Simasteride

Package Leaflet: Information for the User

Symasteride, 5 mg, Film-Coated Tablets

Finasteride
This Medication is for Use in Men Only

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this Package Leaflet, You May Need to Read it Again.
• If You Have any Further Questions, Ask Your Doctor or Pharmacist.
• This Medication 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 Package Leaflet, Tell Your Doctor or Pharmacist. See Section 4.

Package Leaflet Contents

• 1. What is Symasteride and What is it Used for
• 2. Important Information Before Taking Symasteride
• 3. How to Take Symasteride
• 4. Possible Side Effects
• 5. How to Store Symasteride
• 6. Contents of the Package and Other Information

1. What is Symasteride and What is it Used for

Finasteride, the Active Substance of Symasteride, is a 5-Alpha Reductase Inhibitor, an Enzyme that Converts Testosterone (Male Sex Hormone) into a More Potent Dihydrotestosterone (DHT). Symasteride Causes a Reduction in the Size of the Prostate Gland.
Symasteride is Used in a Condition Called Benign Prostatic Hyperplasia.
The Prostate Gland, Located in the Area of the Urinary Bladder, has Enlarged, Causing Difficulty in Urinating.
Symasteride is Indicated for the Treatment of Benign Prostatic Hyperplasia to:

• Relieve Symptoms,
• Reduce the Risk of Acute Urinary Retention,
• Reduce the Risk of Needing Surgery, including Transurethral Resection of the Prostate (TURP) and Prostatectomy (Surgical Removal of the Prostate).

2. Important Information Before Taking Symasteride

What You Need to Know Before and During Treatment with Symasteride

If Your Sexual Partner is Pregnant or May Become Pregnant, You Should Avoid Exposing her to Your Semen, which may Contain Small Amounts of the Medication.

When Not to Take Symasteride:

• If You are Allergic (Hypersensitive) to the Active Substance or any of the Other Ingredients of this Medication (Listed in Section 6),
• In Women who are Pregnant or May Become Pregnant. 1

Symasteride is not Indicated for Use in Women.

Warnings and Precautions

Before Starting Treatment with Symasteride, Discuss it with Your Doctor.
Tell Your Doctor about all Your Current or Past Illnesses and Allergies.
Benign Prostatic Hyperplasia is a Condition that Develops Over Many Years, and it may Take Some Time to Notice Symptoms. Symasteride may Relieve Symptoms and Allow for Control of the Disease if Taken Regularly for a Long Time.

Children

Symasteride is not Indicated for Use in Children.

Mood Changes and Depression

Patients Taking Symasteride have Reported Mood Changes, such as Depressive Mood and Depression, and Rarely, Suicidal Thoughts. If You Experience any of these Symptoms, Seek Medical Advice Immediately.

Symasteride and Other Medications

Tell Your Doctor about all Medications You are Currently Taking or Plan to Take. Symasteride Usually Does not Affect the Action of Other Medications.

Taking Symasteride with Food, Drink, and Alcohol

Symasteride can be Taken with or Without Food.

Pregnancy and Breastfeeding Pregnancy

Women who are Pregnant or Breastfeeding, or Think They may be Pregnant, or are Planning to Have a Child, must not Take this Medication. They should also not Handle Crushed or Broken Symasteride Tablets.
If the Active Substance of the Medication Enters the Body (Orally or Through Skin Contact) of a Pregnant Woman, it may Cause Abnormalities in the Development of the Male Fetus's Genital Organs. If a Pregnant Woman is Exposed to the Active Substance of Symasteride, She should Inform Her Doctor. The Tablets are Coated to Prevent Direct Contact with the Active Substance, Provided that the Tablets are not Damaged or Crushed.
Your Doctor can Provide More Information on this.

Driving and Using Machines

There is no Evidence to Suggest that Finasteride Affects the Ability to Drive or Operate Machinery.

Symasteride Contains Lactose Monohydrate

If You have been Diagnosed with an Intolerance to Some Sugars, Consult Your Doctor Before Taking the Medication.

Symasteride Contains Sodium

The Medication Contains Less than 1 mmol (23 mg) of Sodium per Film-Coated Tablet, which means it is Essentially Sodium-Free.

3. How to Take Symasteride

This Medication should Always be Taken as Directed by Your Doctor. If You have any Questions, Ask Your Doctor.
The Recommended Dose is One 5 mg Tablet per Day, which can be Taken with or Without Food.
The Medication should be Taken Orally.
Remember that Benign Prostatic Hyperplasia is a Long-Term Condition, and it may Take Some Time to Notice Symptoms. Symasteride may Relieve Symptoms and Allow for Control of the Disease if Taken Regularly for a Long Time.

Taking Symasteride in Patients with Kidney or Liver Impairment

No Dose Adjustment is Required in Patients with Kidney or Liver Impairment.

Taking Symasteride in the Elderly

No Dose Adjustment is Required in the Elderly.

Taking More than the Recommended Dose of Symasteride

If You Take More Tablets than Recommended, Contact Your Doctor Immediately.

Missing a Dose of Symasteride

Take Symasteride as Directed by Your Doctor. If You Miss a Dose, Do not Take an Extra Tablet. The Next Day, Continue with the Prescribed Dose.
If You have any Further Questions on the Use of this Medication, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Symasteride can Cause Side Effects, although not Everybody gets them.
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 Disappear During Treatment. However, if the Side Effects Persist, Consult Your Doctor, who may Decide to Stop the Treatment with Symasteride.
Uncommon(may affect up to 1 in 100 people):

• Rash,
• Ejaculation Disorders,
• Enlargement and/or Tenderness of the Breasts.

Frequency Not Known(cannot be estimated from the available data):
Stop Taking the Medication 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: Swelling of the Lips, Tongue, Throat, or Face,
• Depression,
• Persistent Decreased Sex Drive after Stopping Treatment,
• Palpitations,
• Changes in Liver Function, which may be Visible in Blood Tests,
• Itching, Hives,
• Testicular Pain,
• Impotence that Persists after Stopping the Medication,
• Ejaculation Disorders that Persist after Stopping the Medication,
• Male Infertility and/or Poor Sperm Quality (Improvement in Sperm Quality has been Reported after Stopping the Medication),
• Anxiety,
• Rarely, Breast Cancer.

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 those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. Side Effects can be Reported Directly to the Department of Medicinal Product Monitoring, 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.
Side Effects can also be Reported to the Marketing Authorization Holder.
Reporting Side Effects will Help to Gather More Information on the Safety of this Medication.

5. How to Store Symasteride

Keep the Medication out of Sight and Reach of Children.
There are no Special Requirements for Storing the Medication.
Do not Use this Medication after the Expiration Date Stated on the Carton after EXP. The Expiration Date refers to the Last Day of the Month Stated.
Do not Throw Away Medications via Wastewater or Household Waste. Ask Your Pharmacist how to Dispose of Medications that are no Longer Needed. This will Help Protect the Environment.

6. Contents of the Package and Other Information

What Symasteride Contains

The Active Substance is Finasteride.
Each Film-Coated Tablet Contains 5 mg of Finasteride.
The Other Ingredients are:
Tablet Core:
Lactose Monohydrate, Microcrystalline Cellulose, Maize Starch, Lauryl Macrogolglycerides, Sodium Carboxymethylcellulose (Type A), Magnesium Stearate.
Coating:
Hypromellose 6cps, Titanium Dioxide (E171), Indigo Carmine (E132), Lacquer, Macrogol 6000.

What Symasteride Looks Like and Contents of the Package

Symasteride Film-Coated Tablets are Blue, Round, 7 mm in Diameter, and Marked with "F5" on one Side.
Package Sizes:
Aluminium/PVC Blister Pack in a Carton:
7, 10, 14, 15, 20, 28, 30, 50, 60, 90, 98, 100 Film-Coated Tablets.
28x1, 30x1, 50x1, 98x1, 100x1 Film-Coated Tablets in a Divisible Blister Pack.
HDPE Bottle with LDPE Cap:
100, 250, 500 Film-Coated Tablets.
Not all Package Sizes may be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw

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

This Medicinal Product is Authorized in the Member States of the European Economic Area under the Following Names:

Poland:
Symasteride
Date of Last Revision of the Package Leaflet:May 2025