Proflosin, retard capsules 0.4mg, 100pcs

Composition

Active ingredients:

tamsulosin hydrochloride 400 mcg.

Auxiliary substances:

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.

Pellet shell composition:

copolymer of methacrylic acid and ethyl acrylate (1: 1) – 21.63 mg,

talc – 8.65 mg,

triethyl citrate – 2.16 mg.

Capsule body composition:

iron oxide red dye – 0.0239 mg,

titanium dioxide-0.53 mg,

iron oxide yellow dye-0.258 mg,

gelatin-38.938 mg.

Capsule cap composition:

indigo carmine – 0.00152 mg,

iron oxide black dye-0.0107 mg,

titanium dioxide-0.356 mg,

iron oxide yellow dye-0.114 mg,

gelatin-23.889 mg

Pharmacological action

Pharmacodynamics

Tamsulosin selectively and competitively blocks postsynaptic α1A-adrenergic receptors located in the smooth muscles of the prostate, bladder neck and prostatic part of the urethra. This leads to a decrease in the smooth muscle tone of the prostate, bladder neck, and prostatic part of the urethra, and an improvement in the outflow of urine.

Alpha-adrenergic blockers can reduce blood pressure (BP) by reducing peripheral vascular resistance. However, in clinical studies of tamsulosin, no clinically significant reduction in blood pressure was observed in patients with normal blood pressure levels.

Pharmacokinetics

Suction

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

Distribution

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

Metabolism

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

Deduction

Tamsulosin and its metabolites are mainly excreted 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 a meal), with regular intake -13 hours.

Indications

Benign prostatic hyperplasia (treatment of dysuric disorders).

Use during pregnancy and lactation

The drug is prescribed only for men.

Contraindications

• Hypersensitivity to tamsulosin or other components of the drug;
• orthostatic hypotension (including in the anamnesis);
• severe hepatic insufficiency.

With caution: chronic renal failure (creatinine clearance less than 10 ml / min); hypotension.

Side effects

Possible side effects when using the drug are listed below in descending frequency of occurrence:

• often ( < 1/10, > 1/100);< 1/10, >
• infrequently ( < 1/100, > 1/1000);< 1/100, >
• rarely ( < 1/1000, > 1/10000);< 1/1000, >
• very rare (

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

CCC violations:  infrequently-tachycardia, orthostatic hypotension.

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

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

Skin and subcutaneous tissue disorders:  infrequently-rash, pruritus, urticaria; rarely-angioedema.

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

Interaction

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

When used concomitantly with cimetidine, there was a slight increase in the concentration of tamsulosin in blood plasma; with furosemide, a decrease in the concentration, but this does not require dose adjustment of Proflosin®, since the concentration of the drug remains within the normal range.

Diclofenac and warfarin may increase the rate of tamsulosin elimination.

Concomitant use of tamsulosin with other a1-adrenergic blockers may lead to a decrease in blood pressure.

How to take, course of use and dosage

Inside,1 capsule 1 time a day after breakfast or the first meal.

The capsule should be swallowed whole, without chewing, with a sufficient amount of water. The capsule should not be divided into parts or broken, as this may affect the rate of release of the Active ingredient.

The duration of application is not limited.

Overdose

Cases of overdose while taking the drug have not been observed to date.

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 orthostatic hypotension) and heart rate to normal values, the patient must be laid down. Hemodialysis is impractical, since tamsulosin has a high affinity for 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).

Special instructions

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

Before starting therapy with Proflosin®, the patient should be excluded from the presence of diseases and conditions that may cause symptoms similar to those of benign prostatic hyperplasia.

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

If angioedema develops, treatment with Proflosin should be discontinued immediately. Repeated use of the drug is contraindicated. With surgical intervention for cataracts while taking the drug, atonic iris syndrome may develop, which should be taken into account by the surgeon for preoperative preparation of the patient and during the operation.

Influence on the ability to drive vehicles and other mechanisms that require increased concentration of attention

Caution should be exercised when driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions, due to the fact that dizziness may develop.

Form of production

Long-acting capsules

Storage conditions

Store at a temperature not exceeding 30°C. Keep out of the reach of children.

Shelf

life is 3 years.

Active ingredient

Tamsulosin

Conditions of release from pharmacies

By prescription

Dosage form

long-acting capsules

Description

For men, For adults as prescribed by a doctor

Indications

Prostatic Hyperplasia