Instructions Prostamol Uno soft capsules 320 mg blister No. 90
Composition
active ingredient: 1 soft capsule contains 320 mg of thick alcoholic extract from the fruits of the saw palmetto (Serenoa repens) (9–11:1);
soft capsule shell: succinylated gelatin, glycerol, titanium dioxide (E 171), yellow iron oxide (E 172), black iron oxide (E 172), carmine lake (E 120).
Dosage form
Soft capsules.
Main physicochemical properties: oval, soft gelatin capsules with an opaque, two-tone red-black shell, containing an oily liquid from brown to yellowish or greenish-brown in color.
Pharmacotherapeutic group
Means for use in urology. Preparations for the treatment of benign prostatic hypertrophy. ATC code G04C X02.
Pharmacological properties
Pharmacodynamics
In the etiology of benign prostatic hyperplasia, an increased production of the androgen dihydrotestosterone (DHT) plays a significant role, which causes the growth of prostate tissue by binding to cytoplasmic androgen receptors. The androgen dihydrotestosterone is converted from testosterone by activating the enzyme 5-a-reductase. The action of the extract from the fruits of the saw palmetto (Serenoa repens) is associated with its antiandrogenic effect, namely, blocking the binding of DHT to the receptor that inhibits the activity of 5-a-reductase. Other factors that can also inhibit the growth of prostate tissue: inhibition of prolactin receptor binding and disruption of signal transduction processes, anti-inflammatory effect due to inhibition of the action of 5-lipoxygenase, inhibition of proliferation of the prostate epithelium, anti-edematous effect.
Prostamol Uno does not affect sexual function.
Benign prostatic hyperplasia may have the following symptoms:
- the need to urinate more frequently, especially at night;
̶ weak or intermittent urination;
- feeling of incompletely emptied bladder;
- pain during urination;
- sexual dysfunction.
Most of the symptoms listed are caused by an enlarged prostate gland, which compresses the urethra (the tube through which urine exits the bladder).
Prostamol Uno prevents further enlargement of prostate tissue.
Pharmacokinetics
After oral administration, the extract is rapidly absorbed, and the maximum concentration in blood plasma is reached after 1.5 hours.
Indication
Prostamol® Uno is used to treat adult men with difficulty urinating due to benign prostatic hyperplasia stage I and II according to the Alken classification.
Classification of benign prostatic hyperplasia by stages (Alken *):
| Stage | Name | Violation |
| I | Irritation stage | Pollakiuria (day and night), nocturia, urinary retention, weak urine stream, bladder emptying - complete |
| II | Residual urine stage | Beginning of decompensation, incomplete bladder emptying, residual urine |
| III | Decompensation stage | Urinary incontinence due to bladder overflow, acute urinary retention, congestive kidney, hydronephrosis, renal failure |
* Alken CE. Leitfaden der Urologie. Stuttgart: Thieme, 1973 180-2
Contraindication
Hypersensitivity to the active substance or to other excipients.
Interaction with other medicinal products and other types of interactions
In isolated cases, an interaction with warfarin has been reported. An increase in the international normalized ratio (INR) has been described.
Application features
Prostamol® Uno only relieves the symptoms of prostate enlargement, but does not eliminate the enlargement itself. Therefore, the patient should visit a doctor regularly. Especially in the case of fever, cramps or blood in the urine, painful urination, urinary incontinence due to bladder overfilling or in the case of acute urinary retention, you should consult a doctor.
Prostamol Uno should not be used in benign prostatic hyperplasia in the decompensation phase.
Use during pregnancy or breastfeeding
The medicine is intended for use in adult men.
There are no data on fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
No studies have been conducted on the effect on reaction speed when driving vehicles or other mechanisms.
Method of administration and doses
Dosage.
Prostamol® Uno is taken 1 soft capsule once a day at the same time.
For oral use. The soft capsule should be swallowed whole after a meal and washed down with sufficient liquid.
The duration of treatment depends on the type, severity and course of the disease and is not limited in time. Regular daily consumption is particularly important for the success of the treatment. A reduction in the symptoms of the disease can be expected only after 6 weeks. Full effectiveness can be achieved no earlier than after 3 months. If the symptoms of the disease do not decrease or, on the contrary, increase, you should consult a doctor.
Children.
The medicine is intended for use in adult men.
Overdose
No cases of overdose with Prostamol® Uno have been reported.
Adverse reactions
The frequency of adverse reactions is defined as follows: very common: ≥ 1/10; common: ≥ 1/100 to 1/10; uncommon: ≥ 1/1000 to 1/100; rare: ≥ 1/10000 to 1/1000; very rare: < 1/10000; frequency unknown: cannot be estimated from the available data.
Immune system disorders: allergic or hypersensitivity reactions. Frequency unknown.
Nervous system disorders: headache. Frequency unknown.
On the part of the digestive tract: infrequently - nausea, vomiting, diarrhea, abdominal pain (especially when taking the drug on an empty stomach).
If you experience any other side effects not mentioned above, you should consult a doctor or pharmacist.
Reporting of suspected adverse reactions.
Reporting suspected adverse reactions after a medicine has been authorised plays an important role. This allows for continued monitoring of the benefit-risk balance of the medicine. Healthcare professionals should report any suspected adverse reactions.
Expiration date
3 years.
Do not use the medicine after the expiry date stated on the packaging.
Storage conditions
No special storage conditions are required. Keep out of the reach of children.
Packaging
15 soft capsules in a blister; 2 or 4 blisters in a cardboard box.
Vacation category
Without a prescription.
Producer
Berlin-Chemie AG
Location of the manufacturer and address of its place of business
Glienicker Weg 125, 12489 Berlin, Germany.
