In this manual :
1. WHAT IS MINOXIDIL BAILLEUL 5%, solution for cutaneous application AND WHAT IS IT USED FOR?
2. WHAT YOU SHOULD KNOW BEFORE USING MINOXIDIL BAILLEUL 5%, solution for cutaneous application
3. HOW TO USE MINOXIDIL BAILLEUL 5%, solution for cutaneous application?
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
5. HOW TO USE MINOXIDIL BAILLEUL 5%, solution for cutaneous application?
6. ADDITIONAL INFORMATION
1. WHAT IS MINOXIDIL BAILLEUL 5%, solution for cutaneous application AND WHAT IS IT USED FOR?
Pharmacotherapeutic class
Not applicable.
This medicine is recommended in certain cases of alopecia (excessive hair loss), known as androgenetic, of moderate intensity in men.
It is not recommended for women because of the high frequency of hypertrichosis (abnormal development of the hair system) at a distance from the application sites.
2. WHAT YOU SHOULD KNOW BEFORE USING MINOXIDIL BAILLEUL 5%, solution for cutaneous application
List of information needed before taking the medicine
Not applicable.
Never use MINOXIDIL BAILLEUL 5%, solution for cutaneous application
- if you are allergic to minoxidil or to any of the other ingredients of the solution(see What does MINOXIDIL BAILLEUL 5%, solution for cutaneous application, contain?)
- if you have experienced intolerance to the 2% solution form of minoxidil
- if you are under 18 or over 65 years of age
- if you have scalp lesions.
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Precautions for use; special warnings
Take special precautions with MINOXIDIL BAILLEUL 5%, solution for cutaneous application:
In subjects with scalp lesions, an increase in the passage of the active ingredient into the blood is possible(see Never use MINOXIDIL BAILLEUL 5%, solution for cutaneous application).
In some rare cases, it is possible that a drop in blood pressure, an increase in pulse rate and oedema may occur: treatment should be stopped immediately and your doctor informed.
The risk of hypertrichosis (abnormal development of the hair system) at a distance justifies not using this medicine in women.
This treatment requires regular medical monitoring, especially at the beginning of treatment.
Stop the treatment and consult your doctor in case of redness or persistent irritation of the scalp.
It is important to follow the recommended dosage and method of administration:
- do not increase the dose per application, do not increase the frequency of applications,
- Apply minoxidil only to a healthy scalp. Do not apply minoxidil to irritated, red, inflamed or painful scalps,
- do not apply minoxidil at the same time as other products used in dermatology or any other medication that irritates the skin.
KEEP THIS MEDICINE OUT OF THE REACH OF CHILDREN.
DO NOT SWALLOW.
DO NOT INHALE.
In case of accidental contact with the eye, a wound, irritated skin, mucous membrane, the solution (containing ethyl alcohol) may cause a burning sensation and irritation: rinse thoroughly with running water.
Do not expose the treated scalp to the sun: protection is necessary (hat).
A change in hair colour and/or texture has been observed in some patients.
Inform your doctor in case of heart problems.
IF IN DOUBT, DO NOT HESITATE TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.
Interactions with other medicines
Taking or using other medicines
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Interactions with food and drink
Not applicable.
Interactions with herbal products or alternative therapies
Not applicable.
Use during pregnancy and lactation
Pregnancy and lactation
The use of this medicine is not recommended in women. However, if used in women:
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Do not take this medicine without asking your doctor or pharmacist.
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It is best not to use minoxidil during pregnancy. Also, the use of minoxidil during breast-feeding should be avoided.
Not applicable.
Effects on ability to drive and use machines
Not applicable.
List of excipients with a known effect
List of excipients with a notable effect:propylene glycol, alcohol.
3. HOW TO USE MINOXIDIL BAILLEUL 5%, solution for cutaneous application
Instructions for proper use
Not applicable.
Dosage, Method and/or route(s) of administration, Frequency of administration and Duration of treatment
Apply twice daily a dose of 1 ml to the scalp starting from the centre of the area to be treated.
The total daily dose should not exceed 2 ml, regardless of the size of the area to be treated.
In all cases, strictly follow your doctor's prescription.
Cutaneous use. External use.
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.
Sprayer: This system is suitable for application to large areas.
1. Remove the cap of the bottle.
2. Point the pump at the centre of the area to be treated, squeeze once and spread the product with your fingertips to cover the entire area. Repeat 6 times to apply a 1 ml dose (7 sprays in total).
Avoid inhaling the product.
3. Replace the cap on the bottle after use.
Sprayer with applicator: This system is suitable for application to small areas or under the hair.
1. Remove the cap from the bottle.
2. Remove the upper part of the pump. Fit the applicator and press firmly.
3. Point the pump at the centre of the area to be treated, squeeze once and spread the product with your fingertips to cover the entire area. Repeat 6 times to apply a 1 ml dose (7 sprays in total).
Avoid inhaling the product.
4. Fold down the applicator tip. Replace the cap on the bottle after use.
One application of 1 ml in the morning and 1 ml in the evening.
Do not increase the dose or frequency of application.
In all cases, strictly follow your doctor's prescription.
The onset and degree of response to the treatment varies from subject to subject.
The result is not immediate: the cessation of hair loss and/or hair growth may not appear until some time after the start of treatment (about 3 or 4 months).
A treatment of 2 months with 2 applications per day may be necessary before a stimulation of hair growth is demonstrated. The onset and degree of response varies from subject to subject. Some observations suggest a return to baseline in 3 to 4 months if treatment is stopped.
Symptoms and instructions in case of overdose
If you have used more MINOXIDIL BAILLEUL 5%, solution for cutaneous application than you should have:
Accidental ingestion may cause effects due to the cardiovascular action of minoxidil: SEEK MEDICAL ATTENTION.
Instructions in case of missed dose(s)
If you forget to use MINOXIDIL BAILLEUL 5%, solution for cutaneous application:
Repeat at the usual frequency: 1 application in the morning and 1 application in the evening. Do not use a double dose to make up for the dose you forgot to take.
Risk of withdrawal syndrome
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Description of side effects
Like all medicines, MINOXIDIL BAILLEUL 5%, solution for cutaneous application is likely to have undesirable effects, although not everyone is subject to them:
- Local irritation with desquamation (removal of dead skin cells), itching, erythema (redness of the skin), dry skin, burning sensation and hypertrichosis (abnormal development of the hair system at a distance) or, more rarely, allergic reactions may occur. You should inform your doctor.
- In rare cases, a drop in blood pressure, rapid pulse, hair loss, irregular hair growth, chest pain, hepatitis or kidney stones may occur: stop the treatment immediately and inform your doctor.
- More rarely, other reactions have been described, such as allergy (rhinitis, skin rash, generalized redness, facial swelling), dizziness, tingling, headache, weakness, edema (fluid in the tissues), alteration of taste, ear infection, vision problems, eye irritation, neuritis (nerve damage).
It should be noted, however, that these effects, especially those that have been reported most rarely, have been reported without definite evidence that they were caused by the treatment.
Component-related:
- cause irritation and dryness of the skin.
- Due to the presence of propylene glycol, there is a risk of eczema (allergic skin reactions).
In all these cases, you should stop your treatment and tell your doctor.
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
5. HOW TO USE MINOXIDIL BAILLEUL 5%, solution for cutaneous application
Keep out of the reach and sight of children.
Do not use MINOXIDIL BAILLEUL 5%, solution for cutaneous application after the expiry date stated on the bottle.
Flammable product.
If necessary, warnings against certain visible signs of deterioration
Medicines should not be disposed of down the drain or in the household waste. Ask your pharmacist what to do with unused medicines. This will help to protect the environment.
6. ADDITIONAL INFORMATION
Full list of active ingredients and excipients
What does MINOXIDIL BAILLEUL 5%, solution for cutaneous application, contain?
The active substance is:
Minoxidil ................................................................................................................................................ 5 g
Per 100 ml.
The other ingredients are:
Propylene glycol, 96% ethanol, purified water.
Pharmaceutical form and contents
What is MINOXIDIL BAILLEUL 5%, solution for cutaneous application and contents of the pack?
This medicinal product is presented as a solution for cutaneous application.
60 ml bottle with a metering pump. Box of 1 or 3 bottles.
Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different
Holder
BAILLEUL-BIORGA LABORATORIES
8, rue Laugier
75017 Paris
Operator
LABORATOIRES BAILLEUL
8 rue Laugier
75017 PARIS
Manufacturer
LABORATOIRES OPODEX INDUSTRIE
34-46 avenue du Vieux Chemin de Saint Denis
92390 VILLENEUVE LA GARENNE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
Date of approval of the package leaflet
The last date on which this package insert was approved was {date}.
MA under exceptional circumstances
Not applicable.
Detailed information on this medicinal product is available on the website of Afssaps (France).
Information reserved for health professionals
Not applicable.
What is androgenetic alopecia?
Normally, hair has a lifespan of 3 to 6 years and 50 to 100 hairs fall out per day.
More significant hair loss can occur seasonally (in autumn) or after childbirth: this loss is normal, transitory and there is no need to start a 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 in patches (alopecia) and is most often due to known causes (aggressive hair care, poor general condition, poorly balanced weight loss treatment, certain medications, psychological shock, stress, etc.).
These acute alopecias should not be treated with this medication.
Chronic alopecia (long term) is almost always diffuse.
They are sometimes due to a specific disease (thyroid, metabolic...) and should not be treated with this medication. In the vast majority of cases, these chronic alopecias are of poorly known origin, most often hereditary in nature: this is androgenetic alopecia. Only this type of alopecia can be treated with minoxidil.
How to recognize androgenetic alopecia?
In women
Androgenetic alopecia is diffuse: there is an overall decrease in hair density. The hair becomes progressively thinner from the parting.
In men
Androgenetic alopecia begins with a balding of the temporal gulfs. Then a slight baldness appears at the top of the skull. These two hairless areas will progressively enlarge: androgenetic alopecia progressively evolves towards baldness.
Some advice for use
Use a shampoo that is not too aggressive (preferably silicone-free).
If you shampoo after applying minoxidil, leave it on for 4 hours. If you apply minoxidil after shampooing, it is recommended to do so on a dry scalp.
You can use a hair dryer after applying minoxidil, preferably in a warm position.
You can use styling foams, gels or sprays, but you must wait at least 1 hour between applications.
There is no interaction between your treatment with minoxidil and your perms or colouring treatments but it is preferable to limit them because of their aggressiveness on the hair.
If you plan to expose yourself to the sun after an application of minoxidil, it is recommended to cover your hair.
Some additional information
At the beginning of treatment, over a short period of time, it is possible that hair loss increases. These hairs were intended to fall out and do so more quickly. This is a normal phenomenon, continue the treatment.
The first hair to grow will be soft, fluffy and not very visible. As you continue your treatment, they may change and become thicker.
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