Poldanen

Leaflet attached to the packaging: patient information

You should carefully read the contents of the leaflet before each treatment, as it contains important information for the patient.
The medicine should always be used exactly as described in the patient leaflet or according to the instructions of a doctor, pharmacist, or nurse.
You should keep this leaflet so that you can read it again if necessary.
If you need advice or additional information, you should contact 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.

• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

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

1. What is Poldanen and what is it used for

Poldanen is a medicine containing an extract of African plum tree bark, used in patients with mild prostate enlargement (prostatitis), in the early stages of the disease to alleviate symptoms such as: frequent urination, nocturia, difficult urination, and urinary dribbling.
Poldanen is a herbal medicine used exclusively in adult men.

2. Important information before using Poldanen

When not to use Poldanen

• - in case of hypersensitivity to African plum tree bark extract or to Rosaceae plants or any of the other ingredients of this medicine (listed in section 6).
• - in patients with diagnosed prostate cancer.

Warnings and precautions

Before starting to use Poldanen, you should consult a doctor, pharmacist, or nurse.
Regular prostate check-ups are necessary, as recommended by your doctor. Poldanen is not a medicine used to treat prostate cancer and does not prevent its development.
Patients with rare hereditary lactose intolerance, lactose intolerance, or lactose malabsorption should not use this medicine.

3. How to use Poldanen

Always use the dose of the medicine recommended by your doctor or pharmacist.
Recommended dose:1 soft capsule 2 times a day.
The capsules should be swallowed whole, with a glass of water.
The medicine should be used regularly for at least 4-6 weeks to assess its effectiveness.
In case of worsening symptoms, you should consult your doctor.

4. Possible side effects

Like all medicines, Poldanen can cause side effects, although not everybody gets them.
Possible side effects:

• Gastrointestinal disorders (e.g., nausea, abdominal pain, diarrhea, constipation) – occur infrequently.
• Allergic reactions (e.g., rash, itching) – occur rarely.

If you experience any side effects, you should stop using the medicine and consult your doctor.

5. How to store Poldanen

Store in a cool, dry place, out of reach of children.

6. Package contents and other information

What Poldanen contains

• Active substance: African plum tree bark extract (Pygeum africanum) 70:1. 1 soft capsule contains 100 mg of African plum tree bark extract.
• Other ingredients: soybean oil, gelatin, glycerol, purified water, titanium dioxide (E171), yellow iron oxide (E172).

What Poldanen looks like and what the package contains
Soft capsules, yellow, containing an oily substance.
Package: 30 soft capsules
Responsible entity
Poldanen, 46 mg, film-coated tablets
Pruni africanae corticis extractum spissum

Pregnancy and breastfeeding

The medicine is for use in men only.
Driving and using machines
Using the medicine does not affect the ability to drive vehicles or operate machinery.

Poldanen contains sucrose and orange yellow lac E 110

The medicine contains sucrose. If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.
The medicine contains a colorant – orange yellow lac E 110, which may cause allergic reactions.

3. How to use Poldanen

Take the medicine orally.
Unless otherwise prescribed by your doctor, take 1-2 tablets 2 times a day during meals for at least 4 weeks. If necessary, the treatment can be repeated.
Overdose of Poldanen
No cases of overdose have been reported. If you take more than the recommended dose and experience worrying symptoms, you should contact your doctor or pharmacist.

Missing a dose of Poldanen

If you miss a dose, you can return to your previous dosing schedule. Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like any medicine, Poldanen can cause side effects, although not everybody gets them.
During treatment, gastrointestinal disorders may occur, so it is recommended to take the medicine during meals.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel. 501102353, fax: 224927255 or e-mail: [email protected]

5. How to store Poldanen

Store at room temperature up to 25°C, in the original packaging, out of sight and reach of children.

6. Package contents and other information

Poldanen contains: active substance – bromowerek hydrochloride 2 mg.
Other ingredients: lactose monohydrate, microcrystalline cellulose, corn starch, talc, magnesium stearate, orange yellow lac (E 110).
Manufacturer: Polpharma S.A.ul. Pelplińska 19, 83-200 Starogard Gdański
Date of leaflet update: 2019-03-22

What Poldanen contains

Active substance
1 tablet contains 46 mg of dense extract from Prunus africana(Hook f.) Kalkm., cortex (African plum tree bark) (20:1), extractant: methylene chloride.
Other ingredients of the medicine are: calcium phosphate, potato starch, sucrose, talc, magnesium stearate, hypromellose, macrogol 6000, titanium dioxide, orange yellow lac E 110.

What Poldanen looks like and what the package contains

Poldanen is in the form of film-coated tablets.
Available packages: 2 blisters of Al/PVC foil, each containing 15 tablets, placed in a cardboard box.

Responsible entity and manufacturer

Poznańskie Zakłady Zielarskie „Herbapol” S.A.
ul. Towarowa 47-51, 61-896 Poznań, Poland
tel. + 48 61 886 18 00, fax + 48 61 853 60 58
Date of last update of the leaflet:
2019-04-15
Head of
Registration Department
Agnieszka Meller

ARTICLE I. NAME

This organization shall be known as the National Association of State Departments of Agriculture (NASDA).

ARTICLE II. PURPOSE

The purposes of this Association shall be:

• To provide a forum for the exchange of information and ideas among state departments of agriculture.
• To promote the development and implementation of sound agricultural policies.
• To represent the interests of state departments of agriculture before the federal government and other national organizations.
• To foster cooperation among state departments of agriculture in areas of mutual concern.
• To promote the agricultural industry and rural communities.

ARTICLE III. MEMBERSHIP

Membership in NASDA shall be open to the Commissioner, Secretary, or Director of Agriculture, or their designated representative, of each state, territory, and the District of Columbia.

ARTICLE IV. OFFICERS

The officers of NASDA shall be a President, President-Elect, Vice President, and Secretary-Treasurer. These officers shall be elected by the membership at the annual meeting.

ARTICLE V. DUTIES OF OFFICERS

The duties of the officers shall be as follows:

1. President: The President shall preside at all meetings of the Association and shall be the chief executive officer.
2. President-Elect: The President-Elect shall assist the President and shall assume the duties of the President in the event of the President’s absence or inability to serve.
3. Vice President: The Vice President shall assist the President and President-Elect and shall assume the duties of the President-Elect in the event of the President-Elect’s absence or inability to serve.
4. Secretary-Treasurer: The Secretary-Treasurer shall be responsible for the financial affairs of the Association and shall keep accurate records of all transactions.

ARTICLE VI. MEETINGS

NASDA shall hold an annual meeting at a time and place to be determined by the Executive Committee. The Executive Committee may also call additional meetings as needed.

ARTICLE VII. EXECUTIVE COMMITTEE

The Executive Committee shall consist of the President, President-Elect, Vice President, Secretary-Treasurer, and immediate past President. The Executive Committee shall be responsible for the day-to-day operations of the Association.

ARTICLE VIII. AMENDMENTS

These Bylaws may be amended by a two-thirds vote of the membershipat any annual meeting.

ARTICLE IX. FISCAL YEAR

The fiscal year of NASDA shall begin on October 1and end on September 30.