NOTICE
ANSM - Updated: 23/11/2020
Name of the drug
MINOXIDIL COOPER 2%, solution for skin application in a vial
Minoxidil
Framed
Read all of this leaflet carefully before using this medicine because it contains important information for you.
You should always use this medicine by scrupulously following the information given in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Contact your pharmacist for any advice or information.
· If you get any side effects talk to your doctor or pharmacist. This also applies to any side effects that are not mentioned in this leaflet. See section 4.
· You should contact your doctor if you do not feel any improvement or if you feel less well.
What does this booklet contain ?
1. What is MINOXIDIL COOPER 2%, solution for skin application in a vial and in which cases is it used?
2. What information should be known before using MINOXIDIL COOPER 2%, solution for skin application in a vial?
3. How to use MINOXIDIL COOPER 2%, solution for skin application in a vial?
4. What are the possible side effects?
5. How to store MINOXIDIL COOPER 2%, solution for skin application in a vial?
6. Contents of the pack and other information.
1. WHAT IS MINOXIDIL COOPER 2%, solution for skin application in a vial AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group: MINOXIDIL FOR TOPICAL USE (D: Dermatology) - ATC code: D11AX01.
This medication is indicated in cases of moderate hair loss (androgenetic alopecia) in adults, men or women. It promotes hair growth and stabilizes the phenomenon of hair loss.
2. WHAT YOU NEED TO KNOW BEFORE USING MINOXIDIL COOPER 2%, solution for skin application in a vial?
Never use MINOXIDIL COOPER 2%, solution for skin application in a vial:
· If you are allergic (hypersensitive) 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 COOPER 2%, solution for skin application in a vial.
Do not swallow. Do not inhale.
In case of even old heart diseases, it is necessary to consult a doctor before the first use of minoxidil.
Do not apply minoxidil:
· In case of sudden hair loss, hair loss due to illness or drug 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 section "health education advice");
· On another part of the body.
Stop treatment and see your doctor if you experience redness or persistent irritation of the scalp.
It is important to respect the recommended dosage and mode of administration:
· Do not increase the dose per application, do not increase the frequency of applications,
· Only apply minoxidil 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 irritant dermatology drug.
In the event of non-compliance with the recommended dosage and / or mode of administration, the passage of minoxidil into the general circulation could be increased and lead to undesirable effects such as chest pain, drop in blood pressure, tachycardia (acceleration of heart rate), dizziness or lightheadedness, sudden and unexplained weight gain, swelling of the hands and feet.
If these symptoms appear: stop the treatment and consult your doctor.
Use this medication only with caution.
In case of accidental contact with the eye, a wound, a mucous membrane, the solution (containing ethanol) may cause a burning sensation and irritation: rinse thoroughly with running water.
Do not use this medication near an open flame, a lighted cigarette, or certain devices (eg, hair dryers).
Avoid inhaling the product.
Do not expose the treated scalp to the sun: protection is necessary (hat).
Children
Not applicable.
Other medicines and MINOXIDIL COOPER 2%, solution for skin application in a vial
Tell your doctor or pharmacist if you are using, have recently used or might take any other medicines.
MINOXIDIL COOPER 2%, solution for skin application in a vial with food, drink and alcohol
Not applicable.
Pregnancy and breast feeding
It is best not to use minoxidil during pregnancy and breastfeeding.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
MINOXIDIL COOPER 2%, solution for skin application in a vial contains propylene glycol and ethanol.
This medicine contains 0.2 ml of propylene glycol per dose and may cause skin irritation.
This medicinal product contains 521 mg of ethanol per dose equivalent to 521 mg / ml (52.1% (w / v)). It can cause a burning sensation on damaged skin.
3. HOW TO USE MINOXIDIL COOPER 2%, solution for skin application in a vial?
Reserved for adults.
Dosage
Apply a dose of 1 ml twice a day to the scalp, starting from the center of the area to be treated.
The daily dose should not exceed 2 ml, regardless of the size of the area to be treated.
Spread the product with your fingertips so as to cover the entire area to be treated.
Before and after applying the solution, wash your hands thoroughly.
Apply to perfectly dry hair and scalp.
Method and route of administration
Dermal. External use.
Using the dosing pump :
Remove the black cap from the bottle and unscrew the cap that closes it.
Adapt, by screwing, the dosing pump to the bottle, then apply the product as follows: at each application, bring the end of the nozzle into contact with the scalp, squeeze once and spread the product with the tip of the fingers.
Repeat the operation 6 times to apply a dose of 1 ml (ie 7 sprays in total), by moving the nozzle over the area to be treated, as the pressure is applied, starting from the center.
Important note: avoid leaving the dosing system on the bottle, the constant immersion of the tubing in the solution is detrimental to its conservation, which under these conditions cannot exceed 1 month.
After use, remove the dosing system, rinse it and recap the bottle with the cap provided for this purpose.
Frequency of administration
One application of 1 ml in the morning and 1 ml in the evening. Do not increase the doses or the frequency of application.
Duration of the treatment
The onset and degree of response to treatment vary depending on the subject.
The result is not immediate: stopping hair loss and / or hair growth may not appear until some time after the start of treatment (about 3 or 4 months).
Always use this medicine exactly as described in this leaflet or as told by your doctor or pharmacist. Check with your doctor or pharmacist if in doubt.
If you used more MINOXIDIL COOPER 2%, solution for skin application in a vial than you should
Accidental ingestion may cause effects due to the cardiovascular action of minoxidil.
See a doctor quickly.
If you forget to use MINOXIDIL COOPER 2%, solution for skin application in a vial
Do not take a double dose to make up for the dose you forgot to take.
Resume at the usual frequency: 1 application in the morning and 1 application in the evening.
If you stop using MINOXIDIL COOPER 2%, solution for skin application in a vial
Not applicable.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist for more information.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Tell 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 serious allergic reaction (frequency not known, cannot be estimated from the available data).
Like all medicines, this medicine can cause side effects, although not everybody gets them.
· Possibility of local irritation with scaling, itching, redness of the skin, dry skin (especially due to the presence of alcohol), hypertrichosis (abnormal development of the hair system away from the point of application), burning sensation ;
· More rarely, occurrence of allergic reactions (rhinitis, localized or generalized rashes, generalized redness, swelling of the face), dizziness, tingling, headache, weakness, edema, taste alteration, ear infection, blurred vision, eye irritation, neuritis (inflammation of a nerve);
· In a few rare cases, there has been a drop in blood pressure, an acceleration of the pulse, hair loss especially at the start of treatment, chest pain, a change in liver function, kidney stones;
· Due to the presence of propylene glycol, risk of eczema.
In all these cases you should 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 that are 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.signalement-sante.gouv.fr
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE MINOXIDIL COOPER 2%, solution for skin application in a vial?
Keep this medication out of the sight and reach of children.
Store at a temperature not exceeding 25 ° C.
Flammable product.
Do not use this medicine after the expiry date which is stated on the pack.
Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION
What MINOXIDIL COOPER 2% contains, solution for skin application in a vial
· The active substance is:
Minoxidil ................................................. .................................................. ......................... 2.0 g
For 100 ml of solution for skin application.
A dose of 1 ml contains 20 mg of minoxidil or 7 sprays.
· The other ingredients are: 96% ethanol, purified water, propylene glycol
What is MINOXIDIL COOPER 2%, solution for skin application in a vial and contents of the outer packaging
This medication is in the form of a solution for skin application in a vial in a box of 1 or 3 vial (s).
Not all presentations may be marketed.
Marketing authorization holder
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Marketing authorization operator
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
Maker
FARMACLAIR
440 AVENUE DU GENERAL DE GAULLE
14200 HEROUVILLE SAINT CLAIR
Names of the drug 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]
Other
Detailed information on this medication 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 50 to 100 hairs per day fall out.
More significant hair loss can occur seasonally (in the fall) or after childbirth: this loss is normal, transient and there is no need to start treatment. Alopecia is defined by hair loss greater than 100 hairs per day.
There are two types of alopecia:
· acute alopecia,
· chronic alopecia.
Acute alopecia (sudden hair loss over a short period) can be diffuse or in patches (alopecia areata) and are most often of known cause (aggressive hair care, poor general condition, poorly balanced weight loss, certain medications, shock psychic, stress ...).
These acute alopecia should not be treated with this medicine.
Chronic (long-term) alopecia is almost always diffuse.
They are sometimes due to a specific disease (thyroid, metabolic ...) and they should not be treated with this medication. In the great majority, these chronic alopecias are of poorly understood origin, most often of a hereditary nature : it is androgenetic alopecia. Only this type of alopecia can be treated with minoxidil.
b / How to recognize androgenetic alopecia?
In women: androgenetic alopecia is diffuse: there is an overall decrease in hair density. The hair gradually lightens from the parting.
In humans: androgenetic alopecia begins with baldness of the temporal gulfs. Then a slight tonsure appears at the top of the head. These two areas devoid of hair will gradually enlarge: androgenetic alopecia gradually evolves into baldness.
c / Some advice for use
· Use a mild shampoo (preferably without silicone).
If you shampoo after applying minoxidil, respect a period of 4 hours after this one. If you are applying 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 mousse, gels or sprays with a minimum delay of 1 hour between applications.
· There is no interaction between your treatment with minoxidil and your perms or coloring treatments, but it is preferable to limit them because of their aggressiveness on the hair.
· If you plan to be in the sun after applying minoxidil, it is recommended that you cover your hair.
d / Some additional information
· At the start of treatment, over a short period of time, an increase in hair loss may occur. This hair was meant to fall out and does it faster. This is normal, please continue treatment.
· The first hair that grows will be soft, fluffy and not very visible. As you continue with your treatment, they may change and thicken.