Package Insert: Information for the Patient

Alocare 2,275 mg/ml Topical Solution for Pulverization

finasteride

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

This medication contains the active ingredient finasteride. It is administered to bald scalp skin using a spray applicator consisting of a bottle with a pump and a cone.

Alocare is used for the treatment of mild to moderate male hair loss (also known as androgenetic alopecia). This medication increases hair growth and prevents further hair loss in men. Alocare can only be used by men aged 18 to 41 years.

Male hair loss is a common disorder believed to be caused by a combination of genetic factors and a particular hormone, called dihydrotestosterone (DHT).

It is believed that this hormone contributes to shortening the hair growth phase and making it thinner.

As hair follicles become smaller, baldness becomes apparent. Alocare reduces DHT levels in the scalp. This helps to reverse the balding process, leading to increased hair growth and prevention of further hair loss.

No use Alocare

• If you are allergic to finasteride or any of the other components of this medication (listed in section 6).
• If you are a woman and are or may become pregnant.

Warnings and Precautions

Consult your doctor or pharmacist before starting to use Alocare

Possible transmission of Alocare

If the active ingredient is absorbed through the skin of a pregnant woman, the baby may be born with abnormalities in its sexual organs.

Avoid any contact between the treated area and a woman who is or may become pregnant. Also, avoid touching exposed surfaces. If contact with Alocare occurs, the affected woman must wash the affected area quickly and thoroughly.

Children and adolescents should not come into contact with this medication. If contact with Alocare occurs, the affected child or adolescent must wash the affected area quickly and exhaustively.

Effects on Prostate-Specific Antigen (PSA)

If you are to have a blood test for prostate-specific antigen (PSA) for prostate cancer detection, inform your doctor that you are using Alocare, as it may affect the interpretation of the results.

Effect on male hormone dihydrotestosterone (DHT)

Alocare reduces the concentration of male hormone (DHT) in blood. However, this occurs infrequently and the decrease is also less than with finasteride tablets. The sexual side effects known for finasteride tablets may also occur with Alocare but are less likely (see section 4). Therefore, respect the dose prescribed by your doctor. Do not use more than 4 sprays per day.

Breast Cancer

Although breast cancer has not been detected in men treated with Alocare in clinical studies, it has been reported during treatment with finasteride tablets. If you experience any change in breast tissue, such as lumps, pain, breast tissue enlargement, or nipple discharge, contact your doctor as soon as possible.

Mood changes and depression

Although mood changes have not been observed in patients treated with Alocare in clinical studies, they have been reported during treatment with finasteride tablets. If you experience symptoms such as depressed mood, depression, or suicidal thoughts, contact your doctor for advice as soon as possible.

Children and Adolescents

This medication should not be used in children or adolescents. There is no data to demonstrate the efficacy and safety of finasteride in children under 18 years old.

Other Medications and Alocare

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Do not apply Alocare if you are using other topical products, such as cosmetics, sunscreens, or other medications, in the same area.

Pregnancy

Women should not take Alocare.

Women who are or may become pregnant should avoid contact with treated scalp or exposed surfaces. See the "Possible transmission of Alocare" section above. If direct contact with this medication occurs, the woman must wash the affected area quickly and thoroughly and seek advice from her doctor.

Driving and Operating Machinery

Alocare does not affect the ability to drive or operate machinery.

Alocare contains Ethanol

This medication contains 25 mg of ethanol (96%) per spray, equivalent to 0.5 mg/microliter (5.5%). It may cause a burning sensation on damaged skin.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will prescribe between 1 and 4 sprays per day, depending on the extent of your bald scalp area. Do not use more than 4 sprays per day.

This medication is for topical use only. It should only be used on the scalp.

Alocare is composed of two separate components: a bottle with a pump attached and a cone. These components require assembly before first use. Before the first application, read all the instructions indicated below.

Ensure that your hair and scalp are completely dry before application. Apply Alocare to the scalp by yourself. If more than one spray is prescribed, apply them to non-overlapping areas. Do not apply the solution to other areas of the body that are not the scalp. Once applied, leave Alocare to act for at least 6 hours.

This medication may transfer through contact with tissues, hands, or other surfaces and objects. Avoid contact of the treated scalp with pillows, helmets, hats, etc. until the solution has dried.

Alocare may transfer from your own body to others if they touch your treated scalp or other exposed surfaces. If contact with Alocare occurs, the person should wash the affected area quickly and thoroughly.

Store Alocare in a safe place out of the reach of children. Inform family members or other individuals with access to the storage location of the precautions for contact.

Components and assembly of the sprayer

Assembly of the sprayer

1. Align and press

Align the cone with the pump button and press firmly.

1. Correct assembly

The sprayer applicator is correctly assembled when a click is heard after pressing, the spray nozzle of the pump is in the central position of the cone

1. and the lower part of the pump button is aligned with the lower part of the cone without separation.

1. Incorrect assembly if there is a gap. Realign and press again

If no click is heard during assembly or a gap is seen between the lower part of the pump button and the cone, realign the components and press again.

Preparation of the pump

• After assembling the sprayer applicator, the pump must be prepared for the first use. If the sprayer applicator has not been used for 2 weeks or more, the pump will need to be prepared again. It is not necessary to prepare it again for each use.

• To prepare the pump for the first time, press the pump four times firmly with the thumb or index finger, directing the sprayed solution to a sink. Then, rinse the sink with water. To prepare the pump again after not using it for 2 weeks or more, press the pump once completely.

• Do not spray Alocare towards the face.

If solution is released during assembly or preparation, clean the surfaces where it may have been deposited.

Application of the dose

• Your doctor will prescribe between 1 and 4 sprays per day, depending on the size of the bald scalp area.
• No need to shake the bottle before using it.
• Hold the sprayer applicator with the flat cone against the scalp to avoid dispersing the solution in the air.
• Press the pump once completely for one spray.
• Move the cone to different areas of the scalp to apply other doses as prescribed by your doctor. Do not overlap and treat areas that have already been sprayed.
• After use, do not remove the cone from the pump. Return the sprayer applicator to the box.
• Once applied, do not rinse Alocare for at least 6 hours.

Ensure that Alocare does not come into contact with your hands or any other part of your body. Wash immediately and thoroughly any exposed body part that is not your scalp.

If the cone becomes dirty, clean it with a clean and dry paper towel. Dispose of the used towel safely and wash your hands well.

Dose and treatment days per dose

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 the 180 sprays, as the remaining solution in the bottle may not provide a complete dose, which may limit the effect of your treatment.

• The pharmacist will note on the box the prescribed dose and the remaining number of treatment days until the product is depleted.
• On the date of the start of treatment with Alocare, note on your calendar the prescribed dose (from 1 to 4 sprays) and calculate when you will need a new bottle. Contact your doctor before your supply runs out to avoid treatment interruption.

If you use more Alocare than you should

If more Alocare is applied than recommended, talk to your doctor. Alocare will not work faster or better if applied more than once a day, but side effects may occur more likely.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount administered.

If you forget to take Alocare

If you forget to apply Alocare, do not apply a double dose to compensate for the missed application. Continue using the recommended dose prescribed by your doctor.

If you interrupt treatment with Alocare

The effect of treatment may take 3 months to develop. It is essential to continue using Alocare for the time your doctor indicates. If you stop applying Alocare, you may lose the hair you have gained.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Frequent (may affect up to 1 in 10 people)

• Itching or redness of the scalp

Very frequent (may affect more than 1 in 10 people)

• Decrease in a male hormone (dihydrotestosterone) in blood

Other known side effects of oral finasteride may also occur with Alocare.

This includes:

• Allergic reactions (hypersensitivity) that include skin rash, itching, swelling around the mouth (angioedema)
• Depressed mood
• Anxiety
• Heartbeat sensation (palpitations)
• Increased liver enzymes
• Breast tenderness and increased sensitivity
• Testicular pain
• Blood in the ejaculation (hematospermia)
• Decreased libido
• Difficulty achieving an erection
• Ejaculation disorder, including decreased ejaculation volume
• Infertility

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist even if they are possible adverse effects not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es . By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Alocare contains alcohol and is therefore flammable. Avoid spraying the medication near open flames or while smoking.

Do not use Alocare for more than 6 months after opening the bottle for the first time.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Alocare

• The active ingredient is finasteride. Each mL of solution contains 2.275 mg of finasteride. Each spray provides 50 microliters, which contain 114 micrograms of finasteride.

• The other components are: ethanol (96%), purified water, propylene glycol, hydroxypropyl chitosan.

Appearance of the product and contents of the package

Alocare is an incolor, transparent, and slightly viscous cutaneous spray solution.

Package size:

• 1 bottle (corresponding to 180 sprays) with a mechanical pressure spray pump and 1 separate cone.
• 3 bottles (corresponding to 3 x 180 sprays) with a mechanical pressure spray pump and 3 separate cones.

Before the first use, fix the cone to the bottle pump, as described in section 3.

Only some package sizes may be marketed

Marketing authorization holder

Industrial Farmacéutica Cantabria, S.A.

Ctra. Cazoña-Adarzo, s/n

39011 Santander

Spain

Responsible for manufacturing

Almirall Hermal GmbH

Scholtzstrasse 1 and 3- Reinbek

Schleswig-Holstein – 21465

Germany

This medicinal product is authorized in the EEA member states with the following trade names:

Last review date of this leaflet:February 2022

Thedetailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/