Patient Information Leaflet

Sterko, 320 mg, soft capsules
Sabalis serrulatae fructus extractum spissum
Please read the entire leaflet carefully before using 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 a
physician or pharmacist.

Keep this leaflet for future reference.
If you need advice or further information, consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

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

1. What Sterko is and what it is used for

Sterko relieves symptoms related to benign prostatic hyperplasia (enlargement of the prostate gland), such as urinary frequency, nocturia (frequent urination at night), and weak urinary stream.
Sterko is used in the treatment of urinary disorders occurring in the early stages of benign prostatic hyperplasia.

2. Important information before using Sterko

When not to use Sterko:

if the patient is allergic to the active substance, peanuts and soy, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Sterko, discuss it with a doctor or pharmacist.
If the patient is scheduled for a prostate-specific antigen (PSA) test, discontinuation of Sterko is recommended prior to the test.
The medicine alleviates symptoms associated with benign prostatic hyperplasia without reducing the size of the prostate gland; therefore, it does not eliminate the disease. The patient should consult a doctor regularly. Medical consultation is especially necessary if blood in the urine or urinary retention is observed.

Sterko with other medicines
Inform the doctor or pharmacist about all medicines currently used, recently used, or planned for use. Inform the doctor or pharmacist if the patient is taking oral diuretics.
No interactions with other medicines are known.

Sterko with food and drink
Sterko should be taken during or after a meal. Capsules must not be chewed; they should be swallowed whole with water.

Pregnancy and breastfeeding
Not applicable.
Sterko is intended for use in men only.

Driving and operating machinery
No influence of Sterko on the ability to drive or operate machinery has been observed.

Sterko contains trace amounts of soya lecithin (E322).
This medicine should not be used if the patient is allergic to peanuts or soy.

3. How to use Sterko

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Unless otherwise prescribed by a doctor, the usual dose is 1 capsule (320 mg) daily.
The capsule should be taken during or after a meal. The capsule must not be chewed; it should be swallowed whole with water. Regular use of the medicine is important for effective treatment.

Duration of treatment
The duration of treatment depends on the type, severity, and course of the disease.
The decision on how long treatment should last is made by the doctor based on the results of regular check-ups.
Improvement in the patient's condition and reduction of symptoms are usually observed about 4 weeks after starting treatment.
Contact your doctor if symptoms do not improve or worsen.

Use of a higher than recommended dose of Sterko
Cases of overdose or poisoning with this medicine are not known.

Missed dose of Sterko
Do not take a double dose to make up for a missed dose.

Stopping the use of Sterko
Do not stop treatment without consulting your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Sterko is generally well tolerated.
Gastrointestinal disturbances may occur rarely.
Nausea may occur after taking Sterko on an empty stomach.
If adverse reactions do not resolve, consult a doctor.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of using this medicine.

5. How to store the medicine Sterko

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard packaging following:
"Expiry date". The expiry date refers to the last day of the specified month.
Do not store above 25°C.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the pack and other information

What Sterko contains

The active substance is ethanolic extract, dry, from the fruits of saw palmetto. Each soft capsule contains 320 mg of dry ethanolic extract from saw palmetto fruits (Sabalis serrulatae fructus extractum spissum) (9-11:1). Extraction solvent: ethanol 96% (v/v).
Other ingredients are: succinylated pork gelatin, glycerol 85%, copper chlorophyllin complex (E 141), titanium dioxide (E 171), soy lecithin (E 322), and medium-chain triglycerides.

What Sterko looks like and contents of the pack
Soft gelatin capsule.
Sterko capsules are packed in blisters made of PVC/PVDC/Aluminium foil and placed in a cardboard box.
Each blister contains 15 soft capsules.
Available pack sizes:
30 soft capsules
60 soft capsules
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

Manufacturer
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
566 17 Vysoke Myto
Czech Republic

For further information, please contact the local representative of the Marketing Authorisation Holder.
Glenmark Pharmaceuticals Sp. z o.o.
Dziekonińskiego 3
00-728 Warsaw, Poland
Email: [email protected]