PENESTER 5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Penester, 5 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. The medicine is for use in men only
   3. Table of Contents of the Leaflet
3. What Penester is and what it is used for
4. Important information before taking Penester
   1. When not to take Penester
   2. Warnings and precautions
   3. Mood changes and depression
   4. Children
   5. Penester and other medicines
   6. Penester with food and drink
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Penester contains sodium
5. How to take Penester
   1. Taking a higher dose of Penester than recommended
   2. Missing a dose of Penester
   3. Stopping treatment with Penester
6. Possible side effects
   1. Immediately report to your doctor any changes in breast tissue, such as lumps, pain, breast enlargement, or discharge from the nipples, as these may be symptoms of serious disorders, such as breast cancer.
   2. Reporting side effects
7. How to store Penester
8. Contents of the pack and other information
   1. What Penester contains
   2. What Penester looks like and contents of the pack
   3. Marketing authorization holder and manufacturer:
   4. For more information, contact the representative of the marketing authorization holder in Poland:
   5. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Penester, 5 mg, Film-Coated Tablets

Finasteride

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

The medicine is for use in men only

Table of Contents of the Leaflet

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

1. What Penester is and what it is used for

Finasteride, the active substance of Penester, is a 5-alpha reductase inhibitor, an enzyme that converts testosterone (male sex hormone) into a more potent dihydrotestosterone (DHT). Penester reduces the volume of the prostate gland.
Penester is used to treat a condition called benign prostatic hyperplasia. The prostate gland, located in the area of the initial fragment of the urethra, has enlarged.
As a result of the enlargement of the gland, difficulties in urinating have appeared.
The medicine is indicated for the treatment of benign prostatic hyperplasia (BPH) to:
relieve symptoms,
reduce the risk of acute urinary retention,
reduce the risk of needing a transurethral resection of the prostate (TURP) and (or) prostatectomy (surgical removal of the prostate gland),
reduce the enlarged prostate gland, improve urine flow, and reduce symptoms associated with prostate enlargement.

2. Important information before taking Penester

Penester is not indicated for use in women or children.

When not to take Penester

if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
in women who are pregnant or breastfeeding (see below).

Warnings and precautions

Before starting treatment with Penester, discuss it with your doctor.
Benign prostatic hyperplasia is a condition that develops over a long period. In some patients, relief of symptoms occurs shortly after starting therapy. However, it may be necessary to take the medicine for at least 6 months to achieve significant improvement. Regardless of whether symptoms improve, taking Penester may reduce the risk of acute urinary retention and delay the need for surgical treatment. To monitor the progress of treatment, the patient should remain under constant medical supervision.
Benign prostatic hyperplasia is not a tumor, nor does it lead to the development of a tumor, but these conditions can occur simultaneously. Only a doctor can properly assess the symptoms and their likely cause.
Tell your doctor about all diseases that are currently present or have occurred in the past and about any allergies.
The medicine affects the results of PSA (prostate-specific antigen) blood tests. Patients undergoing PSA testing should inform their doctor about taking Penester.
Penester is intended for use only in men for the treatment of benign prostatic hyperplasia.

Mood changes and depression

In patients taking Penester, mood changes, such as depressive mood, and depression, as well as suicidal thoughts, have been reported. If any of these symptoms occur, seek medical advice immediately.

Children

Penester is not indicated for use in children.

Penester and other medicines

Tell your doctor about all medicines you are currently taking or plan to take. Penester usually does not affect the action of other medicines taken.

Penester with food and drink

The medicine can be taken with or without food.

Pregnancy and breastfeeding

Pregnancy
Women who are pregnant or breastfeeding should not take Penester. Pregnant or breastfeeding women, or those who suspect they may be pregnant, should not even touch broken or crushed Penester tablets due to the possible absorption of finasteride and the associated risk to the male fetus.
If the active substance of the medicine penetrates the body (after oral administration or through skin contact) of a pregnant woman carrying a male fetus, it may cause developmental disorders of the genital organs in the fetus. In case of contact between a pregnant woman and the active substance of Penester, inform your doctor. Penester tablets are film-coated, which prevents direct contact with the active substance, provided that the tablets are not damaged.
If your partner is pregnant or may be pregnant, it is recommended that you minimize your partner's exposure to semen (e.g., by using condoms).
Your doctor can provide more information on this.
Breastfeeding
It is not known whether finasteride passes into human milk.

Driving and using machines

There is no data indicating that the medicine impairs the ability to drive or operate machines.
Penester contains lactose monohydrate(a type of sugar)
If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.

Penester contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means the medicine is considered "sodium-free".

3. How to take Penester

Take this medicine always as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
The recommended dose is 5 mg once a day, regardless of meals.
The medicine should be taken orally.
Remember that benign prostatic hyperplasia is a process that takes many years before symptoms appear. Penester may relieve symptoms and allow control of the disease if taken regularly for a long time.
Dosing in elderly patients
No dose adjustment is required in elderly patients.
Dosing in patients with renal and/or hepatic impairment
No dose adjustment is required in patients with renal impairment of any degree and/or liver impairment.

Taking a higher dose of Penester than recommended

Do not take more tablets than your doctor has recommended.
In case of overdose or accidental ingestion, contact your doctor immediately.

Missing a dose of Penester

If you miss a dose, take the next dose the next day as scheduled.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Penester

Do not stop taking the medicine without consulting your doctor.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Penester can cause side effects, although not everybody gets them.
Common(occurring in 1 to 10 patients in 100):

• decreased libido,
• impotence (inability to achieve an erection),
• decreased semen volume (amount of semen). This does not affect normal sexual function. In some cases, these symptoms may resolve during treatment. However, if side effects persist, consult your doctor, who may decide to stop treatment with Penester.

Uncommon(occurring in 1 to 10 patients in 1000):

• ejaculation disorders,
• rash,
• breast tenderness and/or enlargement.

Frequency not known(frequency cannot be estimated from available data):
Stop taking the medicine and contact your doctor immediately if you experience any of the following symptoms (angioedema): swelling of the face, lips, tongue, or throat, difficulty swallowing, hives, and difficulty breathing.

• allergic reactions, including swelling of the lips, tongue, throat, or face,
• depression,
• persistent decreased libido after stopping treatment,
• blood in semen,
• itching, hives,
• testicular pain,
• palpitations,
• liver function changes, which may be visible in blood tests,
• inability to achieve an erection, also after stopping treatment,
• ejaculation disorders, also after stopping treatment,
• male infertility and/or poor semen quality (improvement in semen quality has been reported after stopping the medicine),
• rarely, development of breast cancer,
• anxiety.

Immediately report to your doctor any changes in breast tissue, such as lumps, pain, breast enlargement, or discharge from the nipples, as these may be symptoms of serious disorders, such as breast cancer.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 gather more information on the safety of the medicine.

5. How to store Penester

Keep the medicine out of sight and reach of children.
There are no special precautions for storage.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Penester contains

• The active substance of the medicine is finasteride. One tablet contains 5 mg of finasteride.
• The other ingredients are: tablet core: lactose monohydrate, corn starch, povidone K 30, sodium docusate, carboxymethylcellulose sodium (type A), magnesium stearate, coating: hypromellose 2910/5, macrogol 6000, talc, titanium dioxide, simethicone emulsion SE4, yellow iron oxide.

What Penester looks like and contents of the pack

Yellow, round, biconvex film-coated tablets.
Pack sizes: 30 or 90 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Zentiva k.s., U Kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic.

For more information, contact the representative of the marketing authorization holder in Poland:

Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. +48 22 375 92 00

Date of last revision of the leaflet: