Prostamol uno

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PROSTAMOL® UNO (PROSTAMOL® UNO)

Composition:

Active substance: 1 soft capsule contains 320 mg of a concentrated ethanolic extract of saw palmetto fruit (Serenoa repens) (9–11:1);

Capsule shell, soft: succinylated gelatin, glycerol, titanium dioxide (E 171), yellow iron oxide (E 172), black iron oxide (E 172), carmine lake (E 120).

Pharmaceutical form. Soft capsules.

Main physicochemical characteristics: oval, soft gelatin capsules with an opaque, two-colored red-black shell, containing an oily liquid ranging in color from brown to yellowish-brown or greenish-brown.

Pharmacotherapeutic group.

Agents used in urology. Preparations for the treatment of benign prostatic hyperplasia. ATC code G04C X02.

Pharmacological properties.

Pharmacodynamics.

In the etiology of benign prostatic hyperplasia, a significant role is played by increased formation of the androgen dihydrotestosterone (DHT), which causes prostate tissue growth by binding to cytoplasmic androgen receptors. The androgen dihydrotestosterone 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 by blocking DHT binding to the receptor, thereby inhibiting 5-α-reductase activity. Other factors that may also inhibit prostate tissue growth include inhibition of prolactin receptor binding and disruption of signal transduction processes, anti-inflammatory effects due to inhibition of 5-lipoxygenase, inhibition of prostate epithelial cell proliferation, and anti-edematous effects.

Prostamol Uno does not affect sexual function.

Benign prostatic hyperplasia may present with the following symptoms:

• need for more frequent urination, especially at night;
• weak or interrupted urine stream;
• sensation of incomplete bladder emptying;
• pain during urination;
• sexual dysfunction.

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

Prostamol Uno prevents further growth of prostate tissue.

Pharmacokinetics.

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

Clinical characteristics.

Indications.

Prostamol® Uno is used for the treatment of adult men with impaired urination due to benign prostatic hyperplasia (BPH) stage I and II according to Alken classification.

Classification of benign prostatic hyperplasia by stages (Alken *):

* Alken CE. Leitfaden der Urologie. Stuttgart: Thieme, 1973 180-2

Contraindications.

Hypersensitivity to the active substance or to other excipients.

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

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

Prostamol Uno should not be used in benign prostatic hyperplasia in 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.

Effect on the ability to drive vehicles or operate machinery

No studies on the effect on the ability to drive vehicles or operate machinery have been conducted.

Method of administration and dosage.

Dosing.

Prostamol® Uno is taken as 1 soft capsule once daily at the same time each day.

Method of administration.

For oral use. The soft capsule should be swallowed whole after a meal with sufficient 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 until at least 3 months. If symptoms do not improve or, conversely, worsen, consult a physician.

Children.

The medicinal product is intended for use in adult men.

Overdose.

There have been no reports of overdose with Prostamol® Uno.

Side effects

The frequency of side effects 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; frequency not known: cannot be estimated based on available data.

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

Nervous system disorders: headache. Frequency not known.

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

If any other adverse reactions occur that are not listed above, a physician or pharmacist should be consulted.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after medicine authorization is important. It allows continued monitoring of the benefit-risk balance of the medicine. Healthcare professionals should report any suspected adverse reactions.

Shelf life: 3 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions

No special storage conditions required. Keep out of the reach of children.

Packaging

15 soft capsules in a blister; 2, 4, or 6 blisters per cardboard box.

Classification of distribution

Over-the-counter (without prescription).

Manufacturer

Berlin-Chemie AG

Manufacturer's address and place of business

Glinker Weg 125, 12489 Berlin, Germany.