Tanise -K - instructions for use, doses, side effects, contraindications

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Dosage form: & nbspsustained-release capsules

Composition:

1 capsule

THE NUCLEUS OF PELLETS

Active substance:

Tamsulosin hydrochloride 0.40 mg

Excipients:

Microcrystalline cellulose 276.90 mg

Methacrylic and ethacrylic acids copolymer (1:1) 16.50 mg

(Dispersion 30% with emulsifiers:

polysorbate 80 -

sodium lauryl sulfate)-

Triethyl citrate 1.65 mg

Talc 16.50 mg

Purified water 12.48 mg

PELLET SHELL

Methacrylic and ethacrylic acids copolymer (1: 1) 21.63 mg

(Dispersion 30% with emulsifiers:

polysorbate 80 -

sodium lauryl sulfate)-

Talc 8.65 mg

Triethyl citrate 2.16 mg

Capsule composition:

Capsule body composition:

Iron colorant red oxide (E172) 0.0239 mg

Titanium dioxide (E171) 0.5300 mg

Iron colorant oxide yellow (E172) 0.2580 mg

Gelatin 38.9380 mg

Composition of cap capsule:

Indigocarmine FD&C blue 2 (E132) 0.00152 mg

Iron coloring agent black oxide (E172) 0.0107 mg

Titanium dioxide (E171) 0.356 mg

Iron colorant oxide yellow (E172) 0.114 mg

Gelatin 23.268 mg

Composition of ink:

Shellac glaze - 59,420 % 45% (20% esterified in ethanol)

Iron coloring agent black oxide (E172) 24,650%

Butanol 9,750 %

Purified water 3,249 %

Propylene glycol 1,300%

Ethanol anhydrous 1,080%

Isopropyl alcohol 0,550 %

Ammonium hydroxide 28% 0,001 %

Description:

Pellets white or almost white in two-color hard gelatin capsules number 2. The body of the capsule is orange, the cap of the capsule is olive green.The cap and body of the capsule on the top are marked with a strip of black color. The cap is inscribed TSL0.4.

Pharmacotherapeutic group:alpha1 - adrenoblocker.

Pharmacodynamics:

Tamsulosin selectively and competitively blocks postsynaptic α1A- adrenoreceptors, located in the smooth muscles of the prostate gland, the neck of the bladder and the prostatic part of the urethra. This leads to a decrease in the tone of the smooth muscles of the prostate gland, the neck of the bladder and the prostatic part of the urethra and improve detrusor function. This reduces the symptoms of obstruction and irritation associated with benign prostatic hyperplasia (BPH). Typically, the therapeutic effect develops 2 weeks after the start of the drug, although in a number of patients, the decrease in the severity of symptoms is noted after the first dose. The ability of tamsulosin to affect α1 A-adrenoceptors is 20 times greater than its ability to interact with - adrenergic receptors, which are located in the smooth muscles of the vessels. Due to this high selectivity, the drug does not cause any clinically significant reduction in the systemicblood pressure (BP) both in patients with arterial hypertension, and in patients with normal initial BP.

Pharmacokinetics:

Suction

After oral administration tamsulosin quickly and almost completely absorbed from the gastrointestinal tract (GIT). This dosage form provides a sustained and slow release of tamsulosin. Bioavailability of the drug is about 100%.

Immediately after taking a niche, the absorption of tamsulosin decreases. Uniformity of absorption increases if the patient takes the drug every day after the same reception of pshci.

After a single dose of the drug inside - 0.4 mg (after a dense meal), the maximum concentration (C_max) of the active substance in the plasma is achieved after 6 hours. In the equilibrium state (after 5 days of the course intake), the values of C_max active substance in blood plasma is 60-70% higher than Stach after a single dose of the drug.

Distribution

Binding to plasma proteins - 90%. Tamsulosin has a small volume of distribution (approximately 0.2 l / kg).

Metabolism

Tamsulosin is practically not exposed to the effect of "first passage" and is slowly biotransformed in the liver with the formation of pharmacologically active metabolites that retain high selectivity to aiAadrenoreceptors.None of the metabolites is more active than the original substance - tamsulosin. Most of the active substance is present in the blood in unchanged form.

With hepatic failure, a dose change is not required.

Excretion

Tamsulosin and its metabolites are mainly excreted by the kidneys, with approximately 9% of the dose being excreted unchanged.

The half-life of Tamsulosin at a single dose is 10 hours (after eating), after repeated intake of -13 hours, the final elimination half-time is 22 hours.

Indications:

Benign prostatic hyperplasia (treatment of dysuric disorders).

Contraindications:

- The drug should not be administered to patients with increased sensitivity to tamsulosin or other components of the drug;

- Orthostatic arterial hypotension in history;

- Severe hepatic insufficiency.

Carefully:

severe renal failure (creatinine clearance (CC) below 10 ml / min) (safety not proven).

Pregnancy and lactation:Tamsulosin is for men only.

Dosing and Administration:

Inside, after the first meal, squeezed enough water in a sitting or standing position.By 0.4 mg (1 capsule) per day.

Capsule should not be broken and chewed.

Side effects:

From the central and peripheral nervous system: often - dizziness; infrequently - a headache; rarely - fainting, asthenia, sleep disturbance (drowsiness or insomnia).

From the genitourinary system: infrequently - retrograde ejaculation; very rarely - priapism, decreased libido.

From the side of the digestive system: infrequently - nausea, vomiting, constipation or diarrhea.

From the side of the cardiovascular system: infrequently - tachycardia, increased heart rate, orthostatic hypotension; very rarely - pain in the chest Allergic reactions: infrequently - skin rash, hives; very rarely - skin itching, angioedema.

Other: infrequently - rhinitis; rarely - backache.

Overdose:

Cases of acute overdose are not described.

Symptoms: A marked decrease in blood pressure (BP), sometimes accompanied by syncope, compensatory tachycardia.

Treatment: symptomatic, the patient must be immediately placed in a horizontal position. In the absence of effect, it is recommended to use medicines,it is necessary to introduce volume-substituting solutions or vasoconstrictors. It is necessary to monitor kidney function. Dialysis is ineffective (binding to proteins - 90%). To prevent further absorption of the drug, it is advisable to wash the stomach, taking activated charcoal and osmotic laxatives, (sodium sulfate).

Interaction:

There was no interaction with simultaneous application of tamsulosin with atenolol, enalapril, nifedipine or theophylline.

Simultaneous application cimetidine increases the level of tamsulosin in the blood plasma; furoSemid reduces its level in the plasma crOvi. However, in both cases, these levels remain within the therapeutically active levels and dosage should not be changed.

Diclofenac and indirect anticoagulants (warfarin) slightly increase the rate of excretion of tamsulosin.

In studies in vitro There was no interaction at the level of hepatic metabolism with amitriptyline, salbutamol, glibenclamide and finasteride. The simultaneous use of tamsulosin with other alphaiadrenoblokatorami and other drugs that reduce blood pressure, can lead to a marked increase in the hypotensive effect.

The concentration of tamsulosin in plasma did not change in the presence of diazepam, trichloromethiazide or simvastatin. Also tamsulosin did not change concentration diazepam, propranolol, trichloromethiazide and chloromadinone.

Special instructions:

Tamsulosin should be used with caution in patients with a predisposition to orthostatic hypotension, as in the case of taking other alpha-1 blockers, some patients may have decreased blood pressure during the course of treatment, which can sometimes lead to a fainting condition. When the first signs of orthostatic hypotension (dizziness or weakness) appear, the patient should be placed or transferred to the "lying" position until the symptoms disappear.

Before starting therapy with the drug, the patient should be examined to exclude the presence of other diseases that can cause the same symptoms as BPH .. Before starting treatment and regularly during therapy, a digital rectal examination and, if necessary, the determination of a specific antigen prostate (PSA).

In patients with severe renal failure (CC less than 10 ml / min), the drug should be used with caution (safety not proven).

Effect on the ability to drive transp. cf. and fur:During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Form release / dosage:

Long-acting capsules 0.4 mg. 10 capsules per blister. For 1,2, 3, 6, 9 and 20 blisters in a pack of cardboard along with instructions for use.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

2.5 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-007250/08

Date of registration:10.09.2008

The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Manufacturer: & nbsp

KRKA, d.d. Slovenia

Representation: & nbspKRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Information update date: & nbsp30.08.2015

Illustrated instructions

Instructions

Tanise®-K (Tanyz®-K)