Prostamol Uno

Leaflet attached to the packaging: patient information

Prostamol uno

320 mg, soft capsules
Sabalis serrulatae fructus extractum

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• -If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Prostamol uno and what is it used for
• 2. Important information before using Prostamol uno
• 3. How to use Prostamol uno
• 4. Possible side effects
• 5. How to store Prostamol uno
• 6. Contents of the packaging and other information

1. What is Prostamol uno and what is it used for

Prostamol uno contains an extract of sabal palm fruit ( Sabalis serrulatae fructus extractum),it is a herbal medicine that alleviates the symptoms associated with prostate enlargement that occur when urinating, such as: weak urine stream, urgency to urinate, frequent urination, and frequent nighttime urination.
Most of these symptoms are caused by an enlarged prostate gland, which presses on the urethra (the passage through which urine flows from the bladder).
A doctor should be consulted if there is no improvement or the patient feels worse.

2. Important information before using Prostamol uno

When not to use Prostamol uno:

If the patient is allergic to the extract of sabal palm fruit or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions:

Before starting to use Prostamol uno, the patient should discuss it with their doctor or pharmacist.
Prostamol uno alleviates the symptoms associated with prostate enlargement without reducing its size. Therefore, patients should regularly consult their doctor.
A doctor should be consulted, especially if:

• the patient has a fever, cramps, or blood is found in the urine
• the patient experiences pain while urinating
• the patient experiences continuous leakage of urine due to an overfilled bladder (urinary incontinence with constant leakage from an overfilled bladder)
• the patient experiences painful urination with sudden inability to urinate (acute urinary retention).

Children and adolescents

The use of Prostamol uno is not recommended in children and adolescents under 18 years of age.

Prostamol uno and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
A few cases of suspected interaction with warfarin (anticoagulants) have been reported. Increased INR values have been described.
No interactions with other medicines have been found so far.

Pregnancy, breastfeeding, and fertility

Prostamol uno is not intended for use in women, so its use during pregnancy and breastfeeding is not recommended. There is no available data on the effect on fertility.

Driving and using machines

No studies have been conducted on the effect on the ability to drive and use machines.

3. How to use Prostamol uno

This medicine should always be used exactly as described in the leaflet or as directed by a doctor or pharmacist. If there are any doubts, a doctor or pharmacist should be consulted.

Dosage

The recommended dose is one soft capsule of Prostamol uno once a day, at the same time. The soft capsule should be swallowed whole after a meal, with a sufficient amount of liquid.

Use in children and adolescents

The use of Prostamol uno is not recommended in children and adolescents under 18 years of age.

Duration of treatment

The duration of treatment depends on the type, severity, and course of the disease and is not limited in time. A doctor should be consulted.
Treatment with Prostamol uno is long-term and regular. Regular intake of Prostamol uno is particularly important for the effectiveness of the treatment. After about 6 weeks, an improvement in the patient's condition can be expected.

Using more than the recommended dose of Prostamol uno

No cases of overdose have been reported so far.

Missing a dose of Prostamol uno

A double dose should not be taken to make up for a missed capsule.

Stopping the use of Prostamol uno

If the use of Prostamol uno is stopped, the symptoms of the disease may recur.
In case of any further doubts about the use of the medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Prostamol uno can cause side effects, although not everybody gets them.

Uncommon (may affect up to 1 in 100 people):

• nausea, vomiting, diarrhea, abdominal pain (especially if the medicine is taken on an empty stomach).

Frequency not known (cannot be estimated from the available data):

• allergy or hypersensitivity reactions may occur
• headache may occur

Reporting side effects
If any side effects occur, including any possible side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Prostamol uno

Do not store above 30°C..
The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging after the term EXP. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Prostamol uno contains

Active substance:
The active substance of the medicine is an extract of sabal palm fruit ( Sabalis serrulatae fructus extractum).
One soft capsule contains 320 mg of sabal palm fruit extract (Serenoa repens (W.Bartram) Small (Sabal serrulata (Michaux) Nichols), fructus)(9-11:1).
Extraction solvent: ethanol 96% (V/V).
The other ingredients are:
Succinylated gelatin, glycerol, purified water, titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), carmine (E 120), medium-chain triglycerides.

What Prostamol uno looks like and contents of the packaging

Oval, soft gelatin capsules with an opaque, two-color red-black coating, filled with a brown to yellowish- or greenish-brown (oily) liquid.
Soft capsules.
The capsules are packaged in a PVC/PVDC-AL blister pack.
Prostamol uno is available in packs containing 30, 60, and 90 capsules.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany
For more detailed information, please contact the representative of the marketing authorization holder:
Berlin-Chemie / Menarini Polska Sp. z o.o.
Phone: (22) 566 21 00
Fax: (22) 566 21 01

Date of last revision of the leaflet: