Alocutan Forte

Leaflet attached to the packaging: information for the user

Alocutan Forte, 50 mg/ml, spray for the skin, solution

Minoxidil

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Alocutan Forte and what is it used for
• 2. Important information before using Alocutan Forte
• 3. How to use Alocutan Forte
• 4. Possible side effects
• 5. How to store Alocutan Forte
• 6. Contents of the packaging and other information

1. What is Alocutan Forte and what is it used for

Alocutan Forte is indicated for the treatment of male pattern baldness (androgenetic alopecia).
Alocutan Forte is used to treat male pattern baldness (androgenetic alopecia) on the scalp within
a diameter of 3 to 10 cm of hairy skin on the head in men aged 18 to 49 years.
Treatment with Alocutan Forte stimulates hair growth and counteracts the progression of androgenetic alopecia.
The therapeutic effect may vary between individual patients and cannot be predicted.
The onset of androgenetic alopecia in men is characterized by a receding hairline on the forehead
and temples with the formation of a so-called tonsure. Then, hair loss on the top of the head (in the tonsure area) increases.
The following illustrations show the stages of male pattern baldness.

2. Important information before using Alocutan Forte

When not to use Alocutan Forte

• if the patient is hypersensitive to minoxidil or any of the other ingredients of this medicine (listed in section 6);
• in women, due to single cases of disturbing, reversible hair growth on the face during treatment;
• if the patient is using other medicines for hairy skin on the head;
• if the patient is using any dressing or bandage on hairy skin on the head;
• if the patient has sudden and uneven hair loss;
• if the patient has any scalp disorders, including psoriasis (inflammatory skin disease with itching), sunburn, shaved head or if the hairy skin on the head has been damaged by burns or scarring, as hair follicles are not present.

Warnings and precautions

Before starting treatment with Alocutan Forte, the patient should discuss it with their doctor or pharmacist.
Hormonal causes, underlying diseases, or malnutrition should be ruled out. In these cases, the patient will need special treatment.
Alocutan Forte should only be applied to healthy, hairy skin on the head. Alocutan Forte should not be used if the cause of hair loss is unknown, in case of infections of the hairy skin on the head, or if it is red, painful, or inflamed.
There is no clinical experience regarding the efficacy of use in the case of hair loss in the temple area (receding hairline).
In the event of systemic effects (systemic action) or severe skin reactions, treatment with Alocutan Forte should be discontinued.
Alocutan Forte is intended for external use on hairy skin on the head only.
Alocutan Forte should not be used on other parts of the body.
Alocutan Forte should not be used:

• if the patient has symptoms of cardiovascular disorders or heart rhythm disorders;
• if the patient has high blood pressure;
• if the patient is taking medicines used to treat high blood pressure (antihypertensive drugs).

Treatment with Alocutan Forte should be discontinued and the patient should consult their doctor if:

• low blood pressure occurs,
• one of the following symptoms occurs: chest pain, rapid heartbeat, weakness, or dizziness, sudden unexplained weight gain, swelling of hands or feet, persistent redness of the hairy skin on the head or its irritation, or if new, unexpected symptoms appear (see "Use of a higher dose of Alocutan Forte than recommended").

If the medicine is transferred to areas other than the hairy skin on the head, unwanted hair growth may occur in those areas.
Patients with very light hair have reported single cases of minor changes in hair color during concomitant use of hair care products or after bathing in heavily chlorinated water.
Accidental ingestion may lead to severe side effects from the cardiovascular system. Therefore, this medicine should be kept out of the reach of children.
There have been cases of excessive hair growth on the body of infants following skin contact with minoxidil application sites in patients (caregivers) using minoxidil topically.
Hair growth returned to normal within a few months when the infant was no longer exposed to minoxidil.
Children should be kept away from areas of the body where minoxidil has been applied topically.
If excessive hair growth on the body of a child is observed during the use of minoxidil-containing products, the patient should consult their doctor.
Caution should be exercised to avoid inhaling the medicine during application.

Children and adolescents

The use of this medicine is not recommended in children and adolescents under 18 years of age, as the safety and efficacy of use in this age group have not been established.

Alocutan Forte and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
There is currently no available information on interactions between Alocutan Forte and other medicines.
Although not clinically confirmed, there is a theoretical possibility that absorbed minoxidil may enhance orthostatic hypotension (a drop in blood pressure when changing position from lying down to standing) in patients who are also taking peripheral vasodilators used to treat high blood pressure.
Alocutan Forte should not be used with other dermatological medicines (medicines intended for external use, containing corticosteroids, retinoids, or ditranol) or with medicines that increase the absorption of the active substance through the skin.

Pregnancy and breastfeeding

Alocutan Forte is indicated for use in men only. There are only limited data on the use of Alocutan Forte in pregnant women.
Absorbed minoxidil may pass into breast milk. Therefore, Alocutan Forte should not be used in pregnant or breastfeeding women.

Driving and using machines

This medicine may cause dizziness or hypotension (see section 4). If symptoms occur, the patient should not drive or operate machinery.

Alocutan Forte contains propylene glycol (E 1520) and ethanol 96% (alcohol)

This medicine contains 509 mg of propylene glycol (E 1520) per ml.
This medicine contains 248 mg of alcohol (ethanol) per ml.
The medicine may cause burning of damaged skin.
Alcohol may cause burning and irritation of the eyes. In case of accidental contact of the medicine with sensitive areas (eyes, damaged skin, mucous membranes), the irritated surface should be rinsed with a large amount of water.
Alocutan Forte contains ethanol and propylene glycol, so repeated spraying of the medicine on hair instead of the scalp may lead to increased dryness and (or) stiffness of the hair.

3. How to use Alocutan Forte

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
In case of doubts, the patient should consult their doctor or pharmacist.
Alocutan Forte is intended for external use on dry, hairy skin on the head.
Alocutan Forte should only be applied to healthy, undamaged hairy skin on the head and used each time according to the following instructions.
Alocutan Forte should not be used on parts of the body other than hairy skin on the head.
Recommended dose
A dose of 1 ml of Alocutan Forte should be applied to the affected area of hairy skin on the head twice a day (morning and evening).
The daily dose should not exceed 2 ml, regardless of the size of the affected skin area.
Use in children and adolescents
Alocutan Forte should not be used in children and adolescents under 18 years of age, as there are no available results of controlled clinical trials regarding its efficacy and safety in these age groups.

Method of administration

Topical application (hairy skin on the head).
Each package of Alocutan Forte contains two different applicators for the spray pump:

• a pre-mounted applicator for use on large areas,
• a separate applicator with an extended tip for use on small areas.

Both applicators can be exchanged by detaching one applicator and replacing it with the other.
To obtain a single dose of 1 ml of solution, 6 sprays of the aerosol are required.
Instructions for use/application
The solution is sprayed directly onto the hairy skin on the head in the area of baldness.
To do this, the pump should be pressed six times.
After each press of the pump, the liquid should be spread with the fingertips over the affected area, avoiding inhalation of the sprayed mist.

What to remember when using

After applying Alocutan Forte, the patient should carefully wash their hands to prevent accidental contact with mucous membranes and eyes.
After applying Alocutan Forte, the hair can be styled as usual.
However, the hairy skin on the head should not be wetted for about 4 hours.
This prevents the washing out of Alocutan Forte.

Duration of treatment

The onset and degree of hair regrowth are different in individual patients.
To achieve visible effects, treatment usually involves applying the medicine twice a day for 2 to 4 months.
To maintain the effect, continued use is recommended without interruption, twice a day.
Using the medicine in larger amounts and more frequently does not lead to better results.
There is sufficient clinical experience regarding the possible therapeutic effect in the case of treatment for up to 1 year.
If there is no improvement after 4 months, treatment should be discontinued.

Information about increased hair loss

During treatment of hair follicles with minoxidil, the resting phase (telogen) in the hair growth cycle is shortened, and the transition to the growth phase (anagen) occurs faster.
This stimulates the growth of new hair, causing old, inactive hair to fall out.
As a result, there is initially an impression of increased hair loss.
In some patients, this reaction is observed for two to six weeks after starting treatment with minoxidil.
However, this reaction is related to hair regrowth and should not cause concern.
This effect subsides within a few weeks and may be considered the first sign of the effect of minoxidil.
If the patient feels that the effect of Alocutan Forte is too strong or too weak, they should contact their doctor or pharmacist.

Use of a higher dose of Alocutan Forte than recommended

Using Alocutan Forte in doses higher than recommended and on relatively large areas of the body or on other parts of the body than hairy skin on the head may lead to increased systemic absorption of minoxidil.
So far, there are no known cases of poisoning caused by topical application of a solution containing minoxidil.
Due to the concentration of the active substance in Alocutan Forte, accidental ingestion may cause systemic symptoms, such as those that occur when the active substance is taken in tablet form.
This may lead to the following side effects: rapid heartbeat, low blood pressure, fluid retention, and consequently sudden weight gain, dizziness.
In case of accidental ingestion of the medicine or if symptoms of overdose occur, the patient should immediately inform their doctor so that they can decide what to do next.
The patient should take the packaging of the medicine with them to inform the doctor what active substance was taken.

Missing a dose of Alocutan Forte

A double dose should not be used to make up for a missed dose.
Treatment should be continued, using the recommended dose.
Making up for a missed dose will not provide any benefits and may lead to side effects.

Discontinuing use of Alocutan Forte

Treatment should be continued to improve and maintain hair growth.
Otherwise, baldness will recur.
If treatment with Alocutan Forte is discontinued, baldness will recur within 3 to 4 months, and the condition will return to what it was before treatment.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The patient should immediately contact their doctor if they experience any of the following symptoms - they may need immediate medical attention.

• Swelling of the face, lips, or throat, which makes swallowing and breathing difficult.
  This may be a sign of a severe allergic reaction (frequency not known, cannot be estimated from the available data).
• Generalized redness of the skin (frequency not known, cannot be estimated from the available data).
• Generalized itching (frequency not known, cannot be estimated from the available data).
• Throat constriction (frequency not known, cannot be estimated from the 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 occurring outside the hairy skin on the head (including hair growth on the face in women),
• skin inflammatory reactions (including acne-like rash and skin rash),
• shortness of breath, breathing difficulties,
• swelling of hands and feet,
• weight gain,
• high blood pressure,
• irritation of the hairy skin on the head, such as pricking, burning, dryness, itching, flaking, or folliculitis.

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

• dizziness, nausea.

Frequency not known(frequency cannot be estimated from the available data):

• contact dermatitis (skin inflammation related to allergy),
• depressive mood,
• eye irritation,
• rapid heartbeat, palpitations, low blood pressure,
• vomiting,
• local reactions, including ears and face, such as itching, skin irritation, pain, redness, swelling, dryness, inflammatory rash, dermatitis, blisters, bleeding, and ulceration,
• temporary hair loss, changes in hair color, changes in hair structure,
• chest pain.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Alocutan Forte

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after: EXP.
The expiry date refers to the last day of the month.
Do not freeze.
Contains flammable ethanol. Keep away from heat sources or open flames.

Shelf life after first opening

Shelf life after first opening of the bottle: 6 weeks.
Medicines should not be disposed of via wastewater or household waste.
The patient should ask their pharmacist how to dispose of medicines that are no longer needed.
This will help protect the environment.

6. Contents of the packaging and other information

What Alocutan Forte contains

• The active substance of Alocutan Forte is minoxidil.
  1 ml of solution contains 50 mg of minoxidil.
• The other ingredients are: ethanol 96% (V/V), propylene glycol (E 1520), purified water.

What Alocutan Forte looks like and what the pack contains

Alocutan Forte is a clear, colorless to light yellow solution available in the following packs:
1 x 60 ml and 3 x 60 ml solution for cutaneous use in white HDPE bottles with a spray pump, in a cardboard box.
Each pack contains two applicators: one pre-mounted and one with an extended tip.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

Manufacturer

mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany
SUN-FARM Sp. z o.o.
ul. Dolna 21
05-092 Łomianki

This medicine is authorized in the Member States of the European Economic Area under the following names:

Austria
Alocutan forte 50 mg/ml Lösung zur Anwendung auf der Haut
Germany
Minoxicutan Männer 50 mg/ml Lösung zur Anwendung auf der Haut (Kopfhaut)
Poland
Alocutan Forte
Date of last revision of the leaflet:09.2024