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Urimak 30s 0.4 mg modified-release capsules




The instruction for medical use of Urimak Torgovoye medicine a name Urimak Mezhdunarodnoye the unlicensed name Tamsulozin Lekarstvennaya the Capsule form with the modified release, 0.4 mg Ingredients: One capsule contains active agent – a tamsulozin a hydrochloride of 0.4 mg, excipients: polysorbate 80, copolymer of methacrylic acid, triacetin, sodium lauryl sulfate, cellulose microcrystalline (PH 101), calcium stearate, structure of a cover of the capsule: indigotin (FD&C, blue No. 2) (E 132), gland (III) oxide black (E 172), gland (III) oxide red (E172), gland (III) oxide yellow (E 172), titan dioxide (E 171), gelatin. The description Solid gelatin capsules 2 of No. in size, a lid opaque olive-green color and the body of opaque orange color, with the inscription CL 23 on a lid and 0.4 on the body of black color. Contents of capsules: balls (spheroids) of white or almost white color. Pharmacotherapeutic group Drugs for treatment of a benign hypertrophy of a prostate. Alpha adrenoblockers. Tamsulozin. The ATX G04CA02 code the Pharmacological Pharmacokinetics Absorption Later properties of intake on an empty stomach is almost completely soaked up from a GIT. Its bioavailability is nearly 100%. Absorption of a tamsulozin decreases if to take the drug right after food. The uniformity of absorption can be maintained at constant use of a tamsulozin after meal, in one and too time. The kinetics of a tamsulozin is linear. The maximum concentration (Cmax) in blood plasma is reached approximately in 6 hours after reception of a single dose of a tamsulozin, the accepted ambassador of food. Equilibrium concentration is reached in 5 days of reception of a course dose, in this condition of Cmax is two thirds higher than Cmax after reception of one dose of drug. Though it was shown only at elderly, but the same result can be expected also at young patients. There are significant changes in level of a tamsulozin in blood plasma among patients after single and repeated introduction. Tamsulozin’s distribution a hydrochloride actively contacts proteins of plasma (from 94% to 99%), and its volume of distribution is insignificant (about 0.2 l/kg). Biotransformation Tamsulozin is metabolized slightly at the first passing. The most part of a tamsulozin is present at plasma in not changed look. Tamsulozin is metabolized in a liver. Any of metabolites has no activity exceeding activity of the most active ingredient of drug. At insignificant and moderate degree of a liver failure the correction of the mode of dosing is not required. Elimination (discharge) Tamsulozin and its metabolites, mainly, are allocated with urine, about 9% of a dose are allocated in not changed form. Elimination half-life of a tamsulozin makes about 10 hours if it was accepted after a meal and 13 hours – in an equilibrium state. In a renal failure the dose decline, in the presence is required from the patient of a heavy renal failure (clearance of creatinine less than 10 ml/min.) purpose of a tamsulozin needs to be carried out with care the Pharmacodynamics Urimak is a selection competitive inhibitor of alfa1-adrenoceptors, drug has affinity to alfa1a and alfa1d to subtypes, binding of active agent of drug – the tamsulozina with these receptors relaxes unstriated muscles of a prostate and an urethra. Urimak increases the maximum speed of outflow of urine due to undervoltage of unstriated muscles of a prostate and an urethra, thereby weakening obstruction. Besides, drug reduces ischuria symptoms in which an important role is played by instability of a bladder. These effects concerning symptoms of an ischuria and disturbance of urination remain at long therapy therefore need of surgical intervention can be considerably delayed. Alpha 1 – blockers due to decrease in peripheric resistance can reduce arterial blood pressure. However clinically significant lowering of arterial pressure was not observed. Indications – the benign hyperplasia of a prostate (BHP). A route of administration and doses Adult On one capsule a day after a breakfast. The capsule is swallowed entirely, washing down with a glass of water, in a sitting position or standing (without lying). Capsules cannot be broken or opened. Disturbance of integrity of the capsule can influence release of the long operating active agent. In case of the termination or a break for several days in reception of capsules of a tamsulozin in a dosage of 0.4 mg, treatment should be begun anew with daily single dose of drug in a dosage of 0.4 mg. Duration of treatment is defined by the doctor depending on a condition of the patient. With care apply at the patients inclined to arterial hypotension, in the profound renal failures and a liver. Side effects Often ((& gt, 1/100, & lt, 1/10)): – dizziness – disturbance of an ejaculation, including a retrograde ejaculation Infrequently (& gt, 1/1000, & lt, 1/100): – a headache – tachycardia – orthostatic hypotension – rhinitis – a constipation, diarrhea, nausea, vomiting – skin rash, an itching, urticaria – an asthenia Seldom (& gt, 1/10,000, & lt, 1/1000): – a faint – a Quincke’s disease Very seldom (& lt, 1/10,000): – Stephens-Jones’s syndrome – a priapism – 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 the long time accepting tamsulozin With an unknown frequency – exfoliative dermatitis, a mnogoformny erythema – illegibility of sight, a disorder of vision – nasal bleedings – dryness in a mouth Post-marketing experience In addition to the adverse events which are listed above, fibrillation of auricles, arrhythmia, tachycardia and dispnoe was registered in connection with use of a tamsulozin. However, the frequency of events and a role of a tamsulozin in their relationship of cause and effect cannot be authentically determined. The contraindication – hypersensitivity to a tamsulozin or to other components of drug – orthostatic hypotension in the anamnesis – a heavy liver failure – children’s and teenage age up to 18 years Medicinal interactions was Not noted adverse medicinal interactions when assigning a tamsulozin along with atenolol, enalapril or theophylline. The concomitant use of drug with Cimetidinum leads to increase in concentration of a tamsulozin in blood plasma, and reception with furosemide – to decrease in plasma concentration of drug, however, concentration remain within acceptable level. In the researches in vitro with use of microsomes of a liver (reflect the processes happening to participation of isoforms of P450 cytochrome) the interaction at the level of hepatic metabolism with amitriptyline, salbutamol, glibenclamide and finasteridy was not revealed. However, diclofenac and warfarin can increase the clearance rate of a tamsulozin. At co-administration with the drugs reducing arterial blood pressure, for example, drugs for the general anesthesia or other antagonists α1-адренорецепторов, increase in their hypotensive action can be noted. Simultaneous use of a tamsulozin with CYP3A4 inhibitors can lead to strengthening of effect of a tamsulozin. Co-administration of a ketokonazol (known strong CYP3A4 inhibitor) led to increase in AUC and Cmax of a tamsulozin respectively in 2.8 and 2.2 times. Tamsulozin it is not necessary to apply in a combination with the expressed CYP3A4 inhibitors at patients – slow metabolizator with CYP2D6 phenotype. Tamsulozin a hydrochloride should be used with care in combination with strong (for example, ketokonazol) and moderate inhibitors (for example, erythromycin) from CYP3A4. Co-administration of a tamsulozin with paroksetiny, the expressed CYP2D6 inhibitor, was followed increase in Cmax and AUC of a tamsulozin respectively in 1.3 and 1.6 times, however these changes are regarded as clinically not significant. Special instructions As well as when using other antagonists α1-адренорецепторов, in some cases treatment by Urimak can be followed by a lowering of arterial pressure, as a result, in rare instances perhaps development of an unconscious state. At emergence of the first symptoms of orthostatic hypotension (dizziness, weakness) of the patient it is recommended to seat or lay and leave in such situation until signs do not disappear. Before an initiation of treatment Urimak it is necessary to perform examination of the patient for an exception of other states, the followed similar symptoms with a benign hyperplasia of a prostate. Before an initiation of treatment and subsequently through regular intervals it is necessary to conduct a manual rectal research and if it is necessary, definition of prostatspetsifichesky antigen (DOG). Treatment of patients with a heavy renal failure (clearance of creatinine & lt, 10 ml/min.) has to be performed with care as researches at such patients were not conducted. At the certain patients who were receiving or earlier accepting tamsulozin at operational treatment concerning a cataract or glaucoma the intraoperative syndrome of a flabby iris (Intraoperative Floppy Iris Syndrome, IFIS), option of a syndrome of a narrow pupil was observed. Existence of IFIS can increase risk of complications from eyes in time and after operation. It is known that there can be useful a cancellation of a tamsulozin of a hydrochloride in 1-2 weeks prior to operation, but effects of such cancellation of therapy are not established yet. Also it was reported about development of IFIS in the patients who stopped reception of a tamsulozin long before operation. At patients to whom carrying out operational treatment of a cataract or glaucoma is planned, are not recommended to begin therapy of a tamsulozin with a hydrochloride. In process of a preparation for surgery the surgeons and ophthalmologists have to specify, accepts or whether the patient to whom operational treatment of a cataract or glaucoma is planned, tamsulozin accepted earlier to be ready to treatment of IFIS in case of its development during operation. Pregnancy and the period of a lactation Drug is intended only for treatment of men. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms of the Research of influence on ability to driving of the car and to control of mechanisms were not carried out. However, patients have to show care, in connection with a possibility of development of dizziness. Overdose Symptoms: heavy arterial hypotension. Treatment: in case of overdose it is recommended to turn the patient to horizontal position and to hold the events directed to maintenance of function of a cardiovascular system (restoration of arterial blood pressure), gastric lavage, administration of activated carbon and osmotic depletive, such as sodium sulfate. In the absence of effect it is necessary to enter the substances increasing the volume of the circulating blood and if necessary, vasoconstrictors. Are necessary assessment of function of kidneys in dynamics and performing maintenance therapy. Dialysis is a little effective at overdose of a tamsulozin as drug substantially contacts proteins of blood plasma. The form of release and packing On 10 capsules place in blister strip packagings from aluminum PVC/PE/PVDH/foil. On the 3rd blister strip packagings together with the instruction for medical use in the state and Russian languages put in a cardboard pack. To Store storage conditions in the place protected from light at a temperature not over 30 ºС. To store out of children’s reach! 2 years not to apply a period of storage after an expiration date. Prescription status According to the prescription the Name and the country of the Macleods Pharmaceuticals Limited 304, Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai manufacturing organization – 400,059, India. The holder of the registration certificate of Macleods Pharmaceuticals Limited, India the Name and the country of the organization of the packer of Macleods Pharmaceuticals Limited, India the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of the products and responsible for post-registration observation of safety of medicine in the territory of the Republic of Kazakhstan Branch KOO Macleods Pharmaceuticals Limited, Republic of Kazakhstan Almaty, Tulebayev St. 38/61, 5
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