Finjuve

Package leaflet: Information for the patient

Finjuve, 2.275 mg/ml, cutaneous aerosol, solution
Finasteride
Please read the entire leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What Finjuve is and what it is used for
2. Important information before using Finjuve
3. How to use Finjuve
4. Possible side effects
5. How to store Finjuve
6. Contents of the pack and other information

1. What Finjuve is and what it is used for

Finjuve contains finasteride as the active substance. It is applied to the scalp using an aerosol applicator consisting of a pump bottle and cone.
Finjuve is used in the treatment of mild to moderate male pattern hair loss (also known as androgenetic alopecia). Finjuve increases hair growth on the scalp and prevents further hair loss in men. Finjuve is intended for use only in men aged 18 to 41 years.
Male pattern hair loss is a common condition. It is believed that its causes involve a combination of genetic factors and a specific hormone, dihydrotestosterone (DHT). In male pattern hair loss, increased levels of DHT are present in the balding scalp. This hormone is thought to contribute to shortening the hair growth phase and to hair thinning. Hair follicles become smaller (miniaturized), and hair loss becomes increasingly visible.
Finjuve reduces the concentration of DHT in the scalp. This helps reverse the hair loss process, leading to increased hair growth and preventing further hair loss.

2. Important information before using Finjuve

When not to use Finjuve

• if the patient is allergic to finasteride or any of the other ingredients of this medicine (listed in section 6).
• in pregnant women or women who may become pregnant. Finjuve must not be used in women.

Warning and precautions
Before starting treatment with Finjuve, discuss this with your doctor or pharmacist.
Potential transfer of Finjuve
This medicine may cause congenital abnormalities of the genital organs in male fetuses if the active substance of the medicine, finasteride, is absorbed through the skin into the body of a pregnant woman. Pregnant women or women who may become pregnant should avoid touching skin treated with this medicine. Women should also be advised not to touch surfaces exposed to Finjuve.
If contact with Finjuve occurs, the woman should immediately wash the affected area of the body thoroughly.
Children and adolescents must not come into contact with Finjuve; however, if contact occurs, they should immediately wash the exposed area of the body thoroughly.

Effect on prostate-specific antigen (PSA)
If the patient undergoes blood testing for prostate-specific antigen (PSA) as a screening test for prostate cancer, the patient should inform the doctor that they are using Finjuve, as this may affect interpretation of test results.

Effect on the male hormone dihydrotestosterone (DHT)
Finjuve reduces the level of the male hormone DHT in the blood, often even below normal values. However, this occurs less frequently and the decrease in DHT levels is smaller compared to oral finasteride tablets. Sexual adverse effects, known to occur with oral finasteride, may also occur during treatment with Finjuve, but are less likely (see section 4). Therefore, it is important to follow the dosing instructions provided by the doctor. Do not use more than 4 sprays per day.

Breast cancer
Although breast cancer was not observed in clinical studies among men treated with Finjuve, such cases have been reported during treatment with oral finasteride. If any changes in the breasts are noticed, such as lumps, pain, breast enlargement, or nipple discharge, medical advice should be sought immediately.

Mood changes and depression
Although mood changes were not observed in clinical studies in patients treated with Finjuve, they have been reported during treatment with oral finasteride. If symptoms such as low mood, depression, or suicidal thoughts occur, medical advice should be sought immediately.

Children and adolescents
Finjuve should not be used in children and adolescents. There are no data available on the efficacy and safety of finasteride in children and adolescents under 18 years of age.

Finjuve and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
If the patient is using other topical products such as cosmetics, sunscreen products, or other topical medicines, Finjuve should not be used simultaneously on the same area of skin.

Pregnancy
Finjuve must not be used in women.
Pregnant women or women who may become pregnant must avoid touching skin treated with Finjuve or other surfaces exposed to Finjuve. See the section "Potential transfer of Finjuve" above. If direct contact with the medicine occurs, the woman should immediately wash the affected area of the body thoroughly and contact her doctor.

Driving and operating machinery
Finjuve has no influence on the ability to drive or operate machinery.

Finjuve contains ethanol
This medicine contains 25 mg of ethanol (96%) per spray, equivalent to a concentration of 0.5 mg/microlitre (55%). This may cause stinging on damaged skin.

3. How to use Finjuve

This medicine should always be used exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
Depending on the extent of scalp area affected by hair loss, your doctor will recommend
1 to 4 sprays per day to be applied to different areas of the scalp. Do not use more than
4 sprays per day.
Finjuve is intended for topical use only and should be applied exclusively to the scalp skin.

Finjuve consists of two separate parts: a bottle with an attached pump and a cone-shaped
applicator. These components must be assembled before first use. Before using the medicine
for the first time, read carefully the complete device instructions provided below.

Before applying the medicine, ensure that the hair and scalp are completely dry. Finjuve
should be applied by the patient themselves. If more than 1 spray is recommended,
subsequent sprays should be applied to non-overlapping areas of the scalp. Do not spray
the solution onto any other parts of the body apart from the scalp. After applying Finjuve,
leave it on the skin for at least 6 hours.

Finjuve may transfer via contact with fabric, hands, or other surfaces and objects. Avoid
contact between the treated scalp area and pillows, helmets, hats, etc., until the skin is
completely dry.

Finjuve may be transferred from the patient’s body to another person if that person touches
the treated scalp or any surface exposed to the medicine. If such contact occurs, the person
should immediately wash the exposed area of the body thoroughly.

Keep Finjuve in a safe place out of reach of children. Family members and others who have
access to where the medicine is stored should be informed about the necessary precautions
regarding contact with the medicine.

Components and assembly of the aerosol applicator

Assembly of the aerosol applicator

A Fit and press
Align the cone with the pump head and press firmly.

B Correct assembly
The aerosol applicator is correctly assembled when a clicking sound is heard upon pressing,
and the spray nozzle is positioned centrally within the cone.

C Correct assembly
The lower edge of the pump head is aligned with the lower edge of the cone,
with no gap between them.

D Incorrect assembly – gap present. Adjust alignment and press again.
If no clicking sound is heard during assembly, or if a gap is visible between the lower edge
of the pump head and the cone, realign the components and press again.

Priming the pump

• After assembling the aerosol applicator, check the pump function before first use.
  If the aerosol applicator has not been used for 2 weeks or longer, the pump function should
  be re-primed. It is not necessary to prime the pump before each use.
• To prime the pump for the first time, press the pump 4 times with your thumb or index finger,
  directing the spray into the sink. Then rinse the sink with water. To re-prime the pump after
  non-use of 2 weeks or longer, press the pump only once.
• Do not spray Finjuve towards the face.
• If solution leaks from the device during assembly or priming, clean any surface that may
  have come into contact with the solution.

Pump priming – Do not spray medicine towards the face

Dose application

• Depending on the size of the affected scalp area, your doctor will recommend 1 to 4 sprays per day.
• There is no need to shake the bottle before using the medicine.
• Hold the aerosol applicator so that the cone is in contact with the scalp to avoid dispersing the solution into the air.
• Press the pump fully once to deliver one spray.
• Move the cone to other areas of the scalp to apply additional sprays as prescribed by your doctor.
  Each subsequent application area should not overlap with previously treated areas.
• After application, do not remove the cone from the pump. Return the applicator to its box.
• Do not wash off Finjuve for at least 6 hours after application.

Cone in contact with the scalp

Move cone to next area of skin
ensuring treated areas do not overlap

Avoid contact between Finjuve and hands or other body parts. Any body areas other than the scalp
that come into contact with Finjuve should be washed immediately and thoroughly.
If the cone becomes soiled, wipe it with a clean, dry tissue. Dispose of the tissue safely and wash hands thoroughly.

Dosage and duration of treatment depending on dose
The bottle contains up to 180 sprays. The number of treatment days depends on the prescribed dose,
which may range from 1 to 4 sprays per day. Do not use the medicine from the bottle after 180 sprays
have been delivered, as the remaining solution in the bottle may not provide a full dose, which could
reduce treatment effectiveness.

• The recommended dose and the corresponding number of treatment days until the complete use of the medication will be recorded on the package by the pharmacist.
• On the day of starting treatment with Finjuve, make a note in your calendar regarding the recommended dose (from 1 to 4 sprays) and calculate when a new bottle of the medication will be needed. Before the medication runs out, contact your doctor to avoid interruption of treatment.

Use of a higher than recommended dose of Finjuve
If more than the recommended dose of Finjuve is used, consult your doctor. Finjuve will not work faster or better if used more frequently than once daily, and the risk of adverse reactions may increase.

Missed use of Finjuve
If a dose of Finjuve is missed, do not use a double dose to make up for the missed application. Continue using the medication at the dose recommended by your doctor.

Discontinuation of Finjuve
Therapeutic effects may not appear until after 3 months. It is important to continue using Finjuve for as long as your doctor recommends. If treatment with Finjuve is discontinued, hair that has been regained will likely be lost again.
If you have any further questions about the use of this medication, consult your doctor or pharmacist.

4. Possible adverse reactions
Like all medicines, this medication may cause adverse reactions, although not everyone experiences them.

Common (may affect up to 1 in 10 people):

• Itching or redness of the scalp

Very common (may affect more than 1 in 10 people):

• Decreased blood levels of male hormones (dihydrotestosterone)

Other adverse reactions observed during oral administration of finasteride may also occur during use of Finjuve. These include:

• Allergic reactions (hypersensitivity), such as skin rash, itching, swelling around the mouth (angioedema)
• Depressed mood
• Anxiety
• Palpitations
• Increased liver enzyme activity
• Breast tenderness and enlargement
• Testicular pain
• Blood in semen (haematospermia)
• Decreased libido
• Erectile difficulties
• Ejaculation disorders, including reduced ejaculate volume
• Infertility

Reporting 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 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medication.

5. How to store Finjuve

Keep Finjuve out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and on the label of the bottle after the abbreviation "EXP". The expiry date refers to the last day of the stated month.
There are no special storage instructions for this medicine.
Finjuve contains alcohol and is therefore flammable. Do not spray the medicine near an open flame or while smoking tobacco.
Period of use after first opening the bottle: 6 months.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Following this advice helps protect the environment.

6. Contents of the pack and other information

What Finjuve contains

• The active substance is finasteride. 1 ml of solution contains 2.275 mg of finasteride. Each spray delivers 50 microliters of solution, corresponding to 114 micrograms of finasteride.
• The other ingredients are: ethanol 96%, purified water, propylene glycol, hydroxypropylchitosan.

What Finjuve looks like and contents of the pack
Finjuve is a colourless, transparent, slightly viscous solution for cutaneous application as an aerosol spray.
Pack sizes:
1 bottle (180 doses) with a mechanical spray pump and a separate cone
3 bottles (3 x 180 doses) with a mechanical spray pump and 3 separate cones
Before first use, the cone must be attached to the pump of the bottle as described in section 3.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Polichem S.A.
50, Val Fleuri
L-1526 Luxembourg
Manufacturer
Almirall Hermal GmbH
Scholtzstrasse 1 and 3,
21465 Reinbek,
Germany
This medicinal product is authorised in the European Economic Area countries under the following names:
Germany Finjuve für Männer 2.275 mg/ml Spray zur Anwendung auf der Haut (Kopfhaut), Lösung
Bulgaria Финюве за мъже 2,275 mg/ml спрей за кожа, разтвор / Finjuve for men 2.275 mg/ml cutaneous spray, solution
Czech Republic Fynzur 2.275 mg/ml kožní sprej, roztok
Hungary Fynzur férfiaknak 2,275 mg/ml külsőleges oldatos spray
Italy CARETOPIC 2.275 mg/ml spray cutaneo, soluzione
Luxembourg Finjuve für Männer 2.275 mg/ml Spray zur Anwendung auf der Haut (Kopfhaut), Lösung
Poland Finjuve
Portugal Finasterida Cantabria 2.275 mg/ml Solução para Pulverização Cutânea
Romania Finjuve pentru bărbați 2,275 mg/ml spray cutanat, soluție
Slovakia Finjuve pre mužov 2,275 mg/ml dermálny roztokový sprej
Spain Alocare 2,275 mg/ml Solución para pulverización cutánea
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Egis Pharmaceuticals PLC
Telephone number: +48 22 417 92 00