Alopexy Minoxidil 2% Solution

Alopexy 2% from Ducray Laboratories is a solution for cutaneous application containing 2% minoxidil, which stimulates hair growth.

It is indicated for moderate hair loss in adults, both men and women. This condition is called androgenetic alopecia.
Alopexy 2% promotes hair growth and stabilizes hair loss.

Dosage and Application of Alopexy 2%
Apply 1 ml (6 sprays) of this product to the scalp twice a day, morning and evening, starting from the center of the area to be treated, then spread the product with your fingers over the entire area. This application is done on dry hair and scalp. Wash your hands thoroughly after using Alopexy 2%.

Hair loss can stop and hair regrow, and hair loss can take time and varies from person to person. However, the first results generally appear after 3 to 4 months of treatment.

Alopexy for Women and Precautions
This medication should not be used during pregnancy or breastfeeding.

Alopexy 2% is not suitable for sudden hair loss resulting from illness or drug treatment (chemotherapy), as it will not be effective. It should also not be used on any part of the body (beard, torso, etc.) other than the scalp.

Minoxidil should not be used on an irritated scalp, whether it is irritated, red, inflamed, or painful. It should not be applied concurrently with other potentially irritating dermatological treatments such as retinoic acid, betametasone dipropionate, or anthralin, which can also alter the amount of minoxidil entering the systemic circulation.

If Alopexy 2% is misused, minoxidil may enter the bloodstream and cause cardiac side effects such as chest pain, low blood pressure, tachycardia (rapid heart rate), but also dizziness or lightheadedness, sudden and unexplained weight gain, or swelling of the hands and feet. If you have a history of heart disease, seek medical advice before starting minoxidil treatment.

Alopexy 2% should not expose your scalp to the sun; therefore, you must protect yourself with a hat.

In case of accidental contact with the eye or a wound, rinse thoroughly with water. If irritation or pain persists, do not hesitate to seek advice from your pharmacist or doctor.

An allergy to any of the compounds (?-Cyclodextrin, 96% ethanol, propylene glycol, purified water) in the Alopexy 2% formula is a contraindication to its use.

Packaging: 3 x 60 ml bottles, equivalent to 3 months of treatment.

Pierre Fabre Laboratory also offers Lobamine Cysteine ??anti-hair loss capsules.








LEAFLET
ANSM - Updated on: 11/26/2024
Name of the medicinal product
ALOPEXY 2%, 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 take 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 you do not feel better or if you feel worse.
What is in this leaflet?
1. What is ALOPEXY 2%, solution for cutaneous application and what is it used for?
2. What you need to know before using ALOPEXY 2%, cutaneous solution?
3. How to use ALOPEXY 2%, cutaneous solution?
4. Possible side effects?
5. How to store ALOPEXY 2%, cutaneous solution?
6. Contents of the pack and other information.
1. WHAT IS ALOPEXY 2%, cutaneous solution AND WHAT IS IT USED FOR?
Pharmacotherapeutic group: OTHER DERMATOLOGICAL MEDICINES - ATC code: D11AX01.
This medication is presented as a cutaneous solution containing minoxidil as the active ingredient.
It is indicated for moderate hair loss (androgenetic alopecia) in adults, both men and women. It promotes hair growth and stabilizes hair loss. 2. WHAT YOU NEED TO KNOW BEFORE USING ALOPEXY 2%, cutaneous solution?
Never use ALOPEXY 2%, cutaneous solution:
· if you are allergic to minoxidil or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before using ALOPEXY.

In case of heart disease, even long-standing, it is necessary to consult a doctor before using minoxidil for the first time.

Cases of excessive body hair growth in infants have been reported after skin contact at the 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 hair growth on your child's body while using topical products containing minoxidil.
You should not use this medication:
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 this medication 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 (see section: "How to use ALOPEXY 2%"). In people with scalp lesions, an increase in the active ingredient (minoxidil) may be present in the blood.
· At the same time as other medications applied to the scalp.
· On another part of the 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 symptoms persist, consult a doctor.
· Do not expose the treated scalp to the sun; protection (a hat) is necessary.
· Do not swallow. Accidental ingestion can cause serious cardiac effects. Therefore, the product must be kept out of the sight and reach of children. CONSULT A DOCTOR PROMPTLY.
· Do not inhale the sprayed medication.
You must stop treatment immediately and consult your doctor:
· If you experience a drop in blood pressure (hypotension), chest pain, or a rapid pulse. · In case of weakness or dizziness.
· In case of sudden and unexplained weight gain, swelling of the hands or feet (edema).
· In case of persistent redness or irritation of the scalp.
It is important to follow the recommended dosage and method of administration:
If the recommended dosage and/or method of administration are not followed, the passage of minoxidil into the systemic circulation could be increased and lead to adverse effects such as chest pain, low blood pressure, tachycardia (rapid heart rate), dizziness (lightheadedness), sudden and unexplained weight gain, and swelling of the hands and feet.
Children and Adolescents
There is no relevant use of this medication in subjects under 18 years of age for the indication of moderate androgenetic alopecia. Elderly
This medicine should not be used in people over 65 years of age because its efficacy and safety have not been studied.
Other medicines and ALOPEXY 2%, solution for cutaneous application
Do not apply this medicine at the same time as other products intended for application to the scalp, such as tretinoin, anthralin, 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 2%, solution for cutaneous application with food, drink, and alcohol
Not applicable.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The use of this medicine is not recommended during pregnancy. Breastfeeding
This medicine should not be used during breastfeeding.
Driving and using machines
ALOPEXY has no or negligible influence on the ability to drive and use machines.
ALOPEXY 2%, cutaneous solution contains propylene glycol and alcohol (ethanol).
This medicine contains 50 mg of propylene glycol per dose, equivalent to 50 mg/ml.
This medicine contains 443.9 mg of alcohol (ethanol) per dose, equivalent to 443.9 mg/ml. This may cause a burning sensation on damaged skin.
3. HOW TO USE ALOPEXY 2%, cutaneous solution?

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

Use this medicine only in adults.

Dosage
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 in doubt.
Apply a 1 ml dose to the scalp twice daily, starting from the center of the 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.
Method of Administration
Cutaneous use.
External use.
Spread the product with your fingertips to cover the entire area to be treated, starting from the center of the area to be treated.
Before and after applying the solution, wash your hands thoroughly. Apply to perfectly dry hair and scalp.
Do not apply the product to any other part of the body.
Application Instructions
Opening the bottle: The bottle is equipped with a child-resistant cap. Here's how 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 with the bottle (graduated pipette or dosing pump with applicator):
1 ml graduated pipette

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

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

1. Snap the cannula into the pump: hold the pump body firmly while pressing on the push-button part of the cannula.

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 toward 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.

Treatment Duration
The onset and degree of response to treatment vary from person to person.
Results are not immediate: hair loss may stop and/or hair growth may not appear until some time after starting treatment (approximately 3 or 4 months).
If you use more ALOPEXY 2%, cutaneous solution than you should:
Overdose is unlikely when used according to the recommended dosage. In case of overdose, misuse, or accidental ingestion: Contact your doctor immediately (see section 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ALOPEXY 2% cutaneous solution).
Signs of overdose may include low blood pressure (hypotension) and rapid heart rate (tachycardia).
If you use more ALOPEXY 2% cutaneous solution than directed, or if you/your child accidentally ingests it, contact your poison control center or doctor immediately.
If you forget to use ALOPEXY 2% 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 2% cutaneous solution:
Not applicable. If you have any further questions about using 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 common reactions are minor skin reactions.
Frequent application to the skin may cause skin irritation and dryness due to the presence of alcohol (ethanol).
The following side effects have been reported and are listed by frequency:
Very common (may affect more than 1 in 10 people)
Headache.
Common (may affect 1 to 10 in 100 people)
Local skin reactions at the site of application of the product: local irritation, peeling (sloughing off of dead skin cells), itching, skin reddening (erythema), dermatitis, dry skin, pain.
Allergic skin reaction, inflammatory skin reaction, skin rashes that may resemble acne, hypertrichosis (excessive hair growth) at a distance from the application site, musculoskeletal pain, peripheral edema (infiltration of fluid into the tissues), difficulty breathing (dyspnea), and depression.
Frequency not known (cannot be estimated from the available data)
Ear infection, external otitis, rhinitis, hypersensitivity, inflammation of a nerve (neuritis), tingling sensation, altered sense of taste (dysgeusia), burning sensation of the skin, dizziness (vertigo), visual disturbances, eye irritation, low blood pressure, rapid heart rate (tachycardia), palpitations, chest pain, facial swelling (infiltration of fluid into the tissues), generalized redness, hair loss and uneven distribution of hair, change in hair color or texture, fatigue (asthenia), liver inflammation (hepatitis).
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 can help provide more information on the safety of this medicine.
5. HOW TO STORE ALOPEXY 2%, solution for cutaneous application?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date indicated on the outer packaging 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.
This medicine does not require any special storage conditions.
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 2%, cutaneous solution contains
· The active ingredient is:
Minoxidil............................................................................................................................. 2 g
Per 100 ml of cutaneous solution
· The other ingredients are: g-Cyclodextrin, 96% ethanol*, propylene glycol*, purified water.
· *See section 2 "ALOPEXY contains"
What ALOPEXY 2%, cutaneous solution looks like and contents of the outer packaging
This medicine is a clear or 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 applicator. Box of 1 or 3 bottles.
60 ml bottle with a child-resistant cap and a 1 ml graduated pipette. Box of 1 or 3 bottles.
Not all pack sizes may be marketed.
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
PROGIPHARM SITE
RUE DU LYCEE
45500 GIEN
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
This leaflet was last revised:
[To be completed later by the holder]
Other
Detailed information on this medicine is available on the ANSM website (France).
HEALTH EDUCATION ADVICE
A/ 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 loss is normal, transient, and there is no need to start 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 of time) can be diffuse or patchy (alopecia areata) and most often have a known cause (aggressive hair care, poor general health, poorly balanced weight-loss program, certain medications, psychological shock, stress, etc.). These acute alopecias should not be treated with this medication.
Chronic alopecia (long-term) is almost always diffuse.
It is sometimes due to a specific disease (thyroid, metabolic, etc.) and should not be treated with this medication.
The vast majority of these chronic alopecias have an unknown origin, most often hereditary: this is androgenetic alopecia. Only this type of alopecia can be treated with minoxidil.
B/ 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 bald spot appears on the crown of the head. These two hairless areas will gradually enlarge: the alopecia gradually progresses to baldness.

C/ 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.
D/ Some additional information
At the beginning of treatment, over a short period of time, an increase in hair loss may occur. These hairs were meant to fall out and are 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.