Instruction for use: Tamsulon-FS

Trade name of the drug – Tamsulon-FS

Active substance: Tamsulosinum

Dosage Form: Modified release capsule

Composition (per tablet): Tamsulosin hydrochloride 0.4 mg

Other ingredients: MCC; methacrylic acid copolymer (type C); polysorbate 80; sodium lauryl sulfate; glycerol; talc; magnesium stearate

Capsule composition: titanium dioxide, iron oxide yellow, gelatin

in strip cellular or bezgyachakova packing 10 pcs .; in Patsch. cardboard. 1 or 3 or the packaging in polyethylene bottles of 10 or 30 pcs .; in Patsch. cardboard. 1 bottle.

Description of Tamsulon – Fs: Hard gelatin capsules or ¹1 ¹2 yellow. The contents of capsules: microgranules spherical shape, white or white with a light yellow tint.

Pharmacotherapeuticgroup:

Alpha-blocker

ATX C04AE02 Nicergoline

The nosological classification (ICD-10)

N40 Hyperplasia of prostate gland: Prostate adenoma; BPH; Prostatauxe; prostate Hypertrophy; Dysuric disorders caused by benign prostatic hyperplasia; Dizuricheskie disorder with benign prostatic hyperplasia; Dysuria with prostate cancer; Benign prostatic giperpalaziya; Benign prostatic hyperplasia; Benign prostatic hyperplasia stages 1 and 2; Benign prostatic hyperplasia I degree; Benign prostatic hyperplasia II degree; Benign prostatic hypertrophy; The disease of the prostate gland; Acute urinary retention related to benign prostatic hyperplasia; Benign prostatic hyperplasia stages 1 and 2 in combination with prostatitis; paradoxical ischuria

Pharmacological Properties of Tamsulon-FS

Pharmachologic effect - Mode of action - alpha adrenoliticheskoe, antidizuricescoe.

Pharmacodynamics

Selectively and competitively blocks postsynaptic α1A-adrenergic receptors located in the smooth muscle of the prostate, bladder neck and prostatic urethra and α1D-adrenergic receptors located predominantly in the body of the bladder. This leads to a reduction in smooth muscle tone of the prostate, bladder neck and prostatic urethra improve detrusor function, resulting symptoms are reduced irritation and obstruction associated with BPH. The therapeutic effect usually develops within 2 weeks after starting the drug, although in some patients the decrease of symptoms observed after the first dose. Due to the high selectivity of action against α1A-adrenoceptor (20 times higher than activity against α1B-adrenergic receptor) tamsulosin does not cause a clinically significant decrease in systemic blood pressure in patients with normal blood pressure source and in hypertensive patients.

Pharmacokinetics

The bioavailability of the drug - about 100%. After ingestion tamsulosin rapidly and almost completely absorbed from the gastrointestinal tract, with single dose of 0.4 mg Cmax is achieved within 6 hours in the blood plasma. In a state of equilibrium concentration (after 5 days of course taking) the maximum level of tamsulosin in plasma at 60-70 % higher than after a single dose. Binding to plasma proteins - 99%. The volume of distribution - 0.2 l / kg. The product is not subject to first-pass effect and is slowly metabolised in the liver with the formation of pharmacologically active metabolites, which also have a high selectivity to α1A-adrenoceptor. Most tamsulosin is present in the blood in an unmodified form. The drug and its metabolites are excreted by the kidneys, with about 9% of the drug is excreted unchanged form. T1 / 2 with single dose is 10-12 hours.

Indications for Tamsulon-FS

Treatment of the functional symptoms of benign prostatic hyperplasia.

Contraindications for Tamsulon-FS

Hypersensitivity.

Carefully:

chronic renal failure (Cl creatinine below 10 ml / min);

hypotension (including orthostatic);

severe hepatic impairment.

Tamsulon-FS Dosage and Administration

The inside is not liquid, after the first meal, drinking plenty of water - 0.4 mg (1 capsule.) Per day.

Side effect of Tamsulon-FS

Rarely - headache, dizziness, fatigue, sleep disturbance (insomnia or drowsiness), retrograde ejaculation, decreased libido, pain, back pain, rhinitis, nausea, vomiting, constipation or diarrhea. In extremely rare cases - hypersensitivity reactions (rash, pruritus, angioedema). In rare cases - orthostatic hypotension, tachycardia, palpitations, chest pain.

Overdose of Tamsulon-FS

No cases of acute overdose have been reported.

Symptoms: theoretically may cause acute hypotension.

Treatment: kardiotropnyh therapy. If the symptoms do not disappear, enter obemozameschayuschie solutions or vasoconstrictor drugs. To prevent further absorption of tamsulosin may gastric lavage, activated charcoal or osmotic laxative.

Interaction

When applied simultaneously observed: cimetidine - some increase in the concentration of tamsulosin in blood plasma and furosemide - decrease, but it does not require changing the dose of tamsulosin; diclofenac and warfarin - a slight increase in the elimination rate of tamsulosin.

The simultaneous use of tamsulosin with other α1-blockers can lead to a marked increased hypotensive effect.

SPECIAL INSTRUCTIONS for Tamsulon-FS

Caution should be used in patients with a predisposition to orthostatic hypotension. At the first signs of orthostatic hypotension (dizziness, weakness), the patient should sit or lay. In patients with impaired renal function dose reduction is required. Before the start of the drug should verify the diagnosis.

During the period of treatment must be careful when driving and occupation of other potentially hazardous activities that require high concentration and speed of psychomotor reactions.

Storage conditions of Tamsulon-FS

In a dry, dark place at a temperature no higher than 25 ° C.

Keep out of the reach of children.

Shelf life

2 years.

Do not use beyond the expiration date printed on the package.