Finpros 5 mg

Package Leaflet: Information for the Patient

Finpros 5 mg, Film-Coated Tablets

Finasteride

Read All of This Leaflet Carefully Before Taking This Medicine Because It Contains Important Information for You.

• 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 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 of the Following Side Effects, or Any Other Unwanted Effects Not Listed in This Leaflet, Tell Your Doctor or Pharmacist. See Section 4.

Table of Contents of the Leaflet

• 1. What Is Finpros and What Is It Used For
• 2. Important Information Before Taking Finpros
• 3. How to Take Finpros
• 4. Possible Side Effects
• 5. How to Store Finpros
• 6. Contents of the Pack and Other Information

1. What Is Finpros and What Is It Used For

Finpros Belongs to a Group of Medicines Called 5-Alpha-Reductase Inhibitors. These Work by Reducing the Size of the Prostate Gland in Men.
Finpros Is Used to Treat and Prevent the Progression of Mild to Moderate (Non-Cancerous) Enlargement of the Prostate Gland.

2. Important Information Before Taking Finpros

When Not to Take Finpros

• If You Are Allergic to Finasteride or Any of the Other Ingredients of This Medicine (Listed in Section 6),
• In Women (See Also Section on Pregnancy and Breast-Feeding) or Children.

Warnings and Precautions

You Should Consult Your Doctor or Pharmacist Before Taking Finpros:

• In Case of Liver Function Disorders.
• In Case of Difficulty Completely Emptying the Bladder or Significantly Impaired Urine Flow, Your Doctor Should Examine You Carefully Before Taking Finpros to Rule Out Other Obstructions in the Urinary Tract.
• In Case You Need to Have a Blood Test Called Prostate-Specific Antigen (PSA) Test, You Should Inform Your Doctor or Nurse About Taking This Medicine, as Finasteride May Alter the Test Results.

If Your Sexual Partner Is or May Become Pregnant, You Should Avoid Exposing Her to Semen That May Contain Small Amounts of the Medication (See Also Section on Pregnancy and Breast-Feeding).

Mood Changes and Depression

Mood Changes, Such as Depressive Mood and Depression, and Rarely Suicidal Thoughts, Have Been Reported in Patients Taking Finpros. If You Experience Any of These Symptoms, You Should Stop Taking Finpros and Consult Your Doctor for Further Medical Advice.

Children

Finpros Should Not Be Taken by Children.

Finpros and Other Medicines

Tell Your Doctor or Pharmacist About All Medicines You Are Taking Now or Have Recently Taken, as Well as Any Medicines You Plan to Take.
Finpros Can Usually Be Taken with Other Medicines.

Finpros with Food and Drink

Finpros Can Be Taken with or Without Food.

Pregnancy and Breast-Feeding

Finpros Is for Use in Men Only.
If Your Sexual Partner Is or May Become Pregnant, You Should Avoid Exposing Her to Semen That May Contain Small Amounts of the Medication.

Women Who Are Pregnant or May Become Pregnant Should Not Handle Crushed or Broken

Finpros Tablets.Absorption of Finasteride Through the Skin or Ingestion by a Pregnant Woman Carrying a Male Fetus May Cause the Birth of a Child with Genital Abnormalities.
The Tablets Are Film-Coated, Which Prevents Contact with Finasteride Contained in the Tablets That Have Not Been Crushed or Broken.

Driving and Using Machines

There Is No Evidence to Suggest That Finpros Affects the Ability to Drive or Operate Machines.

Finpros Contains Lactose and Sodium

If You Have Been Told by Your Doctor That You Have an Intolerance to Some Sugars, Contact Your Doctor Before Taking This Medicinal Product.
This Medicinal Product Contains Less Than 1 Mmol Sodium (23 Mg) per Tablet, Which Means It Is Essentially Sodium-Free.

3. How to Take Finpros

This Medicine Should Always Be Taken Exactly as Your Doctor Has Told You. If You Are Not Sure, Consult Your Doctor or Pharmacist.
The Usual Dose Is One Tablet per Day.
The Tablet Should Be Swallowed Whole, Without Crushing or Chewing. The Medication Can Be Taken with or Without Food.
Although Improvement Is Often Seen Within a Short Period, Treatment for at Least 6 Months May Be Necessary. Do Not Change the Dose or Stop Treatment Without Consulting Your Doctor.
Your Doctor May Prescribe Finpros Along with Another Medication (e.g., Doxazosin) to Help Control BPH.
If You Have Any Further Questions on the Use of This Product, Ask Your Doctor or Pharmacist.

Taking More Than the Recommended Dose of Finpros

Contact Your Doctor, Go to the Accident and Emergency Department of Your Nearest Hospital, or Contact the Poisons Information Centre for Advice.

Forgetting to Take a Dose of Finpros

Do Not Take a Double Dose to Make Up for a Forgotten Dose. Take the Next Dose at the Normal Time.
If You Have Any Further Questions on the Use of This Product, Ask Your Doctor or Pharmacist.

4. Possible Side Effects

Like All Medicines, This Medicine Can Cause Side Effects, Although Not Everybody Gets Them.

Stop Taking Finpros and Contact Your Doctor Immediately If You Experience Any of the Following Side Effects:

• Swelling of the Face, Tongue, or Throat,
• Difficulty Swallowing,
• Hives and Difficulty Breathing. The Above Side Effects May Be Signs of an Allergic Reaction, Such as Angioedema, Which Has Been Reported as an Uncommon Side Effect (Frequency Cannot Be Estimated from the Available Data).

Other Side Effects:
Common Side Effects (May Affect Up to 1 in 10 People):

• Impotence,
• Decreased Libido,
• Reduced Semen Volume.

Uncommon Side Effects (May Affect Up to 1 in 100 People):

• Rash,
• Breast Tenderness and/or Enlargement,
• Difficulty Achieving Ejaculation.

Side Effects with Unknown Frequency (Frequency Cannot Be Estimated from the Available Data):

• Depression,
• Anxiety,
• Decreased Libido, Which May Continue After Stopping Treatment,
• Palpitations (Feeling of a Strong Heartbeat),
• Changes in Liver Function Tests,
• Itching, Hives,
• Testicular Pain,
• Blood in Semen,
• Erectile Dysfunction, Which May Continue After Stopping Treatment,
• Ejaculation Disorders, Which May Continue After Stopping Treatment,
• Infertility and/or Poor Semen Quality. Improvement in Semen Quality Has Been Observed After Stopping Treatment.

You Should Immediately Inform Your Doctor If You Notice Any Changes in Your Breasts, Such as Lumps, Pain, Enlargement, or Discharge from the Nipples, as These May Be Signs of a Serious Condition, Such as Breast Cancer.

Reporting Side Effects

If You Experience Any Side Effects, or Any Other Unwanted Effects Not Listed in This Leaflet, Tell Your Doctor or Pharmacist. 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:
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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.
By Reporting Side Effects, You Can Help Provide More Information on the Safety of This Medication.

5. How to Store Finpros

Keep This Medicinal Product Out of the Sight and Reach of Children.
Do Not Use This Medicinal Product After the Expiry Date Stated on the Packaging. The Expiry Date Refers to the Last Day of the Month Stated on the Packaging.
There Are No Special Precautions for Storage.
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 Finpros Contains

• The Active Substance Is Finasteride. Each Film-Coated Tablet Contains 5 Mg of Finasteride.
• The Other Ingredients Are: Lactose Monohydrate, Microcrystalline Cellulose, Pregelatinized Maize Starch, Lauryl Macrogolglycerides, Sodium Carboxymethylcellulose (Type A), Magnesium Stearate in the Tablet Core; the Tablet Coating Contains Hypromellose 6 Cps, Macrogol 6000, Titanium Dioxide (E171), and Indigo Carmine (E132), Aluminum Lake. See Section 2 "Finpros Contains Lactose and Sodium".

What Finpros Looks Like and Contents of the Pack

Finpros Film-Coated Tablets Are Blue, Round, Biconvex, with "F5" Engraving, 7 Mm in Diameter.
Packaging: 28, 30, 60, or 90 Film-Coated Tablets in Blisters, in a Cardboard Box.

Marketing Authorization Holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Actavis hf., Reykjavikurvegur 78, IS-220 Hafnarfjördur, Iceland

This Medicinal Product Is Authorized in the Member States of the European Economic Area Under the Following Names:

Date of Last Revision of the Leaflet:22.12.2021