Sterko

Leaflet attached to the packaging: patient information

Sterko, 320 mg, soft capsules

Sabalis serrulatae fructus extractum spissum

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

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

• Keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, talk to a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Sterko and what is it used for
• 2. Important information before taking Sterko
• 3. How to take Sterko
• 4. Possible side effects
• 5. How to store Sterko
• 6. Package contents and other information

1. What is Sterko and what is it used for

Sterko alleviates symptoms associated with benign prostatic hyperplasia (prostate enlargement) that occur when urinating, such as: frequent urination, frequent nighttime urination, weak urine flow. Sterko is used to treat urinary disorders that occur in the initial period of benign prostatic hyperplasia.

2. Important information before taking Sterko

When not to take Sterko:

Warnings and precautions

Before starting to take Sterko, discuss it with your doctor or pharmacist. If the doctor plans to perform a prostate-specific antigen (PSA) test on the patient, it is recommended to stop taking Sterko before the test. The medicine alleviates symptoms associated with benign prostatic hyperplasia without reducing its size, and therefore does not eliminate the disease. The patient should regularly consult a doctor. A medical consultation is necessary, especially if blood is found in the urine or if there is urinary retention in the bladder.

Sterko and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking, has recently taken, or plans to take. Inform your 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. The capsules should not be chewed, but swallowed whole with water.

Pregnancy and breastfeeding

Not applicable. Sterko is used exclusively in men.

Driving and operating machinery

No effect of Sterko on the ability to drive and operate machinery has been found.

Sterko contains small amounts of soy lecithin (E322).

Do not take this medicine if the patient is allergic to peanuts or soy.

3. How to take Sterko

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist. Unless the doctor advises otherwise, the usual dose is 1 capsule (320 mg) per day. The capsule should be taken during or after a meal. The capsules should not be chewed, but swallowed whole with water. Regular intake of the medicine is important for its effectiveness.

Duration of treatment

The duration of treatment depends on the type, severity, and course of the disease. The duration of treatment is decided by the doctor based on the results of regular check-ups. Improvement in the patient's condition and reduction of symptoms are usually observed after about 4 weeks of treatment. Consult a doctor if symptoms do not improve or worsen.

Taking a higher dose of Sterko than recommended

No cases of overdose or poisoning with this medicine are known.

Missing a dose of Sterko

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

Stopping treatment with Sterko

Do not stop treatment without consulting a doctor. If you have any further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Sterko can cause side effects, although not everybody gets them. Sterko is generally well-tolerated. Rarely, gastrointestinal disorders may occur. After taking Sterko on an empty stomach, nausea may occur. If side effects do not improve, consult a doctor.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. 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, tel.: +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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sterko

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

6. Package contents and other information

What Sterko contains

• The active substance of Sterko is a dense ethanolic extract of sabal palm fruit. Each soft capsule contains 320 mg of dense ethanolic extract of sabal palm fruit (Sabalis serrulatae fructus extractum spissum)(9-11:1). Extractant: 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 what the package contains

Soft gelatin capsule. Sterko capsules are packaged in PVC/PVDC/Aluminum blisters in a carton box. Each blister contains 15 soft capsules. Available package sizes:30 soft capsules, 60 soft capsules. Not all package sizes may be marketed.

Marketing authorization 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 Vysoké Mýto, Czech Republic