Finasteridum Bluefish

Package Leaflet: Information for the User

Finasteridum Bluefish, 5 mg, Film-Coated Tablets

Finasteridum

Read All of This Leaflet Carefully Before Taking This Medicine.

• Keep This Leaflet. You May Need to Read It Again.
• If You Have Any Further Questions, Ask Your Doctor, Pharmacist, or Nurse.
• 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 of the Following Symptoms, Tell Your Doctor, Pharmacist, or Nurse. See Section 4.

Contents of the Pack

• 1. What is Finasteridum Bluefish and What is It Used For
• 2. Before You Take Finasteridum Bluefish
• 3. How to Take Finasteridum Bluefish
• 4. Possible Side Effects
• 5. How to Store Finasteridum Bluefish
• 6. Contents of the Pack and Other Information

1. What is Finasteridum Bluefish and What is It Used For

Finasteride belongs to a group of medicines called 5-alpha reductase inhibitors.
These medicines work by reducing the size of an enlarged prostate gland in men.
Finasteridum Bluefish is used to treat and control benign prostatic hyperplasia (BPH), a non-cancerous enlargement of the prostate gland. The medicine reduces the size of the enlarged prostate gland, improves urine flow, and relieves symptoms caused by BPH, as well as reduces the risk of sudden inability to urinate (called acute urinary retention) and the need for surgical intervention.

2. Before You Take Finasteridum Bluefish

When Not to Take Finasteridum Bluefish

• If You Are Allergic to Finasteride or Any of the Other Ingredients of This Medicine (Listed in Section 6).
• Because Finasteride is Indicated for Use Only in Men, Women (See Also Section on Pregnancy and Breast-Feeding) and Children Should Not Take This Medicine.

Warnings and Precautions

Before Taking Finasteridum Bluefish, Discuss This with Your Doctor, Pharmacist, or Nurse.

• If You Have a Large Amount of Urine Left in the Bladder After Urinating and (or) a Significantly Reduced Urine Flow. In Such Cases, You Should Be Closely Monitored for Narrowing of the Urinary Tract.
• If You Have Liver Function Disorders, the Concentration of Finasteride in the Blood May Increase.
• If Your Sexual Partner is Pregnant or May Become Pregnant, You Should Avoid Exposing Her to Your Semen, as It May Contain Small Amounts of the Medicine.
• If You Are Going to Have a Blood Test to Measure the Level of a Substance Called Prostate-Specific Antigen (PSA), You Should Inform Your Doctor That You Are Taking Finasteride, as It May Affect the Test Results.

If Any of the Above Applies to You, Tell Your Doctor.
You Should Immediately Inform Your Doctor of Any Changes in Breast Tissue, Such as Lumps, Pain, Enlargement of the Breasts, or Discharge from the Nipple, Which May Be Signs of Serious Conditions, Such as Breast Cancer.
You Should Discuss Any Health Problems with Your Doctor, Including Allergies.
What You Should Know Before Taking Finasteridum Bluefish?
BPH Develops Over a Long Time. Some Patients May Experience Early Improvement in Symptoms, but in Some Cases, It May Be Necessary to Take Finasteridum Bluefish for at Least 6 Months to See a Beneficial Effect.
Regardless of Whether You Notice an Improvement or Changes in Symptoms, Treatment with Finasteridum Bluefish May Reduce the Risk of Sudden Inability to Urinate or the Need for Surgical Intervention. You Should Maintain Regular Contact with Your Doctor to Periodically Assess the Progress of Your Condition.
Although BPH is Not Cancerous and Does Not Lead to Cancer, These Two Conditions Can Occur Together. Only Your Doctor Can Assess Your Symptoms and Their Possible Causes.
Finasteride May Affect a Blood Test Called PSA. If You Have Had a PSA Test, You Should Inform Your Doctor That You Are Taking Finasteride.
What Other Precautions Should You Take?
Finasteridum Bluefish is Indicated Only for the Treatment of BPH in Men.
Pregnant or Potentially Pregnant Women Should Not Take Finasteridum Bluefish.
You Should Not Crush or Chew the Tablets. If the Active Substance of Finasteridum Bluefish is Absorbed Through the Mouth or Skin by a Pregnant Woman, It May Cause Deformation of the Genital Organs of the Male Fetus. If a Pregnant Woman Comes into Contact with the Active Substance of Finasteridum Bluefish, She Should Consult a Doctor.
The Tablets of Finasteridum Bluefish are Coated, Which Prevents Contact with the Active Substance During Normal Use, Provided That the Tablets Are Not Crushed or Broken.
In Case of Doubt, Consult Your Doctor.

Finasteridum Bluefish and Other Medicines

Finasteridum Bluefish is Not Expected to Interact with Other Medicines.
No Significant Interactions with Other Medicines Have Been Found.
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.

Finasteridum Bluefish with Food and Drink

Finasteridum Bluefish Can Be Taken with or Without Food.

Pregnancy and Breast-Feeding

Finasteridum Bluefish is for Use in Men Only.(See Also Section on Precautions).
If Your Sexual Partner is Pregnant or May Become Pregnant, You Should Avoid Exposing Her to Your Semen (e.g., by Using a Condom), as It May Contain Small Amounts of the Medicine, or Stop Taking Finasteride. If a Pregnant Woman Has Come into Contact with Finasteride, She Should Consult a Doctor.

Driving and Using Machines

Finasteride Should Not Affect Your Ability to Drive or Use Machines.

Finasteridum Bluefish Contains Lactose Monohydrate

If You Have Been Told by Your Doctor That You Have an Intolerance to Some Sugars, Contact Your Doctor Before Taking This Medicinal Product.

Finasteridum Bluefish Contains Sodium

This Medicinal Product Contains Less Than 1 mmol (23 mg) of Sodium per Tablet, Which Means It is Essentially Sodium-Free.

Mood Changes and Depression

In Patients Taking Finasteridum Bluefish, Mood Changes, Such as Depressive Mood, and Depression, as Well as Suicidal Thoughts, Have Been Observed. If You Experience Any of These Symptoms, You Should Immediately Consult Your Doctor for Further Medical Advice.

3. How to Take Finasteridum Bluefish

This Medicine Should Always Be Taken Exactly as Your Doctor Has Told You. If You Are Not Sure, Ask Your Doctor or Pharmacist.
The Recommended Dose is One Tablet a Day (Equivalent to 5 mg of Finasteride), Every Day, with or Without Food. Follow Your Doctor's Instructions.
Swallow the Tablet Whole and Do Not Crush or Chew It.
Although Improvement in Symptoms May Occur Early, It May Be Necessary to Take Finasteridum Bluefish for at Least 6 Months to Assess Whether a Beneficial Response to Treatment Has Been Achieved.
Your Doctor Will Tell You How Long to Take Finasteridum Bluefish. Do Not Stop Taking Finasteridum Bluefish Without Consulting Your Doctor, as Symptoms May Return.

Patients with Liver Function Disorders

There Are No Data on the Use of Finasteridum Bluefish in Patients with Liver Function Disorders (See Also Section on Warnings and Precautions).

Patients with Kidney Function Disorders

No Dose Adjustment is Necessary. No Studies Have Been Conducted on the Use of Finasteridum Bluefish in Patients Undergoing Hemodialysis.

Elderly Patients

No Dose Adjustment is Necessary.
If You Feel That the Effect of Finasteridum Bluefish is Too Strong or Too Weak, Talk to Your Doctor or Pharmacist.

Overdose

If You Take More Finasteridum Bluefish Than Your Doctor Has Prescribed, or If Someone Else Takes Your Medicine, Contact the Nearest Hospital or Doctor Immediately. Bring the Remaining Tablets or the Empty Package with You, So That the Medicine Can Be Easily Identified.

Missed Dose

Take Finasteridum Bluefish as Directed. If You Miss a Dose, Take It as Soon as You Remember, Unless It is Almost Time for Your Next Dose. Do Not Take a Double Dose to Make Up for the Forgotten Dose. Take the Next Tablet at the Scheduled Time.

Stopping Treatment

Do Not Stop Treatment Unless Your Doctor Tells You to.
Remember That Prostate Enlargement Develops Over Many Years. Finasteridum Bluefish Will Only Treat and Control Your Symptoms as Long as You Take the Medicine as 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, Finasteridum Bluefish Can Cause Side Effects, Although Not Everybody Gets Them.
They Are Not Common and Do Not Affect Most Men.
The Following Terms Are Used to Describe the Frequency of Side Effects:
Very Common: Affects More Than 1 in 10 Patients
Common: Affects More Than 1 in 100, but Less Than 1 in 10 Patients
Uncommon: Affects Less Than 1 in 100, but More Than 1 in 1,000 Patients
Rare: Affects Less Than 1 in 1,000, but More Than 1 in 10,000 Patients
Very Rare: Affects Less Than 1 in 10,000 Patients
The Most Common Side Effects Are Impotence (Inability to Achieve an Erection) and Decreased Libido. Some Men May Experience Changes or Problems with Ejaculation, Such as Reduced Semen Volume. This Decrease in Semen Volume Does Not Appear to Affect Normal Sexual Function. In Some Cases, These Side Effects Disappeared During Treatment with Finasteridum Bluefish, but If Symptoms Persist, They Usually Disappear After Stopping Treatment.
Some Men May Also Experience Breast Enlargement and/or Tenderness. Some Have Also Reported the Presence of Blood in Semen, Male Infertility, and/or Poor Semen Quality. Improvement in Semen Quality Has Been Observed After Stopping Treatment.
Immune System Disorders
Unknown:Hypersensitivity Reactions, Including Swelling of the Lips, Tongue, Throat, and Face
Psychiatric Disorders
Common:Decreased Libido
Unknown:Persistent Decreased Libido After Stopping Treatment, Depression, Anxiety
Cardiac Disorders
Unknown:Palpitations
Hepatobiliary Disorders
Unknown:Increased Liver Enzyme Activity
Skin and Subcutaneous Tissue Disorders
Uncommon:Rash
Unknown:Itching, Urticaria
Reproductive System and Breast Disorders
Common:Impotence
Uncommon:Ejaculation Disorders, Breast Tenderness, Breast Enlargement
Unknown:Testicular Pain, Sexual Function Disorders (Decreased Libido, Erectile Dysfunction, and Ejaculation Disorders)
Diagnostic Tests
Common:Decreased Semen Volume
Finasteride May Affect the Results of a Blood Test Called PSA.
You Should Immediately Inform Your Doctor of Any Changes in Breast Tissue, Such as Lumps, Pain, Enlargement of the Breasts, or Discharge from the Nipple, Which May Be Signs of Serious Conditions, Such as Breast Cancer.
You Should Stop Taking Finasteridum Bluefish and Immediately Consult Your Doctor If You Experience Any of the Following Symptoms (Angioedema): Swelling of the Lips, Face, Tongue, or Throat; Difficulty Swallowing; Urticaria and Difficulty Breathing.
If You Experience Any Side Effects, Including Those Not Listed in This Leaflet, You Should Tell Your Doctor, Pharmacist, or Nurse.

Reporting of Side Effects

If You Experience Any Side Effects, Including Those Not Listed in This Leaflet, You Should 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 181 C, 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 Medicine.

5. How to Store Finasteridum Bluefish

Keep This Medicine Out of the Sight and Reach of Children.
There Are No Special Storage Instructions for This Medicinal Product.
Do Not Use This Medicine After the Expiry Date, Which is Stated on the Packaging After "Expiry Date" or "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 Finasteridum Bluefish Contains

The Active Substance is Finasteride. Each Tablet Contains 5 mg of Finasteride.
The Other Ingredients Are:
Tablet Core: Lactose Monohydrate (200 M), Microcrystalline Cellulose (PH 102), Maize Starch, Sodium Starch Glycolate (Type A), Magnesium Stearate.
Opadry Blue 03A80928: Hypromellose 2910/6cP, Titanium Dioxide (E 171), Indigo Carmine (E 132), Aluminum Lake, Talc, Yellow Iron Oxide (E 172).

What Finasteridum Bluefish Looks Like and Contents of the Pack

Film-Coated Tablet
Blue, Round, Biconvex Film-Coated Tablet with "H" Engraved on One Side and "37" on the Other Side.
PVC/PE/PVDC/Aluminum Blister Pack in a Cardboard Box.
15, 28, 30, 50, 60, 90, 98, or 100 Film-Coated Tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Bluefish Pharmaceuticals AB, P.O. Box 49013, 100 28 Stockholm, Sweden, Tel. +46 8 51 91 16 00

Manufacturer

Bluefish Pharmaceuticals AB, Gävlegatan 22, 113 30 Stockholm, Sweden
Pharmadox Healthcare Ltd., KW20A Corradino Industrial Estate, Paola, PLA 3000, Malta

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:September 2024