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Description:
Bailleul Biorga 3 x 60ml bottles helps to promote hair growth.
Indications:
N/A
Composition:
N/A
Directions:
N/A
Details:
EAN/UPC: 03400936891371
Contents: N/A
Presentation: N/A
Please read the following full disclosure before using this product:
MINOXIDIL BAILLEUL 5%, topical solution
Boxed Warning
Please read this leaflet carefully before using this medication as it contains important information for you.
You must always use this medication following the instructions provided in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Consult your pharmacist for any advice or information.
· If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. See section 4.
· You should consult your doctor if you don't notice any improvement or if you feel worse.
What does this leaflet contain?
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What is MINOXIDIL BAILLEUL 5%, topical solution and in which cases is it used?
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What information should you know before using MINOXIDIL BAILLEUL 5%, topical solution?
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How to use MINOXIDIL BAILLEUL 5%, topical solution?
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What are the possible side effects?
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How to store MINOXIDIL BAILLEUL 5%, topical solution?
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Contents of the pack and other information.
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WHAT IS MINOXIDIL BAILLEUL 5%, topical solution AND IN WHAT CASES IS IT USED?
Pharmacotherapeutic class - ATC code: D11AX01
OTHER DERMATOLOGICAL PREPARATION
This medication is indicated for moderate hair loss (androgenetic alopecia) in males.
- WHAT SHOULD YOU KNOW BEFORE USING MINOXIDIL BAILLEUL 5%, topical solution?
Never use MINOXIDIL BAILLEUL 5%, topical solution:
· If you are allergic to Minoxidil or any of the other components contained in this medication, mentioned in section 6.
· If you have scalp lesions,
· If you are intolerant to the 2% formulation,
· If you are under 18 years or over 65 years,
· If you have any alopecia (hair loss) in females.
Warnings and precautions
Talk to your doctor or pharmacist before using MINOXIDIL BAILLEUL 5%, topical solution.
· In case of even past heart diseases, it is necessary to consult a doctor before the first use of minoxidil.
In subjects with scalp lesions, an increased absorption of the active ingredient into the bloodstream is possible (see Never use MINOXIDIL BAILLEUL 5%, topical solution).
In some rare cases, or in case of non-compliance with the recommended dosage and/or administration method, the entry of minoxidil into the general circulation could be increased and lead to side effects such as chest pain, decrease in blood pressure, tachycardia (acceleration of heart rate), dizziness or vertigo, sudden and unexplained weight gain, swelling of the hands and feet.
If these symptoms occur: stop treatment and consult your doctor.
The risk of hypertrichosis (abnormal development of body hair) at a distance justifies not using this medication in women.
It is important to respect the recommended dosage and administration method:
o do not increase the dose per application, do not increase the frequency of applications,
o only apply minoxidil to a healthy scalp. Avoid this application in case of irritation, persistent redness, inflammation, painful sensation of the scalp,
o do not apply minoxidil at the same time as retinoic acid or anthralin (medications 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 a disease or medication, DO NOT USE THIS MEDICINE AND SEEK THE ADVICE OF YOUR DOCTOR. Indeed, minoxidil would not be effective for this type of hair loss (see Health education advice).
o On another part of the body.
Precautions for use
This treatment requires regular medical follow-up, especially at the start of treatment.
o Inform your doctor in case of heart problems.
o Do not swallow. Do not inhale.
o In case of accidental contact with the eye, a wound, a mucous membrane, rinse thoroughly with running water.
o A change in color and/or texture of the hair has been noticed in some patients.
o Sun exposure is discouraged when applying minoxidil.
Children - Not for use in Children. For adult use only.
Not applicable.
Other medicines and MINOXIDIL BAILLEUL 5%, topical solution
Inform your doctor or pharmacist if you are using, have recently used or could use any other medicine.
MINOXIDIL BAILLEUL 5%, topical solution with food and drink
Not applicable.
Pregnancy and breastfeeding - Do not use this is for men only.
This medication is contraindicated in women.
Women should not use this medication due to potential risks, side effects, or lack of efficacy. In the context of Minoxidil 5%, it's likely due to a higher risk of side effects such as unwanted hair growth in areas other than the scalp. It's important to always follow the advice of healthcare professionals when using any medication.
Driving and using machines
Not applicable.
MINOXIDIL BAILLEUL 5%, topical solution contains
o propylene glycol: it may cause skin irritation,
o alcohol: it can cause irritation and dry skin with frequent applications on the skin.
- HOW TO USE MINOXIDIL BAILLEUL 5%, topical solution?
For adults only.
Dosage
Apply twice a day a dose of 1 ml on the scalp, starting from the center of the area to be treated.
This dose should be respected regardless of the extent of the affected area.
The total daily dose should not exceed 2 ml.
Administration method
Topical use.
Spread the product with the fingertips to cover the entire area to be treated. Only apply minoxidil to a healthy scalp. Avoid this application in case of irritation, persistent redness, inflammation, painful sensation of the scalp.
Thoroughly wash your hands after use.
Apply to perfectly dry hair and scalp.
Do not apply the product to another part of the body.
The application method varies depending on the delivery system used with the bottle.
Sprayer: This system is suitable for application on extensive surfaces.
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Remove the cap from the bottle.
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Point the pump towards the center of the surface to be treated, trigger it once and spread the product with the fingertips to cover the entire area to be treated. Repeat the operation 6 times to apply a dose of 1 ml (7 sprays in total).
Avoid inhaling the product.
- Rinse the sprayer and/or applicator and replace the cap on the bottle after each use.
Sprayer equipped with an applicator: This system is suitable for application on small surfaces or under the hair.
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Remove the cap from the bottle.
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Remove the upper element of the pump. Adapt the applicator and press firmly.
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Then proceed as described for the sprayer.
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
Be careful with MINOXIDIL BAILLEUL 5%, topical solution:
Special warnings
Duration of Treatment
A treatment duration of 2 months with 2 applications per day may be necessary before evidence of hair growth stimulation is seen.
The start and degree of response vary from person to person.
Do not stop applying the treatment as there is a risk of reverting to the previous state after a period of 3 or 4 months.
Always use this medication following exactly the instructions in this notice or the directions of your doctor or pharmacist. Check with your doctor or pharmacist.
If you have used more MINOXIDIL BAILLEUL 5%, cutaneous solution than you should
Accidental ingestion can cause effects due to the cardiovascular action of minoxidil: SEEK MEDICAL ATTENTION QUICKLY.
If you forget to use MINOXIDIL BAILLEUL 5%, cutaneous solution
Resume at the usual frequency: 1 application in the morning and 1 application in the evening.
Do not take a double dose to compensate for the dose you forgot to take.
If you stop using MINOXIDIL BAILLEUL 5%, cutaneous solution
Not applicable.
- WHAT ARE THE POSSIBLE SIDE EFFECTS?
Inform 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 in swallowing or breathing. These symptoms could be a sign of a severe allergic reaction (frequency not known, cannot be estimated from the available data).
Like all medications, this medication can cause side effects, but they do not always occur in everyone.
o You may experience local irritation with desquamation (shedding of dead skin cells), itching, erythema (skin redness), dry skin, acne, burning sensation, and hypertrichosis (abnormal hair growth at a distance) or more rarely allergic reactions. Breathing difficulties have also been reported. You should notify your doctor.
o In rare cases, there may be a drop in blood pressure, increased heart rate, palpitations, hair loss, irregular hair, chest pain, hepatitis, or kidney stones: you should immediately stop the treatment and notify your doctor.
o More rarely, other reactions have been described, such as allergies (rhinitis, skin rashes, generalized redness, facial swelling), dizziness, tingling, headaches, weakness, edema (fluid infiltration into tissues), altered taste, ear infection, vision disturbances, eye irritation, neuritis (nerve damage).
However, it should be noted that these effects, especially those that have been reported most rarely, have been reported without it being possible to formally establish that they were caused by the treatment.
o Due to the presence of propylene glycol, there is a risk of eczema (allergic skin reaction).
o Due to the presence of ethanol, frequent applications to the skin can cause skin irritation and dryness.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not listed in this notice. 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.signalement-sante.gouv.fr
By reporting side effects, you are helping to provide more information on the safety of the medication.
- HOW TO STORE MINOXIDIL BAILLEUL 5%, cutaneous solution?
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle.
No special storage conditions.
Flammable product.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
- CONTENT OF THE PACKAGING AND OTHER INFORMATION
What MINOXIDIL BAILLEUL 5%, cutaneous solution contains
· The active substance is:
Minoxidil........................................................................................................... 5 g
Per 100 ml.
· The other components are:
· Propylene glycol, 96% ethanol, purified water.
What MINOXIDIL BAILLEUL 5%, cutaneous solution is and what the outer packaging contains
This medicine comes in the form of a cutaneous solution.
60 ml bottle with a dosing pump. Box of 1 or 3 bottle(s).
Not all pack sizes may be marketed.
Marketing Authorization Holder
LABORATOIRES BAILLEUL S.A.
10-12, AVENUE PASTEUR
L-2310 LUXEMBOURG
LUXEMBOURG
Operator of the marketing authorization
LABORATOIRES BAILLEUL
264 RUE DU FAUBOURG SAINT-HONORE
75008 PARIS
Manufacturer
DELPHARM HUNINGUE SAS
26 RUE DE LA CHAPELLE
68 330 HUNINGUE
OR
LICHTENHELDT GMBH PHARMACEUTICAL FACTORY
INDUSTRIESTR. 7-11
23812 WAHLSTEDT
SCHLESWIG-HOLSTEIN
GERMANY
Medicine Names in the Member States of the European Economic Area
Not applicable.
The last date on which 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 (France) website.
Health Education Advice:
a) What is Androgenetic Alopecia?
Normally, hair has a lifespan of 3 to 6 years, and 50 to 100 hairs fall out per day.
A more significant hair loss can occur seasonally (in the fall) or after childbirth: this loss is normal, temporary, and there is no need to start treatment.
Alopecia is defined by a hair loss of more 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) can be diffuse or patchy (bald patches) and are most often of a known cause (aggressive hair care, poor general condition, unbalanced dieting, certain medications, psychological shock, stress...). These acute alopecias should not be treated with this medicine.
ð Chronic alopecias (long-term) 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 vast majority of cases, these chronic alopecias are of poorly understood origin, often hereditary: this is androgenetic alopecia. Only this type of alopecia can be treated with minoxidil.
b) How to recognize androgenetic alopecia in males?
Androgenetic alopecia begins with a thinning of the temporal hairline.
Then a slight bald spot appears at the top of the scalp.
Androgenetic alopecia begins with a thinning of the temporal hairline.
Then a slight bald spot appears at the top of the scalp.
These two hairless areas will gradually expand: androgenetic alopecia progressively evolves towards baldness.
c) Some Usage Tips
Use a gentle shampoo (preferably without silicone).
If you wash your hair after applying minoxidil, allow a period of 4 hours after the application.
If you apply minoxidil after shampooing, it is recommended to do so on a dry scalp.
You can use a hairdryer, preferably on a warm setting, after applying minoxidil.
You can use mousses, gels, or styling sprays, allowing a minimum of 1 hour between applications.
There is no interaction between your minoxidil treatment and your perms or coloring treatments, but it is preferable to limit them due to their aggressiveness 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 the treatment, over a short period, there may be an increase in hair loss. These hairs were destined to fall and are doing so more quickly. This is a normal phenomenon, continue the treatment.
The first hairs to grow will be soft, fluffy, and barely visible. As you continue your treatment, they may change and thicken.
