NOTICE
ANSM - Updated: 07/11/2017
Name of the drug
minoxidil bailleul 2%, 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 2% solution for skin application and in which cases is it used?
2. What is the information to know before using MINOXIDIL BAILLEUL 2%, solution for skin application?
3. How to use MINOXIDIL BAILLEUL 2%, solution for cutaneous application?
4. What are the possible side effects?
5. How to store MINOXIDIL BAILLEUL 2% solution for skin application?
6. Contents of the package and other information.
1. WHAT MINOXIDIL BAILLEUL 2% solution for skin application AND WHAT IT IS USED FOR
Pharmacotherapeutic group - ATC code: D11AX01
OTHER DERMATOLOGICAL PREPARATION
This medicine is indicated in case of moderate hair loss (androgenetic alopecia ) of the adult, male or female. It promotes hair growth and stabilizes the phenomenon of falling.
2. BEFORE YOU USE MINOXIDIL BAILLEUL 2% solution for skin application?
Never use MINOXIDIL BAILLEUL 2%, solution for skin application:
· 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 MINOXIDIL BAILLEUL 2% Cutaneous Solution .
Take care with MINOXIDIL BAILLEUL 2%, solution for cutaneous application:
In case of even old heart diseases, it is necessary to consult a doctor before the first use of minoxidil. |
Do not apply minoxidil:
o in the event of sudden hair loss, hair loss due to disease or drug treatment, 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 Tips / Health Education ).
o on another part of the body.
Stop treatment and consult your doctor if redness or persistent irritation of the scalp occurs.
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.
In case of non-compliance with the recommended dosage and / or method of administration, the passage into the general circulation of minoxidil could be increased and cause undesirable effects such as chest pain, lowering of blood pressure, tachycardia (acceleration of rhythm cardiac), dizziness or feeling dizzy, sudden and unexplained weight gain, swelling of the hands and feet.
If these symptoms occur: stop treatment and consult your doctor.
DO NOT LEAVE THIS MEDICINE WITHIN THE REACH OF CHILDREN.
DO NOT SWALLOW.
DO NOT INHALE.
In case of accidental contact with the eye, a wound, a mucous membrane, the solution (containing ethyl alcohol) may cause a burning sensation and irritation: rinse thoroughly with running water.
Do not expose the sun-treated scalp: protection is needed (hat).
children
Not applicable.
Other medicines and MINOXIDIL BAILLEUL 2%, solution for cutaneous application
Tell your doctor or pharmacist if you use, have recently used, or may use any other medicines.
MINOXIDIL BAILLEUL 2%, solution for cutaneous application with food and drinks
Not applicable.
Pregnancy and breast feeding
Do not take this medicine without seeking the advice of your doctor or pharmacist.
It is best not to use minoxidil during pregnancy. Similarly, the use of minoxidil when breastfeeding should be avoided.
Driving and using machines
Not applicable.
MINOXIDIL BAILLEUL 2% 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 2%, solution for cutaneous application?
Ve illez Always use this medicine exactly the instructions in this leaflet or as your doctor or pharmacist. Check with your doctor or pharmacist.
Use this medicine only in adults.
Apply 2 times daily a dose of 1 ml on the scalp starting from the center of the area to be treated.
The total daily dose should not exceed 2 ml, regardless of the extent of the area to be treated.
Extend the product with the fingertips so as to cover the entire area to be treated (see Application Mode).
Before and after application of the solution, wash hands thoroughly.
Apply on hair and scalp perfectly dry.
Dermal. External use.
MODE OF APPLICATION
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. Point the pump towards the center of the surface to be treated, actuate 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.
Avoid inhaling the product.
3. Replace the cap on the vial 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. Then operate according to the process described for the sprayer.
An application of 1 ml in the morning and 1 ml in the evening.
Do not increase doses or application frequencies.
The onset and degree of response to treatment varies by subject.
The result is not immediate: the stop of hair loss and / or the growth of the hair can appear only some time after the beginning of the treatment (about 3 or 4 months).
If you use more than MINOXIDIL BAILLEUL 2%, solution for skin application that you should have
Accidental ingestion may cause effects due to the cardiovascular action of minoxidil: CONSULT A DOCTOR QUICKLY .
If you forget to use MINOXIDIL BAILLEUL 2%, 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 2%, 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.
o 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 Due to the presence of alcohol, frequent applications on the skin can cause irritation and dryness of the skin.
o Due to the presence of propylene glycol, risk of eczema (allergic reactions of the skin),
o Possibility of local irritation with desquamations, itching, redness of the skin, dry skin, hypertrichosis (abnormal development of the hair system away from the point of application), burning sensation,
o More rarely, allergic reactions (rhinitis, localized or generalized rashes, generalized redness, swelling of the face), dizziness, tingling, headache, weakness, edema, taste changes, ear infection, blurred vision, eye irritation, neuritis (inflammation of the nerve).
o In some rare cases, there has been a drop in blood pressure, an acceleration of the pulse, hair loss especially at the beginning of treatment, chest pain, a change in liver function.
In all these cases, stop your treatment and tell your doctor.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This also applies to any 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: 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 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 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 2% contains, solution for cutaneous application
· The active substance is:
Minoxidil ................................................. .................................................. .......................... 2 g
For 100 ml.
· The other components are:
Propylene glycol, 96% ethanol, purified water.
What MINOXIDIL BAILLEUL 2% 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:
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:
o acute alopecia,
o chronic alopecia.
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.
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.
How to recognize androgenetic alopecia?
In the woman
Androgenetic alopecia is diffuse: there is an overall decrease in capillary density.
The hair gradually clears from the line.
In humans
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.
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 after applying minoxidil preferably in a warm position.
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.
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.