Finaran

Package Leaflet: Information for the Patient

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

1. What is Finaran and What is it Used for

Finasteride, the Active Substance of Finaran, is a 5-Alpha Reductase Inhibitor, an Enzyme that Converts Testosterone (Male Sex Hormone) into a More Potent Dihydrotestosterone (DHT). Finaran Causes a Reduction in Prostate Volume.
Finaran 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.
This Medication is Indicated for the Treatment of Benign Prostatic Hyperplasia to:

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

2. Important Information Before Taking Finaran

What You Need to Know Before and During Treatment with Finaran

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 Finaran

• 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 of Childbearing Age. Finaran is not Indicated for Use in Women.

Warnings and Precautions

Before Starting Treatment with Finaran, Discuss it with Your Doctor.
Tell Your Doctor about any Current or Past Illnesses and Allergies.
Benign Prostatic Hyperplasia is a Condition that Develops Over Many Years Before Symptoms Become Apparent. Finaran may Relieve Symptoms and Allow Control of the Condition if Taken Regularly Over a Long Period.

Mood Changes and Depression

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

Children

Finaran is not Indicated for Use in Children.

Finaran and Other Medications

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

Pregnancy and Breastfeeding Pregnancy

Women who are Pregnant or of Childbearing Age Must not Take this Medication. They Should also not Handle Crushed or Broken Finaran Tablets. If the Active Substance of Finaran Enters the Body (Orally or Through Skin Contact) of a Pregnant Woman, it may Cause Abnormal Development of the Fetus's Genital Organs. If a Pregnant Woman is Exposed to the Active Substance of Finaran, She Should Inform Her Doctor. The Tablets are Film-Coated to Prevent Direct Contact with the Active Substance, Provided that the Tablets are not Damaged or Broken. Your Doctor can Provide More Information on this.

Driving and Operating Machinery

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

Finaran Contains Lactose

If You have been Diagnosed with an Intolerance to some Sugars, You Should Consult Your Doctor Before Taking this Medication.

Finaran Contains Sodium

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

3. How to Take Finaran

This Medication Should Always be Taken as Directed by Your Doctor. If You have any Questions, Ask Your Doctor.
If You are Unsure, Consult Your Doctor.
The Recommended Dose is One 5 mg Tablet per Day, Regardless of Meals.
The Medication Should be Taken Orally.
Remember that Benign Prostatic Hyperplasia Develops Over Many Years Before Symptoms Become Apparent. Finaran may Relieve Symptoms and Allow Control of the Condition if Taken Regularly Over a Long Period.

Taking Finaran in Patients with Renal and/or Hepatic Impairment

No Dose Adjustment is Required in Patients with Renal Impairment of any Degree and/or Hepatic Impairment.

Taking Finaran in the Elderly

No Dose Adjustment is Required in the Elderly.

Overdose of Finaran

In Case of Overdose, Seek Medical Attention Immediately.

Missing a Dose of Finaran

Take Finaran as Directed by Your Doctor. If You Miss a Dose, Do Not Take an Extra Tablet. Continue with the Next Scheduled Dose as Directed by 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, Finaran can Cause Side Effects, although not Everybody Gets them.
Common(may Affect up to 1 in 10 People):

• Decreased Libido,
• Impotence (Inability to Achieve an Erection),
• Decreased Ejaculate Volume (Semen Quantity). This Does Not Affect Normal Sexual Function.

In Some Cases, these Symptoms may Resolve During Treatment. However, if Side Effects Persist, Consult Your Doctor, who may Decide to Discontinue Treatment.
Uncommon(may Affect up to 1 in 100 People):

• Rash,
• Ejaculation Disorders,
• Breast Enlargement and/or Tenderness.

Frequency Not Known(Frequency Cannot be Estimated from the Available Data):
Stop Taking this Medication and Seek Medical Attention Immediately if You Experience any of the Following Symptoms (Angioedema): Face, Lip, Tongue, or Throat Swelling, Difficulty Swallowing, Hives, and Difficulty Breathing.

• Allergic Reactions: Lip, Tongue, Throat, or Face Swelling,
• Depression,
• Persistent Decreased Libido After Discontinuation of Treatment,
• Blood in Semen,
• Palpitations,
• Changes in Liver Function, which may be Visible in Blood Tests,
• Itching, Hives,
• Testicular Pain,
• Impotence that Persists After Discontinuation of the Medication,
• Ejaculation Disorders that Persist After Discontinuation of the Medication,
• Male Infertility and/or Poor Semen Quality (Improvement in Semen Quality has been Reported After Discontinuation of the Medication),
• Rarely, Development of Breast Cancer,
• Anxiety.

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, including Breast Cancer.

Reporting Side Effects

If You Experience any Side Effects, including those not Listed in this Package Leaflet, Tell Your Doctor, Pharmacist, or Nurse.
Side Effects can be Reported Directly to the Department of Medicinal Product Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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 Finaran

Keep this Medication out of the Sight and Reach of Children.
There are no Special Precautions for Storage.
Do not Use this Medication after the Expiry Date Stated on the Blister and Outer Packaging. The Expiry Date refers to the Last Day of the Month.
Medications should not be Disposed of via Wastewater or Household Waste. Ask Your Pharmacist how to Dispose of Medications no Longer Needed. This will Help Protect the Environment.

6. Package Contents and Other Information

What Finaran Contains

• The Active Substance is Finasteride. One Film-Coated Tablet Contains 5 mg of Finasteride.
• The Other Ingredients are: Lactose Monohydrate, Microcrystalline Cellulose, Pregelatinized Maize Starch, Sodium Lauryl Sulfate, Magnesium Stearate. The Film Coating Sepifilm 002 Contains: Hypromellose, Microcrystalline Cellulose, Macrogol 8000 Stearate (Type I).

What Finaran Looks Like and Contents of the Package

Finaran Film-Coated Tablets are White, Round, Biconvex, 7 mm in Diameter, with ‘F’ and ‘5’ Engraved on one Side.
Finaran PVC/PVDC/Aluminium Blisters are Available in Packs of 15, 30, and 90 Tablets.
Not all Pack Sizes may be Marketed.

Marketing Authorization Holder:

Ranbaxy (Poland) Sp. z o.o., Idzikowskiego 16, 00 – 710 Warsaw

Manufacturer:

Siegfried Malta Ltd
HHF070 Hal Far Industrial Estate
Hal Far BBG3000
Malta
Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster, Germany
Date of Last Revision of the Package Leaflet:02.05.2023