Penester

Package leaflet: Information for the patient

Penester, 5 mg, film-coated tablets
Finasteride
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

This medicine is intended 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 in Penester, is a 5-alpha reductase inhibitor, an enzyme that converts testosterone (a male sex hormone) into the more potent dihydrotestosterone (DHT). Penester reduces the volume of the prostate gland.
Penester is used in a condition called benign prostatic hyperplasia. The prostate gland, located near the beginning of the urethra, has become enlarged.
As a result of this enlargement, difficulties in urination have occurred.
Penester 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 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 using Penester

Penester is not indicated for use in women or children.
When not to use Penester
if the patient is allergic to the active substance or to any of the other ingredients of this
medication (listed in section 6).
in pregnant women and women of childbearing age (see below).
Warnings and precautions
Before starting treatment with Penester, you should discuss this with your doctor.
Benign prostatic hyperplasia is a condition that develops gradually over time. In some
patients, symptoms may improve shortly after starting therapy. However, treatment may need to be continued for at least 6 months to achieve significant improvement. Regardless of whether symptoms improve, treatment with Penester may reduce the risk of acute urinary retention and delay the need for surgical treatment. For monitoring treatment progress, the patient should remain under continuous medical supervision.
Benign prostatic hyperplasia is not cancer and does not lead to cancer development,
but these conditions may coexist. Only a physician can properly evaluate symptoms
and their probable cause.
Inform your doctor about any current or past medical conditions and allergies.
This medication affects blood levels of PSA (prostate-specific antigen). If you are undergoing PSA testing, you should inform your doctor that you are taking Penester.
Penester is intended exclusively for use in men for the treatment of benign
prostatic hyperplasia.
Mood changes and depression
Mood changes such as depressive mood and depression, and less frequently suicidal thoughts, have been reported in patients taking Penester. If any of these symptoms occur, you should immediately contact your doctor for further medical advice.
Children
Penester is not indicated for use in children.
Penester and other medicines
Inform your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Penester usually does not affect the action of other medications.
Penester with food and drink
This medication can be taken during or independent of meals.
Pregnancy and breastfeeding
Pregnancy
Penester must not be used by pregnant women or women of childbearing potential. Women who are pregnant, breastfeeding, suspect they may be pregnant, or who are planning to become pregnant should not handle broken or crushed Penester tablets due to the risk of absorption of finasteride and the associated risk to a male fetus.
If the active substance of this medication is absorbed by a woman expecting a male child (either orally or through skin contact), it may cause developmental abnormalities of the fetal genital organs. Any case of exposure of a pregnant woman to the active substance of Penester should be reported to a physician. Penester tablets are coated, which prevents direct contact with the active substance, provided the tablets are not damaged.
If your sexual partner is pregnant or may be pregnant, it is recommended that you minimize her exposure to semen (e.g. by using condoms).
Your doctor can provide further information on this subject.
Breastfeeding
It is unknown whether finasteride passes into human milk.
Driving and operating machinery
There are no data indicating impairment of the ability to drive or operate machinery after taking this medication.
Penester contains monohydrate lactose (a type of sugar)
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medication.
Penester contains sodium
This medication contains less than 1 mmol of sodium (23 mg) per tablet, meaning it is considered "sodium-free".

3. How to use Penester

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
The recommended dose is 5 mg once daily, regardless of food intake.
The medicine should be taken orally.
Please note that benign prostatic hyperplasia is a process that develops over many years before
symptoms become apparent. Penester may relieve symptoms and help control the progression of
the disease, provided it is taken regularly over a prolonged period.
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 any degree of renal and/or hepatic impairment.
Taking more Penester than recommended
Do not take more tablets than prescribed by your doctor.
In case of overdose or accidental ingestion, seek immediate medical advice from your doctor.
Missed dose of Penester
If a dose is missed, take the next dose the following day, according to the prescribed schedule.
Do not take a double dose to make up for a missed dose.
Stopping Penester treatment
Do not stop taking this medicine without consulting your doctor.
If you have any further questions regarding 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 everyone will experience them.
Common (occur in 1 to 10 patients out of 100):

• decreased libido,
• impotence (inability to achieve erection),
• reduced ejaculate volume (amount of semen). This does not affect normal sexual function. In some cases, these symptoms may resolve during treatment. However, if adverse symptoms persist, you should consult your doctor, who may decide to discontinue the use of Penester.

Uncommon (occur in 1 to 10 patients out of 1,000):

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

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

• hypersensitivity reactions including swelling of lips, tongue, throat and face,
• depression,
• persistent decrease in libido after discontinuation of treatment,
• blood in semen,
• itching, urticaria (hives),
• testicular pain,
• palpitations,
• changes in liver function, which may be observed in blood tests,
• inability to achieve erection persisting after discontinuation of treatment,
• ejaculation disorders persisting after discontinuation of treatment,
• male infertility and/or poor semen quality (improvement in semen quality has been reported after discontinuation of the drug),
• in rare cases, development of breast cancer,
• anxiety,
• suicidal thoughts.

Any changes observed in breast tissue, such as lumps, pain, breast enlargement or nipple discharge, should be reported immediately to the attending physician, as they may indicate serious conditions such as breast cancer.
Reporting adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Penester

Keep the medicine out of sight and reach of children.
No special storage instructions apply.
Do not use this medicine after the expiry date stated on the packaging. 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. Following this advice helps protect the environment.

6. Contents of the pack and other information

What Penester contains

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

What Penester looks like and contents of the pack
Yellow, round, biconvex coated tablets.
Pack sizes: 30 or 90 coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
Zentiva k.s., U Kabelovny 130, Dolní Měcholupy, 102 37 Prague 10, Czech Republic.
For more detailed information, contact the representative of the Marketing Authorisation Holder in Poland:
Zentiva Polska Sp. z o.o.
ul. Bonifraterska 17
00-203 Warsaw
Tel. +48 22 375 92 00