Patient Information Leaflet

Prostamol Uno
320 mg, soft capsules
Sabalis serrulatae fructus extractum
Please read carefully the entire leaflet before taking the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist.
If symptoms do not improve or worsen, contact your doctor.

Table of contents:

What Prostamol Uno is and what it is used for
Important information before taking Prostamol Uno
How to take Prostamol Uno
Possible side effects
How to store Prostamol Uno
Contents of the pack and other information

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

Prostamol Uno contains an extract of saw palmetto fruit (Sabalis serrulatae fructus extractum),
a herbal medicine used to relieve urinary symptoms associated with benign prostatic hyperplasia,
such as weak urine stream, urgency to urinate, frequent urination, and nocturia (frequent urination at night).
Most of these symptoms are caused by an enlarged prostate gland pressing on the urethra (the passage through which urine flows from the bladder).
You should contact your doctor if there is no improvement or if you feel worse.

2. Important information before using Prostamol Uno

When not to use Prostamol Uno:
If the patient is allergic to the extract from the fruit of saw palmetto (Serenoa repens) or to any of the other
components of this medicine (listed in section 6).

Warnings and precautions:
Before starting treatment with Prostamol Uno, discuss this with your doctor or pharmacist.
Prostamol Uno relieves symptoms associated with benign prostatic hyperplasia without causing reduction of the prostate.
Therefore, patients should have regular medical check-ups.
Consult a doctor immediately, especially if:

the patient develops fever, spasms, or blood in the urine
the patient experiences pain during urination
there is continuous leakage of urine due to bladder overfilling (urinary incontinence with constant leakage from an overfilled bladder)
the patient experiences painful urge to urinate with sudden inability to pass urine (acute urinary retention).

Children and adolescents
Prostamol Uno is not recommended for use in children and adolescents under 18 years of age.

Prostamol Uno and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
A few cases of suspected interactions with warfarin (anticoagulants) have been reported, with increased INR values described.
To date, no interactions with any other medicines have been established.

Pregnancy, breastfeeding and fertility
Prostamol Uno is not intended for use in women; therefore, its use during pregnancy and breastfeeding is not recommended. There is a lack of available data regarding its effect on fertility.

Driving and operating machinery
Studies on the influence on the ability to drive vehicles and operate machinery have not been conducted.

3. How to use Prostamol Uno

This medicine should always be used as instructed in this leaflet or as directed by a physician or pharmacist. In case of doubt, consult a physician or pharmacist.
Dosage
The recommended dose is 1 soft capsule of Prostamol Uno once daily, at the same time each day. The soft capsule should be swallowed whole with sufficient fluid, after a meal.
Use in children and adolescents
Prostamol Uno is not recommended for use 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 time-limited. A physician should be consulted.
Treatment with Prostamol Uno is long-term and regular. Regular use of Prostamol Uno is particularly important for treatment efficacy. Improvement in the patient's condition may be expected after approximately 6 weeks.
Use of a higher than recommended dose of Prostamol Uno
Cases of overdose with Prostamol Uno have not been reported to date.
Missed dose of Prostamol Uno
Do not take a double dose to make up for a missed capsule.
Discontinuation of Prostamol Uno
If treatment with Prostamol Uno is discontinued, symptoms of the disease may recur.
If you have any further questions regarding the use of this medicine, consult your physician or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Not common (may affect up to 1 in 100 patients):

nausea, vomiting, diarrhoea, abdominal pain (particularly if the medicine is taken on an empty stomach).

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

allergic reactions or hypersensitivity reactions may occur
headache may occur

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

5. How to store Prostamol Uno

Do not store at temperatures above 30°C.
Keep the medicine in a place invisible and out of reach of children.
Do not use this medicine after the expiry date stated on the packaging following the abbreviation
EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Prostamol Uno contains
Active substance:
The active substance in this medicinal product is extract of sabal palm fruit (Sabalis serrulatae fructus extractum).
One soft capsule contains 320 mg of extract from sabal palm fruit (Serenoa repens (W.Bartram) Small (Sabal serrulata (Michaux) Nichols), fructus) (9-11:1).
Extraction solvent: 96% (V/V) ethyl alcohol.
Other ingredients are:
Succinylated gelatin, glycerol, purified water, titanium dioxide (E171), yellow iron oxide (E172), black iron oxide (E172), carmine (E120), medium-chain triglycerides.

What Prostamol Uno looks like and contents of the pack
Oval, gelatin soft capsules with an opaque, two-coloured red-black shell, filled with brown to yellowish or greenish-brown (oily) liquid.
Soft capsules.
The capsules are packed in PVC/PVDC-AL blister packs.
Prostamol Uno is available in pack sizes containing 30, 60 and 90 capsules.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

For further information, please contact the representative of the Marketing Authorisation Holder:
Berlin-Chemie / Menarini Polska Sp. z o.o.
Tel: (22) 566 21 00
Fax: (22) 566 21 01