Finahit

Package leaflet: Information for the user

Finahit, 1 mg, film-coated tablets
Finasteride
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Finahit, 1 mg is and what it is 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 Finahit, 1 mg is and what it is used for
Finahit, 1 mg contains finasteride. Finasteride belongs to a group of medicines known as 5-alpha-reductase inhibitors.
Finahit, 1 mg is indicated 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 treatment results with Finahit, 1 mg are achieved in men with mild to moderate, but not complete, hair loss. Finahit, 1 mg specifically inhibits the activity of an important enzyme (type II 5α-reductase), which is involved in regulating hair follicle activity. Finahit, 1 mg specifically reduces the concentration of dihydrotestosterone (DHT), which is the main cause of male pattern hair loss. Thus, Finahit, 1 mg helps reverse the hair loss process and prevents further hair loss.

2. Important information before taking Finahit, 1 mg

When not to use Finahit, 1 mg

• In women (because this medicine is intended for men only, see section "Pregnancy and breastfeeding"). 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 known as PSA measurement. This test is used to detect prostate cancer. If you are having your PSA level measured, you should inform your doctor that you are taking this medicine, as it reduces PSA levels.
Effect on fertility
Cases of infertility have been reported in men taking finasteride long-term who also had other risk factors affecting fertility. Normalization or improvement in semen quality has been observed after discontinuation of finasteride treatment. However, long-term studies on the effect of finasteride on male fertility have not been conducted.
Breast cancer
See section 4.
Mood changes and depression
Mood changes such as depressive mood, depression, and less frequently suicidal thoughts have been reported in patients taking Finahit, 1 mg. If any of these symptoms occur, treatment with Finahit, 1 mg should be stopped immediately and you should seek medical advice from your doctor without delay.
In some patients, sexual dysfunction has been reported, which may contribute to mood changes, including suicidal thoughts. If you experience symptoms of sexual dysfunction, consult your doctor for further medical advice. Your doctor may consider discontinuing treatment (see section 4 below for further information on these adverse effects).
A Patient Warning Card reminding of the above has been included in the Finahit, 1 mg packaging.
Children
Finahit, 1 mg must not be used in children. There is a lack of data on the efficacy and safety of finasteride in children and adolescents under 18 years of age.
Finahit, 1 mg and other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking Finahit, 1 mg with food and drink
Finahit, 1 mg can be taken with or without food.
Pregnancy and breastfeeding and effect on fertility
Finahit, 1 mg is used for the treatment of male pattern hair loss, and is intended for use in men only.
Effect on male fertility, see section 2.

• Finahit, 1 mg must not be used in women.
• Pregnant women or women who suspect they might be pregnant must not handle crushed or damaged Finahit, 1 mg tablets.
• If the active substance of Finahit, 1 mg is absorbed orally or through the skin by a pregnant woman carrying a male fetus, it may cause congenital abnormalities of the genital organs.
• If a pregnant woman has had contact with the active substance of Finahit, 1 mg, she should consult her doctor.
• Finahit, 1 mg tablets are film-coated, which prevents direct contact with the active substance during normal handling.

Driving and operating machinery
There are no data indicating that Finahit, 1 mg may affect the ability to drive or operate machinery.
Finahit, 1 mg contains lactose
If you have been previously diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.
Finahit, 1 mg contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. the medicine is considered "sodium-free".

3. How to take Finahit, 1 mg

This medicine should always be taken as recommended by your doctor. If in doubt,
contact your doctor or pharmacist.
The recommended dose is 1 tablet of Finahit, 1 mg, per day (corresponding to 1 mg of finasteride).
The coated tablets may be taken on an empty stomach or with food. The coated tablets
should be swallowed whole. Do not divide or crush them.

• Taking Finahit, 1 mg more often than once daily does not increase effectiveness and does not accelerate the onset of the medicine's action.
• Male pattern hair loss develops over a long period. Usually, daily treatment for 3 to 6 months is required before the first signs of increased hair density or reduced hair loss become noticeable.
• Your doctor will assess the effectiveness of Finahit, 1 mg. It is important to continue taking Finahit, 1 mg for the duration recommended by your doctor.

Patients with liver function disorders
There is no experience with the use of Finahit, 1 mg in patients with liver function disorders.
Patients with kidney function disorders
Dose adjustment is not necessary in patients with impaired kidney function.
Taking more Finahit, 1 mg than recommended
If you take more Finahit, 1 mg than recommended, or if someone else takes the medicine, go immediately to the nearest hospital emergency department. Take any remaining tablets or the empty packaging with you to help identify the medicine.
Missed dose of Finahit, 1 mg
If you miss a dose of Finahit, 1 mg, take the next tablet at your usual time.
Do not take a double dose to make up for a missed dose.
Stopping Finahit, 1 mg
To achieve the best treatment results with Finahit, 1 mg, continuous use of the medicine is recommended. Discontinuation of treatment leads to reversal of its effects (hair loss) within 9 to 12 months.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions are usually transient and resolve during treatment or after its completion.
You must discontinue use of Finahit 1 mg and immediately consult a doctor if the patient experiences any of the following symptoms:

• Signs of an allergic reaction: swelling of the lips, face, tongue, and throat; difficulty swallowing; subcutaneous nodules (urticaria), and breathing difficulties.
• Suicidal thoughts

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

• Decreased interest in sex
• Difficulty achieving erection
• Ejaculation disorders, e.g. reduced ejaculate volume during intercourse
• Depression

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

• Allergic reactions such as rash, itching, skin eruptions (urticaria), and swelling of lips and face
• Breast swelling or tenderness
• Testicular pain
• Blood in semen
• Rapid heartbeat
• Erectile dysfunction persisting after discontinuation of treatment
• Reduced libido persisting after discontinuation of treatment
• Ejaculation disorders persisting after discontinuation of treatment
• Cases of male infertility have been reported in men taking finasteride long-term, in whom other risk factors possibly affecting fertility were also present. It has been described that after discontinuation of finasteride treatment, semen parameters normalize or semen quality improves. No long-term clinical trials have been conducted to determine the effect of finasteride on male fertility.
• Blood test results indicating changes in liver function
• Anxiety
• Suicidal thoughts

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Finahit 1 mg

Keep the medicine out of sight and reach of children.
No special precautions for storage of the medicinal product are required.
Do not use this medicine after the expiry date stated on the packaging after EXP.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such 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 coated tablet contains 1 mg of finasteride.
• Other ingredients are: tablet core – monohydrate lactose, microcrystalline cellulose (E460), pregelatinized maize starch, sodium carboxymethyl starch (type A), macrogol glyceryl monostearate, and magnesium stearate (E572); coating composition: hypromellose 6 cP (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

Coated tablet.
Finahit, 1 mg tablets are red-brown, round, biconvex, coated tablets, marked “F1” on one side and unmarked on the other side.
Finahit, 1 mg is packed in aluminium/aluminium blisters containing 28, 30, 84 or 98 tablets.
Not all pack sizes may be marketed.

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

Manufacturer/Importer:
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
The Netherlands

Accord Healthcare Polska Sp. z o.o.
Lutomierska Street 50
95-200 Pabianice
Accord Healthcare Single Member S.A.
64th Km National Road Athens
32009 Lamia
Greece
This medicinal product is authorized for marketing in the European Economic Area member states under the following names: