Tamsulosin-LF modified release capsules 0.4mg #10×3

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Tamsulosin-LF caps. with MV 0.4 mg in a cell. pack No. 10×3
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Hard gelatin capsules No. 1 of a cylindrical shape with hemispherical ends with a white body and a green cap. The main active ingredient Tamsulosin Release formCapsules with modified release. Dosage 0.4 mg Special instructions As with the use of other ?1-adrenergic blockers, in some cases, when using Tamsulosin-LF, a decrease in blood pressure is possible, which can sometimes lead to loss of consciousness. When the first signs of orthostatic hypotension (dizziness, weakness) appear, the patient should take a horizontal position until the above symptoms disappear. Before starting treatment with Tamsulosin-LF, it is necessary to undergo a medical examination in order to identify other concomitant diseases that can cause the same symptoms as benign prostatic hyperplasia. Before starting treatment, it is necessary to conduct a rectal examination of the prostate gland and, if necessary, a prostate specific antigen (PSA) test before and at regular intervals during treatment. It is necessary to prescribe the drug to patients with severe renal insufficiency (creatinine clearance <10 ml / min) with extreme caution, since clinical studies using tamsulosin in such patients have not been conducted. In rare cases, when using tamsulosin, the development of angioedema has been reported, in the event of which, treatment with tamsulosin should be stopped immediately, the patient should be monitored until the swelling disappears, tamsulosin is not re-prescribed. Some patients who have taken or are taking tamsulosin have experienced atonic iris syndrome (ISAR) during cataract surgery, which may increase the number of complications during cataract surgery. For this reason, tamsulosin is not recommended for patients scheduled for cataract surgery. It is generally recommended to stop tamsulosin treatment 1 to 2 weeks before cataract surgery. However, the feasibility and timing of discontinuation of tamsulosin has not yet been clearly established. In preparation for surgery, ophthalmic surgeons should determine whether the patient has been (or is taking) tamsulosin in order to prevent possible complications associated with ISAR. Pharmacotherapeutic groupMeans for the treatment of urological diseases. Agents for the treatment of benign prostatic hyperplasia. Antagonists of alpha-adrenergic receptors. Tamsulosin. Indications for use Treatment of functional symptoms in benign prostatic hyperplasia. Method of administration and doses For oral administration. Adults and children over 18 years of age are recommended to take 1 capsule per day - after breakfast, drinking plenty of water, without chewing or breaking. Patients with impaired liver and kidney function. In case of renal insufficiency, as well as in mild and moderate hepatic insufficiency, no dosage adjustment is required. Use during pregnancy and lactation The drug is used only for the treatment of men. Use in children The drug is not used in children under the age of 18 years. Influence on the ability to drive vehicles and control mechanisms A study of the effect of the drug on the ability to drive vehicles or work with other mechanisms was not carried out. Patients should be warned about the possibility of dizziness. Interaction with other drugs With the simultaneous use of tamsulosin hydrochloride with atenolol, enalapril, nifedipine or theophylline, drug interactions were not noted. Simultaneous use with cimetidine increases, and with furosemide reduces the concentration of tamsulosin in the blood plasma, but since these levels remain within the normal range, there is no need for a special dose adjustment of tamsulosin. In vitro studies diazepam, propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin do not affect the free fraction of tamsulosin in plasma. Similarly, tamsulosin does not alter the free fractions of diazepam, propranolol, trichlormethiazide, and chlormadinone in human plasma. In vitro studies did not reveal interactions at the level of hepatic metabolism with the participation of microsomal fractions in the liver (the system of enzymatic metabolism with the participation of cytochrome P450 was indicative) with respect to amitriptyline, salbutamol, glibenclamide and finasteride. However, diclofenac and warfarin may accelerate the elimination of tamsulosin from plasma. Simultaneous administration of tamsulosin with strong inhibitors of the CYP3A4 isoenzyme can lead to an increase in the concentration of tamsulosin. Co-administration with ketoconazole led to an increase in AUC and Cmax of tamsulosin by 2.8 and 2.2 times, respectively. The combination of tamsulosin with strong inhibitors of CYP3A4 should not be used in patients with impaired metabolism of the CYP2D6 isoenzyme. The drug should be used with caution in combination with strong and moderate inhibitors of CYP3A4. The simultaneous administration of tamsulosin and paroxetine led to an increase in AUC and Cmax of tamsulosin by 1.3 and 1.6 times, respectively, but this increase was recognized as clinically insignificant. Simultaneous use with other ?1-adrenergic blockers may enhance the hypotensive effect. Contraindications hypersensitivity to the active substance or any of the auxiliary components of the drug; orthostatic hypotension (including history); severe liver failure. With caution: severe renal failure (creatinine clearance less than 10 ml / min). Composition Each capsule contains: Active substance: tamsulosin hydrochloride (in the form of pellets 0.2%) - 0.4 mg; Excipients: sugar granules, drug coating L100 (methacrylic acid - methyl methacrylate copolymer), macrogol 6000, ethylcellulose; The composition of the hard gelatin capsule: crimson 4R (E 124), orange yellow (E 110), quinoline yellow (E 104), proprietary blue V (E 131), titanium dioxide (E 171), gelatin. Overdose No cases of acute overdose of tamsulosin have been reported. Symptoms: it is possible to develop an acute decrease in blood pressure and compensatory tachycardia. Treatment: symptomatic, supportive therapy should be carried out aimed at restoring the normal function of the cardiovascular system (for example, the patient must take a horizontal position). If this measure does not work, infusion therapy is carried out and vasopressors are prescribed. It is necessary to monitor renal function and carry out general supportive therapy. Due to the high degree of binding of tamsulosin to plasma proteins, hemodialysis is not advisable. In order to stop further absorption of the drug, you can artificially induce vomiting. In case of an overdose of a significant amount of the drug, the patient must wash the stomach with activated charcoal and low-osmotic laxatives, such as sodium sulfate. Side effects When taking tamsulosin, there is a possibility of developing adverse reactions, which are classified by organ systems and by frequency of occurrence: very often (> 1/10), often (> 1/100; <1/10), infrequently (> 1/1000; < 1/100), rare (? 1/10000; < 1/1000), very rare (< 1/10000), unknown (according to the currently available data, the frequency cannot be determined). Common side effects: from the side of the central nervous system: dizziness (1.3%); from the reproductive system: ejaculation disorders. Infrequent side effects: from the side of the central nervous system: headache; from the cardiovascular system: palpitations, postural hypotension; from the side respiratory organs, chest and mediastinum: rhinitis; from the gastrointestinal tract: constipation, diarrhea, nausea, vomiting; from the skin and mucous membranes: skin rash, urticaria, itching; general disorders: asthenia. Rare side effects: with on the part of the central nervous system: syncope; on the part of the skin and mucous membranes: angioedema Very rare side effects: on the part of the reproductive system: priapism. on the part of the skin and mucous membranes: Stevens-Johnson syndrome. Cases of intraoperative instability of the iris of the eye (narrowed pupil syndrome) are described with cataract surgery in patients who have taken tamsulosin for a long time. Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Tamsulosin-LF modified release capsules 0.4mg #10x3