Minoxidil Galenicumderma 50 mg/ml cutaneous solution

Package leaflet: Information for the user

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 exactly the instructions for use provided in this leaflet or as directed 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 any adverse effects, consult your doctor or pharmacist, even if they are adverse effects 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 using Minoxidil GalenicumDerma
3. How to use Minoxidil GalenicumDerma
4. Possible adverse effects
5. How to store Minoxidil GalenicumDerma
6. Contents of the pack and other information

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

This medicinal product is a topical solution containing the active substance minoxidil, for the symptomatic treatment of androgenetic hair loss in men aged between 18 and 55 years.

This medicinal product stabilizes the progression of androgenetic hair loss (androgenetic alopecia) in the vertex area of the scalp in men. Thus, treatment may counteract the progression of androgenetic hair loss.

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

The onset and extent of this effect may vary individually and cannot be predicted.

This medicinal product 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 to any of the other components of this medicine (listed in section 6);
• If you are a woman, as occasional reversible and cosmetically distressing facial hair growth may appear during treatment;
• If you are using any other medicine on your scalp;
• If you have any type of dressing or bandage on your scalp;
• If you experience sudden or patchy hair loss;
• If you have any scalp condition such as psoriasis (an inflammatory skin condition causing itching), sunburn, shaved scalp, or if the scalp skin is damaged by scars or burns, since there are no hair follicles;
• If you have any signs of cardiovascular disease or heart rhythm problems, such as coronary artery disease, arrhythmias, congestive heart failure, or valvular heart 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, intact 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 (temples).

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

Take special care if you have or have had cardiovascular disease or cardiac arrhythmia, such as tachycardia, chest pain, loss of consciousness, dizziness, unexplained weight gain, or signs of fluid retention (swelling of hands or feet). In these conditions, you must not use this medicine (see 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 regularly thereafter.

You must stop using Minoxidil GalenicumDerma and consult a doctor:

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

Unwanted hair growth may result from transferring the product to areas other than the scalp.

Cases of excessive body hair growth in infants have been reported after skin contact with areas where minoxidil was applied in patients (caregivers) using topical minoxidil. Hair growth normalized within months once infants were no longer exposed to minoxidil. Precautions should be taken to ensure that children do not come into contact with body areas where topical minoxidil has been applied.

Consult your doctor if you notice excessive body hair growth in your child during your use of topical minoxidil products.

Isolated cases of mild changes in hair color have been reported in patients with very light hair who used hair care products simultaneously or swam in heavily chlorinated water.

Accidental ingestion may cause serious adverse effects on the cardiovascular system. Therefore, this medicine must be kept out of 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 upon accidental contact with sensitive areas (eyes, mucous membranes, abraded skin). In such cases, the affected area should be thoroughly washed with plenty of tap water. Consult a doctor if burning and/or irritation persists.

Children and adolescents

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

Other medicines and Minoxidil GalenicumDerma

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

To date, there is no available information on interactions between this medicine and other agents. Although not clinically proven, there is a theoretical possibility that systemic absorption of the active ingredient in this medicine (minoxidil) could worsen orthostatic hypotension (a drop in blood pressure felt when standing up after lying down) in patients who are also taking peripheral vasodilators (certain antihypertensive medicines that widen blood vessels).

This medicine must not be used together with other dermatological products (topical preparations containing active ingredients such as corticosteroids, retinoids, or anthralin) or with agents that increase the absorption of the active ingredient through the skin (cutaneous absorption).

Pregnancy and breastfeeding

This medicine is indicated for use only in male patients.

There is only limited experience with the use of this medicine during pregnancy. Therefore, this medicine must 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 absorbed into the body may pass into breast milk. Therefore, this medicine must not be used by breastfeeding mothers.

Driving and operating machinery

This medicine may cause dizziness or changes in blood pressure. If affected, patients 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 thoroughly with plenty of water.

Repeated application of this medicine to your hair instead of your scalp may lead to increased dryness and/or stiffness of the hair due to the ethanol and propylene glycol content of this medicine.

3. How to use Minoxidil GalenicumDerma

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

This medicine is intended for external use on dry scalp only. Use this medicine only on healthy, undamaged scalp and always follow the instructions for use given below. Do not apply this medicine to other areas of the body except the scalp.

Recommended dose:

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

Apply 1 ml of the solution by pressing the spray actuator 6 times, twice daily every 12 hours (morning and night) to the affected area of the scalp.

Apply the solution to the center of the affected area and spread it gently with your fingertips to ensure even distribution. For more localized application, use the applicator provided in the package. To do this, remove the top part of the spray head and insert the applicator. Then press the applicator 6 times, as described above for the spray. Wash your hands thoroughly after each application.

The daily applied amount must not be exceeded, i.e., 2 x 1 ml of solution, regardless of the size of the affected skin area.

Use in children and adolescents

This medicine must not be used in children and adolescents under 18 years of age, as efficacy and safety data from controlled studies are not available in these age groups.

Method of administration

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

Each package of this medicine contains 2 different application devices:

• Pre-assembled spray pump for application to large areas
• Separate applicator with extended tip for smaller areas

Both applicators can be interchanged by removing one and replacing it with the other.

For a dose of 1 ml, the spray must be activated 6 times.

Instructions for use/application

Option 1 — Spray pump

1. This device works best for applying the solution to large areas of the scalp.
2. Remove the outer cap from the bottle.
3. Apply 1 ml of solution by pressing the spray actuator 6 times and spread it with your fingertips to ensure even distribution.
4. Wash your hands and any other area of skin that may have come into contact with this medicine.

Option 2: Extended-tip applicator

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 (the piece with the nozzle) by pulling it upward, and insert the applicator.
4. Apply 1 ml of solution by pressing the applicator 6 times and spread it with your fingertips to ensure even distribution.
5. Wash your hands and any other area of skin that may have come into contact with this medicine.

Cleaning of 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 remove product residue and prevent clogging.

What else should be considered during use?

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

After applying this medicine, you may style your hair as usual. However, do 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 vary from patient to patient. Generally, twice-daily treatment for 2 to 4 months is required before an effect is observed. To maintain the effect, continued twice-daily application without interruption is recommended.

Applying this medicine in larger amounts or more frequently will not produce better results. With regard to potential therapeutic effect, sufficient clinical experience exists for a treatment period of up to one year.

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

Information on increased hair shedding

When treating hair follicles with the active substance 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 out inactive "old" hairs from the scalp. This may initially give the impression of increased hair loss. In some patients, this reaction has been observed between two and six weeks after starting treatment with the active substance minoxidil. However, there is no cause for concern, as this reaction is accompanied by increased hair growth. The effect disappears within a few weeks and can be interpreted as an early sign of minoxidil's effectiveness.

If you use more Minoxidil GalenicumDerma than you should

Applying this medicine in doses higher than recommended, over relatively large body surfaces, or on areas other than the scalp may increase systemic absorption of minoxidil into the body. To date, there have been no reported cases in which topical use of minoxidil solution has caused symptoms of poisoning.

In case of accidental ingestion, the concentration of the active substance minoxidil in this medicine may cause effects on internal organs similar to those seen when the active substance is ingested orally, for example in tablet form. This may cause the following side effects: rapid heartbeat, decreased blood pressure, fluid accumulation, sudden weight gain, and dizziness.

In case of accidental ingestion or signs of overdose, contact a doctor immediately so appropriate measures can be taken. Please keep the medicine packaging available to inform the doctor about the active substance taken.

If you forget to use Minoxidil GalenicumDerma

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

If you stop using Minoxidil GalenicumDerma

Continued treatment is necessary to improve and maintain hair growth. Otherwise, hair loss will resume.

If treatment is stopped within 3 to 4 months, the condition will return to what it would have been without treatment with this medicine.

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

4. Possible adverse effects

Like all medicines, Minoxidil GalenicumDerma can cause side effects, although not everyone experiences them.

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

• Swelling of the face, lips, or throat that may cause difficulty swallowing or breathing. This could be a sign of a severe allergic reaction (frequency unknown, cannot be estimated from available data);
• Generalized skin redness (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 rash, skin eruption)
• Shortness of breath, difficulty breathing
• Swelling of arms and legs
• Weight gain
• High blood pressure
• Scalp irritation, such as stinging, 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)
• Depressed mood
• Eye irritation
• Faster heartbeats, palpitations, low blood pressure
• Vomiting
• Application site reactions that may also affect the ears and face, such as itching, skin irritation, pain, redness, swelling, dry skin, and inflammatory rash, possibly leading to skin peeling (dermatitis), blistering, bleeding, and ulceration
• Temporary hair loss, changes in hair color, alteration in hair structure
• Chest pain

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Minoxidil GalenicumDerma

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

Do not use this medicine after the expiry date stated on the outer packaging and on the bottle after "EXP.". The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Do not refrigerate or freeze. Keep the bottle tightly closed.

Shelf life after first opening: 12 months.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at a SIGRE collection point at your pharmacy. If you have any doubts, please ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

What Minoxidil GalenicumDerma contains

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

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

What Minoxidil GalenicumDerma looks like and contents of the pack

Homogeneous, transparent solution, colorless to slightly yellowish, free from suspended particles.

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

Pack sizes:

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

Not all pack 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 medicine 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 solución cutánea

Romania: Minoxidil Medinfar 50 mg/ml solutie cutanata

This leaflet was last reviewed in: June 2025.

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