Leaflet: Information for the user

Minoxidil GalenicumDerma, 50 mg/ml, topical solution

Minoxidil

Read this leaflet carefully before you start taking this medicine, because it contains important information for you

Follow exactly the administration instructions for the medicine contained in this leaflet or those 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 any 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 using Minoxidil GalenicumDerma

3. How to use Minoxidil GalenicumDerma

4. Possible side effects

5. Storage of Minoxidil GalenicumDerma

6. Contents of the pack and additional information

This medicationis a topical solution containing the active ingredient minoxidil for the symptomatic treatment of androgenetic alopecia in men aged 18 to 55 years.

This medicationstabilizes the course of androgenetic alopecia (male pattern baldness) in the scalp area of the balding zone in men. In this way, the treatment can counteract the progression of androgenetic alopecia.

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

The onset and extent of this effect may be different for each individual and cannot be predicted.

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

No use Minoxidil GalenicumDerma

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

Warnings and precautions

Apply this medication 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 (entrances).

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

Be especially 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 hydrops (swelling of the hands or feet). In these conditions, do not use this medication(consult 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 beginning 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 medications to treat high blood pressure;
• If one or more of the following symptoms appear: chest pain, rapid heart rate, weakness, dizziness, sudden and unexplained weight gain, swelling of the hands or feet, persistent redness or irritation of the scalp, or if other unexpected symptoms appear (consult 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 isolated cases of mild changes in hair color 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 severe side effects in the cardiovascular system. Therefore, keep this medication out of the reach of children.

Avoid inhaling the spray mist.

Since this medication 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 thoroughly washed with plenty of running water from the tap. Consult a doctor if the burning sensation and/or irritation persist.

Children and adolescents

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

Other medications and Minoxidil GalenicumDerma

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

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

This medication should not be used with other dermatological products (external 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 lactation

This medication is intended for use only in male patients.

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

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

The minoxidil incorporated into the body may pass into breast milk. Therefore, this medication should not be used by breastfeeding women.

Driving and operating machinery

This medication may cause dizziness or changes in blood pressure. If affected, patients should not drive or operate machinery.

Minoxidil GalenicumDerma contains propylene glycol

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

Minoxidil GalenicumDerma contains ethanol (96 percent)

This medication contains 510 mg of alcohol (ethanol) in each ml of topical 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, abrasions, mucous membranes), the affected areas should be rinsed with plenty of water.

If you apply this medication repeatedly to your hair instead of your scalp, it may cause an increase in dryness and/or rigidity of the hair due to the content of ethanol and propylene glycol in this medication.

Use this medication exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.

This medication is intended for external use on dry scalp. Use this medication only on healthy, undamaged scalp and follow the usage instructions provided below at all times. Do not apply this medication to any other areas of the body other than the scalp.

The recommended dose is:

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

Apply 1 ml of the solution of this medication by pressing the atomizer's actuator 6 times, twice a day, every 12 hours (morning and night) on the affected area of the scalp.(morning and night)on the affected area of the scalp..

Apply the solution in the center of the affected area and spread it evenly with your fingertips to ensure the medication is distributed uniformly. For a more localized application, use the applicator provided with the packaging. To do this, remove the top part of the atomizer head and insert the applicator. Then, press the applicator 6 times, as indicated earlier for the atomizer. Wash your hands thoroughly 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 medication should not be used in children and adolescents under 18 years of age, as there are no controlled efficacy and safety study results available for these age groups.

Method of administration

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

Each package of this medication contains 2 different application devices:

- Pre-assembled spray pump for applications on extensive areas

- Independent applicator with extended tip for smaller areas

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

To administer a dose of 1 ml, the atomizer needs to be activated 6 times.

Usage/instruction application

Option 1 — Spray pumpr

1. This device works best for applying the solution to extensive areas of the scalp.

2. Remove the outer cap of the bottle.

3. Apply 1 ml of solution by pressing the atomizer's actuator 6 times and spread it evenly with your fingertips to ensure the medication is distributed uniformly.

4. Wash your hands and any other area not on the scalp that may have come into contact with this medication.

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 of the bottle.

3. Remove the top part of the atomizer head (piece with the orifice), pulling it upwards, and insert the applicator.

4. Apply 1 ml of solution by pressing the applicator 6 times and spread it evenly with your fingertips to ensure the medication is distributed uniformly.

5. Wash your hands and any other area not on the scalp that may have come into contact with this medication.

Cleaning the spray pump and applicator

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

What else to consider during use?

Your hands must be washed thoroughly after applying this medication to avoid accidental contact with mucous membranes and eyes.

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

Duration of use

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

You will not achieve better results by applying this medication in larger quantities or with greater frequency. 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, 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, pushing out the "old" hairs that are no longer active. This initially gives the impression of increased hair loss. In some patients, this reaction was observed between two and six weeks after starting treatment with minoxidil. However, there is no need to be alarmed, as this reaction is accompanied by an increase in hair growth. The effect disappears in a few weeks and can be interpreted as an initial sign of the effect of minoxidil.

If you use more Minoxidil GalenicumDerma than you should

The application of this medication in doses higher than recommended and on relatively large body surfaces or in areas other than the scalp may cause increased systemic absorption of minoxidil in the body. To date, there have been no cases of external use of minoxidil solution causing poisoning symptoms.

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

In case of accidental ingestion or suspected overdose, inform your doctor immediately so they can decide what to do next. Please keep the medication packaging handy to inform your doctor about the active ingredient taken.

If you forget to use Minoxidil GalenicumDerma

Do not apply a double dose to compensate for a missed dose; continue treatment with the recommended dose. Compensating 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 discontinued within 3 to 4 months, the condition will be the same as if no treatment had been given with this medication.

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

Like all medications,Minoxidil GalenicumDermamay cause side effects, although not everyone will 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 may cause difficulty in swallowing or breathing. This could be a sign of a severe allergic reaction (unknown frequency, cannot be estimated from available data);

- Generalized redness of the skin (unknown frequency, cannot be estimated from available data);

- Generalized itching (unknown frequency, cannot be estimated from available data);

- Throat constriction (unknown frequency, 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

- Excessive 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

- Irritation of the scalp, such as burning, itching, dryness, itching, peeling, folliculitis

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

- Dizziness, nausea

Unknown(frequency cannot be estimated from available data):

- Contact dermatitis (inflammation of the skin related to allergies)

- Depressive mood

- Eye irritation

- Rapid heartbeats, palpitations, low blood pressure

- Vomiting

- Symptoms at the site of administration that may also affect the ears and face, such as itching, skin irritation, pain, redness, swelling, dry skin, and inflammatory eruption, up to possible skin peeling (dermatitis), blister formation, bleeding, and ulceration

- Temporary hair loss, changes in hair color, alteration of hair structure

- Chest pain.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaRAM.es.By reporting adverse reactions, 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 outer box and the bottle after «VENC.». 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 disposed of through drains or in the trash. Deposit containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

What Minoxidil GalenicumDerma contains

- The active ingredient is minoxidil. Each milliliter of topical solution contains 50 mg of minoxidil.

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

Appearance of Minoxidil GalenicumDerma and contents of the packaging

Homogeneous transparent solution, colorless to yellowish, free of particles in suspension.

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

Packaging sizes:

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

Not all packaging sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Galenicum Derma, S.L.

Ctra. N-1, Km36,

28750 San Agustin de 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 with the following names:

Portugal

Belgium FR: Minoxidil Leman 50 mg/ml Solution for cutaneous application

NL: Minoxidil Leman 50 mg/ml Solution for cutaneous use

DE: Minoxidil Leman 50 mg/ml Solution for application on the skin

Italy SCEVADIL

Luxembourg: Minoxidil Leman 50 mg/ml Solution for cutaneous application

Spain: Minoxidil GalenicumDerma

This leaflet was last revised in: May /2024.

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