Alocutan forte

Package leaflet: Information for the user

Alocutan Forte, 50 mg/ml, cutaneous aerosol, solution
Minoxidilum
Please read all of this leaflet carefully before using this medicine because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

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

Table of contents

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

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

Alocutan Forte is indicated for the treatment of male-pattern baldness (androgenetic alopecia).
Alocutan Forte is used in the treatment of male-pattern baldness (androgenetic alopecia) affecting the vertex area of the scalp, with a diameter of 3 to 10 cm of hairy skin, in men aged 18 to 49 years.
Treatment with Alocutan Forte stimulates hair growth and helps prevent 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 at the forehead and temples, forming so-called "corners". Subsequently, hair loss increases at the top of the head (in the vertex area).
The illustrations below show the stages of male-pattern baldness.

2. Important information before using Alocutan Forte

When not to use Alocutan Forte

• if the patient is allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6);
• in women, due to isolated cases of disturbing, reversible facial hair growth during treatment;
• if the patient is using other medicines for the scalp;
• if the patient is using any dressing or bandage on the hairy scalp;
• if the patient experiences sudden and patchy hair loss;
• 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 absent.

Warnings and precautions
Before starting treatment with Alocutan Forte, consult your doctor or pharmacist.
Hormonal causes, underlying diseases, or malnutrition should be ruled out. In such cases, the patient may require specific treatment.
Alocutan Forte should be applied only to healthy, hairy scalp skin. Alocutan Forte should not be used if the cause of hair loss is unknown, in case of scalp infections, or if the scalp is red, painful, or inflamed.
There is no clinical experience regarding the effectiveness of treatment for hair loss in the temple area (receding hairline).
If systemic effects (whole-body effects) or severe skin reactions occur, discontinue use of the medicine immediately.
Alocutan Forte is intended for external use only on the hairy scalp. Do not apply Alocutan Forte to other parts of the body.
Do not use Alocutan Forte:

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

Discontinue use of Alocutan Forte and consult a doctor 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 or irritation of the hairy scalp, or if any new unexpected symptoms appear (see section "Use of more than the recommended dose of Alocutan Forte").

If the medicine is transferred 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 during simultaneous use of 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 must be stored out of the reach of children.
Cases of excessive body hair growth in infants have occurred following skin contact with the minoxidil application sites of patients (caregivers) using topical minoxidil. Hair growth returned to normal within a few months after 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 body hair growth in a child is observed during topical use of 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 Forte 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 use.
Currently, there is no available information on interactions between Alocutan Forte 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 concurrently taking peripheral vasodilators used to treat hypertension.
Alocutan Forte should not be used together with other dermatological medicines (topically applied medicines containing corticosteroids, retinoids, or dithranol) or with medicines that enhance the absorption of active substances through the skin (skin absorption).

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. Systemically absorbed minoxidil may pass into human milk. Therefore, Alocutan Forte 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 Forte contains propylene glycol (E 1520) and 96% ethanol (alcohol)
This medicine contains 509 mg of propylene glycol (E 1520) in each ml.
This medicine contains 248 mg of alcohol (ethanol) in each ml.
The medicine may cause a burning sensation on damaged skin.
Ethanol may cause stinging and eye irritation. In case of accidental contact with sensitive areas (eyes, damaged skin, mucous membranes), rinse the affected area thoroughly with plenty of water.
Alocutan Forte contains ethanol and propylene glycol; therefore, repeated spraying onto 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 this patient leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Alocutan Forte is intended for external use on dry, hairy scalp skin.
Alocutan Forte should be applied only to healthy, intact hairy scalp skin and used every time according to the instructions below. Alocutan Forte must not be used on any part of the body other than the hairy scalp.

Recommended dose
Apply 1 ml of Alocutan Forte solution to the affected area of the hairy scalp twice daily (in the morning and evening).
Do not exceed a total daily dose of 2 ml, regardless of the size of the affected skin area.

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

Method of administration
Topical application (to the hairy scalp).
Each Alocutan Forte 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. Press the pump six times. After each spray, gently spread the liquid over the affected area using the fingertips, taking care to avoid inhaling the mist.

Additional points to remember during use
After applying Alocutan Forte, wash your hands thoroughly to prevent accidental contact with mucous membranes and eyes.
After application, you may style your hair as usual.
Do not wet the treated scalp area for approximately 4 hours to prevent washing out the Alocutan Forte solution.

Duration of treatment
The onset and extent of hair regrowth vary between individual patients.
For visible results, treatment usually involves applying the medicine twice daily for 2 to 4 months. To maintain the effect, continued use without interruption, twice daily, is recommended.
Using Alocutan Forte in larger amounts or more frequently does not lead to better results. Clinical experience supports its therapeutic effect for treatment periods of up to 1 year.
If no improvement is observed after 4 months, treatment should be discontinued.

Information on increased hair loss
During treatment of hair follicles with the active substance minoxidil, the resting phase (telogen phase) of the hair growth cycle is shortened, and the transition to the growth phase (anagen phase) occurs more rapidly. This stimulates the growth of new hair, causing older, inactive hairs to fall out. As a result, an initial impression of increased hair loss may occur.
In some patients, this reaction is observed 2 to 6 weeks after starting treatment with minoxidil. However, this should not cause concern, as this reaction is associated with new hair growth. This effect subsides within a few weeks and may be considered the first sign of minoxidil's action.
If a 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 than recommended dose of Alocutan Forte
Using Alocutan Forte 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.
To date, there have been no reported cases of poisoning due to topical application of minoxidil-containing solutions.
Due to the concentration of the active substance in Alocutan Forte, accidental ingestion may cause systemic symptoms similar to those seen after swallowing minoxidil 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 or if symptoms of overdose occur, contact a doctor immediately to determine the appropriate course of action. Bring the medicine packaging to inform the doctor which active substance has been ingested.

Missed dose of Alocutan Forte
Do not use 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 lead to adverse effects.

Discontinuation of Alocutan Forte
Continue treatment to improve and maintain hair growth. Otherwise, hair loss will recur.
If treatment with Alocutan Forte is stopped, hair loss will return within 3 to 4 months, and hair 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 will experience them.
You should contact your doctor immediately if any of the following symptoms occur –
the patient 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).
• Generalized redness of the skin (frequency unknown, cannot be estimated from available data).
• Generalized 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 outside the scalp area (including facial hair growth in women),
• Skin inflammatory 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 skin such as stinging, burning, dryness, itching, scaling, 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, dry skin, inflammatory rash up to possible skin peeling, dermatitis, blisters, bleeding and ulceration,
• Temporary hair loss, changes in hair color, changes in hair structure,
• Chest pain.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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
Phone: +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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Alocutan Forte

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the box 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 you no longer use. This will help protect the environment.

6. Contents of the package and other information

What Alocutan Forte contains

• The active substance 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 contents of the pack
Alocutan Forte is a clear, colourless to slightly yellow solution for topical application, available in the following pack sizes: 1 x 60 ml and 3 x 60 ml of solution for application to the scalp in white HDPE bottles with a spray pump dispenser, packed 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
Poland

Manufacturer
mibe GmbH Arzneimittel
Münchener Straße 15
06796 Brehna
Germany

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

This medicinal product is authorised in the European Economic Area countries 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