Alopexy 5% Minoxidil Hair Loss

Alopexyl 5% solution for cutaneous application is indicated for external use in the treatment of moderate hair loss in men, in cases of androgenic alopecia. The solution is intended for local application to the scalp.
Composition of Alopexy 5% minoxidil for topical application

One ml of solution contains 50 mg of minoxidil. The excipients are propylene glycol, 96% ethanol, and purified water.

How to use Alopexy 5% minoxidil for alopecia?
The usual dose is 1 ml applied twice daily to the affected area of ??the scalp.

It takes approximately two months to see the first results of hair growth stimulation. The degree of response and the time to response vary from person to person; your doctor will prescribe a dosage and treatment duration appropriate to your situation. Never exceed a daily dose of 2 ml.

How to apply Alopexy 5% spray?
Alopexy 5% comes in a spray bottle with applicators. This system delivers 1 ml of active ingredient. It takes 6 pumps to deliver 1 ml of solution.

Alopexy 5% is only for use on the scalp (do not apply it to any other part of the body). It should be applied to a healthy, dry scalp, starting in the center of the area to be treated, which should be the starting point for application. The product should then be spread evenly with your fingertips over the entire area. Be sure to wash your hands before and after each application.

To use it, click the nozzle into the pump, then remove the cap from the bottle and insert the spray bottle with the nozzle onto the bottle. Then, simply prime the pump and apply with a single pump. Finally, the cannula should be rinsed with warm water after use.
Precautions to take with Alopexy minoxidil 50 mg/ml for baldness

This medication is reserved for men aged 18 to 65.

In cases of sudden, patchy, or reactive hair loss, this medication will not be suitable. Alopexy 5% is only indicated for androgenic hair loss. Consult your doctor for advice.

You should not use Alopexy 5% if you are allergic to any of the ingredients or if you have scalp damage (the scalp must be completely healthy). This will increase the absorption of the active ingredient into the bloodstream, and adverse effects may occur.
Do not combine the use of Alopexy 5% with any other topical scalp treatment.

During treatment, sun exposure should be avoided.

In case of accidental contact with the eye, irritated skin, or mucous membranes, rinse thoroughly with water.

Changes in hair color and texture may occur in some people.

Alopexy and Heart Disease

If you have a history of heart disease, the use of Alopexy requires medical advice.

Alopexy minoxidil 5% in women

Its use is not recommended for women due to the risk of hypertrichosis (abnormal hair growth). It is not suitable for pregnant or breastfeeding women.

For more information, please consult the information leaflet for this medication.

Side effects of Alopexy minoxidil 5% Pierre Fabre

Treatment requires regular medical monitoring, particularly at the beginning of treatment. Indeed, more or less serious side effects may occur.

If you experience cardiovascular symptoms (low blood pressure, rapid pulse, chest pain, palpitations, etc.), if an allergic reaction occurs with swelling of the face, hands, or feet, or if redness, a burning sensation, or irritation of the scalp occurs, discontinue treatment immediately.

It can cause ear infections, otitis media, eye irritation, blurred vision, altered taste, dizziness, hepatitis, kidney stones, and dry skin.

This medication contains propylene glycol, which can irritate the skin.

It also contains ethanol, and is therefore flammable.

Packaging: Box of three 60 ml bottles with a pipette and dosing pump.

For women, the Alopexy 2% hair loss solution is preferred.








LEAFLET
ANSM - Updated on: 12/26/2024
Name of the medicinal product
ALOPEXY 50 mg/ml, solution for cutaneous application
Minoxidil
Box
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
You must always use this medicine exactly as provided in this leaflet or by your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
Ask your pharmacist for advice or information.
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
You must talk to your doctor if hair loss persists for more than 6 weeks.
What is in this leaflet? 1. What is ALOPEXY 50 mg/ml, solution for cutaneous application and what is it used for?
2. What you need to know before using ALOPEXY 50 mg/ml, solution for cutaneous application?
3. How to use ALOPEXY 50 mg/ml, solution for cutaneous application?
4. Possible side effects?
5. How to store ALOPEXY 50 mg/ml, solution for cutaneous application?
6. Contents of the pack and other information.
1. WHAT IS ALOPEXY 50 mg/ml, solution for cutaneous application AND WHAT IS IT USED FOR?
Pharmacotherapeutic group: OTHER DERMATOLOGICAL DRUGS, ATC code: D11AX01.
ALOPEXY is a solution for cutaneous application that contains minoxidil, an active ingredient that stimulates hair growth. This medication is indicated for men with moderate hair loss (androgenetic alopecia).
It is not recommended for women due to the high incidence of hypertrichosis (abnormal hair growth) at distant sites of application.
2. WHAT YOU NEED TO KNOW BEFORE USING ALOPEXY 50 mg/ml, solution for cutaneous application?
Never use ALOPEXY 50 mg/ml, solution for cutaneous application:
If you are allergic to minoxidil or any of the other ingredients of this medication (listed in section 6).
If you have experienced intolerance to the solution containing 20 mg/ml of minoxidil.
If you have scalp lesions.
Children and Adolescents
The safety and efficacy of ALOPEXY in children under 18 years of age have not been established. No data are available. Therefore, ALOPEXY is not recommended for children under 18 years of age.
Elderly
This medication is not recommended for patients over 65 years of age because its efficacy and safety have not been studied.
Warnings and Precautions
Talk to your doctor or pharmacist before using ALOPEXY.
Be careful if you have or have had low blood pressure (hypotension), cardiovascular disease, or cardiac arrhythmias such as tachycardia, chest pain, fainting, dizziness, unexplained weight gain, or signs of fluid and sodium retention (swelling of the hands or feet).
In these conditions, you should consult a doctor before using this medication. Monitoring should be carried out at the beginning of treatment and regularly thereafter.
· The risk of hypertrichosis (abnormal hair growth) means that this medication is not recommended for women. · Cases of excessive body hair growth in infants have been reported after skin contact at minoxidil application sites of patients (caregivers) using topical minoxidil. Hair growth returned to normal within a few months when the infants were no longer exposed to minoxidil. Ensure that children do not come into contact with areas of your body where you have applied minoxidil topically.
Consult a doctor if you notice excessive body hair growth in your child while using topical products containing minoxidil.
You should not use this product:
· If you have no family history of alopecia, if you have sudden and/or patchy hair loss, hair loss following childbirth, or hair loss of unknown cause. In these cases, you should consult your doctor before taking ALOPEXY as this treatment may not be effective for these types of hair loss. If your scalp is red, inflamed, infected, irritated, or painful. This medication should only be applied to healthy scalp skin (see section: "How to use ALOPEXY 50 mg/ml"). In people with scalp lesions, an increased rate of the active ingredient (minoxidil) entering the bloodstream may occur (see section: "Do not use ALOPEXY 50 mg/ml").
Do not apply this medication at the same time as other dermatological medications applied to the scalp.
Do not apply to any other part of your body.
During treatment
In case of accidental contact with the eye, a wound, irritated skin, or a mucous membrane, this medication, which contains ethanol (alcohol), may cause a burning sensation or irritation: rinse thoroughly with cold running water. If signs persist, consult a doctor.
A temporary increase in hair loss may occur during the first 2 to 6 weeks of treatment. If hair loss persists or worsens after 6 weeks, you should stop using ALOPEXY and consult your doctor.
· Do not expose the treated scalp to the sun; protection (a hat) is required.
· Do not swallow. Accidental ingestion may cause effects due to the cardiovascular action of minoxidil. Therefore, the product must be kept out of the sight and reach of children. CONSULT A DOCTOR PROMPTLY.
· Do not inhale the sprayed medication.
· A change in hair color and/or texture has been observed in some patients. You should stop treatment immediately and consult a doctor:
· If you experience a drop in blood pressure, chest pain, or a rapid pulse
· If you feel faint or dizzy
· If you experience sudden, unexplained weight gain, swelling of the hands or feet (edema)
· If you experience persistent redness or irritation of the scalp.
Other medicines and ALOPEXY 50 mg/ml cutaneous solution
Do not use this medicine at the same time as other dermatological products, such as anthralin, tretinoin, or betamethasone dipropionate, as these products may affect the amount of minoxidil entering the blood.
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines, including medicines obtained without a prescription.
ALOPEXY 50 mg/ml cutaneous solution with food and drink
Not applicable. Pregnancy and breastfeeding
The use of this medicine is not recommended for women.
Avoid taking this medicine during pregnancy or breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist before taking this medicine.
Driving and using machines
ALOPEXY has no or negligible influence on the ability to drive and use machines.
ALOPEXY 50 mg/ml cutaneous solution contains propylene glycol and ethanol.
This medicine contains 240 mg of propylene glycol in each dose, equivalent to 240 mg/ml.
This medicine contains 520 mg of alcohol (ethanol) in each dose, equivalent to 520 mg/ml.
This may cause a burning sensation on damaged skin.
This medicine contains ethanol and is therefore flammable. 3. HOW TO USE ALOPEXY 50 mg/ml, solution for cutaneous application?

Precautions
Flammable product.
Keep away from heat, hot surfaces, sparks, open flames, and other ignition sources.
Do not smoke while using or handling the tube.

Always use this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are unsure.
Dosage
The recommended dose is 1 ml to be applied twice daily to the scalp area to be treated.
The daily dose should not exceed 2 ml, regardless of the size of the area to be treated.
Frequency of application
Apply 1 ml in the morning and 1 ml in the evening.
Do not increase the dose or frequency of application.
In all cases, strictly adhere to the dose. Administration method
Cutaneous route. External use.
Wash your hands thoroughly before and after applying the solution.
Apply to perfectly dry hair and scalp.
Spread the product with your fingertips to cover the entire area to be treated, starting from the center of the area to be treated.
Do not apply the product to any other part of the body.
Application method
Opening the bottle: The bottle is equipped with a child-resistant cap. To open it, press down on the plastic cap while turning it counterclockwise (to the left). Only the tamper-evident seal should remain on the bottle.

Depending on the delivery system used: dosing pipette or sprayer
1 ml graduated pipette

The pipette allows you to precisely collect 1 ml of solution to distribute over the entire area to be treated, starting from the center of the area to be treated.

Metering pump with applicator
This system is suitable for application to small areas or under the hair.

1. Snap the nozzle into the pump: hold the pump body firmly by pressing the push-button part of the nozzle.

2. Insert the sprayer with the nozzle into the bottle and screw it on tightly.

3. Prime the pump: the dispensing system is ready for use.

4. To apply: direct the sprayer towards the center of the area to be treated or under the hair, press once, and spread the product with your fingertips.
Six (6) sprays are required to apply a 1 ml dose.

5. Rinse the nozzle with warm water after each use.

Treatment duration
Results are not immediate; stopping hair loss and/or resuming hair growth requires some time after starting treatment. Continued treatment is necessary to increase and maintain hair regrowth. The first results may appear after 2 to 4 months of twice-daily application. The time and degree of response vary from patient to patient.
If treatment is stopped, some reports suggest a return to baseline may occur within 3 to 4 months.
If you use more ALOPEXY 50 mg/ml cutaneous solution than you should
Overdose is unlikely when used as directed. When applied to a damaged scalp, absorption of the active ingredient may be increased, and side effects may occur (see section 2 BEFORE YOU USE ALOPEXY 50 mg/ml cutaneous solution).
If you forget to use ALOPEXY 50 mg/ml cutaneous solution.
Do not use a double dose to make up for a forgotten dose. Resume at the usual frequency: 1 application in the morning and 1 application in the evening.
If you stop using ALOPEXY 50 mg/ml, solution for cutaneous application:
Not applicable.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you notice any of the following symptoms, as you may need urgent medical treatment:
Swelling of the face, lips, or throat causing difficulty swallowing or breathing. These symptoms could be signs of a serious allergic reaction (frequency not known, cannot be estimated from the available data).
The most commonly observed reactions are minor skin reactions. Frequent cutaneous applications may cause skin irritation and dryness due to the presence of alcohol.
The following side effects have been reported and are listed by frequency:
Very common: may affect more than 1 in 10 people
Hypertrichosis (excessive hair growth) distant from the application site, especially when used by women.
Headache.
Common: may affect up to 1 in 10 people
Local skin reactions at the site of product application: local irritation with desquamation (shedding of dead skin cells), itching, skin reddening, dermatitis, dry skin, allergic skin reaction, inflammatory skin reaction, skin rashes that may resemble acne, musculoskeletal pain, peripheral edema (infiltration of fluid into the tissues), difficulty breathing, depression, and pain.
Frequency not known (cannot be estimated from the available data)
Ear infection, external otitis, rhinitis, hypersensitivity, neuritis, tingling sensation, taste disturbance, burning sensation, vision disturbances, eye irritation, dizziness, low blood pressure, rapid heart rate, palpitations, chest pain, weakness, facial swelling (infiltration of fluid into the tissues), generalized redness, hair loss and uneven distribution of hair, change in hair color or texture, hepatitis, and kidney stones.
In all these cases, stop your treatment and inform your doctor promptly.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the Network of Regional Pharmacovigilance Centers - Website: https://signalement.social-sante.gouv.fr/. By reporting side effects, you help provide more information on the safety of this medicine.
5. HOW TO STORE ALOPEXY 50 mg/ml, solution for cutaneous application?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date printed on the bottle after EXP. The expiry date refers to the last day of that month.
Flammable product. Keep away from heat, hot surfaces, sparks, open flames, and other ignition sources. Do not smoke.
The solution should be used within 1 month after first opening. Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What ALOPEXY 50 mg/ml, solution for cutaneous application contains
· The active substance is:
Minoxidil......................................................................................................................... 50 mg
Per 1 ml
· The other ingredients are: Propylene glycol*, 96% ethanol*, purified water.
*See section 2 "ALOPEXY contains"
What ALOPEXY 50 mg/ml, solution for cutaneous application looks like and contents of the outer packaging
This medicine is a clear, slightly yellow solution. Solution for cutaneous application.
60 ml bottle with a child-resistant cap and a 1 ml graduated pipette and a dosing pump with an applicator. Box of 1 or 3 bottles.
60 ml bottle with a child-resistant cap and a 1 ml graduated pipette. Box of 1 bottle.
Not all sizes may be available for sale. Marketing Authorization Holder
PIERRE FABRE MEDICAMENT
LES CAUQUILLOUS
81500 LAVAUR
Marketing Authorization Holder
PIERRE FABRE MEDICAMENT
PARC INDUSTRIEL DE LA CHARTREUSE
81100 CASTRES
Manufacturer
PIERRE FABRE MEDICAMENT PRODUCTION
SITE PROGIPHARM
RUE DU LYCEE
45500 GIEN
Names of the medicinal product in the Member States of the European Economic Area
This medicinal product is authorized in the Member States of the European Economic Area under the following names: In accordance with current regulations.
[To be completed later by the holder]
This leaflet was last revised:
[To be completed later by the holder]
< {MM/YYYY}>< {month YYYY}.>
Other
Detailed information on this medicinal product is available on the ANSM website (France). Health Education Tip:
What is androgenetic alopecia?
Normally, hair has a lifespan of 3 to 6 years and 50 to 100 hairs are lost per day.
More significant hair loss may occur seasonally (in the fall) or after childbirth: this hair loss is normal, transient, and does not require treatment.
Alopecia is defined as hair 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) can be diffuse or in patches (alopecia areata) and most often has a known cause (aggressive hair care, poor general health, poorly balanced weight loss, certain medications, psychological shock, stress, etc.).
These acute alopecias should not be treated with this medication. Chronic (long-term) alopecia is almost always diffuse.
It is sometimes due to a specific disease (thyroid, metabolic, etc.) and should not be treated with this medication.
In the vast majority of cases, these chronic alopecias are of unknown origin, most often hereditary: this is androgenetic alopecia. Only this type of alopecia can be treated with minoxidil.
How to recognize androgenetic alopecia?

In women

In men

Androgenetic alopecia is diffuse: there is an overall decrease in hair density.
The hair gradually thins from the parting.

Androgenetic alopecia begins with a thinning of the temples.
Then, a slight baldness appears on the crown of the head. These two hairless areas will gradually enlarge: androgenetic alopecia gradually progresses to baldness.

Some usage tips
Use a mild shampoo (preferably silicone-free).
If you shampoo after applying minoxidil, allow 4 hours between applications.
If you apply minoxidil after shampooing, it is recommended to do so on a dry scalp. You can use a hairdryer after applying minoxidil, preferably on a warm setting.
You can use styling mousses, gels, or sprays, allowing at least 1 hour between applications.
There is no interaction between your minoxidil treatment and your perms or coloring treatments, but it is best to limit them due to their harshness on the hair.
If you plan to expose yourself to the sun after applying minoxidil, it is recommended to cover your hair. Additional Information
At the beginning of treatment, over a short period of time, you may experience an increase in hair loss. These hairs were meant to fall out and are now falling out more quickly. This is normal; continue treatment.
The first hairs that grow will be soft, fluffy, and barely visible. Gradually, as you continue your treatment, they may change and thicken.