Fitoprost

Patient Information Leaflet

FITOPROST
160 mg, soft capsules
Sabalis serrulatae extractum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by the
doctor, pharmacist, or nurse.

• 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 adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If symptoms persist, there is no improvement, or the patient feels worse, contact the doctor.

Contents of the leaflet:

1. What Fitoprost is and what it is used for
2. Important information before taking Fitoprost
3. How to take Fitoprost
4. Possible side effects
5. How to store Fitoprost
6. Contents of the package and other information

1. What Fitoprost is and what it is used for

Fitoprost is a herbal medicinal product containing an extract from the fruit of saw palmetto
(Sabalis serrulatae extractum).
This medicine is intended for men only. It facilitates urination and reduces urinary tract symptoms associated with mild benign prostatic hyperplasia (BPH) at stage I and II of the disease.
The effect of the product is attributed to its antiandrogenic and anti-edematous properties.
Fitoprost is indicated for functional disorders associated with benign prostatic hyperplasia, such as: frequent urination at night (nocturia), reduced urinary stream, urinary retention, and pain-related symptoms due to pressure from the enlarged prostate gland.

2. Important information before using Fitoprost medicine

When not to use Fitoprost:

• if the patient is allergic (hypersensitive) to the extract from the fruit of saw palmetto (Sabalis serrulatae extractum) or to any of the other components of this medicine (listed in section 6).

Warnings and precautions
Before starting to take Fitoprost, please discuss this with your doctor, pharmacist, or nurse.
The use of this medicine does not reduce an enlarged prostate gland, but only alleviates urinary symptoms related to this condition. Regular consultations with a doctor are necessary during treatment.
If blood traces in the urine or complete urinary retention are observed, contact a doctor immediately.

Fitoprost and other medicines
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Inform your doctor or pharmacist about all medicines currently used, recently used, or planned for use.
Interactions with other medicines are not known.

Taking Fitoprost with food and drink
Take the medicine after a meal. Swallow with a small amount of liquid.

Pregnancy and breastfeeding
Not applicable

Driving and operating machinery
Fitoprost has no influence on the ability to drive or operate machinery.

3. How to use Fitoprost

This medicine should always be taken exactly as described in the patient leaflet, or as advised by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.
Fitoprost is taken orally.
The recommended dose is 1 capsule twice daily after meals.
Swallow with a small amount of liquid. It is recommended to take the medicine at regular intervals.
The duration of treatment should be determined by the attending physician.
Taking more than the recommended dose of Fitoprost
If more than the recommended dose has been taken, seek immediate advice from a doctor or pharmacist.
Missed dose of Fitoprost
Do not take a double dose to make up for a forgotten dose.
If you have any further doubts concerning 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 everybody will experience them.
The medicine is generally well tolerated. Nausea may occasionally occur, especially if taken on an empty stomach.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions 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.: 22 49 21 301, fax: 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of this medicine can be collected.
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5. How to store Fitoprost

Keep the medicine out of sight and reach of children.
Store in the original tightly closed packaging, at a temperature not exceeding 25°C.
Protect from moisture.
Do not use this medicine after the expiry date stated on the carton and blister pack. 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 required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What the medicine Fitoprost contains

• The active substance in the medicine is an extract from saw palmetto fruit. Each capsule contains 160 mg of extract from saw palmetto fruit (Sabalis serrulatae extractum), equivalent to 1040–1440 mg of saw palmetto fruit. Extraction solvent: carbon dioxide under supercritical conditions.
• Other components of the medicine (excipients) are: gelatin, glycerol, titanium dioxide (E 171), copper chlorophyllin complex (E 141), black iron oxide (E 172).

What Fitoprost looks like and contents of the pack
Fitoprost is oval-shaped green capsules with a smooth, glossy surface.
1 pack contains 2 blisters with 30 capsules each.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, Żmigrodzka 242 E Street
Medicine Information
tel.: (22) 742 00 22
e-mail: [email protected]
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