Fitoprost

Leaflet attached to the packaging: patient information

FITOPROST

160 mg, soft capsules

Sabalis serrulatae extractum

Please read the contents of the leaflet carefully 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, pharmacist, or nurse.

• Please keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If symptoms persist, do not improve, or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is Fitoprost and what is it used for

Fitoprost is a herbal medicinal product containing an extract of saw palmetto fruits (Sabalis serrulatae extractum).

The medicine is intended for men only. It facilitates urination by reducing the discomfort associated with benign prostatic hyperplasia stages I and II.

The product's effect is attributed to its anti-androgenic and anti-edematous properties.

The indications for using the medicine are functional disorders occurring in benign prostatic hyperplasia, such as: frequent urination at night, reduced urine flow, urine retention, and painful symptoms associated with the pressure of an enlarged prostate.

2. Important information before using Fitoprost

When not to use Fitoprost:

Sabalis serrulatae extractum) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Fitoprost, the patient should discuss it with their doctor, pharmacist, or nurse.

Taking the medicine does not reduce the size of an enlarged prostate, but only alleviates the urinary discomfort associated with the condition. Regular consultations with a doctor are recommended during treatment.

If the patient notices blood in their urine or complete urine retention, they should contact their doctor immediately.

Fitoprost 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.

No interactions with other medicines are known.

Taking Fitoprost with food and drink

The medicine should be taken after a meal. The patient should drink a small amount of liquid.

Pregnancy and breastfeeding

Not applicable

Driving and using machines

Fitoprost does not affect the ability to drive or operate machinery.

3. How to use Fitoprost

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

In case of doubts, the patient should consult their doctor, pharmacist, or nurse.

The medicine is taken orally.

The recommended dose is 1 capsule twice a day after a meal.

The patient should drink a small amount of liquid. It is recommended to take the medicine at equal intervals.

The duration of treatment should be determined by the patient's doctor.

Taking more than the recommended dose of Fitoprost

In case of taking more than the recommended dose, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Fitoprost

The patient should not take a double dose to make up for a missed dose.

In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

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

The medicine is generally well-tolerated. Nausea may occasionally occur, especially when taken on an empty stomach.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they 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, tel.: 22 49 21 301, fax: 22 49 21 309,

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Fitoprost

The medicine should be stored out of sight and reach of children.

Store in the original package, in a temperature not exceeding 25°C.

Protect from moisture.

Do not use this medicine after the expiry date stated on the carton and blister.

The expiry date refers to the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste containers.

The patient should ask their pharmacist how to dispose of medicines that are no longer needed.

This will help protect the environment.

6. Package contents and other information

What Fitoprost contains

• The active substance of the medicine is saw palmetto fruit extract. Each capsule contains 160 mg of saw palmetto fruit extract (Sabalis serrulatae extractum), which corresponds to 1040-1440 mg of saw palmetto fruits.
• The other ingredients of the medicine are: gelatin, glycerol, titanium dioxide (E 171), copper chlorophyllin complex (E 141), black iron oxide (E 172).

What Fitoprost looks like and what the package contains

Fitoprost is an oval, green, smooth, and shiny capsule.

One package of the medicine contains 2 blisters of 30 capsules each.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.

51-131 Wrocław, ul. Żmigrodzka 242 E

Medicine information

tel.: (22) 742 00 22

e-mail: [email protected]

Date of last update of the leaflet:

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