NOTICE
ANSM - Last updated: 27/06/2017
Name of the medicinal product
MINOXIDIL COOPER 5%, solution for skin application
minoxidil
framed
Please read this leaflet carefully before you start using this medicine because it contains important information for you.
You should always use this medication exactly as prescribed in this leaflet or by your doctor or pharmacist.
· Keep this leaflet. You might need to read it again.
· Ask your pharmacist for advice or information.
· If you experience any of the 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 talk to your doctor if you do not feel better or feel less well.
What is in this leaflet?
1. What is MINOXIDIL COOPER 5%, solution for dermal application and in which cases it is used?
2. What should I know before using MINOXIDIL COOPER 5% solution for skin application?
3. How to use MINOXIDIL COOPER 5%, solution for skin application?
4. What are the possible side effects?
5. How to store MINOXIDIL COOPER 5%, solution for skin application?
6. Package contents and other information.
1. WHAT IS MINOXIDIL COOPER 5%, solution for dermal application AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: OTHER DERMATOLOGICAL PREPARATION - ATC code: D11AX01 .
This medication is indicated in the case of moderate hair loss (androgenetic alopecia) in the adult male subject.
2. BEFORE YOU USE MINOXIDIL COOPER 5%, solution for skin application?
Do not use MINOXIDIL COOPER 5%, solution for skin application:
· allergy known to minoxidil or to any of the constituents of the product,
· intolerance to form at 2%
· subjects under the age of 18 or over 65,
· lesions of the scalp,
· any alopecia (hair loss) of the woman
IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
Warnings and Precautions
Special warnings
In case of even old heart disease, it is necessary to consult a doctor before the first use of minoxidil.
In subjects with lesions of the scalp, an increase in the passage of the active substance into the blood is possible (see MINOXIDIL COOPER 5% solution for skin application).
In some rare cases or in case of non-compliance with the recommended dosage and / or mode of administration, the passage into the general circulation of minoxidil could be increased and lead to undesirable effects such as chest pain, lowered blood pressure, tachycardia (increased heart rate), dizziness or feeling dizzy, sudden and unexplained weight gain, swelling of the hands and feet.
If symptoms occur, stop treatment and see your doctor.
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,
· apply minoxidil only to a healthy scalp. Avoid this application in case of irritation, persistent redness, inflammation, painful sensation of the scalp,
· do not use minoxidil together with retinoic acid or anthralin (medicines sometimes used in dermatology) or any other irritating dermatology medicines.
Do not apply minoxidil:
· in the event of sudden hair loss, hair loss due to illness or medication, DO NOT USE THIS MEDICINE AND TAKE ADVICE OF YOUR DOCTOR. Indeed, minoxidil would not be effective on this type of hair loss (see Tips / Health Education).
· on another part of the body.
Precautions for use
· DO NOT SWALLOW
· DO NOT INHALE
· In case of accidental contact with the eye, a wound, a mucous membrane. Rinse thoroughly with running water.
· A change in the color and / or texture of the hair has been observed in some patients.
· Do not expose the treated scalp to the sun: protection is necessary (hat).
· Tell your doctor if you have heart problems.
This medicine contains propylene glycol and may cause skin irritation.
IN CASE OF DOUBT DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST
children
Not applicable.
Other drugs and MINOXIDIL COOPER 5%, solution for skin application
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
MINOXIDIL COOPER 5%, solution for skin application with food and beverages
Not applicable.
Pregnancy and breast feeding
This medication is contraindicated in women.
If you are pregnant or breastfeeding, think you may be pregnant or plan a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Not applicable.
MINOXIDIL COOPER 5%, solution for skin application contains propylene glycol.
3. HOW TO USE MINOXIDIL COOPER 5%, solution for skin application?
RESERVED FOR ADULTS.
Dosage
Apply a dose of 1 ml to the scalp twice a day, taking as the starting point the center of the area to be treated.
This dose must be observed regardless of the extent of the area concerned.
The total daily dose should not exceed 2 ml.
Wash hands thoroughly before and after application of the solution.
Do not apply to any part of the body.
Administration mode
Dermal.
Apply only when the hair and scalp are perfectly dry.
The method of application varies according to the delivery system used with the bottle:
Sprayer : This system is suitable for application on extended surfaces.
1. Remove the cover from the bottle
2. Guide the pump to the center of the surface to be treated, operate it once and extend the product with your fingertips to cover the entire area to be treated. Repeat the procedure 6 times to apply a 1 ml dose (a total of 7 sprays).
Avoid inhaling the product.
3. Replace the cover on the bottle after use.
Sprayer with an applicator : This system is suitable for application on small surfaces or under the hair.
1. Remove the cover from the bottle.
2. Remove the top of the pump. Fit the applicator and press firmly.
3. Guide the pump to the center of the surface to be treated, press it once and spread the product with your fingertips to cover the entire area to be treated. Repeat the procedure 6 times to apply a 1 ml dose (7 sprays in total).
Avoid inhaling the product.
4. Lower the applicator tip. Replace the cover on the bottle after use.
Frequency of Administration
1 application twice a day, morning and evening.
Duration of the treatment
A treatment lasting 2 months at the rate of 2 applications per day may be necessary before a stimulation of the growth of the hair is demonstrated.
The beginning and the degree of the response vary according to the subjects. According to some observations, a return to the initial state would appear in 3 to 4 months in the event of discontinuation of treatment.
If you have used more than MINOXIDIL COOPER 5%, a dermal application solution you should not have
Not applicable.
If you forget to use MINOXIDIL COOPER 5%, solution for skin application
Not applicable.
If you stop using MINOXIDIL COOPER 5%, solution for skin application
Not applicable.
4. WHAT ARE POSSIBLE SIDE EFFECTS?
Tell your doctor immediately if you notice any of the following symptoms, as you may need emergency medical treatment.
· Swelling of the face, lips or throat resulting in difficulty swallowing or breathing. These symptoms could be a sign of a severe allergic reaction (indeterminate frequency, impossible to estimate from the available data).
Like all medicines, MINOXIDIL 5%, solution for skin application is likely to have undesirable effects, although not everyone is subject to it:
· It is possible that local irritation with scaling, (elimination of dead skin cells), itching, erythema (redness of the skin), dry skin, burning sensation and hypertrichosis (abnormal development of the hair system at a distance) or more rarely allergic reactions. Tell your doctor.
· In some rare cases, there may be a decrease in blood pressure, an acceleration of the pulse, hair loss, irregular hair, chest pain, hepatitis or kidney stones: you should stop treatment immediately and notify your doctor. doctor.
· More rarely, allergic (rhinitis, rash, generalized redness, swelling of the face), vertigo, tingling, headache, weakness, edema (fluid infiltration in the tissues), alteration taste, ear infection, vision disorders, eye irritation, neuritis (nerve damage).
· It should be noted, however, that these effects, especially those which have been most rarely reported, have been without it being formally established that they were caused by the treatment.
· Due to the presence of propylene glycol, risk of eczema.
· Due to the presence of ethanol, frequent applications on the skin can cause irritation and dryness of the skin.
Declaration of side effects
If you experience any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and network of Regional Centers of Pharmacovigilance - Website: www.ansm.sante.fr
By reporting adverse reactions, you are helping to provide more information about the safety of the drug.
5. HOW TO STORE MINOXIDIL COOPER 5%, solution for skin application?
Keep this medicine out of the reach and sight of children.
Do not use MINOXIDIL COOPER 5%, solution for skin application after the expiry date stated on the bottle.
Store at a temperature not exceeding 25 ° C.
Flammable product.
Keep the bottle tightly closed.
Do not throw any medicines into drains or rubbish. Ask your pharmacist to remove any medications you are no longer using. These measures will help protect the environment.
6. PACKAGE CONTENTS AND OTHER INFORMATION
What MINOXIDIL COOPER contains 5%, solution for skin application
· The active substance is:
Minoxidil ................................................. .................................................. .......................... 5 g
For 100 ml of solution.
· The other components are: propylene glycol, 96 percent ethanol, purified water.
What is MINOXIDIL COOPER 5%, solution for skin application and contents of the pack
This medication is in the form of a solution for dermal application in a vial.
Box of 1 or 3 bottles with dosing pump.
Not all pack sizes may be marketed.
Marketing Authorization Holder
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
LA FRANCE
Marketing Authorization Operator
FRENCH PHARMACEUTICAL COOPERATION
PLACE LUCIEN AUVERT
77020 MELUN CEDEX
LA FRANCE
Maker
FARMACLAIR
440 AVENUE OF THE GENERAL DE GAULLE
14200 HEROUVILLE SAINT CLAIR
LA FRANCE
Names of the medicinal product in the Member States of the European Economic Area
Not applicable.
The last date on which this leaflet was revised is:
31 May 2013
Other
Detailed information on this medicine is available on the ANSM website (France).
Health Education Advice
a / What is an androgenetic alopecia?
Normally the hair has a lifetime of 3 to 6 years and it drops 50 to 100 hair per day.
A greater fall in hair may occur seasonally (in the fall) or after delivery: this 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.
Acute alopecia (sudden hair loss over a short period of time) may be diffuse or patchy (alopecia areata) and are most often of known cause (aggressive hair care, poor general condition, poorly balanced weight loss, psychic, stress ...).
These acute alopecia should not be treated with this medication.
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 drug.
In the vast majority, these chronic alopecia are of poorly known origin, usually of hereditary nature: it is androgenetic alopecia. Only this type of alopecia can be treated with minoxidil.
b / How to recognize androgenetic alopecia in male adult subjects?
Androgenetic alopecia begins with a dislocation of the temporal gulfs. Then a slight tonsure appears at the top of the skull. These two hairless areas will gradually increase: the androgenetic alopecia is gradually evolving towards baldness.
c / Some tips for use
Use a slightly aggressive shampoo (preferably without silicone).
If you do your shampoo after the application of minoxidil, respect a period of 4 hours after this.
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 warm position.
You can use styling foams, gels or sprays within 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 expose yourself to the sun after applying minoxidil, it is recommended to cover your hair.
d / Some additional information
At the beginning of treatment, over a short period, it is possible that an increase in hair loss occurs. These hair were destined to fall and do it more quickly. This is a normal phenomenon, continue treatment.
The first hair that grows will be soft, fluffy and not very visible. As you continue your treatment, they can change and thicken.