller therapeutic effect and smaller toxicity, than an initial product. Removal Tamsulozin and his metabolites are allocated mainly with urine, and about 9% of a dose are allocated in not changed look. Elimination half-life of a tamsulozin at patients makes about 10 hours (at single dose on a full stomach), and at regular reception – 13 hours. Pharmacodynamics Tamsulozin it is selective, competitively, connects postsynaptic α1A-адренорецепторы which excitement causes reduction of smooth muscles. Thus, drug promotes relaxation of smooth muscles of a prostate and an urethra. Pharmakodinamichesky effects Tamsulozin as much as possible increases outflow of urine due to relaxation of unstriated muscles of a prostate and an urethra, facilitating, thus, symptoms of disturbance of passability of urinary tract. This drug facilitates symptoms of irritation and disturbance of passability which are considerably caused by a spasm of unstriated muscles of urinary tract. Blockers of alpha adrenoceptors are capable to lead to a lowering of arterial pressure due to reduction of peripheric resistance of vessels. During clinical trials of a tamsulozin at patients with normal arterial blood pressure, clinically significant lowering of arterial pressure was not observed. The medical effect of this drug concerning symptoms of filling/bladder emptying remains as well at long therapy therefore need of surgical intervention can be considerably delayed. Indications - treatment of dysuric disorders in the benign hyperplasia of a prostate (BHP) the Route of administration and doses On one capsule a day after a breakfast or the first meal. The capsule should be swallowed entirely, without chewing, in a standing position or sitting (without lying), washing down with a glass of water. The capsule cannot be divided into parts or to break as it can influence release of active agent of the prolonged action. Duration of use of drug depends by nature diseases, degrees of its weight and features of its course and is established by the attending physician. Side effects Often (& gt, 1/100, & lt, 1/10) - dizziness Sometimes (& gt, 1/1,000, & lt, 1/100) - a headache, tachycardia, orthostatic hypotonia, an asthenia - rhinitis, a constipation, a diarrhea, nausea, vomiting - rash, a skin itching, a small tortoiseshell - disturbances of an ejaculation is rare (& gt, 1/10,000, & lt, 1/1,000) - a syncope - a Quincke's disease Very seldom (& lt, 1/10,000) - the Contraindication priapism - hypersensitivity to a tamsulozin or excipients, including development of a Quincke's disease in connection with use of a tamsulozin - cases of orthostatic hypotonia in the past (orthostatic hypotonia in the anamnesis) - heavy insufficiency of function of a liver - a heavy renal failure Medicinal interactions At co-administration of a tamsulozin with atenolol, enalapril, nifedipine or theophylline of interactions was not noted. The accompanying prescribing of Cimetidinum increases, and prescribing of furosemide reduces concentration of a tamsulozin in plasma. As concentration of a tamsulozin in plasma at co-administration with these prepara remains within norm, no correction of a dosage of a tamsulozin is required. In the researches in vitro with use of the microsomal fractions of a liver (representing the system of the metabolizing enzymes connected with P450 cytochrome) interactions between tamsuloziny and amitriptyline, salbutamol, glibenclamide or finasteridy were not revealed. The accompanying prescribing of diclofenac and warfarin can increase removal of a tamsulozin. Co-administration of a tamsulozin with other antagonists α1-адренорецепторов can lead to a lowering of arterial pressure. The lowering of arterial pressure can cause the special instructions Use of Proflosina® that in rare instances can lead to attacks of weakness and faints. At emergence of the first symptoms of orthostatic hypotonia (dizziness, weakness), the patient is recommended to sit down or lie down before disappearance of symptoms. Before therapy tamsuloziny it is necessary to exclude existence at the patient of the diseases and states capable to cause symptomatology similar from observed at DGPZh. It is necessary to perform rectal examination of a prostate and if it is required, determination of level of prostatspetsifichesky antigen (DOG) prior to therapy and during therapy with regular intervals. At therapy of patients (clearance of creatinine & lt, 10 ml/min.) it is necessary to be careful with heavy disturbances of renal function as use of drug for this category of patients was not studied. At Proflosin's use ® development of a Quincke's disease was in rare instances noted. In cases of development of a Quincke's disease it is necessary to stop immediately therapy Professional moose ®, and to put the patient under observation before disappearance of hypostasis. Repeated purpose of a tamsulozin at such patients is contraindicated. Development of a syndrome of an atonichny iris (IFIS, option of a syndrome of a narrow pupil) during surgery on removal of a cataract was noted at some patients receiving or shortly before operation receiving therapy Professional moose ®. This syndrome (IFIS) can lead to increase in frequency of technical complications when carrying out operation. At patients with the planned cataract surgery it is not recommended to begin therapy Professional moose ®. Therapy cancellation Professional moose ® in 1-2 weeks prior to operational removal of a cataract in some cases proved to be reasonable, however the advantage and necessary term of drug withdrawal before removal of a cataract are at the moment not established. For the purpose of a possibility of holding necessary actions for stopping of a syndrome of an atonichny iris when carrying out operation, during preliminary estimate in the preoperative period the eye surgeons and ophthalmologists should find out, took or whether therapy Professional moose ® at patients with the planned surgical removal of a cataract takes place. Pregnancy and the period of a lactation Proflosin ® is intended only for use for men. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Influence of drug on ability to run the vehicle and to serve cars is not investigated. However, patients should take possibility of dizziness into account. Overdose Symptoms: It was reported about acute overdose of a tamsulozin of a hydrochloride in a dose of 5 mg. Acute arterial hypotension was observed (in which systolic arterial blood pressure made 70 mm Hg.), vomiting and diarrhea. Treatment: gastric lavage, prescribing of activated carbon and osmotic laxatives. It is necessary to lay the patient in horizontal position, if necessary performing infusional therapy (for the purpose of completion of volume of the circulating liquid), administration of vasoconstrictive drugs is shown. Regular control of function of kidneys is shown. Because of ability of a tamsulozin to contact actively proteins of plasma, the positive effect from use of dialysis is improbable. A form of release and packing On 10 capsules in blister strip packaging from a film of PVH/PE/PVDH and aluminum foil. On 1, 3 or 10 planimetric packs together with the instruction for use in the state and Russian languages place Storage conditions in a cardboard pack to Store at a temperature not higher than 25 wasps. To store out of children's reach! 3 years not to use a period of storage after expiry date. Prescription status According to the prescription the Ispanya S.L. Synthon Producer. Spain Owner of the registration certificate of Menarini International Opereyshnz Village of Luxembourg. And., Luxembourg the Authorized representative BERLIN-HEMI AG (MENARINI GROUP) Gliniker Weg 125 12489 Berlin, Germany the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods): Representative office of JSC Berlin-Hemi AG in RKNomer of phone number: +7 727 2446183, 2446184, 2446185 fax number: +7 727 2446180 the e-mail address:
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