NOTICE
ANSM - Updated: 07/11/2017
Name of the drug
minoxidil bailleul 5%, solution for cutaneous application
framed
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medicine exactly as described in this leaflet or by your doctor or pharmacist.
Keep this leaflet. You might need to read it again.
Talk to your pharmacist for any advice or information.
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned in this leaflet. See section 4.
You should talk to your doctor if you do not feel better or if you feel worse.
What does this booklet contain ?
1. What is MINOXIDIL BAILLEUL 5% solution for skin application and in which cases is it used?
2. What information do you need to know before using MINOXIDIL BAILLEUL 5% solution for skin application ?
3. How to use MINOXIDIL BAILLEUL 5%, solution for cutaneous application ?
4. What are the possible side effects?
5. How to store MINOXIDIL BAILLEUL 5%, solution for cutaneous application ?
6. Contents of the package and other information.
1. WHAT MINOXIDIL BAILLEUL 5%, solution for cutaneous application AND WHAT IT IS USED FOR?
Pharmacotherapeutic group - ATC code: D11AX01
OTHER DERMATOLOGICAL PREPARATION
This medicine is indicated for moderate hair loss (androgenetic alopecia) in men.
2. WHAT YOU SHOULD KNOW BEFORE YOU USE MINOXIDIL BAILLEUL 5% solution for skin application?
Never use MINOXIDIL BAILLEUL 5%, solution for skin application:
If you are allergic to Minoxidil or any of the other ingredients of this medicine, listed in section 6.
If you have scalp lesions,
If you are intolerant to the 2% form,
If you are under 18 or over 65,
If you have any alopecia (hair loss) of the woman.
Warnings and precautions
Talk to your doctor or pharmacist before using MINOXIDIL BAILLEUL 5% Cutaneous Solution .
Take care with MINOXIDIL BAILLEUL 5%, solution for skin application:
Special warnings
In case of even old heart diseases, it is necessary to consult a doctor before the first use of minoxidil. |
In subjects with scalp lesions, an increase in the blood flow of the active substance is possible ( see Never use MINOXIDIL BAILLEUL 5%, solution for cutaneous application ).
In rare cases, or in case of non-compliance with the recommended dosage and / or method of administration, the passage into the general circulation of minoxidil may be increased and cause adverse effects such as chest pain, decreased high blood pressure, tachycardia (fast heart rate), dizziness or lightheadedness, sudden and unexplained weight gain, swelling of hands and feet.
If these symptoms occur: stop treatment and consult your doctor .
The risk of hypertrichosis (abnormal development of the hair system) remotely justifies not to use this drug in women.
It is important to respect the recommended dosage and method of administration:
o do not increase the dose per application, do not increase the frequency of applications,
o apply minoxidil only on a healthy scalp. Avoid this application in case of irritation, persistent redness, inflammation, painful sensation of the scalp,
o do not apply minoxidil together with retinoic acid or anthralin (drugs sometimes used in dermatology) or any other irritating dermatology medication.
Do not apply minoxidil :
o in case of sudden hair loss, hair loss due to disease or medication, DO NOT USE THIS MEDICINE AND TAKE THE ADVICE OF YOUR DOCTOR. Indeed, minoxidil would not be effective on this type of hair loss (see Health Education Tips).
o On another part of the body.
Precautions for use
This treatment requires regular medical monitoring, especially at the beginning of treatment.
o Tell your doctor if you have heart problems.
o Do not swallow. Do not inhale.
o In case of accidental contact with the eye, a wound, mucosa, rinse thoroughly with running water.
o A change in the color and / or texture of the hair has been observed in some patients.
o Sun exposure is not recommended when applying minoxidil.
children
Not applicable.
Other medicines and MINOXIDIL BAILLEUL 5%, solution for cutaneous application
Tell your doctor or pharmacist if you use, have recently used, or may use any other medicines.
MINOXIDIL BAILLEUL 5%, solution for cutaneous application with food and drinks
Not applicable.
Pregnancy and breast feeding
This medicine is contraindicated in women.
Driving and using machines
Not applicable.
MINOXIDIL BAILLEUL 5% solution for cutaneous application contains
o propylene glycol: it can cause irritation of the skin,
o alcohol: it can cause irritation and dryness of the skin in case of frequent applications on the skin .
3. HOW TO USE MINOXIDIL BAILLEUL 5%, solution for cutaneous application?
Reserved for adults.
Dosage
Apply 2 times daily a dose of 1 ml on the scalp starting from the center of the area to be treated.
This dose must be respected regardless of the extent of the area concerned.
The total daily dose should not exceed 2 ml.
Administration mode
Dermal.
Spread the product with the fingertips to cover the entire area to be treated. Apply minoxidil only on a healthy scalp. Avoid this application in case of irritation, persistent redness, inflammation, painful sensation of the scalp.
Wash hands thoroughly after use.
Apply on hair and scalp perfectly dry.
Do not apply the product to another part of the body.
The mode of application varies depending on the delivery system used with the vial.
Sprayer : This system is suitable for application over large areas.
1. Remove the bottle cover.
2. Direct the pump towards the center of the surface to be treated, operate it once and spread the product with the fingertips so as to cover the entire area to be treated. Repeat the procedure 6 times to apply a dose of 1 ml (ie 7 sprays in total).
Avoid inhaling the product.
3. Replace the cover on the bottle after use.
Sprayer with applicator : This system is suitable for application on small areas or under the hair.
1. Remove the bottle cover.
2. Remove the upper element of the pump. Adapt the applicator and press firmly.
3. Direct the pump towards the center of the surface to be treated, operate it once and spread the product with the fingertips so as to cover the entire area to be treated. Repeat the procedure 6 times to apply a dose of 1 ml (ie 7 sprays in total).
Avoid inhaling the product.
4. Leave the applicator in place.
Frequency of administration
An application of 1 ml in the morning and 1 ml in the evening.
Do not increase the dose per application, do not increase the frequency of applications.
Duration of treatment
Treatment lasting 2 months at 2 applications per day may be necessary before stimulation of hair growth is demonstrated.
The beginning and the degree of the answer vary according to the subjects.
Do not stop applications at the risk of returning to the previous state after a period of 3 or 4 months.
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 have used more MINOXIDIL BAILLEUL 5%, solution for skin application than you should
Accidental ingestion may cause effects due to the cardiovascular action of minoxidil: FAST CONSULT A DOCTOR .
If you forget to use MINOXIDIL BAILLEUL 5%, solution for cutaneous application
Resume at the usual frequency: 1 application in the morning and 1 application in the evening.
Do not take a double dose to make up for the dose you forgot to take.
If you stop using MINOXIDIL BAILLEUL 5%, solution for cutaneous application
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Tell your doctor immediately if you notice any of the following symptoms, as you may require emergency medical treatment.
Swelling of the face, lips or throat causing difficulty swallowing or breathing. These symptoms could be a sign of a serious allergic reaction (indeterminate frequency, impossible to estimate from the available data).
Like all medicines, this medicine can cause side effects, although not everybody gets them.
o Local irritation with desquamation (removal of dead skin cells), itching, erythema (redness of the skin), dry skin, acne, burning sensation and hypertrichosis (abnormal development of the hair system at a distance) may occur. more rarely allergic reactions. Respiratory difficulties have also been reported. You must tell your doctor.
o In rare cases, low blood pressure, pulse rate, palpitations, hair loss, irregular hair, chest pain, hepatitis, or kidney stones may occur. treatment and tell your doctor.
o Rarely other reactions have been described, allergy type (rhinitis, rash, generalized redness, swelling of the face), dizziness, tingling, headache, weakness, edema (infiltration of fluid in the tissues) , taste disturbance, ear infection, impaired vision, eye irritation, neuritis (nerve damage).
It should be noted, however, that these effects, especially those that have been most rarely reported, have been without any formal evidence that they were caused by treatment.
o Due to the presence of propylene glycol, risk of eczema (allergic reaction of the skin).
o Due to the presence of ethanol, frequent applications on the skin can cause irritation and dryness of the skin.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any undesirable effect that is not mentioned 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 Network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr
By reporting side effects, you can help provide more information on the safety of the medicine.
5. HOW TO STORE MINOXIDIL BAILLEUL 5%, solution for cutaneous application?
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle.
No special storage conditions.
Flammable product.
Do not dispose of any medication in the sewage system or in the household garbage. Ask your pharmacist to eliminate medications that you no longer use. These measures will help protect the environment.
6. CONTENTS OF PACKAGING AND OTHER INFORMATION
What MINOXIDIL BAILLEUL 5% contains, solution for cutaneous application
The active substance is:
Minoxidil ................................................. .................................................. .......................... 5 g
For 100 ml.
The other components are:
Propylene glycol, 96% ethanol, purified water.
What MINOXIDIL BAILLEUL 5% solution for skin application and contents of the pack
This medicine is in the form of a solution for cutaneous application.
60 ml bottle with a dosing pump. Box of 1 or 3 bottle (s).
Not all presentations may be marketed.
Marketing Authorization Holder
LABORATORIES BAILLEUL SA
10-12 Pasteur Avenue
L-2310 Luxembourg
luxembourg
Operator of the marketing authorization
BAILLEUL LABORATORIES
264 RUE DU FAUBOURG SAINT-HONORE
75008 PARIS
Maker
OPODEX INDUSTRIE LABORATORIES
36-42, avenue Marc Sangnier
92392 VILLENEUVE LA GARENNE CEDEX
or
DELPHARM HUNINGUE SAS
26 CHAPEL STREET
68 330 HUNINGUE
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
[to be completed later by the holder]
{MM / YYYY} {month YYYY}
Other
Not applicable.
Detailed information on this medicine is available on the ANSM website (France).
Health Education Council:
a) What is androgenetic alopecia?
Normally the hair has a lifespan of 3 to 6 years and it falls by day 50 to 100 hairs.
More hair loss can occur seasonally (in the fall) or after childbirth: the fall is normal, transient and there is no need to start treatment.
Alopecia is defined as hair loss greater than 100 hairs per day.
There are two types of alopecia:
acute alopecia,
chronic alopecia.
ð Acute alopecia (sudden hair loss over a short period of time) can be diffuse or by patches (peladic) and are most often of known cause (aggressive hair care, poor general condition, poorly balanced weight loss, certain drugs, shock psychic, stress ...). These acute alopecia should not be treated with this medicine.
ð Chronic (long-term) alopecia are almost always diffuse. They are sometimes due to a specific disease (thyroid, metabolic ...) and they should not be treated with this medicine. In the great majority, these chronic alopecia are of poorly known origin, most often hereditary: it is androgenetic alopecia. Only this type of alopecia can be treated with minoxidil.
b) How to recognize androgenetic alopecia in male subjects?
Androgenetic alopecia begins with a thinning of the temporal gulfs.
Then a slight tonsure appears at the top of the skull.
These two areas without hair will gradually grow: androgenetic alopecia gradually evolves to baldness.
c) Some tips for use
Use a mild shampoo (preferably without silicone).
If you do your shampoo after the application of minoxidil, respect a period of 4 hours after it.
If you apply minoxidil after shampooing, it is recommended to do it on a dry scalp.
You can use a hair dryer preferably in a warm position after applying minoxidil.
You can use mousse, gels or styling sprays with a minimum of 1 hour between applications.
There is no interaction between your treatment with minoxidil and your permanent or coloring care but it is better to limit them because of their aggressiveness on the hair.
If you plan to sunbathe 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. This hair was destined to fall and do it faster. This is a normal phenomenon, continue the treatment.
The first hair that grows will be soft, fluffy and not very visible. As you go on, as you continue your treatment, they can change and thicken.