Alocare 2.275 mg/ml solution for cutaneous spray

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Alocare 2.275 mg/ml cutaneous spray solution

finasteride

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Alocare is and what it is used for

This medicine contains the active substance finasteride. It is applied to the 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 hair loss in men (also known as androgenetic alopecia). This medicine increases hair growth and prevents further hair loss in men. Alocare can only be used in men aged 18 to 41 years.

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

This hormone is thought to contribute to shortening the hair growth phase and causes hair to become thinner.

As hair follicles become smaller, baldness becomes apparent. Alocare 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 Alocare

Do not use Alocare

• 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 and are or may be pregnant.

Warnings and precautions

Talk to your doctor or pharmacist before using Alocare.

Possible transmission of Alocare

If the active ingredient is absorbed through the skin of a woman who is pregnant with a male baby, the baby may be born with abnormalities of the sex organs.

Avoid any contact between the treated area and a woman who is or may become pregnant. You should also avoid touching surfaces exposed to this medicine. If contact with Alocare occurs, the affected woman must wash the affected area of the body quickly and thoroughly.

Children and adolescents must not come into contact with this medicine. If contact with Alocare occurs, the affected child or adolescent must wash the affected body area quickly and thoroughly.

Effect on Prostate-Specific Antigen (PSA)

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

Effect on the male hormone dihydrotestosterone (DHT)

Alocare reduces the concentration of the male hormone (DHT) in the blood. However, this occurs infrequently, and the reduction is smaller than with finasteride tablets. Sexual side effects known to occur with finasteride tablets may also occur with Alocare, but are less likely (see section 4). Therefore, follow your doctor's prescribed dose. 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 notice any changes in breast tissue, such as lumps, pain, breast 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 as soon as possible for advice.

Children and adolescents

This medicine must not be used in children or adolescents. There are no data demonstrating the efficacy and safety of finasteride in children under 18 years of age.

Other medicines and Alocare

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Pregnancy

Women must not take Alocare.

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

Driving and use of machines

Alocare has no influence on the ability to drive or operate machinery.

Alocare contains ethanol

This medicine contains 25 mg of ethanol (96%) per spray, equivalent to 0.5 mg/microliter (55%). It may cause a burning sensation on damaged skin.

3. How to use Alocare

Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Depending on the extent of your bald scalp area, your doctor will prescribe between 1 and 4 sprays per day, which you should apply to different areas. Do not use more than 4 sprays per day.

This medicine is for cutaneous use only. It should only be used on the scalp.

Alocare consists of two separate components: a bottle with an attached pump and a cone. These components must be assembled before first use. Before the first application, read all instructions below carefully.

Ensure that your hair and scalp are completely dry before application. Apply Alocare directly to the scalp only. If more than one spray is prescribed, apply them to non-overlapping areas. Do not apply the solution to any other parts of the body except the scalp. After application, leave Alocare on the scalp for at least 6 hours.

This medicine may transfer 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 completely.

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

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

Components and assembly of the spray pump

Assembly of the spray pump

1. Align and press

Align the cone with the pump button and press firmly.

1. Correct assembly

The spray applicator is correctly assembled when a clicking sound is heard after pressing, and the spray nozzle of the pump is centered within the cone.

1. Correct assembly

and the bottom of the pump button is aligned with the bottom of the cone without any gap.

1. Incorrect assembly if there is a gap. 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.

Preparing 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. It is not necessary to re-prime the pump with each use.

• To prime the pump for the first time, press the pump fully down four times using 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 for 2 weeks or more, press the pump fully down once only.

• Do not spray Alocare toward your face.

If solution leaks during assembly or preparation, clean any surfaces where it may have been deposited.

Applying the dose

• Depending on the size of the bald area on the scalp, your doctor will prescribe between 1 and 4 sprays per day.
• It is not necessary to shake the bottle before use.
• Hold the spray applicator with the flat cone pressed against the scalp to prevent dispersion of the solution into the air.
• Press the pump fully down once for one spray.
• Move the cone to different areas of the scalp to apply additional doses, according to the number of sprays prescribed by your doctor. Do not overlap, and avoid treating areas that have already been sprayed.
• After use, do not remove the cone from the pump. Return the spray applicator to its box.
• After application, do not rinse Alocare off for at least 6 hours.

Ensure that Alocare does not come into contact with your hands or any other part of your body. Immediately and thoroughly wash any part of the body that is exposed, other than your scalp.

If the cone becomes soiled, clean it with a clean, dry paper tissue. Dispose of the used tissue safely and wash your hands thoroughly.

Dosage and number of treatment days per bottle

The bottle contains up to 180 sprays. The number of treatment days depends on the prescribed dosage, ranging from 1 to 4 sprays per day. Do not use the bottle beyond 180 sprays, as the remaining solution in the bottle may not deliver a complete dose, which could reduce the effectiveness of your treatment.

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

If you use more Alocare than you should

If you apply more Alocare than recommended, speak with your doctor. Alocare will not work faster or better if applied more than once a day, but the risk of side effects may increase.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken.

If you forget to use Alocare

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

If you stop using Alocare

The effect of treatment may take up to 3 months to develop. It is important that you continue using Alocare for the length of time indicated by your doctor. If you stop applying Alocare, you may lose the hair you have gained.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will 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 with oral finasteride may also occur with Alocare.

These include:

• Allergic reactions (hypersensitivity) including rash, itching, swelling around the mouth (angioedema)
• Depressed mood
• Anxiety
• Awareness of heartbeats (palpitations)
• Increase in liver enzymes
• Tenderness and enlargement of the breasts
• Testicular pain
• Blood in the ejaculate (haemospermia)
• Decreased sexual desire
• Difficulty in achieving an erection
• Ejaculation disorder, including reduced volume of ejaculate
• Infertility

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es . By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Alocare

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

Do not use this medicine after the expiry date stated on the carton, after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

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

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be handed over to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Alocare

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

Appearance of the product and contents of the container

Alocare is a colorless, transparent, slightly viscous cutaneous spray solution.

Container 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 first use, attach the cone to the bottle pump as described in section 3.

Only certain container sizes may be marketed.

Marketing Authorization Holder
Industrial Farmacéutica Cantabria, S.A.
Barrio Solía 30, La Concha de Villaescusa
39690 Cantabria
Spain

Manufacturer

Almirall Hermal GmbH
Scholtzstrasse 1 and 3 - Reinbek
Schleswig-Holstein – 21465
Germany

This medicinal product is authorized in the EEA Member States under the following names:

Date of the last review of this leaflet: February 2022

The detailed and up-to-date information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/