Penester® (Finasteride) 5 mg, 30 coated tablets

Composition

One tablet contains the active substance – Finasteride 5 mg

Indications for use

Treatment and control of benign prostatic hyperplasia (BPH) (to reduce the size of the prostate; increase the maximum urine flow rate and reduce symptoms associated with hyperplasia; reduce the risk of acute urinary retention and the associated likelihood of surgery).

Penester should only be used in patients with prostatic hypertrophy.

Method of administration and dosage

Recommended dose: 5 mg Penester – 1 tablet per day (regardless of food intake).
Elderly people or with an unstable stage of renal failure (creatinine clearance up to 0.9 ml / sec), a dose change is not required.
The duration of therapy before evaluating its effectiveness should be from 6 to 12 months.

Side effects

Often

– decreased libido, impotence, ejaculation disorders (decrease in ejaculate volume), breast hypertrophy, decreased PSA levels

Rarely

– skin rashes, breast tenderness

Frequency unknown

– hypersensitivity reactions, including itching, hives, and swelling of the lips and face.
– pain in the testicles

Contraindications

– hypersensitivity to any of the components of this drug.
In accordance with the indications, the drug is intended for use exclusively in men.

Drug interactions

No clinically significant drug interactions have been established.

Special instructions

Patients with significant residual urine and / or significantly reduced urine flow should be closely monitored for the likelihood of obstructive uropathy.

Effect on PSA and Prostate Cancer Detection:

Until now, no clinical improvement has been recorded in patients with prostate cancer during treatment with Penester. Patients with BPH and elevated levels of prostate-specific antigen (PSA) were followed up in controlled clinical trials in which PSA levels were re-measured with a study of prostate biopsies.

To exclude prostate cancer, doctors recommend conducting a per rectum examination before starting Penester therapy and then periodically along with other studies.

Serum PSA is also used to detect prostate cancer. In general, PSA concentration> 10 ng / ml (Hybritech) requires additional examination and biopsy decision; in the case of PSA concentrations of 4 – 10 ng / ml, additional examination is recommended. In men, regardless of the presence or absence of prostate cancer, there can be significant variations in PSA concentration. In this regard, prostate cancer cannot be ruled out in men with BPH who have normal PSA concentrations regardless of Penester treatment. A PSA concentration <4 ng / ml does not exclude the presence of prostate cancer.

Penester leads to a decrease in plasma PSA concentrations by about 50% in patients with BPH, even in the presence of prostate cancer. Such a decrease in serum PSA concentrations in patients with BPH during treatment with Penester should be taken into account when evaluating PSA data; it does not exclude concomitant prostate cancer. This decrease can be expected over the entire range of PSA concentrations, although they may differ among patients. Analysis of PSA concentrations was determined during the 4-year study of Penester in more than 3000 patients, which confirmed that a doubling of PSA concentrations in typical patients who received Penester for more than 6 months compared to normal concentrations in untreated men is necessary. This selection preserves the sensitivity and specificity of PSA determination, as well as its ability to detect prostate cancer.

Any persistent increase in PSA concentration in patients treated with Penester should be carefully investigated to determine whether Penester is not appropriate.

Penester does not significantly reduce the concentration of free PSA (the ratio of free PSA to total). The ratio of free PSA to total PSA remains constant under the action of Penester. If the free PSA value is used as a target in the detection of prostate cancer, its value should in any case be corrected.

The drug contains lactose. Patients with rare hereditary problems such as galactose intolerance, congenital lactase deficiency or glucose-galactose malabsorption should not use this drug.

Features of the effect of the drug on the ability to drive a car and control mechanisms

Not observed.

Overdose

In case of overdose, specific therapy is not recommended.

Storage conditions

Store at a temperature not exceeding +25 0С.
Keep out of the reach of children!

Shelf life – 3 years