NOTICE
ANSM - Updated: 14/04/2017
Name of the drug
ALOPEXY 50 mg / ml, solution for cutaneous application
minoxidil
framed
Read this leaflet carefully before taking this medicine. It contains important information for your treatment.
If you have further questions, if you are not sure, ask your doctor or pharmacist for more information.
· This is an authorized and controlled medicine (see identification number on the outer packaging):
· This medicine can be used for self-medication, that is, used without consultation or prescription from a doctor;
· If symptoms persist, if they worsen or if new symptoms appear, seek the advice of your pharmacist or doctor.
· This leaflet is meant to help you use this medicine. Keep it, you may need to read it again.
· If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
· Do not let this medicine within the reach of children.
What does this booklet contain ?
1. What is ALOPEXY 50 mg / ml solution for skin application and when is it used?
2. What you need to know before using ALOPEXY 50 mg / ml solution for skin application.
3. How to use ALOPEXY 50 mg / ml solution for skin application?
4. What are the possible side effects?
5. How to store ALOPEXY 50 mg / ml solution for skin application?
6. Contents of the package and other information.
1. WHAT ALOPEXY 50 mg / ml solution for skin application AND WHAT IT IS USED FOR
This medicine is indicated for moderate hair loss (androgenetic alopecia) in men.
It is not recommended for women because of the high frequency of hypertrichosis (abnormal development of the hair system) away from the application sites.
2. BEFORE YOU USE ALOPEXY 50 mg / ml solution for skin application.
Never use ALOPEXY 50 mg / ml solution for skin application:
· If you are allergic to the active substance (minoxidil) or any of the other ingredients of ALOPEXY 50 mg / ml,
· If you have had an intolerance when using the solution dosed with 2% minoxidil,
· If you have scalp lesions
Warnings and precautions
Take special care with ALOPEXY 50 mg / ml, solution for skin application:
· If you have, or have had, heart disease, you should consult a doctor before using this medicine for the first time.
· The risk of hypertrichosis (abnormal development of the hair system) justifies that this drug is not recommended in women.
You must not apply this product:
· If you do not have a family history of alopecia, if you have a sudden and / or sluggish hair loss, a hair loss after childbirth, or a hair loss of unknown cause. In these cases, you should consult your doctor before taking ALOPEXY 50 mg / ml as this treatment may not be effective on these types of hair loss.
· If your scalp has redness, is inflamed, infected, irritated or painful. This medicine should only be applied to the healthy scalp (see section "How to use ALOPEXY 50 mg / ml"). In subjects with scalp lesions, an increase in the blood flow of the active substance (minoxidil) is possible (see section "Do not use ALOPEXY 50 mg / ml").
· Do not apply this medicine at the same time as other medicines applied to the scalp.
During treatment
· In case of accidental contact with the eye, a wound, an irritated skin, a mucous membrane, the solution containing alcohol may cause a burning sensation or irritation: rinse thoroughly with cold running water. In case of persistent signs, consult a doctor.
· Do not expose the treated scalp to the sun, protection is necessary (hat).
· Do not swallow. Accidental ingestion may cause effects due to the cardiovascular action of minoxidil. Therefore, the product should be kept out of the sight and reach of children. FAST CONSULT A DOCTOR.
· Do not inhale.
· A change in the color and / or texture of the hair has been observed in some patients.
This treatment requires regular medical monitoring, especially at the beginning of treatment.
You must stop treatment immediately and consult a doctor:
· If you experience a drop in blood pressure, chest pain, or pulse rate
· In case of weakness or dizziness
· In case of sudden and unexplained weight gain, swelling of the hands or feet (edema)
· In case of redness or persistent irritation of the scalp
Children and the elderly
The efficacy and safety of this medication have not been studied in subjects under 18 years of age or over 65 years of age.
Other medicines and ALOPEXY 50 mg / ml solution for cutaneous application
Do not apply this medicine at the same time as other dermatological products, such as anthralin, tretinoin, betamethasone dipropionate, as these products may affect the amount of minoxidil in the blood.
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, tell your doctor or pharmacist.
ALOPEXY 50 mg / ml, solution for cutaneous application with food and drinks
Not applicable.
Pregnancy and breast feeding
The use of this medicine is not recommended in women.
Avoid taking this medicine during pregnancy or breastfeeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Effects are unlikely.
ALOPEXY 50 mg / ml solution for skin application contains propylene glycol and ethanol.
Propylene glycol can induce skin irritation. This medicine contains ethanol and is therefore flammable.
3. HOW TO USE ALOPEXY 50 mg / ml solution for skin application?
Dosage
Always take the dose recommended by your doctor. If in doubt, consult your doctor or pharmacist.
The usual dose is 1 ml to be applied twice daily to the area of the scalp to be treated.
The daily dose should not exceed 2 ml, regardless of the extent of the area to be treated.
Frequency of administration
An application of 1 ml in the morning and 1 ml in the evening.
Do not increase doses or application frequencies.
In all cases, strictly observe the dose.
Duration of treatment
The result is not immediate: stopping hair loss and / or hair growth requires some time after the start of treatment. A treatment lasting 2 months at a rate of 2 applications per day may be necessary before being shown stimulation of hair growth. The delay and the degree of response vary according to the subjects.
In case of discontinuation of treatment, according to some observations, a return to the initial state would appear in 3 to 4 months.
Administration mode
Dermal. External use.
Before and after application of the solution, wash hands thoroughly.
Apply on hair and scalp perfectly dry.
Spread the product with the fingertips so as to cover the entire area to be treated, taking as a starting point the center of the area to be treated.
Do not apply the product to another part of the body.
Application mode
Depending on the delivery system used: dosing pipette or sprayer
Graduated pipette at 1ml
| The pipette can accurately take 1 ml of solution to be distributed over the entire area to be treated, taking as a starting point the center of the area to be treated. |
Dosing pump with applicator
This system is suitable for application on small areas or under the hair.
| 1. Snap the cannula into the pump: hold the pump body firmly by pressing the push part of the cannula |
| 2. Unscrew and remove the cap of the vial: it must remain on the vial only the tamper evidence |
| 3. Insert the cannulated sprayer into the vial and screw it firmly into place |
| 4. Prime the pump: the dispensing system is ready for use |
| 5. For the application: direct the sprayer towards the center of the surface to be treated or under the hair, press once and spread the product with the fingertips. 6 sprays are needed to apply a 1 ml dose. |
Rinse the cannula with hot water after each use.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist for more information.
If you have used more ALOPEXY 50 mg / ml solution for skin application than you should have:
Overdose is unlikely if used according to recommendations. If applied to an injured scalp, absorption of the active substance may be increased and undesirable effects may occur (see section 2 BEFORE YOU USE ALOPEXY 50 mg / ml solution for cutaneous application)
If you forget to use ALOPEXY 50 mg / ml, solution for skin application:
Do not apply a double dose to make up for the dose you forgot to apply.
Resume at the usual frequency: 1 application in the morning and 1 application in the evening.
If you stop using ALOPEXY 50 mg / ml solution for skin application:
Not applicable.
4. WHAT ARE THE POSSIBLE SIDE EFFECTS?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately if you notice any of the following symptoms, as you may require emergency medical treatment.
· 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).
Very common: may affect more than 1 in 10 people
Hypertrichosis (excessive hair growth) away from the application site, especially if the product is used in women.
Headache.
Frequent: may affect up to 1 in 10 people
Local skin reactions at the site of application of the product: local irritation with desquamation (removal of dead skin cells), itching, redness of the skin, dermatitis, dryness of the skin, allergic reaction of the skin due to the presence of propylene glycol, inflammatory reaction of the skin, rashes on the skin that may resemble acne, muscle and joint pain, peripheral edema (infiltration of fluid into the tissues), difficulty breathing and depression.
Frequency not known (can not be estimated from the available data)
Ear infections, otitis externa, rhinitis, hypersensitivity, neuritis, tingling, taste disturbance, burning sensation, blurred vision, eye irritation, dizziness, low blood pressure, pulse rate, chest pain, weakness, swelling of the face (fluid infiltration into the tissues), irritation, redness, hair loss and irregular hair, change in hair color or texture, hepatitis, and kidney stones.
In all these cases, you should stop your treatment and quickly tell your doctor.
Reporting of side effects
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. 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 ALOPEXY 50 mg / ml solution for skin 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. The expiry date refers to the last day of this month.
Flammable product.
The solution must be used 1 month maximum after first opening.
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 ALOPEXY contains 50 mg / ml solution for skin application
· The active substance is:
Minoxidil ................................................. .................................................. ........................ 50 mg
for 1 ml
· The other ingredients are: Propylene glycol, 96% ethanol, purified water.
What is ALOPEXY 50 mg / ml, skin application solution and contents of the pack
This medicine is in the form of a solution for cutaneous application.
Bottle of 60 ml with graduated pipette to 1 ml. Box of 1 or 3 bottle (s).
Bottle of 60 ml with graduated pipette to 1 ml and metering pump with applicator. Box of 1 or 3 bottle (s).
Not all presentations may be marketed.
Marketing Authorization Holder
DUCRAY DERMATOLOGICAL LABORATORIES
45 place abel gance
92100 boulogne
Operator of the marketing authorization
stone fabre dermatology
45 place abel gance
92100 - boulogne - france
Maker
PIERRE FABRE MEDICAMENT PRODUCTION
SIMAPHAC website
Industrial Zone of Chateaurenard
45220 Chateaurenard, France
Or
PIERRE FABRE MEDICAMENT PRODUCTION
PROGIPHARM website
High School Street
45500 Gien, France
Names of the drug in the member states of the European Economic Area
This medicine is authorized in the member states of the European Economic Area under the following names: In accordance with the regulations in force.
· Austria, Belgium, France, Germany, Greece, Luxembourg, Poland, Romania, Spain: | Alopexy |
· Italy: | TREFOSTIL |
· Portugal: | ALOREXYL |
The last date this leaflet was revised is:
to be completed later by the holder
Other
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:
· Acute alopecia,
· Chronic alopecia.
Acute alopecia (sudden hair loss over a short period of time) can be diffuse or in 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 the 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 | In humans |
| |
Androgenetic alopecia is diffuse: there is an overall decrease in capillary density. The hair gradually clears from the line. | Androgenetic alopecia begins with a thinning of the temporal gulfs. Then a slight tonsure appears at the top of the skull. These two areas lacking 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 the 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.