Symptoms of the lower urinary tract associated with benign prostatic hyperplasia.
Composition:
One extended-release capsule contains 0.4 mg of Tamsulosin hydrochloride (and 0.0353 mg of sunset yellow, 0.0013 mg of cochineal red, 0.0008 mg of brilliant blue and 0.0019 mg of azorubine).
Action:
Selective and competitive antagonist of postsynaptic α-adrenergic receptors1, especially the α subtypes1A and α1D. Tamsulosin relaxes the smooth muscles of the prostate and urethra. Increases the maximum urinary flow rate. It reduces obstruction due to relaxation of the smooth muscle of the prostate gland and the urethra, reducing the symptoms associated with passing urine. In addition, it reduces the symptoms of frequent urination - bladder irritation. The reduction in symptoms from bladder filling and emptying persists during long-term treatment. Tamsulosin is rapidly absorbed from the digestive tract, the bioavailability is almost complete, the food reduces the absorption of the drug. After taking a single dose of tamsulosin (after a meal), the maximum concentration in the blood occurs after about 6 hours. The state of balance is reached by the fifth day after repeated administration of the drug. Tamsulosin is approximately 99% bound to plasma proteins. It is metabolized in the liver and excreted mainly in the urine in the form of metabolites, approx. 9% of the administered dose is excreted in the urine in unchanged form. T0,5 after a single intake of the preparation after a meal it is about 10 hours, in the state of equilibrium about 13 hours.
Contraindications:
Hypersensitivity to the active substance (including drug-induced angioneurotic edema) or to any of the excipients. Orthostatic decreases in patient's blood pressure. Severe hepatic failure.
Precautions:
Before starting treatment, the patient should be tested to rule out other diseases that may cause the same symptoms as for a benign prostatic hyperplasia. Before starting treatment and then periodically during treatment, it is advisable to perform the testper rectum and, if necessary, determining the specific prostate antigen (PSA). Due to the lack of clinical trials, caution should be used in patients with severe renal impairment (creatinine clearance <10 ml / min). During cataract surgery, some patients treated with tamsulosin have or currently had intraoperative flaccid syndrome (IFIS, a type of small pupil syndrome). IFIS may increase the risk of complications during surgery. Discontinuation of tamsulosin for 1-2 weeks before cataract surgery is sometimes helpful, however, the benefit and time period before surgery for which the drug should not be used has not been established. There have been cases of IFIS in patients who discontinued tamsulosin long before cataract surgery. It is not recommended to start treatment with tamsulosin in patients being prepared for cataract surgery. Physicians carrying out eye surgery should check that patients being prepared for surgery are or have been treated with tamsulosin. There may be allergic reactions associated with the presence of dyes: azorubin, cochineal red and sunset yellow.
Pregnancy and lactation:
Not applicable - preparation intended for use in men.
Side effects:
Common: dizziness, ejaculation problems, ejaculation, no ejaculation. Uncommon: headache, palpitations, orthostatic hypotension, nasal discharge, constipation, diarrhea, nausea, vomiting, rash, pruritus, urticaria, weakness. Rare: fainting, angioneurotic edema. Very rare: Stevens-Johnson syndrome, painful erection. Frequency unknown: blurred vision, visual impairment, nosebleeds, dry mouth, erythema multiforme, dermatitis. Following the marketing of the medicine during cataract surgery, small pupil syndrome, known as intraoperative flaccid assembly (IFIS) has been reported in patients treated with tamsulosin. In addition, after the product was placed on the market, atrial fibrillation, arrhythmia, tachycardia and dyspnoea were also reported.
Dosage:
Orally. Adults: 1 kaps.per day.Special groups of patients. No dose adjustment is necessary in patients with renal impairment, with mild or moderate hepatic impairment. The safety and efficacy of tamsulosin in children and adolescents has not been established. There are no clear indications for use in children.Way of giving. The drug should be taken after breakfast or after the first meal of the day. The capsule should be swallowed whole, it should not be chewed or chewed, because it disturbs the ability to modify the active substance release.
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