Finxta

Package Leaflet: Information for the User

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

1. What is Finxta and What is it Used for

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

What You Need to Know Before and During Treatment with Finxta

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

When Not to Take Finxta

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

Finxta is Not Indicated for Use in Women.

Warnings and Precautions

Before Starting Treatment with Finxta, You Should Discuss it with Your Doctor.
You Should Inform Your Doctor about any Current or Past Medical Conditions and Allergies.
Benign Prostatic Hyperplasia is a Condition that Develops Over Many Years, and Symptoms may not be Noticeable Until Later. Finxta may Relieve Symptoms and Allow for Control of the Disease if Taken Regularly for a Long Time.

Mood Changes and Depression

Patients Taking Finxta have Reported Mood Changes, such as Depressive Mood, and Depression, and Rarely, Suicidal Thoughts. If You Experience any of these Symptoms, You Should Immediately Consult Your Doctor for Further Medical Advice.

Children

Finxta is Not Indicated for Use in Children.

Finxta and Other Medications

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

Pregnancy and Breastfeeding

Pregnancy
Women who are Pregnant or May Become Pregnant Should Not Take Finxta. They Should Also Not Handle Crushed or Broken Finxta Tablets. If the Active Substance of Finxta Enters the Body (Orally or Through Skin Contact), it may Cause Abnormalities of the Male Genitalia in the Fetus. If a Pregnant Woman is Exposed to the Active Substance of Finxta, She Should Inform Her Doctor. The Film-Coated Tablets of Finxta Prevent Direct Contact with the Active Substance, Provided that the Tablets are Not Damaged or Crushed.
More Information is Available from Your Doctor.
Breastfeeding
Finxta is Not Indicated for Use in Women.
It is Not Known if Finasteride Passes into Human Milk.

Driving and Using Machines

There are No Data to Suggest that Finxta Affects the Ability to Drive or Use Machines.

Finxta Contains Lactose

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

3. How to Take Finxta

This Medication Should Always be Taken Exactly as Prescribed by Your Doctor. If You are Unsure, Consult Your Doctor or Pharmacist.
The Recommended Dose is One 5 mg Tablet per Day, Regardless of Meals.
The Medication Should be Taken Orally. The Film-Coated Tablets Should be Swallowed Whole. Do Not Divide or Crush Them.
You Should Remember that Benign Prostatic Hyperplasia is a Long-Term Condition, and Symptoms may not be Noticeable Until Later. Finxta may Relieve Symptoms and Allow for Control of the Disease if Taken Regularly for a Long Time.

Using Finxta in Patients with Renal or Hepatic Impairment

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

Using Finxta in the Elderly

No Dose Adjustment is Required in the Elderly.
If You Feel that the Effect of Finxta is Too Strong or Too Weak, Consult Your Doctor or Pharmacist.

Taking More than the Recommended Dose of Finxta

If You Take More than the Recommended Dose, Consult Your Doctor Immediately.

Missing a Dose of Finxta

Take Finxta as Prescribed by Your Doctor. However, if You Miss a Dose, Do Not Take a Double Dose to Make Up for the Missed Dose. 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, Finxta 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 Semen Volume (Amount of Semen). This Does Not Affect Sexual Function.

In Some Cases, these Symptoms may Disappear During Treatment. However, if the Side Effects Persist, You Should Consult Your Doctor, who may Decide to Stop Treatment with Finxta.
Uncommon(may affect up to 1 in 100 people)

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

Unknown(frequency cannot be estimated from the available data)
You Should Stop Taking Finxta and Immediately Consult Your Doctor 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 Stopping Treatment,
• Blood in Semen,
• Palpitations,
• Changes in Liver Function, which may be Visible in Blood Tests,
• Itching, Hives,
• Testicular Pain,
• Impotence (Inability to Achieve an Erection) that Persists after Stopping the Medication,
• Ejaculation Disorders that Persist after Stopping the Medication,
• Male Infertility and/or Poor Semen Quality (Semen Quality has been Reported to Improve after Stopping the Medication),
• Rarely, Breast Cancer,
• Anxiety.

You Should Immediately Inform Your Doctor if You Notice any Changes in Breast Tissue, 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, including those not Listed in this Package Leaflet, Tell Your Doctor or Pharmacist. You can Report Side Effects 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.
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 Finxta

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 Carton after “Expiry Date” and on the Blister after “EXP”. The Expiry Date Refers to the Last Day of the Month Stated.
Medications Should Not be Disposed of 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. Package Contents and Other Information

What Finxta Contains

• The Active Substance of Finxta is Finasteride. One Film-Coated Tablet Contains 5 mg of Finasteride.
• The Other Ingredients of the Medication in the Tablet Core are: Lactose Monohydrate, Microcrystalline Cellulose, Maize Starch, Sodium Starch Glycolate (Type A), Magnesium Stearate, Sodium Lauryl Sulfate. The Tablet Coating Contains Hypromellose, Microcrystalline Cellulose, Macrogol 8 Stearate (Type I).

What Finxta Looks Like and What the Package Contains:

Finxta is a White, Round, Biconvex Film-Coated Tablet with a Diameter of 7 mm, with “F” and “5” Engraved on One Side.
PVC/PVDC/Aluminum Blisters Containing: 15, 28, 30, 50, 98, and 100 Film-Coated Tablets.
Not all Pack Sizes may be Marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Recordati Polska sp. z o.o.
al. Armii Ludowej 26
00-609 Warsaw
Tel. 22 206 84 50

Manufacturer:

Haupt Pharma Münster GmbH
Schleebrüggenkamp 15
48159 Münster
Germany
Siegfried Malta Ltd
HHF070 Hal Far Industrial Estate
Hal Far BBG3000
Malta

Date of Last Revision of the Package Leaflet: 07/2023