Patient information leaflet

Prostaplant 160 mg + 120 mg soft capsules

160 mg of fruit extract of Serenoa repens (10 - 14, 3:1), extraction agent: ethanol 90% (w/w).
120 mg of dry root extract of Urtica dioica (7.6 - 12, 5:1), extraction agent: ethanol 60% (w/w).
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist.

Contents of this leaflet:

What Prostaplant is and what it is used for
What you need to know before taking Prostaplant
How to take Prostaplant
Possible side effects
How to store Prostaplant
Contents of the pack and other information

1. What Prostaplant is and what it is used for

Prostaplant is a herbal medicinal product used for prostate disorders.
Prostaplant is indicated for the treatment of urinary symptoms (increased frequency of urination during
nighttime, difficult urination, frequent urge to urinate with passage of small amounts of urine) associated with
benign prostatic hyperplasia.

2. What you should know before taking Prostaplant

Do not take Prostaplant

if you are allergic to extracts from the fruit of Serenoa repens or roots of Urtica dioica, or to any of the other ingredients of this medicine (listed in section 6).
if you are allergic to peanuts or soy

Warnings and precautions
No particular precautions are necessary when Prostaplant is taken according to the instructions provided in this package leaflet. Prostaplant can only relieve symptoms caused by an enlarged prostate, but does not eliminate the underlying cause. It is recommended to consult your doctor for regular check-ups, especially if blood in the urine, acute urinary retention, fever, difficulty urinating, or spasms occur.

Children and adolescents
There are no relevant indications for the use of Prostaplant in children and adolescents under 18 years of age.

Other medicines and Prostaplant
Prostaplant does not show any significant interactions with other medicines.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Pregnancy, breastfeeding and fertility
There are no relevant indications for the use of Prostaplant in women.

Driving and operating machinery
No negative effects on the ability to drive or operate machinery are known.

Prostaplant contains soybean oil
If you are allergic to peanuts or soy, you must not take this medicine.

3. How to take Prostaplant

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1 capsule twice daily. Take orally without chewing, with a small amount of liquid.
If you take more Prostaplant than you should
Prostaplant is a well-tolerated medicine. Cases of overdose have not been reported so far.
If you forget to take Prostaplant
Do not take a double dose to make up for the forgotten capsule.
If you stop taking Prostaplant
If you have any doubts about using this medicine, contact your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

Gastrointestinal disorders
Rare: mild gastrointestinal disturbances (nausea, vomiting, diarrhoea), particularly when the medicine is taken on an empty stomach.

Skin and subcutaneous tissue disorders
Allergic reactions, for example itching, rash (appearance of blisters and vesicles on the skin), urticaria (appearance of red patches on the skin). Frequency is not known.

Following the instructions provided in this leaflet reduces the risk of side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist.
You can also report side effects directly via the website: http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Prostaplant

Do not store above 30°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Prostaplant contains
The active substances are:

160 mg of fruit extract of Serenoa repens (10 - 14, 3:1), extraction agent: ethanol 90% (w/w).
120 mg of dry root extract of Urtica dioica (7.6 - 12, 5:1), extraction agent: ethanol 60% (w/w).

The other components are:
succinylated gelatin; glycerin; heavy fats; anhydrous colloidal silicon dioxide; hydrogenated soybean oil;
patent blue V, E 131; yellow iron oxide, E172; black iron oxide, E172.

Description of the appearance of Prostaplant and package contents
Prostaplant is a green, oval soft capsule. It is available in packs of 14, 15, 20, 30, 45, 60, 90 and 120
capsules. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Dr. Willmar Schwabe GmbH & Co. KG
Willmar-Schwabe-Str. 4
76227 Karlsruhe - Germany

Marketing Authorization Holder in Italy
LOACKER REMEDIA S.r.l.
Egna-Neumarkt (BZ)