Proflosin capsules with modified release 0,4 mg, No. 100

• benign prostatic hyperplasia (treatment of dysuric disorders).

Inside, 1 capsule 1 time per day after breakfast or the first meal. The capsule should be swallowed whole without chewing, drinking plenty of water. The capsule must not be divided into parts or broken, as this may affect the rate of release of the active substance. The duration of use is not limited.

Active ingredient: tamsulosin hydrochloride - 400 mcg

Excipients : microcrystalline cellulose - 276.9 mg, copolymer of methacrylic acid and ethyl acrylate (1: 1) - 16.5 mg, triethyl citrate - 1.65 mg, talc - 16.5 mg.

The composition of the pellet shell : copolymer of methacrylic acid and ethyl acrylate (1: 1) - 21.63 mg, talc - 8.65 mg, triethyl citrate - 2.16 mg.
The composition of the capsule body: dye iron oxide red - 0.0239 mg, titanium dioxide - 0.53 mg, dye iron oxide yellow - 0.258 mg, gelatin - 38.938 mg.
The composition of the capsule cap: indigo carmine - 0.00152 mg, iron dye black oxide - 0.0107 mg, titanium dioxide - 0.356 mg, iron dye yellow oxide - 0.114 mg, gelatin - 23.889 mg.

• hypersensitivity to tamsulosin or other components of the drug;

• orthostatic hypotension (including history);

• severe liver failure.

With care: chronic renal failure (CC less than 10 ml / min); arterial hypotension.

Description:

Enteric capsules of prolonged action gelatinous; size # 2; opaque, with a light orange body and a gray-green lid; the body and the lid are marked with one black line, the lid is marked with 'TSLO.4'; the contents of the capsules are white to almost white pellets.

Composition:

Active ingredient: tamsulosin hydrochloride - 400 mcg

Excipients : microcrystalline cellulose - 276.9 mg, copolymer of methacrylic acid and ethyl acrylate (1: 1) - 16.5 mg, triethyl citrate - 1.65 mg, talc - 16.5 mg.

The composition of the pellet shell : copolymer of methacrylic acid and ethyl acrylate (1: 1) - 21.63 mg, talc - 8.65 mg, triethyl citrate - 2.16 mg.
The composition of the capsule body: dye iron oxide red - 0.0239 mg, titanium dioxide - 0.53 mg, dye iron oxide yellow - 0.258 mg, gelatin - 38.938 mg.
The composition of the capsule cap: indigo carmine - 0.00152 mg, iron dye black oxide - 0.0107 mg, titanium dioxide - 0.356 mg, iron dye yellow oxide - 0.114 mg, gelatin - 23.889 mg.

Clinical and pharmacological group: A drug used for urination disorders associated with benign prostatic hyperplasia. Alpha1-blocker

Pharmaco-therapeutic group: Alpha1-blocker

pharmachologic effect

Tamsulosin selectively and competitively blocks postsynaptic ? 1A-adrenergic receptors located in the smooth muscles of the prostate gland, bladder neck and prostatic urethra. This leads to a decrease in the tone of the smooth muscles of the prostate gland, bladder neck, prostatic urethra and an improvement in urine flow.

?-adrenergic receptor blockers can lower blood pressure (BP) by reducing peripheral vascular resistance. However, in the course of clinical trials of tamsulosin, in patients with normal blood pressure, there was no clinically significant decrease in blood pressure.

Pharmacokinetics

Suction

After oral administration, tamsulosin is rapidly and almost completely absorbed from the gastrointestinal tract. The absorption of tamsulosin slows down somewhat after a meal. After a single oral administration of the drug at a dose of 0.4 mg, the maximum concentration (Cmax) of tamsulosin in the blood plasma is reached after approximately 6 hours.

Distribution

The connection with blood plasma proteins is about 99%, the volume of distribution is small - 0.2 l / kg.

Metabolism

Tamsulosin does not undergo a 'first pass' effect and is slowly metabolized in the liver to form less active metabolites. Most of tamsulosin is present in the blood unchanged. The experiment revealed the ability of tamsulosin to slightly induce the activity of liver microsomal enzymes.

Withdrawal

Tamsulosin and its metabolites are excreted mainly in the urine, 9% of the drug is excreted unchanged. The half-life (T1 / 2) of tamsulosin is approximately 10 hours (with a single dose after meals), with a regular intake of 13 hours.

Indications

• benign prostatic hyperplasia (treatment of dysuric disorders).

Dosage regimen

Inside, 1 capsule 1 time per day after breakfast or the first meal. The capsule should be swallowed whole without chewing, drinking plenty of water. The capsule must not be divided into parts or broken, as this may affect the rate of release of the active substance. The duration of use is not limited.

Side effect

Possible side effects when using the drug are listed below in descending frequency of occurrence: often (<1/10,> 1/100), infrequently (<1/100,> 1/1000), rarely (<1/1000,> 1/10000 ), very rarely (<1/10000), including individual messages.

Nervous system disorders: often - dizziness; infrequently - headache; rarely - fainting.

Violations from the CVS: infrequently - tachycardia, orthostatic hypotension.

Gastrointestinal disorders: infrequently - constipation, diarrhea, nausea, vomiting.

Reproductive system disorders: infrequently - violation of ejaculation; very rarely - priapism.

Violations of the skin and subcutaneous tissues: infrequently - rash, pruritus, urticaria; rarely - angioedema.

Others: in some cases - the development of atonic iris syndrome (narrow pupil syndrome) during cataract surgery, asthenia, rhinitis.

Contraindications for use

• hypersensitivity to tamsulosin or other components of the drug;

• orthostatic hypotension (including history);

• severe liver failure.

With care: chronic renal failure (CC less than 10 ml / min); arterial hypotension.

Application during pregnancy and lactation

The drug is prescribed only for men.

Application for violations of liver function

Contraindicated in severe hepatic impairment.

Application for impaired renal function

Use of the drug with caution in chronic kidney disease (CC less than 10 ml / min).

special instructions

At the first signs of orthostatic hypotension (dizziness, weakness), the patient should be seated or laid down.

Before starting therapy with ProflosinЃ, it is necessary to exclude the presence of diseases and conditions in the patient that can cause symptoms similar to those in benign prostatic hyperplasia.

Before starting treatment and regularly during therapy, a digital rectal examination and, if necessary, determination of the concentration of specific prostatic antigen (PSA) should be performed.

In the case of the development of angioedema, therapy with Proflosin should be discontinued immediately. Reappointment of the drug is contraindicated. During surgery for cataracts while taking the drug, the development of atonic iris syndrome is possible, which must be taken into account by the surgeon for the preoperative preparation of the patient and during the operation.

Influence on the ability to drive a vehicle and other complex mechanisms

Care must be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions, due to the fact that dizziness may develop.

Overdose

Cases of overdose while taking the drug have not been observed so far. However, theoretically, there is a possibility of a sharp decrease in blood pressure and tachycardia, which may require appropriate measures. To restore blood pressure (including with orthostatic hypotension) and heart rate to normal values, the patient must be laid down. Hemodialysis is impractical because tamsulosin has a high affinity for blood plasma proteins.

To prevent further absorption of tamsulosin, it is advisable to wash the stomach, take activated charcoal or an osmotic laxative (for example, sodium sulfate).

Drug interactions

Tamsulosin does not interact with atenolol, enalapril, nifedipine and theophylline.

With simultaneous use with cimetidine, there was a slight increase in the concentration of tamsulosin in the blood plasma; with furosemide - a decrease in concentration, however, this does not require an adjustment of the dose of ProflosinЃ, since the concentration of the drug remains within the normal range.

Diclofenac and warfarin can increase the rate of elimination of tamsulosin.

The simultaneous appointment of tamsulosin with other ai-adrenergic receptor blockers can lead to a decrease in blood pressure.

Storage conditions

At a temperature not higher than 30 ? C. Keep out of the reach of children!

Shelf life

Shelf life is 3 years.

Terms of sale

On prescription.