PROSTAKER

Instructions for Medical Use of the Medicinal Product PROSTACARE

Composition:

Active ingredient: lipophilic extract from saw palmetto fruit (Extr. Serenoa repens) — 320 mg (85–95% fatty acids);

Capsule shell: gelatin, glycerin, titanium dioxide (E 171), black iron oxide (E 172), red iron oxide (E 172).

Pharmaceutical form. Capsules.

Main physicochemical characteristics: oval, brown, opaque soft gelatin capsules; the capsules contain a yellowish-brown oily emulsion.

Pharmacotherapeutic group. Agents for treatment of benign prostatic hyperplasia. ATC code G04CX02.

Pharmacological properties.

Pharmacodynamics.

In the etiology of benign prostatic hyperplasia, the increased formation of the androgen dihydrotestosterone (DHT) plays a significant role, promoting prostate tissue growth through binding to cytoplasmic androgen receptors. DHT is formed from testosterone via activation of the enzyme 5-α-reductase. The action of the extract from the fruits of saw palmetto (Serenoa repens) is associated with its antiandrogenic effect, specifically with inhibition of DHT binding to the receptor, resulting in suppression of 5-α-reductase activity. Other factors that may also inhibit prostate tissue growth include inhibition of prolactin receptor binding, disruption of signal transduction processes, anti-inflammatory effects due to inhibition of 5-lipoxygenase activity, inhibition of prostate epithelial cell proliferation, and anti-edematous effects.

Prostaker does not affect sexual function.

Benign prostatic hyperplasia may present with the following symptoms:

• increased frequency of urination, especially at night;
• weak or interrupted urinary stream;
• sensation of incomplete bladder emptying;
• painful urination;
• sexual dysfunction.

Most of these symptoms are caused by enlargement of the prostate gland, resulting in compression of the urethra (the tube through which urine exits the bladder).

Prostaker prevents further prostate tissue growth.

Pharmacokinetics.

After oral administration, the extract is rapidly absorbed, and maximum plasma concentration is reached within 1.5 hours.

Clinical characteristics.

Indications. Urinary disorders in benign prostatic hyperplasia (adenoma) stages I and II, as well as in chronic prostatitis.

Contraindications. Hypersensitivity to the components of the medicinal product.

Special precautions. In case of blood in urine, constant urine leakage due to bladder overdistension, or painful urges to urinate combined with sudden inability to urinate (acute urinary retention), immediate medical attention is required.

Interaction with other medicinal products and other forms of interaction. In isolated cases, interaction with warfarin has been reported. An increase in the international normalized ratio (INR) has been described.

Special precautions for use

Prostacer only relieves symptoms associated with an enlarged prostate gland, but does not eliminate the enlargement itself. Therefore, the patient should regularly visit a physician. Medical advice must be sought especially in case of fever, spasms or blood in the urine, painful urination, urinary incontinence due to bladder overfilling, or in the event of acute urinary retention.

Prostacer should not be used in benign prostatic hyperplasia during the decompensation phase.

Use during pregnancy or breastfeeding
This medicinal product is intended for use in adult men. There is no data available regarding fertility.

Ability to influence reaction speed when driving or operating machinery
No studies on the effect on the ability to drive or operate machinery have been conducted.

Dosage and Administration.

Take 1 capsule of Prostaker daily at the same time each day. Swallow the capsule whole after meals with an adequate amount of liquid.

Treatment Duration.

The duration of treatment depends on the type, severity, and course of the disease and is not time-limited. Regular daily intake is particularly important for successful treatment. A reduction in disease symptoms may be expected only after 6 weeks. Full efficacy may not be achieved earlier than after 3 months. If symptoms do not improve or, conversely, worsen, consult a physician.

Children. This medicinal product is intended for use in adult males.

Overdose. No cases of overdose with the medicinal product Prostaker have been reported to date.

Adverse Reactions

If any unusual reactions occur, it is essential to consult a physician regarding further use of the medicinal product.

The frequency of adverse reactions is defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (available data do not allow assessment of the frequency).

Gastrointestinal disorders: uncommon – nausea, vomiting, diarrhea, abdominal pain (especially when taking the drug on an empty stomach).

Immune system disorders: not known – allergic reactions or hypersensitivity reactions.

Reproductive system disorders: not known – reversible gynecomastia.

Nervous system disorders: not known – headache.

Reporting of suspected adverse reactions. Reporting of suspected adverse reactions after medicinal product registration is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions through the national reporting system (Automated Pharmacovigilance Information System).

Shelf life. 3 years.

Storage conditions. Store in a dry, light-protected place, out of reach of children, at a temperature not exceeding 25 °C.

Packaging. 10 capsules in a blister. 1, 3 or 6 blisters per cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer.

Mega Lifesciences Public Company Limited.

Manufacturer's address and place of business.

Factory 1, 384, Moo 4, Soi 6, Bangpoo Industrial Estate, Pattana 3 Road, Klongluang, Muang 10280 Samutprakarn, Thailand