Caretopic

PACKAGE LEAFLET

Package leaflet: information for the patient

CARETOPIC 2.275 mg/ml cutaneous spray, solution

finasteride
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What CARETOPIC is and what it is used for

CARETOPIC contains the active substance finasteride. It is administered to the bald scalp skin using a spray applicator consisting of a bottle with pump and nozzle.
CARETOPIC is used for the treatment of mild to moderate male hair loss (also known as androgenetic alopecia). CARETOPIC promotes hair growth on the scalp and prevents further hair loss in men. CARETOPIC is intended for use only in men aged between 18 and 41 years.
Male-pattern hair loss is a common condition thought to be caused by a combination of genetic factors and a specific hormone, dihydrotestosterone (DHT). In male baldness, the bald scalp contains higher amounts of DHT. This hormone is believed to contribute to shortening the hair growth phase and to hair thinning. As hair follicles become smaller (miniaturized), baldness becomes apparent. CARETOPIC reduces the level of DHT in the scalp. This helps reverse the balding process, leading to increased hair growth and prevention of further hair loss.

2. What you need to know before using CARETOPIC

Do not use CARETOPIC

• if you are allergic to finasteride or to any of the other ingredients of this medicine (listed in section 6).
• if you are a woman who is pregnant or could become pregnant.

Warnings and precautions
Talk to your doctor or pharmacist before using CARETOPIC.
Possible transfer of CARETOPIC
This medicine may cause a male baby to be born with abnormalities of the sex organs
if the active ingredient finasteride is absorbed through the skin of a pregnant woman. Avoid
any contact between the treated area and a woman who is or could become pregnant. You should also
advise her to avoid touching surfaces exposed to CARETOPIC. In case of contact with CARETOPIC, the
affected woman should wash the affected part of the body quickly and thoroughly.
Children and adolescents must not come into contact with CARETOPIC. In case of contact with
CARETOPIC, the affected child or adolescent should wash the affected part of the body quickly and thoroughly.
Effects on prostate-specific antigen (PSA)
If you have had a blood test for prostate-specific antigen (PSA) for prostate cancer screening, inform
your doctor that you are using CARETOPIC, as it may affect the interpretation of the results.
Effects on the male hormone dihydrotestosterone (DHT)
CARETOPIC reduces the concentration of the male hormone DHT in the blood, commonly
to below normal levels. However, this occurs less frequently and the reduction is also lower compared to finasteride tablets. Sexual side effects known with finasteride tablets may also occur with CARETOPIC, but are less likely (see section 4). Therefore, follow the dose prescribed by your doctor. Do not use more than 4 sprays per day.
Breast cancer
Although breast cancer has not occurred in men treated with CARETOPIC in clinical studies, it has been reported during treatment with finasteride tablets. If you experience changes in breast tissue such as lumps, pain, enlargement, or nipple discharge, contact your doctor as soon as possible.
Mood changes and depression
Although mood changes were not observed in patients treated with CARETOPIC in clinical studies, they have been reported during treatment with finasteride tablets. If you experience symptoms such as low mood, depression, or suicidal thoughts, contact your doctor for advice as soon as possible.
Children and adolescents
CARETOPIC must not be used by children or adolescents. There are no data demonstrating the efficacy or safety of finasteride in children under 18 years of age.
Other medicines and CARETOPIC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not apply CARETOPIC if you are using other topical products, such as cosmetics, sunscreens, or other medicines, on the same area.
Pregnancy
CARETOPIC must not be used by women.
Women who are or could become pregnant must avoid contact with the treated scalp or surfaces exposed to CARETOPIC. See the section "Possible transfer of CARETOPIC" above. In case of direct contact with this medicine, the woman should wash the affected part of the body quickly and thoroughly and seek medical advice.
Driving and using machines
CARETOPIC does not affect the ability to drive or operate machinery.
CARETOPIC contains ethanol.
This medicine contains 25 mg of ethanol (96%) in each spray, equivalent to 0.5 mg/microlitre (55%). It may cause a burning sensation on damaged skin.

3. How to use CARETOPIC

Always use this medicine exactly as instructed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Depending on the extent of scalp baldness, your doctor will prescribe 1 to 4 sprays per day to be applied to separate areas. Do not use more than 4 sprays per day.
CARETOPIC is for topical use. It must be used only on the scalp.
CARETOPIC consists of two separate parts: a bottle with a pump attached and a cone. These components require assembly before first use. Before the first application, read the complete handling instructions below.
Ensure that hair and scalp are completely dry before application.
Apply CARETOPIC to the scalp only. If you are prescribed more than one spray, apply it to non-overlapping areas. Do not apply the solution to areas of the body other than the scalp. After application, leave CARETOPIC on the treated area for at least 6 hours.
CARETOPIC can be transferred through contact with fabrics, hands, or other surfaces and objects. Avoid contact between the treated scalp and pillows, helmets, hats, etc., until the solution has dried.
CARETOPIC may transfer from your body to others if they touch the treated scalp or other exposed surfaces. If contact with CARETOPIC occurs, the affected person should wash the contacted area immediately and thoroughly.
Store CARETOPIC in a safe, secure place out of the reach of children. Inform family members or others who have access to the storage location about contact precautions.

Components and assembly of the spray applicator

Assembly of the spray applicator
A Align and press

Align the cone with the pump button and press firmly into place.
B Correct assembly
The spray applicator is correctly assembled when a click is heard after pressing, and the pump spray nozzle is centered within the cone.
C Correct assembly

and the bottom of the pump button is aligned with the bottom of the cone, with no gap.
D Incorrect, gap present. Realign and press again
If no click is heard during assembly or if a gap is visible between the bottom of the pump button and the cone, realign the components and press again firmly into place.

Priming the pump

• After assembling the spray applicator, the pump must be primed before first use. If the spray applicator has not been used for 2 weeks or more, the pump must be re-primed. Re-priming is not required with each use.
• To prime the pump for the first time, press down fully on the pump four times with your thumb or index finger, directing the sprayed solution into a sink. Then rinse the sink with water. To re-prime the pump after non-use of 2 weeks or more, press down fully on the pump only once.
• Do not spray CARETOPIC on the face.
• If solution is released during assembly or priming, clean any surfaces where it may have been deposited.

Loading	Do not spray towards the face

Application of the dose

• Depending on the size of the bald area on the scalp, your doctor will prescribe 1 to 4 sprays per day.
• It is not necessary to shake the bottle before use.
• Hold the spray applicator with the nozzle pressed against the scalp to prevent the solution from dispersing into the air.
• Press the pump fully once for one spray.
• Move the nozzle to different areas of the scalp to apply additional doses according to the number of sprays prescribed by your doctor. Do not overlap or treat areas that have already been sprayed.
• After use, do not remove the nozzle from the pump. Replace the spray applicator in the box.
• Once applied, do not wash off CARETOPIC for at least 6 hours.

Nozzle pressed against scalp Move nozzle to next area without overlapping

Ensure that CARETOPIC does not come into contact with hands or other parts of the body. Wash
immediately and thoroughly any part of the body exposed other than the scalp.
If the nozzle becomes soiled, clean it with a clean, dry tissue. Dispose of the used tissue safely and
wash your hands thoroughly.
Dose and number of treatment days per bottle
The bottle contains up to 180 sprays. The number of treatment days depends on the prescribed dose,
from 1 to 4 sprays per day. Do not use the bottle beyond 180 sprays, as any remaining solution in the
bottle may not deliver a complete dose, which could limit the effectiveness of treatment.

• The prescribed dose and resulting number of treatment days until product exhaustion will be indicated on the packaging by the pharmacist.
• On the date you start treatment with CARETOPIC, record the prescribed dose (from 1 to 4 sprays) in your calendar and calculate when a new bottle will be needed. Contact your doctor before your supply runs out to avoid interruptions in treatment.

If you use more CARETOPIC than you should
If you apply more CARETOPIC than recommended, inform your doctor. CARETOPIC will not work
faster or better if applied more than once a day, but side effects may become more likely.
If you forget to use CARETOPIC
If you forget to apply CARETOPIC, do not apply a double dose to make up for the missed
application. Continue using it at the dose recommended by your doctor.
If you stop using CARETOPIC
It may take up to 3 months before the treatment effect becomes evident. It is important to continue
using CARETOPIC for as long as your doctor instructs. If you stop applying CARETOPIC, you risk
losing the hair that has regrown.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets 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)
Decrease in a male hormone (dihydrotestosterone) in the blood
Other known side effects of oral finasteride may also be possible with CARETOPIC.
These include:

• Allergic reactions (hypersensitivity) including rash, itching, swelling around the mouth (angioedema)
• Depressed mood
• Anxiety
• Awareness of heartbeats (palpitations)
• Increased liver enzymes
• Tenderness and enlargement of the breasts
• Testicular pain
• Blood in the ejaculate (haemospermia)
• Altered sexual desire
• Problems with erection
• Ejaculation disorders including decreased volume of ejaculate
• Infertility

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store CARETOPIC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
CARETOPIC contains alcohol and is therefore flammable. Avoid spraying the medicine near open flames or while smoking.
Do not use CARETOPIC for more than 6 months after first opening the bottle.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What CARETOPIC contains

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

Description of the appearance of CARETOPIC and contents of the pack:
CARETOPIC is a colourless, clear, slightly viscous cutaneous spray solution.
Pack sizes:
1 bottle (equivalent to 180 sprays) with a mechanical metered pump spray and a separate cone
3 bottles (equivalent to 3x180 sprays) with a mechanical metered pump spray and 3 separate cones.
Before first use, attach the cone to the bottle pump, as described in paragraph 3.
It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
Difa Cooper S.p.A.
Via Milano 160
21042 Caronno Pertusella (Varese)
Manufacturer
ALMIRALL HERMAL GmbH
Scholtzstrasse 3
21465 – Reinbek (Germany)
This medicinal product is authorized in the European Economic Area countries with the following
names: