Adenik modified release capsules 0.4mg #10×3

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Adenik caps with mod. vysv. 0.4 mg in a blister. in pack No. 10×3
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Solid colorless gelatin capsules No. 1. The main active ingredient Tamsulosin Release form 10 capsules in a blister. 3 blisters with leaflet in a cardboard box. Dosage 0.4 mg Patients should be aware that dizziness may occur when taking tamsulosin. Pharmacological action Drugs for the treatment of benign prostatic hyperplasia. Alpha blockers. Drug code according to ATC G04CA02 PharmacodynamicsPharmacodynamics Tamsulosin is a selective competitive inhibitor of postsynaptic ?-1-adrenergic receptors, the drug has an affinity for ?-1A and ?-ID subtypes, binding 30-08-2017 of tamsulosin to these receptors relaxes the smooth muscles of the prostate and urethra. Tamsulosin increases the maximum flow rate of urine. By reducing the severity of obstruction by reducing the tone of the smooth muscles of the prostate and urethra, tamsulosin reduces “emptying symptoms”. In addition, the drug reduces the severity of “filling symptoms”, in the development of which bladder instability plays an important role. With long-term therapy with tamsulosin, a stable reduction in the severity of filling and emptying symptoms is achieved. Thus, treatment with the drug can delay the need for surgery or a bladder catheterization procedure. ?-blockers can lower blood pressure by reducing peripheral vascular resistance. During the clinical trials of tamsulosin, there was no significant decrease in blood pressure. Indications for use Treatment of dysuric disorders in benign prostatic hyperplasia (BPH). Route of administration and doses The use of this medicinal product is possible only after consulting a doctor. If you forget to take Adenic, take the capsule as soon as possible before your next dose is due. If it is time for your next dose of medication, do not take the missed dose. You can not double the dosage of the drug to compensate for the missed! Further, the drug is used according to the recommended dosing regimen. If you have any doubts or questions, please contact your doctor. The drug is prescribed at 0.4 mg (1 capsule) per day. Capsules are taken after the first meal with plenty of water. The capsule is not recommended to be chewed, as this may affect the rate of release of tamsulosin. In case of renal insufficiency, as well as in mild and moderate hepatic insufficiency, no correction of the dosing regimen is required. Use in children The safety and efficacy of tamsulosin in children under 18 years of age have not been established. Use during pregnancy and lactation The drug is intended for use only in males. Precautions The drug should be used with caution in patients with a predisposition to orthostatic hypotension. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should be seated or laid down. In patients with impaired renal function, dose reduction is not required. Before starting the use of the drug, it is necessary to verify the diagnosis. During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions. Before starting the use of the drug, the patient should be examined to exclude other diseases that can cause the same symptoms as benign prostatic hyperplasia. Before starting treatment and regularly during therapy, a digital rectal examination and, if necessary, determination of the level of prostate specific antigen (PSA) should be performed. Some patients taking or previously taking tamsulosin hydrochloride during cataract surgery have developed intraoperative iris instability syndrome (tiny pupil syndrome), which can lead to complications during surgery or in the postoperative period. The expediency of discontinuing tamsulosin hydrochloride therapy 1-2 weeks before cataract surgery has not yet been proven. Cases of intraoperative instability of the iris occurred in patients who stopped taking the drug and at an earlier time before surgery. It is not recommended to start tamsulosin hydrochloride therapy in patients who are scheduled for cataract surgery. During the preoperative examination of patients, the surgeon and ophthalmologist should consider whether the patient is taking or has taken tamsulosin. This is necessary to prepare for the possibility of developing intraoperative iris instability syndrome during surgery. Tamsulosin hydrochloride should not be co-administered with strong inhibitors of CYP3A4 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. Interaction with other drugs If you are currently or have recently taken other drugs, tell your doctor. When prescribing the drug together with atenolol, enalapril or theophylline, no interactions were found. With the simultaneous use of the drug with cimetidine, there was a slight increase in plasma levels of tamsulosin, with furosemide – a decrease in concentration, but dose adjustment is not required, since the concentration of the drug remains within the normal range. Diazepam, propranolol, trichlormethiazide, chlormadinone, amitriptyline, diclofenac, glibenclamide, simvastatin, and warfarin do not alter the free fraction of tamsulosin in human plasma in vitro. In turn, tamsulosin also does not change the free fractions of diazepam, propranolol, trichlormethiazide and chlormadinone. Diclofenac and warfarin may increase the rate of tamsulosin excretion. The simultaneous use of tamsulosin hydrochloride with strong inhibitors of CYP3A4 may lead to an increase in the concentration of tamsulosin hydrochloride. Co-administration with ketoconazole (a strong inhibitor of CYP3A4) led to an increase in AUC and Cmax of tamsulosin hydrochloride by 2.8 and 2.2 times, respectively. Tamsulosin hydrochloride should not be co-administered with strong inhibitors of CYP3A4 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 hydrochloride and paroxetine, a strong inhibitor of CYP2D6, led to an increase in AUC and Cmax of tamsulosin, respectively, by 1.3 and 1.6 times, but this increase is not considered clinically significant. The simultaneous use of other ?l-blockers can lead to a decrease in blood pressure. Contraindications Hypersensitivity to the drug. The drug should be used with caution in chronic renal failure (decreased creatinine clearance below 10 ml / min), arterial hypotension (including orthostatic), severe liver failure. Composition One capsule contains: Active substance: tamsulosin hydrochloride 0.4 mg. Excipients: sugar balls, OY-29020 opadry, ethyl cellulose water dispersion 25%, methacrylic acid-ethyl acrylate copolymer, talc, triethyl citrate. The composition of the capsule shell: gelatin. (Opadry OY-29020: hypromellose 2910, macrogol 400. Ethylcellulose aqueous dispersion 25%: ethylcellulose, ammonium hydroxide, medium chain triglycerides, oleic acid, purified water). Overdose No cases of acute drug overdose have been noted. Symptoms: theoretically, acute hypotension may occur. Treatment: carry out cardiotropic therapy. If symptoms persist, volume-replacing fluids or vasoconstrictors should be administered. To prevent further absorption of tamsulosin, gastric lavage, activated charcoal, or an osmotic laxative may be taken. Blood pressure and heart rate can be restored when a person assumes a horizontal position. It is necessary to monitor kidney function. Dialysis is unlikely to be effective as tamsulosin is highly bound to plasma proteins. Side effect The evaluation of unwanted side effects is based on the following data on the frequency of occurrence: very often (> 1/10), often (> 1/100 to <1/10), infrequently (> 1/1, 000 to <1/100), rare (>1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from available data). often infrequently rarely very rarely unknown Cardiovascular disorders palpitations, orthostatic hypotension Gastrointestinal disordersa constipation, diarrhoea, nausea, vomiting dry mouth* General condition asthenia Nervous system disorders dizziness (1.3%) headache pain fainting Visual disturbances blurred vision*, visual impairment* Reproductive system disorders ejaculation disorders, incl. retrograde ejaculation and anejaculation Respiratory, thoracic and mediastinal disorders rhinitis epistaxis* Skin and subcutaneous tissue disorders rash, pruritus, urticaria angioedema Stevens-Johnson syndrome erythema multiforme*, exfoliative dermatitis* * Noted in the post-registration period. Cases of intraoperative instability of the iris (small pupil syndrome) during cataract surgery in patients who have been taking tamsulosin for a long time have been described. The frequency has not been set. Post-marketing use of the drug: in addition to the side effects described above, atrial fibrillation, arrhythmia, tachycardia and dyspnea have been observed with the use of tamsulosin. Due to the fact that the data were obtained by the method of spontaneous reports in the period after registration, it is difficult to determine the frequency and causal relationship of these events with the use of tamsulosin. If side effects occur, tell your doctor about it. This applies to all possible side effects, including those not described in this package insert. Storage conditionsStore in the manufacturer's packaging at temperatures from 15°C to 25°C. Keep out of the reach of children. Shelf life: 4 years. Do not use after the expiration date. 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