NOTICE
ANSM - Updated on: 08/09/2019
Name of the drug
ALOSTIL 5%, solution for skin application
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 carefully 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 of the 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.
Keep this medicine out of the reach of children.
What does this booklet contain ?
1. What is ALOSTIL 5%, solution for skin application and in which cases is it used?
2. What information should I know before using ALOSTIL 5%, solution for skin application?
3. How to use ALOSTIL 5%, solution for skin application?
4. What are the possible side effects?
5. How to store ALOSTIL 5%, solution for skin application?
6. Contents of the pack and other information.
1. WHAT IS ALOSTIL 5%, solution for skin application AND WHAT IT IS USED FOR?
Pharmacotherapeutic group: MINOXIDIL FOR LOCAL USE (D: dermatological drugs). ATC code: D11AX01
This medication is indicated for moderate hair loss (androgenetic alopecia) in males.
2. WHAT YOU NEED TO KNOW BEFORE USING ALOSTIL 5%, solution for skin application?
Never use ALOSTIL 5%, solution for skin application:
· If you are allergic to minoxidil or any of the other ingredients of this medicine, listed in section 6,
· If you have scalp lesions,
· If you are intolerant of the 2% form,
· If you are under 18 or over 65,
· In case of any alopecia (hair loss) of the woman.
Warnings and Precautions
Talk to your doctor or pharmacist before using ALOSTIL 5%, solution for skin application.
In case of even old heart diseases, it is necessary to consult a doctor before the first use of minoxidil. |
Do not apply minoxidil:
o in the event of hair loss occurring in a patchy and / or sudden manner, of hair loss following an illness, a drug treatment, or if the reason for the hair loss is not known. DO NOT USE THIS MEDICINE AND TAKE THE ADVICE OF YOUR DOCTOR. Indeed, minoxidil would not be effective on this type of hair loss ( see Health Education Council ),
o on another part of the body.
It is important to respect the recommended dosage and mode of administration:
o do not increase the dose per application, do not increase the frequency of applications,
o Only apply minoxidil to a healthy scalp. Avoid this application in case of irritation, persistent redness, inflammation, painful sensation of the scalp,
o 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 subjects with lesions of the scalp, an increase in the passage of the active substance into the blood is possible ( see Never use ALOSTIL 5%, solution for skin application ).
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 cause undesirable effects such as chest pain, drop in blood pressure, tachycardia (acceleration heart rate), dizziness or lightheadedness, sudden and unexplained weight gain, swelling of the hands and feet. If these symptoms appear, if they worsen or if new symptoms appear: stop the treatment and consult your doctor.
This medicine contains 520 mg of propylene glycol per dose.
· Stop treatment and see your doctor if you experience redness or persistent irritation of the scalp.
· Do not swallow. Do not inhale.
· Keep this medicine out of the reach of children.
· Tell your doctor if you have heart problems.
· 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.
· A change in hair color and / or texture has been observed in a few patients.
· Sun exposure is not recommended in the event of application of minoxidil: protection is necessary (hat).
If in doubt, do not hesitate to seek the advice of your doctor or pharmacist.
Children and adolescents
Not applicable.
Other medicines and ALOSTIL 5%, solution for skin application
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Minoxidil should not be used at the same time as other medicines (especially corticosteroids, tretinoin, anthralin) on the scalp.
ALOSTIL 5%, solution for skin application with food and drink
Not applicable.
Pregnancy and breast feeding
This drug is contraindicated in women.
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
Minoxidil may cause dizziness or hypotension (see section 4 “POSSIBLE SIDE EFFECTS?”) . If patients have such disorders, they should not drive or use machines.
ALOSTIL 5%, solution for skin application contains propylene glycol.
3. HOW TO USE ALOSTIL 5%, solution for skin application?
Always use this medicine exactly as it has been told in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
Reserved for adults.
Dosage
Apply 2 times a day (once in the morning and once in the evening) a dose of 1 ml on the bald area of the scalp, starting from the center of the area to be treated.
This dose must be observed regardless of the size of the affected area.
The total daily dose should not exceed 2 ml.
Spread the product with your fingertips so as to cover the entire area to be treated.
Wash hands thoroughly after use.
Do not apply the product to another part of the body.
Administration mode
Dermal.
Apply to perfectly dry hair and scalp.
The method of application varies depending on the delivery system used with the vial:
Sprayer
This system is suitable for the treatment of large areas of the scalp.
1. Remove the outer cap from the vial.
2. Unscrew and remove the inner cap fitted with a child lock.
3. Insert the sprayer into the bottle, screw it on firmly and remove the small transparent cap.
4. Direct the sprayer towards the center of the surface to be treated, squeeze once and spread the product with your fingertips. Repeat the operation 6 times to apply a dose of 1 ml.
Avoid inhaling the product.
After application, remove the sprayer, rinse it and screw the cap fitted with a child safety device back onto the bottle.
Sprayer with applicator
This system is suitable for treating small areas or under the hair.
1. Remove the outer cap from the vial.
2. Unscrew and remove the inner cap fitted with a child lock.
3. Insert the sprayer into the bottle, screw it on firmly and remove the small transparent cap.
4. Pull firmly upward to remove the “head” (marked with an arrow) from the sprayer.
5. Insert the applicator onto the sprayer rod (now headless) and push in all the way. Finally remove the small cap (transparent plastic) from the end of the applicator.
6. Aim the sprayer at the center of the surface to be treated or under the hair, squeeze once and spread the solution with your fingertips. Repeat this six times, to apply the required dose of 1 ml.
Avoid inhaling the product.
After application, remove the sprayer and the applicator, rinse them and screw the cap fitted with a child safety back onto the bottle.
Frequency of administration
1 application twice a day, morning and evening.
Duration of the treatment
A treatment lasting 2 months at a rate of 2 applications per day may be necessary before any stimulation of hair growth is demonstrated.
The onset and degree of response vary depending on the subject.
Do not stop the applications at the risk of returning to the previous state after a delay of 3 or 4 months. Stop using ALOSTIL if there is no improvement after 4 months of use.
Increasing the dose or frequency of application will not lead to improved results.
If you have used more ALOSTIL 5%, solution for skin application than you should
Immediately consult your doctor or pharmacist.
Accidental ingestion may cause effects due to the cardiovascular action of minoxidil.
Keep out of the reach of children. If swallowed, contact a doctor or emergency medical service immediately.
If you forget to use ALOSTIL 5%, solution for skin application
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 ALOSTIL 5%, solution for skin application
When treatment is stopped, regrowth stops and a return to the initial state can be expected within 3 or 4 months.
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?
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 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)
Other possible side effects:
- Local irritation may occur with flaking (removal of dead skin cells), itching, erythema (redness of the skin), dry skin, acne, blistering, bleeding, ulceration, burning sensation, pain and hypertrichosis (abnormal development of the hair system away from the point of application) or more rarely allergic reactions. Breathing difficulties have also been reported. You must tell your doctor.
- In rare cases, low blood pressure, rapid pulse, palpitations, hair loss, uneven hair, change in hair color and / or texture, pain may occur chest, hepatitis or kidney stones: immediately stop treatment and tell your doctor.
- More rarely other reactions have been described, such as allergy (rhinitis, skin rashes, generalized redness), dizziness, tingling, headache, weakness, edema (infiltration of fluid into the tissues ), altered taste, ear infection, blurred vision, eye irritation, neuritis (nerve damage), nausea, vomiting.
- However, it should be noted that these effects, in particular those which have been most rarely reported, have been without it being possible to formally establish that they were caused by the treatment.
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 Medicines and Health Products Safety (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 ALOSTIL 5%, solution for skin application?
Keep this medication out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiration date refers to the last day of that month.
· Flammable product.
· This medication should be stored at a temperature below 25 ° C.
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 ALOSTIL 5% contains, solution for skin application
· The active substance is:
minoxidil ................................................. .................................................. .......................... 5 g
For 100 ml of solution for skin application
· The other ingredients are:
Propylene glycol, 96 percent ethanol, purified water
What is ALOSTIL 5%, solution for skin application and contents of the outer packaging
This medication is in the form of a solution for skin application in a vial. Box of 1 or 3.
Not all presentations may be marketed.
Marketing authorization holder
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Marketing authorization operator
JOHNSON & JOHNSON SANTE BEAUTE FRANCE
1, RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Maker
JANSSEN CILAG
MAIGREMONT DOMAIN
27100 VAL DE REUIL
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]
{MM / YYYY}
Other
Detailed information on this medication is available on the ANSM website (France).
Health education tips:
a) What is androgenetic alopecia?
Normally the hair has a lifespan of 3 to 6 years and 50 to 100 hairs fall per day.
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 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) 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, etc.) 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 males?
Androgenetic alopecia begins with a 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 progressively evolves into baldness.
c) Some tips 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 preferably in a warm position after applying minoxidil.
· 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 a normal phenomenon, continue the 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.