Symasteride

Patient Information Leaflet

Symasteride, 5 mg, film-coated tablets
Finasteridum
MEDICINAL PRODUCT FOR USE IN MALES ONLY
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Symasteride is and what it is used for

Finasteride, the active substance in Symasteride, is an inhibitor of 5-alpha reductase, an enzyme that converts testosterone (a male sex hormone) into the more potent dihydrotestosterone (DHT). Symasteride reduces the volume of the prostate gland.

Symasteride is used in a condition called benign prostatic hyperplasia. The prostate gland, located near the urinary bladder, has enlarged, causing difficulties in urination.

Symasteride is indicated for the treatment of benign prostatic hyperplasia to:

• alleviate 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 Symasteride

What you should know before taking and while using Symasteride
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 medicine, should be avoided.

When not to use Symasteride:

• if the patient is allergic (hypersensitive) to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• in pregnant women and women of childbearing potential. 1

Symasteride is not indicated for use in women.

Warnings and precautions

Before starting treatment with Symasteride, discuss this with your doctor.
Inform your doctor about all current or past medical conditions and any allergies.

Benign prostatic hyperplasia is a slowly progressive condition. In some patients, symptoms may improve shortly after starting therapy. However, treatment for at least 6 months may be necessary to achieve the full therapeutic effect. Regardless of whether symptoms improve, treatment with Symasteride may reduce the risk of acute urinary retention and the need for surgical intervention. 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; however, both conditions may coexist. Only a doctor can properly assess symptoms and their probable cause.

Treatment with Symasteride may affect PSA test (prostate-specific antigen) results. Therefore, inform your doctor before undergoing this test that you are taking Symasteride.

Symasteride is indicated exclusively for use in men for the treatment of benign prostatic hyperplasia.

Children
Symasteride is not indicated for use in children.

Mood changes and depression
Mood changes such as depressive mood and depression, and less frequently suicidal thoughts, have been reported in patients taking Symasteride. If any of these symptoms occur, seek immediate medical advice from your doctor.

Symasteride with 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. Symasteride usually does not affect the action of other concomitantly used medicines.

Taking Symasteride with food, drink and alcohol
Symasteride may be taken regardless of meals.

Pregnancy and breastfeeding

Pregnancy
Women who are pregnant or breastfeeding, suspect they may be pregnant, or are planning to have a child must not use this medicine. They should also not handle crushed or broken Symasteride tablets.

If the active substance of the medicine is absorbed into the body (by oral administration or through skin contact) of a pregnant woman carrying a male fetus, it may cause developmental abnormalities of the fetal genital organs. Any case of exposure of a pregnant woman to the active substance of Symasteride should be reported to a doctor. Symasteride 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 not known whether finasteride passes into human milk.

Driving and operating machinery
There are no data indicating that finasteride affects the ability to drive or operate machinery.

Symasteride contains lactose monohydrate
If the patient has been previously diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Symasteride contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, meaning the medicine is considered "sodium-free".

3. How to use Symasteride

This medicine should always be taken as prescribed by a doctor. If in doubt,
consult your doctor.
The recommended dose is one 5 mg tablet daily, regardless of meals.
The medicine should be taken orally.
Keep in mind that benign prostatic hyperplasia is a process that develops over many years before
symptoms become noticeable. Symasteride may relieve symptoms and help control the progression of
the disease if taken regularly over a long period.
Use of Symasteride in patients with renal and/or hepatic impairment
No dose adjustment is required in patients with any degree of renal and/or hepatic impairment.
Use of Symasteride in elderly patients
No dose adjustment is required in elderly patients.
Taking more than the recommended dose of Symasteride
If more tablets than recommended have been taken, contact a doctor immediately.
Missed dose of Symasteride
Symasteride 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 about 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 (may occur in 1 to 10 out of 100 people):

• decreased libido,
• erectile dysfunction (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 reactions persist, consult your doctor, who may decide to discontinue treatment with Symasteride.

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

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

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

Discontinue use of Symasteride and contact your doctor immediately if any of the following symptoms occur (angioedema): swelling of the face, tongue or throat, difficulty swallowing, urticaria, and breathing difficulties.

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

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

Reporting of 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, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 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 enhance the safety information available for this medicine.

5. How to store the medicine Symasteride

Keep this medicine out of the sight and reach of children.
No special storage instructions apply to this medicine.
Do not use this medicine after the expiry date stated on the carton 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 required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Symasteride contains
The active substance is finasteride.
Each coated tablet contains 5 mg of finasteride.
The other components are:
Tablet core:
monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, glyceryl monostearate,
sodium carboxymethyl starch (type A), magnesium stearate.
Coating:
hypromellose 6 cps, titanium dioxide (E171), indigo carmine (E132), shellac, polyethylene glycol 6000.

What Symasteride looks like and contents of the packaging
Symasteride coated tablets are blue, round, with a diameter of 7 mm, marked with "F5" on one side.

Pack sizes:
Aluminum/PVC blister in cardboard box:
7, 10, 14, 15, 20, 28, 30, 50, 60, 90, 98, 100 coated tablets.
28x1, 30x1, 50x1, 98x1, 100x1 coated tablets in dose-divided blisters.
HDPE bottle with LDPE cap:
100, 250, 500 coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw, Poland

Manufacturer/Importer:
Zentiva k.s.
U Kabelovny 130, 102 37 Praha 10, Czech Republic
Farmak International Sp. z o.o., ul. Chełmżyńska 249, 04-458 Warsaw, Poland

This medicinal product is authorised for sale in the European Economic Area countries under the following names:
Poland: Symasteride