Minoxidil Bailleul sol ext 2% Bottles 3x60ml

In this manual :

1. WHAT IS MINOXIDIL BAILLEUL 2%, solution for cutaneous application AND WHAT IS IT USED FOR?

2. WHAT YOU SHOULD KNOW BEFORE USING MINOXIDIL BAILLEUL 2%, solution for cutaneous application

3. HOW TO USE MINOXIDIL BAILLEUL 2%, solution for cutaneous application?

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

5. HOW TO USE MINOXIDIL BAILLEUL 2%, solution for cutaneous application?

6. ADDITIONAL INFORMATION

1. WHAT IS MINOXIDIL BAILLEUL 2%, solution for cutaneous application AND WHAT IS IT USED FOR?

Not applicable.

This medicine is indicated in the case of moderate hair loss (androgenetic alopecia) in adult men and women. It promotes hair growth and stabilises hair loss.

2. WHAT YOU SHOULD KNOW BEFORE USING MINOXIDIL BAILLEUL 2%, solution for cutaneous application

Not applicable.

Never use MINOXIDIL BAILLEUL 2%, solution for cutaneous application if you are allergic to minoxidil or to any of the other components of the solution (see composition).

Be careful with MINOXIDIL BAILLEUL 2%, solution for cutaneous application:

Do not apply minoxidil:

- in the event of sudden hair loss, hair loss due to illness or medical treatment, DO NOT USE THIS MEDICATION AND TAKE THE ADVICE OF YOUR DOCTOR. Indeed, minoxidil would not be effective on this type of hair loss (see Advice/Health Education).

- on any other part of the body.

Stop treatment and consult your doctor if redness or irritation of the scalp persists.

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. Avoid this application in case of irritation, persistent redness, inflammation, painful sensation of the scalp,

- do not apply minoxidil at the same time as retinoic acid or anthralin (drugs sometimes used in dermatology) or any other irritating dermatological drug.

If the recommended dosage and/or method of administration is not followed, the systemic circulation of minoxidil may be increased, resulting in adverse effects such as chest pain, decreased blood pressure, tachycardia (increased heart rate), dizziness or lightheadedness, sudden unexplained weight gain, and swelling of the hands and feet.

If any of these symptoms occur: stop the treatment and consult your doctor.

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, a 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).

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.

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Not applicable.

Pregnancy and breastfeeding

It is best not to use minoxidil during pregnancy.

Similarly, the use of minoxidil while breast-feeding should be avoided.

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Not applicable.

List of excipients with a notable effect: propylene glycol, alcohol.

3. HOW TO USE MINOXIDIL BAILLEUL 2%, solution for cutaneous application

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.

Spread the product with the fingertips so as to cover the entire area to be treated (see Application Instructions).

Before and after applying the solution, wash hands thoroughly.

Apply to perfectly dry hair and scalp.

Dermal use. External use.

MODE OF APPLICATION

Depending on the delivery system used with the bottle:

Sprayer: This system is suitable for application to large areas.

1. Remove the cap from the vial.

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.

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 top part of the pump. Fit the applicator and press firmly.

3. Then proceed as described for the sprayer.

One application of 1 ml in the morning and 1 ml in the evening.

Do not increase the dose or frequency of application.

The onset and degree of response to treatment varies from person to person.

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).

If you have used more MINOXIDIL BAILLEUL 2%, solution for cutaneous application than you should have:

Accidental ingestion may cause effects due to the cardiovascular action of minoxidil: SEEK MEDICAL ATTENTION.

If you forget to use MINOXIDIL BAILLEUL 2%, 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 use.

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, MINOXIDIL BAILLEUL 2%, solution for cutaneous application is likely to have undesirable effects, although not everyone is subject to them.

- Due to the presence of alcohol, frequent application to the skin may cause irritation and dryness of the skin.

- Due to the presence of propylene glycol, risk of eczema (allergic skin reactions),

- Local irritation with scaling, itching, redness of the skin, dry skin, hypertrichosis (abnormal development of the hair system at a distance from the application site), burning sensation may occur;

- More rarely, allergic reactions (rhinitis, localized or generalized skin rashes, generalized redness, swelling of the face), dizziness, tingling, headache, weakness, edema, alteration of taste, ear infection, visual disturbances, eye irritation, neuritis (inflammation of a nerve).

- In a few rare cases, a drop in blood pressure, an increase in pulse rate, hair loss, particularly at the beginning of treatment, chest pain and changes in liver function have occurred.

In all these cases, you should stop your treatment and inform your doctor.

If you notice any side effects not mentioned in this leaflet, or if any side effects become serious, please inform your doctor or pharmacist.

5. HOW TO USE MINOXIDIL BAILLEUL 2%, solution for cutaneous application

Keep out of the reach and sight of children.

Do not use MINOXIDIL BAILLEUL 2%, solution for cutaneous application after the expiry date shown on the bottle.

No special storage precautions.

Flammable product.

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

What does MINOXIDIL BAILLEUL 2%, solution for cutaneous application, contain?

The active substance is:

Minoxidil ................................................................................................................................................ 2 g

For 100 ml.

The other ingredients are:

Propylene glycol, 96% ethanol, purified water.

What is MINOXIDIL BAILLEUL 2%, solution for cutaneous application and contents of the pack?

This medicinal product is presented as a solution for cutaneous application.

60 ml bottle with metering pump.

Holder

LABORATOIRES BAILLEUL-BIORGA

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

Not applicable.

The last date on which this package insert was approved was {date}.

Not applicable.

Detailed information on this medicinal product is available on the Afssaps website (France).

Not applicable.

HEALTH ADVICE/EDUCATION

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 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 and is sometimes due to a specific disease (thyroid, metabolic...) and should not be treated with this medication. The vast majority of these chronic alopecias are of unknown origin, most often hereditary: 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 may increase. This hair was intended to fall out and is falling out more quickly. This is a normal phenomenon, continue the treatment.

The first hair to grow will be soft, fluffy and not very visible. Over time, as you continue your treatment, they may change and thicken.