Alopexy

Package leaflet: information for the patient

Alopexy, 50 mg/ml, solution for topical use
Minoxidilum
Please read the entire 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 according to
the instructions provided by the doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your doctor or pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If hair loss persists or worsens after 6 weeks of treatment, consult your doctor.

Table of contents

1. What Alopexy, 50 mg/ml, solution for topical use is and what it is used for
2. Important information before using Alopexy, 50 mg/ml, solution for topical use
3. How to use Alopexy, 50 mg/ml, solution for topical use
4. Possible side effects
5. How to store Alopexy, 50 mg/ml, solution for topical use
6. Contents of the pack and other information

1. What Alopexy, 50 mg/ml, solution for topical use is and what it is used for

Alopexy is a topical solution containing minoxidil, an active substance that stimulates hair growth.
Alopexy is indicated in men for the treatment of androgenetic alopecia (moderate hair loss).
This medicine must not be used in women due to the frequent occurrence of unwanted hair growth (hypertrichosis) in areas beyond the site of application.

2. Information before using Alopexy, 50 mg/ml, solution for topical use

When not to use Alopexy, 50 mg/ml, solution for topical use:

• If the patient is allergic to minoxidil or to any of the other ingredients of this medicine (listed in section 6.).
• If the patient has previously experienced adverse reactions to the 20 mg/ml minoxidil solution.
• If the patient has lesions or damaged skin on the hairy scalp.

Children and adolescents
The safety and efficacy of Alopexy, 50 mg/ml, solution for topical use have not been established in children and adolescents under 18 years of age. There are no available data. Therefore, Alopexy, 50 mg/ml, solution for topical use should not be used in children and adolescents under 18 years of age.
Elderly patients
This medicine is not recommended for patients over 65 years of age, as its efficacy and safety have not been studied.
Warnings and precautions
Before starting treatment with Alopexy, discuss this with your doctor or pharmacist.

• Exercise particular caution if the patient currently has or has previously had low blood pressure (hypotension), cardiovascular disease, or heart rhythm disorders such as tachycardia, chest pain, loss of consciousness, dizziness, unexplained weight gain, or symptoms of fluid and (or) sodium retention (swelling of hands or feet). In such cases, consult a doctor before using this medicine. Patients should be monitored at the beginning of treatment and regularly during therapy.
• Due to the risk of excessive hair growth in areas other than the application site, this medicine should not be used in women.
• Cases of excessive body hair growth in infants have occurred following skin contact with application sites of minoxidil in patients (caregivers) using topical minoxidil. Hair growth returned to normal within several 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 hair growth is observed in a child during the use of topical products containing minoxidil, consult a doctor.

Do not use this medicine:

• If hair loss is not hereditary, if hair loss is sudden and (or) patchy, if hair loss occurred after childbirth, or if the cause of hair loss is unknown. In these cases, contact your doctor before using Alopexy, 50 mg/ml, solution for topical use, as treatment may not be effective.
• If the scalp skin is red, inflamed, infected, irritated, or painful. This medicine should only be applied to healthy scalp skin (see section "How to use Alopexy, 50 mg/ml, solution for topical use"). If the scalp skin is damaged, increased amounts of the active substance—minoxidil—may enter the bloodstream (see section "When not to use Alopexy, 50 mg/ml, solution for topical use").
• Do not use this medicine in combination with other medicines applied to the scalp.
• Do not apply to other parts of the body.

During treatment

• The medicine contains ethanol (alcohol) and may cause a burning sensation and irritation if accidentally gets into the eyes, wounds, irritated skin, or mucous membranes: irritated areas should be thoroughly rinsed with running cold water. If irritation persists, contact your doctor.
• Temporary increased hair shedding may occur during the first 2 to 6 weeks of treatment. If hair shedding continues beyond 6 weeks or worsens, discontinue use of Alopexy, 50 mg/ml, solution for topical use and contact your doctor.
• Do not expose the treated scalp to sunlight: wear head covering (e.g., a hat).
• Do not swallow. If swallowed, CONTACT A DOCTOR IMMEDIATELY. Accidental ingestion may cause symptoms related to the effects of minoxidil on the cardiovascular system. Therefore, the medicine should be stored out of sight and reach of children.
• Do not inhale the sprayed medicine.
• In some patients, changes in hair color and (or) texture have occurred.

Discontinue treatment and contact your doctor immediately if:

• Low blood pressure, chest pain, or rapid heartbeat occurs.
• Fainting or dizziness occurs.
• Sudden, unexpected weight gain or swelling of hands or feet (edema) occurs.
• Persistent redness or irritation of the hairy scalp skin occurs.

Alopexy, 50 mg/ml, solution for topical use and other medicines
Do not use this medicine simultaneously with other dermatological medicines containing tretinoin, anthralin, or betamethasone dipropionate, as these medicines may alter the amount of minoxidil in the blood.
Inform your doctor or pharmacist about all medicines currently or recently used, as well as any medicines you plan to use, including those available without prescription.
Alopexy, 50 mg/ml, solution for topical use with food and drink
Not applicable.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
This medicine should not be used in women. Do not use in women of childbearing potential, pregnant women, or breastfeeding women.
Driving and operating machinery
Alopexy, 50 mg/ml, solution for topical use has no effect or has a negligible effect on the ability to drive and operate machinery.
Alopexy, 50 mg/ml, solution for topical use contains propylene glycol and ethanol
Each dose of Alopexy contains 240 mg of propylene glycol, equivalent to 240 mg of propylene glycol per 1 ml of solution.
This medicine contains 520 mg of alcohol (ethanol) per ml, equivalent to 520 mg of ethanol per 1 ml of solution. The medicine may cause a stinging sensation on damaged skin.
This medicine contains ethanol and is therefore flammable.

3. How to use Alopexy, 50 mg/ml, solution for topical use
WARNING:
Flammable product.
Keep away from heat sources, hot surfaces, sparks, open flames, and other sources of ignition. Do not smoke while applying or handling this medicine.
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.
Dosage
The recommended dose is 1 ml applied to the affected area of the hairy scalp twice daily. The total daily dose should not exceed 2 ml, regardless of the size of the treated area.
Frequency of administration
Apply 1 ml of solution in the morning and 1 ml in the evening.
Do not increase the dose or frequency of application.
Always strictly adhere to the recommended dosage.
Route of administration
Topical application. For external use only.
Wash hands thoroughly before and after applying the solution to the scalp.
Before applying the medicine, ensure hair and the hairy scalp are completely dry.
Apply the solution with fingertips to the entire affected area of the scalp, starting from the center of the treated area.
Do not apply this medicine to any other part of the body.
Instructions for use
Open the bottle: The bottle is equipped with a child-resistant cap.
To open the bottle: press down and turn the plastic cap counterclockwise (to the left). Only the safety ring should remain on the bottle.

Depending on the type of applicator: graduated pipette or dosing pump with applicator:
Graduated pipette 1 ml
The graduated pipette allows precise application of 1 ml of solution to the entire treated area, starting from the center.

Dosing pump with applicator
The applicator enables application of the medicine to a small skin area or under the hair.

1. Attach the applicator to the dosing pump: hold the pump firmly while pressing the top part of the applicator.

2. Insert the applicator connected to the dosing pump into the bottle and screw tightly.

3. The pump is prepared: the medicine is ready for administration.

4. Application: direct the applicator to the center of the treated skin area or under the hair, press once, and spread the medicine with fingertips.

Six pump actuations are required to deliver a 1 ml dose.

5. After each use, clean the applicator with hot water.

Duration of treatment
Treatment results are not immediate: stopping hair loss and (or) regrowth of hair may become visible after some time from the start of treatment. Continued treatment is necessary to stimulate and maintain hair regrowth. Initial results may be seen after 2 to 4 months of twice-daily use. The onset and extent of response to treatment vary among individual patients.
If there is no improvement after 4 months of treatment, contact your doctor to consider discontinuing therapy.
Use of a higher than recommended dose of Alopexy, 50 mg/ml, solution for topical use
If used as directed, overdose is unlikely.
If applied to damaged scalp skin, absorption of the active substance may be increased, potentially causing adverse effects (see section "2. Information before using Alopexy, 50 mg/ml, solution for topical use").
Missed dose of Alopexy, 50 mg/ml, solution for topical use
Do not use a double dose to make up for a missed dose.
Continue using the medicine at the usual frequency: once in the morning and once in the evening.
Discontinuation of Alopexy, 50 mg/ml, solution for topical use
Not applicable.
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 –
immediate treatment may be necessary:

• Swelling of the face, lips or throat, which may cause difficulty in swallowing or breathing. This may indicate a severe allergic reaction (frequency unknown, cannot be estimated from available data).

The most commonly observed adverse reactions are mild skin reactions.
Repeated application to the skin may cause irritation and dryness due to the presence of
alcohol in the medicine.
The following adverse reactions have been reported, listed by frequency of occurrence:
Very common: may affect more than 1 in 10 people:
Excessive hair growth (hypertrichosis) in areas where the medicine has not been applied, especially
when the medicine is used in women.
Headache.
Common: may affect up to 1 in 10 people:
Local skin reactions at the site of application such as local irritation with desquamation of the stratum corneum
(elimination of dead skin cells), itching, redness of the skin, skin inflammation, dry skin, skin allergic reactions,
skin inflammatory conditions, acne-like rash, musculoskeletal pain, peripheral oedema (fluid retention in tissues),
pain at the site of application, breathing difficulties, depression and pain.
Frequency not known: frequency cannot be estimated from available data:
Ear infections, otitis externa, nasal mucositis, hypersensitivity, neuralgia, tingling sensation, taste disturbances,
skin burning sensation, visual disturbances, eye irritation, dizziness, hypotension, tachycardia, palpitations,
chest pain, weakness, facial oedema (fluid retention in tissues), generalised flushing, hair loss, uneven body hair,
change in hair colour, change in hair texture, hepatitis and nephrolithiasis.
If any of the above symptoms occur, treatment should be stopped immediately and the doctor should be informed.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions of 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 to provide more information on the safety of the medicine.

5. How to store Alopexy, 50 mg/ml, solution for topical use
The medicine should be stored in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging following EXP.
The expiry date refers to the last day of the stated month.
This medicine is flammable. Keep away from heat sources, hot surfaces, sparks, open flames,
and other sources of ignition. Do not smoke.
Shelf-life after first opening of the bottle: 1 month.
Medicines should not be disposed of via the sewage system 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 Alopexy 50 mg/ml topical solution contains

• The active substance is minoxidil. 1 ml of solution contains 50 mg of minoxidil.
• Other ingredients: propylene glycol*, ethanol 96%*, purified water. *(See section 2. "Alopexy 50 mg/ml topical solution contains propylene glycol and ethanol")

What Alopexy 50 mg/ml topical solution looks like and contents of the pack
The medicine is a clear, light yellow solution.
Packaging:
1 or 3 bottles containing 60 ml of topical solution, with a child-resistant cap, together with a dosing pipette and a dosing pump with an applicator, packed in a cardboard box.
1 bottle containing 60 ml of topical solution, with a child-resistant cap and a dosing pipette, packed in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Pierre Fabre Medicament
Les Cauquillous
81500 Lavaur
France
Manufacturer
Pierre Fabre Medicament Production
Site PROGIPHARM
Rue du Lycée
45500 Gien
France
This medicinal product is authorised in the countries of the European Economic Area under the following names:

For more detailed information, please contact the representative of the marketing authorization holder:
Pierre Fabre Dermo-Cosmetique Polska Sp. z o.o.
ul. Belwederska 20/22
00-762 Warsaw
tel. 22 559 63 60

Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

Educational health advice

What is androgenetic alopecia?

Normally, hair has a lifespan of 3 to 6 years, and 50 to 100 hairs fall out daily. Increased hair loss may occur seasonally (in autumn) or after childbirth: this is normal, temporary, and does not require treatment.

Alopecia is defined as the loss of more than 100 hairs per day.

There are two types of alopecia:

• Acute alopecia,
• Chronic alopecia.

Acute alopecia (sudden hair loss over a short period) may be diffuse or patchy (alopecia areata) and is most often caused by identifiable factors (aggressive hair care, poor general health, unbalanced weight-loss diet, certain medications, psychological shock, stress, etc.).
Acute alopecia should not be treated with this medicine.

Chronic (long-term) alopecia is almost always diffuse.
Sometimes it is caused by a specific disease (related to the thyroid gland, metabolism, etc.).
Chronic alopecia should not be treated with this medicine.

In the vast majority of cases, chronic alopecia has poorly understood origins, most commonly hereditary: this is androgenetic alopecia. Only this type of alopecia can be treated with minoxidil.

How to recognize androgenetic alopecia in men?

Androgenetic alopecia begins with hair loss in the temporal areas.
Subsequently, a slight bald spot appears on the crown of the head.
These two hairless areas will gradually enlarge: androgenetic alopecia progresses slowly, leading to baldness.

Usage advice

Use a gentle shampoo (preferably silicone-free).
If you plan to wash your hair with shampoo after applying minoxidil, wait at least 4 hours before washing.
If you apply minoxidil after shampooing, it is recommended to apply it to dry scalp. After applying minoxidil, you may use a hairdryer, preferably with warm air.
You may use styling mousse, gels, or sprays, but wait at least 1 hour between applications.
There is no interaction between minoxidil treatment and permanent waving or hair coloring; however, these procedures should be limited due to their potentially aggressive effects on hair.
If you plan sun exposure after applying minoxidil, it is recommended to wear a head covering.

Additional information

At the beginning of treatment, there may be a temporary increase in hair loss. These hairs were destined to fall out anyway and are shed more quickly. This is a normal phenomenon and treatment should be continued.
Initially, newly growing hairs will be soft, fine, and barely visible. As treatment continues, they may gradually become thicker.