Index of drugs

Symptoms of the lower urinary tract associated with benign prostatic hyperplasia.

One modified-release capsule contains 0.4 mg Tamsulosin hydrochloride.

Selective and competitive antagonist of α-type adrenergic α-adrenergic receptors₁. Tamsulosin relaxes the smooth muscles of the prostate and urethra, thus increasing the maximum urine flow. It reduces the symptoms of irritation and difficulty in urinating. The reduction of symptoms from filling and emptying is maintained during long-term use of the drug. The drug is quickly absorbed from the digestive tract, the bioavailability is almost complete, the food reduces absorption. After a single dose, the maximum plasma concentration occurs after approximately 6 hours. The steady state is reached on day 5 after repeated administration. Tamsulosin is approximately 99% bound to plasma proteins. It is metabolised in the liver and excreted mainly in the urine, 9% of the dose - unchanged. T_0,5 after a single intake of the drug after a meal is approx. 10 h, in steady state about 13 hours.

Hypersensitivity to the active substance, including angioedema due to drug action or to any of the excipients. Orthostatic hypotension. Severe hepatic failure.

Before starting treatment with Tamsulosin, the patient should be examined to exclude other conditions that may cause symptoms similar to symptoms of benign prostatic hyperplasia. The prostate gland should be examinedper rectum and, if there are indications, indicate in a patient the level of specific prostate antigen (PSA) before treatment and systematically during its course. Caution should be exercised in patients with severe renal impairment (creatinine clearance <10 ml / min) due to lack of testing in this patient group. If angioedema occurs, treatment should be discontinued immediately, subjected to observation until the edema subsides and re-administered tamsulosin. In some patients previously treated with tamsulosin, intraoperative glottic iris syndrome was observed during cataract surgery, which may increase the incidence of complications during surgery. It is not recommended to start therapy with tamsulosin if the patient with cataract is scheduled for surgery. A single report suggests that discontinuation of tamsulosin for 1-2 weeks prior to cataract surgery may be helpful, although no benefit has yet been established and the time period during which tamsulosin should be discontinued prior to surgery. During pre-operative assessment, it should be determined whether the patient is or has been treated with tamsulosin to provide adequate precautions in the event of IFIS occurring during surgery. Due to the risk of hypotension, which may cause fainting, after finding the initial symptoms of orthostatic hypotension (dizziness, weakness) the patient should sit or lie down until the symptoms disappear. Patients with a CYP2D6-slow metabolic phenotype may experience interactions when using tamsulosin with strong CYP3A4 inhibitors - use is not recommended. The safety and efficacy of tamsulosin in children and adolescents under 18 years have not been established.

Not applicable - preparation intended for use in men.

Common: dizziness (of central origin), ejaculation problems, retrograde ejaculation, lack of ejaculation. Uncommon: headache, palpitations, orthostatic hypotension, rhinitis, constipation, diarrhea, nausea, vomiting, rash, pruritus, urticaria, asthenia. Rare: fainting, angioneurotic edema. Very rare: Stevens-Johnson syndrome, priapism. Not known: blurred vision, blurred vision, nosebleeds, erythema multiforme, exfoliative dermatitis.In addition, after the introduction of the preparation, a small pupil syndrome (intraoperative flaccid syndrome) was observed during cataract surgery, atrial fibrillation, arrhythmia, tachycardia, dyspnea.

Orally. Adults: 1 capsule per day, after breakfast or after the first meal of the day. The capsule should be swallowed whole with a glass of water, sitting or standing (not lying down). The capsules should not be broken or burst, as this may have an effect on the release of the long-acting active ingredient.