ZASTERID 5 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Zasterid, 5 mg, Film-Coated Tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
3. What is Zasterid and what is it used for
4. Important information before taking Zasterid
   1. What you need to know before and while taking Zasterid.
   2. When not to take Zasterid:
   3. Warnings and precautions
   4. Mood changes and depression
   5. Children
   6. Zasterid and other medicines
   7. Pregnancy and breastfeeding
   8. Pregnancy
   9. Breastfeeding
   10. Driving and using machines
   11. Zasterid contains lactose monohydrate
5. How to take Zasterid
   1. Taking Zasterid in patients with renal and/or hepatic impairment
   2. Taking Zasterid in elderly patients
   3. Taking more than the recommended dose of Zasterid
   4. Missing a dose of Zasterid
6. Possible side effects
   1. Allergic reactions:
   2. Stop taking Zasterid and contact your doctor immediately if you experience any of the following symptoms (angioedema):
   3. Immediately report to your doctor any changes in breast tissue, such as lumps, pain, enlargement, or discharge, as these may be signs of serious conditions, such as breast cancer.
   4. Reporting side effects
7. How to store Zasterid
8. Contents of the pack and other information
   1. What Zasterid contains
   2. What Zasterid looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Date of last revision of the leaflet:

Package Leaflet: Information for the Patient

Zasterid, 5 mg, Film-Coated Tablets

Finasteride
This medicine is intended for use only in men.

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. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

• 1. What is Zasterid and what is it 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 is Zasterid and what is it used for

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

2. Important information before taking Zasterid

What you need to know before and while taking Zasterid.

If your sexual partner is pregnant or may be pregnant, you should avoid exposing her to your semen, which may contain small amounts of the medicine.

When not to take Zasterid:

• 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 may be pregnant.

Zasterid is not indicated for use in women.

Warnings and precautions

Before starting to take Zasterid, discuss it with your doctor or pharmacist.
Tell your doctor about all your current or past illnesses and allergies.
Benign prostatic hyperplasia is a condition that develops over many years. In some patients, relief of symptoms occurs soon after starting treatment. However, it may be necessary to take the medicine for at least 6 months to achieve significant improvement.
Regardless of whether symptoms improve, taking Zasterid may reduce the risk of acute urinary retention and the need for surgical treatment.
To monitor the progress of treatment, you should remain under regular medical supervision.
Benign prostatic hyperplasia is not a tumor, nor does it lead to the development of a tumor, but these conditions can occur together. Only a doctor can properly assess the symptoms and their likely cause.
Taking Zasterid may affect the results of the PSA (prostate-specific antigen) test. Therefore, before undergoing this test, tell your doctor that you are taking Zasterid. Zasterid is indicated only for men for the treatment of benign prostatic hyperplasia.

Mood changes and depression

Patients taking Zasterid have reported mood changes, such as depressive mood and depression, and less frequently, suicidal thoughts. If you experience any of these symptoms, you should immediately consult your doctor for further medical advice.

Children

Zasterid is not indicated for use in children.

Zasterid and other medicines

Tell your doctor or pharmacist about all the medicines you are taking or have recently taken, as well as any medicines you plan to take. Zasterid usually does not affect the action of other medicines taken.

Pregnancy and breastfeeding

Pregnancy

Pregnant women and women of childbearing age must not take Zasterid. They should also not touch crushed or broken Zasterid tablets. If the active substance of Zasterid enters 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. If a pregnant woman comes into contact with the active substance of Zasterid, she should inform her doctor. Zasterid tablets are film-coated, which prevents direct contact with the active substance, provided that the tablets are not damaged or crushed.
Your doctor can provide more information on this.

Breastfeeding

It is not known whether finasteride passes into human milk.

Driving and using machines

Available data indicate that Zasterid does not affect the ability to drive or use machines.

Zasterid contains lactose monohydrate

The medicine contains 102.63 mg of lactose in one tablet. If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

3. How to take Zasterid

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is one 5 mg tablet per day, taken regardless of meals.
The medicine should be taken orally.
Remember that benign prostatic hyperplasia is a process that takes many years before symptoms appear. Zasterid may relieve symptoms and allow control of the disease if taken regularly for a long time.

Taking Zasterid in patients with renal and/or hepatic impairment

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

Taking Zasterid in elderly patients

No dose adjustment is necessary in elderly patients.

Taking more than the recommended dose of Zasterid

If you have taken more than the recommended dose of Zasterid, contact your doctor or pharmacist immediately.

Missing a dose of Zasterid

Take Zasterid as directed by your doctor. However, if you miss a dose, do not take an extra tablet. The next day, return to the dosing schedule prescribed by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Zasterid can cause side effects, although not everybody gets them.

Allergic reactions:

Stop taking Zasterid and contact your doctor immediately if you experience any of the following symptoms (angioedema):

swelling of the face, tongue, or throat, difficulty swallowing, breathing difficulties, and hives.
Common(may affect up to 1 in 10 people):

• decreased sex drive,
• impotence (inability to achieve an erection),
• decreased semen volume. This does not affect normal sexual function.

In some cases, these symptoms may resolve during treatment. However, if side effects persist, you should consult your doctor, who may decide to stop Zasterid treatment.
Uncommon(may affect up to 1 in 100 people):

• rash,
• breast tenderness or enlargement,
• ejaculation disorder.

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

• hypersensitivity reactions, including swelling of the lips, tongue, and face,
• depression,
• decreased sex drive, which may persist after treatment has stopped,
• blood in semen,
• palpitations (feeling of irregular, rapid, or forceful heartbeat),
• increased liver enzyme activity,
• itching, hives,
• testicular pain,
• sexual dysfunction (inability to achieve an erection and problems with ejaculation) persisting after treatment has stopped,
• male infertility and/or poor semen quality. After finasteride withdrawal, return to normal or improved semen quality has been reported,
• rarely, development of breast cancer.
• anxiety.

Immediately report to your doctor any changes in breast tissue, such as lumps, pain, enlargement, or discharge, as these may be signs of serious conditions, such as breast cancer.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist, or nurse. 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:
Jerozolimskie Avenue 181C
02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
e-mail: [email protected].
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Zasterid

Store in the original package 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 month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Zasterid contains

• The active substance is finasteride. Each film-coated tablet contains 5 mg of finasteride.
• The other ingredients are:

Tablet core: magnesium stearate, talc, starch, microcrystalline cellulose, sodium carboxymethyl cellulose (type A), lactose monohydrate (102.25 mg).
Coating: titanium dioxide (E171), lactose monohydrate (0.3809 mg), macrogol 6000, hydroxypropyl cellulose, hypromellose.

What Zasterid looks like and contents of the pack

White or almost white, slightly convex, film-coated tablets in the shape of a triangle with rounded edges, with the inscription "RG" on one side.
28 film-coated tablets

Marketing authorization holder and manufacturer

Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary
For more information about this medicine, contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Tel. +48 (22)755 96 48
[email protected]
fax: +48 (22) 755 96 24

Date of last revision of the leaflet: