FINAHIT 1 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the Patient
2. Finahit, 1 mg, Film-Coated Tablets
   1. Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.
   2. Table of Contents of the Leaflet:
3. What is Finahit, 1 mg, and what is it used for
4. Important information before taking Finahit, 1 mg
   1. When Not to Take Finahit, 1 mg
   2. Warnings and Precautions
   3. Effect on Prostate-Specific Antigen (PSA)
   4. Effect on Fertility
   5. Breast Cancer
   6. Mood Changes and Depression
   7. Children
   8. Finahit, 1 mg, and Other Medicines
   9. Taking Finahit, 1 mg, with Food and Drink
   10. Pregnancy and Breast-Feeding and Fertility
   11. Driving and Using Machines
   12. Finahit, 1 mg, Contains Lactose
   13. Finahit, 1 mg, Contains Sodium
5. How to Take Finahit, 1 mg
   1. Patient with Liver Impairment
   2. Patient with Kidney Impairment
   3. Overdose of Finahit, 1 mg
   4. Missed Dose of Finahit, 1 mg
   5. Stopping Treatment with Finahit, 1 mg
6. Possible Side Effects
   1. Stop Taking Finahit, 1 mg, and Contact Your Doctor Immediately if You Experience Any of the Following Symptoms:
   2. Reporting of Side Effects
7. How to Store Finahit, 1 mg
8. Contents of the Pack and Other Information
   1. What Finahit, 1 mg, Contains
   2. What Finahit, 1 mg, Looks Like and Contents of the Pack
   3. Marketing Authorization Holder
   4. Manufacturer/Importer:
   5. This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:
   6. Date of Last Revision of the Leaflet: June 2025

Package Leaflet: Information for the Patient

Finahit, 1 mg, Film-Coated Tablets

Finasteride

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Table of Contents of the Leaflet:

• 1. What is Finahit, 1 mg, and what is it used for
• 2. Important information before taking Finahit, 1 mg
• 3. How to take Finahit, 1 mg
• 4. Possible side effects
• 5. How to store Finahit, 1 mg
• 6. Contents of the pack and other information

1. What is Finahit, 1 mg, and what is it used for

Finahit, 1 mg, contains finasteride. Finasteride belongs to a group of medicines called 5-alpha-reductase inhibitors.
Finahit, 1 mg, is used for the treatment of male pattern hair loss (also known as androgenetic alopecia). Finahit, 1 mg, is used in men to prevent further hair loss. The best results with Finahit, 1 mg, are obtained in men with mild to moderate, but not complete, hair loss. Finahit, 1 mg, works by inhibiting the activity of an important enzyme (5-alpha-reductase type II), which is involved in the regulation of hair follicles.
Finahit, 1 mg, specifically reduces the levels of dihydrotestosterone (DHT), which is the main cause of male pattern hair loss. In this way, Finahit, 1 mg, helps to reverse the hair loss process, preventing further hair loss.

2. Important information before taking Finahit, 1 mg

When Not to Take Finahit, 1 mg

• -in women (since this medicine is for men only, see section "Pregnancy and breast-feeding"). Clinical studies have shown that finasteride is not effective in treating hair loss in women;
• If you are allergic to finasteride or any of the other ingredients of Finahit, 1 mg (listed in section 6);

Warnings and Precautions

Before starting treatment with Finahit, 1 mg, you should consult your doctor.

Effect on Prostate-Specific Antigen (PSA)

This medicine may affect the results of a blood test called PSA. This test is used to detect prostate cancer. If you are having a PSA test, you should tell your doctor that you are taking this medicine, as it may lower the level of PSA.

Effect on Fertility

There have been reports of infertility in men taking finasteride for a long time, who also had other risk factors for infertility. It has been reported that after stopping finasteride, sperm count and quality may return to normal. However, long-term studies on the effect of finasteride on fertility in men have not been conducted.

Breast Cancer

See section 4.

Mood Changes and Depression

In patients taking Finahit, 1 mg, mood changes, such as depressive mood and depression, and less frequently suicidal thoughts, have been reported. If you experience any of these symptoms, you should stop taking Finahit, 1 mg, and consult your doctor immediately.

Children

Finahit, 1 mg, should not be taken by children. There is no data on the efficacy or safety of finasteride in children and adolescents under 18 years of age.

Finahit, 1 mg, and Other Medicines

Tell your doctor or pharmacist about all the medicines you are taking, or have recently taken, and about any medicines you plan to take.

Taking Finahit, 1 mg, with Food and Drink

Finahit, 1 mg, can be taken with or without food.

Pregnancy and Breast-Feeding and Fertility

Finahit, 1 mg, is used to treat male pattern hair loss, in men only.
Effect on fertility in men, see section 2.

• Finahit, 1 mg, must not be taken by women.
• Women who are pregnant or think they may be pregnant should not handle crushed or broken Finahit, 1 mg, tablets.
• If the active ingredient of Finahit, 1 mg, is absorbed through the skin or taken orally by a woman who is pregnant with a male fetus, it may cause abnormal development of the genital organs.
• If a pregnant woman has come into contact with the active ingredient of Finahit, 1 mg, she should consult her doctor.
• The tablets of Finahit, 1 mg, are coated to prevent direct contact with the active ingredient during normal handling.

Driving and Using Machines

There is no evidence to suggest that Finahit, 1 mg, affects the ability to drive or use machines.

Finahit, 1 mg, Contains Lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

Finahit, 1 mg, Contains Sodium

This medicine contains less than 1 mmol sodium (23 mg) per tablet, which is essentially 'sodium-free'.

3. How to Take Finahit, 1 mg

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
The recommended dose is one Finahit, 1 mg, tablet a day (which corresponds to 1 mg of finasteride).
The film-coated tablets can be taken with or without food. The film-coated tablets should be swallowed whole. Do not crush or chew them.

• Taking Finahit, 1 mg, more than once a day will not improve its effects or speed up the onset of effects.
• Male pattern hair loss develops over a long period. It usually takes 3 to 6 months of daily treatment to notice the first signs of increased hair density or decreased hair loss.
• Your doctor will assess the effectiveness of Finahit, 1 mg. It is important to continue taking Finahit, 1 mg, for the period your doctor has prescribed.

Patient with Liver Impairment

There is no experience with the use of Finahit, 1 mg, in patients with liver impairment.

Patient with Kidney Impairment

No dose adjustment is necessary in patients with renal impairment.

Overdose of Finahit, 1 mg

In case of overdose, contact the nearest emergency department of the hospital. Bring the remaining tablets or the empty package to help identify the medicine.

Missed Dose of Finahit, 1 mg

If you forget to take a dose of Finahit, 1 mg, take the next tablet at the usual time. Do not take a double dose to make up for a forgotten dose.

Stopping Treatment with Finahit, 1 mg

To get the best results from the treatment with Finahit, 1 mg, it is recommended to continue taking the medicine. Stopping treatment will lead to a reversal of its effects (hair loss) within 9 to 12 months.
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.
Side effects are usually temporary and disappear during or after treatment.

Stop Taking Finahit, 1 mg, and Contact Your Doctor Immediately if You Experience Any of the Following Symptoms:

• Signs of an allergic reaction: swelling of the lips, face, tongue, and throat; difficulty swallowing; hives and difficulty breathing.

If you experience any changes in the breast, such as lumps, pain, enlargement of the breast tissue, or discharge from the nipple, you should contact your doctor immediately, as these may be signs of breast cancer.
Uncommon (may affect up to 1 in 100 people):

• decreased interest in sex
• difficulty getting an erection
• ejaculation disorders, such as decreased semen volume during intercourse.
• Depression

Frequency not known (cannot be estimated from the available data):

• allergic reactions, such as rash, itching, hives, and swelling of the lips and face
• breast tenderness or enlargement
• testicular pain
• blood in semen
• rapid heartbeat
• erectile dysfunction that persists after stopping treatment
• decreased libido that persists after stopping treatment
• ejaculation disorders that persist after stopping treatment
• there have been reports of infertility in men taking finasteride for a long time, who also had other risk factors for infertility. It has been reported that after stopping finasteride, sperm count and quality may return to normal. However, long-term studies on the effect of finasteride on fertility in men have not been conducted.
• blood test results indicating changes in liver function
• anxiety
• suicidal thoughts

Reporting of Side Effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects 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, 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 medicine.

5. How to Store Finahit, 1 mg

Keep out of the sight and reach of children.
No special precautions for storage are necessary.
Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Finahit, 1 mg, Contains

• The active substance is finasteride. Each film-coated tablet contains 1 mg of finasteride.
• The other ingredients are: tablet core - lactose monohydrate, microcrystalline cellulose (E460), maize starch, sodium starch glycollate (type A), lauryl macrogolglycerides, and magnesium stearate (E572); coating: hypromellose 6cP (E464), titanium dioxide (E171), macrogol 6000, red iron oxide (E172), yellow iron oxide (E172).

What Finahit, 1 mg, Looks Like and Contents of the Pack

Film-coated tablet.
Finahit, 1 mg, tablets are reddish-brown, round, biconvex, film-coated, with the marking "F1" on one side and no marking on the other side.
Finahit, 1 mg, is packaged in aluminum/aluminum blisters in packs of 28, 30, 84, and 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Accord Healthcare Polska Sp. z o.o.
Taśmowa 7
02-677 Warsaw
Tel: +48 22 577 28 00

Manufacturer/Importer:

Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
Netherlands
Accord Healthcare Polska Sp. z o.o.
Lutomierska 50
95-200 Pabianice
Accord Healthcare Single Member S.A.
64th Km National Road Athens
32009 Lamia
Greece

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: June 2025