Instruction for use: Alfinal

Active substance:

Finasteride

ATX code

G04CB01 Finasteride

Pharmacological group

5-alpha-reductase inhibitor [Androgens, antiandrogens]

5-alpha-reductase inhibitor [Medications that affect the metabolism of the prostate gland and correctors of urodynamics]

Nosological classification (ICD-10)

N40 Prostatic hyperplasia

Prostate adenoma, BPH, Hypertrophy of the prostate, Hypertrophy of the prostate, Dysuric disorders due to benign prostatic hyperplasia, Dysuria with prostatic adenoma, Benign prostatic hyperplasia, Benign prostatic hyperplasia of stage 1 and 2, Benign prostatic hyperplasia of the first degree, Benign prostatic hyperplasia of II degree, Benign prostatic hypertrophy, Disease of the prostate, Acute urinary retention associated with benign prostatic hyperplasia, Benign prostatic hyperplasia 1 and 2 stages in combination with prostatitis, The paradoxical ishuria

R33 Retention of urine

The paradoxical ishuria, Acute urinary retention associated with benign prostatic hyperplasia

R39.1 Other difficulties with micturition

Frequent urination, urinary retention, strangury, Obstructed flow of urine, Violation of urination, Violation of urination, Violation of bladder emptying, Violation of the outflow of urine, Frequent urination, Abnormalities of urination

Composition

Tablets, coated with a film membrane 1 tab.

active substance:

Finasteride 5 mg

Auxiliary substances: lactose monohydrate; MCC; Pregelatinized starch; Copovidone (Kollidone BA64); Croscarmellose sodium (admixture); Silicon dioxide colloid (aerosil); Magnesium stearate

Film sheath: Opadry II (series 85) (partially hydrolysed polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc)

Description of dosage form

Tablets: film-coated white, round, biconvex.

On the fracture: white or almost white.

pharmachologic effect

Pharmacological action - antitumor.

Pharmacodynamics

Antitumor hormone drug. It inhibits 5-alpha-reductase type II, which converts testosterone into a more active 5-alpha dihydrotestosterone, reduces its concentration in blood and prostate tissue within 24 hours after oral administration.

Oppressing the stimulating effect of testosterone on the development of the tumor. Suppression of the formation of dihydrotestosterone is accompanied by a decrease in the volume of the prostate gland, an increase in the maximum urinary flow rate and a decrease in symptoms of obstruction of the urinary tract. With constant admission, a statistically significant effect is recorded after 3 months (decrease in the volume of the gland), 4 months (increase in the maximum urinary flow rate) and 7 months (decrease in the general symptoms and symptoms of obstruction of the urinary tract).

Pharmacokinetics

Absorption in the gastrointestinal tract is completed 6-8 hours after ingestion. It is well absorbed and penetrates into the tissues and biofluids, is found in the ejaculate (at a concentration of 5 μg). Bioavailability - 80%, does not depend on food intake. Tmax in blood plasma - 2 h, Cmax in blood plasma - 8-10 ng / ml. Connection with plasma proteins - 93%. It penetrates through the BBB (after 7-10 days of treatment it is detected in cerebrospinal fluid in small amounts).

Systemic clearance - 165 ml / min, Vd - 76 liters. Slightly cumulates with prolonged admission.

T1 / 2 in men 18-60 years - 6 hours, in men over 70 years - 8 hours. It is excreted as metabolites by the kidneys (39%) and through the intestine (57%). In chronic renal failure, part of the metabolites (which is normally excreted in the urine) is excreted with feces.

Indications

Benign prostatic hyperplasia (decrease in the size of the prostate, an increase in the maximum rate of urine outflow, a decrease in the risk of developing an acute urinary retention).

Contraindications

Hypersensitivity;

Obstructive uropathy;

Rare hereditary diseases, such as lactose intolerance, lactase deficiency or glucose-galactose malabsorption (due to the presence of lactose in the composition);

Age to 18 years.

With caution: liver failure.

Side effects

Allergic reactions (rash, skin itching, urticaria, swelling of the lips and face), decreased potency and / or libido, ejaculation, decreased ejaculate volume, increased and soreness of the mammary glands, increased concentrations of LH and FSH in the blood, decreased concentrations of prostate-specific antigen (PSA ).

Interaction

There were no clinically significant interactions with other drugs.

Dosing and Administration

Inside, regardless of food intake, 1 table. (5 mg) once a day, both in monotherapy and in combination with doxazosin.

The minimum duration of therapy is 6 months.

Overdose

At present, no cases of drug overdose have been reported.

special instructions

In patients with a large volume of residual urine and / or a sharply reduced urine flow, careful monitoring of the possible development of obstructive uropathy is necessary.

Before the start of therapy, it is necessary to exclude diseases that stimulate benign prostatic hyperplasia, prostate cancer, urethral stricture, bladder hypotension, impairment of its innervation and infectious prostatitis.

Womn of childbearing age and pregnant women should avoid contact with the drug (especially touching crushed or lost integrity tablets) because The drug has teratogenic properties (the ability to suppress the conversion of testosterone to dihydrotestosterone can cause impaired development of the genital organs in the male fetus), penetrates into the seminal fluid.

It causes a decrease in PSA at 6 and 12 months of admission by 41 and 48%, respectively. To exclude the development of prostate cancer during therapy with the drug Alfinal®, it is necessary to conduct a patient examination.

In case of missing one dose of the drug, Alfinal® is recommended to continue treatment according to the usual scheme. Do not take an extra dose of the drug.

Form of issue

Tablets, film-coated, 5 mg. In the outline of the cell packaging of PVC film and aluminum foil printed lacquer for 10 pcs. 3 packs in a pack of cardboard.

Terms of leave from pharmacies

On prescription.

storage Conditions

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

Keep out of the reach of children.

Shelf life

2 years 6 months

Do not use after the expiry date printed on the package.