ZASTERID

Package leaflet: Information for the patient

Zasterid, 5 mg, film-coated tablets
Finasteridum
This medicine is intended for use in men only
Please read carefully all the information in this leaflet before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

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

1. What Zasterid is and what it is used for

Finasteride, the active substance in Zasterid, is a 5-alpha-reductase inhibitor, an enzyme that converts
testosterone (a male sex hormone) into the more potent dihydrotestosterone (DHT). Zasterid reduces
the size of the prostate gland.
Zasterid is used in a condition called benign prostatic hyperplasia. The prostate gland, located near the bladder, has enlarged, causing difficulty in urination. Zasterid is indicated for the treatment of benign prostatic hyperplasia to:

• relieve symptoms,
• reduce the risk of acute urinary retention,
• reduce the risk of needing surgical treatment, including transurethral resection of the prostate (TURP) and prostatectomy (surgical removal of the prostate gland).

2. Important information before using Zasterid

What you should know before using and during treatment with Zasterid.
If the patient's sexual partner is pregnant or suspected of being pregnant, exposure to the patient's semen, which may contain small amounts of the drug, should be avoided.

When not to use Zasterid:

• if the patient is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6),
• in pregnant women and women of childbearing potential.

Zasterid is not indicated for use in women.

Warnings and precautions

Before starting treatment with Zasterid, discuss the following with your doctor or pharmacist:

• Inform your doctor about any current or past medical conditions and allergies.
• Benign prostatic hyperplasia (BPH) is a slowly progressive condition. In some patients, symptom relief may occur shortly after starting therapy. However, treatment with Zasterid may need to be continued for at least 6 months before significant improvement is observed. Regardless of whether symptoms improve, continued use of Zasterid may reduce the risk of acute urinary retention and the need for surgical intervention. To monitor treatment progress, the patient should remain under regular medical supervision.
• Benign prostatic hyperplasia is not cancer and does not lead to cancer, but both conditions may coexist. Only a physician can properly evaluate symptoms and their likely cause.
• Treatment with Zasterid may affect PSA (prostate-specific antigen) test results. Therefore, inform your doctor that you are taking Zasterid before undergoing a PSA test. Zasterid is indicated 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 rarely suicidal thoughts, have been reported in patients taking Zasterid. If any of these symptoms occur, seek immediate medical advice from your doctor.

Children
Zasterid is not indicated for use in children.

Zasterid with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. Zasterid generally does not affect the action of other concomitant medications.

Pregnancy and breastfeeding

Pregnancy
Pregnant women and women of childbearing potential must not take Zasterid. They should also avoid handling crushed or broken Zasterid tablets. If the active substance of the medicine passes into the body of a pregnant woman (via oral administration or through skin contact), it may cause developmental abnormalities of the male fetal genital organs. In case of exposure to the active substance of Zasterid, a pregnant woman should inform her doctor immediately. Zasterid tablets are film-coated, which prevents direct contact with the active substance, provided the tablets are not damaged or crushed.
For further information, consult your doctor.

Breastfeeding
It is unknown whether finasteride passes into human milk.

Driving and operating machinery
Available data indicate that Zasterid does not impair the ability to drive or operate machinery.

Zasterid contains lactose monohydrate
The medicine contains 102.63 mg of lactose per tablet. If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Zasterid

This medicine should always be used according to the instructions given by the doctor. If in doubt, consult your doctor or pharmacist.

The recommended dose is one 5 mg tablet per day, taken independently of meals. The medicine should be taken orally.

Please remember that benign prostatic hyperplasia is a condition that develops gradually over many years before symptoms become apparent. Zasterid may relieve symptoms and help control the progression of the disease, provided it is taken regularly over a prolonged period.

Use of Zasterid in patients with renal and/or hepatic impairment
No dosage adjustment is required in patients with any degree of renal and/or hepatic impairment.

Use of Zasterid in elderly patients
Dosage adjustment is not necessary in elderly patients.

Taking more Zasterid than recommended
If more tablets than recommended have been taken, consult a doctor or pharmacist immediately.

Missed dose of Zasterid
Zasterid should be taken as directed by the doctor. If a dose is missed, do not take an extra tablet. Resume the prescribed dosing schedule the next day.

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 may cause adverse reactions, although not everyone experiences them.

Allergic reactions:
You must stop using the medicinal product Zasterid and contact a doctor immediately if any of the following symptoms occur (angioedema): swelling of the face, tongue or throat, difficulty swallowing, difficulty breathing, and urticaria.

Common (may affect up to 1 in 10 people):

• decreased sexual desire,
• impotence (inability to achieve erection),
• reduced ejaculate volume (semen). This does not affect normal sexual function.

In some cases, these symptoms may resolve during treatment. However, if adverse reactions persist, you should consult your doctor, who may decide to discontinue treatment with Zasterid.

Uncommon (may affect up to 1 in 100 people):

• rash,
• enlargement and/or tenderness of the breasts,
• ejaculation disorders.

Frequency not known (frequency cannot be estimated from available data):

• hypersensitivity reactions, including swelling of the lips, tongue and face,
• depression,
• decreased sexual desire which may persist after discontinuation of treatment,
• blood in semen,
• palpitations (feeling of irregular, rapid or forceful heartbeat),
• increased liver enzyme activity,
• itching, urticaria,
• testicular pain,
• persistent sexual dysfunction (inability to achieve erection and problems with ejaculation) after discontinuation of treatment,
• male infertility and/or poor semen quality. After discontinuation of finasteride, return to normal values or improvement in semen quality has been reported,
• in rare cases, development of breast cancer,
• anxiety,
• suicidal thoughts.

Any changes observed in breast glandular tissue, such as lumps, pain, breast enlargement or nipple discharge, should be reported immediately to the treating physician, as they may be symptoms of serious disorders, such as breast cancer.

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 Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warszawa
tel.: 22 49-21-301
fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported directly to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Zasterid medicine

Store in the original packaging to protect from light.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after EXP. 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 in use. This will help protect the environment.

6. Contents of the packaging and other information

What Zasterid contains

• The active substance is finasteride. Each coated tablet contains 5 mg of finasteride.
• Other components are:
  Tablet core: magnesium stearate, talc, pregelatinized starch, microcrystalline cellulose, sodium carboxymethyl starch (type A), monohydrate lactose (102.25 mg).
  Coating: titanium dioxide (E171), monohydrate lactose (0.3809 mg), macrogol 6000,
  hydroxypropylcellulose, hypromellose.

What Zasterid looks like and contents of the pack
White or almost white, slightly biconvex film-coated tablets, triangular in shape with rounded edges, imprinted with "RG" on one side.
Pack contains 28 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary

For further information about this medicine, please contact:
GEDEON RICHTER POLSKA Sp. z o.o.
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22) 755 96 48
[email protected]