MINOXIDIL GALENICUMDERMA 50 mg/ml CUTANEOUS SOLUTION

Introduction

Package Leaflet: Information for the User

Minoxidil GalenicumDerma, 50 mg/ml, Cutaneous Solution

Minoxidil

Read all of this leaflet carefully before you start using this medicine because it contains important information for you

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• Consult your pharmacist if you need more information or advice.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if you do not feel better or if you feel worse after 4 months.

What this leaflet contains

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

1. What Minoxidil GalenicumDerma is and what it is used for

This medicine is a cutaneous solution containing the active ingredient minoxidil for the symptomatic treatment of androgenetic alopecia in men between 18 and 55 years old.

This medicine stabilizes the course of androgenetic alopecia (male pattern baldness) in the vertex area of the scalp in men. Thus, the treatment may counteract the progression of androgenetic alopecia.

The mechanism by which topical minoxidil and/or its metabolite stimulate hair growth is not yet fully understood. However, it is believed that minoxidil acts at the level of the hair follicle, increasing blood flow to the scalp due to local vasodilation.

The onset and extent of this effect may vary from person to person and cannot be predicted.

This medicine is intended for external use only and should only be applied to the scalp.

2. What you need to know before using Minoxidil GalenicumDerma

Do not use Minoxidil GalenicumDerma

• If you are allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6);
• If you are a woman, as occasional reversible and aesthetically disturbing facial hair growth may occur during treatment;
• If you are using any other medicine on the scalp;
• If you have any type of dressing or bandage on the scalp;
• If you are experiencing sudden or irregular hair loss;
• If you have any condition that affects the scalp, such as psoriasis (an inflammatory skin condition that itches), sunburn, shaved scalp, or if the scalp skin is damaged by scars or burns, as there are no hair roots;
• If you have any signs of cardiovascular disease or heart rhythm problems, such as coronary artery disease, arrhythmias, congestive heart failure, or valvular disease;
• If you have high blood pressure (hypertension);
• If you are taking medicines to treat high blood pressure.

Warnings and precautions

Apply this medicine only to a healthy and normal scalp. Do not use if the cause of hair loss is unknown or if the scalp is red, inflamed, or painful.

To date, there is no clinical experience regarding its efficacy for hair loss in the temporal region (receding hairline).

This medicine is intended for external use only on the scalp. Do not apply this medicine to other parts of the body.

Be careful if you have or have had a cardiovascular disease or cardiac arrhythmia, such as tachycardia, chest pain, loss of consciousness, dizziness, unexplained weight gain, or signs of fluid retention (swelling of the hands or feet). In these conditions, you should not use this medicine (see the section "Do not use Minoxidil GalenicumDerma").

Patients with low blood pressure should consult a doctor before using topical minoxidil, and monitoring should be performed at the start of treatment and then regularly.

You should stop using Minoxidil GalenicumDerma and consult a doctor:

• If you discover that you have low blood pressure;
• If you have high blood pressure;
• If you are taking medicines to treat high blood pressure;
• If one or more of the following symptoms appear: chest pain, rapid heart rate, weakness, or dizziness, sudden unexplained weight gain, swelling of hands or feet, redness, or persistent irritation of the scalp, or if other new unexpected symptoms appear (see the section "If you use more Minoxidil GalenicumDerma than you should").

Unwanted hair growth may be due to the transfer of the product to areas other than the scalp.

There have been reports of excessive body hair growth in infants after skin contact with minoxidil application areas in patients (caregivers) using topical minoxidil. Hair growth returned to normal within months when infants were no longer exposed to minoxidil. Precautions should be taken to ensure that children do not come into contact with areas of the body where minoxidil has been applied topically.

Consult your doctor if you notice excessive hair growth on your child's body during the period when using topical minoxidil products.

Isolated cases of slight changes in hair color have been described in patients with very light hair when using hair care products at the same time or after swimming in highly chlorinated water.

Accidental ingestion may cause serious side effects on the cardiovascular system. Therefore, you should keep this medicine out of the reach of children.

Avoid inhaling the spray mist.

Since this medicine contains alcohol and propylene glycol, it may cause a burning sensation and/or irritation in case of accidental contact with sensitive areas (eyes, mucous membranes, worn skin). In these cases, the affected area should be rinsed thoroughly with plenty of running tap water. You should consult a doctor if the burning sensation and/or irritation persist.

Children and adolescents

Do not apply this medicine to children and adolescents under 18 years old, as safety and efficacy have not been established in this age group.

Other medicines and Minoxidil GalenicumDerma

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

To date, there is no information available on interactions between this medicine and other agents. Although it has not been clinically demonstrated, there is a theoretical possibility that the absorption of the active ingredient of this medicine (minoxidil) into the body may worsen orthostatic hypotension (a drop in blood pressure that occurs when standing up after being lying down) in patients who are also taking peripheral vasodilators (certain high blood pressure medicines that widen blood vessels).

This medicine should not be used with other dermatological products (preparations for external use that contain active ingredients such as corticosteroids, retinoids, or anthralin) or with agents that increase the absorption of the active ingredient through the skin (percutaneous absorption).

Pregnancy and breastfeeding

This medicine is indicated for use only in male patients.

There is only limited experience with the application of this medicine during pregnancy. Therefore, this medicine should not be used by pregnant women.

If you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Minoxidil incorporated into the body may pass into breast milk. Therefore, this medicine should not be used by breastfeeding mothers.

Driving and operating machinery

This medicine may cause dizziness or changes in blood pressure. If you are affected, you should not drive or operate machinery.

Minoxidil GalenicumDerma contains propylene glycol

This medicine contains 350 mg of propylene glycol in each ml of cutaneous solution. Propylene glycol may cause skin irritation.

Minoxidil GalenicumDerma contains ethanol (96 percent)

This medicine contains 510 mg of alcohol (ethanol) in each ml of cutaneous solution. It may cause a burning sensation on damaged skin.

Ethanol may cause stinging and irritation in the eyes. In case of accidental contact with sensitive areas (eyes, skin abrasions, mucous membranes), these areas should be rinsed with plenty of water.

If you apply this medicine repeatedly to your hair instead of your scalp, it may cause increased dryness and/or stiffness of the hair due to the content of ethanol and propylene glycol in this medicine.

3. How to use Minoxidil GalenicumDerma

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. You should consult your doctor or pharmacist if you are not sure.

This medicine is intended for external use on the dry scalp. Use this medicine only on a healthy, undamaged scalp, and follow the instructions for use indicated below at all times. Do not apply this medicine to other areas of the body that are not the scalp.

The recommended dose is:

Unless your doctor prescribes otherwise, this medicine should be used as follows:

Apply 1 ml of the solution of this medicine by pressing the actuator of the spray 6 times, twice a day, every 12 hours (morning and night) in the affected area of the scalp.

Apply the solution to the center of the affected area and spread it with your fingertips to ensure that the medicine is distributed evenly. For more localized application, use the applicator provided with the packaging. To do this, remove the top part of the spray head (piece with the hole) by pulling it upwards and insert the applicator. Then, press the applicator 6 times, as indicated above for the spray. Wash your hands well after each application.

Do not exceed the daily applied amount, i.e., 2 x 1 ml of solution, regardless of the size of the affected skin area.

Use in children and adolescents

This medicine should not be used in children and adolescents under 18 years old, as there are no results of efficacy and safety from controlled studies in these age groups.

Method of administration

Cutaneous use (scalp). This medicine is intended for external use only and only on the scalp.

Each pack of this medicine contains 2 different application devices:

• Pre-assembled spray pump for applications in extensive areas
• Independent applicator with extended tip for smaller areas

Both applicators can be changed by separating one applicator and replacing it with the other.

To administer a dose of 1 ml, the spray actuator needs to be pressed 6 times.

Instructions for use/application

Option 1 — Spray pump

1. This device works best for applying the solution to extensive areas of the scalp.
2. Remove the outer cap from the bottle.
3. Apply 1 ml of solution by pressing the actuator of the spray 6 times and spread it with your fingertips to ensure that the medicine is distributed evenly.
4. Wash your hands and any other area that is not the scalp that may have come into contact with this medicine.

Option 2: Applicator with extended tip

1. This applicator works best for applying the solution to small areas of the scalp or under the hair.
2. Remove the outer cap from the bottle.
3. Remove the top part of the spray head (piece with the hole) by pulling it upwards and insert the applicator.
4. Apply 1 ml of solution by pressing the applicator 6 times and spread it with your fingertips to ensure that the medicine is distributed evenly.
5. Wash your hands and any other area that is not the scalp that may have come into contact with this medicine.

Cleaning the spray pump and applicator

Remove the top part of the spray head or applicator and rinse with 70% isopropyl alcohol after each use to clean the product residues and prevent clogging.

What else should be considered during use?

Hands should be washed thoroughly after applying this medicine to avoid accidental contact with mucous membranes and eyes.

After applying this medicine, you can comb your hair as usual. However, you should not wet the scalp for approximately 4 hours. This will prevent the medicine from being washed away.

Duration of use

The onset and extent of hair growth are different in each patient. In general, a twice-daily treatment for 2 to 4 months is required before an effect is observed. To maintain the effect, it is recommended to continue the application twice a day without interruption.

You will not get better results if you apply this medicine in larger amounts or more frequently. As for a possible therapeutic effect, there is sufficient clinical experience for a treatment period of up to one year.

If no effect is observed after 4 months, the treatment should be discontinued.

Information on increased hair loss

In the treatment of hair follicles with the active ingredient minoxidil, the resting phase (telogen phase) of the hair cycle is shortened, and the growth phase (anagen phase) is reached more quickly. This stimulates the growth of new hair, which pushes the "old" inactive hairs out of the scalp. This gives the initial impression of increased hair loss. In some patients, this reaction was observed between 2 and 6 weeks after the start of treatment with the active ingredient minoxidil. However, there is no need to be alarmed, as this reaction is accompanied by an increase in hair growth. The effect disappears within a few weeks and can be interpreted as a first sign of the effect of minoxidil.

If you use more Minoxidil GalenicumDerma than you should

Applying this medicine in doses higher than recommended and on relatively large body surfaces or in areas other than the scalp may cause an increase in the systemic absorption of minoxidil in the body. To date, there are no known cases where the external use of the minoxidil solution has caused poisoning symptoms.

After accidental ingestion, the concentration of the active ingredient minoxidil in this medicine may cause effects on the internal organs corresponding to the effects that occur when the active ingredient is ingested, for example, in a tablet. This may cause the following side effects: rapid heartbeats, decreased blood pressure, fluid accumulation, and subsequent sudden weight gain, dizziness.

In case of accidental ingestion or signs of overdose, inform a doctor immediately so that they can decide what to do next. Please keep the packaging of the medicine at hand to inform the doctor about the active ingredient that has been taken.

If you forget to use Minoxidil GalenicumDerma

Do not apply a double dose to make up for a forgotten dose; continue treatment with the recommended dose. Making up for the missed dose will not provide any benefit and may cause unwanted effects.

If you stop using Minoxidil GalenicumDerma

It is necessary to continue treatment to improve and maintain hair growth. Otherwise, hair loss will recur.

If treatment is stopped within 3 to 4 months, the condition will be the same as if you had not used this medicine.

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

4. Possible Adverse Effects

Like all medications, Minoxidil GalenicumDerma can cause side effects, although not all people experience them.

Contact a doctor immediately if you notice any of the following symptoms - you may need urgent medical treatment:

• Swelling of the face, lips, or throat that can cause difficulty swallowing or breathing. This could be a sign of a severe allergic reaction (frequency unknown, cannot be estimated from available data);
• Generalized redness of the skin (frequency unknown, cannot be estimated from available data);
• Generalized itching (frequency unknown, cannot be estimated from available data);
• Throat tightness (frequency unknown, cannot be estimated from available data).

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

• Headache

Common(may affect up to 1 in 10 people)

• Itching
• Increased hair growth beyond the scalp (including facial hair growth in women), inflammatory skin reaction (such as acneiform exanthema, skin rash)
• Shortness of breath, difficulty breathing
• Swelling of arms and legs
• Weight gain
• High blood pressure
• Irritation of the scalp, such as tingling, burning, dryness, itching, flaking, folliculitis

Uncommon(may affect up to 1 in 100 people):

• Dizziness, nausea

Unknown(frequency cannot be estimated from available data):

• Contact dermatitis (skin inflammation related to allergies)
• Depressive mood
• Ocular irritation
• Faster heartbeats, palpitations, low blood pressure
• Vomiting
• Symptoms at the administration site that can also affect the ears and face, such as itching, skin irritation, pain, redness, swelling, dry skin, and inflammatory rash, up to possible skin peeling (dermatitis), blistering, bleeding, and ulceration
• Temporary hair loss, changes in hair color, alteration of hair structure
• Chest pain.

Reporting Adverse Effects

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

5. Storage of Minoxidil GalenicumDerma

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the outer packaging and the bottle after "EXP.". The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Do not refrigerate or freeze. Keep the bottle perfectly closed.

Shelf life after first opening: 12 months.

Medications should not be thrown away through drains or in the trash. Deposit the packaging and medications you no longer need at the pharmacy's SIGRE Point. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

What Minoxidil GalenicumDerma contains

• The active ingredient is minoxidil. Each milliliter of cutaneous solution contains 50 mg of minoxidil.

• The other components are propylene glycol and ethanol (96 percent).

Appearance of Minoxidil GalenicumDerma and package contents

Homogeneous transparent solution, colorless to yellowish, free of suspended particles.

This medication is available in bottles containing 60 ml of cutaneous solution (bottle with spray pump) with an applicator.

Package sizes:

1 x 60 ml and 3 x 60 ml of cutaneous solution.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Galenicum Derma, S.L.U.

Ctra. N-1, Km36,

28750 San Agustín del Guadalix (Madrid)

Spain

Manufacturer

Medinfar Manufacturing S.A.

Parque Industrial Armando Martins Tavares

Rua Outeiro da Armada No 5,

Condeixa-A-Nova 3150-194 Sebal

Portugal

This medication is authorized in the member states of the European Economic Area under the following names:

Austria: Minoxidil Redcare 50 mg/ml Lösung zur Anwendung auf der Haut (Kopfhaut)

Belgium FR: Minoxidil Leman 50 mg/ml Solution pour application cutanée

NL: Minoxidil Leman 50 mg/ml Oplossing voor cutaan gebruik

DE: Minoxidil Leman 50 mg/ml Lösung zur Anwendug auf der Haut

Germany: Minoxidil Redcare 50 mg/ml Lösung zur Anwendung auf der Haut (Kopfhaut)

Italy SCEVADIL

Luxembourg: Minoxidil Leman 50 mg/ml Solution pour application cutanée

Poland: Minoxidil Medinfar

Portugal: Noage

Spain: Minoxidil GalenicumDerma 50 mg/ml cutaneous solution

Romania: Minoxidil Medinfar 50 mg/ml solutie cutanata

This prospectus was last revised in: June 2025.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es