NOTICE
ANSM - Updated: 08/20/2018
Name of the drug
ALOSTIL 5%, foam for skin application in a pressurized bottle
Minoxidil
Framed
Read all of this leaflet carefully before you use this medicine because it contains important information for your treatment.
Always use this medicine as described in this leaflet, or as your doctor or pharmacist has recommended.
· 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 undesirable effects which 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 after 4 months.
What does this booklet contain ?
1. What is ALOSTIL 5%, foam for skin application in a pressurized bottle and in which cases is it used?
2. What information should be known before using ALOSTIL 5%, foam for skin application in a pressurized bottle?
3. How to use ALOSTIL 5%, foam for skin application in a pressurized bottle?
4. What are the possible side effects?
5. How to store ALOSTIL 5%, foam for skin application in a pressurized bottle?
6. Contents of the pack and other information.
1. WHAT IS ALOSTIL 5%, foam for skin application in a pressurized bottle AND WHAT CASES IS IT USED FOR?
Pharmacotherapeutic group: other dermatological drugs, ATC code: D11AX01 .
This medication is indicated for moderate hair loss (androgenetic alopecia) in males. It is intended for use exclusively on the scalp.
ALOSTIL 5%, foam for skin application contains minoxidil.
Minoxidil allows hair regrowth and stabilization of hair loss in men with baldness of the temporal gulfs and a slight tonsure at the top of the head, by revitalizing the hair follicles.
2. WHAT YOU NEED TO KNOW BEFORE USING ALOSTIL 5%, foam for skin application in a pressurized bottle?
Never use ALOSTIL 5%, foam for skin application in a pressurized bottle:
· if you are allergic to minoxidil or any of the other ingredients of this medication mentioned in section 6.
Warnings and Precautions
Talk to your doctor or pharmacist before using ALOSTIL 5%, foam for skin application in a pressurized bottle.
Ask your doctor or pharmacist for advice before using ALOSTIL, if you suffer from heart disease including abnormal rhythm or heart rate, angina or chest pain and / or circulatory problems.
When minoxidil passes into the bloodstream, it can cause side effects related to low blood pressure such as chest pain, rapid heartbeat, lightheadedness, dizziness, sudden and unexplained weight gain, or swelling of the hands and feet. It can also cause persistent redness or irritation of the scalp. If you notice any of these side effects, stop using the product and notify your doctor.
A change in hair color and texture has been observed in some patients taking this medicine.
Increased hair loss (old hair falls out as new hair grows) is possible during the first 2-6 weeks of treatment. This indicates that the treatment is working and that new hair is replacing the old. This phenomenon should stop within a few weeks. If hair loss persists, stop using ALOSTIL and talk to your doctor.
Accidental ingestion of the product may cause serious cardiac adverse effects. For this reason, it should be kept out of the sight and reach of children.
If the mousse is accidentally applied to other parts of the body besides the scalp, rinse with plenty of water to prevent unwanted hair growth.
Do not use ALOSTIL 5%, foam for skin application if:
· your alopecia is not characterized by a baldness of the temporal gulfs and a slight tonsure at the top of the skull,
· you do not have a family history of baldness,
· your hair loss is sudden and / or in patches,
· you do not know the reason for your hair loss,
· your scalp is inflamed, infected, irritated, or painful.
This medicine contains butylated hydroxytoluene (E321) and may cause local skin reactions (eg eczema) or irritation of the eyes and mucous membranes.
This medicine contains cetyl alcohol and stearyl alcohol and may cause local skin reactions (eg eczema).
This medicine contains ethanol (alcohol) and may cause burns and / or irritation if accidentally contacted with eyes. If ALOSTIL gets in eyes, mouth, or a cut or lesion on the skin, wash it off with plenty of cold running water.
Special warnings
ALOSTIL 5%, foam for skin application is EXTREMELY FLAMMABLE.
Stay away from fire or flame and do not smoke during or immediately after application.
Children and adolescents
ALOSTIL should not be used in children and adolescents under 18 years of age.
Other hair products and ALOSTIL 5%, foam for skin application
Use of shampoo during treatment
You should use a mild shampoo while you are taking ALOSTIL. Your scalp must be dry before applying ALOSTIL.
Use of styling products during treatment
For best results, ALOSTIL should be allowed time to penetrate the scalp before using any styling product. Apply ALOSTIL first, then use your styling products in the usual way. Do not mix ALOSTIL with any other preparation before applying to the scalp.
Recommendations for coloring or perms
There is no information available regarding the use of stains or perms with ALOSTIL. However, in order to avoid possible scalp irritation, make sure that ALOSTIL has been fully removed from the hair and scalp before using these chemicals.
You should also tell your hairdresser that you are using ALOSTIL.
Other medicines and ALOSTIL 5%, foam for skin application in a pressurized bottle
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
ALOSTIL should not be used in combination with any other medicine applied to the scalp.
ALOSTIL 5%, foam for skin application in a pressurized bottle with food and drink and alcohol
Not applicable.
Pregnancy and breast feeding
ALOSTIL is not intended for use by women.
This drug is not recommended during pregnancy, breastfeeding or during the period of conception.
Driving and using machines
ALOSTIL may cause dizziness or hypotension. If you notice these side effects, do not drive or use machines.
ALOSTIL 5%, foam for skin application in a pressurized bottle contains: ethanol (alcohol), butylated hydroxytoluene (E321), cetyl alcohol and stearyl alcohol
3. HOW TO USE ALOSTIL 5%, foam for skin application in a pressurized bottle?
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor or pharmacist if in doubt.
Dosage
Use this mousse twice a day to achieve and maintain the desired effect on hair growth.
This foam is intended for use on the normal scalp and breast only. It should not be applied to an inflammatory, infected, irritated or painful scalp. NEVER apply it to any other part of the body.
Make sure to apply the mousse directly to the scalp.
Avoid all contact with eyes. If the foam gets in your eyes, rinse them immediately with plenty of cold running water.
Administration mode
Apply to perfectly dry hair and scalp.
Apply a dose of 1 g (equivalent to the volume of half a capful) to the area of hair loss twice a day.
1. To open the container, place the arrow on the ring opposite the one on the cap. Remove the cap (Figure 1).
2. The foam may melt on contact with hot skin. If your fingers are hot, rinse them with cold water first. Dry them thoroughly before handling the foam.
3. Hold the bottle upside down and press the button to deposit the foam on your fingertips (Figure 2). The total amount of foam applied should not exceed 1 g (equivalent to the volume of half a capful).
4. Using your fingers, massage the foam lightly onto the affected areas of the scalp (Figure 3), then wash your hands immediately after applying the foam.
5. After each use, close the container by pushing the stopper to snap it onto the bottle.
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figure 1 | figure 2 | figure 3 |
Frequency of administration
1 application twice a day.
Duration of treatment
Hair regrowth takes time. Results may appear after 2 months of twice daily use. For some men, it may take at least 4 months of application before results are visible.
What can be expected while using ALOSTIL?
During the first months of using this mousse, some users observe an increase in hair loss during the first few months of application. This may indicate that ALOSTIL is working. This temporary increase in hair loss usually occurs between 2 and 6 weeks after starting treatment and then disappears.
If hair loss persists after 6 weeks, see your doctor.
The hair is generally soft, fluffy, colorless. Over time, new hair will normally be the same color and thickness as other hair. As hair growth is slow, ALOSTIL takes time to act.
Results may appear within 2 to 4 months of twice daily use.
If the hair does not grow back after 4 months, stop using ALOSTIL.
The extent of hair regrowth varies among users. This product does not work for all men
Continued use is needed to increase and maintain hair regrowth, otherwise hair loss will start again.
If you have used more ALOSTIL 5%, foam for skin application in a pressurized bottle than you should
Observe the instructions for use.
Do not use more than 2 g (the equivalent of the volume of a capful) per day and do not apply the product more than twice per day. Your hair will not grow back any faster and the effect will not be better if you use it more often.
If a child takes ALOSTIL, take it to the hospital immediately (with the ALOSTIL vial if possible, so the doctor can get an idea of how much the child has ingested).
If you forget to use ALOSTIL 5%, foam for skin application in a pressurized bottle
Don't worry if you miss an application or two, just keep using the product as if you haven't missed a dose.
Do not apply a double amount of ALOSTIL to your scalp if you have missed an application, excessive use may cause hypotension, rapid heartbeat, and drowsiness or fatigue.
If you stop using ALOSTIL 5%, foam for skin application in a pressurized bottle
If you stop using the mousse, the regrown hair may fall out and your scalp will likely return to its original condition within 3 to 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.
Stop using the foam and tell your doctor immediately if you notice any of the following symptoms, as you may need urgent medical treatment:
· Swelling of the hands or feet, (uncommon),
· 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),
· Persistent redness, rash or irritation of the scalp (frequency not known),
· Malaise with feeling of imminent loss of consciousness or dizziness (uncommon),
· Fast heartbeat or irregular heartbeat (rare),
· Chest pain (rare),
· Arterial hypotension (frequency not known),
· Sudden and unexplained weight gain (common).
Other possible side effects:
Common (less than 1 in 10 patients):
· Headache,
· Itching or rash,
· Shortness of breath or difficulty in breathing
· Excessive growth of hair and hair.
Uncommon (less than 1 in 100 patients):
· Nausea.
Other possible side effects, the frequency of which is not known:
· Eye irritation,
· Vomiting,
· Temporary hair loss,
· Modification of hair color and / or texture,
· Reactions at the application site including itching, irritation, pain, rash, swelling, dry skin and redness of the scalp, ears or face, but which can sometimes be more severe and include peeling, eczema, appearance of blisters, bleeding and ulceration.
Reporting of side effects
If you get any side effects, talk to <,> . This also applies to any undesirable effects which 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.ansm.sante.fr
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE ALOSTIL 5%, foam for skin application in a pressurized bottle?
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 bottle. The expiration date refers to the last day of that month.
Dangerous extremely flammable aerosol.
Pressurized container: may burst if heated. Keep away from heat, hot surfaces, sparks, open flames and other sources of combustion. No smoking. Do not spray on an open flame or any other source of combustion. Do not puncture or burn, even after use. Protect from sunlight and keep the aerosol in its outer packaging. Do not expose to a temperature exceeding 50 ° C.
Exposure to ignition sources should be avoided when disposing of the container and its contents.
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, foam for skin application in a pressurized bottle
· The active substance is:
minoxidil ................................................. .................................................. ....................... 50 mg
For 1g of foam for skin application.
· The other ingredients are:
Anhydrous ethanol, purified water, butylhydroxytoluene (E321 ) , lactic acid, anhydrous citric acid, glycerol, cetyl alcohol, stearyl alcohol, polysorbate 60 and propane / butane / isobutane (propellant).
What is ALOSTIL 5%, foam for skin application in a pressurized bottle and contents of the outer packaging
This medication is in the form of a foam for skin application in a pressurized bottle with a child-resistant polypropylene cap . The foam is white to yellowish and unscented. This medication is packaged in an aerosol bottle containing 60 g of foam (corresponding to 73 ml). The bottle contains a quantity of product sufficient for one month of treatment. Box of 1 or 3 pressurized bottles.
Not all presentations may be marketed.
Marketing authorization holder
JOHNSON & JOHNON SANTE BEAUTE FRANCE
1 RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Marketing authorization operator
JOHNSON & JOHNON SANTE BEAUTE FRANCE
1 RUE CAMILLE DESMOULINS
92130 ISSY-LES-MOULINEAUX
Maker
JANSSEN CILAG
MAIGREMONT DOMAIN
27100 VAL DE REUIL
OR
JOHNSON & JOHNSON CONSUMER NV / SA
ANTWERPSEWEG 15-17
B-2340 BEERSE
BELGIUM
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:
[to be completed later by the holder]
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 tips:
Normally the hair has a lifespan of 3 to 6 years and 50 to 100 hairs fall out 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 gradually 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 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.