ALOCUTAN

Package leaflet: Information for the user

Alocutan, 20 mg/ml, cutaneous aerosol, solution
Minoxidilum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if you feel worse, contact your doctor.

Contents of the leaflet

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

1. What Alocutan is and what it is used for

Alocutan is indicated for the treatment of female-pattern hair loss.
Alocutan is used in the treatment of androgenetic alopecia (excessive hair loss)
in women (characterized by diffuse thinning of hair in the fronto-central region of the scalp). Treatment with Alocutan stimulates hair growth and helps prevent the progression of androgenetic alopecia.
The onset of female-pattern androgenetic alopecia is characterized by reduced hair thickness at the crown and frontal areas of the scalp, with preservation of the hairline. Thinning affects the central area of the scalp, but complete baldness is very rare.
The illustrations below show the stages of female-pattern hair loss for which efficacy of Alocutan has been demonstrated.

2. Important information before using Alocutan

When not to use Alocutan

• if the patient is allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6);
• if the patient is using other medicines for the hairy scalp;
• if the patient is using any dressing or bandage on the hairy scalp;
• if the patient has sudden and patchy hair loss;
• if the patient is pregnant or breastfeeding;
• if the patient has any abnormalities of the hairy scalp, including psoriasis (an inflammatory skin disease with itching), sunburn, shaved scalp, or if the hairy scalp has been damaged by burns or scarring, as hair follicles are not present.

Warnings and precautions
Before starting treatment with Alocutan, discuss this with your doctor or pharmacist.
Hormonal causes, underlying diseases, or malnutrition should be ruled out. In such cases, the patient will require specific treatment.
Alocutan should be applied only to healthy, hairy scalp skin. Alocutan should not be used if the cause of hair loss is unknown, in cases of postpartum hair loss, scalp infections, or if the scalp is red, painful, or inflamed.
If systemic effects (i.e. effects on internal organs) or severe skin reactions occur, treatment should be discontinued.
Alocutan is intended for external use only on the hairy scalp. Alocutan should not be applied to other parts of the body.
Do not use Alocutan:

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

Treatment with Alocutan should be discontinued and medical advice sought if:

• low blood pressure occurs,
• any of the following symptoms occur: chest pain, rapid heartbeat, weakness or dizziness, sudden unexplained weight gain, swelling of hands or feet, persistent redness, irritation of the hairy scalp, or if new unexpected symptoms appear (see section "Use of more than the recommended dose of Alocutan").

If the medicine is accidentally applied to areas other than the hairy scalp, unwanted hair growth may occur in those areas.
Patients with very light hair have reported isolated cases of minor hair color changes (slight bleaching of blonde hair) during concomitant use of the medicine and other hair care products or after swimming in heavily chlorinated water.
Accidental ingestion may lead to serious adverse effects on the cardiovascular system. Therefore, this medicine should be stored out of reach of children.
Cases of excessive body hair growth in infants have been reported following skin contact with application sites of minoxidil in patients (caregivers) using topical minoxidil. Hair growth returned to normal within a few months once the infant was no longer exposed to minoxidil. Care should be taken to prevent children from coming into contact with areas of the body where minoxidil has been applied topically.
If excessive hair growth is observed in a child during topical treatment with minoxidil-containing products, consult a doctor.
Avoid inhaling the medicine during application.

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

Alocutan and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Currently, there is no available information on interactions between Alocutan and other medicines.
Although not clinically confirmed, there is a theoretical possibility that absorbed minoxidil may exacerbate orthostatic hypotension (a drop in blood pressure when changing from lying to standing position) in patients who are simultaneously taking peripheral vasodilators used to treat hypertension.
Alocutan should not be used together with other dermatological medicines (topical medicines containing corticosteroids, retinoids, or dithranol) or with medicines that enhance the absorption of active substances through the skin (skin absorption).

Pregnancy and breastfeeding
There are only limited data on the use of Alocutan in pregnant women. Systemically absorbed minoxidil may pass into human milk. Therefore, Alocutan must not be used in pregnant or breastfeeding women.

Driving and operating machinery
This medicine may cause dizziness or hypotension (see section 4). If such symptoms occur, do not drive or operate machinery.

Alocutan contains propylene glycol (E 1520) and 96% ethanol (alcohol)
This medicine contains 199 mg of propylene glycol (E 1520) in each ml.
This medicine contains 494 mg of alcohol (ethanol) in each ml.
The medicine may cause a burning sensation on damaged skin.
Ethanol may cause stinging and irritation of the eyes. In case of accidental contact with sensitive areas (eyes, damaged skin, mucous membranes), rinse the affected area thoroughly with plenty of water.
Alocutan contains ethanol and propylene glycol; therefore, repeated spraying of the product onto hair instead of the scalp may lead to increased dryness and/or stiffness of the hair.

3. How to use Alocutan

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Alocutan is intended for external use on dry, hairy scalp skin. Alocutan should be applied only to healthy, intact hairy scalp skin and used every time according to the instructions below. Alocutan must not be used on any parts of the body other than the hairy scalp.

Recommended dose
Unless otherwise prescribed by a doctor, Alocutan should be used as described below.
Apply a dose of 1 ml of Alocutan solution to the affected area of the hairy scalp twice daily (morning and evening).
The total daily dose must not exceed 2 ml, regardless of the size of the affected skin area.

Use in children and adolescents
Alocutan must not be used in children and adolescents under 18 years of age, as there are no results from controlled studies on its efficacy and safety in these age groups.

Method of administration
Topical application (to the hairy scalp).
Each Alocutan package contains two different spray pump applicators:

• a pre-attached applicator for use on larger areas,
• a separate applicator with an extended tip intended for smaller areas.

Both applicators can be interchanged by detaching one and replacing it with the other.
To deliver a single dose of 1 ml of solution, 6 sprays of aerosol are required.

Instructions for use/application
The solution should be sprayed directly onto the affected area of the hairy scalp. To do this, press the pump six times. After each pump actuation, spread the liquid with the fingertips over the affected area to avoid inhaling the sprayed mist.

Additional points to remember during use
After applying Alocutan, hands should be washed thoroughly to prevent accidental contact with mucous membranes and eyes. Hair may be styled as usual after application.
Do not wet the hairy scalp for approximately 4 hours after application to prevent washing out the medicine.

Duration of treatment
The onset and extent of hair regrowth vary among individual patients.
Visible results are usually achieved after treatment with twice-daily application for a period of 2 to 4 months. To maintain the effect, continued use without interruption, twice daily, is recommended.
Using Alocutan in larger amounts or more frequently than recommended does not lead to better results.
There is sufficient clinical experience regarding possible therapeutic effects with treatment lasting up to 48 weeks.
If no improvement is observed within 8 months, treatment should be discontinued.

Information regarding increased hair loss
During treatment of hair follicles with the active substance minoxidil, the resting phase (telogen) of the hair growth cycle is shortened, and transition to the growth phase (anagen) occurs more rapidly. This stimulates the growth of new hair, causing old, inactive hairs to fall out. As a result, an initial impression of increased hair loss may occur.
In some patients, this reaction is observed for two to six weeks after starting treatment with the active substance minoxidil. However, this should not cause concern, as this reaction is associated with new hair growth. This effect resolves within a few weeks and may be considered the first sign of minoxidil's action.

If you feel that the effect of Alocutan is too strong or too weak, consult your doctor or pharmacist.

Use of more than the recommended dose of Alocutan
Using Alocutan in doses higher than recommended, over a relatively large body surface area, or on areas other than the hairy scalp may lead to increased systemic absorption of minoxidil.
There have been no reported cases of poisoning due to topical application of minoxidil-containing solutions.
However, due to the concentration of the active substance in Alocutan, accidental ingestion may cause systemic symptoms similar to those seen after ingestion of the active substance in tablet form.
This may lead to the following adverse effects: rapid heartbeat, low blood pressure, fluid retention, and consequently sudden weight gain, and dizziness.
In case of accidental ingestion of the medicine or if symptoms of overdose occur, contact a doctor immediately so that appropriate measures can be taken. Bring the medicine packaging to inform the doctor about the active substance ingested.

Missed dose of Alocutan
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 provides no benefit and may lead to adverse effects.

Discontinuation of Alocutan treatment
Treatment should be continued to improve and maintain hair growth. Otherwise, hair loss will recur.
If treatment with Alocutan is discontinued, hair loss will return within 3 to 4 months, and the condition will revert to the pre-treatment state.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
You should contact your doctor immediately if you experience any of the following symptoms
– you may require immediate medical attention.

• Swelling of the face, lips or throat, causing difficulty in swallowing and breathing. This may be a sign of a severe allergic reaction (frequency unknown, cannot be estimated from available data).
• Generalised redness of the skin (frequency unknown, cannot be estimated from available data).
• Generalised itching (frequency unknown, cannot be estimated from available data).
• Tightness in the throat (frequency unknown, cannot be estimated from available data).

Very common (may affect more than 1 in 10 people):

• Headache.

Common (may affect less than 1 in 10 people):

• Itching,
• Excessive hair growth in areas other than the scalp (including facial hair growth in women),
• Inflammatory skin reactions (including acne-like rash and skin rash),
• Shortness of breath, difficulty breathing,
• Swelling of hands and feet,
• Weight gain,
• High blood pressure,
• Irritation of the scalp such as stinging, burning, dryness, itching, flaking, folliculitis.

Uncommon (may affect less than 1 in 100 people):

• Dizziness, nausea.

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

• Contact dermatitis (skin inflammation due to allergy),
• Depressed mood,
• Eye irritation,
• Rapid heartbeat, palpitations, low blood pressure,
• Vomiting,
• Application site reactions, including ears and face, such as itching, skin irritation, pain, redness, swelling, dryness, inflammatory rash up to possible skin peeling, dermatitis, blisters, bleeding and ulceration,
• Temporary hair loss, changes in hair colour, changes in hair texture,
• Chest pain.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Alocutan

Keep this medicine 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 stated month.
Do not freeze.
Contains flammable ethanol. Store away from heat sources or open flames.
Expiry after first opening
Period of validity after first opening of the bottle: 6 weeks.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Alocutan contains

• The active substance is minoxidil. 1 ml of solution contains 20 mg of minoxidil.
• The other ingredients are: ethanol 96% (V/V), propylene glycol (E 1520), purified water.

What Alocutan looks like and contents of the pack
Alocutan is a clear, colourless to slightly yellow solution available in the following pack sizes: 1 x 60 ml and 3 x 60 ml of solution for topical use in white HDPE bottles with a spray pump, in a cardboard box.
Each pack contains two applicators: one pre-attached, and one with an extended tip.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries under the following names:
Austria Alocutan 20 mg/ml solution for application on the skin
Germany Minoxicutan Frauen 20 mg/ml solution for application on the skin (scalp)
Poland Alocutan