Finaride

Package Leaflet: Information for the Patient

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

1. What is Finaride and What is it Used for

Finaride Film-Coated Tablets Contain the Active Substance Finasteride, a Medication that Inhibits the Conversion of the Male Sex Hormone Testosterone to the More Potent Androgen Dihydrotestosterone. Finasteride Reduces the Concentration of Dihydrotestosterone in the Blood and in the Prostate, Resulting in a Reduction in Prostate Volume, Improved Urine Flow, and Reduced Tension in the Urinary Bladder Sphincter.
Finaride is Used in the Treatment and Control of Benign Prostatic Hyperplasia to:

• Reduce the Size of an Enlarged Prostate,
• Improve Urine Flow,
• Relieve Symptoms Associated with Benign Prostatic Hyperplasia,
• Reduce the Risk of Acute Urinary Retention and the Need for Surgical Treatment.

This Medication Should be Used in Patients with an Enlarged Prostate (Approximate Prostate Volume of More than 40 ml).

2. Important Information Before Taking Finaride

When Not to Take Finaride

If You are Allergic to Finasteride or any of the Other Ingredients of this Medication (Listed in Section 6),
In Women, Especially Pregnant or Breastfeeding Women, Due to the Risk to the Male Fetus,
In Children.

Warnings and Precautions

Before Taking Finaride, Discuss with Your Doctor if You Currently Have or Have Had:
Kidney Problems,
Liver Problems.
If You Notice any Changes in Your Breasts, such as Lumps, Pain, Enlargement, or Discharge, Tell Your Doctor Immediately.
If You Plan to Father a Child, You Should Consult Your Doctor, as it may be Necessary to Stop Taking Finaride.
Mood Changes and Depression
Patients Taking Finaride 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.

Children and Adolescents

There are no Indications for the Use of Finasteride in Children and Adolescents.

Finaride and Other Medications

Tell Your Doctor or Pharmacist About all Medications You are Currently Taking or Have Recently Taken, as well as any Medications You Plan to Take. This Includes Herbal Products, Health Foods, or Dietary Supplements Available Without a Prescription.
No Clinically Significant Interactions with Other Medications have been Found.

Finaride with Food and Drink

This Medication can be Taken with or Without Food.
Swallow the Tablets Whole (Do not Divide or Crush), with a Glass of Water.

Pregnancy and Breastfeeding

This Medication is for Use in Men Only. Its Use in Women (Especially Pregnant or Breastfeeding Women) is Contraindicated.
Pregnant or Breastfeeding Women Should not Handle Crushed or Broken Finaride Tablets Due to the Risk of Absorption of the Medication Through the Skin and the Risk of Abnormal Development of the External Genitalia in the Male Fetus.
The Film-Coated Finaride Tablets have a Coating that Protects Against Contact with the Active Substance, Provided the Tablets are not Crushed or Broken.
It is not Known Whether Contact Between a Pregnant Woman and the Semen of a Patient Taking Finasteride can Harm the Male Fetus. Therefore, if the Sexual Partner of a Patient Taking Finasteride is Pregnant or May Become Pregnant, the Patient Should Either Avoid Exposure of the Partner to Semen (e.g., by Using a Condom) or Stop Taking Finaride After Consulting a Doctor.

Driving and Operating Machinery

There are no Data to Suggest that Finaride Affects the Ability to Drive or Operate Machinery.

Finaride Contains Lactose and Sodium

If You have been Diagnosed with an Intolerance to Some Sugars, Consult Your Doctor Before Taking this Medication.
This Medication Contains Less than 1 mmol (23 mg) of Sodium per Tablet, which is Considered to be Essentially Sodium-Free.

3. How to Take Finaride

Always Take this Medication Exactly as Your Doctor has Told You. If You are not Sure, Ask Your Doctor or Pharmacist.
Usually, the Dose is 1 Tablet (5 mg) Once a Day.
Use in Patients with Renal Impairment
No Dose Adjustment is Necessary in Patients with Renal Impairment.
Use in Patients with Hepatic Impairment
Your Doctor will Determine the Appropriate Dose for Patients with Hepatic Impairment.
Dosage in the Elderly
No Dose Adjustment is Necessary.
Duration of Treatment
Improvement in Symptoms may Occur Early in Treatment, but it may Take 6 Months or More to Determine if the Treatment is Effective. Continue Taking the Medication as Long as Your Doctor Recommends.

Overdose of Finaride

If You Take More than the Prescribed Dose, Consult Your Doctor or Pharmacist.
There are no Specific Recommendations for the Treatment of Overdose with Finasteride.

Missed Dose of Finaride

If You Miss a Dose, Take the Next Dose at the Usual Time. Do not Take a Double Dose to Make up for the Missed Dose.

Stopping Treatment with Finaride

Do not Stop Taking Finaride Without Consulting Your Doctor.
If You have any Further Questions on the Use of this Medication, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like all Medications, Finaride can Cause Side Effects, although not Everybody gets them.
The Most Common Side Effects are Impotence and Decreased Libido, which Usually Occur at the Beginning of Treatment and are Temporary.
Cases of Breast Cancer have been Reported in Patients Taking Finasteride.
The Following Side Effects have been Observed in Patients Taking Finasteride:
Common (May Affect up to 1 in 10 People):
Impotence, Decreased Libido, Reduced Ejaculate Volume
Uncommon (May Affect up to 1 in 100 People):
Breast Tenderness, Breast Enlargement, Ejaculation Disorders, Skin Rash
Rare (May Affect up to 1 in 10,000 People):
Breast Discharge, Breast Lumps
Frequency not Known (Cannot be Estimated from the Available Data):
Hypersensitivity Reactions, such as Angioedema (Including Swelling of the Lips, Tongue, Throat, and Face, Difficulty Swallowing, Hives, and Difficulty Breathing)*, Palpitations, Increased Liver Enzymes, Testicular Pain, Itching, Hives, Depression, Anxiety, Decreased Libido that Persists after Discontinuation of Treatment, Erectile Dysfunction that Persists after Discontinuation of Treatment, Ejaculation Disorders that Persist after Discontinuation of Treatment, Male Infertility and (or) Poor Semen Quality
* If You Experience any Symptoms of Angioedema, Stop Taking the Medication and Seek Medical Attention Immediately.
Laboratory Test Results
In the First Few Months of Treatment, a Rapid Decrease in Prostate-Specific Antigen (PSA) Levels is Observed, to About Half of the Pre-Treatment Value.

Reporting Side Effects

If You Experience any Side Effects, including those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. You can also Report Side Effects Directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
You can also Report Side Effects to the Marketing Authorization Holder.
By Reporting Side Effects, You can Help Provide More Information on the Safety of this Medication.

5. How to Store Finaride

Keep this Medication out of the Sight and Reach of Children.
Do not Use this Medication After the Expiry Date Stated on the Carton and Blister Pack. The Expiry Date refers to the Last Day of the Month.
Store in a Temperature not Exceeding 25°C.
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. Package Contents and Other Information

What Finaride Contains

The Active Substance is Finasteride. Each Tablet Contains 5 mg of Finasteride.
The Other Ingredients are: Lactose Monohydrate, Microcrystalline Cellulose, Povidone, Sodium Lauryl Sulfate, Magnesium Stearate, Talc, Sodium Carboxymethylcellulose.
Coating:Hypromellose, Propylene Glycol, Titanium Dioxide, Talc, Indigo Carmine (E132).

What Finaride Looks Like and Contents of the Pack

Finaride Film-Coated Tablets are Blue, Round, Biconvex, and Approximately 8 mm in Diameter.
The Pack Contains 30 or 90 Film-Coated Tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder
Synoptis Pharma sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
Importer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
For Further Information, Please Contact:
Synoptis Pharma sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw

Date of Last Revision of the Package Leaflet: