NOTICE
ANSM - Updated: 13/02/2017
Name of the drug
ALOPEXY 2%, solution for cutaneous application
minoxidil
framed
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
This is an authorized and controlled medicine (see identification number on the outer packaging):
· This medicine can be used for self-medication, that is to say 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.
Do not let this medicine within the reach of children.
What does this booklet contain ?
1. What is ALOPEXY 2% solution for skin application and when is it used?
2. What is the information you need to know before using ALOPEXY 2%, skin application solution?
3. How to use ALOPEXY 2%, solution for cutaneous application?
4. What are the possible side effects?
5. How to store ALOPEXY 2%, solution for cutaneous application?
6. Contents of the package and other information.
1. WHAT ALOPEXY 2% dermal solution is AND WHAT IT IS USED FOR
This medicine is in the form of a solution for cutaneous application. It is indicated in case of moderate hair loss (androgenetic alopecia) of the adult, male or female. It promotes hair growth and stabilizes the phenomenon of falling.
2. BEFORE YOU USE ALOPEXY 2% solution for skin application?
Never use ALOPEXY 2%, solution for skin application:
· If you are allergic to MINOXIDIL or any of the other ingredients of this medicine given in section 6.
Warnings and precautions
Talk to your doctor or pharmacist before using ALOPEXY 2% Cutaneous Solution .
Warnings :
In case of even old heart diseases, it is necessary to consult a doctor before the first use of minoxidil.
You must not apply this medicine:
· 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 this medicine 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 2%"). In subjects with scalp lesions, an increase in the blood flow of the active substance (minoxidil) is possible (see section "Do not use ALOPEXY 2%").
· Do not apply this medicine at the same time as other medicines applied to the scalp.
· On another part of the body.
You must stop the treatment immediately and consult your 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.
It is important to respect the recommended dosage and method of administration:
· do not increase the dose per application, do not increase the frequency of applications,
· do not apply minoxidil together with retinoic acid or anthralin (drugs sometimes used in dermatology) or any other irritating dermatology medication.
In case of non-compliance with the recommended dosage and / or method of administration, the passage into the general circulation of minoxidil could be increased and cause undesirable effects such as chest pain, lowering of blood pressure, tachycardia (acceleration of rhythm cardiac), dizziness or feeling dizzy, sudden and unexplained weight gain, swelling of the hands and feet.
If these symptoms occur: stop treatment and consult your doctor.
DO NOT LEAVE THIS MEDICINE WITHIN THE REACH OF CHILDREN.
DO NOT SWALLOW.
DO NOT INHALE.
Precautions for use
· 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 cold running water.
· Do not expose the sun-treated scalp: protection is needed (hat).
children
Not applicable.
Other medicines and ALOPEXY 2%, solution for cutaneous application
Do not apply this medicine at the same time as other products intended to be applied to the scalp, such as tretinoin, anthralin, betamethasone dipropionate, as these products may affect the amount of minoxidil passing through the skin. blood.
If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, tell your doctor or pharmacist.
Pregnancy and breast feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
It is best not to use minoxidil during pregnancy.
feeding
Similarly, the use of minoxidil when breastfeeding should be avoided.
Sport
Not applicable.
Driving and using machines
Effects on the ability to drive or use machines are unlikely when the medication is used according to the instructions.
ALOPEXY 2% solution for cutaneous application contains propylene glycol.
This excipient can induce irritation of the skin.
3. HOW TO USE ALOPEXY 2% solution for skin application?
Use this medicine only in adults . |
Dosage
Apply 2 times daily a dose of 1 ml on the scalp starting from the center of the area to be treated.
The daily dose should not exceed 2 ml, regardless of the extent of the area to be treated.
Spread the product with the fingertips to cover the entire area to be treated.
Before and after application of the solution, wash hands thoroughly.
Apply on hair and scalp perfectly dry.
Dermal.
External use.
Application mode
Depending on the delivery system used with the vial:
Graduated pipette 1 ml
| The pipette allows to accurately collect 1 ml of solution to be distributed over the entire 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. |
The onset and degree of response to treatment varies by subject.
The result is not immediate: the stop of hair loss and / or the growth of the hair can appear only some time after the beginning of the treatment (about 3 or 4 months).
Accidental ingestion may cause effects due to the cardiovascular action of minoxidil.
FAST CONSULT A DOCTOR.
If you have used more ALOPEXY 2% skin solution than you should have:
Signs of overdose may include hypotension and increased heart rate. If you have used ALOPEXY 2%, skin application solution, skin application solution more than necessary, or if you / your child has accidentally ingested, contact your poison control center or doctor immediately.
If you forget to use ALOPEXY 2%, solution for skin application:
Do not increase the doses.
Resume at the usual frequency: 1 application in the morning and 1 application in the evening.
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).
The most frequently observed reactions are minor skin reactions.
Frequent skin applications can cause irritation and dryness of the skin due to the presence of ethanol.
Very common (may occur in more than 1 in 10 people)
Headache.
Frequent (may occur in more than 1 in 100 people)
Local skin reactions at the site of application of the product: local irritation, desquamation (removal of dead skin cells), itching, redness of the skin, dermatitis, dryness of the skin, pain.
Allergic reaction of the skin due to the presence of propylene glycol, inflammatory reaction of the skin, rashes on the skin that may look like acne, hypertrichosis (excessive pushing of the hair) away from the application site, muscle pain and joints, 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 (nerve involvement), tingling, taste disturbance, burning sensation, dizziness, impaired vision, eye irritation, low blood pressure, increased blood pressure pulse, palpitations, chest pain, swelling of the face (fluid infiltration into the tissues), generalized irritation and redness, hair loss and irregular hair, change in hair color or texture, fatigue, hepatitis.
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 2%, solution for cutaneous 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 outer carton after EXP. The expiry date refers to the last day of this month.
No special storage conditions.
The solution must be used 1 month maximum after first opening.
Do not dispose of any medication in the sewage system or in 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 2% contains, solution for cutaneous application
· The active substance is:
Minoxidil ................................................. .................................................. ................................ 2 g
For 100 ml of solution for cutaneous application.
· The other ingredients are: g-cyclodextrin, ethanol 96 percent, propylene glycol, purified water.
What ALOPEXY 2%, 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 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
LA FRANCE
Operator of the marketing authorization
PIERRE FABRE DERMATOLOGY
45, PLACE ABEL GANCE
92100 BOULOGNE
LA FRANCE
Maker
PIERRE FABRE MEDICAMENT PRODUCTION - CHATEAURENARD
SIMAPHAC SITE
INDUSTRIAL ZONE OF CHATEAURENARD
45 220 CHATEAURENARD
LA FRANCE
Or
PIERRE FABRE MEDICAMENT - GIEN
PROGIPHARM SITE
RUE DU LYCEE
45 500 GIEN
LA FRANCE
Names of the drug in the member states of the European Economic Area
Not applicable.
The last date this leaflet was revised is:
[to be completed later by the holder]
{MM / YYYY}> <{YYYY month}
Other
HEALTH EDUCATION ADVICE
A / 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 (pelt) and are most often of known cause (aggressive hair care, poor general condition, poorly balanced weight loss, certain drugs, shocks 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 a 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.
B / How to recognize androgenetic alopecia?
In the woman Androgenetic alopecia is diffuse: there is an overall decrease in capillary density. The hair gradually clears from the line. | In humans Androgenetic alopecia begins with a thinning of the temporal gulfs. Then a slight tonsure appears at the top of the skull. These two areas without hair will gradually grow: alopecia gradually evolves to baldness |
C / Some tips for use
· Use a mild shampoo (preferably without silicone). If you make your shampoo after applying minoxidil, respect a period of 4 hours after it.
If you apply minoxidil after the shampoo, 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 perms or coloring care, but it is best 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.
D / 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.