Prospecto:Information for the Patient

Alocutan50 mg/ml Solution for Cutaneous Aerosolization

Minoxidil

Read this entire prospectus carefully before starting to use this medication, as it contains important information for you.

Follow exactly the medication administration instructions contained in this prospectus or those indicated by your doctor or pharmacist.

• Keep this prospectus, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 4 months.

1.What is Alocutan 50 mg/ml and for what it is used

2.What you need to know before starting to use Alocutan 50 mg/ml

3.How to use Alocutan 50 mg/ml

4.Possible adverse effects

1. Storage of Alocutan 50 mg/ml

6. Contents of the package and additional information

Alocutan 50 mg/ml prevents hereditary hair loss in men aged 18 to 65 years and stimulates hair growth. It also promotes the regeneration of new hair in weakened or bald areas and thickens existing hair.

After application, Alocutan 50 mg/ml penetrates the scalp and reaches the hair roots. The mechanism by which hair growth is stimulated has not yet been clarified. However, the active ingredient in Alocutan 50 mg/ml may stop hereditary hair loss by:

• increasing the diameter of the hair shaft

• stimulating growth and

• prolonging the growth phases of the hair

However, at least four months will be needed before any results can be seen. If the hair roots are still present, fine and weak hair may regrow, becoming longer, denser, and darker over time. The rate at which hair growth begins and how many hairs regrow depends on the patient. Large bald spots or hair loss present for more than 10 years are less sensitive to Alocutan 50 mg/ml.

The following images show the stages of male pattern hair loss, for which the effectiveness of minoxidil, the active substance in Alocutan 50 mg/ml, has been demonstrated.

Children and adolescents under 18 years, patients 65 years and older

Alocutan 50 mg/ml should not be used in these patient groups, as there are no available efficacy and safety study results in these age groups..

No useAlocutan50 mg / ml

- 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 there are occasional signs of facial hair growth that can be cosmetically bothersome and reversible during treatment

- if you are using other medications on your scalp

- if you have any type of bandage or dressing on your scalp

- if you experience sudden or uneven hair loss

- if you have any condition that affects your scalp, including psoriasis (inflammatory skin condition with itching), sunburn, scalp shaving, or if the scalp skin is damaged by scars or burns, as there are no hair follicles.

Warnings and precautions

Consult your doctor or pharmacist before usingAlocutan50 mg / ml.

The underlying causes, diseases, or malnutrition should be excluded.In these cases, specific treatment is needed.

ApplyAlocutan50 mg / ml only on a healthy normal scalp. Do not useAlocutan50 mg / ml if the cause of hair loss is unknown or if hair loss is due to childbirth or if the scalp is red, inflamed, or painful.

No clinical experience to date regarding its effectiveness for hair loss in the temporal region (hair recession).

If systemic effects or severe skin reactions occur, treatment should be discontinued.

Alocutan50 mg / ml is intended only for external use on the scalp. Do not applyAlocutan50 mg / ml to other parts of the body.

Do not useAlocutan50 mg / ml

• if you have any signs of cardiovascular disease or heart rhythm problems

• if you have high blood pressure

• if you are taking medications to treat high blood pressure (anti-hypertensive agents).

You should stop using Alocutan 50 mg / ml and consult a doctor

• if you have low blood pressure or

• if any of the following symptoms appear: chest pain, rapid heartbeats, weakness, dizziness, sudden and unexplained weight gain, swelling of hands or feet, persistent redness or irritation of the scalp, or if any new unexpected symptoms appear (see the section "If you use more Alocutan 50 mg / ml than you should").

Unwanted hair growth may be caused by transferring the product to other areas of the scalp.

There have been isolated reports of slight changes in hair color in patients with very light hair when using other 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.

There have been reports of excessive hair growth in infants after skin contact with areas of minoxidil application on patients (caregivers) who used topical minoxidil. Hair growth normalized within months when infants stopped being exposed to minoxidil. Be cautious to ensure that children do not come into contact with areas of the body where minoxidil has been applied topically.

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

Avoid breathing in the spray mist.

Children and adolescents

Do not administer 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 andAlocutan50 mg/ml

Inform your doctor or pharmacist if you are using / taking, have taken / used recently, or could take / use any other medication.

To date, there is no information available on interactions betweenAlocutan50 mg / ml and other active ingredients. Although not clinically proven, there is a theoretical possibility that the absorption of the active substance inAlocutan50 mg / ml (minoxidil) in the body may worsen orthostatic hypotension (a decrease in blood pressure when standing up) in patients who are also taking peripheral vasodilators (certain medications for high blood pressure that dilate blood vessels).

Alocutan50 mg / ml should not be used with other dermatological products (external preparations containing active ingredients such as corticosteroids, retinoids, or ditranol) or with active ingredients that increase the absorption of the active substance through the skin (cutaneous absorption).

Pregnancy and breastfeeding

Alocutan50 mg / ml is indicated only for male patients.

Experience is limited with the application of Alocutan50 mg / ml during pregnancy.Minoxidil absorbed by the body may pass into breast milk.Therefore, Alocutan 50 mg / ml should not be used by pregnant women and breastfeeding women.

Driving and operating machinery

This product may cause dizziness or hypotension (see section 4). If affected, do not drive or operate machinery.

Alocutan50 mg/ml contains propilenglycol (E 1520) and ethanol 96% (alcohol)

This medication contains 509 mg of propilenglycol (E 1520) in each ml of solution.

This medication contains 248 mg of alcohol (ethanol) in each ml of solution.

May cause a burning sensation on damaged skin

Alcohol may cause itching and irritation in the eyes. In case of accidental contact with sensitive areas (eyes, skin abrasions, mucous membranes), rinse them with plenty of water.

If you apply Alocutan 50 mg / ml repeatedly to the hair instead of the scalp, this may increase the dryness and/or stiffness of the hair due to the content of ethanol and propilenglycol in Alocutan 50 mg / ml.

Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Consult your doctor or pharmacist if you are unsure.

Alocutan 50 mg / ml is for external use on dry scalp. Use Alocutan 50 mg / ml only on healthy and undamaged scalp and follow the usage instructions exactly at all times. Do not apply Alocutan 50 mg / ml to areas of the body other than the scalp.

The recommended dose is:

Apply 1 ml of Alocutan 50 mg / ml twice a day (morning and evening) to the affected areas of the scalp.

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

Use in children and adolescents

Alocutan 50 mg / ml should not be used in children and adolescents under 18 years, as there are no available results of safety and efficacy studies for these age groups.

Form of administration

Topical use (scalp).

Each package of Alocutan 50 mg / ml contains 2 different spray applicators:

- pre-mounted applicator for large surface applications

- separate applicator with extended tip for smaller areas

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

To administer a dose of 1 ml, 6 sprays are required.

Usage / application instructions:

The solution is sprayed directly onto the scalp within the hair loss area. To do this, press down the pump six times. After each pumping action, extend the liquid over the affected area with the fingertips. At the same time, avoid inhaling the spray mist.

What else to note during use

Hands must be washed carefully after applying Alocutan 50 mg / ml to avoid accidental contact with mucous membranes and eyes.

After applying Alocutan 50 mg / ml, you can comb your hair normally. However, do not wet the scalp for approximately 4 hours. This will prevent the removal of Alocutan 50 mg / ml.

Treatment duration

The onset and degree 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 Alocutan 50 mg / ml in larger quantities or with greater frequency.Regarding a possible therapeutic effect, there is sufficient clinical experience for a treatment period of up to one year.

If the desired therapeutic response is not obtained within 4 months, treatment should be discontinued.

Information on increased hair loss

During treatment of hair follicles with the active ingredient minoxidil, the resting phase of the hair cycle (telogen phase) is shortened and the growth phase (anagen phase) is reached more quickly. This stimulates the growth of new hair, which pushes out the "old" inactive hair from the scalp. This initially gives the impression of increased hair loss. In some patients, this reaction has been observed 2 to 6 weeks after starting 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 the first sign of the effect of minoxidil.

Inform your doctor or pharmacist if you think the effect of Alocutan 50 mg / ml is too strong or too weak.

If you use more Alocutan 50 mg / ml than you should

The application of Alocutan 50 mg / ml in a dose higher than recommended and on relatively large body surfaces or different areas of the scalp may lead to a possible increased absorption of minoxidil in the body.Up to the present, there have been no cases in which the external use of minoxidil solution has caused symptoms of poisoning.

After accidental ingestion, the active ingredient minoxidil in Alocutan 50 mg / ml may produce effects on internal organs that correspond to the effects that result when the active substance is ingested, for example, in a tablet.This may cause the following side effects: faster heart rate, decreased blood pressure, fluid accumulation, and subsequent sudden weight gain, dizziness.

In case of accidental ingestion or if signs of overdose occur, inform your doctor immediately, so that they can decide what to do next. Please have the medication leaflet handy so that the doctor can inform themselves about the active substance taken.

If you forgot to use Alocutan 50 mg / ml

Do not apply a double dose to compensate for a missed dose; continue your treatment at the recommended dose. Recovering the omitted dose will not bring any benefit and may cause unwanted effects.

If you interrupt treatment with Alocutan 50 mg / ml

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

If treatment is interrupted within 3 to 4 months, the effects correspond to those that would have been achieved without treatment with Alocutan 50 mg / ml.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Seek immediate medical attention if you notice any of the following symptoms: you may need urgent medical treatment.

• Swelling of the face, lips, or throat that makes it difficult to swallow or breathe. 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 in women), skin inflammatory reaction (including acneiform rash, skin rash)

•Difficulty breathing, shortness of breath

• Swollen arms and legs

•Weight gain

•High blood pressure

•Scalp irritation as itching, burning, dryness, itching, peeling, folliculitis

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

• Dizziness, nausea

Unknown(frequency cannot be estimated from available data):

•Contact dermatitis (skin inflammation related to allergy)

•Depressed mood

•Eye irritation

•Faster heart rate, palpitations, low blood pressure

•Vomiting

•Symptoms at the injection site that may also affect the ears and face, such as itching, skin irritation, pain, redness, swelling, dry skin, and inflammatory rash to possible skin peeling, skin inflammation (dermatitis), blisters, bleeding, and ulceration

•Temporary hair loss, changes in hair color, altered 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 an adverse reaction that does not appear in this prospectus. You can also report them directly through the national notification system included in theSpanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse reactions, you can contribute toproviding more information on the safety of this medicine.

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 and the bottle after "EXP".The expiration date refers to the last day of that month.

Do not freeze.

It contains ethanol, which is flammable. Store away from heat sources or flames.

Expiration Date Note Once Opened

After opening the vial, use the solution within 6 weeks.

Medications should not be disposed of through drains or trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist if you are unsure how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofAlocutan50 mg/ml

The active ingredient is minoxidil.

1 ml of solution contains 50 mg of minoxidil.

The other components are: ethanol at 96% (v/v), propylene glycol (E1520), purified water.

Appearance ofAlocutan 50mg/ml and contents of the packaging

Alocutan 50 mg/ml is a clear, colorless to pale yellow solution and is available in 60 ml and 3 x 60 ml skin solution containers in white HDPE bottles.

Each container contains 2 different applicators, a pre-mounted pump spray applicator and a applicator with an extended tip.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Mibe Pharma España S.L.U.

C/Amaltea 9, 4th floor, letter B,

28045, Madrid

Spain

Responsible for manufacturing

Mibe GmbH Arzneimittel

Münchener Strasse, 15

06796 Brehna

Germany

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

Austria:Minoxidil Dermapharm 50mg/ml Spray for application on the skin, solution

Italy:Phalanx50mg/ml skin spray, solution

Spain:Alocutan50mg/ml skin solution for spraying

Date of the last review of this leaflet:October 2024

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